Delay Discounting as a Target for Self-Regulation in Prediabetes
Phase: NA
Conditions: PreDiabetes
Sponsor: Leonard Epstein

 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federalwide Assurance ID#: FWA00008824 
Page 1 of 49 
 
 
 
MINDD 3: Prediabetes and Delay Discounting 
 
NCT number: NCT03664726 
 
Document Date: 7/20/2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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IRB Version: JAN2016 
Complete Research Protocol (HRP-503) 
 
Table of Contents 
Template Instructions.......................................................................................................... 3 
1.0 
Objectives ................................................................................................................ 5 
2.0 
Scientific Endpoints ................................................................................................. 5 
3.0 
Background .............................................................................................................. 6 
4.0 
Study Design ............................................................................................................ 9 
5.0 
Local Number of Subjects ..................................................................................... 10 
6.0 
Inclusion and Exclusion Criteria ............................................................................ 10 
7.0 
Vulnerable Populations .......................................................................................... 12 
8.0 
Eligibility Screening .............................................................................................. 13 
9.0 
Recruitment Methods ............................................................................................. 15 
10.0 Procedures Involved............................................................................................... 17 
11.0 Study Timelines ..................................................................................................... 24 
12.0 Setting .................................................................................................................... 24 
13.0 Community-Based Participatory Research ............................................................ 25 
14.0 Resources and Qualifications ................................................................................. 26 
15.0 Other Approvals ..................................................................................................... 27 
16.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 28 
17.0 Data Management and Analysis ............................................................................ 29 
18.0 Confidentiality ....................................................................................................... 30 
A. 
Confidentiality of Study Data ............................................................................ 30 
B. 
Confidentiality of Study Specimens ................................................................... 31 
19.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 32 
20.0 Withdrawal of Subjects .......................................................................................... 33 
21.0 Risks to Subjects .................................................................................................... 34 
22.0 Potential Benefits to Subjects ................................................................................ 37 
23.0 Compensation for Research-Related Injury ........................................................... 37 
24.0 Economic Burden to Subjects ................................................................................ 38 
25.0 Compensation for Participation ............................................................................. 38 
26.0 Consent Process ..................................................................................................... 39 
27.0 Waiver or Alteration of Consent Process ............................................................... 43 
28.0 Process to Document Consent ............................................................................... 44 
29.0 Multi-Site Research (Multisite/Multicenter Only)................................................. 45 
30.0 Banking Data or Specimens for Future Use .......................................................... 47 
31.0 Drugs or Devices.................................................................................................... 47 
32.0 Humanitarian Use Devices .................................................................................... 48 
 
 
 

 
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IRB Version: JAN2016 
Template Instructions 
Sections that do not apply: 
• In several sections, the addition of checkboxes for Not Applicable have been 
added to the template as responses.   
o If an N/A checkbox is present, select the appropriate justification 
from the list.   
o If an N/A checkbox is not present, or if none of the existing 
checkboxes apply to your study, you must write in your own 
justification. 
• In addition: 
o For research where the only study procedures are records/chart 
review:  Sections 19, 20, 22, 23, 24, 25, 31, and 32 do not apply. 
o For exempt research:  Sections 31 and 32 do not apply. 
 
Studies with multiple participant groups: 
 
• If this study involves multiple participant groups (e.g. parents and children), 
provide information in applicable sections for each participant group. Clearly 
label responses when they differ.  For example: 
Response:  
Intervention Group: Episodic Future Thinking (EFT) 
 
Control Group: Episodic Recent Thinking (ERT) 
 
Formatting: 
• Do not remove template instructions or section headings when they do not apply 
to your study. 
If you are pasting information from other documents using the “Merge Formatting” 
Paste option will maintain the formatting of the response boxes. 
Amendments: 
• When making modifications or revisions to this and other documents, use the 
Track Changes function in Microsoft Word. 
• Update the version date or number on Page 3. 
 
 

 
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IRB Version: JAN2016 
PROTOCOL TITLE: 
Include the full protocol title. 
Response:  
MINDD 3: Prediabetes and Delay Discounting 
 
 
PRINCIPAL INVESTIGATOR: 
Name 
Department 
Telephone Number 
Email Address 
Response:  
Leonard H. Epstein 
Division of Behavioral Medicine, Pediatrics 
716-829-3400 
lhenet@buffalo.edu 
 
At Virginia Tech Carilion Research Institute 
Warren K. Bickel 
Virginia Tech Carilion Research Institute 
540-739-5101 
wkbickel@vtc.vt.edu 
 
VERSION: 
Include the version date or number. 
Response:  
4 – VTC 
07/20/2018 
  
GRANT APPLICABILITY: 
Indicate whether this protocol is funded by a grant (e.g. NIH, foundation grant).  
For a grant with multiple aims, indicate which aims are covered by this research 
proposal. 
NOTE: This question does not apply to studies funded by a sponsor contract. 
Include a copy of the grant proposal with your submission.     
Response:  
This study is Specific Aim 3 of the grant “Delay Discounting as a target for self-
regulation for prediabetics” funded by NIDDK RFA-RM-14-020, “Science of 

 
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IRB Version: JAN2016 
Behavior Change: Assay Development and Validation for Self-Regulation Targets 
(UH2/UH3)” 
 
 
RESEARCH REPOSITORY: 
Indicate where the research files will be kept, including when the study has been 
closed.  The repository should include, at minimum, copies of IRB 
correspondence (approval, determination letters) as well as signed consent 
documents.  This documentation should be maintained for 3 years after the study 
has been closed.   
Response:  
Location: G56 Farber Hall 
Address: 3435 Main Street, UB South Campus, Buffalo, NY 14214 
Department: Pediatrics 
1.0 Objectives 
1.1 Describe the purpose, specific aims, or objectives of this research. 
Response: The proposed research will translate research on delay discounting to 
the prevention of Type 2 diabetes (T2D) in persons with prediabetes. In this 
study, we will test our ability to engage and change the target, delay discounting 
(DD). 
1.2 
State the hypotheses to be tested, if applicable. 
NOTE:  A hypothesis is a specific, testable prediction about what you expect to 
happen in your study that corresponds with your above listed objectives. 
Response: We predict that poverty conditions will increase discounting of the 
future for ERT subjects, but those receiving EFT will show levels of DD similar 
to levels observed for participants in the neutral condition. We also predict that 
EFT will activate brain regions associated with delay of gratification and 
prospection, and improve executive functions related to EFT, such as working 
memory. 
2.0 Scientific Endpoints 
 
2.1    Describe the scientific endpoint(s), the main result or occurrence under 
study.   
 
NOTE:  Scientific endpoints are outcomes defined before the study begins to determine 
whether the objectives of the study have been met and to draw conclusions from the data.  
Include primary and secondary endpoints.  Some example endpoints are:  reduction of 
symptoms, improvement in quality of life, or survival.  Your response should not be a 
date.   

 
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Response: The primary endpoint is the reduction of discounting of the future and 
increase activation in regions associated with delay of gratification and 
prospection. 
3.0 Background 
3.1 Provide the scientific or scholarly background, rationale, and significance 
of the research based on the existing literature and how it will contribute to 
existing knowledge.  Describe any gaps in current knowledge.  Include 
relevant preliminary findings or prior research by the investigator.  
Response: DD has been related to several adverse health behaviors 
including smoking (Bickel et al., 1999) and obesity (Rollins et al., 2010). 
Our laboratories have extensive experience collecting information about 
DD and these various health outcome behaviors. 
Initial research on Type 2 diabetes (T2D) using a brief monetary choice 
questionnaire showed T2D individuals who discount the future have worse 
metabolic control than those who delay gratification (Reach et al., 2011). 
To our knowledge, there has been no research on the effects of EFT on 
DD among patients with prediabetes.  
Adults with greater DD is associated with obesity (Appelhans et al., 2012), 
and low activation of brain sites critical for self-control in DD predicts 
longitudinal weight gain in adults (Kishinevsky et al., 2012). Likewise, 
inability to delay gratification predicts greater subsequent weight gain in 
young children (Francis and Susman, 2009) and poorer response to 
evidence-based pediatric weight control programs (Seeyave et al., 2009).  
In turn, the prevalence of T2D is associated with obesity (Kahn et al., 
2006). Moreover, T2D (Vanhanen et al., 1997, Kanaya et al., 2004, Yaffe 
et al., 2004) and risk for T2D (Vanhanen et al., 1997) are associated with 
increased risk of executive dysfunction. This association suggests one of 
two possibilities: (1) diabetes causes a decline in executive function, or (2) 
inadequate executive function contributes to obesity and then diabetes. In 
either case, the relationship between executive function and both obesity 
and diabetes can present challenges in adhering to behavioral and medical 
therapies (Smith et al., 2011, Primožič et al., 2012). Poor planning, low 
working memory, cognitive inflexibility, poor attention to detail in 
combination with excessive DD can lead to weight gain and poor 
metabolic outcomes.  
Research supports Episodic Future Thinking (EFT), self-projection into the future 
to pre-experience an event (Atance & O'Neill, 2001), as an effective approach to 
reduce bias towards immediate gratification (Daniel & Epstein, 2013; Daniel, 
Stanton, & Epstein, 2013). However, little is known about EFT’s effect in 
individuals at risk for Type 2 Diabetes. Understanding the effect of EFT in 
prediabetics can be efficacious in translating this technique into an efficacious 
health intervention.   
 

 
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3.2 Include complete citations or references.  
Response:  
Allison, DB, Kalinsky, LB, & Gorman, BS (1992). A comparison of the 
psychometric properties of three measures of dietary restraint. 
Psychological Assessment, 4(3), 391. 
Appelhans BM, Waring ME, Schneider KL, Pagoto SL, DeBiasse MA, 
Whited MC, Lynch EB (2012). Delay discounting and intake of ready-to-
eat and away-from-home foods in overweight and obese women. Appetite, 
59:576-584. 
Atance CM, O'Neill DK (2001). Episodic future thinking. Trends in 
Cognitive Sciences, 5, 533-539. 
Bickel WK, Odum AL, Madden GJ (1999). Impulsivity and cigarette 
smoking: Delay discounting in current, never, and ex-smokers. 
Psychopharmacology (Berl), 146:447-454. 
Bonato DP, Boland FJ (1983). Delay of gratification in obese children. 
Addictive Behaviors, 8:71-74. 
Bourget V, White DR (1984). Performance of overweight and normal-
weight girls on delay of gratification tasks. International Journal of Eating 
Disorders, 3:63-71. 
Daniel TO, Epstein LH. (2013). The future is now: Comparing the effect 
of episodic future thinking on impulsivity in lean and obese individuals. 
Appetite, 71, 120-125. 
Daniel TO, Stanton CM, Epstein LH. (2013). The future is now: Reducing 
impulsivity and energy intake using episodic future thinking. 
Psychological Science, 24, 2339-2342. 
Davis C, Patte K, Curtis C, Reid C. (2010). Immediate pleasures and 
future consequences. A neuropsychological study of binge eating and 
obesity. Appetite, 54, 208-213. 
Francis LA, Susman EJ (2009). Self-regulation and rapid weight gain in 
children from age 3 to 12 years. Archives of pediatrics & adolescent 
medicine, 163:297-302. 
Graziano PA, Bagner DM, Waxmonsky JG, Reid A, McNamara JP, 
Geffken GR (2012). Co-occurring weight problems among children with 
attention deficit/hyperactivity disorder: the role of executive functioning. 
Int J Obes (Lond), 36:567-572. 
Group DPPR (2003). Reduction in the incidence of type 2 diabetes with 
lifestyle intervention or metformin. Obstetrical & Gynecological Survey, 
58:182-183. 
Jacobs, EA, Bickel, WK (1999). Modeling drug consumption in the clinic 
using simulation procedures: demand for heroin and cigarettes in opioid-

