Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
Phase: NA
Conditions: Traumatic Brain Injury
Sponsor: Virginia Commonwealth University

Title: Intervention to Promote Survivor Resilience and Adjustment: Efficacy 
and Sustainability 
VCU IRB Protocol Number: HM20011840 
 
NCT03421964 
 
 
The original grant was submitted to the IRB 11/15/2017 but the final version 
of the IRB approval for the study was 1/17/2018.  When this study was 
initially reviewed by the Virginia Commonwealth University IRB, a separate 
protocol with the statistical analysis was not required.  It is now.  Sadly, this 
is the only way I can provide both documents.   

Descriptive Title:
Traumatic Brain Injury Model Systems
Submission Title: Traumatic Brain Injury Model System
Opportunity ID:
HHS-2017-ACL-NIDILRR-DPTB-0204
Opportunity Title: Disability and Rehabilitation Research Projects (DRRP) Program: 
Traumatic Brain Injury (TBI) Model System Centers Program
Agency Name:
Administration for Community Living

Table of Contents
Application For Federal Assistance (SF-424) V2.1..........................................................................3
Research & Related Project/Performance Site Location(s) V2.0.....................................................6
Budget Information for Non-Construction Programs (SF-424A) V1.0..............................................7
Assurances for Non-Construction Programs (SF-424B) V1.1 .......................................................11
Grants.gov Lobbying Form V1.1....................................................................................................13
Dept of Education Supplemental Information for SF-424 V1.3......................................................14
Attachments V1.1...........................................................................................................................24
Budget Narrative Attachment Form V1.1.....................................................................................202
Project Narrative Attachment Form V1.1 .....................................................................................236
Project Abstract Summary V1.1...................................................................................................312

OMB Number: 4040-0004
Expiration Date: 10/31/2019
Application for Federal Assistance SF-424
*1. Type of Submission:
*2. Type of Application
*If Revision, select appropriate letter(s):
 [  ] 
Pre-application
[X] 
New
 [X] 
Application
[  ] 
Continuation
*Other (Specify):
 [  ] 
Changed/Corrected Application
 [  ]
Revision
*3. Date Received:
4. Applicant Identifier:
5.a. Federal Entity Identifier:
5.b. Federal Award Identifier:
State Use Only:
6. Date Received by State: 
7. State Application Identifier: 
8. APPLICANT INFORMATION:
*a. Legal Name: Virginia Commonwealth University
*b. Employer/Taxpayer Identification Number (EIN/TIN):
*c. Organizational DUNS:
1546001758A1
1053004460000
d. Address:
*Street 1:
800 East Leigh St, Suite 3200
*Street 2:
PO Box 980568
* City:
Richmond
* County:
* State:
VA: Virginia
* Province:
* Country: 
USA: UNITED STATES
* Zip/Postal Code:
23298-0568
e. Organizational Unit:
Department Name:
Division Name:
f. Name and contact information of person to be contacted on matters involving this application:
* Prefix:
* First Name: 
Jeffrey
* Middle Name:
S
* Last Name:
Kreutzer
* Suffix:
Title: Professor and Eminent Scholar
Organizational Affiliation:
* Telephone Number: 8048286772
Fax Number: 8048282521
* Email: dirospa@vcu.edu

OMB Number: 4040-0004
Expiration Date: 10/31/2019
Application for Federal Assistance SF-424
Version 02
9. Type of Applicant 1: Select Applicant Type:
H: Public/State Controlled Institution of Higher Education
Type of Applicant 2: Select Applicant Type:
Type of Applicant 3: Select Applicant Type:
Other (Specify):
* 10. Name of Federal Agency:
Administration for Community Living
11. Catalog of Federal Domestic Assistance Number:
93.433
CFDA Title:
ACL National Institute on Disability, Independent Living, and Rehabilitation Research
* 12. Funding Opportunity Number: 
HHS-2017-ACL-NIDILRR-DPTB-0204
* Title: 
Disability and Rehabilitation Research Projects (DRRP) Program: Traumatic Brain Injury (TBI) Model System Centers Program
13. Competition Identification Number:
HHS-2017-ACL-NIDILRR-DPTB-0204
Title:
Disability and Rehabilitation Research Projects (DRRP) Program: Traumatic Brain Injury (TBI) Model System Centers Program
14. Areas Affected by Project (Cities, Counties, States, etc.):
15. Descriptive Title of Applicant’s Project:
Traumatic Brain Injury Model Systems
Attach supporting documents as specified in agency instructions.

OMB Number: 4040-0004
Expiration Date: 10/31/2019
Application for Federal Assistance SF-424
Version 02
16. Congressional Districts of:
* Applicant: VA-003
* Program/Project: VA-003
Attach an additional list of Program/Project Congressional Districts if needed.
17. Proposed Project: 
* a. Start Date: 10/1/2017 4:00:00 AM
* b. End Date: 9/30/2022 4:00:00 AM
18. Estimated Funding ($):
* a. Federal
$2,324,745.00
* b. Applicant
$914,932.00
* c. State
$0.00
* d. Local
$0.00
* e. Other
$0.00
* f. Program Income
$0.00
* g. TOTAL
$3,239,677.00
* 19. Is Application Subject to Review By State Under Executive Order 12372 Process?
 [  ]
a. This application was made available to the State under the Executive Order 12372 Process for review 
on 
 [  ]
b. Program is subject to E.O. 12372 but has not been selected by the State for review.
 [X]
c. Program is not covered by E.O. 12372.
* 20. Is the Applicant Delinquent On Any Federal Debt? (If “Yes”, provide explanation.)
 [  ]  Yes
 [X]  No
If “Yes”, provide explanation and attach
21. *By signing this application, I certify (1) to the statements contained in the list of certifications** and (2) that the 
statements herein are true, complete and accurate to the best of my knowledge. I also provide the required assurances** and 
agree to comply with any resulting terms if I accept an award. I am aware that any false, fictitious, or fraudulent statements or 
claims may subject me to criminal, civil, or administrative penalties. (U.S. Code, Title 218, Section 1001)
 [X]  ** I AGREE
** The list of certifications and assurances, or an internet site where you may obtain this list, is contained in the announcement or agency 
specific instructions.
Authorized Representative: 
Prefix:
* First Name:
Andrea
Middle Name:
J
* Last Name:
Publow
Suffix:
* Title: Dir, OSP - Gov
* Telephone Number: 8048286772
Fax Number: 8048282521
* Email: dirospa@vcu.edu
* Signature of Authorized Representative: 
* Date Signed: 

OMB Number: 4040-0010
Expiration Date: 10/31/2019
Project/Performance Site Location(s)
Project/Performance Site Primary Location
[  ] I am submitting an application as an individual, and not on behalf of a company, state, 
local or tribal government, academia, or other type of organization.
Organization Name:  
Virginia Commonwealth University
DUNS Number:
1053004460000
Street 1:
800 East Leigh St, Suite 3200
Street 2:
PO Box 980568
City:
Richmond
County:
State:
VA: Virginia
Province:
Country:
USA: UNITED STATES
ZIP / Postal Code:
23298-0568
Project/Performance Site Congressional District:
VA-003
Additional Location(s):  

BUDGET INFORMATION – Non-Construction Programs
OMB Number: 4040-0006
Expiration Date: 07/30/2010
SECTION A – BUDGET SUMMARY
Estimated Unobligated Funds
New or Revised Budget
Grant Program
Function or
Activity
(a)
Catalog of Federal
Domestic Assistance
Number
(b)
Federal
(c)
Non-Federal
(d)
Federal
(e)
Non-Federal
(f)
Total
(g)
1.
DRRP
93.433
$2,324,745.00
$2,324,745.00
2.
DRRP
$914,932.00
$914,932.00
3.
$0.00
4.
$0.00
5.
Totals
$0.00
$0.00
$2,324,745.00
$914,932.00
$3,239,677.00

SECTION B – BUDGET CATEGORIES
GRANT PROGRAM, FUNCTION OR ACTIVITY
6. Object Class Categories
(1)
DRRP
(2)
DRRP
(3)
(4)
Total
(5)
a. Personnel
$234,776.00
$133,372.00
$368,148.00
b. Fringe Benefits
$87,335.00
$49,614.00
$136,949.00
c. Travel
$5,000.00
$5,000.00
d. Equipment
$0.00
e. Supplies
$2,220.00
$2,220.00
f. Contractual
$0.00
g. Construction
$0.00
h. Other
$22,903.00
$22,903.00
i. Total Direct Charges (sum of 6a-6h)
$352,234.00
$182,986.00
$0.00
$0.00
$535,220.00
j. Indirect Charges
$112,715.00
$112,715.00
k. TOTALS (sum of 6i and 6j)
$464,949.00
$182,986.00
$0.00
$0.00
$647,935.00
7. Program Income
$0.00

SECTION C - NON-FEDERAL RESOURCES
(a) Grant Program
(b) Applicant
(c) State
(d) Other Sources
(e)TOTALS
8.
DRRP
$0.00
9.
DRRP
$914,932.00
$914,932.00
10.
$0.00
11.
$0.00
12. TOTAL (sum of lines 8-11)
$914,932.00
$0.00
$0.00
$914,932.00
SECTION D - FORECASTED CASH NEEDS
Total for 1st Year
1st Quarter
2nd Quarter
3rd Quarter
4th Quarter
13. Federal
$464,948.00
$116,237.00
$116,237.00
$116,237.00
$116,237.00
14. Non-Federal
$182,984.00
$45,746.00
$45,746.00
$45,746.00
$45,746.00
15. TOTAL (sum of lines 13 and 14)
$647,932.00
$161,983.00
$161,983.00
$161,983.00
$161,983.00
SECTION E - BUDGET ESTIMATES OF FEDERAL FUNDS NEEDED FOR BALANCE OF THE PROJECT
FUTURE FUNDING PERIODS (YEARS)
(a) Grant Program
(b)First
(c) Second
(d) Third
(e) Fourth
16. DRRP
$464,949.00
$464,949.00
$464,949.00
$464,949.00
17. DRRP
18.
19.
20. TOTAL (sum of lines 16 - 19)
$464,949.00
$464,949.00
$464,949.00
$464,949.00

SECTION F - OTHER BUDGET INFORMATION
21. Direct Charges: $1,761,170
22. Indirect Charges: $563,575
23. Remarks: 

OMB Approval No.:  4040-0007
Expiration Date: 07/30/2010
ASSURANCES - NON-CONSTRUCTION PROGRAMS
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for reviewing 
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of 
information. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions 
for reducing this burden, to the Office of Management and Budget, Paperwork Reduction Project (0348-0040), Washington, DC 20503.
PLEASE DO NOT RETURN YOUR COMPLETED FORM TO THE OFFICE OF MANAGEMENT AND BUDGET. SEND 
IT TO THE ADDRESS PROVIDED BY THE SPONSORING AGENCY.
NOTE:
Certain of these assurances may not be applicable to your project or program. If you have questions, please contact the
awarding agency. Further, certain Federal awarding agencies may require applicants to certify to additional assurances.
If such is the case, you will be notified.
As the duly authorized representative of the applicant, I certify that the applicant:
1.
Has the legal authority to apply for Federal 
assistance and the institutional, managerial and 
financial capability (including funds sufficient to pay 
the non-Federal share of project cost) to ensure 
proper planning, management and completion of the 
project described in this application.
2.
Will give the awarding agency, the Comptroller 
General of the United States and, if appropriate, the 
State, through any authorized representative, access 
to and the right to examine all records, books, 
papers, or documents related to the award; and will 
establish a proper accounting system in accordance 
with generally accepted counting standards or 
agency directives.
3.
Will establish safeguards to prohibit employees from 
using their positions for a purpose that constitutes or 
presents the appearance of personal or 
organizational conflict of interest, or personal gain.
4.
Will initiate and complete the work within the 
applicable time frame after receipt of approval of the 
awarding agency.
5.
Will comply with the Intergovernmental Personnel 
Act of 1970 (42 U.S.C. §§4728-4763) relating to 
prescribed standards for merit systems for programs 
funded under one of the 19 statutes or regulations 
specified in Appendix A of OPM's Standards for a 
Merit System of Personnel Administration (5 C.F.R. 
900, Subpart F).
6.
Will comply with all Federal statutes relating to 
nondiscrimination. These include but are not limited 
to: (a) Title VI of the Civil Rights Act of 1964  P.L. 88-
352) which prohibits discrimination on the basis of 
race, color or national origin; (b) Title IX of the 
Education Amendments of 1972, as amended (20 
U.S.C.§§1681-1683,  and 1685-1686), which 
prohibits discrimination on the basis of sex; (c) 
Section 504 of the Rehabilitation 
Act of 1973, as amended (29 U.S.C. §794), which 
prohibits discrimination on the basis of handicaps; (d) 
the Age Discrimination Act of 1975, as amended (42 
U.S.C. §§6101-6107), which prohibits discrimination 
on the basis of age; (e) the Drug Abuse Office and 
Treatment Act of 1972 (P.L. 92-255), as amended, 
relating to nondiscrimination on the basis of drug 
abuse; (f) the Comprehensive Alcohol Abuse and 
Alcoholism Prevention, Treatment and Rehabilitation 
Act of 1970 (P.L. 91-616), as amended,  relating to 
nondiscrimination on the basis of alcohol abuse or 
alcoholism; (g) §§523 and 527 of the Public Health 
Service Act of 1912 (42 U.S.C. §§290 dd-3 and 290 
ee- 3), as amended, relating to confidentiality of 
alcohol and drug abuse patient records; (h) Title VIII 
of the Civil Rights Act of 1968 (42 U.S.C. §§3601 et 
seq.), as amended, relating to nondiscrimination in 
the sale, rental or financing of housing; (i) any other 
nondiscrimination provisions in the specific statute(s) 
under which application for Federal assistance is 
being made; and, (j) the requirements of any other 
nondiscrimination statute(s) which may apply to the 
application.
7.
Will comply, or has already complied, with the 
requirements of Titles II and III of the Uniform 
Relocation Assistance and Real Property Acquisition 
Policies Act of 1970 (P.L. 91-646) which provide for 
fair and equitable treatment of persons displaced or 
whose property is acquired as a result of Federal or 
federally-assisted programs. These requirements 
apply to all interests in real property acquired for 
project purposes regardless of Federal participation 
in purchases.
8.
Will comply, as applicable, with provisions of the 
Hatch Act (5 U.S.C. §§1501-1508 and 7324-7328) 
which limit the political activities of employees whose 
principal employment activities are funded in whole 
or in part with Federal funds.
Previous Edition Usable
Standard Form 424B (Rev. 7-97)
Authorized for Local Reproduction
Prescribed by OMB Circular A-102

9.
Will comply, as applicable, with the provisions of the 
Davis-Bacon Act (40 U.S.C. §§276a to 276a-7), the 
Copeland Act (40 U.S.C. §276c and 18 U.S.C. §874), and 
the Contract Work Hours and Safety Standards Act (40 
U.S.C. §§327-333), regarding labor standards for 
federally-assisted construction subagreements. 
10.
Will comply, if applicable, with flood insurance purchase 
requirements of Section 102(a) of the Flood Disaster 
Protection Act of 1973 (P.L. 93-234) which requires recipients 
in a special flood hazard area to participate in the program and 
to purchase flood insurance if the total cost of insurable 
construction and acquisition is $10,000 or more. 
11.
Will comply with environmental standards which may be 
prescribed pursuant to the following: (a) institution of 
environmental quality control measures under the National 
Environmental Policy Act of 1969 (P.L. 91-190) and 
Executive Order (EO) 11514; (b) notification of violating 
facilities pursuant to EO 11738; (c) protection of wetlands 
pursuant to EO 11990; (d) evaluation of flood hazards in 
floodplains in accordance with EO 11988; (e) assurance 
of project consistency with the approved State 
management program developed under the Coastal Zone 
Management Act of 1972 (16 U.S.C. §§1451 et seq.); (f) 
conformity of Federal actions to State (Clean Air) 
Implementation Plans under Section 176(c) of the Clean 
Air Act of 1955, as amended (42 U.S.C. §§7401 et seq.); 
(g) protection of underground sources of drinking water 
under the Safe Drinking Water Act of 1974, as amended 
(P.L. 93-523); and, (h) protection of endangered species 
under the Endangered Species Act of 1973, as amended 
(P.L. 93-205). 
12.
Will comply with the Wild and Scenic Rivers Act of 
1968 (16 U.S.C. §§1271 et seq.) related to protecting 
components or potential components of the national 
wild and scenic rivers system. 
13.
Will assist the awarding agency in assuring compliance 
with Section 106 of the National Historic Preservation 
Act of 1966, as amended (16 U.S.C. §470), EO 11593 
(identification and protection of historic properties), and 
the Archaeological and Historic Preservation Act of 
1974 (16 U.S.C. §§469a-1 et seq.). 
14.
Will comply with P.L. 93-348 regarding the protection of 
human subjects involved in research, development, and 
related activities supported by this award of assistance. 
15.
Will comply with the Laboratory Animal Welfare Act of 
1966 (P.L. 89-544, as amended, 7 U.S.C. §§2131 et 
seq.) pertaining to the care, handling, and treatment of 
warm blooded animals held for research, teaching, or 
other activities supported by this award of assistance. 
16.
Will comply with the Lead-Based Paint Poisoning 
Prevention Act (42 U.S.C. §§4801 et seq.) which 
prohibits the use of lead-based paint in construction 
or rehabilitation of residence structures. 
17.
Will cause to be performed the required financial and 
compliance audits in accordance with the Single Audit 
Act Amendments of 1996 and OMB Circular No. A-133, 
"Audits of States, Local Governments, and Non-Profit 
Organizations." 
18. Will comply with all applicable requirements of all other 
Federal laws, executive orders, regulations, and policies 
governing this program. 
* SIGNATURE OF AUTHORIZED CERTIFYING OFFICIAL
* TITLE
Completed  on  submission  to  Grants.gov
Dir, OSP - Gov
* APPLICANT ORGANIZATION
* DATE SUBMITTED
Virginia Commonwealth University
Completed  on  submission  to  Grants.gov
Standard Form 424B (Rev. 7-97) Back

                                           CERTIFICATE REGARDING LOBBYING
Certification for Contracts, Grants, Loans, and Cooperative Agreements
The undersigned certifies, to the best of his or her knowledge and belief, that:
(1) No Federal appropriated funds have been paid or will be paid, by or on behalf of the undersigned, to any
person for influencing or attempting to influence an officer or employee of an agency, a Member of
Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with
the awarding of any Federal contract, the making of any Federal grant, the making of any Federal loan, the
entering into of any cooperative agreement, and the extension, continuation, renewal, amendment, or
modification of any Federal contract, grant, loan, or cooperative agreement.
(2) If any funds other than Federal appropriated funds have been paid or will be paid to any person for
influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an
officer or employee of Congress, or an employee of a Member of Congress in connection with this Federal
contract, grant, loan, or cooperative agreement, the undersigned shall complete and submit Standard
Form-LLL, ''Disclosure of Lobbying Activities,'' in accordance with its instructions.
(3) The undersigned shall require that the language of this certification be included in the award documents
for all subawards at all tiers (including subcontracts, subgrants, and contracts under grants, loans, and
cooperative agreements) and that all subrecipients shall certify and disclose accordingly. This certification
is a material representation of fact upon which reliance was placed when this transaction was made or
entered into. Submission of this certification is a prerequisite for making or entering into this transaction
imposed by section 1352, title 31, U.S. Code. Any person who fails to file the required certification shall be
subject to a civil penalty of not less than $10,00 0 and not more than $100,000 for each such failure.
Statement for Loan Guarantees and Loan Insurance
The undersigned states, to the best of his or her knowledge and belief, that:
If any funds have been paid or will be paid to any person for influencing or attempting to influence an officer
or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of
a Member of Congress in connection with this commitment providing for the United States to insure or
guarantee a loan, the undersigned shall complete and submit Standard Form-LLL, ''Disclosure of Lobbying
Activities,'' in accordance with its instructions. Submission of this statement is a prerequisite for making or
entering into this transaction imposed by section 1352, title 31, U.S. Code. Any person who fails to file the
required statement shall be subject to a civil penalty of not less than $10,000 and not more than $100,000
for each such failure.
* APPLICANT’S ORGANIZATION
Virginia Commonwealth University
* PRINTED NAME AND TITLE OF AUTHORIZED REPRESENTATIVE
  Prefix:                        * First Name:  Andrea                                                           Middle Name:  J                              
  * Last Name:  Publow                                                                                                        Suffix:  
  * Title:  Dir, OSP - Gov
* SIGNATURE:  Andrea.Publow                                                                                         *DATE:  

OMB Number: 1894-0007
Expiration Date: 08/31/2017
U.S. DEPARTMENT OF EDUCATION
SUPPLEMENTAL INFORMATION
FOR THE SF-424
1. Project Director:
Prefix:
First Name:
Middle Name:
Last Name:
Suffix:
Jeffrey
S
Kreutzer
Address:
Street1:
PO Box 980206
Street2:
City:
Richmond
County:
State:
VA: Virginia
Zip Code:
23298-0206
Country:
USA: UNITED STATES
Phone Number (give area code)
Fax Number (give area code)
8043271166
Email Address:
jeffrey.kreutzer@vcuhealth.org
2. Applicant Experience:
Are you a novice applicant as defined in the regulations in 34 CFR 75.225 (and included in the definitions page in the 
attached instructions)?
[  ]  Yes
[X]  No
[  ]  Not applicable to this program
3. Human Subjects Research
a. Are any research activities involving human subjects planned at any time during the proposed project Period?
[X]  Yes
[  ]  No
b. Are ALL the research activities proposed designated to be exempt from the regulations?
[  ]  Yes
Provide Exemption(s) #:
[  ] 1    [  ] 2    [  ] 3    [  ] 4    [  ] 5    [  ] 6
[X]  No
Provide Assurance #, if available:
FWA0005287
c. If applicable, please attach your "Exempt Research" or "Nonexempt Research" narrative to this form as indicated in the 
definitions page in the attached instructions.
Nonexempt Research Narrative.pdf

VCU TBIMS Proposal 
Nonexempt Research Narrative 
 
1
HUMAN SUBJECTS NONEXEMPT RESEARCH NARRATIVE (FORM 424) 
  
The VCU TBIMS proposal includes data collection from human subjects for three studies: 
1. Data collection for the NIDILRR-funded TBIMS National Database 
2. Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability  
3. Caregiver Resilience: A Longitudinal Investigation  
 
Grouped by individual research project, are responses to each question regarding human subjects 
protection. 
 
1. Data collection for the NIDILRR-funded TBIMS National Database 
(1)  Human Subjects Involvement and Characteristics: Provide a detailed description of the 
proposed involvement of human subjects. Describe the characteristics of the subject population, 
including their anticipated number, age range, and health status. Identify the criteria for inclusion or 
exclusion of any subpopulation. Explain the rationale for the involvement of special classes of 
subjects, such as children, children with disabilities, adults with disabilities, persons with mental 
disabilities, pregnant women, prisoners, institutionalized individuals, or others who are likely to be 
vulnerable. 
Individuals included in this project will be adults (18 years or older) who have experienced a 
traumatic brain injury (TBI). We expect to enroll approximately 200 new research participants over 
the course of the grant. TBI often causes physical and mental disabilities. Thus, adults with 
physical and/or mental disabilities will be included. Pregnant women will also be enrolled, as there 
is no indication of additional risk to mother or fetus. Individuals in the following special classes 
will not be studied: children, prisoners, and institutionalized individuals.  
 
(2)  Sources of Materials: Identify the sources of research material obtained from individually living 
human subjects in the form of specimens, records, or data. Indicate whether the material or data will 
be obtained specifically for research purposes or whether use will be made of existing specimens, 
records, or data. 
Research materials will be comprised of data obtained through questionnaires, medical records 
review, interviews, and administration of neuropsychological tests. Information will be obtained 
specifically for the research purposes of the project. 
 
(3)  Recruitment and Informed Consent: Describe plans for the recruitment of subjects and the 
consent procedures to be followed. Include the circumstances under which consent will be sought 
and obtained, who will seek it, the nature of the information to be provided to prospective subjects, 
and the method of documenting consent. State if the Institutional Review Board (IRB) has 

VCU TBIMS Proposal 
Nonexempt Research Narrative 
 
2
authorized a modification or waiver of the elements of consent or the requirement for 
documentation of consent. 
Participants will be solicited from inpatient admissions to the Brain Injury Rehabilitation Unit at 
the Virginia Commonwealth University Health System (VCUHS). Patients will be approached by 
Jennifer Marwitz, M.A. (TBIMS Project Coordinator) or Daniel Klyce, Ph.D. (the Brain Injury 
Rehabilitation Unit’s neuropsychologist). A description of the project will be provided to patients. 
If the patient is interested in participating, Ms. Marwitz or Dr. Klyce will review the nature of the 
research (completion of questionnaires and neuropsychological testing). The consent form will be 
carefully reviewed with the patient and written consent obtained. Ms. Marwitz and Dr. Klyce will 
emphasize that participation is voluntary and the patient’s decision to participate will not affect the 
quality of their medical care.  
In any case where the investigator has concerns about the patient’s ability to provide informed 
consent, formal assessment of decision-making capacity will be made using the MacArthur 
Competence Assessment Tool, Clinical Research version (MacCAT-CR). As allowed under 
Virginia state law, an alternative procedure will be used to consent persons lacking the capacity to 
give informed consent, as determined by the MacCAT-CR, or as judged by the investigators. 
Investigators will seek to obtain consent from a legally designated substitute decision maker. In 
every case, an effort will be made to obtain assent from the patient. Patients who decline to 
participate will not be enrolled regardless of their respective substitute decision maker’s desire.  
The consent form was approved for the 2012-2017 funding cycle of this project by the 
Institutional Review Board (IRB) (VCU internal code CCHR Protocol #00223) through March 31, 
2018. No request has been made to modify or waive any of the elements of consent. 
Documentation of consent is required. 
 
(4) Potential Risks: Describe potential risks (physical, psychological, social, legal, or other) and 
assess their likelihood and seriousness. Where appropriate, describe alternative treatments and 
procedures that might be advantageous to the subjects. 
There are minimal risks (physical, psychological, social, legal, or other) associated with human 
subjects use for this project. Some individuals may experience feelings of sadness or frustration 
when completing the tests. The only inconvenience to research participant will be the time it takes 
to answer the questionnaires and take the tests. Questions of a sensitive nature (e.g., substance 
use/abuse, criminal history) are included; however patients are given the option to omit questions 

VCU TBIMS Proposal 
Nonexempt Research Narrative 
 
3
that they do not wish to answer. 
 
5) Protection Against Risk: Describe the procedures for protecting against or minimizing potential 
risks, including risks to confidentiality, and assess their likely effectiveness. Where appropriate, 
discuss provisions for ensuring necessary medical or professional intervention in the event of 
adverse effects to the subjects. Also, where appropriate, describe the provisions for monitoring the 
data collected to ensure the safety of the subjects. 
This project is directed by a licensed clinical psychologist (Dr. Jeffrey Kreutzer). In the event 
that a patient is found to have significant psychological problems, Dr. Kreutzer will provide 
individual psychotherapy or refer the patient for further psychiatric intervention. Confidentiality of 
information will be guaranteed in the database. No names or social security numbers will be 
included - only identification numbers assigned by the Project Coordinator. The Project 
Coordinator and Research Assistants will keep any contact information for follow-up purposes 
separate from research data collected. 
 
(6) Importance of the Knowledge to be Gained: Discuss the importance of the knowledge gained or 
to be gained as a result of the proposed research. Discuss why the risks to subjects are reasonable in 
relation to the anticipated benefits to subjects and in relation to the importance of the knowledge 
that may reasonably be expected to result. 
The longitudinal National Database is the largest longitudinal database addressing outcomes 
after TBI. Knowledge gained regarding long-term outcomes is important to better serve persons 
with disabilities. There are minimal risks (physical, psychological, social, legal, or other) 
associated with the project. The possibility that some individuals may experience feelings of 
sadness or frustration during testing is outweighed by the potential benefits of the project. The 
VCU TBIMS places an emphasis on providing patients with psychological support and education 
to assist in recovery following TBI. 
 
(7) Collaborating Site(s): If research involving human subjects will take place at collaborating 
site(s) or other performance site(s), name the sites and briefly describe their involvement or role in 
the research. 
Not applicable. 
 
 

VCU TBIMS Proposal 
Nonexempt Research Narrative 
 
4
2.  Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability 
(1)  Human Subjects Involvement and Characteristics: Provide a detailed description of the 
proposed involvement of human subjects. Describe the characteristics of the subject population, 
including their anticipated number, age range, and health status. Identify the criteria for inclusion or 
exclusion of any subpopulation. Explain the rationale for the involvement of special classes of 
subjects, such as children, children with disabilities, adults with disabilities, persons with mental 
disabilities, pregnant women, prisoners, institutionalized individuals, or others who are likely to be 
vulnerable. 
Individuals included in this project will be adults (18 years or older) who have experienced a 
TBI. Participants with any of the following will be excluded from the study: imminent risk of 
psychiatric hospitalization, imminent danger of hurting themselves or others, or active substance 
abuse (e.g., intoxicated at intake), as judged by the investigators.  
The proposed study will evaluate the benefits of the Resilience and Adjustment Intervention for 
improving resilience and emotional well-being after TBI. The study is a two-arm randomized 
controlled trial comparing the benefits of a basic resilience-building intervention (RAI) with an 
expanded, patient-centered resilience intervention (RAI+).  
We expect to enroll approximately 154 participants over the course of the grant. TBI often 
causes physical and mental disabilities. Thus, adults with physical and/or mental disabilities will be 
included. Pregnant women will also be enrolled, as there is no indication of additional risk to 
mother or fetus. Individuals in the following special classes will not be studied: children, prisoners, 
and institutionalized individuals.  
 
(2)  Sources of Materials: Identify the sources of research material obtained from identifiable living 
human subjects in the form of specimens, records, or data. Indicate whether the material or data will 
be obtained specifically for research purposes or whether use will be made of existing specimens, 
records, or data. 
Research materials will be comprised of data obtained through questionnaires, interviews, and 
medical records review. Information will be obtained specifically for the research purposes of the 
project. 
 
(3)  Recruitment and Informed Consent: Describe plans for the recruitment of subjects and the 
consent procedures to be followed. Include the circumstances under which consent will be sought 
and obtained, who will seek it, the nature of the information to be provided to prospective subjects, 
and the method of documenting consent. State if the Institutional Review Board (IRB) has 
authorized a modification or waiver of the elements of consent or the requirement for 
documentation of consent. 

VCU TBIMS Proposal 
Nonexempt Research Narrative 
 
5
Individuals who are referred for outpatient brain injury services will be contacted by Dr. Jeffrey 
Kreutzer (Principal Investigator), Jennifer Marwitz (Project Coordinator), Dr. Ana Mills, or Dr. 
Nancy Hsu (therapists) to determine their eligibility and interest in participation. The details of the 
study will be explained, and the consent form will be carefully reviewed with the eligible 
participant. Written consent will be obtained at the initial intake session. Project staff will 
emphasize that participation is voluntary and the individual’s decision to participate will not affect 
the quality of their medical care.  
In any case where the investigator has concerns about the person’s ability to provide informed 
consent, formal assessment of decision-making capacity will be made using the MacArthur 
Competence Assessment Tool, Clinical Research version (MacCAT-CR).  
As allowed under Virginia state law, an alternative procedure will be used to consent persons 
lacking the capacity to give informed consent, as determined by the MacCAT-CR, or as judged by 
the investigators. Investigators will seek to obtain consent from a legally designated substitute 
decision maker. In every case, an effort will be made to obtain assent from the patient. Patients 
who decline to participate will not be enrolled regardless of their respective substitute decision 
maker’s desire.  
The consent form is currently under review by the Institutional Review Board (IRB). No request 
has been made to modify or waive any of the elements of consent. Documentation of consent is 
required. 
 
(4) Potential Risks: Describe potential risks (physical, psychological, social, legal, or other) and 
assess their likelihood and seriousness. Where appropriate, describe alternative treatments and 
procedures that might be advantageous to the subjects. 
There are minimal risks (physical, psychological, social, legal, or other) associated with human 
subjects use for this project. Some individuals may experience feelings of sadness or frustration 
when answering questions about their current status. Participants will be given the option to omit 
any questions that they do not wish to answer. 
 
5) Protection Against Risk: Describe the procedures for protecting against or minimizing potential 
risks, including risks to confidentiality, and assess their likely effectiveness. Where appropriate, 
discuss provisions for ensuring necessary medical or professional intervention in the event of 
adverse effects to the subjects. Also, where appropriate, describe the provisions for monitoring the 
data collected to ensure the safety of the subjects. 

VCU TBIMS Proposal 
Nonexempt Research Narrative 
 
6
This project is directed by a licensed psychologist (Dr. Kreutzer). Dr. Kreutzer will be on call 
during each assessment and treatment session. He will be responsible for monitoring the status of 
enrolled participants and addressing urgent situations. When concerns arise, Dr. Kreutzer will 
make a clinical decision regarding the need for further evaluation, treatment, or referral.  
Confidentiality of information will be guaranteed in the databases. No names or social security 
numbers will be included - only identification numbers assigned by the Project Coordinator. The 
Project Coordinator, Therapists, and Research Assistants will keep any contact information for 
follow-up purposes separate from research data collected. 
 
(6) Importance of the Knowledge to be Gained: Discuss the importance of the knowledge gained or 
to be gained as a result of the proposed research. Discuss why the risks to subjects are reasonable in 
relation to the anticipated benefits to subjects and in relation to the importance of the knowledge 
that may reasonably be expected to result. 
Empirical investigation of a structured, replicable, outpatient intervention to address resilience 
and emotional adjustment after TBI will guide clinicians serving individuals post-discharge, 
enabling more effective and efficient service delivery. There are minimal risks (physical, 
psychological, social, legal, or other) associated with the project. The possibility that some 
individuals may experience feelings of sadness and frustration during protocol implementation is 
outweighed by the potential benefits of the project. The VCU TBIMS places an emphasis on 
providing patients with psychological support and education to assist in recovery following TBI. 
 
(7) Collaborating Site(s): If research involving human subjects will take place at collaborating 
site(s) or other performance site(s), name the sites and briefly describe their involvement or role in 
the research. 
Not applicable. 
 
 
3.  Caregiver Resilience: A Longitudinal Investigation  
 (1)  Human Subjects Involvement and Characteristics: Provide a detailed description of the 
proposed involvement of human subjects. Describe the characteristics of the subject population, 
including their anticipated number, age range, and health status. Identify the criteria for inclusion or 
exclusion of any subpopulation. Explain the rationale for the involvement of special classes of 
subjects, such as children, children with disabilities, adults with disabilities, persons with mental 
disabilities, pregnant women, prisoners, institutionalized individuals, or others who are likely to be 
vulnerable. 

VCU TBIMS Proposal 
Nonexempt Research Narrative 
 
7
Individuals included in this project will be adults (18 years or older) who are caregivers of a 
TBIMS National Database (NDB) research participant.  We expect to enroll approximately 78 
research participants over the course of the grant. Adults with physical and/or mental disabilities 
will be included. Pregnant women will also be enrolled, as there is no indication of additional risk 
to mother or fetus. Individuals in the following special classes will not be studied: children, 
prisoners, and institutionalized individuals.   
 
(2)  Sources of Materials: Identify the sources of research material obtained from identifiable living 
human subjects in the form of specimens, records, or data. Indicate whether the material or data will 
be obtained specifically for research purposes or whether use will be made of existing specimens, 
records, or data. 
Research materials will be comprised of data obtained through questionnaires and interviews. 
Information will be obtained specifically for the research purposes of the project. 
 
(3)  Recruitment and Informed Consent: Describe plans for the recruitment of subjects and the 
consent procedures to be followed. Include the circumstances under which consent will be sought 
and obtained, who will seek it, the nature of the information to be provided to prospective subjects, 
and the method of documenting consent. State if the Institutional Review Board (IRB) has 
authorized a modification or waiver of the elements of consent or the requirement for 
documentation of consent. 
Newly enrolled TBIMS NDB participants will be contacted after discharge and no more than six 
months postinjury by a research assistant (Marie Grace Martinez or Abigail Welch). NDB 
participants will be asked to identify a caregiver. The research assistant will then approach the 
caregiver, providing them with information about the project, and inviting study participation. If 
the caregiver agrees, the research assistant will then explain study details and obtain written 
informed consent. Information regarding the project’s focus and the caregiver’s right to decline to 
participate will be given both orally and in writing. Research assistants will emphasize that 
participation is voluntary and the caregiver’s decision to participate will not affect the quality of 
the patient’s medical care.   
In any case where the investigator has concerns about the caregiver’s ability to provide informed 
consent, formal assessment of decision-making capacity will be made using the MacArthur 
Competence Assessment Tool, Clinical Research version (MacCAT-CR).   
As allowed under Virginia state law, an alternative procedure will be used to consent persons 
lacking the capacity to give informed consent, as determined by the MacCAT-CR, or as judged by 

VCU TBIMS Proposal 
Nonexempt Research Narrative 
 
8
the investigators. Investigators will seek to obtain consent from a legally designated substitute 
decision maker. In every case, an effort will be made to obtain assent from the patient’s caregiver.  
Caregivers who decline to participate will not be enrolled regardless of their respective substitute 
decision maker’s desire.   
Once collaborating centers are established, the study will be submitted for review and approval 
by the Institutional Review Board (IRB). No request will be made to modify or waive any of the 
elements of consent. Documentation of consent will be required. 
 
(4) Potential Risks: Describe potential risks (physical, psychological, social, legal, or other) and 
assess their likelihood and seriousness. Where appropriate, describe alternative treatments and 
procedures that might be advantageous to the subjects. 
There are minimal risks (physical, psychological, social, legal, or other) associated with human 
subjects use for this project. Some individuals may experience feelings of sadness when answering 
questions or talking about their current status. The only inconvenience to research participants will 
be the time it takes to answer the questionnaires and complete the interviews.  Questions of a 
sensitive nature (e.g., substance use/abuse) are included, and caregivers will be given the option to 
omit questions that they do not wish to answer. 
 
5) Protection Against Risk: Describe the procedures for protecting against or minimizing potential 
risks, including risks to confidentiality, and assess their likely effectiveness. Where appropriate, 
discuss provisions for ensuring necessary medical or professional intervention in the event of 
adverse effects to the subjects. Also, where appropriate, describe the provisions for monitoring the 
data collected to ensure the safety of the subjects. 
This project is directed by a licensed psychologist (Dr. Kreutzer). In the event that a participant 
is found to have significant psychological problems, Dr. Kreutzer will provide individual 
psychotherapy or refer the patient for further psychiatric intervention.  Confidentiality of 
information will be guaranteed in the databases.  No names or social security numbers will be 
included - only identification numbers assigned by the Project Coordinator.  The Project 
Coordinator and Research Associates will keep any contact information for follow-up purposes 
separate from research data collected. 
 
(6) Importance of the Knowledge to be Gained: Discuss the importance of the knowledge gained or 
to be gained as a result of the proposed research. Discuss why the risks to subjects are reasonable in 
relation to the anticipated benefits to subjects and in relation to the importance of the knowledge 
that may reasonably be expected to result. 

VCU TBIMS Proposal 
Nonexempt Research Narrative 
 
9
As a result of this research, we will better understand and conceptualize caregivers’ experiences 
after TBI.  Further, we will gain a new and better understanding of how caregiver attributes, 
namely resilience, relate to survivor outcomes and caregiver burden and needs. There are minimal 
risks (physical, psychological, social, legal, or other) associated with the project. The possibility 
that some individuals may experience feelings of sadness or frustration is outweighed by the 
potential benefits of the project. The VCU TBIMS places an emphasis on providing patients and 
family members/caregivers with psychological support and education to assist in recovery 
following TBI. 
 
(7) Collaborating Site(s): If research involving human subjects will take place at collaborating 
site(s) or other performance site(s), name the sites and briefly describe their involvement or role in 
the research. 
Not yet identified. 
 
 

ATTACHMENTS FORM
Instructions: On this form, you will attach the various files that make up your grant application. Please consult with the appropriate Agency 
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Important:  Please attach your files in the proper sequence. See the appropriate Agency Guidelines for details
1)
Table of Contents.pdf
2)
Appendices.pdf
3)
Data and Safety Monitoring Plan.pdf
4)
VCU Indirect Rate Agreement.pdf
5)
6)
7)
8)
9)
10)
11)
12)
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VCU TBIMS Proposal 
 
 
 
TRAUMATIC BRAIN INJURY MODEL SYSTEM 
 
DISABILITY REHABILITATION RESEARCH PROJECT (DRRP)  
FOR NEW AWARD FOR FISCAL YEAR 2017 
 
HHS-2017-ACL-NIDILRR-DPTB-0204 
United States Department of Health and Human Services 
Administration for Community Living 
CFDA No. 93.433 
 
Project Director: Jeffrey S. Kreutzer, Ph.D. 
Project Co-Director: David X. Cifu, M.D. 
 
Department of Physical Medicine and Rehabilitation 
Virginia Commonwealth University 
Box 980542 
Richmond, VA 23298-0542 
(804) 828-3704 
FAX: (804) 828-2378 
 
May 9, 2017 

VCU TBIMS Proposal 
 
TABLE OF CONTENTS 
I.      Importance of the Problem ..................................................................................................... 1 
II. 
Responsiveness to Priorities .................................................................................................   4 
III. Design of Research Activities ................................................................................................ 7 
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability .. 8 
Caregiver Resilience: A Longitudinal Investigation ............................................................ 29 
IV. Design of Dissemination Activities ...................................................................................... 40 
V. 
Plan of Operation.................................................................................................................. 45 
VI. Collaboration ........................................................................................................................ 53  
VII. Adequacy and Reasonableness of the Budget ...................................................................... 55 
VIII. Plan of Evaluation ................................................................................................................ 57 
IX. Project Staff .......................................................................................................................... 62 
X. 
Adequacy and Accessibility of Resources ............................................................................ 70 
XI. Appendices 
A. References  
B. Key Personnel Curriculum Vitae  
C. Letters of Commitment and Support 
D. Biographical Sketches of Scientific Advisors and Project Associates 
E. VCU Contribution to National Database and Continuum of Care 
F. Model Systems Publications 1987-2017 
G. Resilience and Adjustment Intervention Implementation Manual Including Booster 
Sessions (RAI+) 
H. Listing of Every Collaborating Organization and Individual Named in Application 
 

VCU TBIMS Proposal 
Data & Safety Monitoring Plan 
1 
 
Data and Safety Monitoring Plan 
For all proposed clinical trials, NIDILLR is requiring that applicants address the safety of human 
subjects. The VCU TBIMS proposal includes one clinical trial, our site-specific project: 
 
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability 
The monitoring of this study will involve a continuous and ongoing process of reviewing the 
conduct of the trial, including adherence to the study design and documentation of AEs/SAEs. The 
responsibility of monitoring the safety of participants is held primarily by Dr. Kreutzer as Project 
Director and Principal Investigator. Considering that the interventions in this study carry less than 
minimal risk to participants, and that Dr. Kreutzer and his research team have appropriate clinical 
skills and training to monitor for AEs/SAEs, it is appropriate for the research team to carry the 
primary responsibility for monitoring.  
Monitoring the Safety of Participants: As noted above, a specific protocol will be used to 
monitor for and report AEs/SAEs. The Project Director, in collaboration with the Project 
Coordinator, are primarily responsible for monitoring the safety of participants, in collaboration 
with the study therapists (Dr. Mills and Dr. Hsu, both clinical psychologists), in the following ways: 
 Monitor for Psychological AE (worsening depressive symptoms from one assessment time point 
to the next by 5 points on the BSI-18 Depression scale with no endorsement of suicidality): 
o 
Participants will be provided with the contact information for the Project Coordinator, 
Project Director, and therapist. They will be advised to call with any questions or concerns 
or to report any unusual emotional feelings; and  
o 
Research Assistants will be trained in the definition of AE (worsening depressive symptoms 
without endorsement of suicidality) and will report any obvious psychological changes in 
participants to the Project Director immediately. 
 Monitor for Psychological SAE (suicidality): 
o 
The Project Coordinator will administer the MINI suicide module immediately to assess 
suicidality risk in any of the following situations: 
x a participant reports suicidal thoughts to study staff; and/or, 
x a participant endorses suicidality on the depression scale of the BSI-18 during data 
collection 
o 
If the suicide risk is low on the MINI (<8), the Project Coordinator will ask the participant to 
be in touch with his/her healthcare provider for follow-up. If the participant scores high for 

VCU TBIMS Proposal 
Data & Safety Monitoring Plan 
2 
 
suicide risk (9-17), the Project Coordinator will ensure that the participant is accompanied 
by a family member or friend to their healthcare provider or the local emergency department 
for immediate evaluation. The Project Coordinator will consult with Dr. Kreutzer (a clinical 
psychologist) regarding additional questions/concerns. 
In all of the above cases, the Project Director will determine the severity of the AE/SAE and the 
relatedness to the intervention. The Project Director will document actions taken and outcomes. If 
any of these events occurs and are directly related to the intervention, the IRB and NIDILRR will be 
alerted. 
Summary of Study Review Plan: Study progress and safety will be reviewed by the Project 
Director on a monthly basis, and more frequently if needed. Progress reports, including participant 
accrual, participant status and adherence data will be provided regularly to the Project Director. 
Data about AEs/SAEs will be reported with each occurrence. As part of the IRB continuing review, 
an Annual Report will be compiled and will include a list and summary of AEs/SAEs. In addition, 
the Annual Report will address (1) whether AEs/SAEs have been severe and related to the 
intervention; (2) reason for dropouts from the study; (3) whether all participants met entry criteria; 
and (4) whether continuation of the study is justified on the basis that additional data are needed to 
accomplish the stated aims of the study. 
Validity and Integrity of Data: In collaboration with the research team, the Project Director will 
maintain responsibility for all aspects of data collection, entry, and analysis. The Project Director 
and study staff will review all data collected on an ongoing basis for completeness and accuracy, as 
well as protocol compliance. The frequency of data review is described below: 
 Participant accrual: Review of the rate of participant accrual and compliance with 
inclusion/exclusion criteria will occur monthly during the recruitment phase to ensure that a 
sufficient number of participants are being enrolled and that they meet eligibility criteria. 
 Participant status and Adherence data: Review of the status of enrolled participants will occur on 
a consistent basis throughout the study, including data on adherence to study visits and the 
intervention protocol. If there are concerns about whether adherence has reached a level that 
might inhibit the ability of the study to evaluate the specific aims, a conference call will be 
scheduled with Scientific Advisors and the Advisory Board to discuss methods for improving 
adherence. 
 AEs and SAEs and rates: Review of every AE and SAE will be closely evaluated by the Project 
Director at each occurrence and reported in annual reviews. 

VCU TBIMS Proposal 
 
Abstract  
Virginia Commonwealth University’s (VCU) Traumatic Brain Injury Model System (TBIMS) 
proposal is comprised of four major components. One component, a site-specific research project, is 
a two-arm randomized controlled trial comparing the benefits of a basic resilience-building 
intervention with an expanded, patient-centered, resilience intervention. Outcome measures will 
focus on resilience, emotional distress, adjustment, and stress management. The sustainability of 
treatment benefits will be investigated. A second component is focused on caregivers. The adverse 
impact of TBI on caregivers has been well-documented. Reflecting the recent focus on positive 
psychology, we propose to conduct a multi-center, longitudinal investigation of caregiver resilience. 
The module will examine caregiver factors associated with resilience including emotional well-
being, needs, and perceived burden. Survivor characteristics, including emotional distress, 
functional status, resilience, and injury characteristics, will also be examined. A third major 
component relates to the National Database. VCU will continue to collect data for the National 
Database, and will lead and participate in multi-center, collaborative efforts to examine TBI 
outcomes and prognostic indicators. A fourth component of our proposal relates to dissemination. 
VCU will maintain a highly active dissemination program in collaboration with the Model Systems 
Knowledge Translation Center. As in the past, VCU’s dissemination efforts will include a high 
volume of peer-reviewed publications and consumer-oriented outreach. In partnership with Brain 
Injury Services and the National Resource Center for TBI, the VCU TBIMS recently hosted our 41st 
TBI rehabilitation conference in Williamsburg, VA. The conference was the first and remains the 
longest running TBI rehabilitation conference in the world. The conference planning committee will 
continue to include research and researchers from other TBIMS sites in planning the next five years 
of conferences.  
 
VCU has been a major provider of brain injury acute care and inpatient and outpatient rehabilitation 
services to a large, culturally diverse population for more than three decades. VCU Medical Center 
provides nearly one-third of Virginia’s indigent care and is the largest provider of indigent care in 
the state. Uninsured patients represent 20 percent of all patients treated, substantiating our strong 
commitment to serve persons regardless of ability to pay. We have been an active collaborator in 
the TBIMS since 1987. Since program inception, we have: extended our system of care; developed 
new partnerships with service providers and advocacy organizations; improved outcome 
measurement techniques; and successfully developed innovative interventions. Consumer 
involvement, emphasis on community-based rehabilitation, relevance, and active dissemination to 
consumer and professional audiences have been cornerstones of program development and 
implementation. The nearly 400 model systems manuscripts published by our interdisciplinary 
research team in the past 30 years substantiates assertions that the urban, academic health center 
setting is ideal for scientific research, innovation, collaboration, and dissemination. 
 

