Effectiveness and Implementation of eScreening in Post 9/11 Transition Programs
Phase: NA
Conditions: Depression, Stress Disorders, Post-Traumatic, Suicide
Sponsor: VA Office of Research and Development

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VASDHS IRB
Human Subjects Protocol
v20190121
Section 1 - Preliminaries
Principal Investigator:
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Protocol Title:
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IRB Protocol Number:
$
Protocol Nickname:
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Form Template Version:
N
Date Prepared:

Please be advised that this protocol application form has changed as a result of the 2018 Common Rule.  There are new 
questions and sections, and you may be required to provide additional information to previous sections.
1a) Is this study considered human research?
4=K
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1b) Please select:
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Section 2 - Research Subjects
2a) What is the total planned number of VA-consented subjects?
Include the total number of subjects who will prospectively agree to participate in the study (e.g., documented consent, 
oral consent, or other).

2b) What is the total number of VA subjects who WILL NOT be consented?
Include the total number of subjects that will be included without consent (e.g., chart review).  Note: Data about people 
are still considered “human subjects” by the IRB, so even if you do not intend to contact the patients whose charts you 
will review, you still should enter the number of charts as your “planned subjects."

Section 2.1 Consented Subject Groups
2.1) For each of the subject categories listed below, indicate whether or not these subject groups will participate in the study: 
2.1a) Children under the age of 18
Note:   If neonates or children will be involved in this study, certification by the Medical Center Director will be required. 
Only minimal risk research may be performed with children.  Only non-invasive monitoring and/or prospective 
observational and retrospective record review studies that are minimal risk can be conducted in VA involving neonates.
4=K
*G
2.1b) Pregnant women
4=K
*G
2.1c) Individuals with cognitive/decisional impairment
4=K
*G
2.1d) Non-English-speaking individuals
4=K
*G
2.1e) Prisoners of War (explicitly targeting this group)
4=K
*G
2.1f) Non-Veterans (Note: Justification for inclusion of non-Veterans will be required)
4=K
*G
2.1g) Incarcerated individuals (Note: VA CRADO approval will be required)
4=K
*G
2.1h) VA employees - including VA paid, IPA, or WOC (Note: Union review and authorization may be required)
4=K
*G
2.1i) Students of the institution (e.g., resident trainees) or of the investigator
4=K
*G
2.1j) Patients with cancer (or high cancer risk) [explicitly targeting this group]
4=K
*G

Section 2.2 Subject Categories without consent
2.2) Indicate if data or specimens only will be used without enrollment consent for each category listed below:
2.2a) Non-Veterans
4=K
*G
2.2b) Prisoners
4=K
*G
2.2c) Neonates or Children
Note:  If neonates or children will be involved, certification by the Medical Center Director will be required. Only minimal 
risk research may be performed with children.  Only non-invasive monitoring and/or prospective observational and 
retrospective record review studies that are minimal risk can be conducted in VA involving neonates.
4=K
*G
Section 3 - Study Features   (these items default to "No" for convenience)
3) This section consists of several Yes/No questions addressing protocol characteristics.    Click on 
.
Save and Continue
Section 3.1 Protocol Basics
$,3,*:(33:/(:(773?
3.1a) The research 
 the participant.
intends to change
4=K
*G
3.1b) 
 with living participants to collect data or specimens with no intent to change them.
Interactions
4=K
*G
3.1c) This is a study that 
 has any 
never
subject contact and does not collect subject identifiers
4=K
*G
3.1d) This is a 
study involving retrospective or prospective medical records.
chart review 
4=K
*G
3.1e) This is a 
study occurring in-part or in-full at other locations.
multi-site 
4=K
*G
3.1f) There is an 
 component to this research. 
international
International research includes sending or receiving human 
derived data or specimens (identifiable, limited data set, coded, or deidentified) to or from an international 
source.  International research does not include studies in which VA is only one of multiple participating sites where the 
overall study-wide PI is not a VA investigator.
4=K
*G
3.1g) This study includes 
 (not including VA-leased space or CBOC clinics) conducted under 
off-station activity
VASDHS IRB approval.  Note: this does not include research conducted by a collaborator at their home institution under 
their institutional approval.
4=K
*G
3.1h) VA subjects will 
 in part or in full 
 (not including VA-leased space or clinics) under 
participate
at other locations
VASDHS IRB approval.