 
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dependent outpatients. Experimental and clinical psychopharmacology, 
7(4), 412. 
Kanaya AM, Barrett-Connor E, Gildengorin G, Yaffe K (2004). Change in 
cognitive function by glucose tolerance status in older adults: a 4-year 
prospective study of the Rancho Bernardo study cohort. Archives of 
Internal Medicine, 164:1327-1333. 
Kahn SE, Hull RL, Utzschneider KM (2006). Mechanisms linking obesity 
to insulin resistance and type 2 diabetes. Nature, 444, 840-846. 
Karlsson, J, Persson, LO, Sjöström, L, Sullivan, M (2000). Psychometric 
properties and factor structure of the Three-Factor Eating Questionnaire 
(TFEQ) in obese men and women. Results from the Swedish Obese 
Subjects (SOS) study. International Journal of Obesity & Related 
Metabolic Disorders, 24(12). 
Kishinevsky FI, Cox JE, Murdaugh DL, Stoeckel LE, Cook EW, Weller 
RE (2012). fMRI reactivity on a delay discounting task predicts weight 
gain in obese women. Appetite, 58:582-592. 
Kuczmarski RJ, Ogden CL, Guo S, Grummer-Strawn LM, Flegal KM, 
Mei Z, Wei R, Curtin LR, Roche AF, Johnson CL (eds.) (2002) CDC 
growth charts for the United States: Methods and development. 
Hyattsville, MD: National Center for Health Statistics. 
Peters, J, Büchel, C (2010). Episodic future thinking reduces reward delay 
discounting through an enhancement of prefrontal-mediotemporal 
interactions. Neuron, 66(1), 138-148. 
Picone, Sloan, Taylor (2004). Effects of risk and time preference and 
expected longevity on demand for medical tests. Journal of Risk and 
Uncertainty, 28, 39-53. 
Primožič S, Avbelj M, Dernovšek MZ, Oblak MR (2012). Specific 
cognitive abilities are associated with diabetes self-management behavior 
among patients with type 2 diabetes. Diabetes research and clinical 
practice, 95:48-54. 
Reach G, Michault A, Bihan H, Paulino C, Cohen R, Le Clésiau H (2011). 
Patients’ impatience is an independent determinant of poor diabetes 
control. Diabetes & metabolism, 37:497-504. 
Rendell, P.G., & Craik, F. I. M. (2000). Virtual and Actual Week: Age-
related differences in prospective memory. Applied Cognitive Psychology. 
Special Issue: New Perspectives in Prospective Memory. 14, S43-S62. 
Rollins BY, Dearing KK, Epstein LH (2010). Delay discounting 
moderates the effect of food reinforcement on energy intake among non-
obese women. Appetite, 55:420-425. 
Sanders AF, Lamers JM (2002). The Eriksen flanker effect revisited. Acta 
psychologica, 109:41-56. 

 
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Seeyave DM, Coleman S, Appugliese D, Corwyn RF, Bradley RH, 
Davidson NS, Kaciroti N, Lumeng JC (2009). Ability to delay 
gratification at age 4 years and risk of overweight at age 11 years. 
Archives of Pediatric and Adolescent Medicine, 163:303-308. 
Shallice T (1982). Specific impairments of planning. Philosophical 
transactions of the Royal Society of London Series B, Biological sciences, 
298:199-209. 
Shellock, FG, Kanal, E (1996). Magnetic resonance: bioeffects, safety, 
and patient management. Lippincott Williams & Wilkins. 
Smith E, Hay P, Campbell L, Trollor J (2011). A review of the association 
between obesity and cognitive function across the lifespan: implications 
for novel approaches to prevention and treatment. Obesity Reviews, 
12:740-755. 
Strathman A, Gleicher F, Boninger DS, Edwards CS (1994). The 
consideration of future consequences: Weighing immediate and distant 
outcomes of behavior. Journal of Personality and Social Psychology, 
66:742. 
Stunkard, AJ, & Messick, S (1985). The three-factor eating questionnaire 
to measure dietary restraint, disinhibition and hunger. Journal of 
psychosomatic research, 29(1), 71-83. 
Tombaugh TN (2004). Trail Making Test A and B: normative data 
stratified by age and education. Archives of clinical neuropsychology: the 
official journal of the National Academy of Neuropsychologists, 19:203-
214. 
van Beek, Antonides, & Handgraaf. (2013). Eat now, exercise later: The 
relation between consideration of immediate and future consequences and 
healthy behavior. Personality and Individual Differences, 54, 785-791. 
Vanhanen M, Koivisto K, Karjalainen L, Helkala E-L, Laakso M, 
Soininen H, Riekkinen Sr P (1997). Risk for non‐insulindependent 
diabetes in the normoglycaemic elderly is associated with impaired 
cognitive function. Neuroreport, 8:1527-1530. 
Watson D., Clark LA, Tellegen A. (1988) Development and Validation of 
Brief Measures of Positive and Negative Affect: The PANAS Scales. 
Journal of Personality and Social Psychology, 52 (6), 1063-1070. 
Yaffe K, Blackwell T, Kanaya A, Davidowitz N, Barrett-Connor E, Krueger K 
(2004). Diabetes, impaired fasting glucose, and development of cognitive 
impairment in older women. Neurology, 63:658-663. 
4.0 Study Design 
4.1 Describe and explain the study design (e.g. case-control, cross-sectional, 
ethnographic, experimental, interventional, longitudinal, observational). 

 
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Response: This study is an experimental between-subjects design; subjects in the 
behavioral arm will be randomized to poverty/neutral scenarios crossed with 
EFT/ERT in a 2 x 2 factorial design. Subjects in the fMRI arm will be randomized 
to one of two groups: episodic future thinking (EFT) versus episodic recent 
thinking (ERT) control. 
5.0 Local Number of Subjects 
5.1 Indicate the total number of subjects that will be enrolled or records that 
will be reviewed locally. 
Response: Up to 100-150 subjects will be enrolled (up to 250 nationally) with 50-
75 enrolled in each arm of the study. In addition, a small sample (approximately 
4-6 subjects) will be assigned to be pilot participants to help with quality 
assurance and data validity procedures. Participants will be informed if they are a 
pilot participant at the time of consent. 
5.2 If applicable, indicate how many subjects you expect to screen to reach your 
target sample (i.e. your screen failure rate).  
Response: We expect to screen approximately 250 subjects to reach our target 
sample with about a 40% attrition expected based on the screen fail rate and a 
50% MRI ineligible rate from the previous two studies, MINDD 1 (Aim 1) and 
MINDD 2 (Aim 2). 
5.3 Justify the feasibility of recruiting the proposed number of eligible subjects 
within the anticipated recruitment period. For example, how many potential 
subjects do you have access to? What percentage of those potential subjects 
do you need to recruit? 
Response: The Division of Behavioral Medicine has access to a password 
protected database that has been approved for use by previous IRB committees 
(385420, 389912, 385442030-796526, STUDY00000936). This is a large 
database of people interested in participating in future studies. Research staff has 
extensive experience using the database for recruitment purposes and we feel 
confident that we can recruit the required number of subjects from this database 
and through our community based efforts. In addition, physicians will refer 
people from their clinics that may be interested in participating. 
6.0 Inclusion and Exclusion Criteria 
6.1 Describe the criteria that define who will be included in your final study 
sample.  
NOTE:  This may be done in bullet point fashion. 
Response: Adults: Participants must be 18 years of age or older to 
participate. 
Prediabetes: Participants must have a diagnosis of prediabetes within the 
last 2 years or meet criteria for prediabetes or meet criteria for prediabetes 
during screening for the study. The American Diabetes Association 
guidelines (Group, 2003) defines prediabetes as Fasting Plasma Glucose 

 
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(FPG) 100-125 mg/dl, 2h glucose 140-199 mg/dl after Oral Glucose 
Tolerance Test (OGTT), or hemoglobin A1c (HbA1c) approximately 5.7-
6.4%.  
 
6.2 Describe the criteria that define who will be excluded from your final study 
sample.   
NOTE:  This may be done in bullet point fashion.  
Response:  Type 2 Diabetes: Individuals will be excluded if they have Type 2 
Diabetes.  
Pregnancy: Women who are pregnant or lactating will be excluded from 
participation. 
Substance use, abuse, or dependence: Individuals that currently have problems 
with substance dependence, addiction, or problematic substance use that would 
limit participation (e.g., binge drinkers, alcoholics, daily recreational 
stimulant/opiate users) will be excluded. 
Conditions that affect adherence: Participants should not have a condition that 
would limit participation which include medical conditions that would affect 
individuals’ ability to use the computer for prolonged period of time; leave the 
individual unable to ambulate; or current diagnoses of an eating disorder 
(anorexia, bulimia,), unmanaged psychiatric disorder (depression, anxiety, 
attention deficit hyperactivity disorder (ADHD), schizophrenia), or an intellectual 
impairment that would impact study adherence. 
Abnormal glucose related to medications: Participants should not be taking 
medications that would limit participation and cause abnormal glucose levels (e.g. 
atypical antipsychotic medications or glucocorticoids) including diabetic drugs 
such as Metformin. 
Unwilling or unable to eat study food: Participants who are unwilling or not able 
to eat the study food (a PowerBar) will not be able to take part in this study. 
Prior participation in similar studies:  Individuals who have recently participated 
in a laboratory study using similar methods may also be excluded.   
Anyone who cannot have an MRI (e.g. anyone who has any type of metallic implant 
in his/her body, including pacemakers, aneurysm clips, shrapnel, metal fragments, 
orthopedic pins, screws or plates, IUD’s or piercings that cannot be removed) will 
not be able to participate in the imaging portion of the study (3b). Those who 
cannot have an MRI may be eligible to participate in the behavioral version of the 
study. 
Do not meet discounting criteria: Individuals who do not meet discounting criteria 
(e.g. nonsystematic discounting) on a delay discounting task may be excluded. 
6.3 Indicate specifically whether you will include any of the following special 
populations in your study using the checkboxes below.   
 

 
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NOTE:  Members of special populations may not be targeted for enrollment in 
your study unless you indicate this in your inclusion criteria. 
Response: Individuals who are not yet adults, adults unable to consent, pregnant 
women, and prisoners will be excluded from this study. 
☐ 
Adults unable to consent 
☐ 
Individuals who are not yet adults (infants, children, teenagers) 
☐ 
Pregnant women 
☐ 
Prisoners 
 
6.4 Indicate whether you will include non-English speaking individuals in your 
study.  Provide justification if you will exclude non-English speaking 
individuals.  
In order to meet one of the primary ethical principles of equitable selection 
of subjects, non-English speaking individuals may not be routinely excluded 
from research as a matter of convenience. 
In cases where the research is of therapeutic intent or is designed to 
investigate areas that would necessarily require certain populations who 
may not speak English, the researcher is required to make efforts to recruit 
and include non-English speaking individuals.  However, there are studies 
in which it would be reasonable to limit subjects to those who speak 
English.  Some examples include pilot studies, small unfunded studies with 
validated instruments not available in other languages, studies with 
numerous questionnaires, and some non-therapeutic studies which offer no 
direct benefit. 
Response:  
This study will not include non-English speaking participants. Since all the 
materials in this study will be in English, and the validated measurements are not 
provided in other languages, we will be excluding individuals who do not speak 
English. 
7.0 Vulnerable Populations 
If the research involves special populations that are considered vulnerable, 
describe the safeguards included to protect their rights and welfare.   
NOTE: You should refer to the appropriate checklists, referenced below, to ensure you 
have provided adequate detail regarding safeguards and protections. You do not, 
however, need to provide these checklists to the IRB. 
7.1 For research that involves pregnant women, safeguards include: 
NOTE CHECKLIST: Pregnant Women (HRP-412) 
Response:  
☒ 
N/A:  This research does not involve pregnant women. 