VCU TBIMS Proposal 
1 
I.  Importance of the Problem 
Need and Target Population 
With an estimated annual incidence rate of 1.7 million,1 traumatic brain injury (TBI) continues 
to be a leading cause of death and disability in the United States.2 Each year, TBI results in 2.5 
million visits to the emergency department (ED).3 One-third of all injury deaths in the U.S. are due 
to TBI,4 and there are 3.2 to 5.3 million persons,5 or ~1.1% of U.S. population living with 
permanent TBI-related disabilities.6 The societal toll of TBI is enormous and growing. Since 2007, 
there has been a 56% increase in the rate of TBI-related ED visits.5 The increase in TBI-related 
visits far outpaces the increase in total ED visits, representing an eight-fold greater increase.7 
Despite the magnitude, these numbers do not account for all occurrences of TBI because they do not 
include individuals who go without medical care, had outpatient or office-based visits, and those 
who received treatment at a federal facility.5 Estimates place the annual indirect and direct financial 
costs near $76.5 billion.8,9 
Brain injury causes drastic life changes, with losses affecting survivors, their families, and 
society.9-12 TBI often results in a diversity of problems13,14 and life-long impairments.15,16 The 
complex and long-term nature of sequelae create special challenges.17-19 Difficulties are well 
documented and have been categorized into at least five different areas, including: (1) functional 
status;20-23 (2) neurological and medical status;24-27 (3) neurobehavioral and emotional status;16,28-30 
(4) familial and marital adjustment;31-34 and (5) vocational status.35-37 For example, five years after 
inpatient rehabilitation, one-third of TBI survivors remain dependent for everyday activities and 
12% are institutionalized.14 While fewer people die from TBI, survivors must often contend with 
poorer health, including hastened neurodegenerative processes and increased risk for Parkinson’s 
disease and Lewy body accumulation.38 Emotional adjustment following TBI is fraught with high 
rates of depression (25-53%),39-41 anxiety (21%),42 and suicidal ideation (7-10%).39 Return to work 
after TBI is suboptimal, with more than 60% of working age individuals being unemployed two 
years after completing rehabilitation.36 Given these pervasive deleterious consequences, family 
members of survivors of TBI are especially burdened, frequently reporting emotional distress, lack 
of respite, financial stress, and lack of community support.43-45 Of particular concern, caregiver 

VCU TBIMS Proposal 
2 
burden appears to increase over time, underscoring the need to care for these caregivers, including 
enhancing their resilience, as a critical effort in mitigating the chronic toll of TBI.46  
Although the last decade has seen advances in TBI management,47 much remains to be 
understood about how to effectively address the lifelong needs of this vulnerable population.48-53 
There have been marked improvements in reducing mortality and managing major medical 
complications, yet addressing the emotional and psychosocial needs of persons with TBI remains an 
area of development. Questions pertain to how to optimize rehabilitation services and effective 
psychological interventions along the continuum of care after inpatient rehabilitation.5 For example, 
despite accumulating evidence about the importance of fostering resilience after TBI,54 questions 
remain about the long-term trajectory of resilience postinjury and how it relates to other outcomes. 
Experts agree that additional research needs to be conducted on the efficacy of various 
rehabilitation treatments and strategies,55-57 especially as there is greater appreciation for 
rehabilitation beyond the acute phase. More serious questions have arisen from the ranks of third-
party payers. Long-term rehabilitation is expensive and efficacy questions have diminished the 
insurance industry’s willingness to provide reimbursement.58,59 
While an increasing number of researchers have focused their interests on TBI management 
during the past decade, many important questions remain unanswered, especially questions relating 
to treatment efficacy. Progress has been limited partly by funding and a lack of trained researchers. 
Many professionals choose to work solely as clinicians because they view the immediate needs of 
their clients as a priority. Progress has also been constrained by the use of retrospective designs and 
small samples.60,61 In addition, few investigators have pursued systematic, long-term research plans.  
Virginia Commonwealth University (VCU) researchers have been immersed in TBI 
rehabilitation research for nearly three decades. Our earliest studies were descriptive, focusing on 
cognitive and neurobehavioral functioning, emotional adjustment, employment, and family 
functioning (see VCU Model Systems Publications, Appendix F). Our more recent research, 
involving development and evaluation of psychological interventions for survivors and families, has 
produced promising results. Studies have yielded evidence of improved: (1) problem solving, 

VCU TBIMS Proposal 
3 
communication, and goal setting skills; (2) emotional well-being and stress management; and (3) 
knowledge about TBI.62-66 Still, survivors face many additional challenges and more work remains. 
In moving forward, we firmly believe that standardized, targeted interventions focused on resilience 
and adjustment are key to helping survivors live meaningful and productive lives. Little is known 
about caregiver resilience, and better understanding will allow the opportunity to improve 
outcomes.67,68 Feedback from patients and families, research participants, and Advisory Board 
members substantiates that VCU’s proposed projects are relevant, worthy of investigation, and 
likely to improve the lives of survivors and caregiving family members.  
Beneficial Impact on Target Population 
The VCU TBI Model System (TBIMS) aims to conduct one new site-specific research project 
and new multi-site module project, continue to collect data for the TBIMS National Database, and 
carry out a wide variety of dissemination activities. A strong interest in benefiting consumers and 
professionals guided our choice and design of program activities. Specific information about the 
expected benefits of each activity is provided in respective sections of the grant (e.g., Design of 
Research Activities; Design of Dissemination Activities).  
The overall expected benefits of the VCU TBIMS program are as follows: 
1. Analysis of the National Database will identify characteristics of patients with optimal and sub-
optimal outcomes. An understanding of factors that influence outcomes will aid in needs assessment 
and establishing priorities for program development and training. 
2. Professionals often face uncertainty when choosing appropriate treatment outcome measures. The 
proposed research programs will help identify sensitive measures, allowing professionals to make 
more informed choices in selecting outcome measurement tools. 
3. Progress in rehabilitation practice has been limited by concerns about the foundations of evidence-
based practice. Increased knowledge about outcomes and the elements of efficacious treatment to 
improve resilience and adjustment will benefit practice, ultimately improving the lives of survivors 
and their caregivers. 
4. Identifying the characteristics of treatment-resistant research participants will further development 
of effective treatment alternatives. 
5. Improved outcomes for survivors will help alleviate the stress and distress that often affects 
caregivers and other family members, enabling them to live healthier lives. 
6. A better understanding of caregiver resilience and how it relates to survivor outcomes and caregiver 
burden and needs will provide a foundation for more effective intervention development. 
7. A strong, effective research dissemination plan will help rehabilitation professionals improve their 
practice and enable consumers to make more informed treatment choices. 
8. All systems of care have resource limitations. Improved understanding of effective intervention 
strategies will enable systems to more efficiently allocate resources. 

VCU TBIMS Proposal 
4 
9. Within managed care systems, rehabilitation consumers often suffer great financial hardships partly 
because third-party payers are unwilling to pay for services with uncertain effectiveness. 
Demonstration of intervention effectiveness will increase the willingness of third-party payers to 
fund services. 
10.New hypotheses will be generated for future intervention research focused on resilience, adjustment, 
and caregiving. 
 
II. Responsiveness to Priorities 
The VCU Health System (VCUHS) encompasses a long-standing, comprehensive 
multidisciplinary continuum of care that includes a full range of inpatient and outpatient follow-up 
services (see Adequacy and Accessibility of Resources and Appendix E). Emergency, acute, 
inpatient rehabilitation care, and post-acute services are centered in the region’s only Level I trauma 
center. In partnership with other providers and agencies, a network of outpatient rehabilitation 
services is also offered in community-based settings. Consistent with priorities stated in the 2017 
Federal Register, VCU researchers will generate novel information about intervention effectiveness 
and outcomes, providing a foundation for evidence-based clinical practice guidelines.  
We are firmly committed to addressing the newly announced priorities, and a number of factors 
will enable success. First, the proposed projects will build upon a solid foundation of existing 
knowledge. We have thoroughly reviewed and analyzed the literature (see Design of Research 
Activities - Literature Review, Rationale). Second, we were guided by extensive clinical experience 
to develop relevant projects most likely to advance treatments and improve outcomes for 
individuals with TBI and their families. Importantly, individuals with disabilities and their family 
members have participated in planning this proposal, helping to assure the relevance of our research 
program. Indeed, they will be integral to future planning, implementation, dissemination, and 
evaluation (see Plan of Operation, Plan of Evaluation).Third, our health system resources (see 
Adequacy and Accessibility of Resources and Appendix E), highly qualified personnel (see Project 
Staff), and practical experience gained through preliminary research in the proposed areas will 
ensure attainment of our objectives. Fourth, we have developed and will implement a rigorous 
program evaluation plan to prevent problems and make certain that objectives are accomplished in a 
timely, cost-efficient, and high quality manner.  

VCU TBIMS Proposal 
5 
Our site-specific project examines the short and longer-term benefits of a curriculum-based, 
skill-building, education, and psychological support intervention for persons with TBI. Our 
proposed module project will examine caregivers’ well-being with a focus on resilience, emotional 
adjustment, burden, and needs. As such, VCU TBIMS research falls primarily within NIDILRR’s 
Health and Function research domain, and secondarily in the Participation and Community Living 
domain. The selection and design of projects were guided by the need for methodological rigor, 
NIDILRR’s Long-Range Plan, and our Advisory Board. Information regarding stage of research, 
sample size, power calculations, methodology, and quality control procedures is provided within the 
text of each research project. We are confident that the proposed research designs and sample sizes 
will enable us to achieve meaningful and robust findings. With the guidance of our Advisory Board 
and VCU colleagues, data collection instruments were selected based on their sensitivity and 
cultural relevance. With Richmond’s culturally diverse population, we anticipate successfully 
enrolling persons from traditionally underserved populations. As in the past, guidance will also be 
sought from the National Data and Statistical Center (NDSC) and the Model Systems Knowledge 
Translation Center (MSKTC). We have worked and will continue to work closely with the NDSC 
and MSKTC, as outlined in their letters of support (see Appendix C).  
High quality data collection, following established TBIMS National Database protocols, will 
remain a foundation of our project. VCU has been a member of the NIDILRR-funded TBIMS 
program since 1987. Data on over 700 patients has been collected thus far, and nearly 2,200 follow-
up evaluations have been completed. VCU’s data collection expertise has been recognized by the 
NDSC in many ways. For example, our staff have been involved in NDSC quality support visits, 
training other centers, developing prototype interview formats, and J. Marwitz serves as chair of the 
TBIMS Data Committee. We will apply our considerable expertise to ensure continued high quality 
data collection.  
Considering our enrollment rate over the past five years (average of 44 patients per year), we 
anticipate accrual of no less than 35 participants per year for the National Database. Collaborative 
relationships with medical centers outside our region (e.g., University of Virginia, Mary 

VCU TBIMS Proposal 
6 
Washington, and Norfolk Sentara Hospitals) ensure our ability to recruit a substantial number of 
National Database participants. Further, VCU is now collaborating with Sheltering Arms 
Rehabilitation Hospital to build a 114-bed acute rehabilitation center in Richmond. Our analysis of 
admissions for both hospitals leaves us to anticipate a 50% increase in National Database 
enrollment with the merger. Descriptive statistics detailing VCU data collection and follow-up rates 
are provided in Appendix E. VCU researchers are uniquely positioned to continue following 
patients well beyond 25 years postinjury. Multiple TBIMS manuscripts have described long-term 
outcomes and trends in rehabilitation care up to ten years postinjury (see Appendix F), and VCU 
has contributed a considerable proportion of the data. As requested by NIDILRR, specific estimates 
for follow-up data collection costs are provided in the Budget Narrative. 
As directed by NIDILRR, VCU will participate in at least one Module project. As specified in 
the Budget Narrative, no less than 15% of our annual budget will be reserved to fund module 
project operations. Also, as requested by NIDILRR, funds have been budgeted for participation in 
two annual, in-person Project Directors’ meetings. 
For nearly 25 years, we have actively collaborated with other TBIMS centers, organizations, 
and agencies in carrying out program activities. We have solidified relationships with the Virginia 
Department of Aging and Rehabilitative Services, Brain Injury Association of Virginia, VA 
Polytrauma Rehabilitation Centers, and Brain Injury Services of Virginia (see also Appendices C 
and E, Letters of Commitment and Support and VCU Contribution to National Database and 
Continuum of Care). Information on collaborative mechanisms, entities, and coordination is 
provided in the Collaboration section of the proposal. A review of our publications list (see 
Appendix F) substantiates our many successes in collaborative research endeavors. For example, in 
the past five years, VCU has shared authorship with other model system centers in 22 peer-
reviewed journal manuscripts published or in press. 
A Guide for Reviewers 
The following table was developed to help reviewers evaluate our application. The table 
indicates where in the grant text information relevant to the selection criteria are provided. 

VCU TBIMS Proposal 
7 
SELECTION CRITERIA 
PRIMARY LOCATION WITHIN TEXT 
Importance of the Problem 
Importance of the Problem; Rationale and Expected Beneficial 
Impact sections provided in text of each project within Research 
Activities 
Responsiveness to Priorities 
Responsiveness to Priorities; Objectives/Research Questions, 
Rationale, and Expected Beneficial Impact sections within Research 
Activities 
Design of Research Activities 
Research Activities:  
 
Review of the Literature; Rationale; References in Appendix A 
 
Hypotheses and Objectives or Research Questions 
 
Sample, Power Analyses (see Data Analysis section)  
 
Feasibility: Project Staff, Potential Problems and Anticipated 
Solutions 
 
Input from Persons with Disabilities and Stakeholders (see 
Research Activities overview and individual projects)  
 
Data collection and measurement (Methodology section- 
intervention, measures, procedure, quality control)  
 
Data Analysis  
 
Stage of Research (see Methodology section) 
 
Implementation Manual for Intervention (Appendix G) 
Design of Dissemination Activities  Dissemination Activities 
Plan of Operation 
Plan of Operation; Project Staff section within Research Activities,  
Collaboration 
Collaboration; Letters of Commitment and Support (Appendix C); 
Model Systems Publications (Appendix F) 
Adequacy and Reasonableness of 
Budget 
Adequacy and Reasonableness of Budget; Budget Narrative in front 
matter 
Plan of Evaluation 
Plan of Evaluation 
Project Staff 
Project Staff; Project Staff section within Research Activities,; Vitae, 
Biographical Sketches (Appendix B, and D) 
Adequacy and Accessibility of 
Resources 
Adequacy and Accessibility of Resources; separate sub-sections 
entitled, Quality of Past Grant Performance, Access to Clinical 
Populations; VCU Contribution to National Database and 
Continuum of Care (Appendix E); Model Systems Publications 
(Appendix F) 
III. Research Activities 
Resilience is the theme of VCU’s two proposed research projects. The site-specific project is 
entitled, Intervention to Promote Survivor Resilience and Adjustment: Efficacy and 
Sustainability. The second project, a “module,” is entitled, Caregiver Resilience: A Longitudinal 
Investigation. Research will also include data collection for the National Database. 
For several reasons, we are highly confident that our projects will: accomplish their stated 
objectives; represent a coherent, sustained approach to research in the field; and contribute 
substantially to the state-of-the-science. First, we have closely monitored, analyzed, and synthesized 
the literature to characterize the current state of knowledge, trends, and shortcomings. Second, we 

VCU TBIMS Proposal 
8 
have conducted a substantial amount of research in each area, affording us an invaluable fund of 
knowledge and expertise. Each proposed project builds on the findings of researchers within and 
outside the University. Third, we have consulted with consumers, clinicians, and scientists, 
including Advisory Board members, to determine current needs and priorities. For example, 
participants in the TBIMS National Database (NDB) and their family members provided input on 
site-specific and module project selection, project design, methods, and intervention content 
through in-person meetings, telephone interviews, and surveys. Our research projects were designed 
with the goal of providing new and useful information to consumer, research, and clinical 
audiences. VCU’s proposed projects utilize the most rigorous applied-research designs possible. 
Finally, we have strong commitments of support from departmental, health system, university, and 
community organizations. 
For the record, collecting and contributing data to the NIDILRR TBIMS NDB will be an 
integral part of our research program. As a past contributor to the NDB, we are well versed in 
enrollment, collection, and data submission procedures. We are certain we can enroll more than 35 
participants annually and have done so on a regular basis. We are now collecting data on patients 
who are more than 25 years postinjury with excellent follow-up rates (e.g., 80-94% at each time 
point). Appendix E provides a summary of our contributions to the NDB, as well as information 
about our local database developed to track research participants and our continuum of care.  
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability 
Director: J. Kreutzer 
Introduction and Review of the Literature 
Persons with TBI across all degrees of injury severity often struggle mightily with cognitive,69-
71 emotional,72-74 psychological,75-77 and psychosocial78-80 challenges, some for the remainder of 
their lives. A broad range of rehabilitation interventions have been designed in efforts to mitigate 
obstacles to complete recovery.81-88 However, concerns about efficacy remain. Frequently, 
intervention outcomes are limited to specific domains or generate non-transferable skills,13,87 cannot 
be reproduced,89,90 or show transitory gains.81 Without treatment approaches that can produce 

VCU TBIMS Proposal 
9 
sustainable, holistic gains, TBI survivors will continue to struggle to establish productive and 
meaningful lives postinjury. 
The Resilience Framework: A recent paradigm shift in the field of psychology has led clinicians 
and researchers to explore the relationship between resilience and trauma outcomes.91-93 Resilience 
has been defined as, “positive adaptation in the face of a traumatic event.”94 The exploration of 
resilience began with the study of individuals who emerge from various types of traumatic 
situations unharmed and even strengthened.95,96 Although many of the skills associated with 
resilience correspond with seemingly static personality characteristics, a key feature of resilience 
lies in the distinction between skills and traits.92 While traits are innate, skills can be promoted and 
developed throughout the life span. As indicated in the following table, researchers have identified 
core skill sets evident in resilient individuals.97 Combined, these skills create a prototypical profile 
of resilience. Researchers in the area of resilience have determined that (a) the skills associated with 
a resilient and adaptive response to trauma are neither “superhuman” nor extraordinary; and, (b) 
resilient skills can be initiated and/or enhanced in individuals who have previously demonstrated 
non-resilient profiles.94,98 
Common TBI Deficits and Challenges 
Skills Necessary for Resilience 
Anxiety / Depression99-101  
Even Temperament / Stable Emotionality102-104  
Survivor Focus on Deficits and a Comparison with 
Pre-Injury Functioning105,106 
Positive Outlook / Optimism107-109  
Irritability / Aggressive Behaviors110,111  
Self-Regulatory Skills and Even-Tempered 
Behaviors112-114 
Discomfort with Socialization115,116  
Social Perception / Arousal of ‘Liking 
Responses’ in Others109,117,118  
Impaired Self-Awareness106,119,120  
Insightful Modification of Behavior121-123  
Cognitive Deficits / Impaired Executive Functioning 
(hypothesizing, problem solving124,125)  
Good Problem Solving Skills104,126,127  
Diminished Communication Skills128-130  
Effective Communication97,98,131 
Outcomes following trauma are inextricably linked to an individual’s ability to consistently 
apply resiliency skills.92,132 Having and applying highly resilient skills facilitates a competent and 
effective response to crisis.92,133-135 Conversely, poor use of a resilient skill-set is related to 
instability and poor outcomes. Richardson’s96 metatheory of resilience clarifies the divergent paths 
an individual might take in response to trauma: “resilient reintegration” or “dysfunctional 

VCU TBIMS Proposal 
10 
reintegration.” While individuals who achieve resilient reintegration are more likely to find 
meaning, be productive, and engage in life, those who follow the path of dysfunctional reintegration 
are unlikely to set goals, maintain a support system, or achieve stability.  
Early on in the development of Resilience Theory, researchers recognized the possibility that 
resilience could be promoted in previously non-resilient individuals.92,94 A seminal longitudinal 
study of resilience investigated children on the island of Kauai who had at least four predictors of 
negative outcomes (e.g., extreme poverty, mental illness in the family).136 During the nearly 40 
years of data collection, researchers discovered that a few of the children who did not exhibit 
resilience at early data-collection points were later able to demonstrate resilient skills and associated 
positive outcomes. These findings formed the basis of the notion that resilience is not an inborn 
trait, but rather, is a set of skills amenable to intervention. Subsequent studies support these 
conclusions.96,137 
Over the last decade, researchers have begun to examine the hypothesis that resilience can be 
enhanced. In fact, the development of interventions designed to promote resilience in other 
populations has led to positive outcomes.135 Research on adults facing cancer,138,139 PTSD,140,141 
anxiety disorders,142 diabetes,143 and other illness and injury types144 has demonstrated substantial 
gains on measures assessing degrees of resilience. More specifically, a number of the skill-deficits 
often associated with non-resilient profiles have shown significant improvement following 
resilience-promotion interventions. Measures of emotional well-being consistently improve, while 
indicators of psychological distress decline.138,142,144,145 Furthermore, measures of injury/illness 
adjustment often show gains.138,140,143,146 Improvement in ability levels on measures of problem 
solving, communication, and stress reduction are also frequently noted.138,140,142-144 Moreover, 
health-behaviors and functional abilities have also improved following treatment.140,143,144  
Resilience and TBI: Given the long-term challenges of TBI, many authors have asserted the 
critical need for developing a resilience-promotion approach to treatment in brain injury 
rehabilitation settings.91,92,95,147 In a recent study, VCU researchers93 investigated the relationship 
between resilience, emotional distress, and participation in a treatment-seeking, outpatient sample 

VCU TBIMS Proposal 
11 
with mild, moderate, and severe TBI. The investigators found a relationship between resilience, 
emotional adjustment, and depressive symptoms. Lower levels of resilience were associated with 
greater psychological distress. The authors concluded that interventions that successfully target 
resilience are likely to benefit emotional well-being. In a series of recent studies, Losoi and 
colleagues148-150 and Sullivan and colleagues151 examined postinjury resilience in patients with mild 
TBI. Greater resilience was associated with fewer post-concussion symptoms and better quality of 
life. Sullivan, in a later systematic review, reaffirmed that higher levels of resilience were associated 
with fewer post-concussion symptoms.152  
In 2016, a TBIMS multi-center study led by VCU researchers examined resilience at three 
months postinjury among a sample of adults with moderate to severe TBI. The investigation yielded 
evidence that resilience levels were relatively low in comparison to the general population.54 
Investigators also showed that greater resilience was related to higher education, absence of pre-
injury substance abuse, and lower anxiety. In the same year, Hanks and colleagues reported on 
resilience within 5 years following mild, moderate, and severe injury.153 Generally, resilience was 
unrelated to injury or demographic factors, although the relationship to education approached 
significance, with higher education levels predicting greater resilience. In summary, there is 
consensus that resilience is a quality likely to help mitigate emotional distress after TBI. 
Interventions Promoting Resilience: The parallel between common TBI deficits and the skills 
necessary for a resilient response to trauma elucidates the reasons why many survivors struggle to 
respond to injury in a resilient manner (see table on page 9). These challenges to resilience explain 
why the many existing post-TBI interventions have largely struggled to demonstrate sustained 
gains:81 TBI diminishes an individual’s ability to be resilient. Without specific efforts to engender 
resilience, survivors are unable to “bounce back” from the myriad of postinjury complications they 
are likely to face. White and colleagues92 call for the generation of “specific interventions that could 
enhance factors of resilience” as a strategy to improve sustainable postinjury outcomes. Lefebvre 
and Levert154 echo this sentiment, asserting that resilience is likely a primary factor in survivors’ 
adjustment to injury and development of new competencies. 

VCU TBIMS Proposal 
12 
VCU Research: A Curriculum-Based Approach: One of the greatest challenges to designing a 
TBI resilience intervention is the need for a treatment modality that will effectively deliver the 
intervention content. Resilience Theory sets forth a specific set of skills to target to encourage 
resilience.155-157 The American Psychological Association asserts that while everyone is able to 
become more resilient, individuals with cognitive, emotional, or psychological challenges need 
multi-faceted intervention models which consider the specific needs of the population.94 Due to the 
cognitive limitations and lability which often accompany TBI,70,72,158 the specific needs of survivors 
call for an integrative approach to the design and delivery of therapeutic interventions.  
VCU researchers have had great success in implementing effective interventions for TBI 
survivors. Through the use of Curriculum-Based (C-B) approaches, studies have demonstrated 
efficacy for interventions focused on inpatient neurobehavioral functioning,62,159,160 return to 
work,161 and caregiver needs.63,64,66,162 The C-B approach to intervention development was designed 
to specifically address the unique needs of persons with TBI.159,161,162 The fundamental structures 
included in C-B interventions are tripartite: (1) education regarding a challenge or issue; (2) 
psychological support; and (3) skill building of abilities associated with improvement in the targeted 
domain.64,66,162 This three-part intervention structure has proven to be an appropriate and effective 
design to meet the needs of individuals challenged with post-TBI complications.  
In 2012, with NIDILRR TBIMS funding, VCU researchers developed a structured C-B 
intervention to promote postinjury resilience and adjustment: the Resilience and Adjustment 
Intervention (RAI).163 The intervention development project, which was designed to address post-
acute TBI needs, concerns, and challenges (e.g., common injury effects, coping with loss and 
change, one’s role in recovery, problem solving, communication, and stress management), 
emphasized education, skill building, and psychological support. Our site-specific investigation was 
also implemented to test the feasibility of the intervention and measurement protocol.  
Outpatients (n=160) with mild to severe TBI were randomly assigned to either a treatment 
(RAI) or wait list control (WLC) group. Treatment was delivered in seven one-hour sessions with 
outcome measurement pre- and post-treatment, and three months after treatment completion. 

VCU TBIMS Proposal 
13 
Outcome measures included the Connor-Davidson Resilience Scale (CD-RISC),97 Mayo Portland 
Adaptability Inventory-4 (MPAI-4),164 Brief Symptom Inventory-18 (BSI-18),165 and 13 Item Stress 
Test.162 As indicated in the table that follows, treatment group participants showed improvement in 
outcomes, whereas controls did not. At three months post-treatment, improvements were 
maintained relative to pre-treatment.  
Outcome 
Group 
Baseline 
Mean (SD) 
Post-treatment 
Mean (SD) 
Follow-up 
Mean (SD) 
CD-RISC 
RAI 
21.1 (8.1) 
28.4 (6.9) 
25.5 (7.8) 
 
WLC 
23.4 (9.0) 
23.7 (8.1) 
- 
MPAI-4: Adjustment Index 
RAI 
55.4 (9.1) 
51.2 (9.5) 
50.7 (10.0) 
 
WLC 
55.8 (10.5) 
54.5 (9.2) 
- 
MPAI-4: Ability Index 
RAI 
55.0 (9.7) 
51.0 (8.3) 
50.7 (9.5) 
 
WLC 
53.5 (10.8) 
54.2 (9.5) 
- 
BSI-18 
RAI 
63.8 (11.7) 
57.2 (10.6) 
58.7 (10.4) 
 
WLC 
64.1 (10.7) 
64.0 (9.4) 
- 
Stress 
RAI 
6.7 (3.3) 
4.5 (3.4) 
5.0 (3.1) 
 
WLC 
6.5 (3.5) 
6.0 (3.3) 
- 
A linear mixed-effect model was used to model each outcome, with the time point (baseline, 
post-treatment, 3-month follow-up), treatment, and interaction as explanatory variables. Each of 
these models was also adjusted for education level, time postinjury, and injury severity. The table 
below displays between group outcome differences from baseline to post-treatment, as well as 
changes from baseline to 3-month follow-up for the RAI group. 
 
RAI – WLC at Post-treatment 
3-Month Follow-up – Baseline for RAI 
Outcome 
Difference (95% CI) 
P 
Difference (95% CI) 
P 
CD-RISC 
6.70 (4.96, 8.43) 
<0.001 
4.36 (2.42, 6.30) 
<0.001 
MPAI-4: Adjustment  
-2.48 (-4.55, -0.41) 
0.019 
-4.61 (-6.95, -2.27) 
<0.001 
MPAI-4: Ability  
-3.75 (-5.85, -1.65) 
<0.001 
-4.05 (-6.41, -1.69) 
<0.001 
BSI-18 
-6.51 (-8.73, -4.30) 
<0.001 
-5.01 (-7.52, -2.50) 
<0.001 
Stress 
-1.50 (-2.23, -0.77) 
<0.001 
-1.60 (-2.40, -0.81)  
<0.001 
Overall, analyses suggest that intervention benefits are sustained for three months and perhaps 
longer. Important questions remain regarding the sustainability of treatment benefits. First, are 
treatment benefits sustained beyond three months? Second, are there patient characteristics that 
predict longevity of benefits? Qualitative feedback from research participants was carefully 
reviewed to provide direction for further development of the RAI. Every single participant stated 
that they would recommend the program to others. However, a number of participants wanted more 
sessions with additional time to focus on individual needs. Input was also sought from our Scientific 

VCU TBIMS Proposal 
14 
Advisors, Advisory Board members, and NDB participants, who agreed that the clinical research 
program should be continued with their recommended changes. For example, recommendations 
were made to increase the duration and include more individualized content, suggesting that the 
addition of booster sessions could be of great benefit. 
By definition, booster sessions are follow-up sessions implemented after program completion 
to help maintain benefits over time. Boosters provide an opportunity for individuals to review 
course content, consolidate gains, and discuss challenges. Given the high rate of cognitive 
impairments following TBI, booster sessions can provide an important opportunity to reinforce 
learning and ameliorate the impact of memory deficits on skills acquisition. Booster sessions have 
been shown to be beneficial across an array of therapy targets, including reducing anxiety and 
depression,104 facilitating role transition,166 improving communication skills,167 and enhancing 
relationship skills.168 There is also evidence that booster sessions may promote resilience in treating 
individuals with panic disorder.104 In the only known study to utilize psychotherapy booster 
sessions for individuals with TBI, Ponsford and colleagues examined the impact of modified 
cognitive-behavioral therapy with three booster sessions provided between 21 and 30 weeks post-
recruitment.169 The booster program was associated with reduced anxiety and depression and 
increased psychosocial functioning.  
The development and inclusion of booster sessions increases the extent to which the 
intervention is patient-centered. The addition is well in line with an established literature on the 
additional benefits of patient-centered treatment over and above those of standardized 
interventions.170-174 As such, patient-centered care has been championed as a mark of high quality 
healthcare by both the Institute of Medicine175 and U.S. Congress.176 The essence of the patient-
centered approach entails eliciting as well as mindfully and flexibly responding to the individual’s 
needs and preferences.177 Patient-centered care has been examined among persons with TBI, with 
positive findings showing that not only is it feasible for individuals with compromised cognitive 
skills to participate in their care, they are also more satisfied with their treatment when they do 

VCU TBIMS Proposal 
15 
so.178 Additional work is needed to quantify the increased benefits of patient-centered interventions 
in TBI research, and the proposed project will address this knowledge gap. 
A. Rationale: The Need for Effective Interventions to Promote Resilience and Adjustment 
Along with difficulties in obtaining effective care, research shows that survivors encounter a 
wide variety of lingering injury-related challenges. For example, many survivors know little about 
the common consequences of injury and have trouble coping with loss and change. Some have 
difficulty taking an active role in treatment, and impatience with the recovery process is common. 
Poor problem solving, emotional regulation, stress management, and communication skills further 
exacerbate the challenges of maintaining/rebuilding positive relationships. Research shows that the 
many experience depression41,179,180 and are unable to maintain employment,35,181 which speaks to 
the breadth of chronic struggles faced by persons with TBI. Consequently, many survivors become 
discouraged and have difficulty maintaining a positive outlook. 
The Resilience and Adjustment Intervention (RAI) is a standardized educational, support, and 
skill-building program developed for persons with TBI. A preliminary analysis of data derived from 
the VCU TBIMS intervention development project has yielded promising findings. The proposed 
investigation is a logical next step in advancing our understanding of standardized interventions 
designed to promote recovery.  
The proposed investigation differs from prior VCU research in several important ways. 
First, in response to recommendations made by research participants, Scientific Advisors, and 
Advisory Board members, the intervention period has been extended with three booster sessions. 
Boosters will be patient-focused and personalized to address the original RAI topics that were most 
relevant to the individual, as described in the Intervention section which follows. Furthermore, the 
project will thoroughly evaluate the sustainability of treatment gains by extending the follow-up 
period from three to nine months. The research design will compare the benefits of the original 
intervention (RAI) to an expanded, more person-centered intervention (RAI+).  

VCU TBIMS Proposal 
16 
B.  Objectives 
1. to evaluate the short and long-term efficacy of two structured outpatient intervention programs 
(RAI vs. RAI+) on resilience 
2. to evaluate the short and long-term impact of intervention on emotional well-being and postinjury 
adjustment with the RAI vs. the RAI+ 
3. to evaluate the short and long-term impact of the RAI and the RAI+ on abilities including problem 
solving, communication, and stress management 
4. to determine if demographic, lifestyle, injury, or treatment response information can predict 
maintenance of gains 
C.  Hypotheses  
1. Primary: Participants receiving the booster (RAI+ group) will report higher levels of resilience in 
comparison to individuals in the standard RAI group. 
2. Participants in the RAI+ group will show better adjustment and lower levels of emotional distress 
as compared to persons in the standard RAI group. 
3. Additionally, participants in the RAI+ group will report greater abilities in the areas of problem 
solving, communication, and stress management relative to persons in the standard RAI group. 
4. A participant’s demographic, lifestyle, injury, and treatment response information will be 
predictive of maintenance ability. 
D.  Methodology  
D1.  Stage of Research 
VCU’s previous work with the RAI was best labeled as an “Intervention Development” project. 
The present proposal is best labeled as falling within the “Intervention Efficacy” stage of research, 
as the primary goal is to evaluate whether the RAI+ is feasible, practical, and has the potential to 
yield sustainable and positive outcomes over and above the benefits of the RAI. The present 
proposal also seeks to identify individual characteristics associated with positive outcomes. The 
success of the proposed research program will allow for the “scaling up” of the RAI in hopes that 
the evidence-based intervention will be widely adopted in practice. 
D2.  Sample  
Information regarding inclusion and exclusion criteria, enrollment rate, and participant 
incentives is provided herein. Recruitment information is provided in the Procedure section.  
Inclusion criteria: Individuals 18 years of age and older with mild, moderate, or severe TBI who 
are able to understand and provide consent will be eligible to participate. The standard TBIMS brain 
injury definition will be used: damage to brain tissue caused by an external mechanical force as 
evidenced by loss of consciousness due to brain trauma, post-traumatic amnesia (PTA), skull 

VCU TBIMS Proposal 
17 
fracture, or objective neurological findings that can be reasonably attributed to TBI on physical 
examination or mental status examination. Since there is no reason to believe that treatment 
effectiveness varies with chronicity, no maximum has been set for time postinjury. 
Exclusion criteria: Active substance abusers (e.g., intoxicated at arrival to intake), individuals at 
imminent risk of psychiatric hospitalization or in imminent danger of hurting themselves or others, 
as judged by the investigators, will be excluded from the study. Records will be kept indicating the 
number and type of exclusions. The data will be evaluated to help ascertain the representativeness 
of the final sample. 
Enrollment rate: Considering the inclusion and exclusion criteria and past research experience at 
VCUHS, average monthly accrual rates are estimated to range between 3-4 participants. 
Considering potential attrition rates (e.g., 10%), we conservatively estimate an accrual rate of no 
less than 154 participants over the 46-month enrollment period. As noted in the Data Analysis 
section, power analyses indicate our anticipated sample size exceeds recommended minimums.  
Participant incentives: Participants will be provided therapy, educational materials, and referral 
services at no cost. Each participant will receive up to a total of $140. Individuals will receive $25 
for completing each of the first two assessments (pre- and post-treatment) and $30 each for the 
latter three (pre- and post-booster, and long-term follow-up). For participants traveling more than 60 
miles roundtrip, funds will be provided to offset travel costs (IRS mileage rate of 19 cents per mile 
driven). 
D3.  Intervention  
The RAI was developed over the last decade based upon research review and more than 20 
years’ clinical experience. The RAI is a structured, resilience-based approach to helping persons 
with TBI successfully manage their most common needs, concerns, and challenges.91,182,183  
Assumptions underlying the RAI: Helping persons with TBI adjust, cope, and resume normal 
lives is a formidable challenge. Successful intervention requires a clear understanding of commonly 
encountered challenges. For example, survivors must cope with unexpected and unfamiliar 
problems soon after the injury, and in many cases, for years afterward. Many experience frustration, 

VCU TBIMS Proposal 
18 
struggling with their intense desire to recover quickly and completely. Finally, many survivors 
strive for normalcy, yearning for their former lives. Though there are commonalities, survivors 
differ in the extent to which they face and overcome each of these challenges. Intervention can be 
more effective when clinicians appreciate five important guiding assumptions:  
1. Successful survivorship is based in individual resilience. Survivors who possess or learn to adopt 
traits identified as key to resilient living will find increasing success in their recovery, and growing 
satisfaction with their postinjury lives.184  
2. Achieving emotional wellness after TBI requires a clear understanding of injury-related symptoms, 
commonly encountered challenges, and the recovery process.160,178,185 
3. A key feature of resilience is developing insight into one’s own behavioral response to 
trauma.121,122,186,187 Survivors who are more aware of their strengths and limitations are more likely 
to lead productive and meaningful lives.188,189  
4. Resilient individuals are adept at problem solving, goal setting, communication, and managing stress 
and intense emotions.112,127 Helping survivors develop these skills benefits their ability to be 
productive and maintain quality relationships. 
5. Survivors are more likely to improve when they develop resilient traits, such as being actively 
engaged in recovery,126,131 and are able to maintain a positive outlook.107,127  
Intake and treatment planning: Treatment begins with an intake session that helps shape the 
intervention process. Information is gathered using both quantitative and qualitative methods. Via 
interview, participants will be asked about their injury, progress in recovery, and their home, family, 
and work situation. They will be asked about their emotional well-being as well as their personal 
needs, goals, and priorities. Additionally, participants will complete a series of measures (see 
Measures section for a complete description). 
Intervention modalities: The RAI is a curriculum-based intervention which has three major 
components: (1) skill-building: helping clients enhance existing skills and develop new skills; (2) 
psychological support: counseling participants and offering empathy, encouragement, and hope; and 
(3) education via instruction, discussion, and bibliotherapy.  
Several strategies will be used to extend the benefits of in-person sessions. Participants will be 
provided with copies of the book, Getting Better and Better after Brain Injury: A Guide for 
Survivors, 2nd ed.183 The book, developed by the VCU TBIMS’s National Resource Center for TBI, 
contains key elements of the RAI curriculum and self-assessment tools. Participants will be asked to 
review materials and complete self-assessments in advance of, during, or after therapy sessions. 
Post-session discussion with close family members and friends regarding participants’ self-

VCU TBIMS Proposal 
19 
assessment responses and reactions to written materials will be encouraged. Participants will also be 
asked to practice skills and test solutions to problems outside of therapy sessions, as a means of 
consolidating in-session learning.  
The RAI curriculum: Research and clinical experience have taught us that survivors differ in how 
they are affected and how they adjust to injury, yet there are many common problems. Delivered in 
seven 60-minute sessions over seven weeks, the RAI curriculum was developed to provide a solid 
foundation for continuing recovery. Enhancing resilience and helping survivors overcome 
commonly encountered issues, concerns, and challenges are key objectives. The following table 
specifies the RAI content areas to be covered (see Implementation Manual in Appendix G for more 
details).  
Session I: Understanding the Effects of Brain Injury will help survivors… 
1. Understand the typical consequences of brain injury 
2. Appreciate the difference between emotional and physical recovery 
3. Cope effectively with loss and change 
Session II: Active Engagement in Recovery will help survivors… 
4. Realize the important role they have in their recovery 
5. Recognize what they can do to help themselves and feel better 
Session III: Setting Reasonable Goals will help survivors… 
6. Appreciate that success is relative  
7. Improve their ability to be patient  
8. Understand and implement effective goal setting strategies 
Session IV: Solving Problems Effectively will help survivors… 
9. Learn and use more effective problem solving strategies 
Session V: Managing Stress, Anger, and Other Intense Emotions will help survivors… 
10. Monitor and manage stress more effectively 
11. Better manage intense emotions including frustration, anger, and fear 
Session VI: Communicating Effectively and Rebuilding Relationships will help survivors… 
12. Rebuild relationships and overcome loneliness 
13. Learn and apply more effective communication skills 
14. Develop strategies for comfortably discussing their injury with others 
Session VII: Maintaining a Positive Outlook will help survivors… 
15. Avoid a negative focus, feeling guilty, or blaming others 
16. Appreciate positive aspects of their new lives, develop a positive attitude, and consolidate gains 
and move forward 
In response to consistent feedback from past RAI participants and Advisory Board 
recommendations, the original RAI protocol has been expanded for the present investigation. 
One of the most consistent recommendations and requests was to lengthen the duration of the 

VCU TBIMS Proposal 
20 
program and to include more person-centered content within the pre-established curriculum. For 
half of study participants (RAI+ group), three 60-minute follow-up booster sessions are planned 
three months after completion of the RAI. The goal of providing booster sessions is to consolidate 
gains achieved in the core treatment, ameliorate the impact of cognitive deficits on learning, and 
address ongoing or new challenges in rehabilitation. In other populations, booster sessions have 
been shown to improve problem-solving, enhance communication, and strengthen relationship 
skills167,168 and in persons with TBI, boosters are associated with improved emotional and 
psychosocial functioning.169 Reflecting a person-centered approach, a framework for the format and 
content of each booster session follows. More information on booster session content and 
implementation is provided in Appendix G.  
Update on Living Situation, Changes, and Life Events 
At the beginning of each session, participants will be asked to give an update on their living situation 
with reference to relationships, work, and activities. Information about ongoing medical care and 
participation in rehabilitation services will also be sought. 
Review of Next Steps for Improvement as specified in RAI Session VII 
The therapist will review the list of ‘Important Things You Can Do to Keep Getting Better,’ completed 
in Session VII that identifies the most important things participants learned during the course of 
treatment and the steps needed to continue improvement. The therapist and participant will review the 
successes and failures in achieving these goals, with an emphasis on consolidating gains by continuing 
to use the most effective coping strategies. 
Review of Concerns Expressed During Previous RAI Sessions 
The therapist will review primary issues and concerns identified by the participant during previous RAI 
sessions. The status of efforts to resolve difficulties will be discussed. Effective and ineffective 
strategies will be distinguished.  
Identification of Ongoing Issues and Concerns  
Participants will be asked to identify new issues or concerns that have arisen since the most recent 
intervention session.  
Problem Solve and Implement Strategies for Improvement 
Where multiple concerns are identified, priorities will be established and a plan for resolution will be 
formulated. Previously learned skills and strategies (e.g., problem solving; managing stress and intense 
emotions; effective goal setting) will be applied to achieve solutions. 
During the third and final booster session, the therapist will again review the list of ‘Important 
Things You Can Do to Keep Getting Better,’ completed in Session VII. Together, the therapist and 
participant will develop a revised list to reflect new learning and new plans for next steps to 
continue getting better. 

VCU TBIMS Proposal 
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D4.  Measures 
The measures chosen for the present investigation were selected because they: (1) are relevant 
to project objectives and hypotheses; (2) have substantial evidence of reliability and validity; (3) are 
included in the NDB; and (4) are included in the Common Data Elements (CDE).190-192  
Patient demographics and history: Information will be collected including: age, gender, ethnicity, 
marital status, household income, living situation, education, pre- and postinjury occupational 
status, and hours worked per week. Additionally, information will be obtained about pre- and 
postinjury substance abuse (Behavioral Risk Factor Surveillance System, BRFSS) and mental 
health treatment. 
Injury characteristics: The following information will be obtained from medical records: date of 
injury, etiology, admission Glasgow Coma Scale (GCS) score, duration of unconsciousness and 
post-traumatic amnesia, duration of hospitalization, time postinjury, and history of neurosurgical 
intervention. 
Connor-Davidson Resilience Scale (CD-RISC): During the past decade, researchers have 
developed resilience measurement scales, and research suggests that Connor and Davidson have 
been most successful.193,194 The authors first developed a 25-item scale (CD-RISC) reflecting 
resilience characteristics identified by Kobasa and Rutter.195,196 Normative studies including factor 
analyses indicated that the CD-RISC is reliable, valid, and sensitive to treatment effects.97 More 
recently, a 10-item version was developed using exploratory and confirmatory factors analyses.197 
Respondents are presented with a series of descriptors (e.g., “I am able to adapt and change,” 
“Coping with stress can strengthen me”) and rate themselves on a 0-4 scale ranging from rarely true 
(0) to true nearly all the time (4). Campbell-Sills and colleagues have characterized the 10-item 
version, to be used in the present study, as demonstrating excellent psychometric properties, namely 
reliability, internal consistency, and construct validity.197,198  
Mayo Portland Adaptability Inventory-4 (MPAI-4): Included as a CDE-recommended global 
outcome measure, the MPAI-4 is comprised of 30 items rated from 0-4, with higher scores 
indicating greater problem severity. The proposed project will focus on the Adjustment and Ability 

VCU TBIMS Proposal 
22 
indices.164 The Adjustment Index items relate to anxiety, depression, irritability, anger, social 
interaction, and self-awareness. The Ability Index includes items relating to verbal and nonverbal 
communication and problem solving ability. T-scores are obtained based on norms derived from a 
brain injury sample. Research has provided evidence of good concurrent, construct, and predictive 
validity, as well as satisfactory internal consistency.164,199 Sensitivity to treatment-related change 
has also been substantiated.200 
13 Item Stress Test: This self-report measure was developed more than a decade ago for clinical 
research studies on stress management with survivors and caregiving family members.162 Sample 
items include, “I have more to do than I can handle,” “I’m pushing myself too hard,” and “I can’t 
stand living like this.” Items are rated as True (+1) or False (0) with higher scores indicating higher 
stress levels.201 The measure has been shown to be sensitive to family intervention after TBI.63,64 
The Total Score will be the measure of interest in the present investigation. 
Brief Symptom Inventory-18 (BSI-18): This 18-item self-report instrument is the abbreviated 
version of the Symptom Checklist-90-Revised (SCL-90-R) developed to quantify psychological 
distress in the general population.165 A number of investigators have used the measure to quantify 
distress after TBI. In particular, researchers have used the BSI to monitor change in psychological 
status in response to treatment202 and general change in status over time.203 The BSI-18 is often used 
because of its sound psychometric properties,165 brevity, ease of administration, and global 
assessment of psychological issues commonly found in individuals with TBI.191 The measure is 
included in the TBI CDE as a gauge of psychiatric and psychological status. 
Frequency ratings for items in three primary symptom dimensions are added to yield scores for 
Somatization, Depression, and Anxiety. The Global Severity Index (GSI) reflects the sum of scores 
for the three symptom dimensions. T-scores for each dimension and the GSI are calculated based on 
community norms. GSI scores, reflecting overall distress levels, will be the focus of the present 
investigation. A study examining the psychometric properties of the GSI with a TBI sample 
characterized the GSI as having good internal consistency with excellent reliability and validity.204  

VCU TBIMS Proposal 
23 
D5.  Research Setting  
Screening, assessment, and intervention will be centralized in the Brain Injury Outpatient 
Research Center, located on the third floor of West Hospital. In operation for more than 25 years, 
the center is centrally located on the VCUHS campus and is fully accessible to individuals with 
disabilities. The center contains a waiting area and central office where patients will be greeted and 
checked in. The center also houses eight private offices, which are ideal for interviews, testing, and 
therapy. Inpatient psychiatric, emergency, and rehabilitation services are located within 500 yards 
of the outpatient center. The offices also house password-protected computers for secure data entry, 
management, and statistical analysis. Locked file cabinets and offices also ensure data security.  
D6.  Procedure 
Patients will be self-referred or referred by professionals within and outside VCUHS, 
organizations (e.g., Brain Injury Association of Virginia), and agencies (e.g., Virginia Department 
of Aging and Rehabilitative Services). N. Moadab will facilitate recruitment at VCUHS outpatient 
clinics. When persons with TBI contact the Brain Injury Outpatient Research Center, an intake 
session will be scheduled.  
During the intake, a therapist (e.g., Dr. Mills, Dr. Hsu) will provide information about the 
research program, and determine eligibility and interest in participation. Staff will explain study 
details and obtain informed consent. When there are concerns about the individual’s ability to 
provide informed consent, formal assessment of decision-making capacity will be made using the 
MacArthur Competence Assessment Tool, Clinical Research version (MacCAT-CR). An instrument 
derived from pioneering multi-center studies of treatment capacity,205 the MacCAT-CR has 
excellent content validity. Some consider the measure to be the only available instrument that 
assesses the full range of abilities relevant to capacity for giving informed consent for research 
participation.206  
The MacCAT-CR has previously been used with persons having dementia,207 depression,208 
schizophrenia,209 and other psychiatric disorders.210 For the present investigation, minimum values 
on each scale of the MacCAT-CR will be established as two standard deviations below the mean for 

VCU TBIMS Proposal 
24 
the normal population.206 This criterion is commonly used in assessment of decision-making 
capacity211-213 and has been shown to be more stringent than expert assessment of capacity.206 
Generally, 15 to 20 minutes is required for completion.214  
As allowed under Virginia state law, an alternative procedure will be used to consent persons 
lacking the capacity to give informed consent, as determined by the MacCAT-CR or judged by the 
investigators. Investigators will seek to obtain consent from a legally designated substitute decision-
maker. In every case, an effort will be made to obtain assent from the patient. Patients who decline 
to participate will not be enrolled regardless of their respective substitute decision-maker’s desire. 
Readers should note, the protocol for this project has been submitted for review and approval to the 
VCU Office of Research Subjects Protection and formal approval is pending. More detailed 
information regarding human subjects protection and safety monitoring procedures is detailed in the 
Human Subjects Narrative (Form 424) and the Data and Safety Monitoring Plan. Readers should 
also note that, once approved, the study will be registered with ClinicalTrials.gov. 
On giving informed consent, participants will be given baseline assessment materials to 
complete. Estimated time for the completion of baseline measures is 30-40 minutes. Project staff 
will make accommodations for persons with visual, motor, and other impairments.  
Using randomization tables provided by our Biostatistician, Dr. Sima, participants will be 
randomly assigned to either of two groups: (1) RAI or (2) RAI+. After randomization, a second 
appointment will be scheduled. Participants will begin treatment during their second appointment.  
The RAI consists of seven 60-minute sessions scheduled over seven weeks as described in the 
Intervention section. During the first session, participants will receive an empty loose-leaf binder to 
store and organize completed self-assessments, reading materials, and homework assignments from 
each session. Participants will also receive a copy of the curriculum, Getting Better and Better after 
Brain Injury: A Guide for Survivors, 2nd edition.183 They will be asked to review materials and 
complete worksheets between sessions. The RAI will be implemented by two experienced, licensed 
therapists (Dr. Mills, Dr. Hsu). Within each treatment condition, participants will be randomly 
assigned to one of the two therapists. Data will be analyzed to identify any therapist effects. 