4=K
*G
Section 3.2 Specimen Use and Data Repository
Indicate whether or not each of the following applies to this protocol
3.2a) Involves specimens that are left over from pathological or diagnostic testing (
)
non-research specimens
4=K
*G
3.2b) Involves 
 purposes 
specimens collected for research
only
4=K
*G
3.2c) This study includes 
 (specimens are retained for use outside of the purposes of this protocol)
specimen banking
4=K
*G
3.2d) The study involves 
genotyping or other 
DNA 
genetic analysis
4=K
*G
3.2e) Biological
will be sent outside of the VA.
 specimens/material 
4=K
*G
3.2f) A 
 is maintained (data are retained after completion of the protocol for other uses, 
 see 
data repository
IMPORTANT:
 before checking "yes")
4=K
*G
3.2g)  
of the VA (identifiable, coded, limited data set, or deidentified)
Data will be shared outside 
4=K
*G
Section 3.3 Treatment and Clinical Trials
Indicate whether or not each of the following applies to this protocol
3.3a) Includes a 
 component (a research treatment)
treatment
4=K
*G
3.3b) Study is a 
  
clinical trial. Note:  A clinical trial is a research study in which one or more human subjects are 
 (which may include placebo or other control) to evaluate the effects of 
prospectively assigned to one or more interventions
the interventions on biomedical or behavioral health-related outcomes.
4=K
*G
3.3c) Has a data safety monitoring board (
or data safety monitoring committee.
DSMB) 
4=K
*G
3.3d) Has a 
 (but not a DSMB) (this is not the data security plan, it is a safety plan).
data safety monitoring plan
4=K
*G
Section 3.4 Drugs and Devices
Indicate whether or not each of the following applies to this protocol

3.4a) 
 that require 
 action such as an Investigational New Drug (IND) approval or exemption or 510(k) 
Drugs
FDA
approval.
4=K
*G
3.4b) Other drugs, supplement, etc. that
action for inclusion in the study.
 do not require FDA 
4=K
*G
3.4c) Medical 
 IDE approval or waiver
devices requiring FDA
4=K
*G
3.4d)
 medical 
 Other
devices
4=K
*G
Section 3.5 Risk and Hazards
Indicate whether or not each of the following applies to this protocol
3.5a) Study places subjects at 
(do not include risks that are due to standard care)
greater than minimal risk 
4=K
*G
3.5b) Human subjects are exposed to 
 (do not include standard care).
radioisotopes
4=K
*G
3.5c) Subjects have other 
 (e.g., x-rays) (do not include standard clinical use).
radiation exposure
4=K
*G
3.5d) Target population has psychiatric diagnosis or behavioral complaint.
4=K
*G
Section 3.6 Clinical Facilities and Standard Care
Indicate whether or not each of the following applies to this protocol
3.6a) Study 
 (e.g., adds required tests run in the VA lab for study purposes; research procedures 
uses VA clinical services
concurrent with clinical care)
4=K
*G
3.6b) Includes procedures or drugs that will be considered part of standard care.
4=K
*G
3.6c) Involves 
purposes.
lab tests done for research 
4=K
*G
Section 3.7 Subject Expenses and Compensation
Indicate whether or not each of the following applies to this protocol
3.7a) There may be expense or added 
or the subject's insurance.
costs to the subject 
4=K
*G
3.7b) This is a 
 and subjects may be billed for study drugs or procedures.
qualifying cancer treatment trial

4=K
*G
3.7c) This is a cancer treatment trial but 
 for study drugs or procedures.
subjects will not be billed
4=K
*G
3.7d) Subjects will be
(either in cash or other means such as a gift certificate).
 compensated 
4=K
*G
Section 3.8 Subject Activities
Indicate whether or not each of the following applies to this protocol
3.8a) Involves 
 completed by subjects
surveys or questionnaires
4=K
*G
3.8b) Includes the use of 
 such as flyers, advertisements, or letters
recruitment materials
4=K
*G
3.8c) Involves facial 
 or audio or video 
of 
photographs
recordings 
patients
4=K
*G
Section 3.9 Sponsors and Collaboration
Indicate whether or not each of the following applies to this protocol
3.9a) This research is a funded research project (commercial (industry) sponsor, NIH, VA, other).
4=K
*G
3.9b) Other 
is provided (e.g., drugs or supplies).
commercial (industry) non-financial support 
4=K
*G
3.9d) The protocol has 
 involvement (e.g., subjects or funding).
Department of Defense
4=K
*G
3.9c) The PI or other study staff member has a financial interest or other
related to this study.
 real or potential conflict 
4=K
*G
3.9e) This study involves 
research activities (research conducted at other institutions under the authorities or 
c llaborative 
o
approvals of the other institution/s). Note: this may include other VA and/or non-VA institutions, but does not include off-
site VA research.
4=K
*G
Section 4 - Estimated Duration
4) What is the estimated duration of the entire study?  (From IRB approval to IRB closure)
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Section 5 - Lay Language Summary