 
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7.2 For research that involves neonates of uncertain viability or non-viable 
neonates, safeguards include: 
NOTE CHECKLISTS: Non-Viable Neonates (HRP-413), or Neonates of Uncertain 
Viability (HRP-414) 
Response:  
 
☒ 
N/A:  This research does not involve non-viable neonates or neonates of 
uncertain viability. 
7.3 
For research that involves prisoners, safeguards include: 
NOTE CHECKLIST: Prisoners (HRP-415) 
Response:  
 
☒ 
N/A:  This research does not involve prisoners. 
7.4 For research that involves persons who have not attained the legal age for 
consent to treatments or procedures involved in the research (“children”), 
safeguards include:   
NOTE CHECKLIST: Children (HRP-416) 
Response:  
 
☒ 
N/A:  This research does not involve persons who have not attained the 
legal age for consent to treatments or procedures (“children”). 
7.5 For research that involves cognitively impaired adults, safeguards include: 
NOTE CHECKLIST: Cognitively Impaired Adults (HRP-417) 
Response:  
 
☒ 
N/A:  This research does not involve cognitively impaired adults. 
7.6 Consider if other specifically targeted populations such as students, 
employees of a specific firm, or educationally or economically 
disadvantaged persons are vulnerable.  Provide information regarding 
their safeguards and protections, including safeguards to eliminate 
coercion or undue influence. 
Response: N/A  
 
8.0 Eligibility Screening  
8.1 
Describe screening procedures for determining subjects’ eligibility.  
Screening refers to determining if prospective participants meet inclusion and 
exclusion criteria.  
Include all relevant screening documents with your submission (e.g. screening 
protocol, script, questionnaire).  

 
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Response:  
Interested participants will have the opportunity to complete an initial 
screening by phone, online, or paper upon their preference to determine if 
they meet the inclusion criteria as previously described. See attached 
supporting documents “Phone Screening Script” and “MINDD 3 
Prescreen Paper Copy” for questions used on phone screens, online 
screens, and paper screens. Information about the study will be provided 
and consent will be obtained to prescreen for eligibility purposes. 
During the prescreen, along with other screening questionnaires 
participants will also complete the PHQ-2, a shorter version of the PHQ-9, 
which measures current (within the past two weeks) feelings of depression 
or loss of interest in activities. Those that score a 3 or above on the PHQ-
2, will be contacted for follow-up via phone by a trained research staff 
member and be given the remainder of the PHQ-9. The PHQ-9 is a 
validated measure that looks not only at feelings of depression and 
associated symptoms, but also assesses for thoughts of self-harm. Given 
the concern for having a participant indicate thoughts of self-harm, this 
procedure would allow for a real-time conversation with that participant to 
monitor responses and also provide them with appropriate resources. 
Additionally, if the participant appears to be extremely upset and/or 
emotional, we may ask them to fill out Columbia Severity Index, a reliable 
measure of assessing suicide risk. 
After completing the prescreen survey, responses will be reviewed by 
research staff to assess eligibility and determine which arm of the study 
they will be eligible for (e.g. those who do not have a history of 
hypertension and/or hyperlipidemia but may safely participate in an MRI 
may be entered into the fMRI arm of this study. And those who meet all 
other eligibility criteria but cannot safely participate in an MRI may be 
entered into the behavioral part of this study). Participants will be called, 
emailed, or mailed a letter (depending on their preferred method of contact 
provided in the prescreen survey) regarding their eligibility. Those who 
are eligible will be scheduled to come into our lab for an in person 
screening visit (session 1). 
At the in person screening visit (session 1) documented consent will be 
obtained from potential participants. During the screening procedure, 
participants may be asked to sign a medical release form allowing the 
primary care physician to provide us with the information regarding 
eligibility and also allow us to send any pertinent medical information to 
their primary care physician (e.g., diagnoses of obesity, prediabetes, 
hypertension, dyslipidemia, fMRI findings, depression score assessed by 
the BDI). If we do not receive the form within about 5 business days we 
will call to follow up with the primary care physician. At the screening 
visit, participants will have their HbA1c levels measured by finger stick to 
obtain a drop of blood. If subjects meet study eligibility criterion based on 

 
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HbA1c levels (5.4% - 6.7%) at the initial screening visit, they may be 
eligible to participate regardless of confirmatory PCP diagnosis. 
Additionally at the first visit, female participants who have been entered 
into the fMRI arm of the study will provide us with a urine sample to 
check for pregnancy status. If the results are positive the participant will 
be informed and they will not be eligible to continue with study. 
Study personnel will inform participants that this information will be used 
to communicate with them about study eligibility and that this information 
will be kept confidential and not shared with anyone outside of the study 
team. 
The information assessed during screening is recorded in a secure database that 
requires a password to enter. The database is used by all members of the Division 
of Behavioral Medicine and has been approved for use by previous IRB 
committees. Information is retained in the database only if the subject gives 
consent. 
 
☐ 
N/A:  There is no screening as part of this protocol. 
9.0 Recruitment Methods 
☐ 
N/A:  This is a records review only, and subjects will not be 
recruited.  NOTE:  If you select this option, please make sure that 
all records review procedures and inclusion/exclusion screening 
are adequately described in other sections. 
9.1 
Describe when, where, and how potential subjects will be recruited.  
NOTE:  Recruitment refers to how you are identifying potential participants and 
introducing them to the study.  Include specific methods you will use (e.g. 
searching charts for specific ICD code numbers, Research Participant Groups, 
posted advertisements, etc.). 
Response:  
Participants will be recruited through recruitment materials (e.g., flyers, 
letters, and handouts/postcards), and web-based recruitment (e.g., 
departmental website, Facebook, Twitter, Craigslist, ResearchMatch, 
ClinicalTrials) disseminated through the local community, university 
campuses, and medical clinics including UB-MD, the university physician 
network, Urban Family Practice, and the Upstate New York Practice 
Based Research Network which is engaged in multiple research projects to 
improve patient care in Western New York. Used in previous IRB 
approved studies (030-796526, STUDY 00000936), the physicians from 
UBMD have provided us with a list of patient names, addresses, contact 
information, and brief medical history (e.g., diagnosis of hypertension, 
diagnosis of hyperlipidemia, previous HbA1c measurements, BMI) for 
recruitment purposes of the MINDD Grant. These patients may be mailed 
a letter that has been jointly signed from the study team and their 

 
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physician. Included in the mailing are postcards with return address and 
that have been pre-stamped, so that these potential participants have the 
option to send back a reply regarding their interest in the study via postal 
mail Interested patients may contact the research team. Potential 
participants who were mailed a letter jointly signed by the study team and 
the patient’s physician from UB-MD may also be contacted by the study 
team by phone to assess interest if the study team has not received a 
response from the individual after one week.  
Potential participants who were mailed a letter jointly signed by the study 
team and patient’s physician at Urban Family Practice may also be 
contacted by the study team by phone to assess interest if the study team 
has not received a response from the individual after one week. Since this 
is the first time we will be using Urban Family Practice to recruit from, we 
will follow their recruitment protocol, which allows us to contact and 
follow up with potential participants in this manner. 
We may also use the i2b2 database through UB’s Institute for Healthcare 
Informatics (IHI) to recruit participants from the UBMD medical data base. A 
letter will be sent to the eligible patient’s physician (see attached). After one 
week, if the physician doesn’t contact the research team to refuse, a recruitment 
letter will be sent to participants via mail (see attached). If we don’t hear from the 
patients within one week, one follow-up call will be made (see attached phone 
script). If at any point the physician or the patient declines, the patient will be 
removed from the contact list. 
Additionally, a database of participants that have been involved in previous 
studies at the University at Buffalo Behavioral Medicine laboratory that expressed 
interest in future studies will be used. Participants who have indicated interest in 
contact for future studies will be contacted by email or phone with the study 
advertisement and survey link. The database is used by all approved members of 
the Division of Behavioral Medicine and has been approved by previous IRB 
Committees, for phone/email contact (385420, 389912, 385442). No data or 
identifying information is collected prior to a potential participant’s expression of 
interest in the research study. 
9.2 Describe how you will protect the privacy interests of prospective subjects 
during the recruitment process.   
NOTE:  Privacy refers to an individual’s right to control access to him or herself.   
Response:  
Individuals who contact the research team after viewing the above recruitment 
materials disseminated at local sites control their own privacy interests. 
Individuals that have previously indicated interest and willingness to be contacted 
for participating in future studies will be contacted and thus can control their own 
participation. All individuals will be informed that participation is voluntary and 
they can withdraw from participation at any time. The study team will cease 
contact with any individuals that they have learned are not interested. 

 
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The privacy of patients recruited using the i2b2 data will be protected by 
following the UB IRB-approved procedure.  
9.3 Identify any materials that will be used to recruit subjects.  
NOTE:  Examples include scripts for telephone calls, in person announcements / 
presentations, email invitations.  
For advertisements, include the final copy of printed advertisements with your 
submission. When advertisements are taped for broadcast, attach the final 
audio/video tape.  NOTE:  You may submit the wording of the advertisement prior 
to taping to ensure there will be no IRB-required revisions, provided the IRB also 
reviews and approves the final version. 
 Response:  
Web-based advertisements posted on the departmental website, Facebook, 
Twitter, Craigslist, ResearchMatch, ClinicalTrials, flyers, handouts, telephone 
calls, using the approved script, and mailed letters and postcards, will be used to 
recruit subjects. 
10.0 
Procedures Involved 
10.1 Provide a description of all research procedures or activities being 
performed and when they are performed once a subject is screened and 
determined to be eligible. Provide as much detail as possible.   
NOTE:  This should serve as a blueprint for your study and include enough detail 
so that another investigator could pick up your protocol and replicate the research.  
For studies that have multiple or complex visits or procedures, consider the 
addition of a schedule of events table in in your response. 
Response:  
Behavioral Arm: Upon arrival to the Division of Behavioral Medicine 
(G56 Farber Hall), participants will be greeted and escorted to a private 
interview room where they will be given a verbal explanation about the 
study and provide documented consent. Two copies of the consent form 
will be signed by all parties involved, person obtaining consent and the 
participant. One copy will be obtained by study personnel and one copy 
will be given to participants for their records. After signing the consent 
forms, participants will have their blood glucose measured. Participants 
will then consume a PowerBar and begin completing study related tasks in 
which they will have their HbA1c, blood pressure, height and weight 
measured to calculate BMI, and complete measures of delay discounting 
and study questionnaires including demographics, consumption, alcohol, 
tobacco substance use, time perspective, and prospective memory. 
Measures and questionnaires may be completed on either the computer or 
paper/pencil labelled only with the participant’s ID number. About 30-45 
minutes after consuming the PowerBar participants will have their blood 
glucose measured again. In addition, participants will sign forms for 
release of their relevant medical records to confirm their eligibility (e.g., 
diagnosis with prediabetes, hypertension and/or hyperlipidemia, MRI 

 
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eligibility). Participants will be given a choice as to whether they would 
like their screening results shared with them and/or with their physician. If 
participants have values at a certain critical level (e.g. critically high blood 
pressure) they may be automatically notified. Participants may also 
complete a urine drug screen to confirm non-substance abuse and female 
participants may complete a urine pregnancy test to ensure eligibility.  
After completing all study tasks, questionnaires, measures etc. for the first 
session, participants may have their blood glucose measured again. Blood 
glucose will be measured up to 3 separate times during this visit. The first 
visit is expected to last between two to two and a half hours. 
If eligible, participants will be scheduled for an additional session to be 
completed within the next four weeks. The second session will last 
approximately two to two and a half hours. Participants may be asked to 
abstain from eating or drinking (except water) for approximately 2 hours 
prior to both of their sessions and engaging in any activity that may 
influence appetite. Participants who are not about 2 hours post prandial or 
have experienced a major life event that may influence their performance 
on study measures and tasks may have their appointment rescheduled. As 
in the first visit, participants will have their blood glucose measured and 
then offered a PowerBar to consume prior to completing all study related 
tasks. In this visit, participants will again have blood glucose measured 
three separate times (e.g. beginning of session, about 30-45 minutes after 
consuming PowerBar, and at the end of the session).  
Participants will be randomly assigned to one of two groups, EFT or ERT, 
and complete an episodic thinking task. Participants will be randomized 
by stratifying for education level and sex. The episodic thinking task to 
generate episodic cues will be similar to the tasks used in our previous 
studies on EFT’s effect (Daniel et al., 2013). Each group 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, 
and so forth). 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). In contrast, 
the ERT group will list positive recent events (events that have already 
happened) that they have enjoyed that have occurred at different general 
time points (e.g., a few hours ago, 1 day ago, 2-6 days ago, 7-12 days 
ago). All participants will rate the salience, valence, arousal, feasibility 
and vividness of each event and events with the highest ratings for 
vividness will be used in the generation of episodic cues. An “imagery” 
score may be calculated by averaging the frequency/vividness scores for 
each event. Reductions in rate of discounting occur at higher levels of 
episodic imagery (Peters & Buchel, 2010). Additionally, participants will 
record their highest rated events into audio cues. 