VCU TBIMS Proposal 
25 
For the RAI+ participants, three booster sessions will be implemented as described in the 
Intervention section of this proposal. The three weekly booster sessions will be scheduled to start 
three months following completion of Session VII.  
Implementation of quality control procedures: A protocol has been established to ensure the 
quality and standardization of treatment implementation across therapists. 
During the two-month project start-up period, the therapists (A. Mills, N. Hsu), and J. Kreutzer will 
meet to review the manual and discuss implementation and standardization procedures.  
Following, each therapist will meet with volunteer participants, and implement Session I of the RAI 
curriculum. Informed written consent for digital audio-recording will be obtained. Afterward, the 
intervention audio-recordings will be reviewed with Dr. Kreutzer, with the manual in hand, to make 
certain that all steps are faithfully completed. Additionally, Dr. Kreutzer will assure that therapists have 
covered the bolded content areas in the manual, which are considered to be key elements of treatment 
(see Appendix G). Strategies for improving consistency between therapists will be discussed and 
implemented. Changes will be made in the implementation manual (e.g., clarification of procedures) as 
needed. 
The two therapists will meet again with the same volunteer participants, and implement the remaining 
six sessions of the RAI curriculum. Again, the audio-recordings will be reviewed with Dr. Kreutzer, 
and strategies for adherence to the manual will be discussed and implemented after each session.  
Every six months thereafter, the complete quality control procedure will be reapplied.  
Additional quality control procedures will be implemented for booster sessions with each 
therapist. As indicated in the Intervention section, booster sessions are person-centered and thereby 
highly individualized. Audio-recordings will be made for the three booster sessions and reviewed 
with Dr. Kreutzer to ensure that key areas are covered as outlined in the manual. Every six months 
thereafter, quality control procedures will be repeated. 
Data collection procedures: Demographic, injury severity, and history information will be 
collected at baseline using TBIMS standard procedures. For RAI and RAI+ participants, outcome 
measures will be obtained prior to treatment (baseline) and following completion of the RAI. 
Outcome measures for RAI+ participants will be obtained at the start and completion of the booster, 
and six months following completion of the booster sessions. Measures for RAI participants will be 
obtained at three, four, and nine months post-RAI treatment. Data collection will occur within the 
same timeframe for both RAI and RAI+ participants as outlined in the figure that follows.  
 
 
 

VCU TBIMS Proposal 
26 
Project timeline: The major activities for the research project are sequentially delineated in the 
Plan of Operation section. 
E.  Data Analysis 
Descriptive statistics (e.g., means, standard deviations, proportions) will be calculated for all 
measures at designated time intervals. Analyses will be performed using the university licensed 
statistical program SAS v.9.3 (© 2002- 2010; SAS Institute Inc.; Cary, NC). The following table 
provides a description of major statistical analysis procedures, emphasizing priority areas related to 
research hypotheses. Information is provided regarding statistical hypotheses, statistical methods, 
power analysis and sample size estimates. Analyses evaluating the RAI+ are based on the intent-to-
treat principle if drop-out is assumed as missing at random or missing completely at random. 
Hypothesis 1 – Primary: Participants receiving the booster (RAI+ group) will report higher levels of 
resilience in comparison to individuals in the standard RAI group. 
Statistical Methods: A linear mixed-effects model will be used to model the CD-RISC scores over 
time for the RAI and RAI+ groups. The model will include fixed-effects for time at RAI+Booster 
initiation, conclusion, and long-term follow-up (e.g. 5, 6, and 11 months), group (RAI or RAI+) and the 
interaction between group and time. The model will also adjust for fixed-effects for injury severity, 
time postinjury, and education. Within-subject correlations in the CD-RISC scores over time will be 
modeled using a spatial power covariance pattern structure. Specific contrast statements will be used to 
test for a difference in the CD-RISC change scores between the treatment groups at both RAI+Booster 
initiation and conclusion as well as RAI+Booster initiation and long-term follow-up at a significance 
level of .05. 
Power Analysis: Data obtained by our group indicated that the mean CD-RISC increased from a 
baseline value of 21.1 units to a mean of 28.4 units post-treatment (Difference=7.3), followed by a 
decline to 25.5 at the 3-month follow-up (Difference=2.9), with a standard deviation (SD) of the change 
score equal to 5.0. Considering a conservative SD of 6.0, this study will require 138 participants (n=69 
per group) using a two-sample t-test performed at the 0.05 significance level to achieve 80% power. 
This effect translates to an effect size d=2.9/6.0=0.48, which is typically considered a moderate effect 
size. 
Hypothesis 2: Participants in the RAI+ group will show better adjustment and lower levels of 
emotional distress as compared to persons in the standard RAI group. 
Statistical Methods: Separate mixed-effects models, similar to that outlined in the methods for 
Hypothesis 1, will be used to model the responses for the MPAI-4 Adjustment Index and the BSI-18 
GSI scores over time for each group. Specific contrast statements will be used to test the hypotheses of 
interest, each assuming a significance level of .05. Using a similar 40% decrease between the baseline 
to post-treatment values observed in our pilot study, we would expect the RAI+ to ameliorate declines 
in the MPAI-4 Adjustment and BSI-18 GSI scores by 1.7 and 2.6 points, respectively. Considering a 
conservative SD of 7.0, the 138 participants enrolled would provide power of 29% and 58% for the two 
outcomes, if analyzed by a two-sample t-test at the 0.05 level. 
Hypothesis 3: Participants in the RAI+ group will report greater abilities in the areas of problem 
solving, communication, and stress management relative to persons in the standard RAI group. 
Statistical Methods: Two additional mixed-effect models, similar to the first three, will be used to 

VCU TBIMS Proposal 
27 
model the MPAI-4 Ability scores and the 13-Item Stress Test scores over time for each group. Again, a 
specific contrast statement will be used to test the hypothesis of interest at a significance level of α = 
.05. In a similar fashion to Hypothesis 2, a 40% decrease between the observed baseline to post-
treatment values yields differences of 1.6 and 0.9 for the MPAI-4 Ability Index and the 13-Item Stress 
Test. Considering a conservative SD of 7.0 and 2.0, respectively, the 138 participants enrolled would 
provide power of 27% and 75% for the two outcomes, if analyzed by a two-sample t-test at the 0.05 
level. 
Hypothesis 4 (exploratory): A participant’s demographic, lifestyle, injury, and treatment response 
information will be predictive of maintenance ability. 
Statistical Methods: Separate linear regression models will be used to determine the relationship 
between each of the demographic, lifestyle, injury, and initial RAI response characteristics and both the 
change in the 5 and 6 month CD-RISC scores, as well as the change in the 5 and 11 month CD-RISC 
scores. Assuming 69 participants in the RAI group complete the study and 8 predictor variables are in 
the linear regression model, this analysis will have 80% power to detect effect sizes of f2=0.12, which is 
considered a moderate effect size. 
Power analyses relating to the primary hypothesis indicate minimum group sizes of 69 participants. 
If we allow for a maximum of 10% attrition, then an additional 8 individuals per treatment group 
(16 individuals total) should be recruited (138/(1-0.1)-138 = 15.3) for a total sample size of 154. 
F.  Feasibility 
F1. Project Staff  
Personnel effort levels are based on thorough consideration of our prior experience conducting 
similar projects. Following is information on responsibilities of personnel allocating >5% effort:  
J. Kreutzer, Ph.D. (12% effort): (1) assume primary administrative responsibility for the project; (2) 
staff training, supervision, and performance monitoring; (3) formulation of data collection protocols; 
(4) obtaining informed consent; (5) being present or on call during each assessment and treatment 
session or ensuring another psychologist is on call throughout the study period; (6) analysis, 
interpretation, and dissemination of findings; (7) completion of progress reports. 
A. Mills, Psy.D. (30% effort): (1) intervention implementation; (2) assist with analysis and 
interpretation of findings; (3) assist in preparing reports, presentations, and publications. 
N. Hsu, Psy.D. (30% effort): (1) intervention implementation; (2) assist with analysis and 
interpretation of findings; (3) assist in preparing reports, presentations, and publications. 
J. Marwitz, M.A. (15% effort): (1) database development; (2) supervision of data coding and entry; (3) 
data management and quality control. 
A. Welch, B.A. (45% effort): (1) obtaining informed consent; (2) coordination and scheduling of 
appointments, providing appointment reminders; (3) collection of assessment and outcome data; (4) 
tracking and maintaining high follow-up rates; (5) medical records review; (6) data coding/entry. 
Dr. Sima, M. Martinez, and N. Moadab will also have a role in the project (each 5% effort). Dr. 
Sima will supervise statistical analysis, conducting a subset of the analyses, and interpreting the 
results for reports and dissemination. M. Martinez will serve as back-up to A. Welch. N. Moadab 
will assist with participant screening and recruitment in outpatient clinics. 

VCU TBIMS Proposal 
28 
F2.  Potential Problems and Anticipated Solutions.  
Our confidence in successful completion of this project stems from our long history of success 
conducting intervention research programs. In consultation with the Advisory Board and R. 
Rawlins, project consultant, potential obstacles have been identified and discussed. Following are 
descriptions of potential problems and proposed solutions. 
Accrual rates may be lower than anticipated. Based on our past research success, we are confident 
in accrual rate estimates, particularly given commitments from the director of the Brain Injury 
Association of Virginia (BIAV) to facilitate recruitment. BIAV's Executive Director helped develop 
the treatment protocol, and has expressed optimism about the protocol's helpfulness. BIAV is in an 
excellent position to assist with recruitment because of their close, daily contacts with individuals with 
TBI and their families. Individuals often contact BIAV to request information about treatment 
alternatives and referral information. BIAV has agreed to help encourage participation in our research 
by dissemination of information in their newsletters and at conferences and workshops they sponsor. 
BIAV will also help disseminate information about the need for research participants to professionals 
and agencies. Advisory Board members, representing a variety of organizations (e.g., Department of 
Aging and Rehabilitative Services, Brain Injury Services, Mill House) and service providers (e.g., Tree 
of Life, Concussion Care Centre of Virginia), have also agreed to disseminate information about the 
project and the potential benefits of treatment (see Appendix C for letters of support). 
Individuals with TBI may have difficulty completing measures because of difficulties with 
fatigue, vision, motor functioning, or other impairments. Failure to include participants with 
severe disabilities may also create a biased sample. Based on our experience, we anticipate that 
fewer than 10% of individuals who are three or more months postinjury will have significant difficulty 
completing the proposed measures. To reduce the likelihood of sample bias, we will invite participants 
to indicate whether they have difficulties and we will offer a variety of accommodations. 
Accommodations may include reading questionnaire items to the person or recording responses for 
them. A record will be kept of accommodations made for each person, allowing an evaluation of 
whether accommodations affected response patterns. 
A number of participants may be unavailable for follow-up. The accrual numbers presented in this 
proposal are based upon a review of data collection rates in past studies conducted at VCU. 
Furthermore, with more than 25 years of experience conducting follow-up studies, we have developed 
an effective follow-up system. The cornerstones of the system include: (a) providing high quality 
clinical follow-up services; (b) maintaining up-to-date contact information; and (c) employing an 
efficient appointment reminder system. Our system employs a combination of in-person, written, and 
telephone reminders. Most of our studies have included annual follow-ups, and follow-up rates have 
ranged between 90-95%.  
Participants may be involved in concurrent individual psychotherapy or support groups or may 
be taking psychotropic medications. Individuals will be eligible for this study regardless of 
concurrent mental health treatment. As a matter of ethical practice, psychiatric consultation will be 
offered to individuals requesting services or who appear to be in need. Information about concurrent 
treatment will be obtained during each assessment session and recorded for each participant. Statistical 
analysis will be implemented to assess the relationship between concurrent therapy participation and 
treatment (RAI) outcome. 
Interventions may not be completed within the proposed timeframe. Ideally, the RAI will be 
completed in seven weeks. For RAI+ participants, ideally booster sessions begin three months after 
completion of the RAI and will be completed in three weeks. Unforeseen delays may arise (e.g., related 

VCU TBIMS Proposal 
29 
to illness, transportation) that may affect timelines. We have built in windows that allow a modicum of 
flexibility. We will record completion dates and statistically evaluate how outcome data are affected by 
deviation from prescribed time intervals. 
G.  Expected Beneficial Impact 
 An effective intervention for survivors will improve psychological outcomes and provide a means of 
counteracting the adverse, far-reaching effects of reduced inpatient lengths of stay.  
 Use of effective patient-focused intervention and outcome tracking will provide an empirical 
foundation for utilizing person-centered interventions. 
 All systems of care have resource limitations. Improved understanding of effective skill building, 
support, and education strategies will help systems more efficiently allocate resources. 
 Identifying the attributes of participants who are treatment-resistant will facilitate development of 
effective alternative treatments. 
 Effective treatment to promote resilience and adjustment will reduce the adverse impact on family 
members who are often in a caregiving role. 
 Providing empirically-based guidance to clinicians serving participants will enable them to deliver 
more effective and efficient services.  
 Development of a structured, replicable intervention will allow treatment providers and advocacy 
organizations to provide services in more settings. 
 New hypotheses will be generated for future treatment studies. 
 Empirically-based research findings will provide a rationale for requiring third party payers to cover 
the cost of intervention services, previously dismissed as having uncertain efficacy. 
Caregiver Resilience: A Longitudinal Investigation 
Introduction and Review of Literature 
Many persons with moderate to severe TBI require assistance from a caregiver for months or 
years postinjury.215 A caregiver is an individual who provides help, support, guidance, or 
supervision to a person in need. Caregivers for persons with TBI are typically female and a parent 
or spouse of the survivor.216,217 While there is some evidence caregivers have positive feelings about 
their role,218,219 many report emotional distress,43,220-222 perceived burden44,223 and life 
dissatisfaction.224 One of the most widely-cited studies of caregiver distress was a TBIMS, multi-
center prospective study.43 Investigators found clinically significant rates of depression (19%), 
anxiety (18%), and somatic symptoms (24%), with one in ten caregivers exceeding the cut-offs on 
all three scales.  
A shift in the field of psychology has led to a focus on the positive facets of postinjury 
adjustment, notably, resilience. Unfortunately, little is known about caregiver resilience after TBI. 
To date, only two studies have explored caregivers’ postinjury resilience.67,68 Las Hayas and 
colleagues67 found that Spanish caregivers’ resilience was positively correlated with quality of life 

VCU TBIMS Proposal 
30 
and negatively correlated with perceived burden. However, the study aimed to describe the 
psychometric properties of a new resilience questionnaire, and caregivers’ resilience levels were not 
described. Simpson and Jones68 found that higher levels of resilience among Australian caregivers 
were associated with lower rates of negative affect and caregiver burden. Using Wagnild’s criteria, 
the resilience level of Simpson’s sample would be characterized as “moderately low to 
moderate.”225 Las Hayas’ and Simpson’s studies are limited by small sample sizes and use of cross-
sectional data from a single center.  
Given the scarce literature on TBI caregivers, we examined studies of resilience among 
caregivers of persons with dementia. Although dementia differs from TBI in several important 
ways, caregivers of persons with dementia take on somewhat comparable caregiving roles, such as 
support of self-care, instrumental activities of daily living, cognitive functioning, and emotional 
well-being.226 Thus, findings from this literature can offer insight into resilience among TBI 
caregivers. In a Brazilian study of dementia caregivers, investigators found higher levels of 
resilience were related to lower levels of emotional distress. Caregiver resilience was unrelated to 
caregiver gender or patients’ clinical or sociodemographic characteristics.227 Elnasseh and 
colleagues226 found that for Argentinian caregivers, higher levels of resilience were associated with 
empathy, optimism, and fewer family problems. Fitzpatrick and Vacha-Haase228 found that 
resilience was unrelated to marital satisfaction, but was related to self-efficacy. In a study of 
Alzheimer’s caregivers, Wilks found that younger age and African-American ethnicity were 
associated with higher levels of resilience. Marital status, gender and relation to caregiver recipient 
were unrelated to resilience levels.229  
In summary, the literature on resilience among caregivers of persons with dementia is generally 
characterized by small sample sizes227,228 and measurement at a single time point.226-228 Most studies 
did not fully describe resilience levels, leaving questions about the quality of caregivers’ resilience 
unanswered. Of the two studies that did provide mean resilience values,227,229 resilience levels were 
considered to be moderate to moderately low based on general population norms.225 Nevertheless, 

VCU TBIMS Proposal 
31 
the evidence from both the literature on caregivers in TBI and dementia is clear – resilience is 
associated with emotional well-being67,68,227 and perceived burden.67,68  
A. Rationale: The Need for Research  
Caregivers provide integral support to survivors, especially after hospital discharge. Concerns 
have been expressed that many survivors go home to family members who are ill-prepared to 
manage commonly encountered problems.230 Caregiving places a great burden on family members 
that is manifested in high rates of depression, anxiety, and somatic concerns. 
Until recently, research on caregivers had focused on only the negative correlates of caregiving. 
A greater appreciation of strengths-based approaches in psychology mandates that we take a more 
holistic view of caregiving. Whereas there have been several studies exploring resilience among 
survivors of TBI, very little has been written about resilience in their caregivers. As with other types 
of illness, improving outcomes for persons with TBI may be predicated on the well-being of their 
support persons.231,232 Research to quantify and characterize the nature of caregivers’ resilience 
postinjury is a cornerstone to advancing the evidence base on adjustment after TBI. Thus, the 
primary purpose of the proposed study is to investigate TBI caregivers’ resilience over time. 
Understanding factors relating to resilience will likely help identify components of a resilience-
building intervention for caregivers and ultimately help to improve outcomes for survivors. 
B. Research Questions 
For the past 30 years, we have had a strong interest in understanding and serving families after 
TBI. As clinicians, we have interviewed hundreds of caregivers and assessed their needs, concerns, 
and desires for resources. For the past 25 years, we have performed clinical research on family 
functioning, needs, life satisfaction, and emotional well-being with a focus on caregivers after TBI. 
For the past five years, we have been conducting research on resilience, focused on survivors. To 
develop the proposed module, we considered the comments and feedback from caregivers in our 
family practice. Further, the proposed module was also shaped by our Advisory Board, NDB 
participants, and NDB caregivers. Their feedback affirms that our new focus on caregiver resilience 

VCU TBIMS Proposal 
32 
is timely, relevant and complements our prior research. From our discussions, interviews and 
review of the current literature, a series of important questions have emerged: 
1. What is the trajectory of caregiver resilience over the first two years postinjury? Does resilience 
change over time for some caregivers? If yes, what patient and caregiver factors are related to 
decline or improvement? 
2. What is the relationship between caregivers’ resilience and their emotional well-being? Can the 
proposed longitudinal, multi-center study reproduce results from several single-center, small-
sample studies with TBI and dementia caregivers? 
3. A few TBI caregiver studies found a relationship between caregiver resilience and perceived 
burden. In addition to perceived burden, do other caregiver factors (e.g., needs, time spent caring 
for the patient) relate to resilience? 
4. What is the relationship between caregiver resilience and patient characteristics, including 
resilience, emotional distress, and functional status? 
C. Methodology 
C1. Stage of Research 
The proposed module project is best labeled as falling within the “Exploration and Discovery” 
stage of research. The present investigation is intended to generate hypotheses and theories through 
analysis of prospective, multi-center, longitudinal data. There is little information to aid our 
understanding of the construct of resilience in caregivers after TBI, despite the potential relevance 
to patients’ rehabilitation and recovery. Research suggests that resilience can be improved with 
training, and we anticipate that the results of this project will facilitate the development of effective 
interventions that benefit caregivers and patients. 
C2. Sample 
Information regarding inclusion and exclusion criteria, enrollment rate, and participant 
incentives is provided herein. Recruitment information is provided in the Procedure section. 
Inclusion criteria: Caregivers age 18 and older, identified within six months postinjury by TBIMS 
NDB participants (survivors) will be included. Participants will include relatives, friends, or other 
acquaintances involved in providing care, support, or other meaningful assistance to the survivor. In 
cases where there is more than one caregiver available, first priority will be given to the caregiver 
who is providing the most care to the survivor. A script will be developed for data collectors, 
allowing them to better identify a single caregiver for each survivor.  

VCU TBIMS Proposal 
33 
Exclusion criteria: Survivors who are unable to identify a relative, friend, or other caregiver will 
not be enrolled in the study. Formal caregivers, those who are a paid professional, will not be 
included in the study. Records will be kept indicating the number and type of exclusions. The data 
will be evaluated to help ascertain the representativeness of the final sample. 
Enrollment rate: Considering the proposed eligibility criteria and past experience with similar 
research, we estimate accrual of no less than two caregivers per month, for a total of at least 26 
annually. We anticipate three additional TBIMS centers will participate in this module with similar 
accrual rates. Conservatively, 78 VCU participants and 234 partner site participants will be enrolled 
for a total of 312 participants over the 36-month enrollment period. As noted in the Data Analysis 
section, the power analysis indicates our anticipated sample size is more than adequate. 
Participant incentives: Caregiver participants will be given $50 for completing each of the three 
assessments. Survivors will be given $50 for completing the first assessment, as it falls outside of 
NDB protocol. Survivors will receive NDB protocol compensation ($50) for the second and third 
assessments.  
C3. Measures 
The measures chosen for the present investigation were selected because they: (1) are relevant 
to project research questions; (2) have substantial evidence of reliability and validity; and (3) are 
included in the NDB.  
Connor-Davidson Resilience Scale (CD-RISC): A full description of the CD-RISC can be found 
in the site-specific project (Intervention to Promote Survivor Resilience and Adjustment Measures 
section). As mentioned previously, normative studies including factor analyses indicated that the 
CD-RISC has excellent psychometric properties, including reliability, internal consistency, and 
construct validity.97,197,198 The scale has been effectively used with a wide variety of populations, 
including caregivers of relatives with Alzheimer’s disease.229,233 The CD-RISC will be completed 
by both survivor and caregiver. 
Patient Health Questionnaire-9 (PHQ-9): The PHQ-9 is used to assess depressive symptom 
severity and identify depression based on diagnostic criteria.234 The 9-item scale assesses frequency 

VCU TBIMS Proposal 
34 
of symptoms on a scale of “0” (not at all) to “3” (nearly every day). 234 Depression severity can be 
determined by calculating the total score, ranging from 0-27, with interpretation cut-off scores of 0-
4 (minimal), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe) and >20 (severe).234 The 
PHQ-9 has good reliability and validity across clinical and racial/ethnic groups, including 
individuals with a history of TBI.234-236 This widely used measure of depression is also sensitive to 
change over time.237 The PHQ-9 will be completed by both survivor and caregiver. 
Generalized Anxiety Disorder-7 (GAD-7): The GAD-7 is used to screen for generalized anxiety 
disorder and assess symptom severity.238 The 7-item scale is based on diagnostic criteria and review 
of existing measures.238 Frequency of symptoms are assessed on a scale of “0” (not at all) to “3” 
(nearly every day). Total scores range from 0-21, with increasing scores indicating more severe 
levels of anxiety.238 The GAD-7 is a reliable and valid measure of anxiety in the general population 
and in individuals with TBI.238-240 Both survivor and caregiver will complete the measure. 
Family Needs Questionnaire (FNQ): The FNQ is a 37-item questionnaire developed to measure 
family members’ perceived needs after a survivor’s brain injury.241 The items were designed to 
address diverse postinjury psychosocial and educational needs. Caregivers rate the degree to which 
each need has been met (not met, partly met, or met). An early investigation provided evidence of 
content and construct validity. Internal consistency was indicated by a Spearman-Brown split-half 
reliability of .75.242 A later factor analytic investigation revealed six independent factors comprising 
six scales: Health Information, Emotional Support, Instrumental Support, Professional Support, 
Community Support Network, and Involvement with Care.243 Internal consistency for individual 
factors was indicated by Cronbach’s alpha’s ranging from 0.78 to 0.89. For the present 
investigation, the proportion of needs rated as met, converted to a 10-point scale, for the four scales 
most relevant to post-acute needs will be used (e.g., Emotional Support, Instrumental Support, 
Professional Support, Community Support Network). 
Zarit Burden Interview (ZBI): The ZBI was originally developed as a 22-item questionnaire 
designed to quantify caregiving burden and is the most commonly used measure of such.244 
Caregivers are asked to describe perceived changes in their emotional or physical health, social life, 

VCU TBIMS Proposal 
35 
and financial status as a result of caring for a relative. Items are rated on a 5-point Likert scale, 
ranging from 0 (never) to 4 (nearly always). A total score is derived, representing the extent of 
burden, with higher scores denoting greater burden. Research has evaluated the utility of a 12-item 
version.245 The correlations between the short and full version ranged from .92 - .97, substantiating 
the comparability of both versions. In a study among three caregiving populations (advanced 
cancer, dementia, and acquired brain injury), the 12-item ZBI had excellent validity (rho = .95-
.97).246 Both the 12- and 22-item versions have been used with adult and pediatric TBI 
populations.66,219,223,247 The present investigation will utilize the 12-item version.  
Caregiver demographics and history: Demographic data collected will consist of age, gender, 
race/ethnicity, marital status, household income, years of education, occupational status, and nature 
and length of relationship with survivor. To help characterize relationships, the caregiver will also 
be asked to indicate: (a) whether they are living with the survivor; (b) the number of hours spent 
caring for them daily; and (c) and the average number of days per week the caregiver sees the 
survivor. Additionally, information will be obtained about current and past mental health treatment 
and substance abuse, using the same variables as the NDB. 
Survivor demographics and history: Data from the NDB protocol will be used. In addition, at the 
6-month follow-up, the Disability Rating Scale and PART (Participation Assessment with 
Recombined Tools-Objective) will be collected.  
Injury characteristics: The following information will be used from the NDB data collection: date 
of injury, etiology, admission GCS score, duration of unconsciousness and post-traumatic amnesia, 
duration of hospitalization, and history of neurosurgical intervention (e.g., craniotomy/craniectomy, 
ICP monitoring). 
C4. Procedure 
This will be a multi-center, prospective longitudinal investigation. Newly enrolled TBIMS 
NDB participants will be contacted after discharge and no more than six months postinjury and 
asked to identify a caregiver. Caregivers will be approached, provided with information about the 
project, and invited to participate. Informed consent will be obtained. At six months postinjury (+/- 

VCU TBIMS Proposal 
36 
two weeks), caregivers will be asked to complete baseline assessment materials and TBIMS 
participants will complete measures as well. Caregiver participants will be contacted again at 12 and 
24 months postinjury and asked to complete primary outcome measures. TBIMS participants will 
be contacted per standard NDB protocols. Data will be collected via telephone, in person, or by mail 
at the time points specified in the following table.  
Content Area/Measure 
6 months 
12 months 
24 months 
Demographics (caregiver) 
x 
 
 
Functional Outcome (DRS, PART) 
x 
x 
x 
Resilience (CD-RISC) 
x 
x 
x 
Emotional wellbeing (PHQ-9 and GAD-7) 
x 
x 
x 
Family Needs (FNQ) 
x 
x 
x 
Burden (ZBI) 
x 
x 
x 
Estimated time for caregivers to complete measures is 20-30 minutes. Additional time required 
of survivors, beyond the standard NDB protocol, is 10-15 minutes. Project staff will make 
accommodations for persons with visual, motor, and other impairments. To maintain confidentially, 
data collected from the caregiver will not be shared with the survivor, and data collected from the 
survivor will not be shared with the caregiver. The same procedures will be employed at 
collaborating centers. 
With regard to safety monitoring at VCU, Dr. Kreutzer will be on call during each assessment. 
He will monitor the status of enrolled participants and address urgent situations. When concerns 
arise, Dr. Kreutzer will be contacted immediately to make a clinical decision regarding the need for 
further evaluation, treatment, or referral. In-person assessments will be conducted in the hospital 
where a full range of mental health services are available. Once collaborating centers are identified, 
the project will be submitted to the VCU Office of Research Subjects Protection for review and 
approval. More detailed information regarding human subjects protection and safety monitoring 
procedures is detailed in the Human Subjects Narrative (Form 424). 
Implementation of quality control procedures: A standard protocol will be implemented to 
maintain consistency and timeliness of data collection across centers. Each center will have a 
management team consisting of a project director and project coordinator. With assistance from the 
coordinator, the director will have primary responsibility for ensuring: 

VCU TBIMS Proposal 
37 
 enrollment of appropriate participants with respect to inclusion and exclusion criteria 
 proper administration of measures 
 completion of assessments within specified timeframes 
 accurate entry of data 
In collaboration with the NDSC, VCU will develop the project database. Computer scoring will 
be used to eliminate errors in calculating and converting scale scores. Data entry programs will be 
set up to eliminate the possibility of entering out-of-range values. 
D. Data Analysis 
Descriptive information will be computed for each of the variables measured in this study. 
Separate summaries will be provided for those measures collected at each follow-up. Caregivers 
will be classified as having increasing, decreasing, or stable resilience based on a 3-unit change in 
CD-RISC scores. The 3-unit cutoff was chosen since it is approximately the level of decrease we 
found in our previous research focused on postinjury resilience (manuscript under review, Archives 
of Physical Medicine and Rehabilitation). ANOVA and Pearson chi-square tests will be used to 
determine if caregiver characteristics are related to resilience score changes. Additionally, a latent 
class linear mixed model (LCLMM) predicting the longitudinal CD-RISC values will be used to 
identify groups of caregivers that have similar trajectories over time and the characteristics related 
to these groups.248-251 Since data from a maximum of three time points will be available, only 
quadratic trajectories will be considered. The number of latent groups will be chosen by selecting 
the model with the smallest Bayesian information criterion (BIC), while limiting the model to 
include no more than 10 trajectories. After identification of the optimal model, a 3-step process will 
be used to classify and determine the relationship of both caregiver and patient characteristics with 
the latent trajectories.252  
Following our strategy with previous longitudinal studies of resilience (under review, Archives 
of Physical Medicine and Rehabilitation), individual growth curve analyses will be used to assess 
the relationships between caregivers’ resilience and the longitudinal caregiver and patient 
characteristics. These models will include correlated random intercept and slope effects. Separate 
models will be fit with time, each caregiver and patient characteristic, and the interaction of these 
variables. Similar models will be fit without the interactions, and any interaction or individual 

VCU TBIMS Proposal 
38 
characteristic significant at the 0.05 level will be candidates to be entered into the final model. A 
backwards selection procedure will be performed so that all remaining characteristics have a p-
value <0.05. The continuous time variable will remain in the model regardless of statistical 
significance. A random effect will be included to adjust for the different study sites and all 
inferences will be adjusted for the estimation of the random effects using a Kenward-Rogers 
adjustment.253  
The SAS software will be used for all analyses except the LCLMM analysis, which will be 
performed using the ‘lcmm’ package in R.251 All inferences will be made at the 0.05 level and all 
statistical models, with the exception of the ANOVA and Pearson chi-squared tests, are able to 
incorporate data that is missing at random. An adjustment for multiple comparisons will not be 
made due to the exploratory nature of the study.254 
Power Analysis: Conservatively, assuming that 85% of caregivers (N=266) will complete the two 
year follow-up, a one-way ANOVA will be able to detect effect sizes of f=0.19 with 80% power. A 
Pearson’s chi-square test will have power to detect an effect size of ω=0.19 or ω=0.20 for 
characteristics with two levels and three levels, respectively. Each of these are considered small 
effect sizes. Since we do not have an a priori idea of the number or structure of the latent 
trajectories, it is extremely difficult to determine the achieved power of LCLMM analysis. One 
conservative metric indicates that no fewer than ten observations per variable should be obtained for 
adequate power and specificity, while others have suggested that > 500 observations are 
required.255,256 By either metric, our study will achieve recommended samples sizes, even if we 
restrict ourselves to caregivers that contributed data at all three time points (266 participants x 3 
time points=798 observations). Lastly, a linear mixed effect model with a 3-level covariate will 
have 80% power to detect a covariate by time interaction of effect size f=0.10 at the 0.05 level 
assuming a small correlation between time points of 0.25. Two-level variables and continuous 
variables will both be able to detect smaller effect sizes under similar conditions.  

VCU TBIMS Proposal 
39 
E. Feasibility 
E1. Project Staff 
Personnel effort levels are based on thorough consideration of our prior experience conducting 
similar projects. Following is information on responsibilities of personnel:  
J. Kreutzer, Ph.D. (6% effort): (1) assume primary administrative responsibility for the proposed project; 
(2) staff training, supervision, and performance monitoring; (3) formulation of data collection protocols; 
(4) being present or on call during each assessment session or ensuring another psychologist is on call 
throughout the study period; (5) analysis, interpretation, and dissemination of findings; (6) completion of 
progress reports. 
J. Marwitz, M.A. (20% effort): (1) preparation of syllabus and procedures manual; (2) in collaboration 
with NDSC, develop data entry and scoring quality control procedures; (3) scheduling multi-center 
teleconferences and meetings for training, quality control, and dissemination planning; (4) supervision of 
local data collection and entry; (5) assistance with data analysis. 
M. Martinez, B.A. (20% effort): (1) obtaining informed consent; (2) coordination and scheduling of 
appointments, providing appointment reminders; (3) data collection and entry; (4) tracking and 
maintaining high follow-up rates. 
A. Sima, Ph.D. (8% effort): (1) supervise statistical analysis; (2) conducting a subset of analyses; (3) 
interpreting the results for reports and dissemination. 
E2. Potential problems and solutions 
In consultation with the Advisory Board and Scientific Advisors, potential problems with 
procedures in this investigation have been considered to prevent and address them effectively. 
Following are descriptions of potential problems and proposed solutions. 
Accrual rates may be lower than anticipated. We are confident in accrual rate estimates, given the 
success of previous module projects we have managed (e.g., resilience module, caregiver module). A 
variety of strategies will be used to ensure successful recruitment and enrollment. Accrual rates will 
be closely monitored, allowing us to be aware of failures and successes early on. Early identification 
of accrual problems will enable early implementation of corrective actions. A variety of mechanisms 
(e.g., regular conference calls and meetings, list server) will be used to promote sharing of 
information about effective and ineffective recruitment strategies. Sample size calculations are based 
on collaborating with three other centers. Based on prior experience leading modules, we anticipate a 
high likelihood that more than three other centers will participate as collaborators, allowing for 
increased accrual.  
A significant number of participants will be unavailable for follow-up. Our twenty-five years of 
TBI research experience has led us to develop effective follow-up systems. The cornerstones of the 
system include: (a) providing high quality clinical follow-up services; (b) maintaining up-to-date 
contact information; (c) employing an efficient written and telephone appointment reminder system; 
and (d) communication (e.g., sending birthday and holiday greeting cards) and sharing research news 
(e.g., via quarterly newsletter). VCU follow-up rates at one and two years postinjury have ranged 
from 90-95%. With regard to collaborating centers, our expectations about follow-up rates are based 
upon a review of data collection rates for previous modules in which we have participated. 
Furthermore, the TBIMS has established guidelines for optimal follow-up and all centers will adhere 
to these guidelines for the module effort.  

VCU TBIMS Proposal 
40 
F. Expected Beneficial Impact 
 A focus on resilience offers a promising opportunity to better understand and conceptualize 
caregivers’ experiences after TBI. 
 We will gain a new and better understanding of how caregiver attributes, namely resilience, relate 
to survivor outcomes and caregiver burden and needs. 
 New hypotheses will be generated for future caregiver intervention development. 
 The development of empirically-based interventions for caregivers has the potential to benefit 
outcomes for survivors. 
IV. Dissemination Activities 
Disseminating relevant, accurate information about TBI and dispelling public misinformation 
are important goals for this proposal. The following methods and formats will be employed to meet 
these objectives: (a) lectures, workshops, conferences; (b) publications; (c) web sites; (d) technical 
assistance; and (e) internships, practica, and research training experiences. We will disseminate at 
least five categories of information: research knowledge (results of scientific investigations, 
methods of design and analysis), program development (methods of rehabilitation program planning 
and development), evaluation (methods of medical, functional, cognitive, psychosocial, and 
vocational assessment; program evaluation), rehabilitation practice (medical care and rehabilitation 
methods), and resources (identifying appropriate support and rehabilitation services).  
Several factors will help assure that dissemination activities are effective, useful, and of high 
quality. To plan each dissemination activity, input regarding format, content, and quality will be 
solicited from relevant sources, including consumers served by the TBIMS, Advisory Board 
Members, the MSKTC, and intended audiences. Feedback relating to past activities will also be 
reviewed. After completing each activity, feedback will be solicited and used to guide later 
dissemination activities. 
As indicated in their letters of support, BIAV and DARS have agreed to serve an important role 
in dissemination activities. Both organizations’ leaders are members of our Advisory Board. They 
will have planning, implementation, and evaluation roles, ensuring that dissemination activities are 
relevant, useful, and of high quality. BIAV and DARS routinely conduct needs assessments and 
have agreed to share the results with us. Through collaborative dissemination projects, VCU has 
also developed a close working relationship with BrainLine and WETA-TV (see Appendix C, letter 

VCU TBIMS Proposal 
41 
from N. Gunther). WETA is the flagship PBS station in Washington, D.C. We will continue to 
support WETA in developing programming and their website, and we will solicit feedback from 
them regarding VCU projects.  
Kelli Williams Gary, Ph.D., MPH, OTR/L, will serve as Dissemination Coordinator. As a 
person with a disability and over 20 years of experience in the field of TBI rehabilitation, Dr. Gary 
is well-qualified to serve in this capacity. Additionally, she is on the Board of Directors for BIAV. 
Her close working relationships with other regional organizations will enable her to successfully 
solicit feedback about dissemination activities. Dr. Gary’s credentials and responsibilities are 
detailed in the Project Staff and Plan of Operation sections. 
To enhance the usability and accessibility of dissemination materials, program materials will be 
made available in multiple formats with sensitivity to issues of culture, language, literacy, and 
disability. Before, during, and after each activity, individuals will be welcomed to identify desired 
accommodations or modifications to increase their likelihood of benefit. We are strongly committed 
to doing our best to accommodate the needs of all individuals. Further, VCU’s Spanish/English 
Translation and Interpretation Service (SETI) will help translate materials into Spanish and 
facilitate planning of dissemination activities for Spanish-speaking individuals.  
Dissemination Methods and Objectives 
Following are descriptions of dissemination methods and planned activities. Use of multiple 
methods and activities will increase usability and accessibility for persons with different needs. 
A. Conferences: Conference activities will incorporate lectures, workshops, case presentations, 
panel presentations, and invited peer-reviewed papers and posters. Materials normally produced for 
each conference will include a syllabus, and often, audiotapes or videotapes of presentations. 
VCU Sponsored Interdisciplinary Conferences for Professionals 
Annual (“Williamsburg”) Conference on Rehabilitation of the Adult and Child with Brain Injury. 
For 40 years, this international conference has been held in central Virginia. Interdisciplinary faculty 
interact with audiences of 200-300. The VCU TBIMS program has co-sponsored the 2-3 day conference 
since 1992, reaching a total audience of nearly 5,500. Each year, more than 50 hours of instruction are 
provided, and conference faculty from other collaborating TBIMS programs play a vital role in 
presentations. Continuing education credits are offered to attendees by professional certification 
organizations (e.g., CRC, NASW, CCM, APA). Annual conferences are planned during the five-year 
period, and TBIMS program information dissemination will remain a major objective. 

VCU TBIMS Proposal 
42 
Conferences for Persons with TBI and Family Members 
The Getting Better and Better after Brain Injury Workshops have been provided to consumers and 
family members since 1998. Typically, two to four workshops per year have been completed across the 
state. Moving educational programs to rural areas has allowed us to reach underserved persons. We will 
continue to offer regional workshops relating to self-advocacy, adjustment to injury, and accessing 
resources during the proposed funding period. The workshops offer an opportunity to provide education 
and training, as well as a platform to inform individuals about ongoing TBIMS research projects. 
Program staff have routinely served as faculty and program planning committee members at the 
invitation of DARS, BIAV, Brain Injury Services, and other state organizations. We are committed to 
continuing to serve in this capacity. 
Conferences Sponsored by Rehabilitation Providers, Professional Organizations, and Universities 
Project staff have routinely been invited to lecture nationally and internationally because of their 
relevant interests, publication records, and public speaking skills. More than 200 presentations were 
given in the last five years by TBIMS staff. Every effort will be made to continue. 
B. Publications will include books, manuals, and manuscripts in peer-reviewed journals. We will 
continue supporting the National Rehabilitation Information Center (NARIC), providing them with 
copies of materials and responding to inquiries. In addition, we are committed to working with the 
MSKTC and the Brain Injury Association of America (BIAA) to meet organization objectives, and 
will continue to share newly developed program materials with them. Our campaigns to promote 
dissemination of accurate information about TBI in the news and social media (e.g., Twitter, 
Facebook) will also continue. The following table highlights aspects of our publication plans: 
Publications for professionals. Project personnel selection has partly been based on productivity. 
Examination of curriculum vitae (see Appendix B) clearly shows historically high productivity records. 
The VCU TBIMS has greatly exceeded previous commitments to disseminate findings. For example, in 
the successful 2012-2017 TBIMS application, a commitment was made to publish at least 40 
manuscripts during the five-year funding period. More than 45 publications, including books and 
manuscripts, were completed. Since 2000, project personnel have published 19 books on TBI 
rehabilitation (e.g., community integration, vocational rehabilitation, behavioral management, cognitive 
rehabilitation). The books and many of the journal manuscripts emphasize practical treatment 
approaches and NIDILRR priority areas. 
Project personnel are editors of major rehabilitation journals and serve on a number of editorial 
boards. J. Kreutzer is Co-Editor-In-Chief of two international journals, Brain Injury and 
NeuroRehabilitation. As indicated in CV’s, key personnel also serve on journal editorial boards. Here, 
key personnel will enhance accessibility of TBIMS literature. For example, an entire issue of Brain 
Injury (2012; volume 26, issue 11) was allocated to presentation of information regarding NIDILRR’s 
TBIMS research and programs.  
Publications on special topics for consumers. We are committed to developing educational materials 
for consumers that provide practical solutions to commonly encountered problems. The VCU TBIMS 
has developed and disseminated a wide variety of written and audiovisual materials. For example, we 
developed the 25 Ideas Series, a series of four books that provide practical information relating to TBI, 
recovery, resources, and self-advocacy with the second edition of Getting Better and Better after Brain 
Injury: A Guide for Survivors released in 2012. Two additional books were written, Memory Matters 
and Recovering Relationships after Brain Injury. Four of our books have been converted to audio CD 

VCU TBIMS Proposal 
43 
for persons with visual impairments. Other educational materials developed include the Help You Need 
Guides, seven tri-fold brochures on topics relevant to TBI. A similar series of guides was also developed 
to address the needs of family members and friends. For the new funding cycle agreements have been 
reached with BIAV and DARS to identify additional topics and aid in dissemination. When completed, 
multiple copies of each guide will be sent to BIAA, all state-affiliated BIA’s, and DARS regional brain 
injury resource centers. Guides and other materials will also be distributed at regional conferences and 
workshops. Furthermore, materials are provided to all persons with TBI receiving services at VCUHS. 
Quarterly Newsletter. TBI Today is in its fifteenth year of production. The newsletter provides 
educational information to consumers and families. Distribution by regular mail is over 800, with issues 
also emailed to over 2,000 subscribers and posted on the VCU TBIMS website, 
http://model.tbinrc.com/newsletters. Staff will continue to produce TBI Today during the next funding 
cycle. 
BIAV Newsletter. Headway is published quarterly. In each newsletter J. Kreutzer and colleagues are 
contributors and have a long-term agreement to publish at least one new article in each issue. We will 
continue to publish articles describing our research findings.  
Dissemination of Information to Local and National Media through Newspapers, Magazines, 
Radio, and Television. The media provides opportunities to educate a large public audience. The VCU 
News Services Office has assigned the TBIMS a media consultant, Erin Lucero. Ms. Lucero, an 
experienced journalist, has worked with us in the past and is very knowledgeable about TBI and 
rehabilitation (see Appendix D for biographical information). Notably, VCU’s TBIMS experienced 
significant media attention (e.g., front page of the January 10, 2012 NY Times Science section; and 
WETA-TV). Through regular contacts and press releases, Ms. Lucero will continue to distribute 
information about the TBIMS in the proposed funding cycle.  
C. Web Sites: For more than a decade, the VCU TBIMS program has worked to make electronic 
communication and information sharing a helpful resource for consumers and professionals. We 
have established and maintain three active web sites, The National Resource Center for TBI 
(www.tbinrc.com), and The VCU TBI Model System (http://model.tbinrc.com), and VCU Family 
Support Research (www.tbifamilyresearch.com). In addition, we provide support for The Center for 
Outcome Measurement on Brain Injury (COMBI, www.tbims.org/combi). We will continue to 
support the COMBI and serve as the designated expert for the Family Needs Questionnaire, the 
Neurobehavioral Functioning Inventory, and the Service Obstacles Scale. 
The National Resource Center for TBI and VCU TBI Model System sites were created in 1999. 
Following are descriptions of site content information. Site content will be reviewed, updated, and 
improved throughout the project funding period.  
 Mailing list subscription - individuals can subscribe to the web sites’ mailing lists to receive regular 
e-mails. Subscribers will receive updated information about project activities and TBI Today 
newsletters.  
 Frequently Asked Questions (FAQ’s) - an extensive listing with responses from regional and 
national experts; topic areas include networking to locate services, general information on TBI, 
rehabilitation options, cultural issues, return to work, women’s issues, family adjustment, behavioral 

VCU TBIMS Proposal 
44 
issues, and self-advocacy. Responses to questions will be solicited from TBIMS staff and Advisory 
Board members.  
 VCU TBIMS information - a description of research programs along with list of publications. 
 “Chat with Pat” - a support and advice column for everyday problems and concerns. 
 TBI Today - quarterly newsletter for the VCU TBIMS described in section B, Publications. 
 Links to other locations - users can review listings of other helpful sites organized by topic. 
 Announcements of conferences and upcoming meetings - information for both professionals and 
consumers is provided for state, regional, and national conferences and meetings. 
 E-mail - users can directly contact all persons listed at the site, directly through links or indirectly by 
mailing the site manager (J. Marwitz). 
The VCU Family Support Research web site provides information for professionals working 
with families after TBI. Publications, links to resources, and training videos on family intervention 
and education are available. Further content development is planned. 
D. Response to inquiries by phone and correspondence: TBIMS staff receive and respond to 
200-350 inquiries annually from consumers, family members, and professionals. Some request 
copies of publications. Others request referral information or technical assistance (e.g., information 
about selection, administration, or scoring of measures). Continuing responsiveness to inquiries will 
enable us to meet a greater diversity of needs and better gauge the needs of the general public. 
E. Internship, Practica and Research Training Experiences: Students enrolled in our training 
programs disseminate information to their mentors and colleagues. Information about their research 
will be disseminated through conference presentations and publications.  
 
VCU was awarded a NIDILRR Advanced Rehabilitation Research Training (ARRT) Grant in 
September 1992, with additional 5 year awards in 1997, 2004, 2009, and 2015. Current funding will 
run through September 2020. The TBIMS setting serves as the primary foundation for post-graduate 
brain injury rehabilitation research training.  
 
Eight dissertations and five master’s theses were completed within our system during the past 
twenty years. A similar rate of future accomplishment is anticipated.  
 
