A Remotely Delivered Episodic Future Thinking Intervention to Improve Management of Type 2 Diabetes
Phase: PHASE1
Conditions: Type 2 Diabetes
Sponsor: Virginia Polytechnic Institute and State University

 
 
CARILION CLINIC INSTITUTIONAL REVIEW BOARD 
 
IRB RESEARCH APPLICATION INSTRUCTIONS 
 
NOTE: This is a protected document! Please do not remove protections. 
 
The Carilion Institutional Review Board (IRB) is a committee charged with protecting the rights and 
welfare of human subjects in research. You must submit this application and receive IRB approval if 
you wish to conduct human subjects research at Carilion Clinic, including the Jefferson College of 
Health Sciences, or if you will use Carilion patients or services as part of the research process. The 
entire application must be completed. If you are unsure if your research meets the definition of human 
subjects research, please first visit the IRB website for more information. 
 
Research protocols may be reviewed at convened meetings of the IRB or through a single reviewer 
process involving the IRB Chair and staff. The type of review is determined by the nature of the 
project, the level of potential risk to research subjects, and the characteristics of the subject 
population. The final determination of the type of review applicable to a study is made by the IRB.  
 
 
Full Board Reviews: Greater than minimal risk research requires review at a convened meeting of 
the IRB. Research that involving vulnerable populations, experimental drugs or devices, invasive 
procedures, or deception (e.g., in behavioral research) may also require full board review. A 
schedule of IRB meetings and submission deadlines can be found on the Carilion IRB website.  
 
Full Board submissions should be sent to Meredith Talmadge at 
mttalmadge@carilionclinic.org.  For further information, call 540-853-0728.  
 
 
Exempt and Expedited Reviews: Exempt and Expedited studies involve no more than minimal 
risk to subjects.  Federal regulations define minimal risk as the probability that the magnitude of 
harm or discomfort anticipated in the research are not greater in of themselves than those 
ordinarily encountered in daily life or during the performance of routine physical or psychological 
examinations or tests.  The Carilion IRB must determine whether proposed studies meet the criteria 
for Expedited or Exempt review.  
 
Exempt and Expedited submissions should be sent to Janet McDowell at 
jdmcdowell@carilionclinic.org. For further information, call 540-981-8015. 
 
Signature pages may be sent electronically or faxed to (540) 985-5323. For further 
information call 853-0728.  
 
Note:  Consent Form and Information Sheets should be submitted in Word rather than in 
pdf, as IRB staff may need to make revisions and edits to these documents.  The CV of the 
PI should be sent in a separate electronic document so that IRB staff can file them 
individually in our electronic filing system. 
 
Please do not copy this page when submitting paper copies to the IRB office.

 
Carilion IRB Application 
 
       
- 1 - 
 
(13FEB2018) 
Carilion Clinic Institutional Review Board Application 
 
REGISTRATION WITH DEPARTMENT OF RESEARCH & DEVELOPMENT  
 
Per Institutional Policy, all IRB submissions must include the Research & Development (R&D) 
Authorization letter stating R&D has given you permission to submit to the IRB.  Do you have your 
R&D Letter? 
 
  Yes  (If yes, you MUST attach your R&D letter to this submission.)   
 
  No   (If no, do not submit this IRB application until you have your R&D letter. You may contact R&D at 540-
985-8510 or go to http://insidecarilion.org/hubs/office-sponsored-projects/rd-forms-0.)   
 
FINANCIAL CONFLICT OF INTEREST DISCLOSURE 
 
Per Institutional Policy, all research team members on a funded study must submit a study-specific 
Financial Disclosure form through the Carilion Organizational Integrity and Compliance Office. 
Please contact kecooper1@carilionclinic.org immediately to do so. 
 
*Please note it is the PI’s responsibility to ensure all members of the research team have disclosed any 
financial or other relationships to the funding source.  Failure to do so may be considered serious 
noncompliance and result in study suspension or termination. 
 
 
SECTION I: APPLICATION DATA 
 
Date Completing Form: 3/20/19 
(This date MUST be updated by you each time you make changes to this document to submit to the IRB) 
 
Complete Title of Study: Healthy Habits for Type 2 Diabetes 
 
Research Team (All individuals participating in the conduct of research under the direction of the Carilion 
Principal Investigator, including investigators, coordinators, those obtaining consent, those accessing identifiable 
data, etc.*. If you need additional entries, visit the IRB website Forms page.): 
 
Carilion Principal Investigator: John Epling  
Credentials: MD, MSEd 
Department: Family and Community Medicine 
Inter-office address: 1 Riverside Circle, Suite 102, Roanoke, VA, 24016 
Mailing Address (if external): Same 
 
 
 
 
 
  
Phone: 540-581-0166   
E-mail: jwepling@carilionclinic.org 
 
Fax:        
 
Other Investigator: Warren Bickel      
 
Credentials: PhD 
Role & Responsibilities: Co-Investigator  
 
 
 
 
  
Phone: 540-526-2088   
E-mail: wkbickel@vtc.vt.edu 
 
  
 
Other Investigator: Jeff Stein     
 
 
Credentials: PhD 
Role & Responsibilities: Co-Principal Investigator  
Phone: 540-526-2124   
E-mail: 540-526-2124 
 
  
 
Study Coordinator: Kirstin Gatchalian   
 
Credentials: BS 
Role & Responsibilities: Program Manager 
Phone: 540-526-2071   
E-mail: kmgatch@vtc.vt.edu 
 
  
 
Other Research Team Member: Megan Stuart  
Credentials: MS 
Role & Responsibilities: Coach/Interventionist 
Phone: 540-526-2260   
E-mail: stuartma@vtc.vt.edu 
 
  
 
 
Other Research Team Member: Chesley Ammermann  
Credentials: BS 
Role & Responsibilities: Research Assistant 
Phone: 540-526-2113   
E-mail: chebbie1@vtc.vt.edu 
 
  
 
Other Research Team Member: Gemma Porras  
Credentials: BS 
Role & Responsibilities: Research Assistant 
Phone: 540-526-2237   
E-mail: abrown34@vtc.vt.edu 
 
  
 
Other Research Team Member: Jeremiah Brown  
Credentials: MS. 
Role & Responsibilities: Coach/Interventionist 

 
Carilion IRB Application 
 
       
- 2 - 
 
(13FEB2018) 
Phone: 540-526-2260   
E-mail: jeremiahmbrown@vtc.vt.edu 
 
 
Other Research Team Member: Julia Basso  Credentials: PhD 
Role & Responsibilities: Coach/Interventionist 
Phone: 540-526-2168   
E-mail: jbasso@vtc.vt.edu 
 
 
Other Research Team Member: Hailey Snyder  
Credentials: N/A 
Role & Responsibilities: Undergraduate intern/research assistant 
Phone: N/A  
 
E-mail: haileys19@vt.edu 
 
Other Research Team Member: Drew McCauley  
Credentials: N/A 
Role & Responsibilities: Undergraduate intern/research assistant 
Phone: N/A  
 
E-mail: jd11mcc@vt.edu 
 
Other Research Team Member: Laila Krysta  Credentials: N/A 
Role & Responsibilities: Undergraduate intern/research assistant 
Phone: N/A  
 
E-mail: lailak98@vt.edu 
 
 
 
*If this research involves external collaborators: If non-Carilion affiliates will be obtaining IRB approval through their home 
institution, they should not be listed on this application. If you would like to request that one IRB to defer to another, please 
contact the IRB immediately to discuss the feasibility of this agreement. 
 
Note: All research team members must complete Carilion IRB education requirements before submitting this 
application. Further information regarding education requirements can be found on the Carilion IRB website.  
 
1. Has the Principal Investigator ever had any research suspended or terminated by an IRB? 
 
  Yes          
  No    
 
 If yes, please explain:            
 
2. Has any version of this research protocol ever been submitted to any other IRB? 
 
  Yes          
  No         
 
 If yes, please attach a copy of all IRB correspondence  
     
3. Has the Principal Investigator ever been convicted of a crime, disciplined by a public or private medical 
organization, disciplined by a licensing authority or is the Principal Investigator currently the subject of such a 
proceeding? 
 
  Yes          
  No     
 
 If yes, please explain:            
 
 
4. Have any of the other investigators or study team members ever been convicted of a crime, disciplined by a 
public or private medical organization, disciplined by a licensing authority, or are any currently the subject of 
such a proceeding? 
 
  Yes          
  No     
 
 If yes, please explain:       
   
5. Location of Research: 
 
 
Check the facility where research activities will take place (please check all that apply): 
 
  CRMH 
 
  CNRVMC 
 
  JCHS 
 
  CC Physician’s Office 
  CRCH 
 
  CFMH 
 
  CRMH Rehab          
  Other: Fralin 
Biomedical Research Institute, Corporate Research Center) 
 
 
List all departments within the facility where research activities will take place: Center for 
Transformative Research on Health Behavior (CTRHB) at the Fralin Biomedical 
Research Institute (FBRI); 1 Riverside Circle 
 
Virginia Tech Corporate Research Center; 1715 Pratt Drive, Suite 1000, 
Blacksburg, VA 
6. Collaboration: 

 
Carilion IRB Application 
 
       
- 3 - 
 
(13FEB2018) 
 
 
Will this research involve collaboration with another institution?  
 Yes    
  No 
 
If yes, name the institution(s):  
 
University at Buffalo School of Medicine and Biomedical Sciences, Division of 
Behavioral Medicine, G56 Farber Hall, 3435 Main Street, Buffalo, NY 14214  
 
Dr. Leonard Epstein is a Co-Investigator on the NIH grant. Dr. Epstein will not be 
reviewing identifiable Carilion subject data. No human subject activities will 
occur at the University at Buffalo. 
 
If yes, will the collaborating institution’s IRB also review the study?  
 Yes    
  No 
Note: If the collaborating institution’s IRB has already approved the study, please submit their approval letter with 
this application. 
 
7. Sponsor:  
 
 
Will this research be sponsored by an institution/entity outside of Carilion?   
 Yes    
  No 
 
If yes, name the institution/entity:  National Institute of Nursing Research 
 
8. Funding Source:   If this study is or will be funded, every research team member MUST submit a study-
specific Financial Disclosure form through the Carilion Organizational Integrity and Compliance Office 
immediately. Please contact kecooper1@carilionclinic.org to do so. The IRB application cannot be approved 
until it is determined that there is not conflict, or that the conflict has been disclosed and managed. 
 