 
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Participants may also be instructed to use and think about their episodic 
cues as they engage in a set of executive function tasks (e.g., The Virtual 
Week) and other decision making tasks such as measures of delay 
discounting (e.g., discounting of money, food, sedentary 
behaviors/physical activity, future health; a series of single and cross 
commodity discounting tasks) and food preferences. Participants will be 
randomized to which cues (future or recent) they will be instructed to 
think about when engaging in The Virtual Week task. Executive function 
tasks may take place on a computer screen or paper and pencil. 
Participants will complete questionnaires regarding their attention to their 
episodic cues while engaged in study tasks.  
fMRI Arm: If it is determined that the participant is willing and eligible to 
complete an fMRI they may be entered into the fMRI arm of this study. 
For these participants, the first visit is identical to that of the first visit in 
the behavioral arm of the study, with the exception that participants will 
not complete an episodic thinking task, and the MRI screening form may 
be reviewed with the participant to ensure safety and eligibility. 
Eligible participants will be scheduled for an additional session to be 
completed within the next 30 days. The second session will last 
approximately an hour and a half to two hours.  Participants may be asked 
to abstain from eating or drinking (except water) for approximately 2 
hours prior to their sessions and engaging in any activity that may 
influence appetite. Participants who are not about 2 hours post prandial or 
have experienced a major life event that may influence their performance 
on study measures and tasks may have their appointment rescheduled. As 
in the first visit, participants will have their blood glucose measured and 
then offered a PowerBar to consume prior to completing all study related 
tasks. In this visit, participants will again have blood glucose measured 
three separate times (e.g. beginning of session, 30 minutes after 
consuming PowerBar, and at the end of the session). 
In the second visit, female participant will again be asked to provide a 
urine sample to confirm non-pregnancy status. Eligible participants will be 
randomly assigned to one of two groups, EFT or ERT, and complete an 
episodic thinking task identical to the thinking task in the first visit of the 
behavioral study. They may also be asked to complete decision making 
tasks while engaged in episodic thinking and undergoing an fMRI without 
contrast scan at their second session. Prior to the scan, MRI safety trained 
personnel will assess the safety of all participants. During the fMRI scan, 
the participant will be given a small box with buttons to press in response 
to the display that appears on the screen above them within the machine. 
The participant will be selecting objects that they prefer in decision-
making tasks. Additionally, interested participants may have the 
opportunity to receive a copy of their brain images. 
Following their last session, all participants will be debriefed.  

 
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Pilot participants will complete identical procedures, but may complete fewer 
sessions and/or activities than those described above.  
Participants who are considered “screen fails” for having low blood HbA1c, not 
within the prediabetes range (5.4-6.7%), will be logged to track our “screen fail 
rate” and will not be included in the final data analysis. Participants who were 
initially tested on the A1CNow+® system and were screened ineligible for having 
a blood HbA1c measurement near the prediabetes range (i.e., between 5.0 and 
5.3) may be invited back to our lab for an additional HbA1c measurement using 
the Alere AfinionTM AS100 Analyzer System. Upon retesting, if their HbA1c 
measure is now in the prediabetes range, they will be eligible to continue with the 
rest of the study and will be recorded as “initially ineligible, eligible upon 
retesting HbA1c”, and will be included in the final data analysis. 
 
10.2 Describe what data will be collected.   
NOTE:  For studies with multiple data collection points or long-term follow up, 
consider the addition of a schedule or table in your response. 
Response:  
Data consists of demographic measures, subjective preference and hunger, food 
questionnaires, energy intake, delay discounting, executive function, relative 
reinforcing efficacy, substance consumption, pregnancy, temporal perspective, 
blood pressure, HbA1c, blood glucose, fMRI images, and participants’ heights 
and weights recorded during the experimental session. 
10.3 List any instruments or measurement tools used to collect data 
(e.g. questionnaire, interview guide, validated instrument, data collection 
form).   
 
Include copies of these documents with your submission. 
Response:  
Please see the attachment labeled, “questionnaires (M3).”  
Demographics and Health Behavior: Race/ethnicity, household income, and 
educational level will be assessed using a survey-based questionnaire. Participants 
will also be asked about their health behavior, including substance use, mental 
health, medical history, and food consumption. 
Food Consumption Questionnaire. Food consumption, including any food 
or beverages ingested in the last 10-12 hours. 
Major Life Events: Individuals will be asked to complete the major life events 
questionnaire which measures major life events that may have been experienced 
during their involvement in the study. Individuals who are undergoing major life 
events such as a move, new baby or a new job may influence their performance 
on study measures and tasks. 

 
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Financial Planning and Longevity. Individual differences in time period of 
financial planning will be assessed with the question, “In planning your, or 
your family’s, saving and spending, which of the time periods is more 
important to you and your partner, if you have one?” (Picone, Sloan, & 
Taylor, 2004). Answer choices provided will range from not planning, to 
planning longer than ten years. Financial planning will be reported 
categorically, and will be converted to a continuous variable for analysis 
using midpoints of the categories. Subjective probability of living to age 
75 will be measured by asking “What do you think are the chances you 
will live to be 75 or more (where 0 means there is no chance you will live 
to 75 or more, and 100 means you will definitely live to 75 or more)?” 
(Picone et al., 2004). Higher values on either question will indicate greater 
future orientation.  
Time Perspective: Individual differences in temporal perspective will be assessed 
using measures that assess temporal orientation. Consideration of Future 
Consequences Scale (CFCS). CFCS assesses the extent to which individuals 
consider the potential future outcomes of their current behavior and the extent to 
which they are influenced by the imagined outcomes (Strathman et al., 1994).   
Positive and Negative Affect Schedule (PANAS): The PANAS comprises two 
mood scales, one that measures positive affect and the other which measures 
negative affect (Watson et. al., 1988) 
Height, Weight, BMI: Participants’ height will be assessed using a digital 
stadiometer. Participants’ weight will be assessed using a digital scale. Based on 
the height and weight data, Body Mass Index (BMI) will be calculated according 
to the following formula: BMI = kg/m2. These are the current standards set forth 
by the Centers for Disease Control and Prevention (Kuczmarski et al., 2002). 
Blood pressure: Blood pressure will be measured 3 times using an OMRON 
automated blood pressure device by trained personnel. The latter two readings 
will be averaged. 
Hemoglobin A1c (HbA1c): HbA1c will be measured using the A1CNow+® 
system (PTS Diagnostics, Sunnyvale, CA) or the Alere AfinionTM AS100 
Analyzer System (Abbott, Abbott Park, IL). 
Blood Glucose: Blood glucose will be measured using the FreeStyle Lite Glucose 
Monitor (Abbott, Abbott Park, IL) 
Subjective Hunger: Participants will be asked to provide subjective ratings of 
their hunger. Hunger will be assessed using a 5-point Likert scale (anchored by 1- 
Extremely Full and 5-Extremely Hungry). 
Subjective Preferences: Participants may be asked to provide subjective ratings of 
their food/activity preferences by ranking, rating their liking using a 5-point 
Likert scale (anchored by 1-Do not like and 5-Like very much), and making 
choices between their food/activity. 
Same Day Food Recall: Participants will be asked if they are willing to eat the 
study food during a 24-hour recall questionnaire assessing past food behavior 

 
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(e.g. what time they ate their last meal, food items consumed in the past 24 hours, 
etc.). Those who say they are not willing to eat the study food will not be included 
in the study. 
Cue Attention: A Likert-style scale assessing attentiveness to the episodic cues 
and vividness cues during tasks will be assessed on a scale from 1 to 5, where 1 
indicates “not at all” and 5 indicates “very much”.   
Delay Discounting: An operational definition of impulsivity is delay discounting, 
the degree to which a person will discount the value of a larger delayed reward in 
favor of a smaller immediate reward. Computerized/ experimenter administered 
assessments will provide participants with choices between a smaller amount of a 
hypothetical commodity available immediately or a larger amount available later. 
Participants will make choices between rewards such as money, food, physical 
activity, and health gains. Two methods will be used to measure discounting, 
Adjusting Amount and Adjusting Delay. 
 
Adjusting Amount Discounting. The magnitude of the immediate 
commodity is adjusted until it is subjectively equivalent to the later larger amount. 
Subjective equivalence will be obtained at delays such as; 1 day, 1 week, 1 
month, 3 months, 6 months, and 1 year. To ensure comparison between money 
and non-monetary rewards, prior to running the discounting programs for food, 
physical activity and health, participants will indicate the amount of the 
commodity whose receipt “right now” would be equally valuable to the 
participants as receiving a set amount of money, for example $100.  
Adjusting Delay Discounting. The adjusting delay discounting task is a 
five trial task in which participants are asked how much money they would prefer 
(e.g. $500) immediately or a larger reward after a delay (e.g. $1000). This task is 
presented on a computer screen and is designed to measure the amount of 
monetary discounting that occurs when rewards are presented at a delay. This task 
adjusts the delay to the larger reward and allows for the calculation of k-values. 
This task will be completed matching each of the traditional tasks parameters (i.e. 
type and magnitude of the reinforcer).  
Executive Function: Cognitive processes, such as planning, cognitive flexibility, 
working memory, prospective memory, retrospective memory and attention may 
be measured by using computerized tasks (e.g., with Inquisit) or paper and pencil 
that involves solving problems, remembering a set of letters or spatial locations 
while alternating with a distracter tasks, responding to specific stimulus in the 
presence of an orienting cue, or playing the computer game “The Virtual Week” 
where users will plan out typical events that could actually happen during the 
week (e.g., taking their medication, calling their friend, picking up their dry 
cleaning) (Rendell, & Craik, 2000) 
Relative Reinforcing Efficacy Food Purchasing Task: The food purchasing task is 
modified off of the cigarette purchasing task (CPT) that has been used by Jacobs 
and Bickel (1999) and assesses a number of different metrics of relative 
reinforcing efficacy. The procedure we will use is a modified version of this 
procedure and will assess the relative reinforcing efficacy of a range of foods via 

 
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an online survey or computerized task.  The chosen food will be displayed during 
the task so that participants have a frame of reference when completing the 
questionnaire. 
Neuroimaging: The MRI data will be collected during approximate 60 min 
sessions that will include positioning participants in the scanner, collecting T1-
weighted structural scans, and conducting target fMRI experiments. Some 
parameters may be modified to accommodate the specifics of this multisite study. 
MRI scanning performed at the Dent Neurologic Institute will be performed on a 
Philips Ingenia 3T system (200 T/m/s slew rate). T1 weighted anatomical images 
will be acquired with a 3D Turbo Field Echo (TFE) sequence at 1mm isotropic 
resolution and scanning parameters: Shot interval = 2500ms, TR = 7.7ms, TE = 
3.5ms, FA = 8 deg., BW = 191.5 Hz/2.26 pixel, and SENSE parallel imaging 
factor of 2.2, for an acquisition time of 5 minutes and 10 seconds. MRI scanning 
at Virginia Tech Carilion Research Institute or at the Virginia Tech Corporate 
Research Center will be performed on a Siemens 3T Tim Trio system outfitted 
with a 45 mT/m gradient system (200 T/m/s slew rate). T1 weighted anatomical 
images will be acquired with a 3D MPRAGE sequence at 1 mm isotropic 
resolution and scanning parameters: TI = 900 ms, TR = 2.6 s, TE = 3 ms, FA = 
8°, BW = 130 Hz/pixel, and GRAPPA parallel imaging factor of 2, for an 
acquisition time of 4 minutes and 38 seconds. FMRI data will be acquired using a 
T2* weighted single-shot EPI sequence, matched across the two sites (see also 
section 6.6.3). Whole-brain functional volumes will be acquired in 26 3.4-mm 
axial slices (with a 20% slice gap), each with 3.4 mm x 3.4 mm in-plane 
resolution. Additional fMRI imaging parameters include: TR = 2 s, TE = 25 ms, 
FA = 90 deg., BW = 1953 Hz/pixel.  
 