Our relationship with students has extended beyond VCU, and includes University of Richmond, 
the College of William and Mary, University of Virginia, Eastern Virginia Medical School, 
Washington and Lee University, and University of Mary Washington students. We will continue to 
work with universities to provide opportunities for research and clinical training. 
Information Products and Production Rates 
An active web site and mailing list substantially increase our ability to provide information and 
technical assistance. Including web site visits, emails, and phone calls, we anticipate responding to 
5,000-10,000 information requests. Serving as a benchmark, the following table depicts the 
minimum number of major products we intend to develop and distribute annually, beginning Year 1: 

VCU TBIMS Proposal 
45 
Annual Production 
Information Product Type 
6-10 
Peer reviewed publications, book chapters, and books 
20-30 
Presentations at regional and national meetings 
8-12 
Special topic reports, reference lists, Help You Need Guides. 
4-8 
Newsletter, newspaper and magazine articles 
Our Dissemination Coordinator, Dr. Gary, will compile and maintain a listing of products 
completed and in preparation. The list will be updated monthly and revisions will be posted online. 
Completion of new products will be announced via newsletters, mailing lists, and social media. 
Expected Beneficial Impact 
Information developed through the VCU TBIMS has been and will be used to directly extend 
and improve the continuum of care in our region. Successful dissemination will ensure that benefits 
also accrue for persons outside our geographic area. The following primary benefits are anticipated: 
 
Increased knowledge about TBI and rehabilitation resources 
 
Improvement in consumers’ ability to self-advocate and serve actively in rehabilitation planning 
 
Increased accessibility to appropriate rehabilitation and support services 
 
Improved communication between consumers and professionals 
 
Increased inclusion of persons with disabilities through reduction and removal of barriers created by 
negative stereotypes and misinformation 
 
Improved life satisfaction for survivors and their families as a result of increased knowledge 
 
Greater levels of support for effective rehabilitation programs 
V.  Plan of Operation  
The management plan will make certain that all project objectives are accomplished within 
budget, on time, and with integrity. The plan is based on the following activities and principles: 
 Clear designation of responsibilities for all personnel including Advisory Board members 
 Designation of authority lines with clear hierarchies 
 Establishment of clear, coordinated timelines for all project activities 
 Coordinated use of resources to maintain operations within budget and in a cost-effective manner 
 Designation of responsibilities for organizational entities 
 Establishment of clear research and dissemination objectives towards achieving project goals 
Organizational entities integral to this project and their major responsibilities are described below: 
NIDILRR – Project Officer and other personnel provide guidance and leadership, monitor project’s rate 
and quality of accomplishments.  
Senior Management Team – senior project personnel responsible for management and quality 
monitoring of research and dissemination activities; share primary responsibility for assuring objectives 

VCU TBIMS Proposal 
46 
are accomplished within timeframes and within budget, assure cost-effective utilization of resources 
Research Project Directors – highly experienced, senior faculty responsible for managing day-to-day 
project operations and staff; each research project has been assigned a director 
Project Associates – highly qualified medical center faculty and personnel, integral to the system of 
care, serving as clinical research advisors 
SOM-Tech (School of Medicine Technology Services) - will maintain computer software, hardware and 
back-up systems; design and implement protocols for system security, data integrity, capacity planning, 
and computer performance; and provide ongoing staff consultation and training 
Advisory Board – includes persons with brain injury, family members, scientists, professionals, and 
representatives of advocacy organizations (will help develop and implement relevant, innovative, and 
high quality research; evaluate and monitor progress toward research and dissemination objectives; and 
provide ongoing feedback) 
Scientific Advisors – leading interdisciplinary scientists, based in VCU’s Center for Rehabilitation 
Science and Engineering (CERSE), will provide expertise relating to project management, research 
methodology, data analysis, and interpretation of findings 
Project Evaluator – Dr. Kim, from outside the TBIMS, will monitor program progress, provide 
feedback for improvement, and ensure the quality and timely accomplishment of program objectives  
TBIMS NDSC – monitors VCU NDB contributions including enrollment and follow-up rates; also 
conducts quality support visits to ensure that data is collected per established protocols 
Project oversight will be shared by members of the Senior Management Team whose 
responsibilities are described below. An organizational chart depicting the framework of authority 
for this project is presented following descriptions of the Senior Management Team. 
Principal Investigator - Jeffrey S. Kreutzer, Ph.D. will assume primary administrative 
responsibility for the proposed project, including: (1) maintaining adherence to federal and state 
regulations; (2) monitoring budgetary expenditures; (3) coordinating research program 
development; and (4) monitoring program activities to ensure progress toward stated objectives. Dr. 
Kreutzer will take an active leadership role in project development, implementation, quality control, 
and dissemination. Identifying, allocating, and helping to coordinate resources will be a major 
responsibility. Dr. Kreutzer, with Dr. Cifu, will maintain close communication with NIDILRR 
representatives, the Project Evaluator, and the project Advisory Board. 
Co-Principal Investigator - David X. Cifu, M.D., Chairman, VCU Department of Physical 
Medicine and Rehabilitation (PM&R), will work closely with Dr. Kreutzer to manage the TBIMS 
program. Dr. Cifu will share primary administrative responsibility for coordinating fiscal, research, 
and clinical program activities. Supervising medical programs and maintaining quality assurance of 
medical and follow-up data for the NDB will be important and unique roles.  

VCU TBIMS Proposal 
47 
Project Coordinator - Jennifer H. Marwitz, M.A., under the direction of the Principal 
Investigators, will help: (1) coordinate and implement research activities including NDB data 
collection; (2) coordinate resource allocation; (3) serve as a liaison between project staff, advisory 
groups, community agencies, survivors, and family members; (4) monitor progress toward program 
objectives; (5) supervise research assistants and address staff training needs; and (6) coordinate and 
synthesize program evaluation procedures. Database creation and management responsibilities 
include setting up and maintaining reliable data entry systems, developing data tracking and 
reporting systems. 
Biostatistician – Adam P. Sima, Ph.D. will provide and supervise statistical analysis for research 
projects and have a critical role in manuscript preparation. He will identify and apply appropriate 
statistical methodologies necessary to address hypotheses based on factors such as measurement 
scaling, data distribution, and sample size. In addition to completing sophisticated statistical 
modeling and analysis, he will assist with methodological and design issues as they arise.  
Dissemination Coordinator – Kelli Williams Gary, Ph.D., MPH, OTR/L will: (1) help develop, 
facilitate, and coordinate dissemination activities, including social media, in collaboration with 
project staff and Advisory Board members; (2) respond to requests for information; and (3) monitor 
progress toward dissemination objectives. Dr. Gary will identify audience needs and make certain 
that TBIMS information is made available in alternative formats. Dr. Gary will have a primary role 
in making certain that dissemination activities are relevant, innovative, high quality, and 
implemented in a timely, cost-efficient manner. 
Grant Administrator – Christie Atkins will have responsibility for initial review of purchase 
orders, organizing and maintaining financial records, coordination of equipment purchases, and 
review of expenditures to ensure adherence to University and federal guidelines. Working closely 
with the Principal Investigators, she will facilitate communication with University, federal, and 
departmental fiscal representatives. As Grant Administrator, Ms. Atkins will have a primary role in 
assuring the cost-efficient utilization of resources. 

VCU TBIMS Proposal 
48 
The VCU TBIMS Senior Management Team will meet weekly. Monitoring progress toward 
meeting objectives, making sure that activities are completed as scheduled, and maintaining fiscal 
control and accountability are essential responsibilities shared by the team. The team will also 
evaluate progress of individual research projects and data collection for the TBIMS NDB. Initial 
meetings will focus on staffing and training issues, project development, quality assurance 
standards, and establishing communication networks. As depicted at the end of this section, a 
Project Work Plan details major activities with corresponding timeframes and objectives. The work 
plan will facilitate project evaluation and coordination of resources. 
Project Directors and Project Personnel - The directors for each project are shown in the TBIMS 
Organizational Chart. Their responsibilities include: (1) coordinating and supervising day-to-day 
operations; (2) coordinating and monitoring allocation of individual project resources; (3) hiring, 
 
* denotes members of Senior Management Team 
TBI MODEL SYSTEMS ORGANIZATIONAL CHART 
Principal Investigators 
J. Kreutzer* 
D. Cifu* 
Independent Oversight 
Advisory Board 
A. McDonnell 
Program Evaluator 
J. Kim 
Project Coordinator 
J. Marwitz* 
Fiscal Administrator 
C. Atkins* 
PROJECTS 
SITE-SPECIFIC:  
Resilience & Adjustment 
Intervention  
J. Kreutzer 
DISSEMINATION 
ACTIVITIES 
K. Gary* 
MODULE: 
Caregiver Resilience 
J. Kreutzer 
Data Collection: 
National Database 
D. Cifu 
Biostatistics and Programming 
A. Sima* 
Scientific Advisors 
B. McMahon, R. 
Merchant, G. Moeller, 
A. Valadka, P. Wehman 

VCU TBIMS Proposal 
49 
training, supervising, and evaluating staff; (4); monitoring progress and preparing written reports 
for the Senior Management Team; and (5) maintaining ongoing communication with the Senior 
Management Team. Project Directors will assist the Project Coordinator (J. Marwitz) and facilitate 
dissemination activities for individual projects.  
Research Associates assigned to each project will meet regularly with their respective individual 
Project Directors who will serve as team leaders. Team meetings will provide an opportunity to 
problem solve and plan. Project teams will meet with the Senior Management Team on a monthly 
basis for the first 12 months of the grant, and on a quarterly basis thereafter. Written reports 
regarding progress and adherence to timelines will be provided on a quarterly basis as well.  
Research Associates and Assistants will have an active role in many of the team meetings. 
Following is a general description of Research Associates’ responsibilities relating to the individual 
program and to the TBIMS NDB: 
 Collecting data from medical records 
 Scheduling appointments and completing interviews for research participants and caregivers 
 Carrying out neuropsychological, psychological, and vocational evaluations 
 Data entry and verification 
 Completing coding forms necessary for TBIMS NDB 
 Assisting in literature reviews and manuscript preparation 
 Compiling information for written publication and dissemination on the Internet 
 Completing basic summaries of statistical analyses and reporting on analyses 
 Implement treatment protocols (doctoral level Research Associates) 
 Assist with statistical analyses, interpretation, dissemination (doctoral level Research Associates) 
 Managing project web sites and social media accounts 
The Advisory Board will play a major role in project implementation, helping make certain 
that TBIMS programs are relevant, innovative, and of high quality. Bringing a multi-cultural 
perspective, this diverse group is composed of survivors with advanced degrees, family members of 
persons with disabilities, and interdisciplinary professionals who are nationally known leaders in the 
field. This highly qualified group will meet as a whole with the Senior Management Team three 
times during the first year of operation and at least twice annually thereafter. Meetings with 
individual board members or groups of members will also take place as needed.  
Meetings will provide an important opportunity for communication, soliciting input, reviewing 
progress, and planning. On a quarterly basis, Advisory Board members will be updated on project 

VCU TBIMS Proposal 
50 
activities and accomplishments. Board members will be provided with copies of all dissemination 
materials including manuscripts and reports. They have agreed to collaborate and participate in 
training and other educational activities. Board members have also agreed to regularly solicit and 
convey feedback from their constituents about goals and products developed through the grant. 
The following table delineates board members and qualifications. Per NIDILRR’s request, 
initials rather than full names are provided. Letters of commitment and support from board 
members are provided in Appendix C. Anne McDonnell, MPA, OTR/L, Executive Director of 
BIAV, will serve as Advisory Board Chair. A member of the VCU TBIMS Advisory Board since 
2001, Ms. McDonnell has over 25 years of experience in TBI rehabilitation across a continuum of 
hospital and community-based settings. She holds a clinical faculty position in the VCU School of 
Occupational Therapy and also serves as a consultant to state agencies. 
Board Member 
Qualifications 
Anne McDonnell, 
MPA,OTR/L 
Chair, Advisory Board 
Executive Director, Brain Injury Association of Virginia. Expertise: 
community integration, survivor and family members’ perspectives, 
survivor and family support and education programs. 
Rosemary Rawlins, B.A., 
Consultant 
Author, lecturer, and spouse of a survivor. Expertise: Caregiver and 
spousal needs and services, family and survivor adjustment. 
JM, M.S. 
Survivor, Rehabilitation Counselor. Expertise: post-acute rehabilitation 
services, consumers’ needs and perspectives. 
JC, B.A. 
Survivor. Expertise: survivor needs, continuum of care. 
KB, M.Ed,CBIS 
Executive Director, Brain Injury Services. Expertise: community-based 
needs assessment and intervention, networking. 
CG, RN,MScN,AAMFT 
Family Therapist, Holland Bloorview Kids Rehabilitation Hospital. 
Expertise: solution focused therapy after TBI, clinical program 
development, rehabilitation science and methodology. 
PG, Ed.S. 
Coordinator of Brain Injury Services, Commonwealth of Virginia 
Department of Aging and Rehabilitative Services. Expertise: program 
development and evaluation, community needs assessment, employment 
and disability, and regional TBI resources. 
CL, MSW,CBIS 
Case Manager, Community Futures Foundation. Expertise: community 
program development, case management, and program evaluation. 
LS, Ph.D.,LCP 
Principal Investigator, McGuire VAMC TBIMS program; Psychologist. 
Expertise: adjustment to injury and resilience in both civilian and veteran 
populations. 
Scientific Advisors, drawn from CERSE, will serve as an important resource to the Senior 
Management Team. They will provide ongoing guidance regarding design, methodology, data 

VCU TBIMS Proposal 
51 
analysis, and interpretation. Biographical sketches (P. Wehman, B. McMahon, R. Merchant, G. 
Moeller, and A. Valadka) are provided in Appendix D. 
Dr. Jeong Han Kim will serve as Program Evaluator to assess progress in implementing the 
plan of operation, meeting objectives and timelines, and achieving proposed outcomes. He is adept 
at program evaluation and will independently evaluate implementation, impact, and efficiency. The 
principal investigators will translate his recommendations into an effective action plan.  
Rosemary Rawlins, B.A. will serve as a Program Consultant and Advisory Board member. 
The spouse of a survivor and an accomplished author, Ms. Rawlins is uniquely qualified to guide 
TBIMS program activities. She will have a significant role in program planning and evaluation, 
with Dr. Kim (see Plan of Evaluation section). Ms. Rawlins will help judge the relevance, quality, 
and impact of research and dissemination activities.  
Administrative and Fiscal Management Procedures: We are firmly committed to careful 
fiscal monitoring given the magnitude of funds involved and the scope of work. Management 
procedures will meet the highest standards. Examination of key personnel’s vitae substantiates our 
experience managing large scale grant funding. Previous grants awarded have been audited by the 
state budget office, as a matter of routine procedure, over the last 25 years. Historically, no 
deficiencies have been identified.  
The University and the Commonwealth of Virginia have built an effective checks and balances 
system to maintain budgets and monitor compliance. Purchase orders for expenditures and travel 
reimbursement procedures will be initiated, approved, and later verified by the Principal 
Investigators. They will share responsibilities for personnel recruitment, management, and payroll. 
For monitoring purposes, bi-annual effort certification forms are issued by the University's budget 
office for all personnel. Effort reports will be routinely checked by Dr. Kreutzer and Ms. Atkins to 
verify accuracy and posting to appropriate accounts.  
All financial expenditures for the proposed project will be recorded by the Grant Administrator 
in our offices and also recorded in the University's Office of Grants and Contracts. The Office of 
Grants and Contracts will have major budgetary oversight responsibility. The Principal 

VCU TBIMS Proposal 
52 
Investigators will communicate regularly with the Grants and Contracts staff to maintain 
compliance with state and federal policies.  
The partial duplication of effort between the Office of Grants and Contracts and the Senior 
Management Team will ensure scrutiny of expenditures and careful adherence to agency guidelines. 
The project’s Grant Administrator will work closely with the University Office of Grants and 
Contracts to maintain communication and coordination of fiscal monitoring activities. 
Following is a detailed project work plan for key activities by time (in months). The overall goal 
for the VCU TBIMS is to advance our knowledge of resilience relating to persons with TBI and 
their caregivers, with the ultimate hope of improving health and function and community 
participation.  
Months 
Project and Major Tasks 
1-
6 
7-
12 
13-
18 
19-
24 
25-
30 
31-
36 
37-
42 
43-
48 
49-
54 
55-
60 
Program Management Activities (J. Kreutzer) 
Weekly Senior Management Team meetings 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Review monthly project progress reports  
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Quarterly Implementation Assessment meeting 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Advisory Board meeting 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Annual Performance Reports 
 
x 
 
x 
 
x 
 
x 
 
x 
Site-Specific Project: Intervention to Promote Survivor Resilience and Adjustment (J. Kreutzer) 
Review project management and implementation 
plans with staff.  
x 
 
 
 
 
 
 
 
 
 
Develop data collection, treatment coordination, and 
scheduling plans. 
x 
 
 
 
 
 
 
 
 
 
Format, complete, and duplicate written protocols for 
data collection. 
x 
 
 
 
 
 
 
 
 
 
Train staff to implement the RAI as required in 
research protocols. 
x 
 
 
 
 
 
 
 
 
 
Quality control procedures 
x 
 
x 
 
x 
 
x 
 
x 
 
Begin database development to accommodate data 
elements. 
x 
 
 
 
 
 
 
 
 
 
Complete databases to accommodate data elements 
for all participants 
x 
 
 
 
 
 
 
 
 
 
Enroll study participants 
x 
x 
x 
x 
x 
x 
x 
x 
 
 
Deliver intervention  
x 
x 
x 
x 
x 
x 
x 
x 
 
 
Follow-up assessment protocol implemented 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Review data accrual rates and summarize data 
collected 
 
x 
 
x 
 
x 
 
x 
 
x 
Preliminary data analysis and summarize results 
 
 
 
 
 
x 
 
 
 
 
Initiate formal dissemination activities relating to 
results 
 
 
 
 
 
 
 
 
x 
x 
Prepare final project report for NIDILRR 
 
 
 
 
 
 
 
 
 
x 

VCU TBIMS Proposal 
53 
Months 
Project and Major Tasks 
1-
6 
7-
12 
13-
18 
19-
24 
25-
30 
31-
36 
37-
42 
43-
48 
49-
54 
55-
60 
Module Project: Caregiver Resilience (J. Kreutzer) 
Develop and distribute multi-center project 
implementation manual and syllabus 
x 
 
 
 
 
 
 
 
 
 
All centers will submit final protocol for review and 
approval to respective IRB’s 
x 
 
 
 
 
 
 
 
 
 
Develop database to accommodate data elements for 
participants at all centers 
x 
 
 
 
 
 
 
 
 
 
Multi-center project staff teleconferences 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Enroll study participants 
x 
x 
x 
x 
x 
x 
 
 
 
 
Complete follow-up data collection 
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Prepare and distribute accrual, follow-up, and quality 
control reports 
 
x 
 
x 
 
x 
 
x 
 
x 
Preliminary data analysis and summarize results 
 
 
 
 
 
x 
 
 
 
 
Initiate formal dissemination activities relating to 
results 
 
 
 
 
 
 
 
 
x 
x 
Prepare final project report for NIDILRR 
 
 
 
 
 
 
 
 
 
x 
Dissemination Activities (K. Gary) 
Produce quarterly newsletter 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Update project web site and social media posts 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Prepare presentations for national conferences 
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Prepare manuscripts and submit for publication 
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Implement annual TBI rehabilitation conference 
 
x 
 
x 
 
x 
 
x 
 
x 
Implement consumer workshops 
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
National Database (D. Cifu) 
Enroll and follow-up with NDB participants 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
VI. Collaboration 
This project will involve collaboration between a variety of programs and service organizations 
within and outside the University. Ongoing close communication, shared interests in achieving 
optimal outcomes, focus on constructive solutions, and mutual respect and support are principles 
shared by the VCU TBIMS Senior Management Team. These principles are the philosophical 
cornerstones of effective collaborative efforts. Within the University system, collaboration will 
occur between clinical programs, University departments, and administrative offices.  
Outside of VCU, we will collaborate with health care providers, survivors, family members, 
advocacy organizations, other TBIMS centers, the MSKTC and other federally-funded programs. 
The following table illustrates involvement of entities necessary for effective completion of 
research and dissemination activities. Letters of commitment to collaborate, offered by program 
directors and leaders who will serve on our Advisory Board, are provided in Appendix C.  

VCU TBIMS Proposal 
54 
VCU MANAGED PROGRAMS 
PROGRAMS SPONSORED BY PARTNERS 
On-Campus Services 
Community-Based Medical Services 
 Emergency Room 
 Neuroscience Intensive Care Unit 
 Acute Neuroscience Care Unit 
 Acute Inpatient Rehabilitation 
 Outpatient Rehabilitation Clinics/Services 
 Psychiatric and Mental Health Services 
including the Substance Abuse Program 
 Emergency Medical Transport Services 
 Polytrauma Rehab Center at McGuire VAMC 
Community-Based Rehab Services 
 BIAV and affiliated support programs 
 Brain Injury Association of America 
 Brain Injury Services 
 Central Virginia Center for Independent Living 
 Community Futures Foundation 
 Concussion Care Center of Virginia  
 Tree of Life Supported Living Center 
 Virginia DARS  
 Virginia Institute of Neuropsychiatry 
Off-Campus Medical Services 
 Neurologic Recovery (subacute) Care Unit at 
Retreat Hospital 
 Neuroscience, Orthopaedic, & Wellness Center 
Community-Based Rehab Services 
 Supported Employment Program  
 Sheltering Arms Day Rehabilitation Centers 
A variety of factors will help assure that collaborative efforts are successful: 
 Model systems activities involve building and expanding on existing positive relationships. All 
the collaborative relationships have existed for many years. 
 On a local, state-wide, and regional level, we are collaborating with many other organizations on 
projects hosted by them. The model systems effort provides an excellent opportunity to enhance 
the reciprocity of relationships. 
 All collaborators value high-quality service, and all were involved in the planning of this 
proposal. Each collaborator has a vested interest in the success of this project. Commitments have 
been made to refer potential participants for involvement in individual research projects, and to 
provide guidance to ensure that projects remain innovative, relevant, and scientifically sound. 
 For almost 30 years, the VCU TBIMS program has worked productively with other NIDILRR-
funded model systems and the VCU Rehabilitation Research and Training Center on 
Employment of People with Physical Disability. Our many joint publications with other TBIMS 
centers affirms our ability to collaborate successfully (see Appendix F). 
 Many of our proposed research projects share data elements with the NIDILRR TBIMS NDB. 
Shared data elements will enhance opportunities for future collaboration. As in the past, we will 
invite other model systems to collaborate with us in our new data collection efforts. Involvement 
in dissemination activities will be invited as well. 

VCU TBIMS Proposal 
55 
 As outlined in the Dissemination section of the proposal, we will continue to collaborate with 
other centers by contributing information to the Center for Outcome Measurement on Brain 
Injury (COMBI). The VCU TBIMS has contributed information on the Family Needs 
Questionnaire (FNQ), the Neurobehavioral Functioning Inventory (NFI), and the Service 
Obstacles Scale (SOS). We will continue to provide technical assistance to persons who inquire 
about the measures through the COMBI.  
 VCU has a long history of research collaboration with other medical and rehabilitation centers 
including NIDILRR-funded centers. Since 1987, we have collaborated with fellow rehabilitation 
centers in the production of 109 peer-reviewed publications. Our history of successful 
collaboration provides the groundwork for future partnerships. 
 We are committed to working with the NIDILRR-funded MSKTC. We have taken a primary role 
in developing fact sheets and educational videos with the MSKTC. In fact, VCU, working with 
the MSKTC, received a Bronze Telly Award for producing the video, Relationships after TBI. 
We will continue to work with the MSKTC, generating new ideas and developing new products 
for dissemination (see MSKTC letter of support and collaboration, Appendix C). 
In summary, we are confident that collaborative efforts will be successful for three reasons. First, 
we have a long-standing history of successful partnerships with other agencies and organizations. 
Second, we and our partners firmly agree that collaboration is in the best interests of all parties. 
Third, we have secured written commitments detailing the specifics of collaboration from agency 
and organizational leaders, who will comprise a major component of our Advisory Board. 
VII. Adequacy and Reasonableness of the Budget 
Reasonableness of Costs 
Detailed information on proposed costs is provided in the Budget Narrative section in the front 
matter of the proposal. We believe the proposed costs are reasonable in relation to project activities 
for a number of reasons. We will build on a solid foundation of resources, most of which have been 
in place for many years. Evolving in response to Virginians’ health care needs, VCU Medical 
Center is a centerpiece for medical care and education in Virginia. As Virginia’s largest university, 

VCU TBIMS Proposal 
56 
VCU has a vast array of resources to meet the needs of more than 30,000 students. As members of 
the academic community, VCU TBIMS researchers have complete access to the university’s 
resources. Detailed information regarding university resources is provided in the Adequacy and 
Accessibility of Resources section. 
To assure that our goals are achieved in a cost-effective manner, we have selected highly 
competent, diligent, and experienced staff. Project personnel were selected because their expertise is 
highly relevant to program requirements and goals. Key personnel and most staff members have a 
long history of working in the VCU TBIMS program. Dr. Kreutzer has been the Principal 
Investigator since 1987, and Dr. Cifu has been Co-Principal Investigator since 1992. J. Marwitz has 
29 years of experience with the program. Reflecting on past accomplishments, we are confident that 
responsibilities will be efficiently and effectively carried out. 
Salaries of all proposed staff are reasonable relative to the local labor market. Proposed effort 
of project staff has been closely scrutinized and allocated to ensure that program activities are 
completed capably and on time.  
An array of university and departmental checks and balances are in place to ensure that 
proposed costs are reasonable and appropriate. Staff salary requirements, effort levels, and all other 
proposed expenditures have been evaluated and agreed upon by the VCU Office of Sponsored 
Programs, the Principal Investigators, the Grant Administrator (C. Atkins), and the Chairman of the 
Department of PM&R’s Research Division (P. Wehman).  
 As evidence of the university’s strong commitment to support TBIMS research, a substantial 
amount of cost share has been allocated. In fact, each year, for five years, VCU will contribute 
$182,986, a total of $914,932. The cost share amount equals 38.3% of the total funding amount 
requested from NIDILRR. In addition, the university has agreed to reduce the on-campus 
Facilities and Administrative (F&A) rate from 55% to 32% on Modified Total Direct Costs 
(MTDC) for this project. The reduction represents an additional $404,963 in financial support from 
VCU.  

VCU TBIMS Proposal 
57 
VIII. Plan of Evaluation 
We are firmly committed to ongoing project evaluation to make certain that objectives are fully 
realized. The Plan of Operation provides a foundation for the evaluation process. VCU TBIMS staff 
share the philosophy that effective program evaluation requires: (1) clearly delineating evaluation 
objectives; (2) creating entities responsible for program evaluation with clearly delineated 
responsibilities; (3) developing and monitoring performance measures according to established 
timetables; and (4) developing and implementing plans for identifying and remedying deficiencies. 
Evaluation Objectives 
Major objectives and primary organizational entities are presented in the following table. 
Timetables for accomplishing project tasks are provided in the Plan of Operation section. 
1. Early and continuing assessment of the extent to which the plan of operation has been activated 
and proposed organizational structures have been established (Senior Management Team, 
Advisory Board, Program Evaluator) 
2. Ongoing collection of quantitative and qualitative performance measures (Project Directors, 
Senior Management Team, Program Evaluator, NDSC) 
3. Assessment of adherence to proposed timelines (Project Directors, Senior Management Team, 
Advisory Board, Program Evaluator, NDSC) 
4. Assessment of project impact on consumers’ needs and on the quality of regional resources 
(Senior Management Team, Program Evaluator, Advisory Board, feedback from project 
participants and individuals requesting information and services) 
5. Utilization of designated, independent evaluation to determine: (a) the reliability of data 
collection; (b) the integrity of methodology; (c) the degree to which consumers and family 
members report that programs are relevant; and (d) overall program effectiveness (Program 
Evaluator, Advisory Board, Scientific Advisors, NDSC, NIDILRR) 
6. Prevention and early remediation of problems (Senior Management Team, Project Directors) 
Entities Responsible for Developing and Implementing Performance Measures 
A number of entities within and outside the TBIMS program will have important roles in 
achieving evaluation plan objectives. Complementary evaluation activities will take place at 
different organizational levels and with varying levels of formality. Following are descriptions of 
program evaluation entities within the VCU TBIMS program: 
 Project Directors. The research Project Directors and the Dissemination Coordinator will 
monitor progress on a day-to-day basis, providing monthly written reports on accomplishments 

VCU TBIMS Proposal 
58 
relative to timelines to the Senior Management Team. Information about research project accrual 
rates and reasons for discontinuations or refusals to participate will be included in reports.  
 Senior Management Team. The Senior Management Team will formally review the progress of 
each project on a monthly basis. Weekly meetings to review project implementation will also 
include an evaluation component. 
Entities outside the TBIMS program will have a critical role. Roles of the VCU TBIMS Program 
Evaluator (J. Kim), Program Consultant (R. Rawlins), Advisory Board, Scientific Advisors, VCU’s 
Senior Leadership, and NIDILRR program officials are delineated in the following text. 
With primary responsibility, Dr. Kim, Program Evaluator, will maintain a centralized 
monitoring and evaluation system for the project. He will carefully monitor successes and identify 
challenges as the project moves forward. In conjunction with the Principal Investigators, he will 
make certain that organizational entities fully participate in the evaluation process. Dr. Kim will 
also assist in documenting the impact of research and dissemination activities by providing: 
 Quarterly Implementation Assessments to determine the extent to which research and 
dissemination activities occur as specified in the timeline, (see Plan of Operation section). 
 Annual Impact Assessments to determine the extent to which expected beneficial impacts have 
been achieved.  
The Implementation Assessment will represent the more formative component of the 
evaluation process throughout the five-year funding period. The Senior Management Team will 
meet with Dr. Kim and Ms. Rawlins quarterly to conduct progress reviews. Reviews will identify 
necessary mid-course adjustments in project implementation. The results of the quarterly 
implementation assessments will be documented by Dr. Kim and included in a formal report, the 
Quarterly Implementation Progress Report. Progress reports will also be used as a monitoring tool 
to systematically identify barriers to full implementation and strategies for their removal. Dr. Kim 
will consult with the Scientific Advisors on an as-needed basis. 
The Impact Assessment will be more summative in nature and address the extent to which the 
TBIMS project meets the overall goal of generating new research knowledge to improve treatment 

VCU TBIMS Proposal 
59 
and service delivery outcomes for individuals with TBI. The Senior Management Team, along with 
Dr. Kim, will formally assess the successes of the TBIMS project annually. Final conclusions about 
the overall success and impact of the project will be made in the last six months of funding, when 
research and dissemination activities are nearing completion.  
Advisory Board Members will formally review the progress of all project activities at least 
three times during the first year of operation, and at least twice each year thereafter. Individual 
board members will take on evaluation responsibilities relevant to their expertise and interest. 
Evaluations will consist of reviewing and rating activities as specified by Dr. Kim. Advisory Board 
members will be provided with copies of evaluation reports as they are completed. 
VCU Senior Leadership (Francis Macrina, Ph.D. and Peter Buckley, M.D.) is fully 
committed to making certain that objectives are completed in a timely fashion and within budget 
(see Letters of Commitment and Support, Appendix C). These individuals have enthusiastically 
offered their support and have fully committed the breadth of University resources. The Principal 
Investigators will keep University leadership fully informed about progress. When difficulties are 
encountered but not promptly remedied, senior leadership officials have offered their personal 
assistance to guarantee resolution.  
National Data and Statistical Center will monitor quality of data contributed to the NDB 
(e.g., enrollment and follow-up rates; missing data and error reports). Their quarterly reports will be 
reviewed by the Senior Management Team and the Program Evaluator. The NDSC will assist in 
developing plans to address deficiencies, if needed.  
NIDILRR Program Officials will be kept abreast of program advancement through verbal and 
quarterly written progress reports. Their direct involvement and advice to improve operations will 
be sought at appropriate times.  
Feedback and guidance will also be sought from Directors and staff of other TBIMS and 
NIDILRR-funded programs, particularly when issues relate to their special expertise or mutual 
concerns. For example, Directors of projects with similar foci and objectives will be contacted for 

VCU TBIMS Proposal 
60 
guidance relating to preventing or resolving problems. The following table depicts important 
additional external sources of evaluative feedback: 
 
Reviewers of manuscripts; journal and book editors; conference program committees 
 
Evaluation forms completed by participants at sponsored conferences 
 
Feedback normally solicited and received during the course of close working relationships with 
BIAA 
 
Program visitors from other agencies and organizations 
 
Survey and e-mail information provided by Web site visitors 
 
Program accreditation site visitors 
Performance Measures 
Measures reflecting intended outcomes have been developed for program administration, 
research projects, and dissemination. The project work plan presented in the Plan of Operation 
section provides an important benchmark for evaluating progress. Following are descriptions of 
primary performance measures:  
Program Administration 
 the extent to which expenditures are consistent with the proposed budget 
 the success of recruitment and retention of highly qualified, competent, and diverse applicants  
 the success of training staff to effectively carry out responsibilities  
Research Activities 
 quarterly enrollment numbers (e.g., meets minimum specified for project) 
 consent (> 80%) and follow-up rates (> 90%) 
 completeness of data collection forms (e.g., < 5% missing data) 
 error rates for data collection and entry (e.g., < 5%) 
 fidelity of intervention maintained as described in Methodology, Implementation of Quality Control 
Procedures sections of Research Activities 
Dissemination 
 annual number of publications, presentations, and other products as specified in Design of 
Dissemination Activities section 
The expected beneficial impacts for each major project activity were identified earlier in this 
proposal (see Importance of the Problem and Design of Research and Dissemination Activities 
sections). To ascertain success, Advisory Board members, including the Program Consultant, will 
rate the extent to which benefits have been achieved. Ratings will be compiled by Dr. Kim and 
presented in the annual Impact Assessment Reports. 
Timetable for Completing Performance Measures 
The following table depicts measurement activities which will be conducted by each entity and 
the frequency with which they will be completed. 

VCU TBIMS Proposal 
61 
Program Evaluation Entities 
Performance Measurement Activities 
Frequency 
Project Directors 
 Prepare written progress reports and submit to 
Senior Management Team 
Monthly 
Senior Management Team 
 Review and evaluate written progress reports 
from Project Directors 
 Review and analyze Implementation 
Assessments 
 Review and analyze Impact Assessments 
Monthly 
 
Quarterly 
 
Annually 
Program Evaluator 
 Prepare Implementation Assessments 
 Prepare Impact Assessments 
Quarterly 
Annually 
Advisory Board Members 
 Review and evaluate progress reports and 
dissemination materials 
 Review Implementation and Impact 
Assessments 
2-3 times Annually 
 
Quarterly/ 
Annually 
VCU Senior Leadership 
 
 Review and analyze Implementation and 
Impact Assessments and other reports 
Quarterly 
NDSC 
 Prepare reports addressing benchmarks 
Quarterly 
NIDILRR 
 Monitor progress and address concerns 
As needed 
Problem Identification and Remediation 
With assistance from Scientific Advisors and Advisory Board members, we will be proactive 
by anticipating potential problems. Within the text of the research projects are sections entitled 
Potential Problems and Solutions. All staff involved in program evaluation will be alert to the 
concerns that have been outlined and the need to address them quickly and effectively. Our strategy 
for effective problem solving emphasizes: 
 identifying potential problems through ongoing monitoring and routine assessment 
 preventing problems before they occur 
 carefully monitoring the success of proposed solutions 
 addressing problems rapidly and effectively, using a team problem solving approach 
In summary, the evaluation plan requires attentively monitoring progress, interrelating 
resources, and addressing concerns proactively. Effective organizational and management strategies 
will be identified and promoted within all aspects of the system. Internal and external groups will 
actively participate in a deliberate and systematic evaluation process focused on clearly delineated 
performance measures. Communication between group members and among groups is viewed as 
essential to program effectiveness. The VCU TBIMS will strive toward continuous improvement, 
diligently applying lessons learned from overcoming challenges to ensure future success. 

VCU TBIMS Proposal 
62 
IX. Project Staff 
The success of this project depends on the qualities and capabilities of personnel. 
Consequently, personnel selection and assignments were based on a careful review of training, 
experience, and past productivity. Staff competencies are closely matched to project objectives. 
Considering our experience, we firmly believe that the knowledge, experience, ability, and time 
commitment of staff are more than sufficient to complete the formidable goals we have proposed.  
Herein, detailed information is provided on recruitment practices, faculty, and staff. Selected 
biographical sketches are presented below; CV’s for key personnel are presented in Appendix B. 
Detailed biographical sketches of Project Associates are provided in Appendix D. Specific time 
commitments of paid personnel were carefully considered and allocated as indicated in the table 
following project staff descriptions. Additional information regarding effort and funding allocations 
is provided in the Budget Narrative and Project Staff sections within each research project. 
Recruitment Practices 
We will work with other entities (e.g., DARS, BIAV, VCU Department of Rehabilitation 
Counseling) to recruit a diverse staff, including individuals with disabilities. Because Richmond is a 
large, diverse community, we are confident that we can effectively recruit a diversity of well-
qualified individuals. VCU is an equal opportunity/affirmative action institution and does not 
discriminate on the basis of race, color, sex, sexual orientation, gender identity, age, religion, 
national origin, or disability. As a matter of policy and history, VCU is clearly dedicated to hiring 
individuals from under-represented groups, including individuals with disabilities, and providing 
training and advancement opportunities. For example, VCU enables all full-time employees to take 
up to six hours of academic credit each semester free of charge. Employment counseling, 
mentoring, and Employee Assistance Program (EAP) services are available and readily accessible. 
The VCU TBIMS program has made a special effort to recruit and promote individuals with 
diverse backgrounds and we have been successful. For example, among our 14 proposed staff are 
four persons from minority backgrounds (K. Gary, J. Kim, M. Martinez, N. Hsu). Two proposed 
primary staff are persons with disabilities (K. Gary, J. Kim). With more than 15 years of experience 

VCU TBIMS Proposal 
63 
in the field of TBI, Dr. Gary will serve as our Dissemination Coordinator. Dr. Kim will serve as 
Program Evaluator for the TBIMS. Over the years, our TBIMS program has successfully recruited a 
number of other highly qualified research team members with disabilities (R. Everley, L. Brown, D. 
Bruer, B. Greenwald, T. Naumann, D. West). All but two of these individuals remain employed in 
the rehabilitation field with more responsibility and better pay.  
Although all positions are currently filled, we have an established recruitment process for 
vacated positions built on the following cornerstones - 
close working relationships with organizations and agencies serving persons with disabilities 
development and implementation of clear, fair, and helpful policies that address the training needs of 
persons with disabilities  
widespread dissemination of information about our policies to potential applicants and sources of 
applicants (e.g., internship and residency programs, university departments) 
As part of the state personnel system in Virginia, VCU carefully follows all rules and 
regulations of affirmative action and equal employment opportunity (EEO). Recruitment for vacant 
positions is done through the VCU Human Resources and Equity and Access Services Offices with 
approval for hiring from the Dean. The search process and committee must be approved by the 
Dean and Provost prior to advertising for a position. Job notices are placed in a diversity of journals, 
newsletters, and newspapers, including Insight to Diversity. To further disseminate information 
about available positions, position descriptions are sent to leading University departments with 
programs in medicine, allied health, psychology, and education. Position availability notices are 
posted in at least one publication directed towards minority populations. Monitoring and 
compliance procedures provide a full system of checks and balances. The VCU Equity and Access 
Services Office routinely guides personnel searches. In addition, the Dean’s Office will use the 
Inclusion and Enhancement Fund to augment salaries for new hires from diverse backgrounds as a 
way to continue to increase the diversity of our faculty and staff. 
Personnel 
Principal Investigator - Jeffrey S. Kreutzer, Ph.D., ABPP (key personnel) is a tenured Professor 
in the Departments of PM&R, Neurosurgery, and Psychiatry. Dr. Kreutzer completed a one year 
internship with Dr. Muriel Lezak in Portland, Oregon before graduating with a clinical psychology 

VCU TBIMS Proposal 
64 
doctoral degree. Following, he completed a one year postdoctoral fellowship in Clinical 
Neuropsychology and Rehabilitation Psychology at VCU. Dr. Kreutzer was a founding member of 
BIAV and the 2010 recipient of the National Academy of Neuropsychology’s Lifetime Contribution 
to Neuropsychology Award. In 2013 he received the Innovations in Treatment Award from the 
North American Brain Injury Society. In 2017 he received the Jennett Plum Award for Clinical 
Achievement in the Field of Brain Injury Medicine, presented by the International Brain Injury 
Association. Since 1987, he has served as the Principal Investigator of the VCU TBIMS project. Dr. 
Kreutzer has been the lead investigator of two successful multi-center, module projects. His 
extensive research and grant administration experience also includes four years as a Co-Investigator 
for the National Traumatic Coma Data Bank and five years as Research Director of the VCU 
Rehabilitation Research and Training Center (RRTC) on Severe TBI. For more than 25 years, Dr. 
Kreutzer has conducted research on family response to TBI. He has spent the last decade 
developing and evaluating skill-building, psychological support, and educational interventions for 
survivors, couples, and families. With 170 peer-reviewed journal publications, 18 published books, 
and more than 500 conference presentations, his strong commitment to innovation and research 
advancement is evident.  
Co-Principal Investigator - David Cifu, M.D. (key personnel) is Chairman and the Herman J. 
Flax, MD Professor of the Department of PM&R at VCU, Chief of PM&R Services of the VCU 
Health System, Founding Director of the VCU-Center for Rehabilitation Sciences and Engineering 
(VCU-CERSE), and Senior TBI Specialist for the U.S. Department of Veterans Affairs. He has 
been Co-Director of the VCU TBIMS program since 1991, and was instrumental in arranging the 
inter-agency agreement between NIDILRR and the VA Polytrauma Centers for collection of 
TBIMS data on veterans as well as civilians. Dr. Cifu is also the Principal Investigator of the 
VA/DoD $62.2 million Chronic Effects of Neurotrauma Consortium (CENC). In his more than 25 
years as an academic physiatrist, he has delivered more than 525 national and international lectures, 
published more than 215 scientific articles, and co-authored or edited 30 books and book chapters. 

VCU TBIMS Proposal 
65 
He served as Editor-in-Chief of the 5th Edition of Braddom’s Physical Medicine and Rehabilitation 
textbook (2015) and Braddom’s Handbook of Rehabilitation Medicine (2017). 
Project Coordinator - Jennifer Marwitz, M.A. (key personnel) is an Associate Professor in the 
Department of PM&R. She has served as the Project Coordinator for the VCU TBIMS since 1990 
with intimate knowledge of data collection, quality assurance, and database systems. Ms. Marwitz is 
a member of the TBIMS Executive Committee (2002-present). She serves as Chair for the Data 
Management Committee (2012-present) and was Co-Chair from 2002-12. Recently, Ms. Marwitz 
has been an NDSC data quality site visitor and provided data collection training to the Richmond 
VA Polytrauma Center. She also served as Research Coordinator for the NIDRR-funded RRTC on 
Severe TBI. Ms. Marwitz has co-authored 48 peer-reviewed journal articles and made 40 
presentations specifically related to TBI. Her diligence, scientific knowledge, efficiency, and 
organizational skills are well known to the rehabilitation community. Ms. Marwitz’s highly 
developed interpersonal skills allow her to readily establish rapport with patients/families, and carry 
out responsibilities as liaison between university programs, collaborating agencies, and consumers.  
Medical Director – William Walker, M.D. is an endowed Professor of PM&R and academic 
physician with board certification in PM&R. For more than a decade, he has been Medical Director 
of the VCU Concussion Care Clinic and Brain Injury Rehabilitation Services, and Principal 
Investigator for the Richmond Defense and Veterans Brain Injury Center (DVBIC) at McGuire 
Veterans Affairs Medical Center (VAMC). He has a strong track record of clinical research 
including leadership positions on large grants, including several multi-center studies, and over 50 
peer-reviewed publications. Dr. Walker was recently awarded a NIH R21 grant, “Practical 
Prognostics: building clinically useful predictive models for long-term functional outcome after 
TBI,” funding to complete secondary analyses of the TBIMS NDB. 
Biostatistician – Adam Sima, Ph.D. is an Assistant Professor of Biostatistics at VCU whose work 
includes development of statistical methods used in clinical trials, longitudinal datasets, and model 
selection. Dr. Sima teaches and advises graduate students in applied statistics and statistical 
consulting, and also mentors post-doctoral fellows and junior faculty who are new to research, 

VCU TBIMS Proposal 
66 
including those interested in TBI rehabilitation. He has provided advanced statistical consultation to 
faculty, staff, and students and served as the biostatistician for the VCU TBIMS since 2013. He 
continues to work on several TBIMS NDB studies in addition to the site-specific projects. Dr. Sima 
is the lead statistician on two additional grants: a NIH-funded grant exploring predictive modeling 
for 1, 2, and 5 year outcomes using the TBIMS, and an armed services-funded clinical trial 
exploring the use of hyperbaric oxygen therapy for Marines who have sustained a TBI and have 
PTSD. He has 30 manuscripts published or under review in peer-reviewed journals including nine 
relating to rehabilitation for patients with TBI. In addition, Dr. Sima serves as Senior Statistical 
Consultant for two international journals, Brain Injury and NeuroRehabilitation. 
Research Associate – Nancy Hsu, Psy.D. is an Assistant Professor and board certified 
rehabilitation psychologist in the Department of PM&R at VCU. She joined the faculty in 2007 
after completing a two-year postdoctoral fellowship as a NIDILRR-funded Advanced Rehabilitation 
Research and Training (ARRT) fellow, under the supervision of Dr. Jeffrey Kreutzer. As the 
assistant director of the Neuropsychology and Rehabilitation Psychology clinic, Dr. Hsu is involved 
in the evaluation and treatment of children and adults with TBI, cancer, stroke, and other 
neurological disorders. She has served as a research interventionist for VCU’s TBIMS RAI project. 
Furthermore, Dr. Hsu serves as the consulting neuropsychologist on the DOD and VA-funded 
Chronic Effects of Neurotrauma Consortium and participates in the NINDS-funded, multi-center 
Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) study as a 
neuropsychologist, administering neurocognitive tests to participants. Dr. Hsu has published peer-
reviewed manuscripts, co-authored book chapters, and presented at professional conferences. 
Research Associate – Ana Mills, Psy.D. is a licensed clinical psychologist and Assistant Professor 
in the Department of PM&R at VCU. Dr. Mills received her doctoral degree from the Institute for 
Graduate Clinical Psychology at Widener University in 2012 and then completed a NIDILRR-
funded ARRT post-doctoral fellowship at VCU. She specializes in the neurocognitive evaluation 
and psychotherapeutic treatment of individuals with acquired neurological disorders, with emphasis 
on TBI. She also regularly consults with the Departments of Neurology and Neurosurgery for the 

VCU TBIMS Proposal 
67 
pre-surgical evaluation of patients with epilepsy and Parkinson’s disease. Dr. Mills’ research 
activities include investigating the efficacy of novel psychoeducational interventions and promoting 
resilience after TBI. She is currently a co-investigator on a Michael J. Fox Foundation-funded study 
to examine the feasibility of novel DBS intervention to treat cognitive symptoms in Parkinson’s 
disease. She has authored a number of peer-reviewed articles, book chapters, and presentations on 
neuropsychology, TBI, and rehabilitation. Additionally, she is a referee for the journals Brain Injury 
and Journal of Neurotrauma, and a support group facilitator for BIAV.  
Research Associate – Daniel Klyce, Ph.D. is a licensed clinical psychologist and Assistant 
Professor in the Department of PM&R. Dr. Klyce completed a fellowship in rehabilitation 
psychology in the Department of PM&R at the University of Washington, where he was based at 
Seattle’s Harborview Medical Center. He has co-authored articles published in the Journal of Head 
Trauma Rehabilitation and Archives of Physical Medicine and Rehabilitation related to resource 
facilitation for individuals with TBI and coping skills training for individuals with TBI and family 
caregivers. Dr. Klyce is an active member of professional organizations such as the American 
Psychological Association’s Division for Rehabilitation Psychology and the American Congress of 
Rehabilitation Medicine. Since 2013, he has served as the rehabilitation psychologist for the 
inpatient brain injury rehabilitation unit at VCU. In this role he works daily with individuals with 
TBI and their family members, while also making substantive contributions to VCU’s teaching, 
research, and service missions. 
Program Evaluator – Jeong Han Kim, Ph.D., CRC is an Assistant Professor in the Department 
of Rehabilitation Counseling. Dr. Kim obtained his doctoral degree from the University of 
Wisconsin-Madison, and served as Program Director of the Rehabilitation Counseling Program at 
Ball State University prior to joining VCU. His research and scholarly accomplishments include 26 
peer-reviewed publications and numerous regional and national presentations. Dr. Kim’s research 
expertise relates to methodology and program evaluation in the following areas: 1) quantitative 
research methodology; 2) inferential statistics; 3) design and execution of psychosocial research; 4) 
use of various statistical packages; 5) psychometric validation of psychological instruments; and 6) 

VCU TBIMS Proposal 
68 
managing and collaborating with research teams to execute multiple projects in a timely manner. He 
has worked in a variety of settings including independent living centers, vocational rehabilitation 
agencies, VAMC’s, and long-term health care agencies. In addition, Dr. Kim served as PI of an 
RSA long-term training grant. Perhaps most relevant to the present application is his experience as 
program evaluator for the VCU TBIMS grant activities (2012-17). Dr. Kim is a retired first 
Lieutenant from the Republic of Korea Army with firsthand experience of disability after being 
treated for burns, undergoing an amputation, and living with hearing loss after a bomb explosion in 
1997. As a member of a minority community and as an individual who has gone through the 
rehabilitation process, Dr. Kim will bring an invaluable perspective to the VCU TBIMS program. 
Dissemination Coordinator – Kelli Williams Gary Ph.D., MPH, OTR/L, has 20 years’ 
experience in the rehabilitation field, including working as an occupational therapist in two 
academic medical centers and a VAMC, as well as serving as rehabilitation director in a skilled 
nursing facility. During her 3-year tenure with VCU PM&R’s Advanced Rehabilitation Research 
Training grant, Dr. Gary completed research projects relating to judgment and safety issues, and 
racial and ethnic differences in receipt of services after TBI. Her personal experience has allowed 
her to develop a special sensitivity to the needs of minority group members and persons with 
disability. Dr. Gary sustained a severe TBI in 1990 and subsequently completed requirements to 
obtain BS, MPH, MS, and Ph.D. degrees after her injury. She worked extensively with Dr. 
Niemeier’s Acute Cognitive and Neurobehavioral Intervention research team, preparing project 
reports and developing research publications. Dr. Gary is actively involved in the brain injury 
community. She co-facilitates a brain injury support group for BIAV and was a member of the 
Virginia Brain Injury Council (VBIC) from 2007-2011, for which she served as Vice-Chair. 
Currently, she is on the Board of Directors of BIAV. 
Research Assistant – Abigail Welch, B.S., B.A. obtained bachelors’ degrees in both Psychology 
and Gender, Sexuality, and Women’s Studies from VCU. She has worked in the Department of 
PM&R for the past year and a half, and is responsible for the Form 1 and Form 2 data collection and 
entry for the TBIMS NDB, as well as working on our site-specific projects. Before joining the 

VCU TBIMS Proposal 
69 
Department, Ms. Welch gained research experience by studying racial discrimination in health and 
food service industries, and gained job experience by counseling children with special needs.  
Research Assistant – Marie Grace Martinez, B.A. obtained bachelors’ degrees in both 
Psychology and French from the University of Virginia, where she gained research experience 
focused on implicit social psychology and developmental psychology. She has worked on the VCU 
TBIMS for almost a year and is responsible for data collection for the TBIMS NDB, including the 
coordination of patient interviews and collection, preparation, and entry of Form 1 and Form 2 data. 
Research Assistant – Naghmeh Moadab, M.S. obtained her Master’s degree in Clinical 
Psychology from Virginia State University. She has been employed in the Department of PM&R 
since 2014. Under Dr. Kreutzer’s supervision, Ms. Moadab provides neuropsychological testing 
services to persons with TBI. Related to the currently funded TBIMS, she inspects the TBI database 
for prior research completion and provides extensive review of records for each patient seen in the 
clinic to determine eligibility. When deemed eligible, she provides the patients with pertinent 
packets of information and notifies senior staff.  
Grant Administrator – Christie Atkins is Finance Manager for the Department of PM&R and 
manages all budgetary, administrative, and contractual aspects of department research programs. 
Ms. Atkins has ten years’ experience in sponsored research and budget administration. Currently, 
she works closely with project directors, managing several million dollars in grant funding. Ms. 
Atkins has had primary accounting and support responsibilities for the VCU TBIMS project. 
The proposed project involves participation in five major program activities: (1) Administration 
and Dissemination; (2) National Database; (3) Resilience and Adjustment Intervention; and (4) a 
multi-center Collaborative Module. The following table provides staff time commitments. 
  