  Carilion RAP grant  
  Federal/state agency (specify): National Institute of Nursing Research 
  Other grant (specify):       
  Industry/commercial (specify):       
  Private, non-profit (specify):       
  No funding; equipment, supplies, and/or services will be provided (specify company):       
  No funding; no equipment, supplies, and/or services will be provided 
  Other (specify):       
 
9. Is this the official project of a VTCSOM medical student as required for graduation and has already 
undergone scientific review by VTCSOM? 
 Yes    
  No 
 
10. Anticipated Start Date: 2/2019 
 
11. Estimated Time Needed to Complete Study: 1.5 years 
 
SECTION II: DRUG, DEVICE AND BIOLOGIC STUDIES ONLY 
   
 
    
  N/A 
 
12. What is the name(s) of the drug, device or biologic that will be used in this study:       
 
13. Please attach documentation to confirm FDA approval of this drug, device or biologic. Check one below: 
  Package Insert   
  Printed Information from the FDA website confirming FDA approval 
  Letter from FDA granting approval  
  Not available; FDA has not approved 
 
14. Does the research study involve an Investigational New Drug (IND) or Biologic? An IND number is required if 
a drug or biologic is used in a manner outside the labeling approved by the FDA. 
 
  Yes          
  No         
 
If yes, please provide the IND number assigned by the FDA. If an IND number is not available please 
explain why an IND was not obtained. If you believe the drug is exempt from IND approval, please 
submit an IND Determination form that can be found on the IRB web site. Note: Investigators may be 
asked to have an IND determination application submitted to the FDA. 
 
     
 
15. Does the research involve a device that is being used outside the labeling approved by the FDA? 
 
  Yes          
  No           
 

 
Carilion IRB Application 
 
       
- 4 - 
 
(13FEB2018) 
If yes: 
 
 
Please provide the Investigation Device Exemption (IDE) number provided by the FDA:       
 
Attach one of the following: 
 
     FDA letter granting an IDE 
     A letter from the sponsor or investigator/sponsor stating the study device is non-significant risk  
     A letter explaining why the investigation is exempt from IDE requirements 
 
16. Does this study meet the definition of an Applicable Clinical Trial (ACT) that requires registration on 
ClinicalTrials.gov? Whether yes or no, please complete the ACT Checklist and submit page 1 with your IRB 
application. 
 
  Yes          
  No           
 
SECTION III: STUDY PROTOCOL 
 
 
 
 
 
17. Study Abstract: Provide a brief, non-technical summary of the study, including study purpose and methods. 
 
In this study, we will test whether a remotely delivered episodic future thinking (EFT) 
intervention, combined with dietary and activity coaching, as well as self-monitoring, 
reduces delay discounting and improves weight loss, glycemic control, and other 
health outcomes in patients with poorly controlled type 2 diabetes. Specifically, the 
study is a randomized trial comparing the effects of EFT versus a control condition 
on delay discounting, medication adherence, diet, physical activity, body weight, and 
glycemic control. Outcome measures will be assessed both remotely (e.g., online) 
and in the laboratory. 
18. Background: Summarize background information about the research question(s.)  Tell why the research is 
needed and include the relevance of this research to the contribution of this field of study.  Also, provide 
references to relevant articles in the literature.  (If you have more than 10 references, please submit the list 
of references as a separate attachment.  Otherwise, please insert them here.) 
 
Successful management of type 2 diabetes (T2D) requires a complex repertoire of 
behaviors, including adherence to physician-recommended medication, dietary, and 
exercise regimens (1, 2). Most of these behaviors provide little to no short-term 
benefit and may rather be aversive (e.g., physical exertion and caloric restriction). 
However, treatment adherence provides critical health benefits in the future, allowing 
patients with T2D to halt or reverse disease progression and avoid T2D-related 
complications (e.g., renal disease or diabetic retinopathy). Thus, successful 
management of T2D requires one’s present behavior to be guided by future 
outcomes. Unfortunately, accumulating evidence indicates that individuals with T2D 
and those at risk for this disease rapidly devalue the future (3, 4), a phenomenon 
known as delay discounting). Moreover, within diabetic and prediabetic populations, 
we and others have shown that high rates of delay discounting are associated with 
poor treatment adherence and clinical outcomes (3, 4, 5). These data indicate that 
rapidly devaluing the future likely prevents successful management of T2D through 
a mechanism in which the health benefits of treatment adherence are too delayed to 
motivate present behavior. Thus, we believe delay discounting serves as a 
therapeutic target in T2D, in which improving valuation of the future will improve 
treatment adherence and, in turn, improve health outcomes such as glycemic control 
and body weight. 
 
Episodic future thinking (EFT) is a form of prospection that involves mental 
simulation of events that might occur in one’s future (6). EFT to some extent is an 
innate human ability that guides decision-making (e.g., simulating the experience of 
an upcoming job interview or social event); however, populations who discount the 
future rapidly show deficits in this ability, considering the future infrequently and 

 
Carilion IRB Application 
 
       
- 5 - 
 
(13FEB2018) 
demonstrating low-quality EFT content (e.g., fewer contextual and sensory details). 
Thus, EFT interventions are designed to remediate this deficit and reduce bias 
toward immediate gratification by guiding individuals to both generate high-quality 
EFT content and prompting them to engage in EFT frequently. Prior laboratory-based 
research by the investigative team and others has shown that EFT reduces both 
delay discounting and a wide range of maladaptive health behaviors and outcomes, 
including overeating (7), food purchasing (8), and weight control in overweight and 
obese populations (9).  
 
These therapeutic effects suggest that EFT may be used to reduce the bias for 
immediate gratification observed in T2D, and thus improve valuation of the long-term 
outcomes associated with treatment adherence. However, little research has 
examined the efficacy of EFT in the real world. This gap in knowledge presents a 
challenge to our understanding of the etiology and treatment of this disease. 
Therefore, our goal is to leverage prior extensive research to engage our behavioral 
target, delay discounting, to develop a clinical intervention for T2D. In pursuit of our 
goal, our objective in this study is to develop a practical, remotely delivered EFT 
intervention to improve delay discounting and treatment adherence in T2D and, in so 
doing, improve management of T2D. 
 
Specific Aim 1 will examine the effects of a 4-month, remotely delivered EFT 
intervention on  delay discounting, medication adherence, diet, physical activity, 
body weight, and glycemic control in patients with poorly controlled T2D. All 
participants will receive access to a standard behavioral treatment (BT), including 
lifestyle coaching, dietary and activity education, and  daily self-monitoring. 
Participants assigned to an EFT+BT group will also be asked to generate vivid, 
episodic events and be sent text-based prompts daily to engage in EFT in the natural 
environment with the assistance of a study website. Participants assigned to a BT 
alone group will not receive EFT, but will be asked to access the study website and 
answer questions about their experience with the same frequency as the EFT group 
in order to control for use of the technology, effort, attention, and experimenter 
contact. We will assess outcome measures both during and immediately after the 
intervention, as well as at a 6-month follow-up session (approximately 2 months 
following the end of the intervention). This will allow us to estimate both short- and 
long-term effects changes in behavior, weight, and glycemic control 
 
Specific Aim 2 will examine the acceptability of the remote EFT intervention. In order 
for an intervention to be effective in clinical settings, it should be easy to use and its 
helpfulness should be apparent. Thus, during the trial and follow-up, participants will 
rate all aspects of the interventions along several dimensions, including helpfulness 
and ease of use.  High intervention ratings would suggest that EFT may be 
implemented with high treatment fidelity in clinical settings and is more likely to be 
disseminated among treatment providers and adopted by patients. 
 
References 
1. Knowler, W. C. et al. Reduction in the incidence of type 2 diabetes with lifestyle 
intervention or metformin. N. Engl. J. Med. 346, 393–403 (2002). 
 
2. Tuomilehto, J., Schwarz, P. & Lindström, J. Long-Term Benefits From Lifestyle 
Interventions for Type 2 Diabetes Prevention. Diabetes Care 34, S210–S214 (2011).  
 

 
Carilion IRB Application 
 
       
- 6 - 
 
(13FEB2018) 
3. Amlung, M., Petker, T., Jackson, J. & Balodis, I. Steep discounting of delayed 
monetary and food rewards in obesity: a meta-analysis. Psychological (2016). 
 
4. Reach, G. et al. Patients’ impatience is an independent determinant of poor 
diabetes control. Diabetes Metab. 37, 497–504 (2011). 
 
5. Epstein, L. N. et al. Delay Discounting and Adherence in Adults with Prediabetes. 
Health Psychol. (under review). 
 
6. Atance, C. M. & O’Neill, D. K. Episodic future thinking. Trends Cogn. Sci. 5, 533–
539 (2001). 
 
7. Daniel, T. O., Stanton, C. M. & Epstein, L. H. The future is now: reducing 
impulsivity and energy intake using episodic future thinking. Psychol. Sci. 24, 2339–
2342 (2013). 
 
8. Sze, Y. Y., Stein, J. S., Bickel, W. K., Paluch, R. A. & Epstein, L. H. Bleak Present, 
Bright Future: Online Episodic Future Thinking, Scarcity, Delay Discounting, and 
Food Demand. Clin. Psychol. Sci. 5, 683–697 (2017). 
 
9. Sze, Y. Y., Daniel, T. O., Kilanowski, C. K., Collins, R. L. & Epstein, L. H. Web-Based 
and Mobile Delivery of an Episodic Future Thinking Intervention for Overweight and 
Obese Families: A Feasibility Study. JMIR Mhealth Uhealth 3, e97 (2015).  
19. Objectives: State the research hypothesis or the question that the research will answer. List the research 
objectives and expected outcomes. A primary outcome or objective must be identified. After the 
statement of the primary objective, secondary objectives may be listed. Objectives should be simple and 
specific. 
 
We hypothesize that participants assigned to the EFT group will show reductions in 
delay discounting and glycemic control (primary outcomes), as well as improvements in 
dietary, weight, and glycemic control and medication adherence (secondary outcomes). 
If similar behavioral and health changes are also observed for the BT control group, we 
hypothesize that these changes will be relatively greater for the EFT group. We also 
hypothesize that participants in both groups will rate the intervention as effective and 
easy to use, although participants in the EFT group will rate the intervention as more 
effective.  
 
20. Study Design: Give a description of the research design including use of placebo, randomization and an 
explanation of what is experimental. Include type of study: descriptive, retrospective, cross-sectional, 
longitudinal, prospective observational, pilot, experimental (controlled or non-controlled) or pilot. 
 