10.4 Describe any source records that will be used to collect data about subjects 
(e.g. school records, electronic medical records). 
Response:  
Electronic medical records will be used. These will include records from patients 
at UBMD, Urban Family Practice, and additional records provided through the 
use of i2b2. 
10.5 Indicate whether or not individual subject results, such as results of 
investigational diagnostic tests, genetic tests, or incidental findings will be 
shared with subjects or others (e.g., the subject’s primary care physician) 
and if so, describe how these will be shared. 
Response:  
Participants will be given a choice as to whether they would like their screening 
results shared with them and/or with their physician, see supporting document 
“Participant Physician Follow-up Form”. If participants have values at a certain 
critical level (e.g. critically high blood pressure), express extreme feelings of 
depression (assessed by the Beck Depression Inventory), express suicidal 
thoughts, or the fMRI images reveal any areas of concern their physician will 

 
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automatically be notified by mail, fax, or phone call. Records may include height, 
weight, blood pressure, HbA1c, pregnancy, drug screen, and brain images.  
10.6 Indicate whether or not study results will be shared with subjects or others, 
and if so, describe how these will be shared. 
Response:  
Study results will not be shared with subjects. Findings may be presented at 
conferences and published in scientific journals. 
11.0 
Study Timelines 
11.1 Describe the anticipated duration needed to enroll all study subjects. 
Response:  
This study will complete rolling recruitment and we anticipate it will take 
approximately 1 year to enroll all study subjects. 
11.2 Describe the duration of an individual subject’s participation in the study. 
Include length of study visits, and overall study follow-up time. 
Response:  
Subjects will attend two appointments, each appointment being approximately 90-
120 minutes. This is the same for both arms of the study. 
11.3 Describe the estimated duration for the investigators to complete this study 
(i.e. all data is collected and all analyses have been completed). 
Response:  
This study will take approximately 2 years to complete. 
12.0 
Setting 
12.1 Describe all facilities/sites where you will be conducting research 
procedures.  Include a description of the security and privacy of the 
facilities (e.g. locked facility, limited access, privacy barriers).  Facility, 
department, and type of room are relevant.  Do not abbreviate facility 
names.   
NOTE:  Examples of acceptable response may be:  “A classroom setting in the 
Department of Psychology equipped with a computer with relevant survey 
administration software,” “The angiogram suite at Buffalo General Medical 
Center, a fully accredited tertiary care institution within New York State with 
badge access,” or, “Community Center meeting hall.” 
Response:  
This research will be conducted at the University at Buffalo (UB) and 
Virginia Polytechnic Institute and State University (VT) as well as their 
corresponding fMRI facilities. All facilities are locked and require key or 
badge access to enter in relevant research areas.  

 
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The UB team will conduct research at the Division of Behavioral 
Medicine Research Labs, located in G56, G58, G90 and 151 Farber Hall, 
University at Buffalo South Campus. The fMRI scans will be conducted at 
local fMRI facilities located at Dent Neurologic Institute (3980 Sheridan 
Drive, Buffalo, NY). 
The VT research team will conduct research at the Virginia Tech Carilion 
Research Institute, in Roanoke and Blacksburg locations. The fMRI scans will 
also be conducted at the Virginia Tech Carilion Research Institute, also in 
Roanoke or Blacksburg. Recruitment and screening will be in collaboration with 
Carilion Clinic Department of Family and Community Medicine in Roanoke and 
surrounding areas. 
12.2 For research conducted outside of UB and its affiliates, describe: 
• Site-specific regulations or customs affecting the research 
• Local scientific and ethical review structure 
NOTE:  This question is referring to UB affiliated research taking place outside 
UB, i.e. research conducted in the community, school-based research, 
international research, etc.  It is not referring to multi-site research.  UB affiliated 
institutions include Kaleida Health, ECMC, and Roswell Park Cancer Institute.   
Response:  
Dent Neurologic Institute will follow the same scientific and ethical review 
structure as the University at Buffalo. All research staff working on the project 
will need to complete Human Subjects Training as per the University 
requirements. Staff will be trained across sites to follow the same procedures and 
weekly/monthly meetings will be organized to ensure this. 
☐ 
N/A:  This study is not conducted outside of UB or its affiliates. 
13.0 
Community-Based Participatory Research 
13.1 Describe involvement of the community in the design and conduct of the 
research.  
NOTE:  Community-Based Participatory Research (CBPR) is a collaborative 
approach to research that equitably involves all partners in the research process 
and recognizes the unique strengths that each brings.  CBPR begins with a 
research topic of importance to the community, has the aim of combining 
knowledge with action and achieving social change to improve health outcomes 
and eliminate health disparities. 
Response:  
 
☒ 
N/A:  This study does not utilize CBPR. 
13.2 
Describe the composition and involvement of a community advisory 
board. 

 
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Response:  
 
☒ 
N/A:  This study does not have a community advisory board. 
14.0 
Resources and Qualifications 
14.1 Describe the qualifications (e.g., education, training, experience, expertise, 
or certifications) of the Principal Investigator and staff to perform the 
research.  When applicable describe their knowledge of the local study sites, 
culture, and society.  Provide enough information to convince the IRB that 
you have qualified staff for the proposed research.  
NOTE:  If you specify a person by name, a change to that person will require prior 
approval by the IRB.  If you specify a person by role (e.g., coordinator, research 
assistant, co-investigator, or pharmacist), a change to that person will not usually 
require prior approval by the IRB, provided that the person meets the 
qualifications described to fulfill their roles. 
Response:  
The Principal Investigator, Dr. Leonard H. Epstein is a Distinguished Professor of 
Pediatrics, and Social and Preventive Medicine at the State University of New 
York at Buffalo. Dr. Epstein has published over 300 papers in peer reviewed 
journals. The project coordinator and research staff have experience in behavioral 
research using similar methodology and have completed the appropriate 
certifications: CITI and CPR/First Aid/AED. 
Describe other resources available to conduct the research.  
14.2 Describe the time and effort that the Principal Investigator and research 
staff will devote to conducting and completing the research. 
NOTE:  Examples include the percentage of Full Time Equivalents (FTE), hours 
per week.  The question will elicit whether there are appropriate resources to 
conduct the research. 
Response:  
The Principle Investigator will devote approximately 8-10 hours per week 
to meet with staff, oversee data safety and discuss recruitment and study 
specific information. 
The Project Coordinator will spend approximately 40% of their time 
training and supervising staff, including conducting weekly project 
meetings, 10% completing the Human Subjects Review Process, 20% 
coordinating the scheduling of appointments for staff and prospective 
subjects, 10% coordinating and assisting in the test sessions, 10% 
coordinating multisite weekly meetings, and 10% overseeing the 
development of study materials. 
Research Assistants will spend approximately 50% of their time training and 
running participants, 20% recruiting subjects, 20% developing project materials, 

 
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including questionnaires, surveys, and forms, and 10% entering data and quality 
control of the data collected during the study 
14.3 Describe the availability of medical or psychological resources that subjects 
might need as a result of anticipated consequences of the human research, if 
applicable. 
NOTE:  One example includes: on-call availability of a counselor or psychologist 
for a study that screens subjects for depression. 
Response:  
The availability of experienced endocrinologists will be available for our study 
that examines subjects at risk for Type 2 Diabetes. 
If a participant scores high on the PHQ-9 (greater than or equal to 10) or they 
respond with any answer other than “not at all” to the suicidality question, the 
project coordinator and PI will be notified. These participants will also be 
provided with a resource list (see supporting document “Resource List” with 
name, address, and phone number of local and national counseling resources, 
crisis services, and emergency services. 
During any of the visits, if the participant appears to extremely upset (e.g. 
emotional, crying,) the project coordinator and PI will be notified. These 
participants will be asked to fill out the Beck Depression Inventory as well as 
provided with the list of resources. We will notify this participant’s physician of 
their depression score by mail, fax, or phone call, and suggest that they follow up 
with their patient. Additionally, we will follow up with the participant within the 
next 24 hours. 
14.4 Describe your process to ensure that all persons assisting with the research 
are adequately informed about the protocol, the research procedures, and 
their duties and functions. 
Response:  
All personnel working on the project are required to complete the CITI training as 
required by IRB. Additionally, there are extensive procedures manuals that are 
read and followed by all personnel. The Project Coordinator is responsible for 
training staff on data collection and recording procedures. 
Project coordinator and the principal investigators will be responsible for ensuring 
proper staff training on study procedures and consistency of data collection 
between each site. This will be achieved through local training, regular 
communication between sites and coordinating procedural materials for 
experimenters. 
 
15.0 
Other Approvals 
15.1 Describe any approvals that will be obtained prior to commencing the 
research (e.g., school, external site, funding agency, laboratory, radiation 
safety, or biosafety). 

 
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Response:  
IRB approval for procedures taking place at Virginia Tech, DENT Neurologic 
Institute, and the Virginia Carilion Clinic. 
☐ 
N/A:  This study does not require any other approvals. 
16.0 
Provisions to Protect the Privacy Interests of Subjects 
 
16.1 Describe how you will protect subjects’ privacy interests during the course 
of this research. 
NOTE:  Privacy refers to an individual’s right to control access to him or herself.  
Privacy applies to the person.  Confidentiality refers to how data collected about 
individuals for the research will be protected by the researcher from release.  
Confidentiality applies to the data.   
Examples of appropriate responses include:  “participant only meets with a study 
coordinator in a classroom setting where no one can overhear”, or “the 
participant is reminded that they are free to refuse to answer any questions that 
they do not feel comfortable answering.”   
Response:  
Prospective participants may contact the laboratory of their own free will and are 
thus controlling access to their privacy. All data will be collected in a secure 
laboratory environment in password protected databases in which only study staff 
has access. Participants will only interact with project research staff and sessions 
will take place in a private laboratory room that includes a closed circuit 
television monitoring system that will be monitored by the experimenter to ensure 
participant protocol adherence and safety. Participants are reminded that they are 
free to refuse to answer any questions that they do not feel comfortable answering 
and that all information is kept confidential to the extent provided by law. 
16.2 Indicate how the research team is permitted to access any sources of 
information about the subjects.   
NOTE:  Examples of appropriate responses include:  school permission for review 
of records, consent of the subject, HIPAA waiver.  This question does apply to 
records reviews. 
Response:  
Participants will be recruited using a secure database of interested participants 
maintained by the Division of Behavioral Medicine and approved for use by 
previous IRB committees. Potential participants will be contacted if they had 
indicated that they are willing to be contacted for participation in studies and thus 
control their own participation. A HIPAA waiver has been completed for the 
recruitment of participants through medical records, which is completed through 
the physician’s office with the consent of the primary care physician. The 
research team may also contact primary care physicians to confirm eligibility after 
participants have completed consent/HIPAA/medical release forms. 