Administration 
Dissemination 
National 
Database 
Resilience 
Intervention 
Collaborative 
Module 
Total 
Kreutzer 
10% 
2% 
12% 
6% 
30% 
Cifu 
5% 
5% 
- 
- 
10% 
Marwitz 
25% 
20% 
15% 
20% 
80% 
Walker 
- 
10% 
- 
- 
10% 
Sima 
- 
2% 
5% 
8% 
15% 
Hsu 
- 
- 
30% 
- 
30% 
Mills 
- 
- 
30% 
 
30% 

VCU TBIMS Proposal 
70 
  
Administration 
Dissemination 
National 
Database 
Resilience 
Intervention 
Collaborative 
Module 
Total 
Klyce 
- 
8% 
- 
- 
8% 
Kim 
5% 
- 
- 
- 
5% 
Gary 
15% 
- 
- 
- 
15% 
Welch 
- 
35% 
45% 
- 
80% 
Martinez 
- 
75% 
5% 
20% 
100% 
Moadab 
- 
- 
5% 
- 
5% 
Atkins 
4.5% 
- 
- 
- 
4.5% 
Project Associates:  
Project Associates will be involved in many important aspects of program implementation. The 
group includes Research Associates, Allied Health Professionals, Psychologists, Educators, Data 
Collectors, and Dissemination Facilitators. Some will contribute time to the TBIMS, as outlined in 
their University job descriptions which emphasize devotion to service, education, and research 
activities. Many associates describe the VCU TBIMS program as an excellent opportunity to be 
involved in exciting scientific research with beneficial outcomes. A listing of all project associates 
is provided in the table below. Detailed biographical sketches are provided in Appendix D.  
Woodford Beach, PhD CCC/SP  
Alice Jesudian, MD 
Randall Merchant, PhD 
Karen Brooke, MT 
John Kregel, EdD 
F. Gerard Moeller, MD 
William Carne, PhD  
Richard Kunz, MD 
Cynthia Rolston, PhD 
Karen Chandler, MSW 
Erin Lucero, BA 
Macon Sizemore, PT, MHA 
Benjamin, Darter, PT, PhD 
Paul Mazmanian, PhD 
Alex Valadka, MD 
Charlotte Gilman, RN, BSN 
Scott McDonald, PhD 
John Ward, MD, MSHA 
Robert S. Graham, MD 
Patrick McGowan, MD 
Paul Wehman, PhD 
Katherine Inge, PhD, OTR 
Brian McMahon, PhD 
Harold F. Young, MD 
In summary, VCU TBIMS staff are a diverse group of highly trained, experienced, and 
knowledgeable interdisciplinary professionals. Each is committed to making certain that program 
objectives are accomplished effectively and efficiently.  
X. Adequacy and Accessibility of Resources 
VCU is a public research university with 12 major schools, including the School of Medicine 
which manages the VCU Health System (VCUHS). Receiving more than $156 million a year in 
sponsored research funding, the University has an impressive infrastructure to support researchers. 
Operating since 1838, VCUHS is the only academic medical center in Central Virginia and a 
national leader. With the region’s only Level I trauma center, 805 inpatient beds and a network of 

VCU TBIMS Proposal 
71 
outpatient clinics, 750 physician/faculty members offer state-of-the-art care in more than 200 
specialty areas. VCUHS records over 50,000 admissions and more than 630,000 outpatient visits 
annually, and is the largest single provider of indigent care in the state (providing nearly one-third 
of Virginia’s indigent care). Uninsured patients represent 20 percent of all patients treated, 
substantiating the strong commitment to serve persons regardless of ability to pay. 
Department of Physical Medicine and Rehabilitation. The Department of PM&R is chaired 
by Dr. Cifu, TBIMS Co-PI. Dr. Cifu will ensure that project staff have full access to space, 
equipment, and administrative support to complete their work. The Department is one of the oldest, 
most well-established university PM&R departments in the country. Comprehensive inpatient and 
outpatient services are provided to patients with a variety of neurological, musculoskeletal, and 
other conditions, including TBI, stroke, spinal cord injury, burns, and cancer.  
Housed within the Department of PM&R is CERSE, the VCU Center for Rehabilitation 
Science and Engineering. Funded by VCU’s Office of Research and the School of Medicine, 
CERSE provides infrastructure for interdisciplinary research project design, implementation, and 
management. Staff have advanced expertise in rehabilitation research design, statistical analysis, 
database development, participant enrollment and tracking, and grants management. The expertise 
of CERSE faculty and staff will be readily available to the TBIMS. For example, Dr. Sima, CERSE 
Statistical Services Director, will also serve as the biostatistician for the present proposal.  
Interdepartmental Relationships. One of the major strengths of our ongoing TBI research 
and clinical program is the quality of interdepartmental and interdisciplinary relationships. This fact 
is probably best exemplified by our relationships with Neurosurgery. Underlying this relationship is 
a mutual commitment to basic science, clinical research, and academic excellence. This 
commitment is evident in funding allocations through federal grants and pharmaceutical research 
projects. 
Excellent relationships have also been developed with a diversity of other medical and therapy 
departments including Psychiatry, Neurology, Physiology, Anatomy, Rehabilitation Counseling, 
Internal Medicine, Occupational Therapy, Speech-Language Pathology, Physical Therapy, and 

VCU TBIMS Proposal 
72 
Nursing. A complete spectrum of learning opportunities is available to staff through these 
departments via regularly scheduled seminars, grand rounds presentations, and conferences. VCU 
faculty and staff have access to the Center for Health Disparities resources, a partnership between 
VCUHS and the University. The Center facilitates research, education, access to health care 
services, and workforce diversity initiatives to eliminate health disparities.  
Quality of Past Grant Performance 
In September 1987, VCU was funded by NIDRR as one of five TBIMS centers. In 1992, 1998, 
2002, 2007, and 2012 NIDRR again funded VCU as a TBIMS. Dr. Kreutzer has served as the 
Principal Investigator for the nearly 30 years of funding managed through the Department of 
PM&R. J. Marwitz has served as chair or co-chair of the TBIMS Data Committee since 2002. For 
the NDB, VCU has collected data about outcomes throughout the continuum of care for more than 
700 research participants (for more information, see Appendix E, VCU Contribution to National 
Database and Continuum of Care). Over the years, VCU has developed empirically-based 
programs for academic and vocational reentry, community support, resilience and adjustment, 
prevention of substance abuse and neurobehavioral dysfunction, and family/caregiver/couples 
support. Collaboration with local schools, BIAV, and DARS has helped us improve academic 
success, increase socialization opportunities, and improve community integration and family 
functioning. 
VCU served as the coordination site for neuropsychological outcome data among the Model 
Systems from 1987-1997, developing quality control and documentation procedures, and 
facilitating communication between the systems. VCU also developed a test administration, scoring, 
and interpretation manual for use by other TBIMS centers. Preparation of neuropsychological data 
summaries for all centers was an important responsibility. More recently, VCU served as the lead 
for the Emotional Module of the TBIMS, leading a six-center, collaborative study on caregiver 
distress and satisfaction with life. In the current grant cycle, VCU serves as lead for the Resilience 
Module, a five-center, collaborative study on resilience in the first year postinjury. J. Kreutzer and 
J. Marwitz developed the research proposals and protocols, data collection forms, questionnaires, 

VCU TBIMS Proposal 
73 
and a syllabus. In addition, J. Kreutzer led meetings at Project Directors’ meetings and regular 
teleconferences, and prepared data reports and publications related to the studies.  
Besides multi-center collaborative research, staff from the VCU TBIMS project have 
completed research on neurobehavioral issues, substance abuse, balance and ambulation disorders, 
re-hospitalization, employment outcome, family functioning, headache, and pharmacologic 
approaches to treatment of depression and seizures. The quality of VCU’s leadership has been 
officially recognized by the TBIMS Project Directors. Every two years, the TBIMS presents an 
award for “Best Scientific Publication using the NIDILRR TBI Model System National Database.” 
Two awards have been given to VCU (Walker and Kreutzer).43,257  
In addition to the TBIMS, the Department of PM&R has had numerous grant awards including: 
NIH-funded RO1 on Acute Neurobehavioral and Cognitive Intervention for TBI (2008-2012), 
Virginia Incarcerated Youth with Brain Injury Program (Commonwealth Neurotrauma Initiative, 
2009-2012), and NIH-funded TBI Clinical Trials Network center grant (2002-2011). Dr. Kreutzer 
manages a NIDILRR-funded Advanced Rehabilitation Research Training Grant (1987-2003, 2005-
present). In addition, Dr. Cifu serves as PI for the Chronic Effects of Neurotrauma Consortium 
(CENC) jointly funded by the Departments of Defense (DOD) and Veterans Affairs (VA) for 
$62.175 million (2010-present). Clearly, VCU has a long and successful history of completion of 
research and training grants. Following is a listing of currently funded TBI research programs 
within the Department of PM&R. 
Ongoing Funded TBI Research Projects 
Advanced Rehabilitation Research Training (ARRT); funding source NIDILRR 
Biomarkers of Injury and Outcome in Pro-TECT III (BIO-ProTECT); funding source NIH/NINDS 
The Chronic Effects of Neurotrauma Consortium (CENC); funding source DOD and VA 
COSBID: Cooperative Study on Brain Injury Depolarizations; funding source DOD 
Defense and Veterans Brain Injury Center, funding source DOD through subcontract with General 
Dynamics Information Technology (GDIT) 
Evaluation and Diagnosis of Potential Research Subjects with TBI; funding source DOD through 
subcontract with GDIT 
Longitudinal Study of Outcomes for CENC; funding source DOD and VA 
Minimally Invasive Surgery plus rt-PA for ICH Evacuation (MISTIE III); funding source 
NIH/NINDS 

VCU TBIMS Proposal 
74 
Ongoing Funded TBI Research Projects 
Practical Prognostics: Building Clinically Useful Predictive Models for Long-term Functional 
Outcome after TBI; funding source NIH 
Progesterone for TBI: Experimental Clinical Treatment Trial (ProTECT III); funding source 
NIH/NINDS 
A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study of NNZ-2566 in Patients 
with TBI; funding source Neuren Pharmaceuticals Ltd. and DoD 
A Randomized Clinical Trial of Glyburide (RP-1127) for TBI; funding source DOD 
Rehabilitation Research and Training Center (RRTC) on Employment for Persons with Physical 
Disabilities; funding source NIDILRR 
Safety and effectiveness of the PoNS™ 4.0 Device for Cranial Nerve Noninvasive Neuromodulation 
(CN-NINM) Training in Subjects with a Chronic Balance Deficit Due to Mild-to-Moderate TBI; 
funding source DOD and Private Industry (Helius Medical Technologies) 
Targeted Transcranial Magnetic Stimulation for Cognitive Rehabilitation after TBI; funding 
source Commonwealth of VA, Dept. of Aging & Rehabilitation Services (Commonwealth 
Neurotrauma Initiative Trust Fund) 
Transforming Research and Clinical Knowledge in TBI II (TRACK-TBI II); funding source 
NIH/NINDS 
Access to Clinical Populations 
VCU provides a comprehensive continuum of care for persons with TBI and their families. 
VCUHS is one of five Level I trauma centers in Virginia and the only one in the region. The Level I 
designation indicates the most severe cases of TBI are treated here. Our system of care includes 
individuals with mild, moderate, and severe injuries. Comprehensiveness, interdisciplinary 
communication, and integration of a continuum of services are important philosophies which have 
guided program development at VCU. Guided by consumer needs assessments, the VCU system of 
care continues to evolve, and partnerships with other rehabilitation agencies are growing.  
As outlined in the Research Activities section, we will have appropriate access to individuals 
with TBI starting in the Intensive Care Unit. Neurosurgery nursing staff (C. Gilman, R.N.) and 
PM&R consult staff (P. McGowan, M.D.) will identify all persons with a TBI diagnosis admitted to 
VCUHS. Dr. Cifu and Dr. Walker both have joint appointments within McGuire VA Medical 
Center’s Defense and Veterans Brain Injury Center. Drs. Cifu and Walker can ensure that McGuire 
VAMC will provide access to their outpatients for our proposed site-specific project.  
A review of VCUHS records indicates that our ED receives an average of 120 TBI-related visits 
per month. Of those ED visits, one-third are mild (admission GCS 13-15) and not admitted. Of 

VCU TBIMS Proposal 
75 
hospital admissions, 30-40 per month are categorized as moderate-severe TBI with the TBI listed as 
primary reason for admission.  
The table that follows provides data regarding the number of patients with mild, moderate and 
severe injuries admitted to the Brain Injury Rehabilitation Unit since 2014. As previously 
mentioned, VCU is collaborating with Sheltering Arms Rehabilitation Hospital to build a 114-bed 
acute rehabilitation center. Estimated completion date is 2019. Based on data from Sheltering Arms, 
we expect a 50% increase in TBI admissions. 
Year 
Severe Injury 
Moderate Injury 
Mild Injury 
Total Number 
2014 
51 
24 
4 
79 
2015 
66 
15 
7 
88 
2016 
60 
19 
8 
87 
Patients also enter the VCUHS system of care through referrals from health professionals outside 
the system. Information regarding the number of patients with mild, moderate and severe injuries 
seen at the Brain Injury Outpatient Services Center are provided below. 
Year 
Severe Injury 
Moderate Injury 
Mild Injury 
Total Number 
2014 
48 
41 
124 
213 
2015 
55 
36 
149 
240 
2016 
61 
29 
138 
228 
 

VCU TBIMS Proposal
Budget Narrative
i
Budget Narrative
Budget information for the five year funding period is presented in spreadsheet format on the 
following pages. The first spreadsheet, “NIDILRR Budget,” details funding requested from the U.S. 
Department of Health & Human Services (DHHS). As indicated, the requested Total Direct Cost is 
$352,234 per year for five years. Total Indirect Costs are $112,715 per year for five years, and the 
Total Costs is $464,949 per year for a cumulative total of $2,324,745. The second spreadsheet 
“Overall TBIMS Budget,” indicates effort levels for personnel with information regarding proposed
federally supported effort, VCU cost share supported effort, and Total Effort. In planning this 
proposal, funding and effort allocations were carefully considered by project management and 
administrative staff. Effort and funding allocations reflect program activity requirements and 
timelines, staff responsibilities, and our nearly 30 years’ experience as a TBIMS center.
Cost Share:
Virginia Commonwealth University (VCU) is firmly committed to supporting the proposed 
TBIMS as indicated by the cost share amounts shown on the third spreadsheet “VCU Cost Share 
Budget”. Each year, for five years, the university will contribute $182,986, a total of $914,932. The 
cost share amount equals 28% of the total amount requested from NIDILRR. The Total Budget for 
the five year project, inclusive of both federal funds and cost-shared funds, is $3,239,676.
Cost share is used entirely to support faculty effort. The VCU Cost Share budget details 
supported effort as well as cost share supported annual salary, fringe benefits, and total costs. 
Fringe benefits are calculated at the current VCU/DHHS negotiated rate of 37.2% of salaries. The
fringe benefit package includes: annual and medical leave; health, dental, and life insurance; 
workman's compensation; retirement savings; and social security. VCU will cost share $49,614
annually in fringe benefits, a total of $248,072 over the course of the project.
Major Project Activities and Effort Allocations:
The fourth spreadsheet, “Staff Effort Allocation,” details each of the five major program
activities: (1) Administration and Dissemination; (2) National Database; (3) Resilience and 
Adjustment Intervention; and (4) Collaborative Module. NIDILRR has indicated that module 

VCU TBIMS Proposal
Budget Narrative
ii
project activities will be determined after the announcement of awards. The agency has required
that at least 15% of the total budget should be set aside for the Collaborative Module project. 
NIDILRR’s requirements and the resources necessary to successfully complete program activities 
have been carefully considered to determine effort allocations.
Program Income:
Any program income funds generated under this award will be utilized under the additional 
cost method as set forth at 34 CFR 74.24(b)(1), which allows the income to be used for costs which 
are in addition to the allowable costs of the project and further the broad objectives of the Federal 
statute under which the grant was made. Estimated program income for project year one will be 
approximately $3,000. We anticipate that the program income generated each year will increase as 
new products (e.g., educational guides, manuals) are produced for dissemination. Program income 
funds will be utilized to defray costs above the funding level provided by DHHS. In addition, 
program income funds will be expended for other costs identified as necessary to ensure that project 
activities are completed and expanded to the greatest extent possible, furthering the objectives of 
the Federal statute of this award.
Follow-Up Data Collection Costs:
Within the grant application package, NIDILRR has requested an estimate of the costs for follow-
up data collection. Staff effort allocations for the National Database are indicated on the Staff Effort 
Allocation spreadsheet. Considering effort levels, the number of patients requiring follow-up, and 
the cost of research incentives, we estimate the need for $244,265 annually, a sum of $1,269,136
over the five year project funding period.

VCU TBIMS Proposal
Budget Narrative
iii
Requested Funds
The following narrative provides information on funds requested from the DHHS. Information 
is provided regarding personnel and salary allocations, fringe benefits, travel, supplies, and other 
costs.
1. Personnel
As indicated in the Project Staff section, VCU TBIMS key personnel have been a very stable 
entity. Dr. Kreutzer has been the Principal Investigator since 1987, Dr. Cifu has been Co-Principal 
Investigator since 1992, and Ms. Marwitz has more than 25 years of experience as Project 
Coordinator. The NIDILRR Budget spreadsheet for this section provides detailed information 
regarding federally supported effort and salary. Annual salary costs of $234,776 per year are
requested, a sum of $1,173,879 over the five year funding period.
Following are descriptions of personnel including information about: (1) requested and cost 
share funding; (2) effort; and (3) primary responsibilities. Detailed information regarding staff 
responsibilities and qualifications is provided in the Plan of Operation and Project Staff sections, as 
well as in the individual descriptions of the research projects (see “Project Staff” in Research 
Activities).

Principal Investigator – Jeffrey S. Kreutzer, Ph.D., will devote a total of 30% effort to the 
TBIMS program. Funds are requested for 5% of Dr. Kreutzer’s time. He will serve as primary 
manager of the VCU TBIMS program as well as Director of the Resilience and Adjustment 
project. Dr. Kreutzer will be responsible for all administrative and dissemination activities. He
will oversee staff training, data collection and quality control for research activities. Funds 
requested for salary support of Dr. Kreutzer are $9,350 annually. Total funds requested for Dr. 
Kreutzer salary support are $46,750 over a period of five years. An additional 25% effort 
annually will be supported by cost share. 

Co-Principal Investigator – David X. Cifu, M.D. has a joint appointment with VCU and VAMC. 
He will devote 10% contributed effort from his VCU appointment to this project. As Co-
Principal Investigator, Dr. Cifu will share primary program management responsibilities with 

VCU TBIMS Proposal
Budget Narrative
iv
Dr. Kreutzer. He will share responsibility for administrative and dissemination activities. Dr. 
Cifu will also be responsible for coding CT scans and ensuring the quality of medical data 
collection for the National Database. Dr. Cifu’s entire effort will be provided to the grant via 
university cost share.

Project Coordinator - Jennifer Marwitz, M.A., will devote 80% effort to the proposed project.
Her substantial effort, and prior experience as coordinator, will ensure the successful 
completion of program activities. Ms. Marwitz will have a major role in helping the Principal 
Investigators manage, implement, and coordinate program activities. She will coordinate and 
implement data collection activities, monitor follow-up and enrollment rates, and help supervise 
Research Assistants (M. Martinez, A. Welch and N. Moadab). Funds requested for salary 
support of Ms. Marwitz are $78,668 in years one through five. Total salary requested is 
$393,340.

Medical Director – William Walker, M.D., will devote 10% contributed effort to the project
annually. Dr. Walker will introduce eligible patients to the TBIMS research projects and assist 
Research Associates with data collection. He will also help Research Associates contact “hard 
to reach” participants for follow-up data collection. Finally, Dr. Walker will participate in 
dissemination activities related to publicity of research.  Dr. Walker’s entire effort will be 
provided to the grant via university cost share.

Biostatistician – Adam Sima, Ph.D., will devote 15% effort to the research project. Dr. Sima 
will provide and supervise statistical analyses, and interpret the results for reports and 
dissemination. Funds requested for salary support of Dr. Sima are $15,450 annually. Total 
funds requested for Dr. Sima are $77,250.

Research Associate - Ana Mills, Ph.D. will devote a total of 30% effort to the project. Funds are 
requested to support 20% of Dr. Mills’ time. She will serve as an interventionist for the
Resilience and Adjustment project. Salary support is requested at $19,200 annually. Total funds 
requested for Dr. Mills’ are $96,000. In addition, 10% of Dr. Mills’ effort will be supported via 
university cost share.

VCU TBIMS Proposal
Budget Narrative
v

Research Associate - Nancy Hsu, Ph.D. will devote a total of 30% effort to the project.  Funds 
are requested to support 20% of Dr. Hsu’s time.  She will serve as an interventionist for the 
Resilience and Adjustment project. Salary support is requested at $22,337 annually.  Total funds 
requested for Dr. Hsu are $111,684.  In addition, 10% of Dr. Hsu’s effort will be supported via 
university cost share.

Research Associate – Daniel Klyce, Ph.D., will devote 8% effort to the research project. Dr. 
Klyce will coordinate inpatient rehabilitation enrollment and data collection for the National 
Database.  Funds requested for salary support for Dr. Klyce are $7,580 annually.  Total funds 
requested for Dr. Klyce are $37,900.

Project Evaluator – Jeong Han Kim, Ph.D., will devote 5% effort to the proposed project. Dr. 
Kim will plan, implement, and oversee program evaluation activities. An amount of $4,692 is 
requested for years one through five for a total of $23,460.

Dissemination Coordinator – Kelli Williams Gary, Ph.D., MPH, OTR/L will devote 15% effort 
to the proposed project. Dr. Gary has primary responsibility for the development and 
implementation of dissemination activities. Funds requested for salary support are $13,650
annually. Total funds requested for Dr. Gary are $68,250 over the five year project span.

Research Assistant – Marie Grace Martinez, B.A. will devote 100% effort to this project. Her
responsibilities will include data collection and follow-up for the National Database. She will 
also coordinate patient interviews and the collection, preparation, and entry of Form I and Form 
II data.  In addition, she will assist Ms. Welch with project activities for the Resilience & 
Adjustment project.  The sum of $33,000 annually is requested for salary support. Total funds 
requested for Ms. Martinez are $165,000.

Research Assistant – Abigail Welch, B.S., B.A. will devote 80% effort to the project. Her 
primary responsibilities will include the Form I and Form II data collection and entry for the 
TBIMS National Database, as well as helping coordinate and carry out the Resilience & 
Adjustment project. Salary support of $26,400 annually is requested. Total funds requested for 
Ms. Welch are $132,000.

VCU TBIMS Proposal
Budget Narrative
vi

Research Assistant – Naghmeh Moadab, M.S., will devote 5% effort to the project. Based in the 
Brain Injury Outpatient Center, she will help recruit research participants and serve as a liaison 
between clinical and research staff. Salary support of $1,785 annually is requested. Total funds 
requested for Ms. Moadab are $8,925.

Grant Administrator – Christie Atkins, will devote 4.5% effort to the proposed project. Working 
closely with the Principal Investigator, she will provide support in the areas of fiscal 
administration and purchasing. The amount of $2,664 is requested annually, a total of $13,320
over the five year funding period.
2. Fringe Benefits
Fringe Benefits are calculated at the current VCU/DHHS negotiated rate of 37.2% of salaries 
for full-time faculty and classified personnel and 7.9% for hourly personnel. VCU's fringe benefit 
package includes annual and medical leave; health, dental, and life insurance; workman's 
compensation; retirement savings; and social security. Funds in the amount of $87,335 annually; a 
total of $436,675 is requested over five years to cover fringe benefits costs for the project.
3. Travel
A sum of $5,000 annually is required to pay travel costs for project staff to attend semi-annual 
Project Directors’ meetings, professional meetings and conferences, and other dissemination-related 
activities. The projected costs relate to airfare, lodging, meals, airport parking, taxi or other 
transportation at the destination. All travel expense will be reimbursed in accordance with the State 
of Virginia travel regulations at the approved rates in effect at the time of travel.
4. Equipment
VCU is not requesting funds for the purchase of equipment. Equipment needed for project 
implementation, including computers, networking software and hardware, and telecommunication 
equipment are provided through the VCU infrastructure. Additional information about VCU
resources is provided in the Adequacy and Accessibility of Resources section of this proposal.

VCU TBIMS Proposal
Budget Narrative
vii
5. Supplies
The supply budget will be utilized to support the development of dissemination materials and 
other consumable supplies and materials required by project staff. Supplies will be needed to 
produce reports, technical assistance materials, journal articles, and conference presentation 
materials. Supplies will include printer toner, paper, envelopes, file folders, pens, pencils, staples, 
paper clips, CD’s, and DVD’s. Supplies have been budgeted at $2,220 in years one through five, a 
total of $11,100 over the five year funding period.
6. Contractual:
Duplication, Printing, etc. - Funds in the amount of $1,800 per year in years one through five 
are requested to support printing, duplication, and other project-related contractual charges. Funds 
will be utilized for the printing, duplication, and dissemination of items such as newsletters, 
research reports, informational booklets, project announcements, and program brochures for 
consumer and professional audiences. Small items such as one or two-page documents will be 
processed through the VCU print shop. Others will be competitively bid to obtain the best price 
available and to ensure quality materials are procured under the project. Additionally funds will be 
utilized to purchase books, training materials, and videos produced by other agencies useful to staff 
for completion of project objectives. The total for contractual expenses requested over the five year
funding period is $9,000.
7. Construction
No funds for construction are requested.
8. Other:

Advisory Board – Annually, $1,000 is requested, to provide board members an honorarium.
Board members will be reimbursed for their time and travel expenses related to attending board, 
planning, and other meetings.

Publications – Funds in the amount of $3,319 annually is requested to support the costs of open 
access publications and other publication- related charges. The publications will be peer 
reviewed, published by a journal and will arise from data analyzed in this project. 

VCU TBIMS Proposal
Budget Narrative
viii

Consultants – An amount of $1,200 is requested annually to support the activities of one
program consultant, R. Rawlins. She will provide 16 hours of effort to the project each year. 
The funds will be used to reimburse her for her time and travel.

Research Incentives – Ensuring that research participants return for follow-up visits can be 
challenging. Some have concerns about travel costs, while others prefer not to take off time 
from work. To increase compliance with measurement and follow-up protocols, we will provide 
each participating individual $50 - $200 for completing each measurement protocol, depending 
on travel costs. Detailed information about research incentives is provided in the Research 
Activities section. Considering anticipated accrual and attrition rates, the following sums are 
budgeted annually for the National Database ($7,800), Resilience and Adjustment Intervention 
($3,864), and Collaboration Module ($3,120). Annually, a total of $14,784 has been budgeted 
for a total of $73,920 for the five year project funding period.

Long Distance Telephone – Funds are requested to support telephone expenses relating to 
necessary project staff communication with research participants, collaborating researchers 
outside the university, Advisory Board members outside the local region, and with NIDILRR
program staff. VCU employees are provided with a telephone authorization code, which ensures 
that TBIMS-related calls are appropriately charged. VCU utilizes the SCATS system that results 
in substantial savings for long distance. Funds of $800 per year are budgeted to support long 
distance and conference call costs.
9. Total Direct Costs
The total annual direct cost requested for years one through five is $352,234. The five-year 
total direct costs will be $1,761,170.
10. Indirect Costs
VCU has an approved DHHS Federal Rate Agreement on-campus Facilities and Administrative 
(F&A) rate of 55% of Modified Total Direct Cost (MTDC). However, VCU is firmly committed 
to supporting the proposed TBIMS and has agreed to reduce the on-campus Facilities and 

VCU TBIMS Proposal
Budget Narrative
ix
Administrative (F&A) rate to 32% on Modified Total Direct Costs (MTDC) for this project.  The 
$404,963 reduction is a further indication of VCU’s support for the project. The requested F&A for 
year one of this project equals $112,715 and the five-year total project requested F&A is $563,575.
Per VCU policy, F&A is not charged on rent, equipment over $5,000, tuition, and is only charged to 
the first $25,000 of a subcontract.
11. Training Stipends
VCU is not requesting funds for training stipends.
12. Total Costs
A total of $464,949 is requested annually for years one through five. The five-year total 
funding request is $2,324,745.
In conclusion, we believe that project operations will be cost effective for several reasons.
First, we will build on well established resources. Second, in order for the stated outcomes and 
accompanying benefits to occur, we will utilize highly competent, diligent, and experienced staff.
To enhance the value of our efforts, we will focus on widespread dissemination and develop 
programs that can easily be replicated by others.

Traumatic Brain Injury (TBI) Model Systems
CFDA Number: HHS-2017-ACL-NIDILRR-DPTB-0204
National Institute on Disability, Independent Living,  and Rehabilitation Research (NIDILRR)
Principal Investigator: Jeffrey Kreutzer, PhD
2017 Application-Proposed
NIDILRR BUDGET
Budget Period: 10/01/2017 - 09/30/2022
Federal
Federal
Federal
Federal
Federal
TOTAL
NIDILRR
YEAR 1
YEAR 2
YEAR 3
YEAR 4
YEAR 5
Federal
PERSONNEL
Title
EFFORT
BUDGET
BUDGET
BUDGET
BUDGET
BUDGET
BUDGET
J. Kreutzer
Principal Investigator
5%
9,350
$
9,350
$
9,350
$
9,350
$
9,350
$
46,750
$
D. Cifu
Co-Principal Investigator
0%
-
$
-
$
J. Marwitz
Project Coordinator
80%
78,668
$
78,668
$
78,668
$
78,668
$
78,668
$
393,340
$
W. Walker
Medical Director
0%
-
$
-
$
A. Sima
Statistician
15%
15,450
$
15,450
$
15,450
$
15,450
$
15,450
$
77,250
$
A. Mills
Research Associate
20%
19,200
$
19,200
$
19,200
$
19,200
$
19,200
$
96,000
$
N. Hsu
Research Associate
20%
22,337
$
22,337
$
22,337
$
22,337
$
22,337
$
111,684
$
D. Klyce
Research Associate
8%
7,580
$
7,580
$
7,580
$
7,580
$
7,580
$
37,900
$
J. Kim
Project Evaluator
5%
4,692
$
4,692
$
4,692
$
4,692
$
4,692
$
23,460
$
K. Gary
Dissemination Coordinator
15%
13,650
$
13,650
$
13,650
$
13,650
$
13,650
$
68,250
$
M. Martinez
Research Assistant
100%
33,000
$
33,000
$
33,000
$
33,000
$
33,000
$
165,000
$
A. Welch
Research Assistant
80%
26,400
$
26,400
$
26,400
$
26,400
$
26,400
$
132,000
$
M. Moadab
Research Assistant
5%
1,785
$
1,785
$
1,785
$
1,785
$
1,785
$
8,925
$
C. Atkins
G & C Administrator
4.5%
2,664
$
2,664
$
2,664
$
2,664
$
2,664
$
13,320
$
Subtotal Personnel
234,776
$
234,776
$
234,776
$
234,776
$
234,776
$
1,173,879
$
Fringes at 
37.2%
87,335
$
87,335
$
87,335
$
87,335
$
87,335
$
436,675
$
Total Personnel & F/B
322,111
$
322,111
$
322,111
$
322,111
$
322,111
$
1,610,554
$
-
$
OTHER COSTS
-
$
Travel
5,000
$
5,000
$
5,000
$
5,000
$
5,000
$
25,000
$
Supplies
2,220
$
2,220
$
2,220
$
2,220
$
2,220
$
11,100
$
Publication Costs
3,319
$
3,319
$
3,319
$
3,319
$
3,319
$
16,595
$
Contractual -Duplication/Printing
1,800
$
1,800
$
1,800
$
1,800
$
1,800
$
9,000
$
Other:
     Consultants
1,200
$
1,200
$
1,200
$
1,200
$
1,200
$
6,000
$
     Advisory Board
1,000
$
1,000
$
1,000
$
1,000
$
1,000
$
5,000
$
     Research Incentives
14,784
$
14,784
$
14,784
$
14,784
$
14,784
$
73,920
$
     Telephone
800
$
800
$
800
$
800
$
800
$
4,000
$
Subtotal Other Costs
30,123
$
30,123
$
30,123
$
30,123
$
30,123
$
150,615
$
Total Direct Costs
352,234
$
352,234
$
352,234
$
352,234
$
352,234
$
1,761,170
$
F&A/Indirect at 
32%
112,715
$
112,715
$
112,715
$
112,715
$
112,715
$
563,575
$
TOTAL COST
464,949
$
464,949
$
464,949
$
464,949
$
464,949
$
2,324,745
$

Traumatic Brain Injury (TBI) Model Systems
CFDA Number: HHS-2017-ACL-NIDILRR-DPTB-0204
National Institute on Disability, Independent Living,  and Rehabilitation Research (NIDILRR)
Principal Investigator: Jeffrey Kreutzer, PhD
2017 Application-Proposed
OVERALL TBIMS BUDGET
Budget Period: 10/01/2017 - 09/30/2022
VCU 
Federal
Federal
Federal
Federal
Federal
TOTAL
NIDILRR
Cost Share
Total
YEAR 1
YEAR 2
YEAR 3
YEAR 4
YEAR 5
Federal
PERSONNEL
Title
EFFORT
EFFORT
EFFORT
BUDGET
BUDGET
BUDGET
BUDGET
BUDGET
BUDGET
J. Kreutzer
Principal Investigator
5%
25%
30%
59,361
$
59,361
$
59,361
$
59,361
$
59,361
$
296,804
$
D. Cifu
Co-Principal Investigator
0%
10%
10%
33,087
$
33,087
$
33,087
$
33,087
$
33,087
$
165,436
$
J. Marwitz
Project Coordinator
80%
80%
78,668
$
78,668
$
78,668
$
78,668
$
78,668
$
393,340
$
W. Walker
Medical Director
0%
10%
10%
29,506
$
29,506
$
29,506
$
29,506
$
29,506
$
147,529
$
A. Sima
Statistician
15%
15%
15,450
$
15,450
$
15,450
$
15,450
$
15,450
$
77,250
$
A. Mills
Research Associate
20%
10%
30%
28,800
$
28,800
$
28,800
$
28,800
$
28,800
$
144,000
$
N. Hsu
Research Associate
20%
10%
30%
33,505
$
33,505
$
33,505
$
33,505
$
33,505
$
167,526
$
D. Klyce
Research Associate
8%
8%
7,580
$
7,580
$
7,580
$
7,580
$
7,580
$
37,900
$
J. Kim
Project Evaluator
5%
5%
4,692
$
4,692
$
4,692
$
4,692
$
4,692
$
23,460
$
K. Gary
Dissemination Coordinator
15%
15%
13,650
$
13,650
$
13,650
$
13,650
$
13,650
$
68,250
$
M. Martinez
Research Assistant
100%
100%
33,000
$
33,000
$
33,000
$
33,000
$
33,000
$
165,000
$
A. Welch
Research Assistant
80%
80%
26,400
$
26,400
$
26,400
$
26,400
$
26,400
$
132,000
$
N. Moadab
Research Assistant
5%
5%
1,785
$
1,785
$
1,785
$
1,785
$
1,785
$
8,925
$
C. Atkins
G & C Administrator
4.5%
4.5%
2,664
$
2,664
$
2,664
$
2,664
$
2,664
$
13,320
$
Subtotal Personnel
368,148
$
368,148
$
368,148
$
368,148
$
368,148
$
1,840,739
$
Fringes at 
37.2%
136,949
$
136,949
$
136,949
$
136,949
$
136,949
$
684,747
$
Total Personnel & F/B
505,097
$
505,097
$
505,097
$
505,097
$
505,097
$
2,525,486
$
-
$
OTHER COSTS
-
$
Travel
5,000
$
5,000
$
5,000
$
5,000
$
5,000
$
25,000
$
Supplies
2,220
$
2,220
$
2,220
$
2,220
$
2,220
$
11,100
$
Contractual -Duplication/Printing
3,319
$
3,319
$
3,319
$
3,319
$
3,319
$
16,595
$
Publications
1,800
$
1,800
$
1,800
$
1,800
$
1,800
$
9,000
$
Other:
     Consultants
1,200
$
1,200
$
1,200
$
1,200
$
1,200
$
6,000
$
     Advisory Board
1,000
$
1,000
$
1,000
$
1,000
$
1,000
$
5,000
$
     Research Incentives
14,784
$
14,784
$
14,784
$
14,784
$
14,784
$
73,920
$
     Telephone
800
$
800
$
800
$
800
$
800
$
4,000
$
Subtotal Other Costs
30,123
$
30,123
$
30,123
$
30,123
$
30,123
$
150,615
$
Total Direct Costs
535,220
$
535,220
$
535,220
$
535,220
$
535,220
$
2,676,101
$
F&A/Indirect at 32%
32%
112,715
$
112,715
$
112,715
$
112,715
$
112,715
$
563,575
$
TOTAL COST
647,935
$
647,935
$
647,935
$
647,935
$
647,935
$
3,239,676
$

Traumatic Brain Injury (TBI) Model Systems
CFDA Number: HHS-2017-ACL-NIDILRR-DPTB-0204
National Institute on Disability, Independent Living,  and Rehabilitation Research (NIDILRR)
Principal Investigator: Jeffrey Kreutzer, PhD
2017 Application-Proposed
VCU COST SHARE
Budget Period: 10/01/2017 - 09/30/2022
Cost-Share
Cost Share
PERSONNEL
Title
EFFORT
Year 1
Year 2
Year 3
Year 4
Year 5
Total
J. Kreutzer
Principal Investigator
25%
50,011
$
50,011
$
50,011
$
50,011
$
50,011
$
250,054
$
D. Cifu
Co-Principal Investigator
10%
33,087
$
33,087
$
33,087
$
33,087
$
33,087
$
165,436
$
W. Walker
Medical Director
10%
29,506
$
29,506
$
29,506
$
29,506
$
29,506
$
147,529
$
A. Mills
Research Associate
10%
9,600
$
9,600
$
9,600
$
9,600
$
9,600
$
48,000
$
N. Hsu
Research Associate
10%
11,168
$
11,168
$
11,168
$
11,168
$
11,168
$
55,842
$
D. Klyce
Research Associate
0%
-
$
-
$
-
$
-
$
-
$
-
$
Subtotal Personnel
133,372
$
133,372
$
133,372
$
133,372
$
133,372
$
666,860
$
Fringes at 
37.2%
49,614
$
49,614
$
49,614
$
49,614
$
49,614
$
248,072
$
Total Personnel with Fringes
182,986
$
182,986
$
182,986
$
182,986
$
182,986
$
914,932
$
-
$
Other
-
$
Total VCU Direct Costs
182,986
$
182,986
$
182,986
$
182,986
$
182,986
$
914,932
$
-
$
-
$
-
$
-
$
-
$
-
$
TOTAL COST SHARE
182,986
$
182,986
$
182,986
$
182,986
$
182,986
$
914,932
$

Traumatic Brain Injury (TBI) Model Systems
CFDA Number: HHS-2017-ACL-NIDILRR-DPTB-0204
National Institute on Disability, Independent Living,  and Rehabilitation Research (NIDILRR)
Principal Investigator: Jeffrey Kreutzer, PhD
2017 Application-Proposed
STAFF EFFORT ALLOCATION
Budget Period: 10/01/2017 - 09/30/2022
Administration 
Dissemination
National 
Database
Resilience 
Intervention
Collaborative 
Module
Total
Kreutzer
10%
2%
12%
6%
30%
Cifu
5%
5%
-
-
10%
Marwitz
25%
20%
15%
20%
80%
Walker
-
10%
-
-
10%
Sima
-
2%
5%
8%
15%
Hsu
-
-
30%
-
30%
Mills
-
-
30%
30%
Klyce
-
8%
-
-
8%
Kim
5%
-
-
-
5%
Gary
15%
-
-
-
15%
Welch
-
35%
45%
-
80%
Martinez
-
75%
5%
20%
100%
Moadab
-
-
5%
-
5%
Atkins
4.5%
-
-
-
4.5%

Budget Narrative
Traumatic Brain Injury Model Systems
Jeffrey Kreutzer, Principal Investigator
Year 1
10/1/2017-9/30/2018
Object Class 
Category
Federal Funds
Non-
Federal 
Funds 
Cash
Non-
Federal    
In-Kind
Total
Justification
Personnel
$234,776
$133,372
$0
$368,148
Principal Investigator (Jeffrey 
Kreutzer) = .05 FTE @ $187,100/yr 
= $9,350 (Salary is more than the 
DHHS Salary Cap Threshold so the 
amount budgeted is at the current 
applicable salary cap) 
Project Coordinator (Jennifer 
Marwitz) = .80 FTE @ $98,335/yr = 
$78,668
Statistician (Adam Sima) = .15 FTE 
@ $103,000/yr = $15,450
Research Associate (Ana Mills) = .20 
FTE @ $96,000/yr = $19,200
Research Associate (Nancy Hsu) = 
.20 FTE @ $111,684/yr = $22,337
Research Associate (Daniel Klyce) = 
.08 FTE @ $94,749/yr = $7,580
Project Evaluator (Jeong Han Kim) = 
.05 FTE @ $93,840/yr = $4,692
Dissemination Coordinator (Kelli 
Williams Gary) .15 FTE @ 
$91,000/yr = $13,650
Research Assistant (Marie Grace 
Martinez) 1 FTE @ $33,000/yr = 
$33,000
Research Assistant (Abigail Welch) 
.80 FTE @ $33,000/yr = $26,400

Research Assistant (Naghmeh 
Moadab) .05 FTE @ $35,700/yr = 
1,785
G&C Administrator (Christie Atkins) 
.045 FTE @ $59,200/yr = $2,664
Non-Federal Cash
Principal Investigator (Jeffrey 
Kreutzer) = .25 FTE @ $200,043/yr 
= $50,011
Co-Principal Investigator (David 
Cifu) = .10 FTE @ $330,871/yr = 
$33,087
Medical Director (William Walker) = 
.10 FTE @ $295,058/yr = $29,506
Research Associate (Ana Mills) = .10 
FTE @ $96,000/yr = $9,600
Research Associate (Nancy Hsu) = 
.10 FTE @ $111,684/yr = $11,168
Total: $368,148
Fringe Benefits
$87,335
$49,614
$0
$136,949
Principal Investigator at 37.2% = 
$3,478
Project Coordinator at 37.2% = 
$29,265
Statistician at 37.2% = $5,747
Research Associate at 37.2% = 
$7,143
Research Associate at 37.2% = 8,309
Research Associate at 37.2% = 
$2,819
Project Evaluator at 37.2% = $1,745
Dissemination Coordinator at 37.2% 
= $5,078

Research Assistant at 37.2% = 
12,275
Research Assistant at 37.2% = 9,821
Research Assistant at 37.2% = $664
G&C Administrator at 37.2% = $991
Retirement (11.45%)
FICA (6.65%)
Group Life (1.32%)
Health Insurance (14.20%)
Health Insurance Credit (1.17%)
Unemployment (0.15%)
Workers Compensation (0.35%)
Long-Term Disability (0.47%)
VRS Long-Term Disability (0.40%)
Faculty-Staff Tuition Waivers 
(0.55%)
Cash Match Plan (0.49%) 
Non-Federal Cash
Principal Investigator at 37.2% = 
$18,604
Co-Principal Investigator at 37.2% = 
$12,308
Medical Director at 37.2% = $10,976
Research Associate at 37.2% = 3,571
Research Associate at 37.2% = 4,155
Retirement (11.45%)
FICA (6.65%)
Group Life (1.32%)
Health Insurance (14.20%)
Health Insurance Credit (1.17%)
Unemployment (0.15%)
Workers Compensation (0.35%)
Long-Term Disability (0.47%)
VRS Long-Term Disability (0.40%)

Faculty-Staff Tuition Waivers 
(0.55%)
Cash Match Plan (0.49%) 
Total: $136,949
Travel
$5,000
$0
$0
$5,000
Travel for project staff to attend 
Semi-Annual Project Directors’ 
meeting, professional meetings, 
conferences and other dissemination-
related activities
Mileage: 210 miles roundtrip to 
Arlington, VA x $0.535 per mile x 2 
trips x 2 people = $449.40
Per Diem: $69 Full Days x 10 /
$51.75 Travel Day x 20 = $1,725
Airfare: 1 out of state conference for 
PI - $523.30
Lodging: $182 per night plus 15% 
taxes = $209.30 x 11 nights = 
$2,302.30
Total: $5,000.00
Equipment
$0
$0
$0
$0
No Equipment Requested
Supplies
$2,220
$0
$0
$2,220
Project supplies and materials
Total: $2,220
Contractual
$0
$0
$0
$0
No Contractual Requested
Other
$22,903
$0
$0
$22,903
Advisory Board: $1,000
Consultants: $1,200
Duplication/Printing: $1,800
Publication Costs: $3,319
University Services 
(telecommunications): $800
Research Incentives: $14,784
Total: $22,903
Indirect Charges
$112,715
$0
$0
$112,715
32% of Modified Direct Costs = 
$112,715
Total
$464,949
$182,986
$0
$647,935