This is a randomized control trial in which we randomly and experimentally assign 
participants to either an EFT or control group and examine the impact of that 
assignment on study outcomes. All participants will also receive access to a lifestyle 
intervention, case management, and self-monitoring.  
 
21. Study Population: Describe the subject population, including age, gender, ethnic characteristics and health 
status. State the inclusion/exclusion criteria along with how this was determined, and by whom. Please state 
whether pregnant women, children, or other vulnerable groups will be included or excluded.  Provide 
rationale for using or excluding special populations.  State the number of subjects or subject records 
necessary to complete the research. 
 
We will enroll up to 150 patients with type 2 diabetes (N  = 54, plus addition to 
account for screen failure following an initial screening session, possible dropout, 
etc.). Recruitment will focus on patients who do not adequately control their blood 

 
Carilion IRB Application 
 
       
- 7 - 
 
(13FEB2018) 
sugar because this is the subpopulation of diabetes patients in greatest need of 
intervention. .   
 
Inclusion Criteria:  
- 
age 18 or over 
- 
type 2 diabetes diagnosis 
- 
prescribed or recommended oral glucose-lowering medication for type 2 diabetes 
-    HbA1c level of ~8% or greater 
-    body mass index of 25 or greater 
   
Exclusion criteria  
-   current insulin therapy for type 2 diabetes 
-   history of gestational diabetes 
-   pregnant or lactating (if female), or plans to become pregnant in the next 6 months 
-   not ambulatory  
-   intellectual impairment that would impact treatment adherence or the ability to 
provide informed consent  
-   medical conditions that affect behavioral or medical adherence: Participants 
should not have a medical condition that would limit participation such as 
individuals with medical conditions that may affect their ability to use the computer 
for a prolonged period of time or follow study protocol will also be excluded, current 
diagnosis with an eating disorder or an unmanaged psychiatric disorder 
-   abnormal glucose related to medications (e.g. atypical antipsychotic medications 
or glucocorticoids) 
-   prior participation in similar studies: Individuals who have recently participated in 
a laboratory study using similar methods may also be excluded.   
  
22. Methodology: List all activities or procedures that will be performed (pre-treatment tests and medications, 
tests and medications used during therapy, diagnostic tests, x-rays, lab tests, questionnaires and other forms, 
interviews, chart reviews etc.) Describe how, when and where research activities will be administered and 
analyzed.  Distinguish any standard processes from those that are research.  Please describe 
activities/procedures in a step-by-step chronological order. State the length of time subjects will be in the 
study and the expected amount of time required for each study visit or activity. 
 
Individuals who are likely eligible based on the online screening questionnaire (see 
Appendix A: pre-screening questionnaire) will be invited to attend a lab session. 
After providing informed consent at the lab session, participants' blood HbA1c, 
height, and weight will be measured, as well as provide demographic, health, and 
medication information, and complete delay discounting and food purchase tasks. 
Participants who are verified to be eligible from lab-based and online screening, will 
continue with the remainder of the study and will be randomly assigned to either an 
EFT+BT group or BT control group. Those who are deemed ineligible at this stage 
(e.g., due to low HbA1C) will be provided with prorated compensation and informed 
that they do not qualify.  If participants are determined to be eligible, they will be 
given a detailed orientation of what will be expected of them during the study, 
including tasks they need to complete, recording food consumption and activity 
levels, and frequency of visits to our lab.  
 
Eligible participants will then initiate further study procedures, consisting of: 1) 
laboratory assessment sessions, 2) physical activity assessments, 3) case 
management meetings, 4) daily self-monitoring of diet, weight, and activity, and 5) 
EFT or control engagement.  The intervention will last approximately from Weeks 0-
16, with an additional follow-up assessment at Week 24). 

 
Carilion IRB Application 
 
       
- 8 - 
 
(13FEB2018) 
 
-Laboratory Assessment Sessions (Weeks 0, 8, 16, and 24) 
At assessment sessions, we will collect measures of blood HbA1c, blood pressure, 
height, and weight. Participants will also complete delay discounting tasks, food 
purchase tasks, and complete other study questionnaires (e.g., demographics).  
 
-Physical Activity Assessments (Weeks 0, 8, and 16).  
Participants will be provided with an Actigraph accelerometer for use during the 
study and instructed how to properly wear it. At each assessment (Weeks 0, 6, and 
16), participants will be asked to wear the accelerometer for a continuous 7-day 
period. Although these assessments are scheduled to take place during Weeks 0, 8, 
and 16, the 7-day period may occur during adjacent weeks, in whole or in part, to 
facilitate scheduling. After the 7-day period of Actigraph wear, participants will be 
asked to return the device until the next assessment or at the end of the study.   
 
-24-hour Dietary Recalls (Weeks 0, 8, and 16) 
On three days during approximately the same period that participants wear the 
Actigraph, participants will be asked to complete 24-hour diet recalls using the 
Automated Self-Administered 24-hour Dietary Assessment Tool (ASA-24). 
Participants may complete these recalls online.  
 
-Case management meetings (Weeks 0-16). 
All participants in both groups will  attend weekly (during approximate Weeks 1-8) 
and bi-monthly (during approximate Weeks 8-16) meetings with a case manager. 
These meetings will occur over the phone, unless the participant prefers to visit the 
laboratory.  At these meetings, participants will be provided general information on 
healthy diet, physical activity and medication adherence. Participants will also be 
provided instruction regarding a number of different healthy habits for patients with 
type 2 diabetes, including: 1) The Traffic Light Diet, which utilizes RED, YELLOW, 
and GREEN labels for food to guide participants toward the goal of consuming low 
energy dense, low glycemic, high nutrient dense foods; 2) the Traffic Light Activity 
Program, which also utilizes RED, YELLOW and GREEN labels for different levels of 
caloric expenditure, 3) a variety of behavioral techniques, including meal planning 
and 4) use of EFT or the control condition. Participants will be provided with 
educational reading materials for each of these topics, be asked to read these 
materials in between meetings, and be asked to complete quizzes to assess mastery 
(see Appendix B: Healthy Habits Manual + Quizzes). These materials will most often 
be provided in Qualtrics software, but may also be provided in paper form.  
These meetings will also review information about weight loss and maintenance, 
engage in problem solving for participants who are struggling with behavior change, 
behavior change techniques, and diet and activity self-monitoring, and other topics 
relevant for weight and diet management. The case manager will also provide 
instruction for using either EFT for behavior change for the EFT+BT group, as well 
as how to access the study website for the BT control group. 
 
At the end of the intervention period (approximately Week 16), case management 
meetings will be discontinued. However, participants will retain access to 
educational materials in Qualtrics through Week 24. 
  
-EFT/Control engagement (Weeks 3-16).  

 
Carilion IRB Application 
 
       
- 9 - 
 
(13FEB2018) 
Beginning in Week 2, participants will be randomly assigned to either the EFT+BT or 
BT control groups. Participants in the EFT+BT group will be asked to generate 
episodic cues similar to the tasks used in our previous studies on EFT’s effect 
(Daniel et al., 2013). Participants will list and describe events for different time 
periods. The episodic component of the thinking task will occur while the 
participants are asked to describe what they are imagining about each event (e.g., 
vacations, weddings, parties, health goals, etc.). EFT participants will list positive 
future events they are looking forward to and list events that could happen at 
different general future time points (e.g., 1 month, 2-6 months, 7-12 months). 
Participants will also create text-based cues for each event, which will consist of 
descriptions of the future event (e.g., "In about 6 months, I am attending my sister's 
wedding in Montana. I am enjoying the crisp air and getting to see my family again."). 
In contrast, the BT control group will not generate these events. 
For the remainder of the intervention, participants in both groups will be sent text-
based prompts via cell phone to access the study website (built in Qualtics survey 
software). Once accessed, the study website will guide EFT+BT participants to 
engage in EFT by presenting cues. Brief questions may also be presented asking 
participants to describe their study experience (e.g., "Have you encountered any diet 
or activity challenges today?"). Participants in the BT control group will only be 
prompted to access the study website to answer these questions. 
 
Experimenters will train participants in both groups on how to access the study 
website from their cell phone or alternative internet accessible device (e.g. laptop, 
tablet, desktop computer), as well as how to pay attention to and think about the 
cues, and how to adhere to the study’s expectations for utilizing the cues (EFT+BT 
group only). Participants may be prompted several times a day to access the website 
and, for the EFT+BT group, instructed to use their cues any time that need to, 
especially around eating episodes. 
 
At the end of the intervention period (approximately Week 16), participants will retain 
access to educational and other materials in Qualtrics through Week 24. However, 
participants will not be provided with prompts to access these materials during this 
period and will not be required to use the website. 
 
-Diet, activity, and weight self-monitoring (Weeks 1-16).  
Participants will be taught how to record food, drink, exercise, and at home weight 
measurements in MyFitnessPal (see Appendix C: Study Websites). MyFitnessPal is a 
smartphone and web based app that tracks diet and exercise and can record the 
number of calories, macro and micronutrients consumed. Participants will be asked 
to use MyFitnessPal for self-monitoring throughout the study, recording the amount 
and types of food they eat and activity they engage in, as well as their weights. User 
accounts will be created for participants and will not include any identifying 
information. 
 
At the end of the intervention period (approximately Week 16), participants may 
retain access to MyFitnessPal through Week 24 to continue self-monitoring of diet, 
exercise, and weight. However, participants will not be required to use this software 
during this period.  
 
References 

 
Carilion IRB Application 
 
       
- 10 - 
 
(13FEB2018) 
1. Sze, Yan Yan, Tinuke Oluyomi Daniel, Colleen K. Kilanowski, R. Lorraine Collins, 
and Leonard H. Epstein. "Web-based and mobile delivery of an episodic future 
thinking intervention for overweight and obese families: a feasibility study." JMIR 
mHealth and uHealth 3, no. 4 (2015). 
 
23. Data Collection: Describe below the data collection methods and how data be compiled for assessment. 
Attach a copy of your data collection tool or spreadsheet listing exactly what data is to be gathered during 
this research study.  If all data is retrospective, please state date range from which data will be collected and 
note that data must be in existence at time of submission of this application. 
 
All protected health information will be stored on a password-protected spreadsheet 
on RedCap provided through Carilion Clinic and linked only to subjects through a 
subject ID number.    
 