 
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17.0 
Data Management and Analysis 
17.1 Describe the data analysis plan, including any statistical procedures.  This 
section applies to both quantitative and qualitative analysis.  
Response:  
Analytic plan is to use factorial ANCOVA to compare between group differences 
in different measures of DD, executive function and fMRI-measured brain 
function for subjects randomly assigned to poverty/neutral conditions and 
EFT/ERT. Covariates will be used if significant differences between groups are 
observed in subject characteristics. We predict a main effect of neutral/poverty, 
such that those assigned to poverty will have higher DD than those assigned to 
neutral, and an interaction between poverty/neutral and EFT such that in the 
poverty condition, EFT will reduce the discounting to levels achieved by the 
wealth, ERT subjects. We also predict when participants who receive EFT under 
challenge of poverty that EFT will increase activation in brain regions associated 
with delay of gratification (LPFC and AC) and prospection (hippocampus) 
relative to those who receive EFT under similar challenges. 
17.2 If applicable, provide a power analysis.   
NOTE:  This may not apply to certain types of studies, including chart/records 
reviews, survey studies, or observational studies.  This question is asked to elicit 
whether the investigator has an adequate sample size to achieve the study 
objectives and justify a conclusion.  
Response:  
The sample size is based on our studies of EFT versus ERT on DD in overweight 
and  obese subjects, which showed an average AUC of 0.54 + 0.28, and our 
unpublished research that poverty simulations reduces DD by 34%. We estimate 
in the ERT condition, neutral simulations will lead to less discounting and higher 
AUC than poverty simulations (0.54 vs 0.36). We estimate in EFT conditions, that 
simulations of neutral are associated with a small improvement in discounting in 
comparison to poverty simulations (0.63 vs 0.54). These predictions suggest that 
DD in EFT/Poverty and ERT/Wealth will be equivalent. The effect size for this 
interaction is 0.35. Using the overall SD we observed of 0.28, alpha of .05 and 
power of 0.80, we can show the effect size for this interaction with 17 Ss/group, 
or 68 total, or 34 per site in the behavioral portion and in the imaging portion. To 
be conservative, we will study up to 100 subjects. 
17.3 Describe any procedures that will be used for quality control of collected 
data. 
Response:  
The principal investigator will be responsible for ensuring data integrity and 
safety monitoring for human subjects who are involved in the research and 
communicating any negative outcomes of the data and safety monitoring plans 
(DSMP) reviews or any serious event or problem (SEP) that occur to the SBSIRB 
and other required offices/agencies. Materials will be checked to make sure that 

 
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all study data are coded with a unique participant ID. The ID will be linked only 
by a name through a master list kept by the project coordinator in a password-
protected file. 
18.0 
Confidentiality 
 
A. Confidentiality of Study Data 
 
Describe the local procedures for maintenance of confidentiality of study data 
and any records that will be reviewed for data collection.   
 
18.1 
A.  Where and how will all data and records be stored?  Include 
information about:  password protection, encryption, physical controls, 
authorization of access, and separation of identifiers and data, as applicable.  
Include physical (e.g. paper) and electronic files. 
Response:  
The i2b2 data will be protected by only accessing identifiable contact information 
remotely on IHI’s “virtual machine”, so the identifiable data never leaves their 
secure encrypted server. All use of identifiable data is done behind the firewall on 
IHI’s secure system. 
Potential participants who have filled out the prescreen survey will have their 
responses stored on a password protected server that only the research staff will 
have access too. Additionally, if there are paper copies of the prescreen survey 
responses they will be de-identified and stored in a locked filing cabinet in a 
locked room (252A Farber hall) which only research staff has access to. 
Participants will be assigned a unique identification number to ensure the 
confidentiality of the data. A master list that links subject ID and participant’s 
name will kept in a secure file that is password protected on a password protected 
computer. Only research staff will access to the master list. Paper files will be 
kept in locked lab offices at the Division of Behavioral Medicine Research Lab 
and electronic files will be kept on password protected computers in password 
protected/encrypted databases only accessible to members of the research staff. 
When the results of the study are presented and/or published, only group data will 
be provided; no individual participant will be identifiable. 
18.2 
A.  How long will the data be stored? 
Response:  
Data will be retained for a period of at least three years. The master list linking 
the study ID with the participant name will be kept in a locked cabinet in G56 for 
three years after the completion of the study at which point it will be destroyed. 
De-identified data will be retained indefinitely. 
18.3 
A.  Who will have access to the data? 
Response:  

 
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Only the principal investigator and research staff associated with the study will 
have access to the data. 
18.4 
A.  Who is responsible for receipt or transmission of the data? 
Response:  
The principal investigator takes primary responsibility for the data. 
18.5 
A.  How will the data be transported? 
Response: 
Data will be transported in password protected/encrypted files via email. fMRI 
data will be uploaded from DENT to a DICOM server so that Researchers at 
Virginia Tech are able to analyze imaging results. All transferred data will be de-
identified  
B. Confidentiality of Study Specimens 
 
Describe the local procedures for maintenance of confidentiality of study 
specimens.   
 
☐ 
N/A:  No specimens will be collected or analyzed in this research.   
(Skip to Section 19.0) 
 
18.6 
B.  Where and how will all specimens be stored?  Include information 
about:  physical controls, authorization of access, and labeling of specimens, as 
applicable.   
Response:  
All blood and urine samples will be analyzed during or immediately after the 
initial screening appointment and will not be saved (i.e., stored). Data will not be 
banked for future use. 
18.7 
B.  How long will the specimens be stored? 
Response:  
N/A, specimens will not be stored. 
18.8 
B.  Who will have access to the specimens? 
Response:  
Research staff conducting appointments will have access to the specimens during 
or immediately after the initial screening appointment. However, specimens will 
not be stored. 
18.9 
B.  Who is responsible for receipt or transmission of the specimens? 
Response:   
N/A, there is no receipt or transmission of the specimens. 

 
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18.10 B.  How will the specimens be transported? 
Response: 
N/A, the specimens will not be transported. 
 
19.0 
Provisions to Monitor the Data to Ensure the Safety of 
Subjects 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
 
NOTE:  Minimal risk studies may be required to monitor subject safety if the research 
procedures include procedures that present unique risks to subjects that require 
monitoring.  Some examples include:  exercising to exertion, or instruments that elicit 
suicidality or substance abuse behavior.  In such cases, N/A is not an acceptable 
response. 
 
19.1 Describe the plan to periodically evaluate the data collected regarding both 
harms and benefits to determine whether subjects remain safe. 
Response:  
Data will be reviewed weekly and secured in Division of Behavioral Medicine 
Research Lab. The Principal Investigator, Leonard H. Epstein, PhD, will be 
responsible for ensuring data integrity and safety monitoring for human subjects 
who are involved in the research along with the Data Safety Officer. 
19.2 Describe what data are reviewed, including safety data, untoward events, 
and efficacy data. 
Response:  
Study questionnaires and measurements that are collected by study personnel will 
be reviewed and monitored. 
19.3 Describe any safety endpoints. 
Response:  
This study poses no greater than minimal risk; therefore, there are no safety 
endpoints. 
19.4 Describe how the safety information will be collected (e.g., with case report 
forms, at study visits, by telephone calls with participants). 
Response:  
Participants will be encouraged to contact study personnel if they experience any 
problems or difficulties, and if any adverse events (AE) are reported, the study 
personnel contacted will record the AE. AE will be recorded as soon as they are 
reported, and the PI and study coordinator will be made aware. The study 
coordinator will summarize the AE in a memo; the participant will be called and 
the summary will be read to them to ensure that the information is accurate. The 

 
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memo will then be submitted to the University at Buffalo IRB and the PI. If the 
PI, or the IRB decide that further action is warranted, the PI and study coordinator 
will then formulate and carry out a plan to respond to the AE. The study 
coordinator will write a memo summarizing such actions; this memo will then be 
forwarded to the IRB. Safety information will be collected and reported to both 
the UBIRB and the Safety Officer in the time frames outlined by the UBIRB. 
19.5 Describe the frequency of safety data collection. 
Response:  
Data will be reviewed weekly and secured in G56 and G252A Farber Hall. A 
weekly review of these data will be conducted by the principal investigator and 
project coordinator during their staff meetings with study personnel. 
19.6 Describe who will review the safety data. 
Response:  
Serious Events and Problems (SEP) will be monitored by the principal 
investigator and project coordinator as well as reported to both the IRB and the 
Safety Officer in the timeframes outlined by the IRB. 
19.7 Describe the frequency or periodicity of review of cumulative safety data. 
Response:  
Cumulative data will be reviewed approximately six months to a year based on 
the requirements of the Grant and NIH committee. 
19.8 Describe the statistical tests for analyzing the safety data to determine 
whether harm is occurring. 
Response:  
N/A, there are no discontinuing criteria. 
19.9 Describe any conditions that trigger an immediate suspension of the 
research. 
Response:  
N/A, there are no discontinuing criteria. 
20.0 
Withdrawal of Subjects 
☐ 
N/A:  This study is not enrolling subjects.  This section does not apply. 
 
20.1 Describe anticipated circumstances under which subjects may be withdrawn 
from the research without their consent. 
Response:  
Subjects who do not adhere to the protocol procedures and study instructions may 
be withdrawn from research analyses, as determined by the Principal Investigator 
and/or NIH Data Safety Committee. In addition to not adhering to study 

 
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instructions, possible reasons for removal include nonsystematic responding to 
questionnaires and HbA1c (blood sugar) levels that are not in the prediabetes 
range. If a participant is withdrawn from the study without their consent, they will 
be debriefed about the nature of the study and be compensated for the amount of 
time spent in the study. We may also stop an ongoing session, or end participation 
in the study because we have collected all the information we need. 
20.2 Describe any procedures for orderly termination.   
NOTE:  Examples may include return of study drug, exit interview with clinician.  
Include whether additional follow up is recommended for safety reasons for 
physical or emotional health. 
Response:  
Participants will be debriefed about the nature of the study and the reason for their 
removal, if a safety concern. No additional follow-up is needed. 
20.3 Describe procedures that will be followed when subjects withdraw from the 
research, including retention of already collected data, and partial 
withdrawal from procedures with continued data collection, as applicable. 
Response:  
Participants can withdraw from the research at any time. If participants withdraw, 
no further data will be collected, but any information that had been provided may 
be retained by the researcher and analyzed. 
21.0 
Risks to Subjects 
21.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related to their participation in the research. 
Consider physical, psychological, social, legal, and economic risks.  Include 
a description of the probability, magnitude, duration, and reversibility of the 
risks.  
NOTE:  Breach of confidentiality is always a risk for identifiable subject data. 
Response:  
There may be some sensitivity associated from certain questions asked 
when filling out questionnaires or having body measurements taken and 
subjects might feel uncomfortable disclosing some personal information 
such as medical history. Subjects can refuse to answer any questions that 
they are not comfortable answering. Subjects 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 may experience hunger due to refraining from eating before 
the session or possibly suffer a new allergic reaction to the PowerBar (i.e., 
an allergic reaction to a food to which he/she was not allergic in the past). 
Feelings of hunger will subside when the participant is able to eat after the 
session and the study food used is a common food thus researchers 
anticipate that participants will know if they should avoid eating them for 

 
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medical, religious, or preference reasons. In addition, only personnel 
certified in CPR, first aid, and AED will conduct study sessions and these 
individuals are trained to contact appropriate medical personnel in the 
event of an emergency. 
Breach of confidentiality is another potential risk. The studies will occur 
in our facilities at the University at Buffalo and the Virginia Tech Carilion 
Research Institute. To protect confidentiality, we will use only ID numbers 
and keep all data in locked cabinets or in locked offices and password 
protected electronic files in password protected computers. Any data 
shared 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 10 years and 
for more than 2,000 subjects across the various protocols employed by our 
group. 
Participants may have a small bruised area on the finger from the pinprick 
site. The bruise should fade over time without treatment. If during the 
course of the study, a subject’s blood glucose exceeds the range for 
prediabetes (Fasting Plasma Glucose (FPG) 100-125 mg/dl, or 2h glucose 
140-199 mg/dl after Oral Glucose Tolerance Test (OGTT) or hemoglobin 
A1c (HbA1c) 5.7-6.4%), that subject will be directed to his or her 
physician or other medical care provider for further evaluation.  
Participants may have their blood pressure measured. If during the course 
of the study, a subject’s blood pressure reaches hypertensive crisis 
(180/110 mmHg), that subject will be directed to his or her physician or 
other medical care provider for further evaluation. 
During the fMRI, movement or heating of metallic implants is a potential 
risk; subjects will thus be carefully screened to exclude individuals with 
metallic implants, fragments, or pacemakers. Some individuals may 
experience mild discomfort or anxiety in the scanner, and all subjects will 
be informed of this possibility prior to the study. In addition, throughout 
the scanning procedures, subjects will be able to communicate with the 
investigators via intercom, and any individual experiencing discomfort 
will be removed from the scanner immediately. 
As noted, physical risk to subjects during fMRI recording is very low. 
Nevertheless, in addition to the measures to ensure the safety and comfort 
of subjects noted above, every effort will be made to provide information 
to subjects to minimize discomfort. There may be additional risks 
associated with scanning at 3 T compared to the conventional clinical 
scanners in the 1.5-2.0 T range. These include: 
Effect of the static field. There is no conclusive evidence for irreversible 
or hazardous bioeffects to acute, short-term exposures of humans up to 2.0 
T (Shellock et al., 1996). Studies have indicated some side-effects at 4.0 
T, namely unusual sensations including nausea, vertigo, and metallic taste. 
However, there is no evidence that these effects are either irreversible or 