Year 2
10/1/2018-9/30/2019
Object Class 
Category
Federal Funds
Non-
Federal 
Funds 
Cash
Non-
Federal    
In-Kind
Total
Justification
Personnel
$234,776
$133,372
$0
$368,148
Principal Investigator (Jeffrey 
Kreutzer) = .05 FTE @ $187,100/yr 
= $9,350 (Salary is more than the 
DHHS Salary Cap Threshold so the 
amount budgeted is at the current 
applicable salary cap) 
Project Coordinator (Jennifer 
Marwitz) = .80 FTE @ $98,335/yr = 
$78,668
Statistician (Adam Sima) = .15 FTE 
@ $103,000/yr = $15,450
Research Associate (Ana Mills) = .20 
FTE @ $96,000/yr = $19,200
Research Associate (Nancy Hsu) = 
.20 FTE @ $111,684/yr = $22,337
Research Associate (Daniel Klyce) = 
.08 FTE @ $94,749/yr = $7,580
Project Evaluator (Jeong Han Kim) = 
.05 FTE @ $93,840/yr = $4,692
Dissemination Coordinator (Kelli 
Williams Gary) .15 FTE @ 
$91,000/yr = $13,650
Research Assistant (Marie Grace 
Martinez) 1 FTE @ $33,000/yr = 
$33,000
Research Assistant (Abigail Welch) 
.80 FTE @ $33,000/yr = $26,400
Research Assistant (Naghmeh 
Moadab) .05 FTE @ $35,700/yr = 
1,785

G&C Administrator (Christie Atkins) 
.045 FTE @ $59,200/yr = $2,664
Non-Federal Cash
Principal Investigator (Jeffrey 
Kreutzer) = .25 FTE @ $200,043/yr 
= $50,011
Co-Principal Investigator (David 
Cifu) = .10 FTE @ $330,871/yr = 
$33,087
Medical Director (William Walker) = 
.10 FTE @ $295,058/yr = $29,506
Research Associate (Ana Mills) = .10 
FTE @ $96,000/yr = $9,600
Research Associate (Nancy Hsu) = 
.10 FTE @ $111,684/yr = $11,168
Total: $368,148
Fringe Benefits
$87,335
$49,614
$0
$136,949
Principal Investigator at 37.2% = 
$3,478
Project Coordinator at 37.2% = 
$29,265
Statistician at 37.2% = $5,747
Research Associate at 37.2% = 
$7,143
Research Associate at 37.2% = 8,309 
Research Associate at 37.2% = 
$2,819
Project Evaluator at 37.2% = $1,745
Dissemination Coordinator at 37.2% 
= $5,078
Research Assistant at 37.2% = 
12,275

Research Assistant at 37.2% = 9,821
Research Assistant at 37.2% = $664
G&C Administrator at 37.2% = $991
Retirement (11.45%)
FICA (6.65%)
Group Life (1.32%)
Health Insurance (14.20%)
Health Insurance Credit (1.17%)
Unemployment (0.15%)
Workers Compensation (0.35%)
Long-Term Disability (0.47%)
VRS Long-Term Disability (0.40%)
Faculty-Staff Tuition Waivers 
(0.55%)
Cash Match Plan (0.49%) 
Non-Federal Cash
Principal Investigator at 37.2% = 
$18,604
Co-Principal Investigator at 37.2% = 
$12,308
Medical Director at 37.2% = $10,976
Research Associate at 37.2% = 3,571
Research Associate at 37.2% = 4,155
Retirement (11.45%)
FICA (6.65%)
Group Life (1.32%)
Health Insurance (14.20%)
Health Insurance Credit (1.17%)
Unemployment (0.15%)
Workers Compensation (0.35%)
Long-Term Disability (0.47%)
VRS Long-Term Disability (0.40%)
Faculty-Staff Tuition Waivers 
(0.55%)
Cash Match Plan (0.49%) 

Total: $136,949
Travel
$5,000
$0
$0
$5,000
Travel for project staff to attend 
Semi-Annual Project Directors’ 
meeting, professional meetings, 
conferences and other dissemination-
related activities
Mileage: 210 miles roundtrip to 
Arlington, VA x $0.535 per mile x 2 
trips x 2 people = $449.40
Per Diem: $69 Full Days x 10 / 
$51.75 Travel Day x 20 = $1,725
Airfare: 1 out of state conference for 
PI - $523.30
Lodging: $182 per night plus 15% 
taxes = $209.30 x 11 nights = 
$2,302.30
Total: $5,000.00
Equipment
$0
$0
$0
$0
No Equipment Requested
Supplies
$2,220
$0
$0
$2,220
Project supplies and materials
Total: $2,220
Contractual
$0
$0
$0
$0
No Contractual Requested
Other
$22,903
$0
$0
$22,903
Advisory Board: $1,000
Consultants: $1,200
Duplication/Printing: $1,800
Publication Costs: $3,319
University Services 
(telecommunications): $800
Research Incentives: $14,784
Total: $22,903
Indirect Charges
$112,715
$0
$0
$112,715
32% of Modified Direct Costs = 
$112,715
Total
$464,949
$182,986
$0
$647,935
Year 3
10/1/2019-9/30/2020

Object Class 
Category
Federal Funds
Non-
Federal 
Funds 
Cash
Non-
Federal    
In-Kind
Total
Justification
Personnel
$234,776
$133,372
$0
$368,148
Principal Investigator (Jeffrey 
Kreutzer) = .05 FTE @ $187,100/yr 
= $9,350 (Salary is more than the 
DHHS Salary Cap Threshold so the 
amount budgeted is at the current 
applicable salary cap) 
Project Coordinator (Jennifer 
Marwitz) = .80 FTE @ $98,335/yr = 
$78,668
Statistician (Adam Sima) = .15 FTE 
@ $103,000/yr = $15,450
Research Associate (Ana Mills) = .20 
FTE @ $96,000/yr = $19,200
Research Associate (Nancy Hsu) = 
.20 FTE @ $111,684/yr = $22,337
Research Associate (Daniel Klyce) = 
.08 FTE @ $94,749/yr = $7,580
Project Evaluator (Jeong Han Kim) = 
.05 FTE @ $93,840/yr = $4,692
Dissemination Coordinator (Kelli 
Williams Gary) .15 FTE @ 
$91,000/yr = $13,650
Research Assistant (Marie Grace 
Martinez) 1 FTE @ $33,000/yr = 
$33,000
Research Assistant (Abigail Welch) 
.80 FTE @ $33,000/yr = $26,400
Research Assistant (Naghmeh 
Moadab) .05 FTE @ $35,700/yr = 
1,785
G&C Administrator (Christie Atkins) 
.045 FTE @ $59,200/yr = $2,664

Non-Federal Cash
Principal Investigator (Jeffrey 
Kreutzer) = .25 FTE @ $200,043/yr 
= $50,011
Co-Principal Investigator (David 
Cifu) = .10 FTE @ $330,871/yr = 
$33,087
Medical Director (William Walker) = 
.10 FTE @ $295,058/yr = $29,506
Research Associate (Ana Mills) = .10
FTE @ $96,000/yr = $9,600
Research Associate (Nancy Hsu) = 
.10 FTE @ $111,684/yr = $11,168
Total: $368,148
Fringe Benefits
$87,335
$49,614
$0
$136,949
Principal Investigator at 37.2% = 
$3,478
Project Coordinator at 37.2% = 
$29,265
Statistician at 37.2% = $5,747
Research Associate at 37.2% = 
$7,143
Research Associate at 37.2% = 8,309 
Research Associate at 37.2% = 
$2,819
Project Evaluator at 37.2% = $1,745
Dissemination Coordinator at 37.2% 
= $5,078
Research Assistant at 37.2% = 
12,275
Research Assistant at 37.2% = 9,821

Research Assistant at 37.2% = $664
G&C Administrator at 37.2% = $991
Retirement (11.45%)
FICA (6.65%)
Group Life (1.32%)
Health Insurance (14.20%)
Health Insurance Credit (1.17%)
Unemployment (0.15%)
Workers Compensation (0.35%)
Long-Term Disability (0.47%)
VRS Long-Term Disability (0.40%)
Faculty-Staff Tuition Waivers 
(0.55%)
Cash Match Plan (0.49%) 
Non-Federal Cash
Principal Investigator at 37.2% = 
$18,604
Co-Principal Investigator at 37.2% = 
$12,308
Medical Director at 37.2% = $10,976
Research Associate at 37.2% = 3,571
Research Associate at 37.2% = 4,155
Retirement (11.45%)
FICA (6.65%)
Group Life (1.32%)
Health Insurance (14.20%)
Health Insurance Credit (1.17%)
Unemployment (0.15%)
Workers Compensation (0.35%)
Long-Term Disability (0.47%)
VRS Long-Term Disability (0.40%)
Faculty-Staff Tuition Waivers 
(0.55%)
Cash Match Plan (0.49%) 
Total: $136,949

Travel
$5,000
$0
$0
$5,000
Travel for project staff to attend 
Semi-Annual Project Directors’ 
meeting, professional meetings, 
conferences and other dissemination-
related activities
Mileage: 210 miles roundtrip to 
Arlington, VA x $0.535 per mile x 2 
trips x 2 people = $449.40
Per Diem: $69 Full Days x 10 / 
$51.75 Travel Day x 20 = $1,725
Airfare: 1 out of state conference for 
PI - $523.30
Lodging: $182 per night plus 15% 
taxes = $209.30 x 11 nights = 
$2,302.30
Total: $5,000.00
Equipment
$0
$0
$0
$0
No Equipment Requested
Supplies
$2,220
$0
$0
$2,220
Project supplies and materials
Total: $2,220
Contractual
$0
$0
$0
$0
No Contractual Requested
Other
$22,903
$0
$0
$22,903
Advisory Board: $1,000
Consultants: $1,200
Duplication/Printing: $1,800
Publication Costs: $3,319
University Services 
(telecommunications): $800
Research Incentives: $14,784
Total: $22,903
Indirect Charges
$112,715
$0
$0
$112,715
32% of Modified Direct Costs = 
$112,715
Total
$464,949
$182,986
$0
$647,935
Year 4
10/1/2020-9/30/2021
Object Class 
Category
Federal Funds
Non-
Federal 
Funds 
Cash
Non-
Federal    
In-Kind
Total
Justification

Personnel
$234,776
$133,372
$0
$368,148
Principal Investigator (Jeffrey 
Kreutzer) = .05 FTE @ $187,100/yr
= $9,350 (Salary is more than the 
DHHS Salary Cap Threshold so the 
amount budgeted is at the current 
applicable salary cap) 
Project Coordinator (Jennifer 
Marwitz) = .80 FTE @ $98,335/yr = 
$78,668
Statistician (Adam Sima) = .15 FTE 
@ $103,000/yr = $15,450
Research Associate (Ana Mills) = .20 
FTE @ $96,000/yr = $19,200
Research Associate (Nancy Hsu) = 
.20 FTE @ $111,684/yr = $22,337
Research Associate (Daniel Klyce) = 
.08 FTE @ $94,749/yr = $7,580
Project Evaluator (Jeong Han Kim) = 
.05 FTE @ $93,840/yr = $4,692
Dissemination Coordinator (Kelli 
Williams Gary) .15 FTE @ 
$91,000/yr = $13,650
Research Assistant (Marie Grace 
Martinez) 1 FTE @ $33,000/yr = 
$33,000
Research Assistant (Abigail Welch) 
.80 FTE @ $33,000/yr = $26,400
Research Assistant (Naghmeh 
Moadab) .05 FTE @ $35,700/yr = 
1,785
G&C Administrator (Christie Atkins) 
.045 FTE @ $59,200/yr = $2,664
Non-Federal Cash

Principal Investigator (Jeffrey 
Kreutzer) = .25 FTE @ $200,043/yr 
= $50,011
Co-Principal Investigator (David 
Cifu) = .10 FTE @ $330,871/yr = 
$33,087
Medical Director (William Walker) = 
.10 FTE @ $295,058/yr = $29,506
Research Associate (Ana Mills) = .10 
FTE @ $96,000/yr = $9,600
Research Associate (Nancy Hsu) = 
.10 FTE @ $111,684/yr = $11,168
Total: $368,148
Fringe Benefits
$87,335
$49,614
$0
$136,949
Principal Investigator at 37.2% = 
$3,478
Project Coordinator at 37.2% = 
$29,265
Statistician at 37.2% = $5,747
Research Associate at 37.2% = 
$7,143
Research Associate at 37.2% = 8,309 
Research Associate at 37.2% = 
$2,819
Project Evaluator at 37.2% = $1,745
Dissemination Coordinator at 37.2% 
= $5,078
Research Assistant at 37.2% = 
12,275
Research Assistant at 37.2% = 9,821
Research Assistant at 37.2% = $664

G&C Administrator at 37.2% = $991
Retirement (11.45%)
FICA (6.65%)
Group Life (1.32%)
Health Insurance (14.20%)
Health Insurance Credit (1.17%)
Unemployment (0.15%)
Workers Compensation (0.35%)
Long-Term Disability (0.47%)
VRS Long-Term Disability (0.40%)
Faculty-Staff Tuition Waivers 
(0.55%)
Cash Match Plan (0.49%) 
Non-Federal Cash
Principal Investigator at 37.2% = 
$18,604
Co-Principal Investigator at 37.2% = 
$12,308
Medical Director at 37.2% = $10,976
Research Associate at 37.2% = 3,571
Research Associate at 37.2% = 4,155
Retirement (11.45%)
FICA (6.65%)
Group Life (1.32%)
Health Insurance (14.20%)
Health Insurance Credit (1.17%)
Unemployment (0.15%)
Workers Compensation (0.35%)
Long-Term Disability (0.47%)
VRS Long-Term Disability (0.40%)
Faculty-Staff Tuition Waivers 
(0.55%)
Cash Match Plan (0.49%) 
Total: $136,949
Travel
$5,000
$0
$0
$5,000
Travel for project staff to attend 
Semi-Annual Project Directors’ 
meeting, professional meetings, 

conferences and other dissemination-
related activities
Mileage: 210 miles roundtrip to 
Arlington, VA x $0.535 per mile x 2 
trips x 2 people = $449.40
Per Diem: $69 Full Days x 10 / 
$51.75 Travel Day x 20 = $1,725
Airfare: 1 out of state conference for 
PI - $523.30
Lodging: $182 per night plus 15% 
taxes = $209.30 x 11 nights = 
$2,302.30
Total: $5,000.00
Equipment
$0
$0
$0
$0
No Equipment Requested
Supplies
$2,220
$0
$0
$2,220
Project supplies and materials
Total: $2,220
Contractual
$0
$0
$0
$0
No Contractual Requested
Other
$22,903
$0
$0
$22,903
Advisory Board: $1,000
Consultants: $1,200
Duplication/Printing: $1,800
Publication Costs: $3,319
University Services 
(telecommunications): $800
Research Incentives: $14,784
Total: $22,903
Indirect Charges
$112,715
$0
$0
$112,715
32% of Modified Direct Costs = 
$112,715
Total
$464,949
$182,986
$0
$647,935
Year 5
10/1/2021-9/30/2022
Object Class 
Category
Federal Funds
Non-
Federal 
Funds 
Cash
Non-
Federal    
In-Kind
Total
Justification
Personnel
$234,776
$133,372
$0
$368,148
Principal Investigator (Jeffrey 
Kreutzer) = .05 FTE @ $187,100/yr
= $9,350 (Salary is more than the 

DHHS Salary Cap Threshold so the 
amount budgeted is at the current 
applicable salary cap) 
Project Coordinator (Jennifer 
Marwitz) = .80 FTE @ $98,335/yr = 
$78,668
Statistician (Adam Sima) = .15 FTE 
@ $103,000/yr = $15,450
Research Associate (Ana Mills) = .20 
FTE @ $96,000/yr = $19,200
Research Associate (Nancy Hsu) = 
.20 FTE @ $111,684/yr = $22,337
Research Associate (Daniel Klyce) = 
.08 FTE @ $94,749/yr = $7,580
Project Evaluator (Jeong Han Kim) = 
.05 FTE @ $93,840/yr = $4,692
Dissemination Coordinator (Kelli 
Williams Gary) .15 FTE @ 
$91,000/yr = $13,650
Research Assistant (Marie Grace 
Martinez) 1 FTE @ $33,000/yr = 
$33,000
Research Assistant (Abigail Welch) 
.80 FTE @ $33,000/yr = $26,400
Research Assistant (Naghmeh 
Moadab) .05 FTE @ $35,700/yr = 
1,785
G&C Administrator (Christie Atkins) 
.045 FTE @ $59,200/yr = $2,664
Non-Federal Cash
Principal Investigator (Jeffrey 
Kreutzer) = .25 FTE @ $200,043/yr 
= $50,011

Co-Principal Investigator (David 
Cifu) = .10 FTE @ $330,871/yr = 
$33,087
Medical Director (William Walker) = 
.10 FTE @ $295,058/yr = $29,506
Research Associate (Ana Mills) = .10 
FTE @ $96,000/yr = $9,600
Research Associate (Nancy Hsu) = 
.10 FTE @ $111,684/yr = $11,168
Total: $368,148
Fringe Benefits
$87,335
$49,614
$0
$136,949
Principal Investigator at 37.2% = 
$3,478
Project Coordinator at 37.2% = 
$29,265
Statistician at 37.2% = $5,747
Research Associate at 37.2% = 
$7,143
Research Associate at 37.2% = 8,309 
Research Associate at 37.2% = 
$2,819
Project Evaluator at 37.2% = $1,745
Dissemination Coordinator at 37.2% 
= $5,078
Research Assistant at 37.2% = 
12,275
Research Assistant at 37.2% = 9,821
Research Assistant at 37.2% = $664
G&C Administrator at 37.2% = $991
Retirement (11.45%)
FICA (6.65%)

Group Life (1.32%)
Health Insurance (14.20%)
Health Insurance Credit (1.17%)
Unemployment (0.15%)
Workers Compensation (0.35%)
Long-Term Disability (0.47%)
VRS Long-Term Disability (0.40%)
Faculty-Staff Tuition Waivers 
(0.55%)
Cash Match Plan (0.49%) 
Non-Federal Cash
Principal Investigator at 37.2% = 
$18,604
Co-Principal Investigator at 37.2% = 
$12,308
Medical Director at 37.2% = $10,976
Research Associate at 37.2% = 3,571
Research Associate at 37.2% = 4,155
Retirement (11.45%)
FICA (6.65%)
Group Life (1.32%)
Health Insurance (14.20%)
Health Insurance Credit (1.17%)
Unemployment (0.15%)
Workers Compensation (0.35%)
Long-Term Disability (0.47%)
VRS Long-Term Disability (0.40%)
Faculty-Staff Tuition Waivers 
(0.55%)
Cash Match Plan (0.49%) 
Total: $136,949
Travel
$5,000
$0
$0
$5,000
Travel for project staff to attend 
Semi-Annual Project Directors’ 
meeting, professional meetings, 
conferences and other dissemination-
related activities

 
Mileage: 210 miles roundtrip to 
Arlington, VA x $0.535 per mile x 2 
trips x 2 people = $449.40
Per Diem: $69 Full Days x 10 / 
$51.75 Travel Day x 20 = $1,725
Airfare: 1 out of state conference for 
PI - $523.30
Lodging: $182 per night plus 15% 
taxes = $209.30 x 11 nights = 
$2,302.30
Total: $5,000.00
Equipment
$0
$0
$0
$0
No Equipment Requested
Supplies
$2,220
$0
$0
$2,220
Project supplies and materials
Total: $2,220
Contractual
$0
$0
$0
$0
No Contractual Requested
Other
$22,903
$0
$0
$22,903
Advisory Board: $1,000
Consultants: $1,200
Duplication/Printing: $1,800
Publication Costs: $3,319
University Services 
(telecommunications): $800
Research Incentives: $14,784
Total: $22,903
Indirect Charges
$112,715
$0
$0
$112,715
32% of Modified Direct Costs = 
$112,715
Total
$464,949
$182,986
$0
$647,935

Project Narrative File(s)
Project Narrative File Attachments: 
ProjectNarrative.pdf

Print
 
Close
HM20011840
View: SF - Study Identification
Date: Monday, February 10, 2025 1:56:41 PM
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Study Identification
1. * Select the Principal Investigator:
Nancy Hsu
2. * Study Title:
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
3. * Is this a student or trainee project in which activities will be carried out by that individual under your
supervision (for example, dissertation or degree-required projects):
  Yes
No
4. * Please select the primary department or center that this study is being conducted under:
Physical Medicine and Rehabilitation
5. Select the VCU IRB numbers assigned to studies that are:
      1. Associated with this study
      2. Research registries this study will utilize
      3. Previously submitted versions of this study (closed, withdrawn, auto-withdrawn studies)
ID
Title
PI
There are no items to display
6. Select all individuals who are permitted to edit the IRB protocol and should be copied on communications
(study staff will be entered later).  These individuals will be referred to as protocol editors:
Last Name
First Name
E-Mail
Phone
Mobile
Abbasi
Katherine
kwalker33@vcu.edu
8048283703
 
Brown
Rochelle
brownr25@vcu.edu
8048284230
 
Frey
Carolyn
cafrey@vcu.edu
8042299143
 
Hsu
Nancy
nhhsu@vcu.edu
 
 
Marwitz
Jennifer
jhmarwit@vcu.edu
8048283704
 
7. * Select one of the following that applies to the project (selection will branch to new pages):
Note: VCU IRB offers guidance for many types of studies, including secondary data analysis studies, internet
research, registries, EFIC, HUD, and Emergency Use protocols.
See https://research.vcu.edu/human_research/guidance.htm 
Research Project or Clinical Investigation [*most exempt, expedited, and full board research studies]
Exception from Informed Consent (EFIC) for Planned Emergency Research
Humanitarian Use of Device for Treatment or Diagnosis
Humanitarian Use of Device for Clinical Investigation
Emergency Use of Investigational Drug, Biologic or Device
Treatment Use (Expanded Access to Investigational Product for Treatment Use)
Center or Institute Administrative Grant Review

Request for Not Human Subject Research Determination (i.e. request a letter confirming that IRB review is not
required)

HM20011840
View: SF2 - Federal Regulations
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Federal Regulations
1. * Is this a FDA regulated study?
FDA regulated research includes all clinical investigations involving a test article and a human subject(s) that
has been submitted for approval to the FDA or may be submitted in the future. 
Check Yes if
•    the study involves an IND/IDE, abbreviated IDE, IND/IDE exemption, HUD, expanded access, or is otherwise
subject to 21 CFR 56, 
•    the study involves a test article being administered or dispensed to subjects NOT according to a clinicians’
medical judgment but rather, per the study protocol, OR
•    the study does not involve a test article but intends to provide safety or efficacy data to the FDA.
 
  Yes
No
2. * Is this study supported by the Department of Defense (DoD):
  Yes
No
3. * Check if any of the following funding sources apply to this research (including Direct and/or Indirect
funding):

Department of Education

Department of Justice

Environmental Protection Agency

None of the above

HM20011840
View: SF2 - IRB Panel Setup
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
IRB Panel Setup
1. * To which IRB is this study being submitted for review?
VCU IRB
WCG IRB
NCI Central IRB
Advarra IRB
Other IRB
2. * Is this study transitioning to review by another IRB?
Yes - transitioning from VCU IRB to an external IRB (WCG, CIRB, Other)
Yes - transitioning from an external IRB (WCG, CIRB, Other) to VCU IRB
No or not applicable

HM20011840
View: SF2 - Review Setup
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Review Setup
1. * Select which study type best describes the majority of the study. Your response will help determine which
IRB panel should review this.
Bio-Medical Research
Social/Behavioral/Education (SBE) Research
2. * Which option(s) best describe the way(s) this study’s procedures will be conducted? (Select all that apply.)
This information may be used by the IRB in triaging studies during an emergency.

In-person interactions / interventions with participants

Remote interactions / interventions with participants

Secondary data/specimen analyses with or without contact with study participants
3. * Does this study involve greater than minimal risk:
  Yes No
4. * Review type requested: (subject to IRB approval):
Full Board
Expedited
Exempt
 
5. * Is this study initiated by a VCU investigator or a sponsor:
VCU Investigator initiated
Sponsor or industry initiated
 
 
The IRB has determined that the selected types of anticipated individual and social benefit apply to this study
 
The below information is read-only to investigators, and the categories are set by the IRB during review. All
categories will appear blank until the IRB has made a determination. If a category is not checked, it does not
apply to this study. This information may be used by the IRB in triaging studies during an emergency
situation.
There are no items to display
 
  
 
The following information applies to studies being reviewed by the VCU IRB.
The IRB has determined that the selected Exempt and/or Expedited categories apply to this study.
The below information is read-only to investigators, and the categories are set by the IRB during review. All
categories will appear blank until the IRB has made a determination. If a category is not checked, it does not
apply to this study or the study is being reviewed by an external IRB.
6. For Expedited Studies:

Category
5
Nonresearch Data
Collection
Involves materials (data, documents, records, or specimens) that have been
collected or will be collected solely for nonresearch purposes including medical treatment
or diagnosis.
Category
6
Research Data
Collection
Involves the collection of data from voice, video, digital, or image recordings made for
research purposes.
Category
7
Behavioral
Is research that will be performed on individual or group characteristics or behavior OR
will employ a survey, interview, oral history, focus group, program evaluation, human
factors evaluation, or quality assurance methodologies.
  

HM20011840
View: SF2 - Initial Setup Complete
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Initial Setup Complete
Protocol Progress:
❶ INITIAL SETUP
② BACKGROUND, RATIONALE & GOALS
③ RESEARCH PLAN
④ CONSENT PLAN
⑤ RISKS, PRIVACY & CONFIDENTIALITY
⑥ POPULATIONS WITH SPECIAL CONSIDERATIONS
⑦ INSTITUTIONAL REQUIREMENTS
⑧ DOCUMENTS
Click Continue below to go to the next section
 

HM20011840
View: SF2 - Background, Rationale and Goals
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Background, Rationale and Goals
1. * Describe the study's background and what is currently known from the scientific literature, including
citations, or upload a citation list in document upload.  Use lay language whenever possible.
Though persons with traumatic brain injury (TBI) often confront a variety of long-term challenges, inpatient and
outpatient services are often limited or unavailable. Review of recent TBI Model Systems National Database reports
provides evidence that lengths of stay in inpatient rehabilitation settings have declined over the last two decades.
Professionals, family members, and survivors have been alarmed by reductions, restrictions, and limitations on
inpatient rehabilitation stays. Concerns have also been expressed that many survivors are discharged home with
serious problems to family members who are not adequately equipped to help. In fact, many communities do not offer
specialized outpatient rehabilitation. Where outpatient rehabilitation is available, insurance companies are often
reluctant to fund services.
In addition to the difficulties in obtaining effective care, research and clinical experience suggest that survivors
experience a wide variety of lingering injury-related challenges. For example, early on, many survivors know little about
the common consequences of injury and have trouble coping with loss and change. Some have difficulty taking an
active role in treatment, while impatience with the recovery process is common. Diminished problem solving, emotional
regulation, stress management, and communication skills add further to the challenges of maintaining and rebuilding
positive relationships. Research suggesting that a majority of survivors experience depression and are unable to
maintain employment illustrates the breadth of struggles brain injury survivors continue to face in the long-term.
Consequently, many survivors become discouraged and struggle to maintain a positive outlook.
Clinical psychology researchers have recently turned their attention to resilience, an individual characteristic that allows
persons who experience trauma to successfully adjust, adapt, and, in many cases, thrive despite adversity.
Researchers have learned that resilience is not a trait, but rather a set of skills which can be developed and enhanced.
A number of studies involving children, adolescents, and adults with anxiety disorders, depression, PTSD, and learning
disabilities have demonstrated the efficacy of resilience-based interventions.
In 2012, with NIDILRR TBIMS funding, VCU researchers developed a structured C-B intervention to promote postinjury
resilience and adjustment after TBI: the Resilience and Adjustment Intervention (RAI) (Godwin et al, 2015). The
intervention development project, which was designed to address post-acute TBI needs, concerns, and challenges
(e.g., common injury effects, coping with loss and change, one’s role in recovery, problem solving, communication, and
stress management), emphasized education, skill building, and psychological support. Our investigation was also
implemented to test the feasibility of the intervention and measurement protocol. Outpatients with mild to severe TBI
were randomly assigned to either a treatment (RAI) or wait list control (WLC) group. Treatment was delivered in seven
one-hour sessions with outcome measurement pre- and post-treatment, and three months after treatment completion.
Treatment group participants showed improvement in outcomes, whereas controls did not. At three months post-
treatment, improvements were maintained relative to pre-treatment.
Important questions remain regarding the sustainability of treatment benefits. First, are treatment benefits sustained
beyond three months? Second, are there patient characteristics that predict longevity of benefits? Qualitative feedback
from research participants was carefully reviewed to provide direction for further development of the RAI. Every single
participant stated that they would recommend the program to others. However, a number of participants wanted more
sessions with additional time to focus on individual needs, suggesting that the addition of booster sessions could be of
great benefit.
By definition, booster sessions are follow-up sessions implemented after program completion to help maintain benefits
over time. Boosters provide an opportunity for individuals to review content, consolidate gains, and discuss challenges.
Given the high rate of cognitive impairments following TBI, booster sessions can provide an important opportunity to
reinforce learning and ameliorate the impact of memory deficits on skills acquisition. Booster sessions have been
shown to be beneficial across an array of therapy targets, including reducing anxiety and depression (Wesner et al.,
2015), improving communication skills (Braukhaus, et al, 2003) and enhancing relationship skills (Vaterlaus et al,
2012). In the only known study to utilize psychotherapy booster sessions for individuals with TBI, Ponsford and
colleagues examined the impact of modified cognitive-behavioral therapy with three booster sessions provided
between 21 and 30 weeks post-recruitment (Ponsford et al., 2016). The booster program was associated with reduced
anxiety and depression and increased psychosocial functioning.
The development and inclusion of booster sessions increases the extent to which the intervention is patient-centered.
The addition is well in line with an established literature on the additional benefits of patient-centered treatment over
and above those of standardized interventions (McMillan et al., 2013; Rathert et al, 2013). As such, patient-centered
care has been championed as a mark of high quality healthcare by both the Institute of Medicine (Institute of Medicine,
2001) and U.S. Congress (U.S. Congress, 2010). The essence of the patient-centered approach entails eliciting as well
as mindfully and flexibly responding to the individual’s needs and preferences (Sidani et al, 2006). Patient-centered
care has been examined among persons with TBI, with positive findings showing that not only is it feasible for
individuals with compromised cognitive skills to participate in their care, they are also more satisfied with their
treatment when they do so (Pegg et al., 2005). Additional work is needed to quantify the increased benefits of patient-
centered interventions in TBI research, and the proposed project will address this knowledge gap.

Braukhaus, C., Hahlweg, K., Kroeger, C., Groth, T., & Fehm-Wolfsdorf, G. (2003). The effects of adding booster
sessions to a prevention training program for committed couples. Behavioural and Cognitive Psychotherapy, 31(3),
325-336.
Godwin, E. E., Lukow II, H. R., & Lichiello, S. (2015). Promoting resilience following traumatic brain injury: Application
of an interdisciplinary, evidence-based model for intervention. Family Relations: An Interdisciplinary Journal of Applied
Family Studies, 64(3), 347-362.
Institute of Medicine. (2001). Institute of medicine: Crossing the quality chasm. Washington, DC.
McMillan, S. S., Kendall, E., Sav, A., King, M. A., Whitty, J. A., Kelly, F., & Wheeler, A. J. (2013). Patient-centered
approaches to health care: A systematic review of randomized controlled trials. Medical Care Research and Review:
MCRR, 70(6), 567-596.
Pegg Jr., P. O., Auerbach, S. M., Seel, R. T., Buenaver, L. F., Kiesler, D. J., & Plybon, L. E. (2005). The impact of
patient-centered information on patients' treatment satisfaction and outcomes in traumatic brain injury rehabilitation.
Rehabilitation Psychology, 50(4), 366-374.
Ponsford, J., Lee, N. K., Wong, D., McKay, A., Haines, K., Alway, Y., . . . O'Donnell, M. L. (2016). Efficacy of
motivational interviewing and cognitive behavioral therapy for anxiety and depression symptoms following traumatic
brain injury. Psychological Medicine, 46(5), 1079-1090.
Rathert, C., Wyrwich, M. D., & Boren, S. A. (2013). Patient-centered care and outcomes: A systematic review of the
literature. Medical Care Research and Review, 70(4), 351-379.
Sidani, S., Epstein, D., & Miranda, J. (2006). Eliciting patient treatment preferences: A strategy to integrate evidence-
based and patient-centered care. Worldviews on Evidence-Based Nursing, 3(3), 116-123.
U.S. Congress. (2010). Patient protection and affordable care act. Public Law, 111, 48.
Vaterlaus, J. M., Allgood, S. M., & Higginbotham, B. J. (2012). Stepfamily education booster sessions. Social Work with
Groups: A Journal of Community and Clinical Practice, 35(2), 150-163.
Wesner, A. C., Gomes, J. B., Detzel, T., Guimaraes, L. S., & Heldt, E. (2015). Booster sessions after cognitive-
behavioural group therapy for panic disorder: Impact on resilience, coping, and quality of life. Behavioural and
Cognitive Psychotherapy, 43(5), 513-525.
2. * Describe the study hypothesis and/or research questions.  Use lay language whenever possible.
1. Primary: Participants receiving the booster (RAI+ group) will report higher levels of resilience in comparison to
individuals in the standard RAI group.
2. Participants in the RAI+ group will show better adjustment and lower levels of emotional distress as compared to
persons in the standard RAI group.
3. Additionally, participants in the RAI+ group will report greater abilities in the areas of problem solving,
communication, and stress management relative to persons in the standard RAI group.
4. A participant’s demographic, lifestyle, injury, and treatment response information will be predictive of maintenance
ability.
3. * Describe the study's specific aims or goals.  Use lay language whenever possible.
1. to evaluate the short and long-term efficacy of two structured outpatient intervention programs (RAI vs. RAI+) on
resilience
2. to evaluate the short and long-term impact of intervention on emotional well-being and postinjury adjustment with the
RAI vs. the RAI+
3. to evaluate the short and long-term impact of the RAI and the RAI+ on abilities including problem solving,
communication, and stress management
4. to determine if demographic, lifestyle, injury, or treatment response information can predict maintenance of gains
4. * Describe the scientific benefit or importance of the knowledge to be gained:
Empirical investigation of a structured, replicable, outpatient intervention to address resilience and emotional
adjustment after TBI will guide clinicians serving individuals post-discharge, enabling more effective and efficient
service delivery. There are minimal risks (physical, psychological, social, legal, or other) associated with the project.
The possibility that some individuals may experience feelings of sadness and frustration during protocol
implementation is outweighed by the potential benefits of the project. The VCU TBIMS places an emphasis on
providing patients with psychological support and education to assist in recovery following TBI.
5. * Describe any potential for direct benefits to participants in this study:
Participants may or may not gain any direct benefit from being in this study. They receive written information about TBI,
including available services or programs that might be helpful.
6. * Describe any potential for direct social impact in this study . For example, any engagement with specific
communities to respond to community-identified needs, or ways the study will strengthen the well-being of
the specific communities if applicable:

7. Upload a supporting citation list if applicable:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Consent Form RAI+ consent_2021
05 25 clean.pdf
0.15
5/27/2021
11:20 AM
Jennifer
Marwitz
Consent/Assent/Information
Sheet
Yes
View Assent Form
RAI+ assent_2021
05 25 clean.pdf
0.10
5/27/2021
11:20 AM
Jennifer
Marwitz
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Consent Script
COVID Contingency
Consent Script RAI+
2021 05 25
clean.pdf
0.10
5/27/2021
11:20 AM
Courtney
Roberts
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Consent Form
COVID Contingency
Consent Info Sheet
RAI+ 2021 05 25
clean.pdf
0.10
5/27/2021
11:20 AM
Courtney
Roberts
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Protocol
COVID Contingency
Protocol v6
HM20011840 2021
05 25.docx
0.06
5/25/2021
2:35 PM
Elicia
Preslan
Research Protocol
Yes
View Flyer
RAI+ Study_Flyer
2021 05 25
clean.doc
0.03
5/25/2021
2:35 PM
Jennifer
Marwitz
Recruitment/Advertising
Yes
View Hsu PI Change
Form
Hsu PI Change
Form 2021 05 11.pdf
0.01
5/25/2021
2:33 PM
Jennifer
Marwitz
Other
Yes
View Hsu CV
Hsu CV 2020
Dec.pdf
0.01
5/25/2021
2:33 PM
Jennifer
Marwitz
CV/Biosketch
Yes
View Marwitz CV
Marwitz,Jennifer CV
2020 12 18.docx
0.01
1/6/2021
2:45 PM
Jennifer
Marwitz
CV/Biosketch
Yes
View Script for
cases where
follow-up done
by phone
Script follow-ups
done by phone 2017
12 17.doc
0.01
12/17/2017
3:24 PM
Jennifer
Marwitz
Research Measure
Yes
View Grant Proposal grantsApplication.pdf 0.01
11/15/2017
2:35 PM
Jennifer
Marwitz
Funding Proposal
Yes
View Data Collection
Forms
RAI+ Measures.pdf
0.01
10/30/2017
5:24 PM
Jennifer
Marwitz
Research Measure
Yes
View RAI+
Implementation
Manual
RAI+ Manual 2017
05 08.pdf
0.01
10/30/2017
5:22 PM
Jennifer
Marwitz
Research Measure
Yes
View MacCAT-CR
(Consent
Evaluation)
MacCAT-CR 2017
10.doc
0.01
10/30/2017
5:22 PM
Jennifer
Marwitz
Research Measure
Yes
View CV/Biosketch-
Kreutzer
JSK CV 2017 10
04.docx
0.01
10/25/2017
12:56 PM
Jennifer
Marwitz
CV/Biosketch
Not
Applicable
 

HM20011840
View: SF2 - Study Population
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Study Population
1. * Provide the maximum number of individuals that
  1. May participate in any study interaction or intervention (Including screening, consenting, and study
activities)
      AND/OR
  2. You obtain any data/specimens about (regardless of identifiability) 
 at VCU and at other sites under the VCU IRB's oversight. See the help text for additional guidance.
192 
2. If this is a multi-Center Project, what is the maximum anticipated number of subjects across all sites?
3. * Provide justification for the sample size by explaining how you arrived at the expected number of
participants and why this number is adequate for answering the research questions:
Power analyses relating to the primary hypothesis indicate minimum group sizes of 69 participants. If we allow for a
maximum of 28% attrition, then an additional 27 individuals per treatment group (54 individuals total) should be
recruited (138/(1-0.28)-138 = 53.67), yielding a sample size of 192.
4. * List the study inclusion criteria:
Individuals meeting the following:
Eighteen years of age and older.
Mild, moderate, or severe TBI defined as: damage to brain tissue caused by an external mechanical force as
evidenced by loss of consciousness due to brain trauma, post-traumatic amnesia (PTA), skull fracture, or objective
neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination.
At least 3 months post-TBI.
Since there is no reason to believe that treatment effectiveness varies with chronicity, no maximum has been set for
time postinjury.
5. * List the study exclusion criteria:
Active substance abusers (e.g., intoxicated at arrival to intake).
Individuals at imminent risk of psychiatric hospitalization, or in imminent danger of hurting themselves or others, as
judged by the investigators, will be excluded from the study.
6. * Will individuals with limited English proficiency be included in or excluded  from this research?
Included
Excluded - safety concerns if participants are unable to communicate with the study team
Excluded - instruments/measures only validated in English
Excluded - no prospect of direct benefit to individual participants
Excluded - minimal risk study
Excluded - lack of budget/resources for translation and interpretation [provide an explanation in next question]
Excluded - other reason [provide an explanation in next question]
7. Justify the inclusion and exclusion criteria if you are either targeting, or excluding, a particular segment of the
population / community. Provide a description of the group/organization/community and provide a rationale.
Individuals with limited English proficiency are excluded, as this is a minimal risk study. Further, the intervention
involves working with an English-speaking interventionist and use of measures that have only been validated in the
English language.
  

HM20011840
View: SF2 - Background, Rationale & Goals Section Complete
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Background, Rationale & Goals Section Complete
Protocol Progress:
❶ INITIAL SETUP
❷ BACKGROUND, RATIONALE & GOALS
③ RESEARCH PLAN
④ CONSENT PLAN
⑤ RISKS, PRIVACY & CONFIDENTIALITY
⑥ POPULATIONS WITH SPECIAL CONSIDERATIONS
⑦ INSTITUTIONAL REQUIREMENTS
⑧ DOCUMENTS
Click Continue below to go to the next section

HM20011840
View: SF2 - Study Procedures
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Study Procedures
 
1. * Describe the study hypothesis and/or research questions.  Use lay language whenever possible.
1. Primary: Participants receiving the booster (RAI+ group) will report higher levels of resilience in comparison to
individuals in the standard RAI group.
2. Participants in the RAI+ group will show better adjustment and lower levels of emotional distress as compared to
persons in the standard RAI group.
3. Additionally, participants in the RAI+ group will report greater abilities in the areas of problem solving,
communication, and stress management relative to persons in the standard RAI group.
4. A participant’s demographic, lifestyle, injury, and treatment response information will be predictive of maintenance
ability.
2. * Describe the study's specific aims or goals.  Use lay language whenever possible.
1. to evaluate the short and long-term efficacy of two structured outpatient intervention programs (RAI vs. RAI+) on
resilience
2. to evaluate the short and long-term impact of intervention on emotional well-being and postinjury adjustment with the
RAI vs. the RAI+
3. to evaluate the short and long-term impact of the RAI and the RAI+ on abilities including problem solving,
communication, and stress management
4. to determine if demographic, lifestyle, injury, or treatment response information can predict maintenance of gains
3. * Choose all types of recruitment materials that may be used and upload them below:

E-mail invitations

Phone Solicitation scripts (i.e. cold calls or random-digit-dialing)

Flyers, Mailed Letters or Newspaper/TV/Radio Ads

TelegRAM announcements

Website text

Study-specific web sites (provide the design and text)

Social Media

EPIC MyChart Patient Portal research study descriptions

Psychology Research Participant Pool (SONA) study descriptions

Scripts for announcements made to groups

Other recruitment document

No recruitment materials
4. * Describe the study procedures/methods for identifying and recruiting participants. Address all of the
following three aspects of recruitment in your response. 
1. Identification of potentially eligible participants or secondary data/specimens of interest.
     - What database(s) will be queried to identify secondary data/specimens
     - How VCU Informatics or VCU IRDS will be used for cohort identification (when applicable, see help text)
    - How potential participants' contact information will be obtained
2. Recruitment procedures to invite participation in the study (when applicable):
     - How each of the written or verbal recruitment materials and reminders (selected above) will be used
     - Who will contact, approach, or respond to potential participants
     - Locations where recruitment procedures will take place
     - The timing and frequency of recruitment attempts
3. Eligibility screening prior to consent and how those activities will be carried out (when applicable)

See the help text for additional guidance.
Potential subjects will be identified in several ways. Flyers advertising the study (attached) will be distributed via local
brain injury support organizations, through PM&R Outpatient Brain Injury (ACC 6) and Neuropsychology VCUHS
(Stony Point) Clinics and on VCU PM&R websites which target both brain injury clinicians (for flyer distribution) and
brain injury survivors. Flyers will direct interested patients to contact the Research Coordinator for more information.
Secondly, the Interventionists and other healthcare providers will take referrals from potential participants at the
Neuropsychology Clinic. Once participants have been identified and express an interest, they will either meet with the
PI or a Research Assistant that day at the clinic to discuss the study, or they will be contacted by the Research
Assistant by phone to further discuss participation and ensure that they meet the criteria for participation.
5. * Does this study have a separate protocol document (i.e. a multisite or sponsor's protocol) that contains a
detailed description of the study's methodology?
  Yes
No
6. * Since a separate protocol document is not uploaded, describe the proposed research using language
understandable to those IRB committee members whose expertise is not scientific. The description must
include:
 1. A statement explaining the study design
 2. A detailed description of all the procedures that will be followed to carry out the study, preferably in
sequential order, and in sufficient detail that the study's methods could be replicated
 3. The schedule and frequency of when and how procedures will be conducted (e.g. in person, online, phone,
paper, etc.)
 4. A description of all research measures/tests/interventions that will be used, including analyses/tests
conducted on specimens/biological samples (if applicable)
See the help text for additional guidance
Participants will be self-referred or referred by professionals within and outside VCUHS, organizations (e.g., Brain
Injury Association of Virginia), and agencies (e.g., Virginia Department of Rehabilitative Services). When persons with
TBI contact the Department of Physical Medicine and Rehabilitation’s (PM&R’s) Neuropsychology Service regarding
the study, an intake session will be scheduled.
During the intake, the Interventionist, Research Coordinator or Research Assistant will provide information about the
research program, and determine eligibility and interest in participation. Staff will explain the study details and obtain
informed consent.
On giving informed consent, participants will complete intake assessment materials. Average estimated time for the
completion of measures is 30 minutes. Information from medical record review will be included on the intake form,
specifically acute care and inpatient rehabilitation length of stay, time to follow commands, time to emerge from post-
traumatic amnesia, neurosurgical intervention, Glasgow Coma Scale score, and severity of injury (mild vs moderate-
severe).
Using randomization tables, participants will be assigned to either of two treatment groups: (1) Resilience and
Adjustment Intervention (RAI), or (2) RAI+. After randomization, a second appointment will be scheduled. All
participants will begin the 7-session treatment during their second appointment. The intervention consists of seven 60-
minute sessions scheduled over seven weeks (see attached RAI Implementation Manual). During the first session,
participants will receive an empty loose leaf binder to store and organize completed self-assessments, reading
materials, and homework assignments from each session. They will be asked to review materials and complete
worksheets between sessions. The intervention will be implemented by experienced, licensed therapists (Ph.D. level
Interventionists). Participants will be randomly assigned to one of the therapists.
The RAI and RAI+ groups will both complete the post-treatment measures immediately after the seventh treatment
session and then 3, 4, and 9 months later. Data collection at 3, 4, and 9 months post-treatment will be completed in-
person, unless the participant requests to complete via phone.
Furthermore, the RAI+ group will complete 3 booster sessions, spaced approximately 7-10 days apart, beginning 3
months after completion of the seventh treatment session (booster sessions will occur between the 3 and 4 month data
collection described above).
Data will be analyzed to identify any therapist effects, as well as treatment effects. For the RAI and RAI+ groups,
demographic, injury severity, and history information will be collected at intake using standard procedures and
protocols. All participants will complete the 4 outcome measures (Connor-Davidson Resilience Scale, CD-RISC; Mayo
Portland Adaptability Inventory-4, MPAI-4; 13 Item Stress Test; and Brief Symptom Inventory-18, BSI-18) at 5 time
points (intake, post-treatment, and 3, 4 and 9 month follow-up).
The RAI is not a standard of care at VCU. Both the RAI and the RAI+ are experimental interventions. Any information
collected during the intervention sessions (e.g., questionnaires, lists generated) is part of the experimental intervention,
not part of the research data.
7. * The IRB only reviews research activities, so indicate for each of the study activities described in the question
above or in the protocol which activities are:
  - Being performed exclusively for research purposes (i.e. they would not otherwise be done apart from this
study) VERSUS.

  - Alterations of routine activities/procedures (e.g. the study is altering the timing, frequency, method,
location, amount, etc.) VERSUS.
  - Being done for other purposes and whose data/results will be used secondarily in the study (e.g. standard
medical or psychological tests, routine education practices, quality improvement initiatives, etc.).
    See the help text for additional guidance
All data is collected specifically for research purposes.
8. If applicable, describe alternatives (research or non-research) that are available to potential participants if they
choose not to participate in this study:
Potential participants will be given referral information for mental health services if they are not interested in
participating in research.
9. Upload any supporting tables or documents (e.g. protocol documents, figures/tables, data collection forms,
study communications/reminders):
Upload ALL instruments/guides that will be used or that participants will experience (i.e. see, hear, complete),
including measures, scripts/questions to guide interviews, surveys, questionnaires, observational guides,
etc,:
Upload ALL recruitment and screening materials, including such as ads, flyers, telephone or in-person scripts,
letters, email invitations, TelegRAM announcements, and postcard reminders, screening scripts, screening
forms, and screening measures:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Consent Form RAI+ consent_2021
05 25 clean.pdf
0.15
5/27/2021
11:20 AM
Jennifer
Marwitz
Consent/Assent/Information
Sheet
Yes
View Assent Form
RAI+ assent_2021
05 25 clean.pdf
0.10
5/27/2021
11:20 AM
Jennifer
Marwitz
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Consent Script
COVID Contingency
Consent Script RAI+
2021 05 25
clean.pdf
0.10
5/27/2021
11:20 AM
Courtney
Roberts
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Consent Form
COVID Contingency
Consent Info Sheet
RAI+ 2021 05 25
clean.pdf
0.10
5/27/2021
11:20 AM
Courtney
Roberts
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Protocol
COVID Contingency
Protocol v6
HM20011840 2021
05 25.docx
0.06
5/25/2021
2:35 PM
Elicia
Preslan
Research Protocol
Yes
View Flyer
RAI+ Study_Flyer
2021 05 25
clean.doc
0.03
5/25/2021
2:35 PM
Jennifer
Marwitz
Recruitment/Advertising
Yes
View Hsu PI Change
Form
Hsu PI Change
Form 2021 05 11.pdf
0.01
5/25/2021
2:33 PM
Jennifer
Marwitz
Other
Yes
View Hsu CV
Hsu CV 2020
Dec.pdf
0.01
5/25/2021
2:33 PM
Jennifer
Marwitz
CV/Biosketch
Yes
View Marwitz CV
Marwitz,Jennifer CV
2020 12 18.docx
0.01
1/6/2021
2:45 PM
Jennifer
Marwitz
CV/Biosketch
Yes
View Script for
cases where
follow-up done
by phone
Script follow-ups
done by phone 2017
12 17.doc
0.01
12/17/2017
3:24 PM
Jennifer
Marwitz
Research Measure
Yes
View Grant Proposal grantsApplication.pdf 0.01
11/15/2017
2:35 PM
Jennifer
Marwitz
Funding Proposal
Yes
View Data Collection
Forms
RAI+ Measures.pdf
0.01
10/30/2017
5:24 PM
Jennifer
Marwitz
Research Measure
Yes
View RAI+
Implementation
Manual
RAI+ Manual 2017
05 08.pdf
0.01
10/30/2017
5:22 PM
Jennifer
Marwitz
Research Measure
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View MacCAT-CR
(Consent
Evaluation)
MacCAT-CR 2017
10.doc
0.01
10/30/2017
5:22 PM
Jennifer
Marwitz
Research Measure
Yes
View CV/Biosketch-
Kreutzer
JSK CV 2017 10
04.docx
0.01
10/25/2017
12:56 PM
Jennifer
Marwitz
CV/Biosketch
Not
Applicable

HM20011840
View: SF2 - Project Details
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Project Details
An intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and
manipulations of the subject or the subject's environment that are performed for research purposes.
An interaction includes communication or interpersonal contact between investigator and subject. It may include in-person,
online, written, or verbal communications.
Secondary information/biospecimens are information or biospecimens that have been or will be collected for some other
“primary” or “initial” activity and that will be used secondarily in the research study.
1. * Select all of the following types of interventions that apply to this study (selections will branch):

Social/Behavioral interventions or experimentation / Tasks / Environmental manipulations

Deception (misleading participants through false or incomplete information)

Drug(s) / Biologics / Supplement(s) / Other Compounds (investigational products or products whose
administration is dictated by the study protocol and not per the physician's clinical judgment)

IV contrast administration for research-related imaging (will branch to the Drugs page)

Placebos

Safety and/or effectiveness evaluation of Bio-Medical Device(s), including in-vitro diagnostic devices/assays,
mobile medical apps, software functions, and HUDs used in clinical investigations

Washout Periods

Expanded Access – Treatment Use of an Investigational Product

Medical or Surgical Procedures (eg: physical exam, clinical procedures, scans, etc)

Specimen/biological sample collection

None of the Above
2. * Select all of the following types of interactions and methods of data collection that apply to this study
(selections will branch):

Surveys / Questionnaires /Written responses to questions (including data entry)

Active Internet data collection (i.e. using the internet to collect data, including online surveys, data collection via
Zoom, apps, etc.)

Passive Internet data collection (i.e. passively observing online behavior, bots)

Interviews / Focus Groups / Verbal responses to questions

Audio / Video recording or photographing participants

Observations

Educational Settings/Assessments/Procedures

None of the Above
3. * Select all types of recordings that will be made:

Audio

Video

Photographs
4. * Describe the purpose of the recordings, who will be recorded and when such recordings will occur:
A protocol has been established to ensure the quality and standardization of treatment implementation across
interventionists.
Each interventionist will meet with one volunteer participant, and implement Session I of the RAI curriculum. Informed
written consent for audio-recording will be obtained. Audio recording consent is addressed within the study consent
form. Afterward, the intervention audio-recordings will be reviewed with the PI, with the manual in hand, to make
certain that all steps are completed. Additionally, the PI will assure that interventionists have covered the bolded

content areas in the manual, which are considered to be key elements of treatment (see uploaded RAI manual).
Strategies for improving consistency between interventionists will be discussed and implemented. Changes will be
made in the implementation manual (e.g., clarification of procedures) as needed.
The interventionist will meet again with the same volunteer participant, and implement the remaining six sessions of
the RAI curriculum. Again, the audio-recordings will be reviewed with the PI, and strategies for adherence to the
manual will be discussed and implemented after each session.
Every six months thereafter, the complete quality control procedure will be reapplied by each interventionist.
Additional quality control procedures will be implemented for booster sessions with each interventionist. Audio-
recordings will be made for the three booster sessions and reviewed with the PI to ensure that key areas are covered
as outlined in the manual. Every six months thereafter, quality control procedures will be repeated.
5. * Select all types of secondary information and/or specimens that apply to this study (selections will branch):
See the help text for definitions.

Individually Identifiable Health Information (PHI)

Secondary data/specimens NOT from a research registry or repository

Information/specimens from a research registry or repository (Usage Protocol)

Information/specimens originally collected for a previous research study

Publicly available information/specimens

Government-generated or collected information that was or will be obtained for nonresearch activities [only
applicable to research conducted by or on behalf of a Federal department or agency]

No secondary data/specimens will be used
  

HM20011840
View: SF2 - Behavioral Intervention/Task Details
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Behavioral Intervention/Task Details
This page asks for details about the social/behavioral intervention, task, or environmental manipulation in the research.
Interventions include both physical procedures by which information is gathered and manipulations of the subject or the
subject's environment that are performed for research purposes. This might include activities such as playing computer
games, performing a task, thought/cognition activities, environmental manipulations, and educational activities.
If the study only involves surveys, interviews, or secondary data collection, go back to the Project Details page and uncheck
“Social/Behavioral interventions or experimentation / Tasks / Environmental manipulations” in Question 1.
1. * Describe the duration of the social/behavioral intervention, task, or environmental manipulation:
The intervention consists of seven 60-minute sessions scheduled over seven weeks, as well as three additional
"booster" sessions scheduled weekly 3 months after completion of the seven sessions.
2. * Describe any potential harms or discomforts that participants could experience during the intervention
activity:
Feelings of mental/emotional discomfort may arise when discussing postinjury changes.
3. * Will the intervention activity be physically invasive or painful?
  Yes
No
4. * Describe the impact the intervention activity will have on participants, including the nature and duration of
any impact(s):
Feelings of discomfort are common when stressed individuals talk about postinjury changes. However, our experience
is that people generally appreciate the opportunity to discuss their life situations. Participants will have the opportunity
to omit or decline to answer any questions. The VCU TBIMS places an emphasis on providing participants with
psychological support and education to assist in recovery following TBI. The duration of discomfort is not expected to
last longer than the duration of the session.
5. * In the investigator's opinion, is there any reason to think that the participants will find the intervention
activity offensive or embarrassing? Explain why or why not.
There is no reason to think that participants will find the intervention offensive or embarrassing. The emphasis is on
psychological support and education.

HM20011840
View: SF2 - Secondary Data/Specimen Details
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Secondary Data/Specimen Details
1. * Describe the source(s) and nature of the information/specimens being obtained. This response should:
  a. Identify where the data/specimens will come from (e.g., another researcher's registry, pathology lab,
commercial source, medical records, etc.); and
  b. List what types of specimens will be obtained (when applicable); and/or
  c. List all data elements that will be obtained (when applicable). A data collection form or other
documentation may be uploaded and referenced here.
Data is collected from medical records (information regarding injury severity). Data is accessed through Cerner.
Specific data points include: acute care and inpatient rehabilitation length of stay, time to follow commands, time to
emerge from post-traumatic amnesia, neurosurgical intervention, Glasgow Coma Scale score, and severity of injury
(mild vs moderate-severe). 
2. * Describe whether any agreement exists between you and data/specimen provider that states you will never
have access to the ability to identify the participants (i.e. access to identifiers or the code key) and that you
will not attempt to re-identify individuals.
Actual date of injury is provided by the participant, though it will be verified in Cerner.
3. * When the information/specimens were originally collected, did individuals provide consent for secondary
research use of their data/specimens (i.e. consent to another research study or to a research registry)?
  Yes
No
 

HM20011840
View: SF2 - Costs to Participants
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Costs to Participants
1. * Select all categories of costs that participants or their insurance companies will be responsible for:

Participants will have no costs associated with this study

Study related procedures that would be done under standard of care

Study related procedures not associated with standard of care

Administration of drugs / devices

Study drugs or devices

Other
  

HM20011840
View: SF2 - Compensation
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Compensation
It is recommended that investigators consult with VCU Procurement Services before proposing a compensation plan
(monetary or non-monetary) to the IRB to ensure the plan will comply with VCU policies. Refer to WPP XVII-2 for the IRB’s
guidelines about compensating research participants.
1. * Describe any compensation that will be provided including:
   1. total monetary amount
   2. type (e.g., gift card, research pre-paid card, cash, check, merchandise, drawing, extra class credit)
   3. how it will be disbursed
   4. how you arrived at this amount
   5. What identifiers and tax forms will be required for compensation purposes (i.e. W-9 form, SSN, V#,
addresses, etc.)
Participants will be provided therapy, educational materials, and referral services at no cost. Each participant will
receive a total of $140. Participants will receive a payment each time measures are completed: $25 for completing the
intake session and post-treatment session surveys, and $30 at each of the remaining 3 survey data time points (3, 4,
and 9 months after the post-treatment session).
If participants travel more than 60 miles roundtrip, funds will be provided to offset travel costs (IRS mileage rate of 19
cents per mile driven).
When data collection is completed by phone, a payment form is mailed to the participant with instructions on
completion and a postage-paid business reply envelope. Participants complete the payment form and then return the
form in the self-addressed envelope. Payment forms are then processed at VCU and a check is mailed to the
participant.
When data collection is completed in person, the participant completes the payment form and then receives cash for
their participation.
As described previously, the payment form requires the following PHI: name, social security number, address, and
phone number.
2. If compensation will be pro-rated, explain the payment schedule.
  

HM20011840
View: SF2 - Contingency Plan
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Contingency Plan
This page will be used by the IRB in the event that an institution-wide emergency situation arises that requires
contingency plans. 
A contingency plan describes the alternative procedures that a study would want to use in case of an emergency that
prevented normal study activities from occurring. It is a form of adaptive protocol. It enables the VCU IRB to quickly
approve alternative study activities along with criteria for when those activities would or would not be put into effect.
For example, in 2020, some studies had a COVID-19 Contingency Protocol approved that described alternative
remote procedures that they would switch to whenever the University restricted in-person research activities.
In all studies, investigators are strongly encouraged to plan prospectively and build flexibilities into their regular
protocols (regardless of whether an emergency situation exists) as well as think about what they would do in an
emergency situation. For example, windows for timed study visits, ranges instead of exact values, flexibilities in
inclusion criteria, etc. Flexibility and adaptations that are built into the protocol will reduce the number of changes
that have to be submitted to the IRB and should reduce the number of incidents of deviations and noncompliance by
investigators.
Further instructions and smartform questions on this page will be released from the IRB in the event of such an
institution-wide emergency situation.
 

HM20011840
View: SF2 - Research Plan Complete
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Research Complete
Protocol Progress:
❶ INITIAL SETUP
❷ BACKGROUND, RATIONALE & GOALS
❸ RESEARCH PLAN
④ CONSENT PLAN
⑤ RISKS, PRIVACY & CONFIDENTIALITY
⑥ POPULATIONS WITH SPECIAL CONSIDERATIONS
⑦ INSTITUTIONAL REQUIREMENTS
⑧ DOCUMENTS
Click Continue below to go to the next section
 

HM20011840
View: SF2 - Consent Process
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Consent Process
1. * List all consent groups:
 
Group
Types
Waivers
Roles
Roles -
Other
Electronic
SignaturesConsent
CoercionDecision Re-
Consent
View Participants
with TBI
Signed Consent
by Participant
Signed Assent
by Child or
Decisionally
Impaired Adult
Signed
Parent/Guardian
Permission or
Legally
Authorized
Representative
Consent
No
Waivers
Requested
Other
Research
Coordinator
Research
Assistant
Interventionist  
Participants will
consent in the
facilities housing
the Department
of Physical
Medicine and
Rehabilitation,
Division of
Neuropsychology
and
Rehabilitation
Psychology
Research
Offices, located
in West Hospital
on the 3rd floor.
 
Individuals
are afforded
as much
time as they
wish to
decide
about
participation,
and they
may
schedule a
follow-up
appointment
with the
study team if
they wish to
take the
consent
form home
to discuss
with others
prior to
deciding.
If the
individual's
cognitive
status
improves
during the
course of
this study,
then
consent
will be
sought.
2. Upload any consent / assent documents:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Consent Form RAI+ consent_2021
05 25 clean.pdf
0.15
5/27/2021
11:20 AM
Jennifer
Marwitz
Consent/Assent/Information
Sheet
Yes
View Assent Form
RAI+ assent_2021
05 25 clean.pdf
0.10
5/27/2021
11:20 AM
Jennifer
Marwitz
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Consent Script
COVID Contingency
Consent Script RAI+
2021 05 25
clean.pdf
0.10
5/27/2021
11:20 AM
Courtney
Roberts
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Consent Form
COVID Contingency
Consent Info Sheet
RAI+ 2021 05 25
clean.pdf
0.10
5/27/2021
11:20 AM
Courtney
Roberts
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Protocol
COVID Contingency
Protocol v6
HM20011840 2021
05 25.docx
0.06
5/25/2021
2:35 PM
Elicia
Preslan
Research Protocol
Yes
View Flyer
RAI+ Study_Flyer
2021 05 25
clean.doc
0.03
5/25/2021
2:35 PM
Jennifer
Marwitz
Recruitment/Advertising
Yes
View Hsu PI Change
Form
Hsu PI Change
Form 2021 05 11.pdf
0.01
5/25/2021
2:33 PM
Jennifer
Marwitz
Other
Yes
View Hsu CV
Hsu CV 2020
Dec.pdf
0.01
5/25/2021
2:33 PM
Jennifer
Marwitz
CV/Biosketch
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Marwitz CV
Marwitz,Jennifer CV
2020 12 18.docx
0.01
1/6/2021
2:45 PM
Jennifer
Marwitz
CV/Biosketch
Yes
View Script for
cases where
follow-up done
by phone
Script follow-ups
done by phone 2017
12 17.doc
0.01
12/17/2017
3:24 PM
Jennifer
Marwitz
Research Measure
Yes
View Grant Proposal grantsApplication.pdf 0.01
11/15/2017
2:35 PM
Jennifer
Marwitz
Funding Proposal
Yes
View Data Collection
Forms
RAI+ Measures.pdf
0.01
10/30/2017
5:24 PM
Jennifer
Marwitz
Research Measure
Yes
View RAI+
Implementation
Manual
RAI+ Manual 2017
05 08.pdf
0.01
10/30/2017
5:22 PM
Jennifer
Marwitz
Research Measure
Yes
View MacCAT-CR
(Consent
Evaluation)
MacCAT-CR 2017
10.doc
0.01
10/30/2017
5:22 PM
Jennifer
Marwitz
Research Measure
Yes
View CV/Biosketch-
Kreutzer
JSK CV 2017 10
04.docx
0.01
10/25/2017
12:56 PM
Jennifer
Marwitz
CV/Biosketch
Not
Applicable
 

HM20011840
View: SF2 - Consent Plan Complete
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Consent Plan Complete
Protocol Progress:
❶ INITIAL SETUP
❷ BACKGROUND, RATIONALE & GOALS
❸ RESEARCH PLAN
❹ CONSENT PLAN
⑤ RISKS, PRIVACY & CONFIDENTIALITY
⑥ POPULATIONS WITH SPECIAL CONSIDERATIONS
⑦ INSTITUTIONAL REQUIREMENTS
⑧ DOCUMENTS
Click Continue below to go to the next section
 

HM20011840
View: SF2 - Risks, Discomforts, Potential Harms and Monitoring
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Risks, Discomforts, Potential Harms and Monitoring
1. * Describe the risks of each research procedure to participants or others. For each identified risk, provide an
assessment of the anticipated seriousness and likelihood of the risk. Some examples of possible risks include
but are not limited to:
Physical risks (e.g. bodily harms or discomforts, side effects, etc.)
Psychological risks (e.g. emotional, mental, or spiritual harms or discomforts, changes to thoughts,
beliefs, or behaviors, etc.)
Research data risks (e.g. loss of confidentiality and privacy)
Social or legal risks (e.g. impacts on relationships or reputation, legal or criminal justice actions for self
or others, etc.)
Financial risks (e.g. impacts on income, employability, or insurability, loss of services, etc.)
Other risks (e.g. unforeseeable risks of experimental procedures, risks related to particular study
designs (randomization, washout, placebo, withholding care/services, deception), etc.)
See the help text for additional guidance.
There is less than minimal risk (physical, psychological, social, legal, or other) associated with enrollment in the study.
The primary potential risk is the feeling of mental/emotional discomfort that may arise when discussing post-TBI
changes. These types of feelings may be common when stressed individuals are talking about postinjury changes.
However, our experience with data collection indicates that people generally appreciate the opportunity to discuss their
life situations. Participants will have the opportunity to omit or decline to answer any questions. The VCU TBIMS places
an emphasis on providing participants with psychological support and education to assist in recovery following TBI.
Another potential risk is a breach in confidentiality and breach in privacy with regard to data collection. The de-
identification and coding process is the safeguard in place to minimize risk of breach in confidentiality, and research
activities are completed in a private clinical setting to minimize risk related to breach in privacy
2. * Describe how each of the risks/harms/discomforts identified above will be minimized:
The research staff will pay particular attention to and attempt to minimize any risks that may occur as a result of
participation in this study. For this study, risks to subjects are less than minimal. Potential risk is mitigated in several
ways. Research staff who collect the data are well trained and very familiar with the population. The de-identification
and coding process is the safeguard in place to minimize risk of breach in confidentiality. And, research activities are
completed in a private clinical setting to minimize risk related to breach in privacy.
3. * Describe any potential risks or harms to a community or a specific population based on study findings (e.g.
information that could be stigmatizing or derogatory):
None.
4. Where appropriate, discuss provisions for ensuring necessary medical, professional, or psychological
intervention in the event of adverse events to the subjects:
The PI is on call during each interview is responsible for monitoring the status of enrolled participants and addressing
urgent situations. When concerns arise, the PI is contacted immediately to make a clinical decision regarding the need
for further evaluation, treatment, or referral.
5. * Describe criteria for when the investigator would withdraw an individual participant from the study; such as
safety or toxicity concerns, emotional distress, inability to comply with the protocol, etc.:
If the participant experiences significant emotional distress during the intervention sessions, the Interventionist may
recommend study withdrawal in order for the person to seek a more appropriate and intensive treatment for mental
health problems. Referrals will be made to the VCUHS Neuropsychology Clinic located at Stony Point. If the
participant’s emotional difficulties improve, they may return to complete the study.
6. * Summarize any pre-specified criteria that would trigger the investigator/sponsor/monitoring committee to
stop or change the study protocol due to safety concerns:
None. 
Data and Safety Monitoring
Data and safety monitoring is a system for checking the study’s data at regular intervals over the study period
to identify and address issues that could affect the safety of research participants. This requirement is in
accordance with 45 CFR 46.111.

The purpose of data and safety monitoring plan is to set forth study team procedures for
monitoring/addressing:
- Participant safety (physical, psychological, etc.)
- Data validity
- Early stopping (termination) based upon changes in risks and benefits.
7. * Indicate if this study will have a Data Safety Monitoring Board (DSMB) or a Data Safety Monitoring Plan
(DSMP): [Required for all greater than minimal risk studies]

DSMB

DSMP

No DSMB/DSMP [Note: This response is not applicable for greater than minimal risk studies]
8. * Describe your Data Safety Monitoring Plan for monitoring the study’s data to ensure the safety of
participants. This plan should include (but is not limited to) the following elements:
1. Who will monitor data
2. What data and/or processes will be reviewed
3. When and how frequently monitoring will occur
4. What report/documentation will be submitted to the IRB at the time of continuing reviews
See the help text for additional guidance.
The monitoring of this study will involve a continuous and ongoing process of reviewing the conduct of the trial,
including adherence to the study design and documentation of AEs/SAEs. The responsibility of monitoring the safety of
participants is held primarily by the PI. Considering that the interventions in this study carry less than minimal risk to
participants, and that the PI and the research team have appropriate clinical skills and training to monitor for
AEs/SAEs, it is appropriate for the research team to carry the primary responsibility for monitoring.
Monitoring the Safety of Participants: A specific protocol will be used to monitor for and report AEs/SAEs. The PI, in
collaboration with the Research Coordinator, are primarily responsible for monitoring the safety of participants, in
collaboration with the study interventionists, in the following ways:
Monitor for Psychological AE (worsening depressive symptoms from one assessment time point to the next by 5 points
on the BSI-18 Depression scale with no endorsement of suicidality):
- Participants will be provided with the contact information for the Research Coordinator, PI, and interventionist. They
will be advised to call with any questions or concerns or to report any unusual emotional feelings; and
- Research Assistants are trained in the definition of AE (worsening depressive symptoms without endorsement of
suicidality) and will report any obvious psychological changes in participants to the PI immediately.
Monitor for Psychological SAE (suicidality):
- The Research Coordinator will administer the MINI suicide module immediately to assess suicidality risk in any of the
following situations: a participant reports suicidal thoughts to study staff; and/or, a participant endorses suicidality on
the depression scale of the BSI-18 during data collection.
- If the suicide risk is low on the MINI (<8), the Research Coordinator will ask the participant to be in touch with his/her
healthcare provider for follow-up. If the participant scores high for suicide risk (9-17), the Research Coordinator will
ensure that the participant is accompanied by a family member or friend to their healthcare provider or the local
emergency department for immediate evaluation. The Research Coordinator will consult with one of the interventionists
(clinical psychologists) regarding additional questions/concerns.
In all of the above cases, the PI or the interventionists will determine the severity of the AE/SAE and the relatedness to
the intervention. The PI will document actions taken and outcomes. If any of these events occurs and are directly
related to the intervention, the IRB and NIDILRR will be alerted.
Summary of Study Review Plan: Study progress and safety will be reviewed by the PI on a monthly basis, and more
frequently if needed. Progress reports, including participant accrual, participant status and adherence data will be
provided regularly to the PI. Data about AEs/SAEs will be reported with each occurrence. As part of the IRB continuing
review, an Annual Report will be compiled and will include a list and summary of AEs/SAEs. In addition, the Annual
Report will address (1) whether AEs/SAEs have been severe and related to the intervention; (2) reason for dropouts
from the study; (3) whether all participants met entry criteria; and (4) whether continuation of the study is justified on
the basis that additional data are needed to accomplish the stated aims of the study.
Validity and Integrity of Data: In collaboration with the research team, the PI will maintain responsibility for all aspects
of data collection, entry, and analysis. PI and study staff will review all data collected on an ongoing basis for
completeness and accuracy, as well as protocol compliance. The frequency of data review is described below:
- Participant accrual: Review of the rate of participant accrual and compliance with inclusion/exclusion criteria will occur
monthly during the recruitment phase to ensure that a sufficient number of participants are being enrolled and that they
meet eligibility criteria.
- Participant status and Adherence data: Review of the status of enrolled participants will occur on a consistent basis
throughout the study, including data on adherence to study visits and the intervention protocol. If there are concerns
about whether adherence has reached a level that might inhibit the ability of the study to evaluate the specific aims, a
conference call will be scheduled with Scientific Advisors and the Advisory Board to discuss methods for improving
adherence.
- AEs and SAEs and rates: Review of every AE and SAE will be closely evaluated by the PI at each occurrence and
reported in annual reviews.

 

HM20011840
View: SF2 - Privacy
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Privacy
Privacy refers to an individual’s right to control how others view, record, or obtain information about them. When
privacy is violated it can involve such things as
Being asked personal questions in a public setting;
Being publicly identified as having a particular characteristic or diagnosis;
Being seen entering a place that might be stigmatizing;
Being photographed, videotaped or observed without consent;
Disclosure of personal information to unauthorized people
Privacy is not the same as confidentiality because privacy protections apply to people, and confidentiality
protections apply to data. Confidentiality protections should be described on the Data Confidentiality page of this
form, not here.
Instructions for this page:
Select all the applicable ways that the research team will protect participants' privacy throughout the course of the
study. The options listed include some of the most common best practices. Not all will be applicable to every study. 
**The IRB will expect studies to operationalize all selected checkboxes into the conduct of the research.
To elaborate on any response, also click the “Other Protections” checkbox to provide further explanation in the last
free-text question.
Read the entire page before filling out the form.
1. * Protections when conducting one-on-one in-person interventions or interactions (for groups see Q2 below):

Conducting study activities in locations that maximize privacy (limited people around, closing doors,
drawing drapes around beds, monitoring voice volume, etc.)

Verifying identity before discussing personal information.

Asking the participant if they are comfortable answering questions in that location

Asking the participant if they are comfortable with having other people present (if any)

Moving away from other people when conducting activities in public spaces or offering a private space

Offering other options of ways to respond to sensitive questions (i.e. pointing, clicking, or writing) if
uncomfortable verbally responding

Using generic signs on research rooms and spaces, particularly for research on stigmatizing or
sensitive topics

Other protections not listed in this question – describe below

N/A – study has no in-person interventions or interactions with participants
 
2. * Protections when conducting group interventions or interactions:

Conducting study activities in locations that maximize privacy (limited people passing by, closing doors,
monitoring voice volume, etc.)

Moving to a more private area to answer questions or to discuss concerns

Discussing privacy with the participants and the importance of not talking outside the group about what other
people say during the group session

Allowing participants to use a pseudonym or limiting use of individuals’ names during the group activity

Asking everyone in a public group setting (e.g. classrooms, workshops) to turn something in (blank or filled) so
participants do not have to self-identify when turning in materials

Collecting paper forms in a closed box or envelope rather than passing to others or leaving in an open area

Limiting participant identifiers that would be visible on paper documents (i.e. using study IDs instead of direct
identifiers)

Allowing people to distance themselves from other participants during group activities


Offering other options of ways to respond to sensitive questions (i.e. pointing, clicking, or writing instead of
speaking)

Using generic signs on research rooms and spaces, particularly for research on stigmatizing or sensitive topics

Ensuring non-participating individuals are not captured on recordings or in photos

Other protections not listed in this question – describe below

N/A – study has no group interventions or interactions
 
3. * Protections when conducting remote interventions or interactions (e.g. phone, text, email, video-conference,
tele-health, online, etc.):

Conducting study activities in locations where study staff can maximize their own privacy (limited
people around, closing doors, monitoring voice volume, etc.)

Leaving/sending generic messages that avoid using study and participant identifiers, such as names,
study titles, clinics, study topics, etc.

Obtaining permission prior to sending text messages

Advising the participant to move to a location where they are comfortable answering questions and will
not be overheard - incorporate this instruction into your study materials

Advising online participants to complete the activity at a time and location where they will be
comfortable answering questions - incorporate this instruction into your study materials

Ensuring non-participating individuals are not captured on recordings or in photos

Offering other options of ways to complete the activity (i.e. online, paper, phone) if more privacy is
desired

Offering a way to save and return later to the online activity if privacy is compromised

Other protections not listed in this question – describe below

N/A – study has no remote interventions or interactions with participants
 
4. * Protections when mailing study materials to/from participants:

Obtaining permission to mail study materials

Confirming/verifying the accuracy of addresses before mailing items

Ensuring the participant is able to personally receive mailed materials and has a way to protect their
own privacy if they do not want others to know they are receiving research communications (i.e.
notifying participants of when to expect it)

Using return address labels and document headers that avoid study identifiers, such as study names,
clinics, study topics, etc.

Avoiding or limiting use of participant identifiers and health information on mailed documents (i.e. using
study IDs instead of direct identifiers)

Providing a return mailing address label or pre-addressed envelope to ensure returned items are sent to
the correct address

Communicating receipt of mail from participants and/or asking them to notify you when they mail it to
ensure study documents are not lost in transfer

Offering other options of ways to complete the activity (i.e. by phone or online) if desired

Other protections not listed in this question – describe below

N/A – not mailing any materials to/from participants
 
5. * Protections when analyzing or disseminating study data *Applicable to all studies*:

Working only in locations where the study team can ensure privacy (not working in close proximity to
non-study personnel, closing doors, closing/putting away documents/files before leaving, etc.)

Securing physical materials only in locations that ensure privacy (access limited to authorized study
personnel)

Obtaining explicit parental permission before disseminating or sharing recordings or photos of children

Blurring/redacting/hiding faces and other identifiable features/marks (tattoos, scars, birthmarks, distinctive voice,
etc.) in recordings or photos prior to disseminating or sharing

Only publishing or presenting aggregate results or findings (i.e. no individual-level information)

Taking additional steps to protect participant identities when publishing or presenting individual-level information,
quotations, results, images – describe below


Other protections not listed in this question – describe below
 
6. Describe any other way(s) that the research team will protect participants' privacy. See the help text for
additional guidance.
Consent and completion of data collection will be conducted in a private room or office.
All participants will be informed that their responses will be held in confidence by research staff and that their
comments will not be shared. Participants will also be told that all research staff are compelled by law to report
incidences of abuse or threat of harm to self or others.
Further, participants are informed that the information from the study may be published in medical journals. Assurance
is given that publications will not reveal participants’ identities.
 

HM20011840
View: SF2 - Data Confidentiality and Storage
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Data Confidentiality and Storage
Confidentiality refers to the way private, identifiable information about a participant or defined community is
maintained and shared. It describes how the study’s research materials (data, specimens, records, etc.) are protected
from unauthorized access.
Instructions for this page:
Select all the ways that the research team will keep the study materials and data confidential throughout the course
of the study. Not all will be applicable to every study. 
To elaborate on any response, also click the “Other Protections” checkbox to provide further explanation in the last
free-text question.
Read the entire page before filling out the form.
1. * Protections for paper research materials:

Maintaining control of paper documents at all times, including when at an off-campus location

Limiting or avoiding use of participant identifiers on paper documents (i.e. using study IDs instead of
direct identifiers)

Storing paper documents in a secure location accessible only to authorized study personnel

Promptly transcribing, scanning, or abstracting data from paper into electronic platforms with destruction of the
paper copy

Proper destruction of paper records (and obtaining prior permission when required) in accordance with VCU
Records Management policies

Other protection not listed in this question – describe below

N/A – no paper research materials
2. * Protections for research specimens:

Maintaining control of specimens at all times, including when at an off-campus location

Storing specimens in a secure location accessible only to authorized study personnel

Labeling specimens with subject ID or other coded information instead of direct identifiers

Final destruction of specimens will be in accordance with VCU policies and specimen containers will be devoid
of any identifiable information

Other protection not listed in this question – describe below

N/A – no research specimens
3. * Protections for electronic files/data - See https://ts.vcu.edu/about-us/information-security/data-management-
system/

*Required for all studies* Use VCU-approved methods of data storage, transmission, and transfer (see
https://dms.vcu.edu)

Remotely accessing VCU network storage to store data when at off-campus locations

Ensuring unauthorized individuals who might share a device do not have access to study materials (e.g.
individual logins, separate accounts)

Using VCU-approved data collection tools and apps (e.g. REDCap) and storing exported analysis files in VCU-
approved storage locations (see https://dms.vcu.edu)

When using non-VCU-approved electronic data collection tools, storage locations, data transfer platforms, and
mobile apps (e.g. Dropbox, Box, Survey Monkey, Fitbits, novel apps, multi-site data collection platforms):
• consulting with VCU Information Security on proper data management (see https://ts.vcu.edu/askit/essential-
computing/information-security/);
• advising participants about the terms of use and privacy policies of those sites/apps;
• limiting or avoiding use of identifiers; and
• removing data promptly from the external location after transferring it to a VCU storage location

De-identifying the research data by replacing subjects’ names with assigned subject IDs

Storing the study’s linkage key in a password-protected and VCU-approved storage location (see
https://dms.vcu.edu)

When analyzing particularly sensitive information, using computers that are unconnected from the internet.

Proper destruction of electronic records (and obtaining prior permission when required) in accordance with VCU
Records Management policies


Other protection not listed in this question – describe below
4. * Protections for computers and research devices/apps that are provided to participants for use in the study
and taken out of the lab (i.e., giving participants a phone or iPad to take home, wearable trackers, apps, etc.):

Transferring data promptly from the device/app given to the participant to a VCU storage location

Setting strong passwords on computers and research devices (when applicable) that leave VCU with
participants

Device/app set up by VCU Information Security

When providing devices or mobile apps to children, informing parents about the settings and how to manage
them (if applicable), internet access, and any other installed apps on the device

Other protection not listed in this question – describe the device/app and protection below

N/A – no computers or devices/apps being provided for participant use outside the lab
5. * Protections for email/online communications

Only using VCU/VCU Health email addresses for study-related communications

Only using VCU/VCU Health–approved methods of teleconferencing or video conferencing (e.g. Zoom)
(for studies involving HIPAA, contact VCU or VCU Health Information Security [as appropriate] about
HIPAA-compliant systems)

Other protection not listed in this question – describe below

N/A – no email/online communications
6. Specify any other places where this study’s paper and electronic research data and/or physical specimens will
be stored and any other ways they will be secured from improper use and disclosure. 
See the help text for additional guidance.
Each participant is assigned a unique identification number, which is used on all paper-based records, so that no
participant may be identified by name. All paper-based records are secured in locked cabinets in a Research
Assistant’s locked office, separate from clinical records. Only the PI, Interventionists, Research Coordinator and
Research Assistants have access to the data.
A master list of participant names and identification numbers, along with contact information is kept in a password-
protected database, accessible by only by the research staff. Each person has their own unique username and
password to access the electronic database.
The research database is also kept in a password-protected database, accessible by only by the research staff. Each
person has their own unique username and password to access the electronic database.
7. * If research data/specimens will be sent/released to person(s) or group(s) outside of the VCU study team or
the PI’s department for the conduct of this protocol (not for future sharing),
1) identify the data/specimen recipient(s) along with their VCU department or other institutional or
organizational affiliation(s).
2) give a description of what identifiers and/or codes will accompany the data/specimens.
If data/specimens are not being sent/released outside of the VCU study team or the PI’s department, state that:
None of the 18 HIPAA identifiers will be released to persons or groups outside of the VCU study team.
8. * Select all identifiers that will be collected at any time as part of this study (including for recruitment, data
gathering, data analysis, etc.), even if the data will eventually be anonymized:

Names

Geographic Locators Below State Level

Social Security Numbers

Dates (year alone is not an identifier)

Ages over 89 (age under 89 is not an identifier)

Phone Numbers

Facsimile Numbers

E-mail Addresses

Medical Record Numbers

Device Identifiers

Biometric Identifiers

Web URLs


IP Addresses

Account Numbers

Health Plan Numbers

Full Face Photos or Comparable Images

License/Certification Numbers

Vehicle ID Numbers

Other Unique Identifier

No Identifiers

Employee V#
9.   * If the study will code (i.e. de-identify) the research data by replacing subjects’ names and/or other identifiers
with assigned subject IDs, explain the following aspects of the coding process:
- The process for how subject IDs will be generated/assigned (e.g. random, sequential)
- Whether there will be a key that links the subject ID with direct identifiers. If there will be no linkage key, state
that.
If a key will be created, describe
- The place where the key will be stored
- The role(s) of all individuals who will have access to the key
- When the key will be destroyed
See the help text for guidance.  
Each participant is assigned a unique identification number (sequentially) by the Research Coordinator or a Research
Assistant. Within an electronic database, a key linking participant names and identification numbers, along with contact
information is kept in a password-protected database, accessible by only the research staff. Each person has their own
unique username and password to access the electronic database. Because this study has a follow-up component, the
key will not be destroyed until after the study is completed.

HM20011840
View: SF2 - Data Retention
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Data Retention
1. * Select all of the ways that individually identifiable information obtained during pre-screening and/or
screening will be handled for individuals who DO NOT qualify for the study:

N/A - study does not require screening procedures

Immediately destroy the information and identifiers (no data collected)

Immediately destroy the identifiers connected with the data (anonymization)

Store until the end of study & then destroy

Use as "screening failure" data by members of the study team

Provide to others outside of the research team (with the participant's permission)

Request permission from participant to maintain and use the identifiable information

Other
2. * Will participants be able to withdraw their data (paper, electronic, or specimens) from the study (e.g. ask that
it be destroyed or returned) if they no longer wish to participate? (FDA-regulated studies should select No –
see help text)
  Yes
No
3. * If Yes , describe the process (oral, written, email, letter, etc.) that participants should use to request
withdrawal of their data/specimens. Identify if there is a timepoint when withdrawal will no longer be an option
and/or if the amount of data that can be withdrawn is reduced at different points in the study.
Participants may request that their data be withdrawn orally. Research staff will keep a written record of the withdrawal.
4. * What will happen to the research materials (e.g. data, specimens, documents, etc.) when the research has
been completed?
Stored indefinitely with identifiers removed
Stored indefinitely with identifiers attached
Destroyed at the end of study once the minimum time required for data retention has been met per VCU Data
Retention Policy and/or sponsor retention requirements
Destroyed when notified by sponsor but not less than the minimum time required for data retention per VCU
Data Retention Policy
Other
5. * Will audio/video recordings and full face photographs be destroyed?
  Yes
No
6. If yes, describe at what point and how recordings will be destroyed:
After review with the PI, the audio-recordings will be destroyed.
7. If no, explain why the recordings need to be maintained:
 
  

HM20011840
View: SF2 - Sharing Plan
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Sharing Plan
This page addresses times when investigators may be required to share information about participants or may desire
to share their research information/specimens with the aim of advancing science. This page creates a plan for when
and how information/specimens could be shared.
Try to anticipate all reasonably foreseeable sharing so that the consent document can also reflect that information.
However, it is acceptable to amend this page later and explain either how re-consent of previously and currently
enrolled participants will occur or why re-consent should not be required.
The IRB reviews this page against the consent document (if one exists) to demonstrate the ethical principle of
Respect for Persons by confirming that plans for sharing do not go against what participants would understand
about the use of their data/specimens.
The IRB also ensures there are adequate protections for the privacy of participants and the confidentiality of
participants' data/specimens when data is shared with others.
1. * Is it likely investigators could discover information about child/elder abuse or neglect that would require
mandatory reporting by the investigators or staff?
The Code of Virginia requires that most medical personnel and all employees of institutions of higher
education report suspected child/elder abuse or neglect.
  Yes
No
2. *  Is it likely investigators could discover a previously unknown reportable disease or condition that would
require mandatory reporting by the investigators or staff (i.e., HIV , coronavirus, hepatitis, etc.)?
  Yes No
3. * Will the sponsor or investigator obtain a Certificate of Confidentiality for this study?
Certificates of Confidentiality  (CoC) are issued by the National Institutes of Health (NIH), the FDA and CDC to
protect identifiable research information from forced disclosure. All human subject research studies
regardless of funding can qualify to receive a CoC. A CoC is automatically issued for research that was
ongoing on December 13, 2016. or initiated after that date. For more information, see
https://humansubjects.nih.gov/coc/
No – Will not obtain CoC for this study
Yes – CoC has been obtained or issued automatically
Yes – CoC request is pending
4. * Select the way(s) that information or biospecimens (including DNA) may be used by the VCU PI or VCU study
team for other future research projects (i.e. analyses beyond/apart from the aims of this study)?
See help text for definitions.

Will use directly identifiable information or specimens.
(‘Directly identifiable’ means that identifiers like name, medical record number, social security number, etc. are
included in/attached to the dataset/specimens. Maintaining identifiable data for future research is treated as a
registry by the VCU IRB. The IRB must approve the new research use in an amendment to this study or as part
of a new study before the project is initiated. VCU IRB studies will be asked more questions about this on a later
page)

Will use de-identified or indirectly identifiable information or specimens.
(‘De-identified’ means that a linkage/key code exists that links identifiers to data/specimens. When the
researcher holds both the data and the key, the VCU IRB considers the subjects to be readily identifiable.
Maintaining identifiable data for future research uses is treated by the IRB as a registry. The IRB must approve
the new research use in an amendment to this study or as part of a new study before the project is initiated.
VCU IRB studies will be asked more questions about this on a later page)


Will use anonymized information or specimens.
(‘Anonymized’ means that 1) no linkage/key codes exist that link identifiers to data/specimens; and 2) subjects
cannot be readily identified, i.e. no direct or indirect identifiers or identifiable combinations of variables. The VCU
IRB considers uses of anonymized data/specimens to not be human subject research.)

Will use aggregate results (summary-level results), not individual-level information or specimens.
(The VCU IRB considers uses of aggregate data to not be human subject research because there are no
individual subjects.)

Will contribute to an existing registry or repository
(VCU IRB studies will be asked more questions about this on a later page.)

Will not use information/specimens for purposes beyond this study.

Not sure and will submit an amendment when known

Other use(s) of individual-level information in a way not listed above
5. * Select the way(s) the VCU PI/study team may share information or biospecimens (including DNA) with other
researchers who are not on this study team (i.e. for analyses beyond/apart from the aims of this study). 
See help text for definitions.

Will share directly identifiable information or specimens with other researchers.
(‘Directly identifiable’ means that identifiers like name, medical record number, social security number, etc. are
included in/attached to the dataset/specimens. Maintaining identifiable data for future research uses is treated
by the VCU IRB as a registry. The data recipient’s use of identifiable data would require them to obtain IRB
review. VCU IRB studies will be asked more questions about this on a later page.)

Will share de-identified or indirectly identifiable information or specimens with other researchers.
(‘De-identified’ means that a linkage/key code exists that links identifiers to data/specimens. The VCU
researcher maintains the key but does not share it with any other researchers. The recipient’s use of de-
identified data/specimens may not be human subject research if there is documentation that the key will never
be shared with the recipient, but they should check with their own IRB about review requirements. VCU IRB
studies will be asked more questions about this on a later page.)

Will share anonymized information or specimens with other researchers.
(‘Anonymized’ means that 1) no linkage/key codes exist that link identifiers to data/specimens; and 2) subjects
cannot be readily identified (i.e. no direct or indirect identifiers or identifiable combinations of variables). The
VCU IRB considers uses of anonymized data/specimens by other researchers to not be human subject
research, but the recipient should check with their own IRB about review requirements.)

Will only share aggregate results (summary-level results), not individual-level information or specimens.
(The VCU IRB considers uses of aggregate data to not be human subject research because there are no
individual subjects. The data recipient should check with their own IRB about review requirements.)

Will contribute to an existing registry or repository (VCU IRB studies will be asked more questions about this on
a later page.)

Will submit data to an NIH genomic data repository (VCU IRB studies will be asked more questions about this on
a later page.)

Will not share information/specimens with other researchers.

Not sure and will submit an amendment when known

Other sharing of individual-level information with other researchers

6. * The Principal Investigator certifies that after the study has been closed with the VCU IRB, the following
conditions will be met whenever individual level research information and/or specimens are used or shared:
  - The identities of participants who are represented in the dataset/specimens will not be readily ascertainable
or otherwise re-identifiable by the recipient;
  - If a linkage/code key is created, it will be maintained at VCU and not shared with the recipient under any
circumstances;
  - The PI will have no knowledge that the remaining information could be used alone or in combination with
any other information to identify the individuals represented in the data; and
  - The PI agrees to abide by this sharing plan even after the study has been closed with the VCU IRB.
Yes
No
N/A - No sharing will occur
 

HM20011840
View: SF2 - Pertinent Results and Incidental Findings
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Pertinent Results and Incidental Findings
1. * Is it likely investigators could discover a participant's previously unknown condition (e.g. pregnancy,
disease, suicidal thoughts, wrong paternity, genetic results, or other findings that may be of importance to
health or well-being) or if a participant is engaging in illegal or reportable activities:
  Yes
No
2. * Describe what possible pertinent results or incidental findings stemming from research-only procedures may
be discovered.
With regard to participants' health or well-being, we will not learn of any pertinent and/or incidental findings that the
participant has not disclosed themselves.
As mentioned above, participants could share concerns about depression/suicidal ideation.
There is the possibility that research participants may, over the course of data collection, report to research staff
incidences of intent to harm others or of committing abuse.
3. * Explain what actions or procedures research personnel should take to inform the PI of such a discovery :
The research staff have resource and referral information for participants asking for medical or mental health care. If a
participant indicates severe depression or suicidal ideation, the research staff will contact the PI. The PI is on call
during each interview is responsible for monitoring the status of enrolled participants and addressing urgent situations.
When concerns arise, the PI is contacted immediately to make a clinical decision regarding the need for further
evaluation, treatment, or referral.
4. * Will findings be disclosed to participants and/or any other person/group outside of the study team?
  Yes
No
5. If pertinent and/or incidental findings will not be disclosed, explain why not:
We will not learn of any pertinent and/or incidental findings that the participant has not disclosed themselves.
In the case of participant-reported severe depression or suicidal ideation, the PI is contacted immediately to make a
clinical decision regarding the need for further evaluation, treatment, or referral.
In the case of participants reporting child or elder abuse or intent to harm others, the consent form clearly indicates that
research staff are required to contact authorities.
  

HM20011840
View: SF2 - Risk Benefit Complete
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Risk Benefit Complete
Protocol Progress:
❶ INITIAL SETUP
❷ BACKGROUND, RATIONALE & GOALS
❸ RESEARCH PLAN
❹ CONSENT PLAN
❺ RISKS, PRIVACY & CONFIDENTIALITY
⑥ POPULATIONS WITH SPECIAL CONSIDERATIONS
⑦ INSTITUTIONAL REQUIREMENTS
⑧ DOCUMENTS
Click Continue below to go to the next section
 

HM20011840
View: SF2 - Populations with Special Considerations
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Populations with Special Considerations
1. * Check all participant groups that will be either
  a) Specifically included in this study or
  b) Discernable in the research data/specimens.
  (Selections will branch)

Children

Emancipated minors

Wards of the State

Pregnant women or fetuses

Neonates or Post-delivery Materials

Prisoners

Decisionally Impaired Adults

VCU Health System or VCU Dental Care patients

VCU / VCUHS students or trainees

VCU / VCU Health System employees

Individuals with limited English proficiency

Active military personnel

Student populations in K-12 educational settings or other learning environments

Members of a federally recognized American Indian and Alaska Native tribe

None of the Above
 
2. * Check all of the following categories that apply to this research:

45 CFR 46.204
Research involving pregnant women or fetuses.

45 CFR
46.205(a) and
(b)
Research involving neonates of uncertain viability.

45 CFR
46.205(a) and
(c)
Research involving nonviable neonates

45 CFR
46.205(d)
Research involving viable neonates.

45 CFR 46.206
Research involving, after delivery, the placenta, the dead fetus, or fetal material.

45 CFR 46.207
Research not otherwise approvable which presents an opportunity to understand, prevent, or
alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or
neonates.
3. Additional considerations for student populations: 
* Select all who will be research participants in the study:

VCU Students

K-12 Students

Parents/Guardians of Students

Teachers

Administrators


Other
4. If applicable, describe any alternative activities for students (including VCU students) who choose not to
participate in the research.
5. * Describe how the study will minimize the possibility of coercion to participate.
The purpose of the study is to evaluate the efficacy of a structured, curriculum-based intervention to promote postinjury
resilience and adjustment. The study is not specifically focused on students, but there is no reason to exclude those
who are students from participating. This is a survey study, and research personnel conducting informed consent will
emphasize the voluntary nature of participation.
6. Additional considerations for VCU/VCU Health System employees:
* Describe how the study will minimize the possibility of coercion to participate.
The purpose of the study is to evaluate the efficacy of a structured, curriculum-based intervention to promote postinjury
resilience and adjustment. The study is not specifically focused on VCU employees, but there is no reason to exclude
those who are employees from participating. This is a survey study, and research personnel conducting informed
consent will emphasize the voluntary nature of participation.         
           
           

HM20011840
View: SF2 - Pregnant Women or Fetuses
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Pregnant Women or Fetuses
1. * When scientifically appropriate, briefly describe any preclinical studies (including studies on pregnant
animals) and clinical studies (including studies on nonpregnant women) that have provided data for assessing
potential risks to pregnant women and fetuses [45 CFR 46.204(a)].
There is no additional risk to the pregnant woman or fetus. This is a survey study to evaluate the efficacy of a
structured, curriculum-based intervention to promote postinjury resilience and adjustment.
2. * Select the condition that is applicable to this study [45 CFR 46.204(b)]:
The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit
for the woman or the fetus.
If there is no prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the
research is the development of important biomedical knowledge which cannot be obtained by any other
means.
3. * Provide protocol-specific information to support the selected condition above [45 CFR 46.204(b)].
Not applicable.
4. * Describe how the risk is the least possible for achieving the objectives of the research [45 CFR 46.204(c)].
There is no additional risk to the pregnant woman or fetus. This is a survey study to evaluate the efficacy of a
structured, curriculum-based intervention to promote postinjury resilience and adjustment.
5. * Describe how consent will be obtained from the pregnant woman if the research may:
_directly benefit the pregnant woman,
_directly benefit the pregnant woman and the fetus, or
_offer no benefit for the woman nor the fetus (when risk to the fetus is not greater than minimal) and the
purpose of the research is the development of important biomedical knowledge that cannot be obtained by
any other means [45 CFR 46.204(d)].
Not applicable. 
6. If the research may directly benefit the fetus only, describe how the consent of the pregnant woman and the
father will be obtained. [45 CFR 46.204(e)]\
Note: The father's consent is not required if he is unable to consent because he is unavailable, incompetent,
temporarily incapacitated, or the pregnancy resulted from rape or incest.
Not applicable.
7. * Describe how each individual providing consent is fully informed regarding the reasonably foreseeable
impact of the research on the fetus or neonate [45 CFR 46.204(f)].
There is no additional risk to the pregnant woman or fetus. This is a survey study to evaluate the efficacy of a
structured, curriculum-based intervention to promote postinjury resilience and adjustment. 
8. For children who are pregnant, describe how you will obtain assent from the child and permission from the
parent(s) of the pregnant child [45 CFR 46.204(g)].
Not applicable. 
9. * Will inducements, monetary or otherwise, be offered to terminate a pregnancy [45 CFR 46.204(h)]?
  Yes
No
 
10. * Will individuals engaged in the research have any part in any decisions as to the timing, method, or
procedures used to terminate a pregnancy [45 CFR 46.204(i)]?
  Yes
No
 
11. * Will individuals engaged in the research have any part in determining the viability of a neonate [45 CFR
46.204(j)]?
  Yes
No
 

 

HM20011840
View: SF2 - Decisionally Impaired Adults
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Decisionally Impaired Adults
1. * Choose the nature of the decisional impairment participants will have:
Temporarily Incompetent to Give Consent
Permanently Incompetent to Give Consent
Unknown
2. * Explain why this population is necessary for the conduct of the study.
The purpose of the study is to evaluate the efficacy of a structured, curriculum-based intervention to promote post-
injury resilience and adjustment. TBI often causes physical and mental disabilities. Thus, adults with physical and/or
mental disabilities are included.
3. * Describe methods for determining whether participants are capable of providing consent or assent.
In any case where the research staff have concerns about the individual’s ability to provide informed consent, formal
assessment of decision-making capacity is made using the MacArthur Competence Assessment Tool, Clinical
Research version (MacCAT-CR). This is a second-generation instrument based on pioneering multicenter studies of
treatment capacity (Appelbaum, 1995). It has excellent content validity, and is the only current instrument that
assesses the full range of abilities relevant to capacity for giving informed consent to participate in research (Kim,
2001). It has previously been used in persons with schizophrenia (Carpenter, 2000), depression (Appelbaum, 1999),
and dementia (Kim, 2001). Minimum values on each scale of the MacCAT-CR are established as two standard
deviations below the norms of competent persons from the community, which have previously been published. (Kim,
2001) Such an approach is commonly used in assessment of decision-making capacity (Grisso, 1995; Grisso, 1998;
Marson, 1995) and has been shown to be more stringent than expert assessment of capacity (Kim, 2001). It generally
requires 15 to 20 minutes to administer and is easily learned by investigators (Appelbaum, 1999; Kim, 2001).
Appelbaum PS, Grisso T. The MacArthur Treatment Competence Study, I: Mental illness and competence to consent to
treatment. Law Hum Behav 1995; 19:109-126.
Appelbaum PS, Grisso T, Frank E, O’Donnell S, Kupfer DJ. Competence of depressed patients for consent to
research. Am J Psychiatry 1999; 156:1380-1384.
Carpenter WT Jr, Gold J, Lahti A, Queern C, Conley R, Bartko J, Kovnick J, Appelbaum PS. Decisional capacity for
informed consent in schizophrenia research. Arch Gen Psychiatry 2000; 57:533-538.
Grisso T, Appelbaum PS. Assessing Competence to Consent to Treatment: A Guide for Physicians and Other Health
Professionals. New York: Oxford University Press, 1998.
Grisso T, Appelbaum PS, Mulvey EP, Fletcher K. The MacArthur Treatment Competence Study, II: Measures of abilities
related to competence to consent to treatment. Law Hum Behav 1995; 19:127-148.
Kim SYH, Caine ED, Currier GW, Leibovici A, Ryan JM. Assessing the competence of persons with Alzheimer’s
disease in providing informed consent for participation in research. Am J Psychiatry 2001; 158:712-717.
Marson DC, Ingram KK, Cody HA, Harrell LE. Assessing the competency of patients with Alzheimer’s disease under
different legal standards: a prototype instrument. Arch Neurol 1995; 52: 949-954.
4. * If a participant is capable of exercising some judgment concerning the nature of the study, describe how
assent will be obtained.
In cases where the patient is too impaired to consent, but family members wish for the person to participate in the
intervention, consent will be obtained by a legally authorized representative (LAR) on behalf of the patient. Assent will
then be sought from the patient. If the patient chooses not to participate, they will not be enrolled in the study.
5. Describe, if applicable, how the individuals' ability to give consent will be assessed throughout the study and
how consent will be obtained when appropriate.
At the 3, 4, and 9 month follow-ups, the Research Coordinator or Research Assistant will review the study details with
the participant. Research staff will confirm that the participant remains interested in continuing their participation. If the
individual's cognitive status improves during the course of the study, then consent will be sought. Participants may
withdraw from the study at any time. 
6. * Describe how and when consent will be obtained from participants' legally authorized representative (LAR).
For persons lacking capacity in the judgment of investigators, consent is obtained from substitute decision makers
(LAR) as allowed under Virginia law. 
  

HM20011840
View: SF2 - Populations with Special Considerations Section Complete
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Populations with Special Considerations Section Complete
Protocol Progress:
❶ INITIAL SETUP
❷ BACKGROUND, RATIONALE & GOALS
❸ RESEARCH PLAN
❹ CONSENT PLAN
❺ RISKS, PRIVACY & CONFIDENTIALITY
❻ POPULATIONS WITH SPECIAL CONSIDERATIONS
⑦ INSTITUTIONAL REQUIREMENTS
⑧ DOCUMENTS
 
Click Continue below to go to the next section

HM20011840
View: SF2 - Study Funding
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Study Funding
1. * Have you applied for funding:
  Yes
No
2. Is this study already funded:
  Yes
No
3. * Select all funding sources for this study (pending or awarded):

Industry

Direct Federal

Indirect Federal

State/Local Government

Non-Profit - Sponsored Project

Non-Profit - Gift

Internal Grant

Investigator/Departmental Funds

None

Other
4. * In addition to providing funding support, what is the funding source’s role in this study? Select all that apply:

Solely providing funding support

Providing resources (e.g. study drug, device)

Providing guidance to the researcher but does NOT make decisions about study design

Study design/Creation of the study protocol

Collaborator in the research (helps design and/or conduct the study) [list the funder as a site on the Types of
Sites page]

Data or sample analysis regardless of identifiability
5. Select all related funding proposals and contracts that have been submitted through the Division of
Sponsored Programs (DSP):
RAMS-SPOT ID#
(FP/PT/PD#)
Direct Sponsor
PI
Title
StatusStartEnd
FP00003652
Department of Health &
Human Services
Jeffrey
Kreutzer
Traumatic Brain Injury Model
Systems Centers
Funded  
 
6. If the following conditions are ALL met, provide the index code where the HRPP will charge Single IRB (sIRB)
fees associated with this review:
1.  The study is externally funded (fees do not apply if the study is not funded), AND
2. Multiple sites are executing the same research protocol (i.e. multicenter research), AND
3. VCU IRB will provide IRB review on behalf of one or more non-VCU sites
7. * Does the funder require the IRB to review this proposal for grant congruence?
  Yes
No

8. If grant congruence review is requested, upload the entire grant proposal (exclusive of budget and
appendices).
If Industry was selected above, upload the DSP Subject Injury Language Memo or other documentation from
DSP approving the consent form's subject injury language.
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Consent Form RAI+ consent_2021
05 25 clean.pdf
0.15
5/27/2021
11:20 AM
Jennifer
Marwitz
Consent/Assent/Information
Sheet
Yes
View Assent Form
RAI+ assent_2021
05 25 clean.pdf
0.10
5/27/2021
11:20 AM
Jennifer
Marwitz
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Consent Script
COVID Contingency
Consent Script RAI+
2021 05 25
clean.pdf
0.10
5/27/2021
11:20 AM
Courtney
Roberts
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Consent Form
COVID Contingency
Consent Info Sheet
RAI+ 2021 05 25
clean.pdf
0.10
5/27/2021
11:20 AM
Courtney
Roberts
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Protocol
COVID Contingency
Protocol v6
HM20011840 2021
05 25.docx
0.06
5/25/2021
2:35 PM
Elicia
Preslan
Research Protocol
Yes
View Flyer
RAI+ Study_Flyer
2021 05 25
clean.doc
0.03
5/25/2021
2:35 PM
Jennifer
Marwitz
Recruitment/Advertising
Yes
View Hsu PI Change
Form
Hsu PI Change
Form 2021 05 11.pdf
0.01
5/25/2021
2:33 PM
Jennifer
Marwitz
Other
Yes
View Hsu CV
Hsu CV 2020
Dec.pdf
0.01
5/25/2021
2:33 PM
Jennifer
Marwitz
CV/Biosketch
Yes
View Marwitz CV
Marwitz,Jennifer CV
2020 12 18.docx
0.01
1/6/2021
2:45 PM
Jennifer
Marwitz
CV/Biosketch
Yes
View Script for
cases where
follow-up done
by phone
Script follow-ups
done by phone 2017
12 17.doc
0.01
12/17/2017
3:24 PM
Jennifer
Marwitz
Research Measure
Yes
View Grant Proposal grantsApplication.pdf 0.01
11/15/2017
2:35 PM
Jennifer
Marwitz
Funding Proposal
Yes
View Data Collection
Forms
RAI+ Measures.pdf
0.01
10/30/2017
5:24 PM
Jennifer
Marwitz
Research Measure
Yes
View RAI+
Implementation
Manual
RAI+ Manual 2017
05 08.pdf
0.01
10/30/2017
5:22 PM
Jennifer
Marwitz
Research Measure
Yes
View MacCAT-CR
(Consent
Evaluation)
MacCAT-CR 2017
10.doc
0.01
10/30/2017
5:22 PM
Jennifer
Marwitz
Research Measure
Yes
View CV/Biosketch-
Kreutzer
JSK CV 2017 10
04.docx
0.01
10/25/2017
12:56 PM
Jennifer
Marwitz
CV/Biosketch
Not
Applicable
 

HM20011840
View: SF2 - Types of Sites
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Types of Sites
VCU Site Information
1. * Select all VCU sites that will be utilized in this study:

Children's Hospital of Richmond at VCU

Clinical Research Services Unit (CRSU)

Massey Cancer Center

VCU Health Community Memorial Hospital

VCU Health Tappahannock Hospital

VCU Medical Center

Other VCU Health Location

VCU Monroe Park Campus

VCU Qatar

Other VCU Site
 
Non-VCU Site Information 
Non-VCU sites should be selected whenever any of the following situations apply:
   a) Non-VCU sites that will be collaborating  on a VCU-led study (i.e. involved in conducting the research,
including being involved in the study interpretation or analysis of data and/or authorship of presentations or
manuscripts related to the research.)  
   b) Non-VCU sites that will be deferring to the VCU IRB for IRB review
   c) Non-VCU sites where VCU investigators will be overseeing study interventions or interactions
   d) Non-VCU sites/locations where VCU investigators will conduct study activities
2. * Select any of the following non-VCU sites utilized in this study:

McGuire VAMC

Foreign Sites

Other Non-VCU Sites

No Non-VCU Sites
3. * Is this a multi-center study being led by VCU?
  Yes No
4. For Non-VCU Sites: For each site or institution listed as "Site Engaged -- Requests to Rely on VCU IRB
Review," upload:
- Completed Local Context Form for Relying on VCU's IRB
- Site specific informed consent form(s)  and HIPAA authorization(s), if applicable
For Foreign Sites: For each Cultural Consultant upload a CV/Biosketch that includes a clear description of
cultural expertise:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Consent Form RAI+ consent_2021
05 25 clean.pdf
0.15
5/27/2021
11:20 AM
Jennifer
Marwitz
Consent/Assent/Information
Sheet
Yes
View Assent Form
RAI+ assent_2021
05 25 clean.pdf
0.10
5/27/2021
11:20 AM
Jennifer
Marwitz
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Consent Script
COVID Contingency
Consent Script RAI+
0.10
5/27/2021
11:20 AM
Courtney
Roberts
Consent/Assent/Information
Sheet
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
2021 05 25
clean.pdf
View COVID
Contingency
Consent Form
COVID Contingency
Consent Info Sheet
RAI+ 2021 05 25
clean.pdf
0.10
5/27/2021
11:20 AM
Courtney
Roberts
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Protocol
COVID Contingency
Protocol v6
HM20011840 2021
05 25.docx
0.06
5/25/2021
2:35 PM
Elicia
Preslan
Research Protocol
Yes
View Flyer
RAI+ Study_Flyer
2021 05 25
clean.doc
0.03
5/25/2021
2:35 PM
Jennifer
Marwitz
Recruitment/Advertising
Yes
View Hsu PI Change
Form
Hsu PI Change
Form 2021 05 11.pdf
0.01
5/25/2021
2:33 PM
Jennifer
Marwitz
Other
Yes
View Hsu CV
Hsu CV 2020
Dec.pdf
0.01
5/25/2021
2:33 PM
Jennifer
Marwitz
CV/Biosketch
Yes
View Marwitz CV
Marwitz,Jennifer CV
2020 12 18.docx
0.01
1/6/2021
2:45 PM
Jennifer
Marwitz
CV/Biosketch
Yes
View Script for
cases where
follow-up done
by phone
Script follow-ups
done by phone 2017
12 17.doc
0.01
12/17/2017
3:24 PM
Jennifer
Marwitz
Research Measure
Yes
View Grant Proposal grantsApplication.pdf 0.01
11/15/2017
2:35 PM
Jennifer
Marwitz
Funding Proposal
Yes
View Data Collection
Forms
RAI+ Measures.pdf
0.01
10/30/2017
5:24 PM
Jennifer
Marwitz
Research Measure
Yes
View RAI+
Implementation
Manual
RAI+ Manual 2017
05 08.pdf
0.01
10/30/2017
5:22 PM
Jennifer
Marwitz
Research Measure
Yes
View MacCAT-CR
(Consent
Evaluation)
MacCAT-CR 2017
10.doc
0.01
10/30/2017
5:22 PM
Jennifer
Marwitz
Research Measure
Yes
View CV/Biosketch-
Kreutzer
JSK CV 2017 10
04.docx
0.01
10/25/2017
12:56 PM
Jennifer
Marwitz
CV/Biosketch
Not
Applicable

HM20011840
View: SF2 - Personnel
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Personnel
1. * List all VCU/VCUHS personnel who are key study personnel.
Key personnel are defined as including:
     - Conflict of interest investigators, including
     - the PI
     - the Lead Student/Trainee Investigator,
     - medically/Psychologically responsible investigator(s)
     - FDA Form 1572 investigators, and
     - Other personnel whose roles are essential to the conduct of the research.
Note: Individuals who are not key personnel are not required to be listed here, but PIs still bear the
responsibility to document the delegation of responsibilities in the study records.
PIs may elect to use the Study Roster activity button in RAMS-IRB (available after approval) as an alternative
way to document study staff involvement and delegation of responsibilities. Personnel changes made to the
non-key personnel listed in the separate Study Roster activity do not require an amendment.
 
Name Roles
Roles -
Other
ResponsibilitiesResponsibilities
- Other
QualificationsQualifications
- Other
COI
Investigator
View Jeffrey
Kreutzer
Consultant
 
Data Analysis
Study Design
 
Experience -
Research
Experience -
Clinical
Education
and/or
Professional
Preparation
 
no
View Ana
Mills
Other
Interventionist Participant
Consent
Participant
Identification
Participant
Recruitment
Intervention
Services
Data Collection -
Interviews/Surveys
 
Experience -
Research
Experience -
Clinical
Education
and/or
Professional
Preparation
 
no
View Nancy
Hsu
Other
Principal
Investigator
Interventionist Data Analysis
Participant
Consent
Participant
Identification
Study Design
Participant
Recruitment
Intervention
Services
Data Collection -
Interviews/Surveys
 
Experience -
Research
Experience -
Clinical
Education
and/or
Professional
Preparation
 
yes
View Kristin
Graham
Other
Interventionist Participant
Consent
Participant
Recruitment
 
Experience -
Research
Experience -
Clinical
 
no

 
Name Roles
Roles -
Other
ResponsibilitiesResponsibilities
- Other
QualificationsQualifications
- Other
COI
Investigator
Intervention
Services
Data Collection -
Interviews/Surveys
Education
and/or
Professional
Preparation
View Laura
Albert
Research
Assistant
 
Participant
Consent
Data Collection -
Clinical
Data Entry
Data Coding
Data Collection -
Interviews/Surveys
 
Experience -
Research
Experience -
Clinical
Education
and/or
Professional
Preparation
 
no
View Ronald
Seel
Co/Sub-
Investigator
 
Data Analysis
 
Experience -
Research
Experience -
Clinical
Education
and/or
Professional
Preparation
 
no
2. Identify all independent investigators and key personnel at non-VCU sites who will be engaged in this study
AND who DO NOT have IRB approval for this study from their own institution.
 NameRoles
Roles
-
Other
ResponsibilitiesResponsibilities
- Other
QualificationsQualifications
- Other
COI
Investigator
There are no items to display
3. If independent investigators or community engaged investigators are listed above,describe the human subjects
training these individuals will complete and the process that will be used to ensure that all persons assisting
with the research are adequately informed about the protocol and their research related duties and functions: 
All members of the research team meet quarterly, at a minimum. The PI meets weekly with the Research Coordinator,
and the Research Coordinator meets weekly with the Research Assistants. In addition, email is used to notify research
team members about any issues related to the project. The Research Coordinator manages a database which has
primary and secondary contact information for all research staff.
4. * Upload a CV or Biosketch for the PI, Medically/Psychologically Responsible Investigators and the lead
Student/Trainee Investigators. Do not upload CVs or Biosketches for other individuals.
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Consent Form RAI+ consent_2021
05 25 clean.pdf
0.15
5/27/2021
11:20 AM
Jennifer
Marwitz
Consent/Assent/Information
Sheet
Yes
View Assent Form
RAI+ assent_2021
05 25 clean.pdf
0.10
5/27/2021
11:20 AM
Jennifer
Marwitz
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Consent Script
COVID Contingency
Consent Script RAI+
2021 05 25
clean.pdf
0.10
5/27/2021
11:20 AM
Courtney
Roberts
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Consent Form
COVID Contingency
Consent Info Sheet
RAI+ 2021 05 25
clean.pdf
0.10
5/27/2021
11:20 AM
Courtney
Roberts
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Protocol
COVID Contingency
Protocol v6
HM20011840 2021
05 25.docx
0.06
5/25/2021
2:35 PM
Elicia
Preslan
Research Protocol
Yes
View Flyer
RAI+ Study_Flyer
2021 05 25
0.03
5/25/2021
2:35 PM
Jennifer
Marwitz
Recruitment/Advertising
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
clean.doc
View Hsu PI Change
Form
Hsu PI Change
Form 2021 05 11.pdf
0.01
5/25/2021
2:33 PM
Jennifer
Marwitz
Other
Yes
View Hsu CV
Hsu CV 2020
Dec.pdf
0.01
5/25/2021
2:33 PM
Jennifer
Marwitz
CV/Biosketch
Yes
View Marwitz CV
Marwitz,Jennifer CV
2020 12 18.docx
0.01
1/6/2021
2:45 PM
Jennifer
Marwitz
CV/Biosketch
Yes
View Script for
cases where
follow-up done
by phone
Script follow-ups
done by phone 2017
12 17.doc
0.01
12/17/2017
3:24 PM
Jennifer
Marwitz
Research Measure
Yes
View Grant Proposal grantsApplication.pdf 0.01
11/15/2017
2:35 PM
Jennifer
Marwitz
Funding Proposal
Yes
View Data Collection
Forms
RAI+ Measures.pdf
0.01
10/30/2017
5:24 PM
Jennifer
Marwitz
Research Measure
Yes
View RAI+
Implementation
Manual
RAI+ Manual 2017
05 08.pdf
0.01
10/30/2017
5:22 PM
Jennifer
Marwitz
Research Measure
Yes
View MacCAT-CR
(Consent
Evaluation)
MacCAT-CR 2017
10.doc
0.01
10/30/2017
5:22 PM
Jennifer
Marwitz
Research Measure
Yes
View CV/Biosketch-
Kreutzer
JSK CV 2017 10
04.docx
0.01
10/25/2017
12:56 PM
Jennifer
Marwitz
CV/Biosketch
Not
Applicable
 

HM20011840
View: SF2 - Conflict of Interest
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Conflict of Interest
The PI should ask the questions on this page of all research personnel who are engaged in the research, including
subrecipient investigators and personnel. 
1. * To the best of your knowledge, do you (as PI) or any other engaged individual have a financial interest
related to this study?
Financial interest include utilizing your licensed intellectual property in the study; serving as a paid
consultant, or advisory board member, or officer/director with a related entity; and equity or business
ownership in a company that is related to this project
  Yes No
2. * To the best of your knowledge, do you (as PI) or any other engaged individual have a non-financial interest
related to this study?
Non-financial Interests could include such things as:
- utilizing your unlicensed intellectual property in the study,
- serving as an unpaid advisory board member or officer/director with a related entity, and
- equity or business ownership in a company that has yet to make a profit and is related to this project
- conflict of time/effort,
- personal and professional relationships/affiliations,
- intellectual passions or personal beliefs
- other factors that could create bias in the study
  Yes No
3. Describe any institutional conflict of interest that you or any member of the research team are aware of that
pertains to this research:
 An institutional conflict of interest is a situation in which financial interests of the University or University
leadership may affect research activities at VCU.
None.
 

HM20011840
View: SF2 - Other VCU Requirementsv2
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Other VCU Requirements
This page asks questions on behalf of other ancillary offices, committees and departments at VCU regarding
institutional requirements that could apply to this research. In some cases, these requirements could also
impact the consent process or other aspects of the IRB's review.
Based upon answers provided earlier in this form, certain ancillary sections below may not have questions
displayed if those requirements are not applicable to this study.
1. Cost Coverage Analysis
         Information on coverage analysis requirements and processes can be found through VCU’s Clinical
Research Compliance Program at https://research.vcu.edu/human-research/clinical-research/vcu-clinical-research-
coverage-analysis/ 
 
1. * VCU requires that all clinical research studies be evaluated to determine if a Coverage Analysis is
required. Has your study been evaluated by an institutionally designated Coverage Analysis Specialist?
Yes
No
Not Applicable
 
2. ClinicalTrials.gov Program & OnCore
For guidance, see https://cctr.vcu.edu/support/consultation/clinical-trials-gov/ or email CCTRCTGOV@vcu.edu
1. * Is this a Clinical Trial?
  Yes No 
2. * ThePI acknowledges awareness of the following requirements for posting clinical trial consent forms:
 
  - Each clinical trial under the 2018 Common Rule that is conducted or supported by a Federal
department or agency must post one IRB-approved consent form that was used to enroll subjects on a
publicly available Federal website [45 CFR 46.116(h)].
  - When engaged in multi-site research, the VCU PI is responsible for confirming with the lead site who
is responsible for posting the informed consent form.
  - When VCU is the lead site, the VCU PI is responsible for posting the informed consent form (unless
the federal department or agency will post it).
  Yes No 
3. Community Engagement
For more information, see https://community.vcu.edu/
1. * Is this a community engaged research study? (See help text for definitions)
  Yes
No
 
4. Family Educational Rights and Privacy Act (FERPA) Requirements
For guidance, see  https://rar.vcu.edu/records/family-educational-rights-and-privacy-act/
1. * Does this study involve obtaining information from VCU students' educational records (see help
text)?
  Yes
No
5. Research Data Privacy Requirements
Contact the VCU Research Data Privacy Office with questions: https://research.vcu.edu/integrity-and-
compliance/compliance/research-data-privacy/

1. * Does this study involve the VCU site (regardless of the IRB of record), or any sites under the VCU
IRB'’s oversight, obtaining data in, or from, a foreign country? 
  Yes No   
 
6. Information Security
For guidance, see https://ts.vcu.edu/askit/essential-computing/information-security/
1. * Using the VCU Data Classification Tool, please determine the appropriate data classification category
for the data that will be collected or used in this research.
Note: if the data falls into Category 1, a data security management plan is required by University
Information Security Office.
See help text for information on accessing the VCU Data Classification Tool, and for information on
creating a data security management plan at https://dms.vcu.edu.
Category 1: all data that require breach notifications in the event of improper release, including
personally identifiable information covered by HIPAA and Commonwealth of Virginia regulations.
Category 2: all proprietary data that if improperly released has the potential to cause harm to the
institution, its mission or its reputation that do not require breach notifications.
2. * I confirm use of the VCU Data Classification Tool at https://go.vcu.edu/dataclassification in determining
the data classification category selected in Question 1:
  Yes
No
3. * The PI is aware that if the study’s data is classified as Category 1, a Data Management Plan must be
submitted to and approved by VCU Information Security prior to IRB approval. See
https://ts.vcu.edu/askit/essential-computing/information-security/data-management-system/
  Yes No  
 
4. * I confirm that any use of external technology has been submitted to Information Security in the
study’s Data Management Plan. If this study uses any technology platforms, apps, services, etc. that
are maintained external to VCU or hosted by another institution and are NOT currently listed in the DMS
system as an approved service for the storage, processing, or transmission of VCU data, I am required
to have VCU Information Security conduct a security review of that technology. I may contact
infosec@vcu.edu with questions.
I also confirm that if the study involves use of external technology and VCUHS HIPAA data, I must also
seek security review from the VCUHS Data Governance group (contact Mary Harmon at
mary.harmon@vcuhealth.org):
Yes
No
N/A - not using external technology
7. Massey Cancer Center Protocol Review and Monitoring Committee (PRMC)
For guidance, see https://www.masseycancercenter.org/research/~/link.aspx?
_id=ee49e95faa8b44d09b6e89d8e3b48b57&_z=z
1. * Does this study involve any of the following?
- Research involving patients with cancer, their families or their health care providers
- Research involving cancer screening, diagnosis or prevention
- Secondary data collected from cancer patients or their medical records
- Cancer-related surveys (e.g., attitudes about risk, prevention and treatment) of the general population
  Yes
No
8. VCU ONETRAC Protocol Review Oversight Committees (PROCs) For guidance, see https://onetrac.vcu.edu/
1. * Does this study involve research with any of the following?
- VCU Health System patients
- VCU Health System facilities

- VCU Health System data   Yes
No
 
 If Yes, upload documentation of approval or review by the PROC or PRMC in this study’s topic area. If
you do not have PROC or PRMC approval, please visit onetrac.vcu.edu for additional information and
to submit your project for review.
 
9. VCU Health Department of Patient Centered Services
 
1. * Does your study involve a satisfaction survey  administered to VCUHS patients (*See Help Text):
Yes
No
Not Applicable
10. VCU Faculty-Held IND or IDE
For guidance, see https://research.vcu.edu/human-research/regulatory-affairs/.
Questions related to if you need an IND or IDE for your study should be emailed to: indide@vcu.edu. Please submit a
copy of your FDA 
submission prior to submitting to the FDA to https://redcap.vcu.edu/surveys/?s=NR7K7LR4JW.
11. VCU Health System locations
1. * Will research activities occur in patient care areas of the VCU Health System (including at CHoR,
Community Memorial Hospital, Tappahannock Hospital, VCU Medical Center and Massey Cancer
Center)?
  Yes
No
12. VCUHS Department of Pathology
Learn more about requesting and establishing an account with Pathology here:  See
https://pathology.vcu.edu/research-services/
1. * I have contacted VCUHS Department of Pathology to determine feasibility if my study involves the
following: 
- Storage of Microbiology isolates
- New instrumentation provided by clinical trial/study sponsor, or 
- Non-routine specimen processing (examples include but aren’t limited to the following: addition of
reagents to samples/aliquots, buffy coat processing, DNA sample processing)
Yes
No
N/A - my study does not involve any of the listed processes.
2. * If my study involves specimen retrieval from the Pathology laboratory, I have established a process
with Pathology to deidentify and retrieve specimens.
Yes
No
N/A - my study won't involve specimen retrieval from Pathology
 
 
13. VCU Institutional Biosafety Committee (IBC)
To contact the Biosafety Office see their website at:  https://research.vcu.edu/integrity-and-
compliance/compliance/regulatory-committees/
1. * Does this project involve any of the following hazardous biological agents (“biohazardous agents”)
that have NOT been FDA approved? These may include, but are not limited to, any of the following. If
you are unsure, please contact the Biosafety Office:
       - Any functional recombinant viruses (especially viruses that may integrate into the patients’
genome).

       - Expression or administration of biological toxins.
       - Live pathogenic or potentially pathogenic organisms of plants or animals (bacteria, fungi, wild-
type viruses, parasites, etc.), that are, or potentially may be, in experimental products.
       - Introduction or expression of rDNA or synthetic nucleic acids
       - Use of a product (e.g., monoclonal antibodies, recombinant cytokines) produced from virally
infected mammalian cells.
       - Use of a product (purified growth factors, cytokines) produced from mammals or their cells.
  Yes No
 
 
14. VCU Radiation Safety Committee (RSC)
To contact the Radiation Safety Section see their website at: https://research.vcu.edu/integrity-and-
compliance/compliance/regulatory-committees/ 
1. * Does this study involve radiation exposure and/or scans involving radiation (e.g.: PET, MRA, CT, DXA,
nuclear medicine, etc.)?
  Yes
No
           
15. VCU Scientific Review Committee (SRC)
For guidance, see https://cctr.vcu.edu/support/consultation/scientific-review-committee/
1. * Has this human subjects protocol (not the grant application) already been reviewed by the funder of a
sponsored project (e.g. a federal, state or non-profit funding sponsor)?
  Yes
No
16. Upload any documents requested in the questions above:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Consent Form RAI+ consent_2021
05 25 clean.pdf
0.15
5/27/2021
11:20 AM
Jennifer
Marwitz
Consent/Assent/Information
Sheet
Yes
View Assent Form
RAI+ assent_2021
05 25 clean.pdf
0.10
5/27/2021
11:20 AM
Jennifer
Marwitz
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Consent Script
COVID Contingency
Consent Script RAI+
2021 05 25
clean.pdf
0.10
5/27/2021
11:20 AM
Courtney
Roberts
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Consent Form
COVID Contingency
Consent Info Sheet
RAI+ 2021 05 25
clean.pdf
0.10
5/27/2021
11:20 AM
Courtney
Roberts
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Protocol
COVID Contingency
Protocol v6
HM20011840 2021
05 25.docx
0.06
5/25/2021
2:35 PM
Elicia
Preslan
Research Protocol
Yes
View Flyer
RAI+ Study_Flyer
2021 05 25
clean.doc
0.03
5/25/2021
2:35 PM
Jennifer
Marwitz
Recruitment/Advertising
Yes
View Hsu PI Change
Form
Hsu PI Change
Form 2021 05 11.pdf
0.01
5/25/2021
2:33 PM
Jennifer
Marwitz
Other
Yes
View Hsu CV
Hsu CV 2020
Dec.pdf
0.01
5/25/2021
2:33 PM
Jennifer
Marwitz
CV/Biosketch
Yes
View Marwitz CV
Marwitz,Jennifer CV
2020 12 18.docx
0.01
1/6/2021
2:45 PM
Jennifer
Marwitz
CV/Biosketch
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Script for
cases where
follow-up done
by phone
Script follow-ups
done by phone 2017
12 17.doc
0.01
12/17/2017
3:24 PM
Jennifer
Marwitz
Research Measure
Yes
View Grant Proposal grantsApplication.pdf 0.01
11/15/2017
2:35 PM
Jennifer
Marwitz
Funding Proposal
Yes
View Data Collection
Forms
RAI+ Measures.pdf
0.01
10/30/2017
5:24 PM
Jennifer
Marwitz
Research Measure
Yes
View RAI+
Implementation
Manual
RAI+ Manual 2017
05 08.pdf
0.01
10/30/2017
5:22 PM
Jennifer
Marwitz
Research Measure
Yes
View MacCAT-CR
(Consent
Evaluation)
MacCAT-CR 2017
10.doc
0.01
10/30/2017
5:22 PM
Jennifer
Marwitz
Research Measure
Yes
View CV/Biosketch-
Kreutzer
JSK CV 2017 10
04.docx
0.01
10/25/2017
12:56 PM
Jennifer
Marwitz
CV/Biosketch
Not
Applicable

HM20011840
View: SF2 - HIPAA
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
HIPAA
In order for VCUHS to meet HIPAA regulations regarding accounting of disclosures, data retention, and data destruction
requirements for PHI data obtained without patient authorization, members of the study team (including principal investigators)
are directed to consult with VCU Informatics to obtain any VCUHS data. This does not include obtaining data for which the
study team has patient authorization. [VCU Health System Authority and Affiliates Policy COMP-014] 
For data requests, including preparatory to research and research with decedents, submit a request for the desired PHI, or for
a consultation on alternate methods to obtain the data, at https://informatics.vcu.edu.
HIPAA Privacy Board Requirements
       For guidance, see https://www.vcuhealth.org/our-story/who-we-are/compliance-services/compliance-services
1. * Select the source of the Individually Identifiable Health Information. See help text for definitions.

PHI associated with or derived from (i.e. obtained from or entered into) VCU Health medical records or
VCU Dental Care records

Research Health Information (RHI) created or received by a study and kept solely in study records (e.g.
self reported or the result of research tests and not entered into health records)

PHI associated with or derived from (i.e. obtained from or entered into) a non-VCU HIPAA covered entity’s health
records
2. * Summarize the types of health information that will be obtained or used in this research. Do not describe
only the identifiers that you will collect or use during the study.
Data collected from participants is obtained through review of medical records, patient interview, and completion of
payment forms for participation in the research. Participants’ VCUHS medical records are reviewed to obtain date of
injury and date of birth. In cases where the participant was not seen at VCU for initial treatment after TBI, this
information is collected directly from the participant. During participant interviews, research staff collect the following
information, so that participants can be contacted for follow-up interviews: name, address, phone numbers, and email
addresses. Payment forms for research participation require social security number, name, address, and phone
number, as mandated by University policy.
3. * Describe the source(s) of the protected health information (e.g. Informatics or which clinical databases):
VCU medical records (Cerner)
Interview with the participant
Payment form for participation
4. * Does the PI certify that this study's access to and use of the protected health information is limited to the
minimum amount necessary to be able to effectively conduct the research?
  Yes No 
5. * Select all pathways this research will employ to use or access PHI  (selections will branch):

De-Identified Data (none of the 18 identifiers are recorded or associated with the research data)

Limited Data Set

Waiver of Authorization

Partial Waiver of Authorization (temporary waiver for recruitment purposes and/or waiver of some elements of
Authorization)

Signed Authorization Combined with Consent Form

Signed Authorization as Stand-Alone Form
 
  

HM20011840
View: SF2 - Institutional Requirements Complete
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Institutional Requirements Complete
Protocol Progress:
❶ INITIAL SETUP
❷ BACKGROUND, RATIONALE & GOALS
❸ RESEARCH PLAN
❹ CONSENT PLAN
❺ RISKS, PRIVACY & CONFIDENTIALITY
❻ POPULATIONS WITH SPECIAL CONSIDERATIONS
❼ INSTITUTIONAL REQUIREMENTS
⑧ DOCUMENTS
Click Continue below to go to the next section
 

HM20011840
View: SF2 - Documents
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Documents
1. Upload any documents that the VCU IRB will need to conduct a review of this submission:
A list of potential documents is given in the help text.
NOTE: The delete function should only be used if an incorrect document is uploaded or added to the system AND that
document has not been reviewed and approved by the IRB. Do NOT delete documents that the IRB previously
reviewed and approved.
Once you have uploaded a document to RAMS-IRB, any changes to that document (i.e. different versions of
the same document) should be added to the IRB submission by using the Update button. To provide updated
documents, follow these steps:
  - Click the Update button located to the left of the document to be updated.
  - In the Add Document window, click the Choose File or Browse button, select the file you are adding, and
click on the Open button.
  - Click OK to close the Add Document window, and the system will upload the revised document. RAMS-IRB
will automatically provide a version number for the document.
To access previous versions of a document in RAMS-IRB you must use the History link associated with the
document.
- Click the View or Update button located to the left of the document you wish to access.
- In the Add/View Document window, click the "History" hyperlink located to the right of the file name.
- A separate window will open that shows all versions of the document that have been added to RAMS-IRB.
Click on any file name to download and view the document.
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Consent Form RAI+ consent_2021
05 25 clean.pdf
0.15
5/27/2021
11:20 AM
Jennifer
Marwitz
Consent/Assent/Information
Sheet
Yes
View Assent Form
RAI+ assent_2021
05 25 clean.pdf
0.10
5/27/2021
11:20 AM
Jennifer
Marwitz
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Consent Script
COVID Contingency
Consent Script RAI+
2021 05 25
clean.pdf
0.10
5/27/2021
11:20 AM
Courtney
Roberts
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Consent Form
COVID Contingency
Consent Info Sheet
RAI+ 2021 05 25
clean.pdf
0.10
5/27/2021
11:20 AM
Courtney
Roberts
Consent/Assent/Information
Sheet
Yes
View COVID
Contingency
Protocol
COVID Contingency
Protocol v6
HM20011840 2021
05 25.docx
0.06
5/25/2021
2:35 PM
Elicia
Preslan
Research Protocol
Yes
View Flyer
RAI+ Study_Flyer
2021 05 25
clean.doc
0.03
5/25/2021
2:35 PM
Jennifer
Marwitz
Recruitment/Advertising
Yes
View Hsu PI Change
Form
Hsu PI Change
Form 2021 05 11.pdf
0.01
5/25/2021
2:33 PM
Jennifer
Marwitz
Other
Yes
View Hsu CV
Hsu CV 2020
Dec.pdf
0.01
5/25/2021
2:33 PM
Jennifer
Marwitz
CV/Biosketch
Yes
View Marwitz CV
Marwitz,Jennifer CV
2020 12 18.docx
0.01
1/6/2021
2:45 PM
Jennifer
Marwitz
CV/Biosketch
Yes
View Script for
cases where
follow-up done
by phone
Script follow-ups
done by phone 2017
12 17.doc
0.01
12/17/2017
3:24 PM
Jennifer
Marwitz
Research Measure
Yes
View Grant Proposal grantsApplication.pdf 0.01
11/15/2017
2:35 PM
Jennifer
Marwitz
Funding Proposal
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Data Collection
Forms
RAI+ Measures.pdf
0.01
10/30/2017
5:24 PM
Jennifer
Marwitz
Research Measure
Yes
View RAI+
Implementation
Manual
RAI+ Manual 2017
05 08.pdf
0.01
10/30/2017
5:22 PM
Jennifer
Marwitz
Research Measure
Yes
View MacCAT-CR
(Consent
Evaluation)
MacCAT-CR 2017
10.doc
0.01
10/30/2017
5:22 PM
Jennifer
Marwitz
Research Measure
Yes
View CV/Biosketch-
Kreutzer
JSK CV 2017 10
04.docx
0.01
10/25/2017
12:56 PM
Jennifer
Marwitz
CV/Biosketch
Not
Applicable

HM20011840
View: SF2 - Documents Complete
ID: HM20011840
HM20011840 - Nancy Hsu
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
  
Documents Complete
Protocol Progress:
❶ INITIAL SETUP
❷ BACKGROUND, RATIONALE & GOALS
❸ RESEARCH PLAN
❹ CONSENT PLAN
❺ RISKS, PRIVACY & CONFIDENTIALITY
❻ POPULATIONS WITH SPECIAL CONSIDERATIONS
❼ INSTITUTIONAL REQUIREMENTS
❽ DOCUMENTS
End of Application
Click Continue below to exit and submit this project
 

HM20011840
View: SF_IRB_ConsentPlan_Groups
ID: HM20011840
  
Consent Groups
1. * Enter a descriptive name for this consent / assent group:
Participants with TBI
2. * Select all that apply to this consent / assent group:
 
Name

Signed Consent by Participant

Signed Parent/Guardian Permission or Legally Authorized Representative Consent

Signed Assent by Child or Decisionally Impaired Adult

Verbal/Other Indication of Assent by Child or Decisionally Impaired Adult

Short Form Consent (limited applicability)

None of the Above (select waiver below)
3. * Select all electronic signature platforms that apply to this consent / assent group:

Not using electronic signature platforms

DocuSign Part 11 (FDA regulated studies)

DocuSign (standard platform for non-FDA regulated studies)

REDCap e-Consent

iMedConsent (Veterans Affairs studies)

Other electronic signature platform
4. If Other is selected, explain:
5. * Select any waivers that apply to this consent / assent group:
 

No Waivers Requested

Waiver of All Consent or Some Elements in Consent Form

Waiver of Parental Permission or Legally Authorized Representative Consent

Waiver of All Assent by Child or Decisionally Impaired Adult

Waiver of Signature on Consent/Permission Forms (waiver of documentation of consent)

Exception from Informed Consent (for emergency research only)
6. * Select all study team role(s) that will obtain consent / assent from this group:
 

Principal Investigator

Co/Sub-Investigator

 

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other

N/A: Requesting Waiver of Consent
7. If Other is selected, explain:
Interventionist
8. * Describe the consent procedures used for this group. Address each point below:
        - When and where consent will occur
        - What will be covered during the consent discussion 
        - How the consent discussion will occur (e.g. in-person, phone, video conference)
        - How you will reconfirm consent on an ongoing basis, if applicable
Participants will consent in the facilities housing the Department of Physical Medicine and Rehabilitation, Division of
Neuropsychology and Rehabilitation Psychology Research Offices, located in West Hospital on the 3rd floor.
9. * Select the processes for minimizing any potential perception of undue influence to participate, particularly
when there is a pre-existing relationship between the participant and the researcher (e.g. treatment
provider/patient; instructor/student; supervisor/employee, etc.):

Having a 3rd person (family/friends, another study team member, etc.) present during the consent / assent
discussion

Having an independent advocate (e.g. advocate for decisionally impaired adults, wards) present during the
consent / assent discussion

Removing physical symbols of authority like white coats or police badges

Sitting down beside the participant instead of standing over them

If obtaining consent / assent in a clinical setting, letting patients sit instead of lie down (if they are able to)

Moving to a more neutral location like a conference room

Obtaining consent / assent after other services/interactions have been completed (e.g. after school or the clinic
visit)

Having a mandatory wait period for the participant to go home and think before they sign consent /assent

Sharing the consent / assent discussion between two people (i.e. a clinician might be the best person to explain
study procedures and risks, but then they could step out and let a research assistant finish the consent process)

Other protection(s) not listed here – describe below

N/A: Requesting Waiver of Consent
10. * Describe the other ways the study team will minimize any potential perception of undue influence to
participate:
Emphasis will be placed on the fact that participation is voluntary; that participants can refuse to answer any questions

that they choose not to answer; and that they can stop being in the study at any time. Research staff will also
emphasize that refusal to participate will not change an individual’s medical care, rehabilitation care, or any other any
other benefits received.
11. * How much time will participants be given to make a decision:
Individuals are afforded as much time as they wish to decide about participation, and they may schedule a follow-up
appointment with the study team if they wish to take the consent form home to discuss with others prior to deciding.
12. If applicable, describe the procedures for consenting children upon entering adulthood or participants who
are no longer decisionally impaired:
If the individual's cognitive status improves during the course of this study, then consent will be sought.
  

HM20011840
View: Personnel
ID: HM20011840
  
Personnel
1. * Name:
Jeffrey Kreutzer
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

Data Collection - Interviews/Surveys

 

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study, the individual is
appropriately credentialed and privileged to practice within the institution where the research will be
conducted:
Individual has no clinical responsibilities
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:
  

HM20011840
View: Personnel
ID: HM20011840
  
Personnel
1. * Name:
Ana Mills
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * If other role is selected, explain:
Interventionist
5. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

 

Data Collection - Interviews/Surveys

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
6. * The PI certifies that if this individual will conduct any clinical activities as part of this study, the individual is
appropriately credentialed and privileged to practice within the institution where the research will be
conducted:
Yes
7. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
8. Additional or Emergency Phone:
  

HM20011840
View: Personnel
ID: HM20011840
  
Personnel
1. * Name:
Nancy Hsu
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * If other role is selected, explain:
Interventionist
5. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

 

Data Collection - Interviews/Surveys

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
6. * The PI certifies that if this individual will conduct any clinical activities as part of this study, the individual is
appropriately credentialed and privileged to practice within the institution where the research will be
conducted:
Yes
7. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
8. Additional or Emergency Phone:
  

HM20011840
View: Personnel
ID: HM20011840
  
Personnel
1. * Name:
Kristin Graham
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * If other role is selected, explain:
Interventionist
5. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

 

Data Collection - Interviews/Surveys

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
6. * The PI certifies that if this individual will conduct any clinical activities as part of this study, the individual is
appropriately credentialed and privileged to practice within the institution where the research will be
conducted:
Individual has no clinical responsibilities
7. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
8. Additional or Emergency Phone:
  

HM20011840
View: Personnel
ID: HM20011840
  
Personnel
1. * Name:
Laura Albert
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

Data Collection - Interviews/Surveys

 

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study, the individual is
appropriately credentialed and privileged to practice within the institution where the research will be
conducted:
Individual has no clinical responsibilities
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:
  

HM20011840
View: Personnel
ID: HM20011840
  
Personnel
1. * Name:
Ronald Seel
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

Data Collection - Interviews/Surveys

 

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study, the individual is
appropriately credentialed and privileged to practice within the institution where the research will be
conducted:
Individual has no clinical responsibilities
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:
  

HM20011840
View: SF_IRB_Summary_Document
ID: HM20011840
Add Document
1. * Document Name:
Consent Form
2. * Type:
Consent/Assent/Information Sheet
3. * File:

RAI+ consent_2021 05 25 clean.pdf(0.15)   
 

HM20011840
View: SF_IRB_Summary_Document
ID: HM20011840
Add Document
1. * Document Name:
Assent Form
2. * Type:
Consent/Assent/Information Sheet
3. * File:

RAI+ assent_2021 05 25 clean.pdf(0.10)   
 

HM20011840
View: SF_IRB_Summary_Document
ID: HM20011840
Add Document
1. * Document Name:
COVID Contingency Consent Script
2. * Type:
Consent/Assent/Information Sheet
3. * File:

COVID Contingency Consent Script RAI+ 2021 05 25 clean.pdf(0.10)   
 

HM20011840
View: SF_IRB_Summary_Document
ID: HM20011840
Add Document
1. * Document Name:
COVID Contingency Consent Form
2. * Type:
Consent/Assent/Information Sheet
3. * File:

COVID Contingency Consent Info Sheet RAI+ 2021 05 25 clean.pdf(0.10)   
 

HM20011840
View: SF_IRB_Summary_Document
ID: HM20011840
Add Document
1. * Document Name:
COVID Contingency Protocol
2. * Type:
Research Protocol
3. * File:
COVID Contingency Protocol v6 HM20011840 2021 05 25.docx(0.06)   
 

HM20011840
View: SF_IRB_Summary_Document
ID: HM20011840
Add Document
1. * Document Name:
Flyer
2. * Type:
Recruitment/Advertising
3. * File:
RAI+ Study_Flyer 2021 05 25 clean.doc(0.03)   
 

HM20011840
View: SF_IRB_Summary_Document
ID: HM20011840
Add Document
1. * Document Name:
Hsu PI Change Form
2. * Type:
Other
3. * File:

Hsu PI Change Form 2021 05 11.pdf(0.01)   
 

HM20011840
View: SF_IRB_Summary_Document
ID: HM20011840
Add Document
1. * Document Name:
Hsu CV
2. * Type:
CV/Biosketch
3. * File:

Hsu CV 2020 Dec.pdf(0.01)   
 

HM20011840
View: SF_IRB_Summary_Document
ID: HM20011840
Add Document
1. * Document Name:
Marwitz CV
2. * Type:
CV/Biosketch
3. * File:
Marwitz,Jennifer CV 2020 12 18.docx(0.01)   
 

HM20011840
View: SF_IRB_Summary_Document
ID: HM20011840
Add Document
1. * Document Name:
Script for cases where follow-up done by phone
2. * Type:
Research Measure
3. * File:
Script follow-ups done by phone 2017 12 17.doc(0.01)   
 

HM20011840
View: SF_IRB_Summary_Document
ID: HM20011840
Add Document
1. * Document Name:
Grant Proposal
2. * Type:
Funding Proposal
3. * File:

grantsApplication.pdf(0.01)   
 

HM20011840
View: SF_IRB_Summary_Document
ID: HM20011840
Add Document
1. * Document Name:
Data Collection Forms
2. * Type:
Research Measure
3. * File:

RAI+ Measures.pdf(0.01)   
 

HM20011840
View: SF_IRB_Summary_Document
ID: HM20011840
Add Document
1. * Document Name:
RAI+ Implementation Manual
2. * Type:
Research Measure
3. * File:

RAI+ Manual 2017 05 08.pdf(0.01)   
 

HM20011840
View: SF_IRB_Summary_Document
ID: HM20011840
Add Document
1. * Document Name:
MacCAT-CR (Consent Evaluation)
2. * Type:
Research Measure
3. * File:
MacCAT-CR 2017 10.doc(0.01)   
 

HM20011840
View: SF_IRB_Summary_Document
ID: HM20011840
Add Document
1. * Document Name:
CV/Biosketch-Kreutzer
2. * Type:
CV/Biosketch
3. * File:
JSK CV 2017 10 04.docx(0.01)