Additional de-identified study data will be collected and stored using Qualtrics 
survey software. These data will be linked to the participants through their subject ID 
(in RedCap). 
 
These de-identified study data include the following measures, which may also be 
found in the attached appendix (see Appendix D: Study Measures). 
 
--Demographic variables and health behavior data.  Race/ethnicity, household 
income, and educational level will be assessed at baseline using a survey-based 
questionnaire. Participants will also be asked about their health and related 
behaviors (e.g., mental health, medical history, financial behaviors, and food 
consumption.) 
 
--Eating Disorder Diagnostic Scale. This 22-item self-report scale screens for the 
presence and severity of symptoms associated with anorexia nervosa, bulima 
nervosa, and binge-eating disorder assess. Participants who provide scores 
consistent with an eating disorder will be provided with referrals to the National 
Eating Disorder's Helpline (800-941-2237), local resources, and/or will be counseld to 
speak with their personal physician.  
 
--Weight, height, BMI.  Participants’ weight will be assessed using a digital scale.  
Height measurements will also be collected.  On the basis of height and weight, BMI 
is calculated according to the following formula: (BMI=kg/m2).  
 
--Blood HbA1c. Hemoglobin A1c (HbA1c) will be measured using the Alere Affinion 
system. 
 
--Blood Pressure. Blood pressure will be measured in triplicate using an automated 
blood pressure device by trained personnel. The latter two readings will be 
averaged.   
 
--Dietary restraint. Participants will complete the three-item "Dietary Restraint" 
portion of the Three Factor Eating Questionnaire (TFEQ) (Stunkard & Messick, 1985), 
a validated instrument to detect dietary restraint (Allison, Kalinsky, & Gorman, 1992). 
 
--Treatment effectiveness and ease of use.  Participants will rate multiple 
components of the intervention (e.g., EFT prompts, self-monitoring) on dimensions 
of perceived effectiveness and ease of use using 5-point Likert scales.   

 
Carilion IRB Application 
 
       
- 11 - 
 
(13FEB2018) 
 
--Delay discounting. Participants will complete hypothetical delay discounting tasks 
for different commodities (e.g. delayed money, weight loss). These tasks assess 
preference between a small, immediately available reward (e.g., $50 now) and a 
larger, delayed reward (e.g., $100 in 6 months) across multiple trials and delays (e.g., 
1 day through 25 years). This task reveals how the subjective value of a reward 
decreases with increases delay. The steepness of the discounting curve, estimated  
by the parameter k, provides a measure of delay discounting.  
 
--Medication adherence. Adherence to oral glucose-lowering medication (e.g., 
Metformin) will be assessed by both a self-report questionnaire and by direct 
observation (pill count). In the self-report questionnaire, participants will complete a 
questionnaire in which they report how often they have taken their prescribed 
medication in the recent past. In the direct observation assessment, participants will 
be asked to bring their prescription bottles to both baseline and follow-up visits. 
Remaining pills will be counted and medication adherence will be calculated as: 
(quantity dispensed – remaining)/(quantity prescribed per day * days since last 
refill))*100, yielding a measure of percent adherence.   
 
--Relative reinforcing efficacy of food. Hypothetical food purchase tasks will assess 
the relative reinforcing efficacy of a range of foods. In this task, participants report 
the hypothetical quantity of foods they would purchase to consume across a range 
of prices (e.g., $0.01 - $30 per serving). 
 
--Dietary intake. Diet will be assessed by self-reporting using the Automated Self-
Administered 24-hour Dietary Assessment Tool (ASA-24) 
 
--Corsi block tapping task. In this test of working memory, blocks are presented on a 
computer screen, which light up one at a time in random order and in sequences of 
increasing length. After each presentation, participants attempt to reproduce the 
patterns shown. 
 
--Physical activity. Physical activity will be measured using an Actigraph 
accelerometer.  Participants will complete three Actigraph assessments during the 
study, with each assessment lasting 7 days. Total activity counts and activity in the 
moderate to vigorous (MVPA) and vigorous (VPA) ranges, among other measures, 
will be estimated.  
 
--Patient Health Questionnaire. This questionnaire assesses frequency of depressive 
symptoms. 
 
 
24. Statistical Analysis: State how qualitative and/or quantitative data will be analyzed. This must include a 
statement from a statistician that there is sufficient power to determine the primary study outcome or 
objective. Other outcomes may be listed as secondary and descriptive. If this is a proof of concept or 
feasibility study that includes limited efficacy testing, there must be a statistician statement that the 
appropriate design is in place to determine whether an intervention should be recommended for broader 
efficacy testing. If a study is meant to be solely descriptive, then results apply only to the sample being 
studied and conclusions cannot be drawn about the larger population; therefore, the primary outcome or 
objective must be limited in scope. 
 
 
Sample size justification:  

 
Carilion IRB Application 
 
       
- 12 - 
 
(13FEB2018) 
 
We propose a total sample size N = 54 completed participants. To estimate an effect 
size for this study, we examined multiple prior data sets. First, our prior laboratory-
based data on effects of EFT on delay discounting and ad-libitum food intake and on 
effects of remotely delivered EFT on dietary intake and BMI revealed generally 
“large” effect sizes (f > .40). However, due to the uncertainty with which similarly 
large effect sizes would be observed for each of the broad range of additional 
measures used in the present study (e.g., medication adherence), we chose to power 
the proposed study for a more conservative, “medium” effect size of f = .25. Using 
this effect size, our power analysis indicated 54 total participants would be required 
based on an ANOVA model with group (EFT/control) as a between-subjects factor, 
time as a within-subjects factor, as well a group x time interaction. This analysis was 
performed in G*Power 3.1, a type 1 error rate of α = 0.05, correlation between 
repeated measures of .50, 95% statistical power. This provides 95% power to detect 
effects of EFT on lab-based measures assessed at baseline and follow-up 
assessments (e.g., HbA1c, BMI).  
 
Data analysis: 
We will use repeated measures ANOVA to examine changes in delay discounting, 
glycemic control, dietary intake, physical activity, medication adherence, BMI, and 
body composition (Specific Aim 1), as well as acceptability of the intervention 
(Specific Aim 2) in subjects who are randomly assigned to EFT and control 
conditions. Covariates will be included, as appropriate, including gender and 
socioeconomic status.  
We will test for attrition bias by comparing participants who drop out versus those 
who complete the study. We will use intention to treat methods, and include all 
randomized subjects. We have a rigorous retention plan but expect up to 15% 
attrition. We will use maximum likelihood-based procedures to impute missing data. 
This approach is associated with more accurate parameter estimates than other 
approaches (e.g., last-observation carried forward), and is appropriate even when 
missing data are not missing at random 
 
Statistical review was conducted by: Jeff Stein, PhD  (name of statistician)   
 
 
   
 
 
Fralin Biomedical Research Institute  (Department/Institution 
of statistician) 
If no statistical review was done, explain why:       
 
SECTION IV: RISKS AND BENEFITS 
 
25. Summarize the possible risks to subjects and how they have been minimized in the study design. Include risk 
of psychosocial harm (e.g., emotional distress, embarrassment, breach of confidentiality), economic harm 
(e.g., loss of employment or insurability, loss of professional standing or reputation, loss of standing within 
the community) and legal jeopardy (e.g., disclosure of illegal activity or negligence), as well as known side 
effects of study medication, if applicable, and risk of pain and physical injury. Define the level of risk (minimal 
risk, risk but with potential benefit to patient, risk but no benefit to patient). Describe any procedures that will 
be used to prevent or minimize risks or discomforts. Note: Most studies create at least a small risk of breach 
of confidentiality or privacy. 
 
Overall, the risks of study participation are minimal. Participants will be informed of 
the risks associated with the study.   
 
In subjects who are enrolled with an A1c between ~8% and 9.9%, an A1c over 10% 
will trigger a notification of their physician or appropriate medical referral.  In 

 
Carilion IRB Application 
 
       
- 13 - 
 
(13FEB2018) 
subjects who are enrolled with an A1c >= 10%, any 1 percentage point increase over 
baseline will trigger a notification of their physician or appropriate medical referral. 
 
Participants will be free to withdraw from the study at any time, and their refusal to 
continue will not affect other medical care provided at any healthcare facility.  
 
Participants might feel uncomfortable disclosing some personal information such as 
medical history. Participants might experience adverse effects associated with 
changes in diet, including feeling hungry, fatigue, or headache. 
 
Participants may, if they are on sulfonylurea or glinide medications, experience 
symptoms associated with hypoglycemia.  Given that insulin use is an exclusion for 
this study, this is likely to be an uncommon and mild clinical issue.  Participants will 
be instructed to discuss the possibility of hypoglycemia with their treating physician 
and the case managers will educate participants about hypoglycemic reactions and 
advise those on hypoglycemic medications to carry an additional source of ready 
sugar. 
 
Participants may experience possible discomfort from blood glucose testing (e.g, 
momentary pain, skin irritation).    
 
To protect confidentiality, we will use only ID numbers and keep all data in in locked 
offices and/or password-protected databases. Any data sharing between sites will 
involve de-identified data only and files will be encrypted or password protected. 
These screening, monitoring, and confidentiality procedures have been in effect for 
more than 15 years and for more than 2,000 subjects across the various protocols 
employed by our group.  
26. Describe all costs, if any, subjects may incur as a result of being in this study. 
 
Costs to the patient include required to travel to the FBRI or CRC sites where 
participants will complete assessment sessions. However, the compensation 
provided for participation should adequately cover these costs, including a bonus 
for completing this 6-month study. The intervention itself has been designed to be 
remotely delivered and, thus, pose minimal costs. 
 
27. Describe how subjects will be compensated for injury incurred as a result of being in the study. 
 
Subjects will not be compensated if they are in some way injured because of 
participation in this study.  
 
28. Is any deception used in the study or any aspect of the study kept secret from the subjects, such as the full 
purpose of the study? 
 
  Yes          
  No           
 
 
If yes, describe the deception involved and the debriefing procedures:       
 
29. Describe any direct benefit to individual subjects, to the group of individuals with the disease process you are 
researching, and/or to society based on scientific knowledge gained. Explain how the potential benefits 
offered by this research outweigh the risks. (Please note: payments, gifts, or other free services given as a 
token for participation are not benefits, but instead are classified as compensation.) 
 
Participants may benefit from possible weight loss and improved glycemic control.    
 
SECTION V: RECRUITMENT 
 
30. Number of Subjects/Enrollment Goal. The enrollment goal must match the number of subjects needed to 
meet the primary outcome.  If this is a retrospective record review, this figure is the number of records that 
will be used for analysis. Prior IRB approval must be given to exceed the enrollment goal. 

 
Carilion IRB Application 
 
       
- 14 - 
 
(13FEB2018) 
 
Locally:  Up to 150 enrolled, (N = 54 target completion goal, plus additional if 
necessary to account for possible dropout, screen failure, etc.)    At all Sites:  up to 150 
 
***If this study is a retrospective record review only, you may skip to Section VII*** 
 
31. Will subjects receive any compensation or gifts to participate? 
 
  Yes         
  No          
  N/A 
 
 
If yes, specify payment amount, how it will be prorated and how payment will be made: Participants 
may receive up to $300 for completion of all study procedures, as follows. 
 
 
Assessment Session 1 (Week 0): $20 
 
Assessment Session 2 (Week 8): $30 
 
Assessment Session 3 (Week 16): $35 
 
Assessment Session 4 (Week 24 follow-up, post-intervention): $40 
 
Physical Activity and Diet Assessments 1-3 (Weeks 0, 8, and 16): $20 per 
assessment week ($60 total possible). These will occur outside the laboratory. At 
each assessment, participants will be asked to wear the Actigraph accelerometer 
to measure physical activity for a period of seven days. On three of those days, 
participants will also be asked to complete the ASA-24 dietary recall 
questionnaire online. 
 
Brief Online Assessments (Weeks 3, 9, and 15). $5 per assessment ($15 total 
possible). Participants will be asked to complete brief online assessments (e.g., 
delay discounting, food purchasing) outside of the laboratory. EFT+BT 
participants will also be asked to complete an EFT event/cue-generation exercise. 
 
Participants will also receive an additional bonus at Week 24 of $100 for 
completing 90% or more of all assessment sessions and at-home assessments 
(Actigraph, brief online assessments, and diet recalls).  The magnitude of this 
bonus was chosen in order to motivate attendance at the follow-up assessments 
for the majority of participants and thus minimize the occurrence of missing data, 
including from those participants who may have been less successful in the 
intervention or follow-up period. 
 
To allow for payments that are both convenient and rapidly available, we may pay 
participants with reloadable prepaid cards through Greenphire ClinCard 
(www.greenphire.com), an FDIC-insured payment provider that specializes in 
clinical trial stipend payments that comply with IRB privacy regulations and 
considerations. At the beginning of the study, the participant will receive a 
prepaid MasterCard debit card that can be used anywhere that accepts 
MasterCard. As payments are earned in the course of the study, additional funds 
will be added to the account for that participant. Funds are immediately available 
when added and participants can check their balance as desired. This system will 
allow frequent, immediately available payments. Payments may also be made via 
check or cash, however remote debit card payments and checks will be used 
most often. 
 
Compensation will be prorated.  
 
To minimize barriers to participation, participants may also be provided with  
travel compensation in addition to the amounts above if they live outside of 
Roanoke or if travel to FBRI from within Roanoke is prohibitive to participation. 
Travel compensation, if provided, will be calculated using an hourly rate equal to 
the US minimum wage. 
 
32. Will you, the sponsor, or Contract Research Organization offer any fee to physicians for the referral of 
potential subjects? 

 
Carilion IRB Application 
 
       
- 15 - 
 
(13FEB2018) 
 
  Yes          
  No 
 
33. Will recruitment materials be used? 
 
  Yes          
  No           
 
If yes, check all that apply and include with this submission: 
 
  Brochure 
 
 
 
  Radio/Television script 
 
 
  E-mail   
 
 
 
  Newspaper Ad 
 
  Recruitment letter 
 
 
  Website advertisement (including Facebook, Craigslist, etc.) 
  Flyer/Poster 
 
 
 
  Telephone or in-person script 
  Clinical trial website posting 
 
  Other (please specify): Roanoke Valley Metro bus 
 
STEP 1: IDENTIFICATION OF POTENTIAL SUBJECTS  
To “identify” a potential subject refers to steps you plan to take to determine which individuals may qualify to 
participate in your study so that you can decide which individuals to contact about taking part. 
 
34. How do you plan to identify potential subjects? (check all that apply) 
 
  Medical Chart Review, Clinic Schedule Review, or QA-QI Database Review (own patient population) 
 
*Study team requests Waiver of Informed Consent and, if any HIPAA identifiers are collected, a Waiver of  
 
HIPAA Authorization for recruitment purposes 
 Medical Chart Review, Clinic Schedule Review, or QA-QI Database Review (other physicians/practices 
 
patient population) 
 
*Study team requests Waiver of Informed Consent/HIPAA Authorization for recruitment purposes 
 Potential subjects will not be directly identified by the researchers.  The potential subject will obtain IRB-
 
approved written information about the study from his or her health care provider/faculty or from an 
 
advertisement, flyer, brochure, website, etc.   The potential subject would then contact the researcher if 
 
he or she is interested. 
 Researchers who ARE NOT treating clinicians of potential subjects will ask treating clinicians for referrals 
 
of eligible patients interested in the study.  Treating clinicians identify potentially eligible patients and 
 
provide researchers with patient contact information with patient permission documented (e.g. 
 
email/letter to researcher from treating clinician states patient permission given. Researcher documents 
 
permission in research record.) 
 
*Study team requests Waiver of Informed Consent/HIPAA Authorization for recruitment purposes 
  Contact information will be provided by a patient’s Carilion health care provider without the patient’s 
 
knowledge to the researchers AND this is a minimal risk study that does not involve investigative drugs, 
 
devices, biologics or medical or surgical procedures.  
 
*Study team requests Waiver of Informed Consent /HIPAA Authorization for recruitment purposes 
 Review of Registry/Database in which individuals have previously signed a consent giving their permission 
 
to be contacted for future studies 
 Student Records 
 
*Study team requests Waiver of Informed Consent for recruitment purposes 
 Other – please explain:       
 
35. Please describe the identification process. List all information you plan to collect during the identification 
process prior to contacting potential subjects. This includes the inclusion/exclusion criteria and demographics 
to determine if a person qualifies for a study before contacting that person to be a potential subject. 
 
Carilion Clinic personnel will conduct a data pull of potentially eligible patients from participating 
Carilion Family and Community Medicine clinics in the greater Roanoke Metropolitan area. An 
additional data pill may also include the New River Valley area. Data pulls will use the inclusion criteria 
of age≥ 18, and may include BMI,  HbA1c, prescribed glucose-lowering medications, as well as ICD-10 
code for type 2 diabetes. The corresponding ICD-9 codes may also be used due to the transition from 
ICD-9 to ICD-10. Carilion Family and Community Medicine physicians will have an opportunity to 
review a list of their patients who have been identified as potentially eligible for this study at each data 
pull. These physicians will be able to request removal of any patient from the recruitment process. The 
data pull will use the exclusion criteria of no telephone number and patient stipulation of “Do Not 
Contact” as indicated in the medical record. The data pull will result in a list of potentially eligible 
patients, which will be provided to the PI. Identifying information in the data pull will consist of 
potentially eligible patients’ names, addresses, and phone numbers. { 
 

 
Carilion IRB Application 
 
       
- 16 - 
 
(13FEB2018) 
36. Who will conduct the identification process? 
 
 Principal investigator 
  Other investigator (specify):       
  Research coordinator (specify): . 
  Other research team member (specify): Health Analytics  
 
STEP 2: CONTACTING OF POTENTIAL SUBJECTS 
To “contact” a potential subject refers to the initial contact method you plan to use to reach a potential subject to 
determine if he or she would be interested in taking part in your study. 
 
37. How will potential subjects be contacted? (please check all that apply) 
 
  Direct in-person contact    
  Telephone call  
  Letter  
 E-mail 
 Potential subject will not be contacted.  Potential subject will contact the researchers by responding to a 
 
flyer, brochure, e-mail, etc.) (Please skip to #39.) 
 
38. Who will contact the potential subject?  (please check all that apply and ensure they are listed as a member 
of the study team) 
 
 Principal investigator 
  Other investigator (specify names): Jeff Stein  
  Research coordinator (specify names):   
  Other research team member (specify names): Megan Stuart, Chesley Ammermann, Gemma 
Porras, Jeremiah Brown, Julia Basso 
 
39. If potential subjects are patients of Carilion Clinic, please check the appropriate scenario: 
 
  Patients will be contacted by the researcher who is also the treating clinician or by a member   
of his/her treatment personnel or by his/her Carilion research personnel. Potential subjects will be  
      assured that their decision will not affect their treatment or care or relationship with the treating clinician.  
    *Submit letter, email, or phone script (if applicable) using appropriate IRB template. 
 
  Patients will be contacted by their treating clinician who is not the researcher by letter with 
 
information about the research study.   * Submit letter using appropriate IRB template.  
 
Check all that apply: 
   The letter will be co-signed by the principal investigator and sent by the research team. 
 
*Study team requests Waiver of Informed Consent/HIPAA Authorization for recruitment 
purposes 
   The letter will indicate that the patient will be called by researchers to discuss study.  The 
letter will include a telephone number to call or post card to return to indicate patient does 
not want to be contacted. *Submit phone recruitment script.   
   The research involves the collection of sensitive information (e.g. illegal behavior, drug, or 
alcohol use; mental illness; sexual behavior.)  The letter will include a telephone number to 
call or post card to return if patient is interested in learning more.  Patient will not be 
contacted until he/she calls or returns post card. 
 
  Researchers who ARE NOT treating clinicians of patients will contact patients: 
 
 after patients have given permission to a treating clinician to share contact information with 
the research team and permission is documented   
 without the patients’ prior permission AND this is a minimal risk study that does not involve 
investigative drugs, biologics or surgical procedures. Check one: 
 Contact will be via letter, phone, direct-email. *Submit letter, email, phone script using the 
appropriate IRB template.  
 Potential subjects will be approached in person while at a Carilion Clinic hospital or clinic. 
 
*Submit recruitment script using the appropriate IRB template. 
 

 
Carilion IRB Application 
 
       
- 17 - 
 
(13FEB2018) 
40. Describe what will be said to potential subjects to introduce them to the research. If an investigator has 
direct authority over potential subjects who are students, medical residents or employees, then explain how 
recruitment will avoid undue influence. For example, someone from the research team who does not have 
direct authority will make the initial contact OR potential subjects will be assured a decision not to participate 
in the research will not affect grades or job evaluations. Submit any letter, email, phone or other recruitment 
script that will be used. 
 
Please see attached recruitment letter. 
 
STEP 3: SCREENING OF POTENTIAL SUBJECTS   
To “screen” a potential subject refers to additional information that will be collected or activities that will take 
place after he or she has been identified and contacted and prior to obtaining informed consent for the study.  
This could include asking questions to a potential subject to determine whether he or she meets eligibility criteria. 
Note: To comply with HIPAA regulations, only the minimum necessary protected health information may be 
collected at this time. This means only questions relating to the inclusion and exclusion criteria may be asked. 
 
41. Please describe the screening process for your study. Please include whether you plan to ask potential 
subjects to do anything or answer questions prior to signing an informed consent document. For example: 
patients will answer questions about their medical history, be expected to come to the first screening visit 
after fasting, stop taking medications, change diet, etc.    
 
The screening process will occur via a website or in person. The screening will ask 
about age, gender, pregnancy status, and other demographic and health information 
related to inclusion/exclusion criteria. Patients will be scheduled for an informed 
consent session that will require no change in routine behavior.  
 
Potential participants will be asked to provide a unique study code during screening 
so that PHI is not collected/stored in the same database as their answers to 
screening questions. Study personnel will inform participants that the screening 
information they provide will be kept confidential and not shared with anyone 
outside of the study team. 
 
Screening data will be collected online using RedCAP (for PHI) and Qualtrics. Stored 
screening data will not include any HIPAA identifiers. Names and other identifying 
information of patients identified through query of Carilion Medical Records will be 
stored in a secure share on a Carilion portal/server. 
 
Carilion patients will be recruited through direct mailings, including a link to the 
screening questionnaire, to adults 18 years and older. Interested participants will 
additionally be screened in person to ensure they meet the inclusion criteria as 
previously described.   
 
In addition, participants will be recruited through flyers posted in Carilion Clinics 
and other places in the community, such as at health and wellness centers and fairs, 
schools, libraries, coffee shops, stores, restaurants, etc. People who are interested 
in the study will contact our research center via phone or email or in person, or 
access the screening questionnaire directly.   
 
 N/A (If N/A, please skip to Section VI) 
 
42. Who will conduct the screening? 
 
 Principal investigator 
  Other investigator (specify):   
  Research coordinator (specify):   
  Other research team member (specify): Megan Stuart, Chesley Ammermann, Gemma 
Porras, Jeremiah Brown, Julia Basso 
 

 
Carilion IRB Application 
 
       
- 18 - 
 
(13FEB2018) 
43. List all information you plan to record during the screening process. (Attach screening data collection tool or 
an inclusion/exclusion checklist.)  *Study team requests Waiver of Informed Consent and, if any HIPAA 
identifiers are collected, a Waiver of HIPAA Authorization for recruitment purposes. 
 
Please see attached screening questionnaire 
 
SECTION VI: STUDY POPULATIONS 
 
44. Does the research involve intervention or interaction with individuals? (Examples include physical procedures, 
written or verbal communication with individuals, or surveys.) 
 
  Yes          
  No    
 
***If no, you may skip the remainder of this section and go directly to Section VII***         
 
45. Which vulnerable populations may be included in this study? Check all that apply: 
  Children/Minors (less than 18 years old) 
  Wards of State 
  Pregnant women 
 
 
  
  Fetuses 
 
  Neonates of uncertain viability OR non-viable neonates 
  Prisoners (Please contact IRB prior to submission of application.) 
  Mentally disabled persons* 
  Cognitively impaired persons* 
  Limited or non-readers 
  Non-English speakers (You must use either a translated consent form or short form. Contact IRB office.) 
  Economically disadvantaged persons 
 Educationally disadvantaged persons 
  Employees under the investigator’s supervision or authority 
  Students under the investigator’s supervision or authority 
  Patients in emergency situations 
 
 
 
 
  Terminally ill patients 
  Others that may be vulnerable to coercion:       
 
*If persons are without decision making capacity, please submit a Legally Authorized Representative 
Investigator Assurance Form.  This form is located on the IRB website. 
 
46. If persons in any of the vulnerable groups checked above will be enrolled into this study, please explain the 
additional safeguards that will be used to protect the rights and welfare of those subjects.  Check all that 
apply: 
  For economically disadvantaged subjects, there will be no financial screening of potential subjects and 
 
any eligible patient will be allowed to enroll regardless of financial standing or insurance status.   
  For educationally disadvantaged subjects, additional time will be spent with them to ensure their 
 
understanding of the research participation by answering questions and clarifying any issues.  The 
 
consent form will be read to them if necessary. 
  For limited or non-readers, the consent will be read to them and additional time will be spent with them 
 
to ensure their understanding of the research participation by answering questions and clarifying any 
 
issues.  This process and the subject’s signature will be witnessed by someone who is not part of the 
 
research team. 
  For students, medical residents, or employees under investigator’s authority, an investigator, research 
 
coordinator, or other member of the research team that does not have direct authority over the students 
 
or employees will obtain informed consent.  
  Other (specify):       
 
 
47. If this research does not exclude children, please assess the level of risk involved (check only one): 
 
  N/A 
  Minimal risk (no greater than those ordinarily encountered in daily life or during the performance of 
 
routine physical or psychological examinations) 
  Greater than minimal risk but has potential benefit 
  Greater than minimal risk but no foreseen benefit 
 

 
Carilion IRB Application 
 
       
- 19 - 
 
(13FEB2018) 
48. For research involving children, will an assent form be used? Assent is not required if the intervention or 
procedure involved in the research holds out a prospect of direct benefit that is important to the health or 
well-being of the child and is available only in the context of research.  Please note: if the child is <7 years of 
age, a discussion is not required. 
 
  Yes          
  No          
  N/A 
 
49. Do you request a waiver of assent? 
 
  Yes          
  No          
  N/A 
 
If yes, please justify:       
 
50. Does the research exclude pregnant women?     
  Yes          
  No 
 
If you marked No above, then please affirm the following by marking each box: 
 
  Preclinical studies and clinical studies have been conducted and provide data for assessing potential risks 
 
to pregnant women and fetuses, or it is not scientifically appropriate to do this. 
  The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct 
 
benefit for the woman and/or fetus; or, if there is no such prospect of benefit, the risk to the fetus is 
 
minimal and the purpose of the research is the development of important biomedical knowledge which 
 
cannot be obtained by any other means. 
  Any risk is the least possible for achieving the objectives of the research. 
  The research holds out the prospect of direct benefit to the pregnant woman and/or fetus, or no benefit 
 
for the woman nor fetus and risk to the fetus is minimal and the purpose of the research is the 
 
development of important biomedical knowledge that cannot be obtained by any other means. 
  Each individual providing consent will be fully informed regarding the reasonably foreseeable impact of 
 
the research on the fetus or neonate. 
  No inducements, monetary or otherwise, will be offered to terminate a pregnancy. 
  Individuals engaged in the research will have no part in any decisions as to the timing, method or 
 
procedures used to terminate a pregnancy. 
  Individuals engaged in the research will have no part in determining the viability of a neonate. 
 
Please affirm the following by marking each box if they apply to your research: 
 
  If the research holds out the prospect of direct benefit solely to the fetus, then the consent of the 
 
pregnant woman and the father will be obtained (father’s consent need not be obtained if he is 
 
unavailable, incompetent, or temporarily incapacitated; or the pregnancy resulted from rape or incest). 
  For children who are pregnant, assent and permission will be obtained. 
 
51. If you plan to enroll subjects that may be cognitively impaired, describe how you plan to assess decision 
making capacity prior to consent: N/A 
 
 
Will consent be obtained from a surrogate decision-maker for incompetent subjects? 
 
  Yes          
  No 
 
 
For guidance on required elements for a Carilion informed consent document, please visit the Carilion IRB 
website; see New Submissions, Section 2, Informed Consent Guidelines.  
 
52. Are you planning to obtain written (signed) informed consent from subjects for this research? 
 
  Yes, I am planning to obtain consent and signature using a consent form (If yes, please skip to #54)    
  No, I am planning to obtain consent without a signature using an information sheet (Please go to #53) 
  No, I am planning to obtain only verbal consent (Please go to #53) 
  No, I am requesting a Waiver of Informed Consent (Please skip to #61) 
 
Waiver of the Requirement to Obtain Signed Consent 
 
53. Please answer the following questions to request a Waiver of the Requirement to Obtain Signed Consent: 
 
SECTION VII: INFORMED CONSENT 

 
Carilion IRB Application 
 
       
- 20 - 
 
(13FEB2018) 
 Is the informed consent document the only record linking the subject and the research, and is the 
principal risk the potential harm resulting from a breach of confidentiality?   
 
  Yes          
  No   
 
If yes, you must ask the participant if they want documentation linking them to the research, and the 
subject’s wishes shall govern.         
 
 Does the research involve greater than minimal risk or any procedure for which written consent is 
normally required outside of the research context? 
 
  Yes          
  No 
 
 
Will you provide the subject with a written statement regarding the research? 
  Yes          
  No 
 
 
Are the subjects or their legally authorized representatives members of a distinct cultural group or 
community in which signing forms is not the norm, and is there is an appropriate alternative mechanism 
for documenting that informed consent was obtained? 
  Yes          
  No 
 
 
54. Describe the process of obtaining informed consent, parental permission, and/or assent from the subject in 
detail (ex: who, when, where, how), and how this process will be documented. 
Patients interested in participating will be provided with the written consent form during 
their scheduled visit to the FBRI or CRC.  They will also be given time in a quiet room in 
the laboratory to read and consider the form. Consenting personnel will review each 
element of the written consent form with the potential participant. The potential 
participant will be given the opportunity to ask questions and will have as much time as 
they need to decide whether they would like to participate in the study. They will be 
encouraged to speak with whomever they wish before making this decision. Personnel 
will reiterate that the patient may choose to decline participation in the study at that 
time or at any time thereafter without consequence. The potential participant and 
person obtaining consent will sign the consent form after the potential participant 
verbally states that s/he understands the conditions of the study. Patients will also be 
offered the opportunity to take home the consent form, consider it more carefully, and 
provide informed consent (if they choose) at a later date. 
 
 
55. Who will conduct the consent discussion with the subject? (Check all that apply): 
 
 Principal investigator 
  Other investigator (specify): Jeff Stein, PhD 
  Research coordinator (specify):   
  Other research team member (specify): Megan Stuart, Chesley Ammermann, Gemma 
Porras, Jeremiah Brown, Julia Basso 
  For Survey Studies only:  Information sheet will be mailed and no discussion will take place 
 
56. Will a student (VTCSOM, Jefferson College, other college or university) be obtaining consent from subjects? 
(This does not include questionnaire or survey studies.) 
 
  Yes          
  No 
 
If yes, then the Principal Investigator must sign an attestation of training at the end of this form. 
 
57. Where will informed consent process take place: 
 
 In a private room 
 In a waiting room 
  In an open ward 
  In a group setting (Group consent is allowed only in special situations.  Explain process):       
  At potential subject’s residence 

 
Carilion IRB Application 
 
       
- 21 - 
 
(13FEB2018) 
  In emergency situations (Explain process):       
  Online (Explain process):       
  Over the phone (Phone consent is allowed only in special situations.  Explain process):       
  Other (specify):       
 
58. How will you assure there is sufficient opportunity for the subject to consider whether to take part? Check all 
that apply: 
 
  Subjects will be allowed to take home unsigned consent form for consideration prior to signing it 
  Subjects will be allowed a waiting period of    hours to consider their decision 
  Other (specify): Participants will be encouraged to ask questions about any concerns 
that they have. 
     
59. What questions will be asked to assess the subjects’ understanding of informed consent? Check all that 
apply: 
 
 What is the purpose of this research? 
 What are the risks and benefits of being in this study?  
 How is being in this study different from ordinary treatment? 
 How long will you be in this study? 
 Other (specify):       
 
60. Please use Carilion IRB Informed Consent Templates located on our website.  How will you assure the 
consent form or information sheet is written at a level that can be understood by the research subjects?  
 
  Determine grade level and reading ease by using spelling and grammar function in Microsoft Word 
 
Provide Scores Here:       
  Use another readability formula or index (specify type used and results here): SMOG Grade Level: 
9.1 
 
Note:  Consent Forms with difficult reading scores may be returned for editing and may delay IRB review 
       
       
***If you are not requesting a Waiver of Consent for any participants, you may skip the 
remainder of this section and go directly to Section VIII*** 
 
Waiver of Informed Consent 
 
61. Does the research involve more than minimal risk (no greater than those ordinarily encountered in daily life 
or during the performance of routine physical or psychological examinations) to subjects or to their privacy? 
 
  Yes         
  No           
 
62. If the research involves using identifiable private information or identifiable biospecimens, could the research 
be carried out without using such information or biospecimens in an identifiable format? 
 
  Yes         
  No          
  N/A (no identifiable data or specimens being used)          
 
If no, please describe why identifiers are necessary to answer the research question:       
 
63. Will the waiver adversely affect the rights and welfare of the subjects? 
 
  Yes         
  No           
 
64. Please check the appropriate option below describing why obtaining consent is impracticable. Note, by 
choosing any option in this category, you confirm that data will not include psychotherapy notes and that the 
study is not subject to FDA research regulations.  
 
o 
This study is a retrospective medical record review and/or retrospective review of specimens 
collected for purposes other than this research. Obtaining informed consent is impracticable because 
of the large number of records and/or specimens involved. Note: If data/specimens are sought from 
a small group of patients, obtaining consent may be considered practicable even it is inconvenient.  
 
  Yes         
  No 
 
o 
Obtaining informed consent is impracticable because the sample size is so large (e.g. population-base 
studies or epidemiology trials) that including only those samples/records/data for which consent can 

 
Carilion IRB Application 
 
       
- 22 - 
 
(13FEB2018) 
be obtained would prohibit conclusions to be drawn or bias the sample such that conclusions would 
be skewed. 
 
  Yes         
  No 
 
o 
Obtaining informed consent is impracticable because the research is looking at issues such as 
outcomes/morbidity data where not having access to data from all subjects would affect the 
statistical outcome of the study. 
 
  Yes         
  No 
 
o 
Other reason obtaining informed consent is impracticable:       
 
65. Will the research yield information of direct clinical relevance for the subjects? 
 
  Yes         
  No 
 
66. Will subjects or their Legally Authorized Representative be provided with additional pertinent information 
after participation? 
 
  Yes         
  No 
 
 
SECTION VIII: HIPAA FOR PROTECTED HEALTH INFORMATION (PHI) 
 
 
 
 
                 
 
67. Will this study require the creation, use, access, or disclosure of a Carilion Clinic patient’s Protected Health 
Information (PHI), including access their medical record for screening or recruitment? 
 
 
  Yes 
  No (If no, please skip to #69) 
 
68. Please check whether these items will be collected, recorded, or created from a Carilion healthcare record: 
 
 
name 
 
 
 
 
 
 
 
 
  Yes   
  No 
 
 
a geographic subdivision smaller than state except for the first 
three digits of the zip code 
 
 
 
 
 
  Yes   
  No 
 
 
an element of a date, except year, for dates related to an individual, 
including birth date, admission date, discharge date and date of death; 
and all ages over 89 and all elements of such ages may be aggregated 
into a category of age 90 or older 
 
 
 
 
  Yes   
  No 
 
 
telephone numbers 
 
 
 
 
 
 
  Yes   
  No 
 
 
fax numbers 
 
 
 
 
 
 
 
  Yes   
  No 
 
 
electronic mail address  
 
 
 
 
 
  Yes   
  No 
 
 
social security number  
 
 
 
 
 
  Yes   
  No 
 
 
medical record number/ master patient index (MPI) 
 
 
  Yes   
  No 
 
 
health plan beneficiary numbers  
 
 
 
 
  Yes   
  No 
 
 
account numbers 
 
 
 
 
 
 
  Yes   
  No 
 
hospital account receivable (HAR)/contact serial number (CSN)  
  Yes   
  No 
 
 
certificate/license numbers 
 
 
 
 
 
  Yes   
  No 
 
 
vehicle identifiers, including license plate number 
 
 
  Yes   
  No 
 
 
device identifiers and serial numbers 
 
 
 
 
  Yes   
  No 
 
 
Web Universal Resource Locators (URLs) 
 
 
 
  Yes   
  No 
 
 
Internet Protocol (IP) address numbers  
 
 
 
  Yes   
  No 
 
 
biometric identifiers, including finger and voice prints 
 
 
  Yes   
  No 
 
 
 
full face photographic images and any comparable image 
 
  Yes   
  No 
 
 
 
any other unique identifying number, characteristic, code 
 
  Yes   
  No 
 
69. Do you plan to collect or record individually identifiable health information about subjects from a healthcare 
record at any other non-Carilion healthcare provider, health plan (e.g. insurer), employer, or healthcare 
clearinghouse (e.g. billing service) at any point in the project? (See list of identifiers above.) 
 
  Yes         
  No  
 
 
 
If yes, please list all identifiers you plan to collect:  
 
 
 

 
Carilion IRB Application 
 
       
- 23 - 
 
(13FEB2018) 
70. Will the individually identifiable data be related to or linked to the past, present, or future physical or mental 
health condition of an individual; the provision of health care to an individual; or the past, present, or future 
payment for the provision of health care to an individual? 
 
  Yes         
  No           
  N/A, we are not collecting or recording any identifiers listed above 
 
71. Will the individually identifiable data be created or received by any person or entity that is a health care 
provider or an employee of any part of Carilion? 
 
  Yes         
  No 
  N/A, we are not collecting or recording any identifiers listed above 
 
If you answered “yes” to #67 OR if you answered “yes” to #69, #70, AND #71 then you must 
either 1) obtain written HIPAA authorization from each research subject (in the informed 
consent form) or 2) request a HIPAA waiver.   
 
72. Do you request a HIPAA waiver to conduct your research?          
  Yes 
   
  No 
 
****If no, please skip to Section IX*** 
 
A HIPAA waiver can only be granted if the research cannot practicably be conducted without the 
waiver and the use of the PHI poses no more than minimal risk to the privacy of the individuals. 
 
 
Waiver of Authorization (HIPAA Waiver) 
 
73. Describe how the use of PHI in this study poses no greater than minimal risk to participants’ privacy. 
 
     
 
 
74. Could the research be carried out practicably without the use of PHI? 
 
  Yes         
  No 
 
75. Is the waiver needed because obtaining HIPAA authorization is impracticable? Please check the appropriate             
option below. 
 
o 
This study is a retrospective medical record review and/or retrospective review of specimens 
collected for purposes other than this research. Obtaining HIPAA authorization is impracticable 
because of the large number of records and/or specimens involved. Note: If data/specimens are 
sought from a small group of patients, obtaining consent may be considered practicable even it is 
inconvenient. 
 
  Yes         
  No 
 
o 
Obtaining HIPAA authorization is impracticable because the sample size is so large (e.g. population-
base studies or epidemiology trials) that including only those samples/records/data for which consent 
can be obtained would prohibit conclusions to be drawn or bias the sample such that conclusions 
would be skewed. 
 
  Yes         
  No 
 
o 
Obtaining HIPAA authorization is impracticable because the research is looking at issues such as 
outcomes/morbidity data where not having access to data from all subjects would affect the 
statistical outcome of the study. 
 
  Yes         
  No 
 
o 
Other reason obtaining authorization is impracticable:       
 
76. Do you assure that any data identifying subjects used in this study will not be disclosed to anyone other than 
the research team, sponsor, and oversight groups? 
 
  Yes         
  No 
 
77. Do you assure that you will not use this data for any other research unless you receive IRB approval? 
 
  Yes         
  No 
 
SECTION IX: DATA PROTECTION PLAN 
 
78. Is the private information being requested the minimum necessary to meet the research goals? 
 
  Yes         
  No          
  N/A 
 
79. What records or data will you be using or collecting? Check all that apply: 
 

 
Carilion IRB Application 
 
       
- 24 - 
 
(13FEB2018) 
  New data for this study 
  Data already collected for another research study 
  Data already collected for administrative purposes 
  Medical records; approximately how many records:  150 
  Electronic information from clinical database 
  Other:       
 
80. Will any sensitive information be collected, such as information regarding sexual behavior, HIV status, 
recreational drug use, illegal behaviors, physical abuse, mental health disorders, etc.? 
 
  Yes       
  No  
 
 
If yes, what sensitive information will you be collecting?   
 
If yes, will you be obtaining a Certificate of Confidentiality? 
  Yes       
  No  
 
81. Where will data be stored? Please note that no other storage options are permitted, including the use of 
Carilion provided or personal laptops, encrypted flash drives or other portable devices. Data must not be 
placed in a cloud or other hosted environment. Any exceptions must first be approved by the Carilion Privacy 
and Information Security Officer and documentation provided to the IRB. 
 
Please check all that apply: 
 
 Hardcopy data in a locked office in a locked cabinet 
 Electronic data on a password protected, secure drive on a Carilion server (contact 
mmtenzer@carilionclinic.org to set up a shared drive) 
 
Select the software to be used:   
 Excel  
  Access 
  Other: Describe Qualtrics 
  REDCap (contact mmtenzer@carilionclinic.org to discuss use of REDCap). If all data, including the code 
link, will be stored in REDCap, skip to #82. 
 
82. The standard at Carilion to protect identifiable data used in research is to use a code and link system. Two 
files should be kept in two separate secure locations.  One file should use a unique code for each subject in 
connection with any sensitive or health information.  The other file (the link) associates the unique code with 
subject identifiers (e.g. name, medical record number). Please describe how you will store data using the 
options below. 
 
  Retrospective Record Review Research Only: The master list will contain direct subject identifiers 
such as name and MRN along with a unique subject code. It will be stored separately from the coded 
research data set at all times. The research data set will not include any HIPAA identifiers with the 
exception of a date. 
  Prospective Collection of Data, including surveys or collection of new data: While initial collection of 
research data may contain identifying information, it must be stored using a code linked to the subject’s 
identity using a master list, or will include only anonymous or de-identified data. All HIPAA identifiers will 
be stripped from the initial research data collection data tools and replaced with a unique subject code. 
  Prospective Collection of Sensitive Data, including surveys or collection of new data: Research data 
 
will be linked to identifiers by a unique subject code at all times. The code will be linked to a master list 
 
that contains identifying information. The master list and coded research data will be stored in separate 
 
locations.   
 
83. Please describe how you plan to protect identifying information from improper use and disclosure by 
answering the questions below. 
 
a) Who will have access to identifiers?  Trained study team personnel 
b) How will you limit access to the identifiers?  Identifiers will be stored separately on a 
password protected master list in Carilion Red Cap or on a Carilion server.  
 
84. When will study files, including informed consent documents, study documents, and the code link with 
identifiers be destroyed?   
Please note that you must retain research records for the greater of: 
 At least three years after completion of the research. 

 
Carilion IRB Application 
 
       
- 25 - 
 
(13FEB2018) 
 If the study involves Protected Health Information, research records must be maintained for a 
minimum of six years after the completion of the research. 
 For drug studies conducted under an IND, two years following the date a marketing application is 
approved for the drug for the indication for which it is being investigated; or, if no application is to 
be filed or if the application is not approved for such indication, until two years after the 
investigation is discontinued and FDA is notified. 
 For device studies conducted under an IDE or abbreviated IDE, two years after the latter of the 
following two dates: The date on which the investigation is terminated or completed, or the date 
that the records are no longer required for purposes of supporting a premarket approval application 
or a notice of completion of a product development protocol. 
 The retention period required by the sponsor 
 The retention period required by local, state, or international law. 
 The retention period required by a site that is not part of Carilion Clinic. 
 
 10 Years after the study has been closed with the IRB (enter # of years) 
  Other (please specify):       
 
 
 
SECTION X: MEDIA USE 
 
 
 
 
 
85. Will any media be used to record subjects’ voice or image? 
 
     
  Yes       
  No 
 
 
If yes, describe what media will be used, how the media will be used, and justify why it is necessary to 
use the media to collect data:       
 
86. Will the subjects’ voice or image be recorded without their knowledge? 
 
     
  Yes       
  No 
 
 
If yes, describe the deception and the debrief procedures:       
 
SECTION XI: SAFETY & MONITORING 
 
87. Describe the process for dealing with adverse events and unanticipated problems. 
 
We do not anticipate any adverse events/unanticipated problems, but these will be 
reported to the IRB immediately upon occurrence 
 
88. Is there a Data Safety Monitoring Board or other safety oversight committee? 
 
  Yes          
  No           
 
 
If yes: 
 
What is the name of the board or committee?       
If the DSMB is local, please name the members.       
How frequently will the data be reviewed for safety? 
 
  Every 3 months          
  Every 6 months          
  Annually          
  Other:        
 
 
If no: 
 
How will the data be monitored to ensure the safety of subjects? The proposed study poses 
minimal risk to patients, and therefore no safety monitoring is required.  
 
89. Are there plans for visits by sponsor monitors or auditors to review study documents for regulatory 
requirements? 
 
  Yes          
  No          
  N/A 
 
 
If yes, Identify the group that will be conducting the monitoring/auditing visit(s) and the number of times 
you anticipate this occurring over the next year:       
 

 
Carilion IRB Application 
 
       
- 26 - 
 
(13FEB2018) 
90. Does this project involve research using any of the following? 
 
  Yes          
  No   
Mammalian cell/tissue culture (includes established cell lines or primary isolation  
 
 
 
 
of cell lines from tissue, blood, etc.)   
  Yes          
  No  
Cultivated microorganisms (isolated, grown in vitro and used for non-diagnostic  
 
 
 
 
research, i.e. isolation of biohazardous organisms from patient samples) 
  Yes          
  No  
Research animals 
  Yes          
  No  
Molecular cloning, recombinant DNA or gene therapy techniques 
 
If you checked yes on any of the above boxes, you are required to contact the Carilion Clinic 
Research Safety Committee at 985-8510 for important guidance. 
 
 
 
SECTION XII: STORED DATA AND HUMAN BIOLOGICAL MATERIALS REPOSITORIES 
 
 
Databases and specimen repositories, also known as registries or banks, are used to store data and/or specimens 
for future use. When the use is for clinical purposes or quality improvement, IRB approval is not required. 
However, when the use is for research purposes, the databases/repositories must be approved by the IRB (45 
CFR 46 and 45 CFR 160 & 164).  
 
91. Will this research collect and store data/specimens (blood, urine, biopsy tissue, saliva, etc.) for future 
research beyond the parameters of this study? 
 
  Yes          
  No   
 
***If no, you may skip the remainder of this section and go directly to Section XIII*** 
 
92. Will the data/specimens collected for this research be stored in an existing repository at Carilion that is used 
for future research? 
 
  Yes          
  No 
 
 
If yes, provide repository name:       
 
93. Will the data/specimens collected for this research be stored in a non-Carilion repository that is used for 
future research? 
 
  Yes          
  No 
 
 
If yes, attach a protocol or other information describing the repository operations. 
 
94. Will the data/specimens collected be stored in a repository for future research that will be developed and 
operated by the researcher(s)? 
 
  Yes          
  No 
 
 
If yes, you must also submit a Specimen/Data Repository Application to the IRB     
 
SECTION XIII: SUBMISSION INCLUSIONS 
 
Please check which of the following required materials you are including with this submission. If information is 
submitted electronically, signature pages must be faxed or hand delivered (mailed). 
 
 
Protocol (Not required for investigator-initiated research; this application serves as protocol.) 
 
Grant application 
 
Main consent form(s), or Information Sheet 
 
Tissue banking consent form 
 
Assent form, if required for research involving children 
 
Legally Authorized Representative Investigator Assurance Form 
 
Recruitment script or other recruitment materials 
 
Any subject questionnaire or survey 
 
Any data collection tool that will be used to record subject information 
 
Inclusion/Exclusion Checklist 
   
Applicable Clinical Trial (ACT) Checklist, if study involves drugs, devices, or biologics 
 
Investigator brochure for drug studies 
 
Completed Form 1572 for drug studies 
 
Manufacturer reference material for device studies 

 
Carilion IRB Application 
 
       
- 27 - 
 
(13FEB2018) 
 
Curriculum Vitae for PI  
 
IRB fee, if applicable: 
   
$1,500 application fee for full-board industry-sponsored research  
  
$750 application fee for expedited industry-sponsored research 
 
 
SECTION XIV: CERTIFICATIONS 
 
Certification of Principal Investigator:   
By signing this document I confirm that I have read and will carry out my responsibilities as 
Principal Investigator as outlined in INVESTIGATOR GUIDANCE: Investigator Obligations 
(IRB-800). 
 
      
 
 
 
 
 
 
      
 
 
 
 
Carilion Principal Investigator (signature) 
 
 
Date 
 
 
      
 
 
 
 
 
Carilion Principal Investigator name (printed) 
 
 
 
 
 
Certification of Department Chair:   
My signature indicates that this project has been reviewed by the appropriate departmental 
parties who have judged that 1) there is a scholarly and scientific justification for the protocol, 
that the study is feasible, and that the proposed methods are scientifically valid, 2) the PI is 
sufficiently qualified by training and experience to conduct the research, 3) that the department 
has made the space and time commitment necessary to carry out the project, 4) that the 
financial implications of the research have been considered and deemed acceptable to the 
department. 
 
      
 
 
 
 
 
 
      
 
 
 
 
Department Chair or designee (signature) 
 
 
Date 
 
 
      
 
 
 
 
 
Department Chair or designee name and title (printed)                              
 
Principal Investigator Attestation of Informed Consent Training for Students:  I certify 
that the following student(s) who will be obtaining informed consent for this study will have 
observed a mock informed consent discussion or actual informed consent discussion 
conducted by an experienced research team member and have been observed conducting a 
mock informed consent discussion or actual informed consent discussion by an experienced 
research team member before being allowed to interact with study subjects. In addition, I 
certify these students have 1) Completed the Cornerstone research modules on “The Informed 
Consent Process for Clinical Research” and “Recruitment of Study Subjects.” 2) Viewed the 
video General Informed Consent Requirements” posted on the Education tab of the Office for 
Human Protections website https://www.hhs.gov/ohrp/education/training/ded_video.html  3) 
Viewed the 3 informed consent videos posted on the IRB website. 
 
       
 
 
 
____________________     ______________________________ 
Student name (printed)  
 
 
 
 
Name of School 
 
       
 
 
 
____________________     ______________________________ 

 
Carilion IRB Application 
 
       
- 28 - 
 
(13FEB2018) 
Student name (printed)  
 
 
 
 
Name of School 
 
       
 
 
 
____________________     ______________________________ 
Student name (printed)  
 
 
 
 
Name of School 
 
 
       
 
 
 
____________________     ______________________________ 
Principal Investigator (signature) 
 
 
 
Date 
 
 
       
 
 
 
___________________ 
Principal Investigator name (printed)