 
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harmful. If subjects experience unusual sensations, they will be 
withdrawn. 
Effect of the gradient field. MRI operates by rapidly changing small 
additional fields, called gradients. This will induce small electrical 
currents in any conductor, and thus could theoretically induce mild 
peripheral nerve stimulation. However, this is not substantially different at 
higher magnetic fields as the gradients are separate from the main magnet. 
There is no evidence that the effect of the gradients is any different at 3 T 
than at 1.5 T. However, if subjects experience peripheral nerve stimulation 
such as tingling or twitching, they will be withdrawn. 
Effect of the RF electromagnetic field. The higher magnetic field strength 
requires that higher RF frequency pulses be used to excite the protons in 
the subject’s brain. The limits of RF energy that can be safely given to 
humans has been clearly defined by the FDA: a) The exposure to RF 
energy below the level of concern is an SAR of 0.4 W/kg or less over the 
body, and 8.0 W/kg or less spatial peak in any 1 g of tissue, and 3.2 W/kg 
or less averaged over the head; or b) The exposure to RF energy that is 
sufficient to produce a core temperature increase of 1 degree C and 
localized heating to no greater extent than 38 degrees C in the head, 39 
degrees C in the trunk, and 40 degrees C in the extremities, except for 
patients with impaired systemic blood flow and/or perspiration. The 
scanner has a large monitor indicating the RF power level which can be 
limited to a specific maximum, and we will adhere to the 
recommendations.  
There are no other risks anticipated. All personnel on the study will be CITI 
course certified and have completed the good research practices certification. All 
identifiable data will be password protected and only the research team will have 
access to that information. Subjects will be informed of the risks associated with 
the study. 
21.2 Describe procedures performed to lessen the probability or magnitude of 
risks, including procedures being performed to monitor subjects for safety. 
Response:  
We have several provisions in place to ensure participants’ privacy and 
safety is protected while the data is being collected. The lab facilities of 
the Division of Behavioral Medicine research laboratory consist of private 
interview rooms that will be used. Only the interviewer and participant 
will be present in the room during interviews. Data is recorded such that 
not even the person putting it in the file would ever be able to associate the 
data with the identity of the person providing it. Data and files that have 
been de-identified and encrypted will be shared between sites. Therefore, 
there is no reasonable risk of a breach of confidentiality. Only personnel 
certified in CPR, first aid, and AED will conduct study sessions and these 
individuals are trained to contact appropriate medical personnel in the case 
of a serious event. Should an emergency situation occur, access to further 

 
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medical care is available via a telephone located in the laboratory and the 
following emergency plan will be followed: 
1. Have the subject immediately stop any activity and lay down. 
2. Call for help! ON CAMPUS EMERGENCY (716-645-2222) or 
POLICE (911). 
3. If the subject is unconscious – assess breathing and heart rate. Initiate 
CPR and call on campus emergency services or police as necessary. 
4. If the subject is conscious – continue to observe subject. 
21.3 If applicable, indicate which procedures may have risks to the subjects that 
are currently unforeseeable. 
Response:  
N/A, subjects will be allowed to refuse to answer any questions they are not 
comfortable with. 
21.4 If applicable, indicate which research procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
Response:  
MRI scans are not recommended for pregnant individuals. We will offer urine 
pregnancy test for females at the beginning and throughout the study. We will 
notify females of positive pregnancy test results and discontinue them from the 
study. 
21.5 If applicable, describe risks to others who are not subjects. 
Response:  
N/A, no foreseeable risks to others who are not subjects. 
22.0 
Potential Benefits to Subjects 
22.1 Describe the potential benefits that individual subjects may experience by 
taking part in the research.  Include the probability, magnitude, and 
duration of the potential benefits.  Indicate if there is no direct benefit.   
NOTE:  Compensation cannot be stated as a benefit. 
Response:  
There are no direct benefits from participating in this study. Participants may 
learn about the experimental research process and their health. 
23.0 
Compensation for Research-Related Injury 
☒ 
N/A:  The research procedures for this study do not present risk of 
research related injury (e.g. survey studies, records review studies).  This 
section does not apply.   

 
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23.1 
If the research procedures carry a risk of research related injury, 
describe the available compensation to subjects in the event that such injury 
should occur.   
Response: 
 
23.2 
Provide a copy of contract language, if any, relevant to compensation for 
research related injury. 
NOTE:  If the contract is not yet approved at the time of this submission, submit the 
current version here.  If the contract is later approved with different language regarding 
research related injury, you must modify your response here and submit an amendment 
to the IRB for review and approval. 
Response:  
 
24.0 
Economic Burden to Subjects 
24.1 Describe any costs that subjects may be responsible for because of 
participation in the research.   
NOTE:  Some examples include transportation or parking. 
Response:  
Subjects are not responsible for any costs because of participation in the research. 
Transportation or parking fees will be reimbursed. 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
25.0 
Compensation for Participation 
25.1 
Describe the amount and timing of any compensation to subjects, 
including monetary, course credit, or gift card compensation. 
Response:  
For participants in either arms of the study they will receive up to $140 for 
completing the experimental study in the form of a reloadable debit card. 
Participants in the behavioral arm of this study will receive $40 for completing 
session 1, $50 for completing session 2, and a $50 completion bonus. Participants 
in the MRI arm of this study will receive $40 for completing session 1, $50 for 
completing session 2, and a $35 completion bonus. Additionally participants who 
are MRI scanned will have the opportunity to receive an MRI scanning bonus of 
$15 for remaining still and awake while inside the scanner. This bonus should 
encourage participants to help optimize the quality of the scans. Incomplete 
sessions will be paid on a prorated basis. Reimbursement may be offered for the 
cost of transportation (i.e. bus, taxi fare). Additionally, to encourage attending 
fMRI appointments on time, due to the high cost of fMRI reservations and 
technicians, we will offer on-time participants an opportunity to participate in a 

 
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lottery for $0, $1, $5 and $10 prizes. Payments will be made after each completed 
session. If a participant was considered ineligible based on HbA1c measurements 
using the A1CNow+® system, and came back to our lab for an additional HbA1c 
measurement using the Alere AfinionTM AS100 Analyzer System, they will be 
compensated an additional $15. 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records 
review procedures only.  This section does not apply. 
☐ 
N/A:  There is no compensation for participation.  This section 
does not apply. 
26.0 
Consent Process 
26.1 Indicate whether you will be obtaining consent.   
NOTE:  This does not refer to consent documentation, but rather whether you will 
be obtaining permission from subjects to participate in a research study.   
Consent documentation is addressed in Section 27.0. 
☒ 
Yes 
(If yes, Provide responses to each question in this Section) 
☐ 
No 
(If no, Skip to Section 27.0) 
 
26.2 Describe where the consent process will take place.  Include steps to 
maximize subjects’ privacy. 
Response:  
Interested participants will be screened over the phone or have an opportunity to 
complete the survey online. Consent to screen for eligibility will be obtained 
verbally over the phone or through an action (e.g. clicking an “I agree” button) 
online. Screening consent will be obtained prior to asking any contact or 
eligibility questions. Documented informed consent will be obtained in a private 
room at the Division of Behavioral Medicine Research Lab during the scheduled 
laboratory appointment. For participants who are invited back to our lab for a 
second screening test using the Alere AfinionTM AS100 Analyzer System, they 
will sign a new consent document. This document will identical to the original 
one they signed, with the exception that it will provide information about why 
they are being invited back and that they will receive additional compensation. 
26.3 Describe how you will ensure that subjects are provided with a sufficient 
period of time to consider taking part in the research study.   
NOTE:  It is always a requirement that a prospective subject is given sufficient 
time to have their questions answered and consider their participation.  See “SOP: 
Informed Consent Process for Research (HRP-090)” Sections 5.5 and 5.6. 
Response:  
There will not be a significant interval of time between obtaining and 
documenting consent and the actual participation in the initial research procedures 
(i.e. shortly after the person signs the document they will begin research 
procedures at their scheduled convenience).  However, if a subject requests more 

 
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time to review the consent form, they are able to take the consent home to review 
and discuss with family members, then schedule a visit at a later date.  
26.4 Describe any process to ensure ongoing consent, defined as a subject’s 
willingness to continue participation for the duration of the research study.   
Response:  
The MRI screening information will be reviewed prior to each scan. Participants 
will be asked about any changes since screening. Participants will be reminded to 
remove all metal and MRI operators will screen accordingly. Participants will also 
be reminded that they can notify experimenters of any extreme discomfort at any 
point during the scan (by a squeeze ball held throughout all scans). Experimenters 
will also communicate with participants between scans/tasks to ensure comfort 
and safety. 
26.5 Indicate whether you will be following “SOP: Informed Consent Process for 
Research (HRP-090).” If not, or if there are any exceptions or additional 
details to what is covered in the SOP, describe: 
• 
The role of the individuals listed in the application who are involved in 
the consent process 
• 
The time that will be devoted to the consent discussion 
• 
Steps that will be taken to minimize the possibility of coercion or 
undue influence 
• 
Steps that will be taken to ensure the subjects’ understanding 
Response:  
 
☒ 
We have reviewed and will be following “SOP: Informed Consent Process 
for Research (HRP-090).” 
 
Non-English Speaking Subjects  
☒ 
N/A:  This study will not enroll Non-English speaking subjects.   
(Skip to Section 26.8) 
26.6 Indicate which language(s) other than English are likely to be 
spoken/understood by your prospective study population or their legally 
authorized representatives. 
 
NOTE: The response to this Section should correspond with your response to 
Section 6.4 of this protocol. 
Response:  
 
26.7 If subjects who do not speak English will be enrolled, describe the process 
to ensure that the oral and written information provided to those subjects 

 
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will be in that language.  Indicate the language that will be used by those 
obtaining consent. 
NOTE:  Guidance is provided on “SOP:  Informed Consent Process for Research 
(HRP-090).” 
Response:  
 
 
Cognitively Impaired Adults 
☒ 
N/A:  This study will not enroll cognitively impaired adults.   
(Skip to Section 26.9) 
26.8   Describe the process to determine whether an individual is capable of 
consent.  
Response:  
 
 
Adults Unable to Consent 
☒ 
N/A:  This study will not enroll adults unable to consent.  
(Skip to Section 26.13) 
When a person is not capable of consent due to cognitive impairment, a legally 
authorized representative should be used to provide consent (Sections 26.9 and 
26.10) and, where possible, assent of the individual should also be solicited 
(Sections 26.11 and 26.12). 
26.9  Describe how you will identify a Legally Authorized Representative (LAR).  
Indicate that you have reviewed the “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013)” for research in New 
York State.  
NOTE:  Examples of acceptable response includes: verifying the electronic 
medical record to determine if an LAR is recorded. 
Response:  
 
☐ 
We have reviewed and will be following “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).”  
26.10 For research conducted outside of New York State, provide information 
that describes which individuals are authorized under applicable law to 
consent on behalf of a prospective subject to their participation in the 
research.  One method of obtaining this information is to have a legal 
counsel or authority review your protocol along with the definition of 

 
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“legally authorized representative” in “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).” 
Response:  
 
26.11 Describe the process for assent of the adults: 
• 
Indicate whether assent will be obtained from all, some, or none of the 
subjects.  If some, indicate which adults will be required to assent and 
which will not. 
Response:  
 
• 
If assent will not be obtained from some or all subjects, provide an 
explanation of why not. 
Response:  
 
26.12 Describe whether assent of the adult subjects will be documented and the 
process to document assent.   
NOTE:  The IRB allows the person obtaining assent to document assent on the 
consent document using the “Template Consent Document (HRP-502)” Signature 
Block for Assent of Adults who are Legally Unable to Consent. 
Response:  
 
 
Subjects who are not yet Adults (Infants, Children, and Teenagers) 
☒ 
N/A:  This study will not enroll subjects who are not yet adults.   
(Skip to Section 27.0) 
26.13 Describe the criteria that will be used to determine whether a prospective 
subject has not attained the legal age for consent to treatments or 
procedures involved in the research under the applicable law of the 
jurisdiction in which the research will be conducted (e.g., individuals under 
the age of 18 years).  For research conducted in NYS, review “SOP: 
Legally Authorized Representatives, Children, and Guardians (HRP-013)” 
to be aware of which individuals in the state meet the definition of 
“children.”  
NOTE:  Examples of acceptable responses include: verification via electronic 
medical record, driver’s license or state-issued ID, screening questionnaire. 
Response: Age of potential participants will be assessed using medical records 
and/or our screening questionnaire. 
 