5) Provide a summary or synopsis of the proposed study using non-technical language (not more than 1 paragraph)
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 Section 6 - Specific Aims
6) Provide a statement of specific aims and 
 that serve as the basis for this protocol.  Emphasize those aspects that 
hypotheses
justify the use of human subjects.
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 Section 7 - Background and Significance
7) Provide a succinct discussion of relevant background information to justify performing the proposed study.
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 Section 9 - Design and Methods
9) Describe the research design and the procedures to be used to accomplish the specific aims of the project.  Provide a precise 
description of the planned data collection (include what systems or databases will be used/accessed to gather data), analysis and 
interpretation.  For chart review studies, include the timeframe of collection.  Address sample size, inclusion of women and 
minorities.  Define in clear terms exactly what will be done to the human subjects.
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 Section 9.8 Questionnaires & Surveys
9.8) Provide the name and a reference for questionnaires/surveys that are standard or identify them here and attach a copy of 
the questionnaire/survey.  Questionnaires or surveys that are not clinical standard references must be uploaded.  Reference the help 
link for additional information related to surveys administered to VA personnel and approved platforms for web-based surveys.
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 Section 9.11 Pictures and Audio/Video Recordings of Patients
9.11) Describe the purpose of photographs (facial), or audio, or video recordings of patients.  Describe whether the recordings 
will contain, or potentially contain, identifiers.  Note: use of photographs or recordings must be covered in the informed consent 
process and documented consent documents (e.g., consent form, information sheets, telephone screen scripts).
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 Section 9.12 Off Station Activities
9.12) Describe each off-station activity including where it occurs, subject involvement, and any additional required protections.  
Note:  if the off-station activity is being conducted under the approval authority of another institution, this is not VA offsite research 
and should be described as collaborative research effort.  Please contact the HRPP office if you have any questions
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 Section 10 - Human Subjects
10) Describe the characteristics of the proposed subject population. Include age, gender, ethnicity, and health status as 
appropriate.  Note: Data about people are still considered “human subjects” by the IRB, so even if you do not intend to contact the 
patients whose charts you will review, you still describe the characteristics related to the subjects whose charts you will review.

Provide inclusion and exclusion criteria as appropriate.  Provide a statement how non pregnancy is confirmed if 
pregnancy is an exclusion criteria.
For multisite studies, provide the total number of subjects from all sites and include description of the local site's role as 
a coordinating center if applicable.
Indicate the number of VA participants to be studied.
Indicate the estimated number of 
 subjects that will fail the screening process, if any.
consented
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Section 10.1 Non-Veteran Subjects
10.1a)  Recruitment of non-Veterans cannot be for the sake of convenience for this study.  Provide the objective and justification 
for the inclusion of non-Veteran subjects.  Identify how the research results will be generalizable to the Veteran population.  
NEW:  ORD now requires completion of a Request to Enroll Non-Veterans form (available in the help section of OnRAMP) for any 
VA studies requesting to enroll non-Veterans.  This form will be reviewed by the local RDC before the application may be considered 
by the IRB.  Complete the form and upload with this submission.  
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Section 10.6 Avoiding coercion of students or employees
10.6) Indicate how coercion of students and/or employees will be avoided:
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Section 11 - Recruitment

11) Describe, step-by-step, the plans for recruitment of subjects (or selection of subjects as in record review). This description 
must include how, when, and where potential subjects are approached as well as procedures for identifying potential 
participants (through medical records, physician referral, third-party sources, etc.).  Include how selection is equitable.  Indicate 
if vulnerability to coercion may be present and if so plans to ensure voluntary participation.
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Section 12 - Informed Consent
12) Indicate whether or not each category of consent is involved in this study:
12a) Will the study team obtain information or biospecimens for the purpose of screening, recruiting, or determining the 
eligibility of prospective subjects without (or prior to) obtaining informed consent of the prospective subject or the 
prospective subject’s LAR?
4=K
*G
12b) 
 informed consent
Signed
4=K
*G
12c) Waiver of documented consent (e.g., 
consent) for all or part of the study.
oral 
4=K
*G
12d) Request for a 
 of consent for all or some study activities.
waiver
4=K
*G
12e) Alteration of 
 of consent.
other required elements
4=K
*G
12f) 
assent to participate (Director approval will be required)
Child 
4=K
*G
12g) Will any language 
 be used by those obtaining consent and understood by the prospective 
other than English
participant or the legally authorized representative?
4=K
*G
12h) 
 to determine if participants have the capacity to consent for themselves.
Decisional Capacity Assessment
4=K
*G
12i) 
 consent (legally authorized representative)
Surrogate
4=K
*G
Section 12.1 Informed Consent Process

12.1a) Will consent be obtained before any study procedures are performed (including screening procedures except screening 
procedures with Consent/HIPAA waiver approval)?
4=K
*G
12.1b) Will the information being communicated to the participant or legally authorized representative during the consent 
process include exculpatory language through which the participant or legally authorized representative is made to waive or 
appear to waive any of the participant’s legal rights or release or appear to release the Researcher, Sponsor, the VA or its agents 
from liability for negligence.
4=K
*G
12.1c) A master list of all VA subjects consented (written or not) under this protocol will be maintained.
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12.1d) Identify the circumstances under which consent will be obtained including where the process will take place; any waiting 
period between describing the research and obtaining consent including sufficient time for the prospective participant to 
consider participation, and any steps taken to minimize the possibility of coercion or undue influence.
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Section 12.4 Waiver of Informed Consent
12.4a) Is it practicable to conduct the research without the waiver or alteration of consent?
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12.4b) Does the research examine public benefit or service programs and is subject to state or local government approval?
4=K
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12.4c) Will the research involve greater than minimal risk?
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12.4d) Will waiving or altering informed consent adversely affect the subjects’ rights and welfare?
4=K
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12.4e) Is it appropriate to provide pertinent information to subjects later BUT this information will NOT be provided?
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12.4f) Identify to what aspects of the study you are requesting a waiver of consent (i.e., full study or specific aspects). Describe 
the waiver or alteration needed and why it can be granted (include why the research is not practical without the waiver or 
alteration and how the waiver enables conducting the study).
Waiver of informed consent or alteration of consent elements may be allowed if the IRB documents these findings and 
approves waiver or alteration.
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Section 12.9 HIPAA Authorization
For each category below, indicate whether or not this study involves the indicated process:
12.9a) 
 HIPAA Authorization.  
Signed
**New Template is available in the  Help section**
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12.9b) HIPAA waiver to cover the entire study
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12.9c) HIPAA waiver for recruitment, screening, and/or for a portion of the study.
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12.9d) HIPAA Authorization or waiver is 
 for some or all of the study subjects (e.g. no health data).
not required
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Section 12.10 HIPAA Waivers and Alterations
12.10a) Describe the purpose/nature of the HIPAA waiver or alteration and list specifically, what identifiers and health 
information are being requested under the waiver/alteration and identify whether the waiver is for access, use, and/or collection 
.
of this information
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12.10b) The proposed access, use, and/or disclosure of PHI involves no more than a minimal risk to the privacy of individuals.
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12.10c) The plan to protect the identifiers from improper use and disclosure is adequate.
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Describe the plan
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12.10d) An adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless 
there is a health or research justification for retaining the identifiers or such retention is otherwise required by law.
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12.10d2) Describe the plan:
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12.10e) By signing this protocol for submission, the PI is providing written assurance that the PHI will not be reused or disclosed 
to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research 
for which the use or disclosure of protected health information would be permitted by the Privacy Rule. 38 U.S.C. 7332 
:  If the waiver of HIPAA authorization is for the use of 38 USC 7332 information (applicable to drug abuse, alcohol 
Information
abuse, HIV infection, and sickle cell anemia records), by signing this protocol for submission the PI is providing written 
assurance that the purpose of the data is to conduct scientific research and that no personnel involved may identify, directly or 
indirectly, any individual patient or subject in any report of such research or otherwise disclose patient or subject identities in 
any manner. (Ref:  38 U.S.C. 7332(b)(2)(B))
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12.10f) The research could not practicably be conducted without the waiver or alteration.
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12.10f2) Describe how the waiver/alteration enables the research to be conducted
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12.10g) The research could not practicably be conducted without access to and use of the PHI.
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12.10g2) Describe why it would be impracticable to conduct this research without the PHI described 12.10a. (v3/8/18)

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 Section 13 - Alternatives to Participation
13) Describe the alternatives to participation in this research study (see  for guidance)
"GJ/L9>>L@=9DL=JF9LAN=LGH9JLA;AH9LAGFAKLGFGLH9JLA;AH9L=AFL@=KLM<Q
 Section 14 - Potential Risks
14) Describe any potential or known risks or discomforts and assess their likelihood and seriousness (see  for guidance)
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 Section 15 - Risk Management
15) Describe the procedures for protecting against or minimizing any potential risks/discomforts, and the adequacy of resources 
for conducting the study and resources participants may need as a consequence of the research.  When applicable, include detail 
of the following safety measures:   
(a) The type of safety information to be collected, including AEs; 
(b) 
Frequency of safety data collection; 
(c) Frequency or periodicity of review of cumulative safety data; 
(d) Statistical tests for analyzing the safety data to determine if harm is occurring; and 
(e) 
Conditions that trigger an immediate suspension of the research.  See  for further 
requirements.
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 Section 17 - Potential Benefits
17) Discuss benefits that may be gained by the subject as well as potential benefits to society in general  (see  for guidance)
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 Section 18 - Risk/Benefit Analysis
18) 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.
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 Section 21 - Responsibilities and Qualifications
Here are the identified study staff members
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21) For each staff member listed above, describe their role and qualifications.  Also indicate which of the study staff are 
authorized to obtain consent, when applicable to the study. 
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 Section 22 - Bibliography
22) List relevant articles that the IRB can use to provide necessary background for the protocol. Do not include an extensive 
NIH-grant-style bibliography.  (Up to 5 recommended, but use more if needed to support the protocol or citations above.)
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 Section 23 - Sponsors and Collaborators
23) Clarify any industry financial or other support (e.g., NIH funds the study or Company X provides the assay kits).Identify 
non-VA Research collaborators and their role in this protocol, including whether or not they have access to subjects or identified 

data.
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 Section 26 - Conflict of Interest
26) Describe any financial interests or other conflicts related to this study:  (see  for instructions on this item)
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 Section 27 - Privacy, Confidentiality, and Information Security
27a) Provide a brief description of how participant privacy and confidentiality will be protected in this study. Describe the 
circumstance under which it may be possible for a research team member to identify subjects and any related protections or 
assurances to prohibit or avoid identification. Describe how the number of people with access to identifiers for research 
purposes is limited in order to protect a participant’s privacy.

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27.b) Entry of a CPRS 
is required when 
Research Informed Consent Note
subjects will be admitted as inpatients or treated as 
for research 
t
an outpatients 
and he study involves research medical care or may affect medical care.
If a Research consent Note is required, then a 
 should also be entered for each procedure or 
Research Progress Note
intervention.
Scanning the Consent and HIPAA Authorization into CPRS is 
.  Linking the Consent to the Research Informed 
not required
Consent Note may be permitted and can be useful for trials involving the Research Pharmacy or when research will be 
performed in conjunction with clinical procedures.
For Non-Veterans, if Research Informed Consent Notes are entered, then the 
 must be scanned into 
NOPP Acknowledgment
the record.  Otherwise a copy of the signed NOPP must be retained with the Investigator's research records and a copy sent 
to the Privacy Officer; see the
 Help for more information.
?
27.b1) Is entry of CPRS notes required based on the above criteria?
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Section 27.1  VA Sensitive Information (VASI)
27.1a) For each type of VASI, indicate all that apply:
Indicate which of the following will be collected/recorded:
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27.1b) Consent Forms and/or HIPAA Authorization
4=K
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27.1c) Images with personal identifiers are used for this study (x-rays, MRI images with patient names, record numbers, dates, 
etc.)?
4=K
*G
27.1d) Photos with faces or audio video recordings are used for this study.
4=K
*G
27.1d1) Identify the device or devices that will be used to take/make the photographs or recordings. 
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27.1d2) Identify where images will be stored (e.g., in the medical record, with study hardcopy records, with study 
electronic VASI records
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9.=K=9J;@
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=FLJ9DAR=<0J9FK;JAHLAGF/=JNA;=K,JG?J9E0/,FQF9E=<AF<ANA<M9DGJDG;9LAGF<AK;MKK=<OADD:=
KLJM;C>JGEL@=L=PLJ=;GJ<LG9NGA<9HGL=FLA9D:J=9;@AF;GF>A<=FLA9DALQ
27.1e) Biological specimens with identifiers are used for this study.
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Section 27.2  Data Collection, Tools, and Resources
27.2a)  Will any specially obtained software be used?
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27.2a1) Describe the software, and identify license requirements and the ownership of the software or license.  Identify on 
what computer/network the software will be used (e.g., VA, VA Research/VMRF, local hard drive) and any data that will 
be stored in temporary files on the computer’s hard drive
3=OADDMK=9K=;MJ=GFDAF=KMJN=QKQKL=EA=
-M9DLJA;KLG;GDD=;L>A=D<FGL=<9L99KO=DD9KKMJN=Q
=D=E=FLK:9K=<GFL@=,.%/)9F<ALK.!%)GML;GE=K0(/LAKG>LO9J=OADD:=MK=<LG9F9DQR=
IM9DAL9LAN=<9L9/L9L99F</,//OADD:=MK=<LG9F9DQR=IM9FLAL9LAN=<9L9
27.2b) Will any mobile devices (laptop, tablet, portable hard-drive, etc.) be used in support of this study?

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27.2b1) Provide details of the device/s.  Indicate whether the device is FIPS 140-2 encryption validated and confirm that 
the device is listed in the VA EIL.  Provide details regarding the nature of the data that will be stored or transmitted on the 
device and confirm whether a copy of all data will be stored on the VA network. 
0@=2=/;J==FAF?HJG?J9EAK9O=::9K=<L=;@FGDG?QL@9L;9F:=9;;=KK=<MKAF?EQ29;;=KKHGJL9D
;J=<=FLA9DK%F<ANA<M9DKAL=KE9Q;@GGK=LGHJGNA<=<=NA;=KKM;@9KA,9<K:9K=<GFL@=AJAEHD=E=FL9LAGF
KLJ9L=?Q0@=K=<=NA;=K9J=FGL;GFKA<=J=<H9JLG>L@=J=K=9J;@ =NA;=KMK=<:Q;DAFA;9DHJG?J9EK9KH9JL
G>JGMLAF=;9J=OADDLJ9FKEAL<9L9MKAF?92K=;MJ=29;;=KKHGJL9D9F<<GFGLKLGJ=<9L9
27.2c) Does the study require use of an electronic data capture system? 
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27.2c1) Provide the web address, details regarding their security features, the nature of the data involved, and the research 
purpose.  Also include a description of how VA retains a copy of the data entered into the system.
0@=2=/;J==FAF?HJG?J9E9DDGOK>GJ<=A<=FLA>A=<=PLJ9;LAGFG><9L9GJA?AF9DDQ;GDD=;L=<>GJ;DAFA;9DMK=
0@AKGHLAGFOADD:=MK=<>GJL@AKHJGLG;GD3@=FL@=<=A<=FLA>A=<=PHGJLGHLAGFAKK=D=;L=<;DAFA;9D<9L99J=
=PHGJL=<<AJ=;LDQAFLG92/GJ)A;JGKG>L!P;=D>GJE9LAF9;;GJ<9F;=OAL@9;;GJ<9F;=OAL@2$$9F<:GGC
HH=F<AP
27.2d) Will any other web-based applications be used (e.g., for recruitment, completing online questionnaires, or processing 
data)?
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27.2d1) Provide the web address, details regarding their security features, the nature of the data involved, and the research 
purpose.  Also include a description of how VA retains a copy of the data generated using these tools.
3=OADDMK=9K=;MJ=29HHJGN=<GFDAF=KMJN=QKQKL=EA=
-M9DLJA;KLG;GDD=;L<9L9>JGEKL9>>
H9JLA;AH9FLK9:GMLAEHD=E=FL9LAGF9F<LG;GDD=;L>A=D<FGL=<9L9DD=D=;LJGFA;<9L9OADD:=KLGJ=<GF9
K=;MJ=J=K=9J;@<JAN=GFGMJ2F=LOGJC
9;;=KKA:D=GFDQLG2J=K=9J;@H=JKGFF=D9KKG;A9L=<OAL@L@=
HJGHGK=<KLM<Q
27.2e)  Will coded data that excludes personal identifiers be used?   Coded data excludes 
HIPAA identifiers (per VHA 
all 
Handbook 1605.1 Appendix B), including dates
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27.2e1) Identify where the code key is stored and in what format (electronic, paper).
"GJKL9>>H9JLA;AH9FL<9L9=D=;LJGFA;J=;GJ<KOADDAF;DM<=9H9KKOGJ<HJGL=;L=<C=QDAFCAF?H9JLA;AH9FL
FME:=JKOAL@KM:B=;LF9E=K
O@A;@OADD:=KLGJ=<K=H9J9L=DQ>JGEL@=<9L9,9H=JJ=;GJ<KOADD:=;G<=<
:QH9JLA;AH9FLFME:=JGFDQ9F<OADDFGLAF;DM<=F9E=KDDH9H=JJ=;GJ<KOADD:=C=HLAFDG;C=<;9:AF=LKAF
9DG;C=<JGGE
!).<9L9OADDFGL:=;G<=<

Section 27.3  Data Sharing and Transportation
27.3a) Does this study involve collecting, sharing or transporting any type of data outside of the local VA?
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27.3b) This study collects VASI outside of VA (i.e., at a non-VA location).
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27.3c) VASI is transported outside of VA for any purpose other than sharing.
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27.3d) PHI may be disclosed to monitoring/auditing agencies by HIPAA Authorization.  Note:  The Research Office must be 
notified when monitors come to audit
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27.3e) Data may be shared with collaborators or others in the conduct of this protocol.
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27.3e1)  Describe the data to be shared or disclosed, the entities to which the data are to be disclosed, how the data are to 
be transmitted, and how the transmitted data will be stored, retained, destroyed, and/or further disclosed and to whom. 
This includes data from individual subjects as well as other data developed during the research such as the analytic data 
and the aggregate data.  For PHI and VASI, indicate the authority/ies permitting the sharing or disclosure of data (HIPAA 
Authorization, Limited Data Set, Data Use Agreement, VA Form 10-5345-Request for and Authorization to Release 
Health Information., etc.).
DAEAL=<<9L9K=LG>!).<9L9;GDD=;L=<>JGEL@=2)=<A;9D.=;GJ<NA9L@=2GJHGJ9L= 9L93=9J@GMK=
OADD:==PLJ9;L=<:Q9G%FN=KLA?9LGJ9L2,ALLK:MJ?9F<HJGNA<=<LG2/ $/J=K=9J;@KL9>>>GJ9F9DQKAK
%FGJ<=JLG>=9KA:DQK@9J=L@AK<9L9
L@=,%9F<@AK9HHJGN=<KLM<QKL9>>9L2/ $/OADD:=?AN=F9;;=KKLG
G%)GJK2,ALLK:MJ?@$=9DL@;9J=/QKL=E
2,$/K=;MJ=DG;9D2K@9J=<KLM<Q>GD<=JAFGJ<=JLG
<AJ=;LDQ9;;=KKKLM<Q<9L9>AD=K;GFL9AFAF?A<=FLA>A=JK>JGEL@9L>GD<=J0@=<9L9:=AF?K@9J=<>JGE2
,ALLK:MJ?@G%OADD:=E9AFL9AF=<AFL@=AJDG;9LAGFGFL@=DG;9D2K@9J=<KLM<Q>GD<=J+FDQ9HHJGN=<
KLM<QKL9>>A<=FLA>A=<:QL@=,%
 J&9E=K,ALLE9F
AF/9F A=?G
OADD9;;=KKL@=E<AJ=;LDQ>JGEL@AK<JAN=
 9L9OADD:=E9AFL9AF=<GFL@=DG;9DK@9J=<KLM<Q>GD<=JMFLAD;GEHAD=<9F<LJ9FK>=JJ=<LG J,ALLE9F
>L=JLJ9FK>=J
2/9F A=?GOADD9KKME=J=KHGFKA:ADALQ>GJE9AFL=F9F;=G>L@=<9L9
9F<DG;9D;GHA=K
KLGJ=<9L2,$/OADD:=<=D=L=<
 9L9;GDD=;L=<>JGEKL9>>H9JLA;AH9FLK=?
AFL=JNA=OKMJN=Q<9L9E9Q:=K@9J=<LG:=9F9DQR=<9F<
AFL=JHJ=L=<OAL@L@=HJ=NAGMKDQDAKL=<;GDD9:GJ9LGJK0@AK<9L9OADD;GFL9AFFGA<=FLA>A=JK9F<OADD:=K=FLNA9
K=;MJ=2=F;JQHL=<=E9AD9F<O@AD=:=AF?9F9DQR=<
OADD:=KLGJ=<GF9H9KKOGJ<HJGL=;L=<;GEHML=J
:QL@=;GDD9:GJ9LGJK

Section 27.4  Research Record Storage and Retention
For each type of record, indicate whether it is collected for this study
27.4a) Hardcopy records/data (includes paper, pictures, film, etc.)
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27.4a1) Identify precisely where hardcopy data will be stored to include physical site, building, and room number, etc.  For 
each location identify whether VASI or non-sensitive information is stored at that location.  For VASI, identify how the 
data is secured. 
$9J<;GHQ<9L9
AF;DM<AF?2/%
OADD:=KLGJ=<AF9DG;C=<;9:AF=LAFL@=,%KDG;C=<G>>A;=:MAD<AF?JGGE
9F<AF9DG;C=<;9:AF=LAFL@=,%KDG;C=<D9:G>>A;=:MAD<AF?JGGE
27.4a2) Are all of the above locations at VA?
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27.4b) Electronic study records (includes computer files, removable disk files, digital files, etc.).
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27.4b1) Identify precisely where 
electronic records/data will be stored to include the full map drive, network 
non-sensitive
location/server name, etc., and a brief description of what data/information is stored at each location.
DDFGF2/%<9L9OADD:=KLGJ=<=D=;LJGFA;9DDQOAL@AFL@=2K=;MJ=F=LOGJCAFL@=,%K2/ $/.<JAN=
>GD<=J.7,%>GD<=JK7,ALLE9F
27.4b2) Identify precisely where 
electronic records/data will be stored to include the full map drive, network location
VASI
/server name, etc., and a brief description of what data/information is stored at each location.
If no VASI is collected or recorded for this study, simply indicate that the “Study does not collect or record VASI”.
DD2/%<9L9A=
F9E=K
=E9AD9<<J=KK=K
L=D=H@GF=>9PFME:=JKOADD:=KLGJ=<=D=;LJGFA;9DDQOAL@AF
L@=2K=;MJ=F=LOGJCAFL@=,%K2/ $/.<JAN=>GD<=J.7,%>GD<=JK7,ALLE9F
27.4b3) Are any of the locations described in 27.4b outside of the VA Secure Network? Note: this includes storage on a 
computer local hard drive.
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	
!*- !/!)/%*)-!,0%-!.*(+'%)!2%/$!*- .*)/-*'$! 0'!"*--!/!)/%*)
*"!'!/-*)%) $- *+4-!*- .*''*2%)#./0 4'*.0-!/$!.!/!(+*--4-!*- .(0./!-!/%)! "*-.%3
4!-.) /$!) !./-*4! *)#!--!/!)/%*)(4!+!-(%//! %"-!,0-! 4*/$!-! !-'-!#0'/%*).*-
-!,0%-!(!)/.%''-!,0%-!(!)/.!"*''*2! %!4!--!/!)/%*)
%OADD9<@=J=LG2$.=;GJ<KGFLJGD/;@=<MD=J=IMAJ=E=FLK

%J=IM=KL9F=P;=HLAGFLG./J=IMAJ=E=FLK
Section 27.5  Additional Privacy or Information Security Details
Provide any other privacy or information security details here.
*
Section 27.6  Attestations
In the event of real or suspected breach of security, the Information Security Officer, Privacy Officer, VA Police (if 
appropriate), and the individual’s supervisor will be notified within one hour of learning of the event.
?J==
 AK9?J==
Study staff will be up to date on any required VHA Privacy Policy and Information Security training or they will not be allowed 
access to VA Sensitive Information.
?J==
 AK9?J==
Access to research sensitive information, if any, will be removed when study personnel are no longer part of the research team.
?J==
 AK9?J==
At least one copy of all study records (whether sensitive or non-sensitive) will be retained under VA control and only destroyed 
in compliance with the approved Records Control Schedule
?J==
 AK9?J==
The VA retains ownership of the research data.  Should the investigator leave the VA, custody of the research records will be 
assigned to another investigator and the Research Service notified in writing, or custody of the research records will be 
transferred to the Research Service.
?J==
 AK9?J==
Section 28 - Protocol Association to New or Existing Project
28) Is this a new R&D Project? Before you go on to complete the 
 (which is used for 
Initial Review Submission Form
attachments), please address the association of this Protocol to an R&D Committee Project.  This Protocol may represent a new 
R&D Project, or it may be an additional Protocol under an existing R&D Project (such as when a single grant supports multiple 
Protocols). Will this Protocol be submitted to the R&D Committee as a new Project?
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The Protocol Application is now complete for a Protocol that will also be a new 
R&D Committee Project.
Next you will go on to the Initial Review Submission Form which is used to package up the 
Protocol Application and any needed attachments and submit them to the IRB.
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