 
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26.14For research conducted outside of New York State, provide information 
that describes which persons have not attained the legal age for consent to 
treatments or procedures involved the research, under the applicable law of 
the jurisdiction in which research will be conducted.  One method of 
obtaining this information is to have a legal counsel or authority review 
your protocol along the definition of “children” in “SOP: Legally 
Authorized Representatives, Children, and Guardians (HRP-013).” 
Response:  
 
26.15 Describe whether parental permission will be obtained from: 
Response:  
☐  One parent even if the other parent is alive, known, competent, reasonably 
available, and shares legal responsibility for the care and custody of the 
child. 
☐ 
Both parents unless one parent is deceased, unknown, incompetent, or not 
reasonably available, or when only one parent has legal responsibility for 
the care and custody of the child. 
☐ 
Parent permission will not be obtained.  A waiver of parent permission is 
being requested. 
NOTE:  The requirement for parent permission is a protocol-specific determination 
made by the IRB based on the risk level of the research.  For guidance, review the 
“CHECKLIST: Children (HRP-416).”  
26.16Describe whether permission will be obtained from individuals other than 
parents, and if so, who will be allowed to provide permission.  Describe 
your procedure for determining an individual’s authority to consent to the 
child’s general medical care. 
Response:  
 
26.17 Indicate whether assent will be obtained from all, some, or none of the 
children.  If assent will be obtained from some children, indicate which 
children will be required to assent. 
Response:  
 
26.18 When assent of children is obtained, describe how it will be documented. 
Response:  
 
27.0 
Waiver or Alteration of Consent Process 

 
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Consent will not be obtained, required information will not be disclosed, or the 
research involves deception. 
☒ 
N/A:  A waiver or alteration of consent is not being requested. 
27.1 If the research involves a waiver or alteration of the consent process, please 
review the “CHECKLIST: Waiver or Alteration of Consent Process (HRP-
410)” to ensure that you have provided sufficient information for the IRB to 
make the determination that a waiver or alteration can be granted.   
NOTE:  For records review studies, the first set of criteria on the “CHECKLIST: 
Waiver or Alteration of Consent Process (HRP-410)” applies.  
Response:  
 
27.2 If the research involves a waiver of the consent process for planned 
emergency research, please review the “CHECKLIST: Waiver of Consent 
for Emergency Research (HRP-419)” to ensure you have provided sufficient 
information for the IRB to make these determinations.  Provide any 
additional information necessary here: 
Response:  
N/A, this research does not involve a waiver for planned emergency research. 
28.0 
Process to Document Consent 
☐ 
N/A:  A Waiver of Consent is being requested.   
(Skip to Section 29.0) 
28.1 Indicate whether you will be following “SOP: Written Documentation of 
Consent (HRP-091).” If not or if there are any exceptions, describe whether 
and how consent of the subject will be obtained including whether or not it 
will be documented in writing.   
NOTE:  If your research presents no more than minimal risk of harm to subjects 
and involves no procedures for which written documentation of consent is normally 
required outside of the research context, the IRB will generally waive the 
requirement to obtain written documentation of consent.  This is sometimes 
referred to as ‘verbal consent.’  Review “CHECKLIST: Waiver of Written 
Documentation of Consent (HRP-411)” to ensure that you have provided sufficient 
information.  
If you will document consent in writing, attach a consent document with your 
submission.  You may use “TEMPLATE CONSENT DOCUMENT (HRP-
502)”.  If you will obtain consent, but not document consent in writing, attach the 
script of the information to be provided orally or in writing (i.e. consent script or 
Information Sheet).   
Response:  
 

 
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☒ 
We will be following “SOP:  Written Documentation of Consent” 
(HRP-091). 
29.0 
Multi-Site Research (Multisite/Multicenter Only) 
☐ 
N/A:  This study is not an investigator-initiated multi-site study.  This 
section does not apply. 
 
29.1 If this is a multi-site study where you are the lead investigator, describe the 
processes to ensure communication among sites, such as: 
• 
All sites have the most current version of the IRB documents, including 
the protocol, consent document, and HIPAA authorization. 
• 
All required approvals have been obtained at each site (including 
approval by the site’s IRB of record). 
• 
All modifications have been communicated to sites, and approved 
(including approval by the site’s IRB of record) before the 
modification is implemented. 
• 
All engaged participating sites will safeguard data as required by 
local information security policies. 
• 
All local site investigators conduct the study appropriately. 
• 
All non-compliance with the study protocol or applicable requirements 
will be reported in accordance with local policy. 
Response:  
Principal Investigator. Leonard H. Epstein, PhD, at the University at 
Buffalo will be responsible for the oversight of subject issues and 
coordination of experimental behavioral medicine approaches. Warren K. 
Bickel, PhD, at Virginia Tech will be responsible for management related 
to behavioral task data collection and analyses and will coordinate 
functional aspect of the fMRI component. Each PI will be responsible for 
recruitment at their site, communication with each other and their team, 
and for his own fiscal and research administration. 
Communication Process. Project coordinator, study staff and/or the PIs 
will have a local weekly meeting to discuss any current issues with the 
study, including, but not limited to; IRB approvals, procedures, staff 
training, data safety, and interim analyses. PI and/or project coordinator 
will schedule monthly conference calls to discuss study information. 
Monthly reports/meetings will be used to track recruitment, data, data 
quality control, interim analyses and any IRB concerns. The agendas and 
reports will be saved and filed at both locations. The PIs will communicate 
as needed, either by phone, e-mail, or in person, to discuss experimental 
design, data analysis, and all administrative responsibilities. Each PI will 
share their respective research results with the other PI, key personnel, and 
collaborators. 

 
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IRB approval records. UB’s IRB will be the IRB of record for both sites. 
UB will have records IRB approval for both sites. This will include copies 
of consents, protocols, questionnaires, and any other IRB-related 
document. Amendments and modifications will be discussed in weekly 
conference call meetings and implemented through UB’s IRB as required. 
Data Safety & Sharing/Transfer. Any and all potential safety concerns will 
be reported both to the IRB and additional site in a timely manner. We 
will follow the outlined procedures based on UB’s IRB New Information 
Reporting form. Any adverse event will be communicated to both sites 
within 24 hours to inform. UB will report new information to the IRB.  
Procedures. The two research groups will work collaboratively to implement 
research methods across the sites, and will develop common training procedures 
for the delay discounting, episodic future thinking, neuroimaging, and prediabetes 
components of the study. Members of each research team will be responsible for 
development of relevant manuals of operation for study methods. These will be 
communicated in regular email and phone meetings, as well as face-to-face 
meetings where investigators will travel to the other University for training and 
quality control issues. Team members are used to this approach since they have 
been involved in multi- center basic science and clinical projects. Each site will be 
responsible for data quality control, based on a common protocol, and quality 
control will be implemented after data sets are built prior to analysis. 
29.2 Describe the method for communicating to engaged participating sites: 
• 
Problems 
• 
Interim results 
• 
Study closure 
Response:  
Problems. Problems will be reported within 24 hours for adverse events 
and within 1 week for any methodological problems to both study 
coordinators. Study coordinators and PI’s will be responsible for reporting 
adverse events to each IRB within the UB IRB Reporting form time frame 
(i.e. 5 days for new information that impacts participant risk). Study 
coordinators and PI’s will be responsible for determining amendments 
required for changes to study protocol. 
Interim results. Data will be shared between sites and all data will be de-
identified prior to sending a password-protected/encrypted file. Study 
coordinators and PI’s will be responsible for communicating any interim 
results that are analyzed. 
Closure. All continuing review and closure forms will be shared between sites in 
an IRB related file. 
29.3 
Indicate the total number of subjects that will be enrolled or records that 
will be reviewed across all sites. 
Response:  

 
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Up to 250. 
29.4 
If this is a multicenter study for which UB will serve as the IRB of record, 
and subjects will be recruited by methods not under the control of the local site 
(e.g., call centers, national advertisements) describe those methods.  
Response:  
This is a multicenter study for which UB will serve as the IRB of record. The 
additional study sites, Virginia Tech and their Carilion clinic, will make use of 
flyers, brochures, and local recruitment mailings on the Virginia tech campus and 
surrounding areas along with community web based advertisements. Recruitment 
and screening will also be in collaboration with Carilion Clinic Department of 
Family and Community Medicine in Roanoke and surrounding areas. 
30.0 
Banking Data or Specimens for Future Use 
☒ 
N/A:  This study is not banking data or specimens for future use or 
research outside the scope of the present protocol.  This section does not 
apply. 
30.1 If data or specimens will be banked (stored) for future use, that is, use or 
research outside of the scope of the present protocol, describe where the 
data/specimens will be stored, how long they will be stored, how the 
data/specimens will be accessed, and who will have access to the 
data/specimens.  
NOTE:  Your response here must be consistent with your response at the “What 
happens if I say yes, I want to be in this research?” Section of the Template 
Consent Document (HRP-502). 
Response:  
 
30.2 List the data to be stored or associated with each specimen. 
Response:  
 
30.3 Describe the procedures to release banked data or specimens for future 
uses, including: the process to request a release, approvals required for 
release, who can obtain data or specimens, and the data to be provided with 
specimens. 
Response:  
 
31.0 
Drugs or Devices 
☐ 
N/A:  This study does not involve drugs or devices.  This section does not 
apply. 

 
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31.1 If the research involves drugs or devices, list and describe all drugs and 
devices used in the research, the purpose of their use, and their regulatory 
approval status.  
Response:  
MRI scanner will be used for data collection. 
31.2 Describe your plans to store, handle, and administer those drugs or devices 
so that they will be used only on subjects and be used only by authorized 
investigators. 
Response: 
IRB approved study team members at DENT Neurologic Institute who are MRI 
safety trained and experienced in neuroimaging research will store, handle, and 
administer the MRI. 
If the drug is investigational (has an IND) or the device has an IDE or a claim 
of abbreviated IDE (non-significant risk device), include the following 
information: 
31.3 Identify the holder of the IND/IDE/Abbreviated IDE. 
Response:  
N/A, this study does not involve IND/IDE/Abbreviated IDE. 
31.4 Explain procedures followed to comply with FDA sponsor requirements for 
the following:   
 
 
Applicable to: 
FDA Regulation 
IND Studies 
IDE studies 
Abbreviated 
IDE studies 
21 CFR 11 
X 
X 
 
21 CFR 54 
X 
X 
 
21 CFR 210 
X 
 
 
21 CFR 211 
X 
 
 
21 CFR 312 
X 
 
 
21 CFR 812 
 
X 
X 
21 CFR 820 
 
X 
 
Response:  
 
32.0 
Humanitarian Use Devices 
☒ 
N/A:  This study does not involve humanitarian use devices.  This does 
not apply. 
32.1 
For Humanitarian Use Device (HUD) uses provide a description of the 
device, a summary of how you propose to use the device, including a description 

 
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of any screening procedures, the HUD procedure, and any patient follow-up 
visits, tests or procedures. 
Response:  
 
32.2 
 For HUD uses provide a description of how the patient will be informed 
of the potential risks and benefits of the HUD and any procedures associated with 
its use. 
Response: