Imagine to Remember: Improving Medication Adherence in Pre- and Type 2 Diabetes
Phase: NA
Conditions: Medication Adherence
Sponsor: State University of New York at Buffalo

 
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 43 
 
 
 
Imagine to Remember: Improving Medication Adherence 
in Pre- and Type 2 Diabetes 
NCT Number: NCT04157673 
Document Date: 7/22/2020 
 
 

 
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 2 of 43 
 
Complete Research Protocol (HRP-503) 
 
Table of Contents 
Template Instructions ...................................................... Error! Bookmark not defined. 
1.0 
Study Summary ........................................................................................................ 4 
2.0 
Objectives* .............................................................................................................. 5 
3.0 
Scientific Endpoints* ............................................................................................... 5 
4.0 
Background* ............................................................................................................ 5 
5.0 
Study Design* .......................................................................................................... 8 
6.0 
Study Intervention/Investigational Agent ................................................................ 8 
7.0 
Local Number of Subjects ....................................................................................... 9 
8.0 
Inclusion and Exclusion Criteria* .......................................................................... 10 
9.0 
Vulnerable Populations* ........................................................................................ 12 
10.0 Eligibility Screening* ............................................................................................ 13 
11.0 Recruitment Methods ............................................................................................. 14 
12.0 Procedures Involved*............................................................................................. 17 
13.0 Study Timelines* ................................................................................................... 26 
14.0 Setting .................................................................................................................... 27 
15.0 Community-Based Participatory Research ............................................................ 28 
16.0 Resources and Qualifications ................................................................................. 28 
17.0 Other Approvals ..................................................................................................... 30 
18.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 30 
19.0 Data Management and Analysis* .......................................................................... 31 
20.0 Confidentiality* ..................................................................................................... 32 
A. 
Confidentiality of Study Data ......................................................................... 33 
B. 
Confidentiality of Study Specimens ................................................................ 34 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 35 
22.0 Withdrawal of Subjects* ........................................................................................ 37 
23.0 Risks to Subjects* .................................................................................................. 38 
24.0 Potential Benefits to Subjects* .............................................................................. 39 
25.0 Compensation for Research-Related Injury ........................................................... 40 
26.0 Economic Burden to Subjects ................................................................................ 40 
27.0 Compensation for Participation ............................................................................. 40 
28.0 Consent Process ..................................................................................................... 40 
29.0 Waiver or Alteration of Consent Process ............................................................... 42 
30.0 Process to Document Consent ............................................................................... 42 
31.0 Multi-Site Research (Multisite/Multicenter Only)*............................................... 43 
32.0 Banking Data or Specimens for Future Use* ........................................................ 43 
 
 
 

 
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PROTOCOL TITLE: 
Include the full protocol title. 
Response:  
Imagine to Remember: Improving Medication Adherence in Pre- and Type 2 
Diabetes 
PRINCIPAL INVESTIGATOR: 
Name 
Department 
Telephone Number 
Email Address 
Response:  
Leonard H. Epstein 
Division of Behavioral Medicine, Pediatrics 
716-829-3400 
lhenet@buffalo.edu 
 
VERSION NUMBER/DATE: 
Include the version number and date of this protocol. 
Response:  
v.8 4/7/2020 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
7 
3/7/2020 
Due to the ongoing concern in our area 
regarding COVID-19, we are updating sections 
12 and 18 to allow for us to take precautions to 
ensure the safety of our participants and staff.  
 
8 
4/7/2020 
Updates for Covid-19 
yes 
9 
7/22/2020 
Updates for CR 
no 
 
 
 
 
 
 
 
 
 
FUNDING: 
Indicate any funding for this proposal. This should match the Funding Sources 
page in Click IRB. 
Response:  

 
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This study is funded by the grant “Delay Discounting as a target for self-
regulation for prediabetics” funded by NIDDK RFA-RM-14-020, 
“Science of Behavior Change: Assay Development and Validation for 
Self-Regulation Targets (UH2)”. 
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 funded by the grant “Delay Discounting as a target for self-
regulation for prediabetics” funded by NIDDK RFA-RM-14-020, “Science of 
Behavior Change: Assay Development and Validation for Self-Regulation Targets 
(UH2)”. This study was submitted and approved in request to carry forward funds 
from the UH2, to UH3 phase of this grant; and covers all three specific aims 
outlined in the application for approval to keep the carryforward funds. 
 
1.0 Study Summary 
 
Study Title 
Imagine to Remember: Improving Medication Adherence in 
Pre- and Type 2 Diabetes 
Study Design 
 Three groups, nonconcurrent multiple baseline experimental 
design 
Primary Objective 
Determine if a 4-8 week intervention consisting of future-
thinking improves medication adherence 
Secondary 
Objective(s) 
Determine if a 4-8 week intervention consisting of future-
thinking improves different facets of memory/executive 
function and/or decision-making. 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
The intervention being researched is called episodic future 
thinking (EFT), which consists of imagining specific 
instances of one’s future. In this study, participants will 
engage in EFT pertaining to medication use, guided by a 
research staff member in intervention sessions across a 4-8 
week period. 
IND/IDE #  
N/A 
Study Population 
Adults with prediabetes or Type 2 diabetes prescribed 
medication, as well as those who are at risk for developing 
pre and type 2 diabetes (BMI ≥ 30 and hyperlipidemia or 
hypertension) 
Sample Size 
20 

 
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Study Duration for 
individual 
participants 
15 weeks 
Study Specific 
Abbreviations/ 
Definitions  
Episodic future thinking (EFT), prospective memory (PM), 
working memory (WM), episodic memory (EM), and delay 
discounting (DD). 
2.0 Objectives* 
2.1 Describe the purpose, specific aims, or objectives of this research. 
Response:  
 
Aim 1: To examine whether EFT improves medication adherence.  
Aim 2: To test the influence of EFT on DD (Aim 2A), and PM (Aim 2B). 
 
2.2 
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:  
 
Aim 1: We hypothesize that EFT will improve medication adherence.  
Aim 2: We hypothesize that EFT will reduce DD and improve PM. 
 
3.0 Scientific Endpoints* 
 
3.1    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.   
Response: 
The primary endpoint is the increase in medication adherence and improvements 
in memory and decision making. 
 
4.0 Background* 
4.1 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.  

 
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Response:  
Adherence to medications in persons with prediabetes, type 2 diabetes or related 
comorbidities (e.g., hypertension, hyperlipidemia) can help prevent the 
development/progression of type 2 diabetes. However, adherence to diabetes 
medications1,2 and medications for its comorbidities is relatively low,3 with a 
commonly cited reason in those with prediabetes being “forgetting”1. The ability 
to recall and successfully engage in an action at an appropriate time in the future 
is referred to as prospective memory (PM). Accumulating research shows that 
poorer prospective memory is related to medication non-adherence among 
individuals using various types of medications;4 and as such, improving PM 
represents a potentially fruitful means of increasing medication adherence.  
An important facet of behavior that may contribute to medication non-adherence 
is delay discounting (DD). Delay discounting refers to the extent to which an 
individual devalues an outcome due to its delay in time. Prior research has shown 
that greater DD is related to poor glycemic control, and this relationship is 
partially mediated by medication adherence.5 Previous research by our group 
within the experimental medicine framework6, which serves as the platform for 
the NIH Science of Behavior Change Initiative7, has shown that DD is related to 
HbA1c levels in those with prediabetes, that changes in DD over a year are 
associated with changes in HbA1c, and that we can manipulate DD with episodic 
future thinking (or the prospection of one’s self in future scenarios; EFT). These 
findings set the stage for our UH3 grant on using EFT to modify DD and HbA1c 
levels. Several laboratory studies have shown EFT is a successful approach to 
improving PM8–11. Given that EFT also produces robust effects on DD12–14, EFT 
may be an especially efficacious intervention in that it has the potential to 
improve two different processes related to poorer medication adherence. Current 
research examining the effects of EFT on PM have been confined to laboratory 
tasks, and research is needed to assess EFT effects on medication adherence.  
We propose an RCT that will assess the effects of EFT on medication adherence, 
general PM, and DD among those with pre- or type 2 diabetes or related 
comorbidities who are currently taking at least one oral medication for diabetes or 
related comorbidities. We will recruit participants who are relatively non-adherent 
to an oral medication (< 80% of prescribed doses taken in the past month; to 
accommodate over-reporting) for prediabetes or type 2 diabetes or other 
conditions that commonly co-occur with these conditions (e.g., hypertension, 
hyperlipidemia). Medication adherence will be monitored using electronic pill 
bottle caps (MEMS caps, which record bottle openings with date and time 
stamps), pill counts, and pharmacy records. Medications for glucose control as 
well as control of hypertension and/or hyperlipidemia will be considered as 
targets for measurement. Participants self-rated as non-adherent (< 80% 
prescribed doses taken), and report difficulty remembering to take one’s 
medication as a primary reason for non-adherence, will undergo a 6 week, 8 
week, or 10 week baseline period. After the staggered baseline periods, all 
participants will receive EFT intervention. In total, participants will be in baseline 
and treatment for a total or 15 weeks.  

 
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Randomized participants will complete bi-weekly in person sessions plus phone 
sessions for the weeks in which they do not come to the lab, in which they learn 
toengage in EFT for medication adherence. Initial EFT for medication adherence 
will focus on taking the targeted medication on a typical day (e.g., a weekday 
when the participant usually works), and in subsequent sessions EFT will be used 
to assist participants in adapting to unusual circumstances that may interrupt 
adherence or have been reported as contributing to non-adherence.  
At an initial baseline session, post-intervention, and follow-up, participants will 
complete measures of working memory, lab-based PM, and DD. Dependent 
measures include change in targeted medication adherence (based on MEMS 
data), change in non-targeted medication adherence (for participants initially 
reporting non-adherence to multiple medications; based on self-report and pill 
count measures), DD, and PM. Moderators to be tested include working. The goal 
of the study will be to collect pilot data to test the feasibility and initial efficacy of 
the approach, as well as effect sizes for a subsequent R01. 
 
4.2 Include complete citations or references.  
Response:  
References 
1.  
Walker EA, Molitch M, Kramer MK, et al. Adherence to preventive 
medications: Predictors and outcomes in the diabetes prevention program. 
Diabetes Care. 2006;29(9):1997-2002. doi:10.2337/dc06-0454 
2.  
Polonsky WH, Henry RR. Poor medication adherence in type 2 diabetes: 
Recognizing the scope of the problem and its key contributors. Patient Prefer 
Adherence. 2016;10:1299-1307. doi:10.2147/PPA.S106821 
3.  
Brown MT, Bussell JK. Medication adherence: WHO cares? Mayo Clin 
Proc. 2011. doi:10.4065/mcp.2010.0575 
4.  
Zogg JB, Woods SP, Sauceda JA, Wiebe JS, Simoni JM. The role of 
prospective memory in medication adherence: A review of an emerging literature. 
J Behav Med. 2012;35(1):47-62. doi:10.1007/s10865-011-9341-9 
5.  
Lebeau G, Consoli SM, Le Bouc R, et al. Delay discounting of gains and 
losses, glycemic control and therapeutic adherence in type 2 diabetes. Behav 
Processes. 2016;132:42-48. doi:10.1016/j.beproc.2016.09.006 
6.  
Bernard C. An Introduction to the Study of Experimental Medicine. 
Oxford, England: MacMillan; 1927. 
7.  
Riddle M. News from the NIH: using an experimental medicine approach 
to facilitate translational research. Transl Behav Med. 2015:486-488. 
doi:10.1007/s13142-015-0333-0 

 
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8.  
Kretschmer-Trendowicz A, Schnitzspahn KM, Reuter L, Altgassen M. 
Episodic future thinking improves children’s prospective memory performance in 
a complex task setting with real life task demands. Psychol Res. 2017:1-12. 
9.  
Altgassen M, Rendell PG, Bernhard A, et al. Future thinking improves 
prospective memory performance and plan enactment in older adults. Q J Exp 
Psychol (Hove). 2015;68(1):192-204. doi:10.1080/17470218.2014.956127 
10.  
Altgassen M, Kretschmer A, Schnitzspahn KM. Future thinking 
instructions improve prospective memory performance in adolescents. Child 
Neuropsychol. 2016;7049(April):1-18. doi:10.1080/09297049.2016.1158247 
11.  
Neroni MA, Gamboz N, Brandimonte MA. Does episodic future thinking 
improve prospective remembering? Conscious Cogn. 2014;23:53-62. 
doi:10.1016/j.concog.2013.12.001 
12.  
Daniel TO, Stanton CM, Epstein LH. The Future Is Now Reducing 
Impulsivity and Energy Intake Using Episodic Future Thinking. Psychol Sci. 
2013;24(11):2339-2342. doi:10.1177/0956797613488780 
13.  
Stein JS, Wilson AG, Koffarnus MN, Daniel TO, Epstein LH, Bickel WK. 
Unstuck in time: episodic future thinking reduces delay discounting and cigarette 
smoking. Psychopharmacology (Berl). 2016;233(21-22):3771-3778. 
doi:10.1007/s00213-016-4410-y 
14.  
Snider SE, LaConte SM, Bickel WK. Episodic future thinking: expansion 
of the temporal window in individuals with alcohol dependence. Alcohol Clin 
Exp Res. 2016;40(7):1558-1566. doi:10.1111/acer.13112 
15. Group DPPR (2003). Reduction in the incidence of type 2 diabetes with 
lifestyle intervention or metformin. Obstetrical & Gynecological Survey, 58:182-
183. 
5.0 Study Design* 
5.1 Describe and explain the study design (e.g. case-control, cross-sectional, 
ethnographic, experimental, interventional, longitudinal, observational). 
Response:  
This study is a nonconcurrent multiple baseline design; participants will be 
randomized to a 6 week, 8 week, or 10 week staggered baseline periods followed 
by 4-8 weeks of Episodic Future Thinking (EFT). 
6.0 Study Intervention/Investigational Agent 
6.1  
Describe the study intervention and/or investigational agent (e.g., 
drug, device) that is being evaluated. 
Response:  
The intervention being researched is called episodic future thinking (EFT), which 
consists of imagining specific instances of one’s future. In this study, participants 
will engage in EFT focused on imagining taking one’s medication, guided by a 
research staff member in their intervention sessions in addition to bi-weekly 

 
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check-in calls across a 4-8 week period. The research staff member will conduct 
the intervention session using a semi-structured interview format in which the 
staff member works to identify situations/circumstances in which the participant 
encounters challenges with taking their medication, and subsequently asking 
questions to prompt the participant to imagine what successful medication 
adherence would consist of (and “look” like). Sessions may also involve 
imagining positive events resulting from successful medication adherence and the 
details surrounding those events. For example: if the research staff member finds 
that a participant struggles to take their medication on weekends, the staff 
member will ask the participant to visualize what successfully doing so might 
entail (getting the medication bottle and putting it next to the waffle iron, which is 
frequently used on the weekends) and to imagine the sensory aspects of the 
experience of doing so (picking up the medication bottle, taking out the waffle 
iron, placing it on the counter—and noting any typically associated smells, items 
one sees, etc.). 
 
 
6.2 
Drug/Device Handling: If the research involves drugs or 
device, 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. 
• 
If the control of the drugs or devices used in this protocol will 
be accomplished by following an established, approved 
organizational SOP (e.g., Research Pharmacy SOP for the 
Control of Investigational Drugs, etc.), please reference that 
SOP in this section. 
Response:  
N/A 
6.3 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: 
• 
Identify the holder of the IND/IDE/Abbreviated IDE. 
• 
Explain procedures followed to comply with sponsor 
requirements for FDA regulated research for the following: 
Response:  
N/A 
7.0 36 Local Number of Subjects 
7.1 Indicate the total number of subjects that will be enrolled or records that 
will be reviewed locally. 
Response:  

 
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Up to 20 subjects will be enrolled from Buffalo, and the neighboring cities.  
Subjects will be randomized after completion of the baseline period. The goal will 
be to randomize at least 10-12 participants. 
7.2 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 initially screen approximately 60 subjects (online or by phone 
screen survey) and complete about 20 in person and baseline screenings. 
7.3 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:  
Given that we will be taking advantage of CTSI resources for recruiting based on 
individuals’ diagnosed medical conditions, we anticipate that recruiting this 
relatively small number of participants for our final sample will be feasible within 
a 4-month period. The Buffalo Research Registry has 200-some potentially 
eligible individuals based on a diagnosis of Pre- or Type 2 Diabetes, and TriNetX 
an additional 15,110 with these diagnoses (with 5,150 of these prescribed an oral 
blood glucose-regulating medication). 
8.0 Inclusion and Exclusion Criteria* 
8.1 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 over the age of 18 with prediabetes or Type 2 Diabetes currently 
prescribed at least one oral medication for blood glucose regulation, or for related 
comorbidities e.g., hypertension, hyperlipidemia, and are relatively non-adherent 
to taking them (< 80% of prescribed doses taken), but are motivated and/or have 
the intent to better comply with their medication regimen, will be studied. 
During the Baseline Period, if participants are adherent to their medications 
(>80%), their participation in the study may be terminated. 
 
Prediabetes and Type 2 Diabetes: Participants must report having have a 
diagnosis of prediabetes or Type 2 Diabetes within the last 2 years or meet criteria 
for prediabetes or Type 2 Diabetes. The American Diabetes Association 
guidelines (Group, 2003) defines prediabetes and Type 2 Diabetes as Fasting 
Plasma Glucose (FPG) 100mg/dl or greater, 2h glucose 140mg/dl or greater after 
Oral Glucose Tolerance Test (OGTT), or hemoglobin A1c (HbA1c) of 
approximately 5.4% or greater. We will also include individuals who have 

 
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increased risk for developing prediabetes and type 2 diabetes, which includes 
individuals who have a BMI of 30 of higher with one or more related 
comorbidities (e.g., hypertension, hyperlipidemia). 
 
8.2 Describe the criteria that define who will be excluded from your final study 
sample.   
NOTE:  This may be done in bullet point fashion.  
Response:   
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 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; unmanaged psychiatric disorder (e.g., depression, 
anxiety, attention deficit hyperactivity disorder,  schizophrenia), cognitive 
impairment that would impact memory (e.g., symptomatic concussion), or an 
intellectual impairment that would impact study adherence. Additionally, 
participants should be able to attend to all intervention sessions (Due to Covid-19 
all sessions will be completed remotely/virtually) and have reliable access to 
technology required to complete the measures in this study. If a participant is not 
able to make most sessions (e.g. participant is out of town during most of the 
study for work or vacation travel), or does not have reliable access to technology, 
they may be excluded from the study.  
Prior participation in similar studies:  Individuals who have recently participated 
in a laboratory study using similar methods may also be excluded.  
Use of medication adherence aids: individuals who currently use aids to assist 
with medication adherence (e.g., pill organizers, reminder apps)may be excluded.  
 
8.3 Indicate specifically whether you will include any of the following special 
populations in your study using the checkboxes below.   
 
NOTE:  Members of special populations may not be targeted for enrollment in 
your study unless you indicate this in your inclusion criteria. 
Response:   
☐ 
Adults unable to consent 
☐ 
Individuals who are not yet adults (infants, children, teenagers) 

 
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☐ 
Pregnant women 
☐ 
Prisoners 
 
8.4 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. 
 
9.0 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. 
9.1 For research that involves pregnant women, safeguards include: 
NOTE CHECKLIST: Pregnant Women (HRP-412) 
Response: 
 ☒ 
N/A:  This research does not involve pregnant women. 
9.2 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:  

 
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☒ 
N/A:  This research does not involve non-viable neonates or neonates of 
uncertain viability. 
9.3 
For research that involves prisoners, safeguards include: 
NOTE CHECKLIST: Prisoners (HRP-415) 
Response:  
☒ 
N/A:  This research does not involve prisoners. 
9.4 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”). 
9.5 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. 
9.6 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:  
 
10.0 
Eligibility Screening* 
10.1 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).  
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. If the participant meets inclusion criteria as assessed in the 
online screen, they will then be invited to an in-lab or virtual screening 
appointment and baseline session screening appointment and baseline session.  
See the Measures.docx document for questions that appear in the online screen 
assessment, as well as the “I2R – Phone Screening Script” document for the script 
for the phone administered version.  

 
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Information about the study will be provided and consent will be obtained to 
prescreen for eligibility purposes, and the same will occur in the in-lab or virtual 
screen/baseline session. 
☐ 
N/A:  There is no screening as part of this protocol. 
11.0 
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. 
11.1 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:  
The different types of recruitment methods to be used are the following: 
1. We will post and/or disseminate recruitment materials (e.g., flyers, letters, and 
handouts/postcards) both in the community (e.g., health clinics, stores, public 
spaces, community and organizational events) and online (e.g., craigslist, 
social media websites/apps, division website). 
2. We will use the i2b2 and TriNetX database through UB’s Institute for 
Healthcare Informatics (IHI) to recruit participants from the UBMD medical 
data base. 
3. The study team may also utilize the University at Buffalo’s Clinical and 
Translational Science Institute (CTSI) for recruitment assistance and 
consultation. The CTSI’s Recruitment Team provides resources, guidance on 
appropriate recruitment strategies, and assistance in linking out study team 
with partners to effectively reach recruitment goals and target populations. We 
may also work with CTSI Community Engagement Team (CET) to create 
awareness of the study through their professional and community contacts. 
The tools they have available may include the Buffalo Research Registry 
(BRR, IRB Approved STUDY00000806), the Patients Voices Network 
(PVN), the Conventus CTSI/PVN Research Table, and conducting outreach at 
various community events. The BRR is a voluntary registry which can 
connect us to community members who have completed a health profile and 
are interested in participating in research. These community members have 
agreed to be contacted about potential research opportunities based on their 
self-reported information.  These tools are method by which the CET 
distributes IRB-approved recruitment information to community members. As 
described in the BRR’s IRB Approved Protocol (STUDY00000806), the 
BRR’s Community Recruitment Liaison (CRL) will complete the process of 
sorting BRR data to reflect the inclusion and exclusion criteria for this study if 

 
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it is appropriate to utilize the BRR for this study. The CRL may reach out to 
potentially eligible participants in the BRR to provide information about our 
research study. After receiving proof that IRB has approved BRR’s use in this 
study, the CRL can then provide our study team with name and contact 
information for potentially eligible participants for the purpose of following 
up with them after they have been informed of the study by the CRL. No 
recorded health information will be shared from BRR data. Our research team 
will proceed to reach out to interested potential participants regarding 
eligibility and moving forward in the study. 
      The CET also tables at many events in the community throughout the year and 
may display the IRB approved flyer for this project at their table at 
community events. Examples of events the CET attends include Good for the 
Neighborhood hosted by Independent Health Foundation, UB on the Green, 
Juneteenth, Elmwood Arts Festival and many others. 
      The CET also hosts a standing table at the Conventus Building on the 4th 
floor of UBMD where the IRB approved flyer and other handouts can be 
made available to community members and patients. This will occur only after 
agreement between the CRL and UBMD Conventus partners that the study is 
appropriate for the Conventus space. 
4. 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. In addition, there are several 
similar but smaller databases maintained by individual labs within our 
department. These labs also conduct studies with type II diabetic and/or 
prediabetic patients, and maintain a list of individuals who were interested in 
participating, but did not meet the eligibility criteria for the given study. We 
plan to collaborate with these labs, sharing information about our study with 
these potential participants who indicated an interest in hearing about other 
study opportunities, and also sharing information about these colleagues’ 
studies with individuals who were interested in, but not eligible for, the 
present study. These interested individuals’ contact information will be shared 
to us by the other labs. Following this, these potential participants will be 
contacted by our study team. 
5. Urban Family Practice: Used in previous IRB approved studies (030-796526, 
STUDY 00000936), the physicians from Urban Family Practice 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. We plan to use this same recruitment method 

 
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with Urban Family Practice. These patients may be mailed a letter that has 
been jointly signed from the study team and their 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 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. 
6.  Trialfacts: A recruitment service that creates advertisements and information 
on landing page. Potential participants will then complete an online 
prescreening questionnaire (which is identical to the prescreen used by the 
study) to determine if eligible to continue to a phone screening. Potential 
participants chose an appointment time for their phone screening to connect 
with the study staff. Potential participants also have the option to either email 
us or phone us for further information. All information collected through this 
service will be made available to the research team using google spreadsheets 
on Trialfacts protected servers.  
 
11.2 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 from our Division’s database and other databases as described in 
section 11.1 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. 
The privacy of patients recruited using the i2b2/TriNetX and Urban Family 
Practice data will be protected by following the UB IRB-approved procedure. A 
letter will be sent to the eligible patient’s physician (see attached). After a 
minimum of 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 a minimum of 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.  

 
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The privacy of patients recruited through Trialfacts: Trialfacts adheres to the 
Principles of Good Clinical Practice (GCP) in all of its recruitment activity. All 
recruitment materials are provided to the research staff to ensure accuracy and 
seek relevant independent review board (IRB) or human research ethics 
committee (HREC) approval. Trialfacts will pass referrals to the research team 
using Google spreadsheets, for which they have a BAA in place to ensure HIPAA 
compliance.  
 
11.3 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, emails, flyers, handouts, telephone calls, using the 
approved text, and mailed letters and postcards, will be used to recruit subjects. 
See supporting documents “I2R - Recruitment Materials ALL”, “I2R – Phone 
Screening Script”, “I2R – Recruitment – Patient Letter on UB” and “I2R – 
Recruitment – Physician Permission Letter” , “I2R-Recruitment Letter-Urban 
Family Practice_Niagara Street”, “I2R-Recruitment Letter-Urban Family 
Practice_Jefferson Ave” 
 
12.0 
Procedures Involved* 
12.1 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:  
Individuals who pass the initial inclusion/exclusion screen and wish to enroll in 
the study will be invited to complete the in-lab or virtual screen/initial assessment. 
Participants invited to this session will be asked to share a copy of their 
medication refill history*. This can be shared either through email or fax. 
*Participants will be able to request these from their local pharmacist. Refill records may 
also be obtained through web or app accounts for their current pharmacy. We may also 

 
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ask participants to fill out a pharmacy release form to receive the information directly 
from their pharmacy/ pharmacist.   
In-Lab Screen/Initial Assessment Session: 
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 more in-depth explanation about the study and provide 
documented consent if they agree to participate. 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.  
Covid-19 Alternative Procedure: Participants will complete this session virtually 
over the video call and remote computing program Zoom. This program allows 
for research staff and participants to communicate, as well as for participants to 
access study measures remotely. Firstly, research staff will provide participants 
with a more in-depth explanation about the study. A consent form will be 
provided on the screen, and participants will have a chance to read through and 
provide an e-signature indicating their consent. A copy of the completed consent 
form will be emailed to participants for their records. 
After the consent process, participants will provide their prescription refill history 
and target prescription medication as well as complete measures of decision 
making and questionnaires including demographics, medical history, alcohol, 
tobacco, and other substance use, participation and medication adherence 
motivation, and schedule availability for study participation.  
Covid-19 Alternative Procedure: After the consent process, participants will 
complete measures of decision making and questionnaires including 
demographics, medical history, alcohol, tobacco, and other substance use, 
participation and medication adherence motivation, and schedule availability for 
study participation. 
In order to confirm that participants are non-adherent, we may request that 
participants conduct a pill count of relevant medications. This may be done 
through sharing a short survey with participants in which they count the 
remaining quantity of relevant medications or sending research staff a photo of 
their medications, so that pill counts may be done remotely. Non-adherence will 
also be confirmed through pharmacy records and self-report. 
The research staff will conduct pill counts to calculate adherence measures from 
pill counts and refill records to verify concordance with those provided in the 
initial screening survey, and that they meet eligibility criteria. The research staff 
will also provide the participant with up to 4 MEMS bottles for the medications 
they are non-adherent to. Measures and questionnaires may be completed on 
either the computer or paper/pencil labelled only with the participant’s ID number 
and date. In addition, participants may sign forms for release of their relevant 
medical records to confirm their eligibility (e.g., diagnosis with prediabetes or 
Type 2 Diabetes, prescription drug use, refill history).). Participants may sign a 
release form for relevant pharmaceutical records (e.g. refill history of medications 

 
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used to treat pre-diabetes, diabetes, and comorbid disorders such as 
hyperlipidemia and hypertension) from their current pharmacy.  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. If 
throughout the study there is reason to believe a participant has become pregnant 
(i.e. the participant expresses that is their belief), we will provide pregnancy 
testing. If the pregnancy results are positive, the participant will be informed and 
they will not be eligible to continue with the study. If in-lab measures of 
adherence and substance use indicate that the participant does not meet study 
criteria, the research staff may choose to end the In-Lab Screen/Initial Assessment 
session early and compensation will be pro-rated (see compensation section below 
in protocol for details). 
If participants still meet eligibility criteria and have availability for sessions, they 
will complete the assessments described below in the Assessment Sessions 
description. Then, the research staff will give the participant a pharmaceutical 
medication vial and a MEMS track-cap (an electronic medication vial cap that 
records and time-stamps medication vial openings). The research staff will 
instruct the participant to transfer their medication into the study bottle and adhere 
the copy of the prescription label onto the study bottle. The staff member will 
then review appropriate use of the study bottle and MEMS cap; and schedule the 
participant’s intervention sessions. Participants will also have their height and 
weight measured.  
Covid-19 Alternative Procedure: If participants still meet eligibility criteria and 
have availability for sessions, they will complete the assessments described below 
in the Assessment Sessions description. Then, the research staff will give the 
participant a pharmaceutical medication vial and a MEMS track-cap (an 
electronic medication vial cap that records and time-stamps medication vial 
openings). This will be given to participants via mail. The research staff will 
instruct the participant to transfer their medication into the study bottle and adhere 
the copy of the prescription label onto the study bottle. The staff member will 
then review appropriate use of the study bottle and MEMS cap via Zoom or 
telephone; and schedule the participant’s intervention sessions. 
 
Baseline Sessions: 
All participants complete a 6-week baseline in which they will use the MEMS 
bottles. At week 6, all participants will attend an in-person lab session to assess 
their adherence levels through looking at data from the MEMS bottles and pill 
counts.  
Covid-19 Alternative Procedure: All participants will complete a 6-week baseline 
in which they will use the MEMS bottles. At week 6, data from the MEMS bottle 
will be obtained. In order to reduce participant and staff interaction due to 
COVID-19, this procedure will involve participants placing the cap from the 
MEMS bottle in a small bag placed in their mailbox.  Research staff will conduct 
mobile data collection, and simply pick up the MEMS cap, and using sanitation 

 
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procedures, remotely download the data from the MEMS cap.The cap will then be 
returned to the participants mailbox. 
Participants will then be randomly assigned to either the 6-week, 8- week or 10-
week baseline. If a participant’s medication adherence is not below 80%, they will 
be asked to come in at week 8 to reassess their adherence level (similarly, if their 
adherence is not below 80% at week 8, they will be asked to come back at week 
10. If their adherence is not below 80% at this point, they will be dismissed from 
the study). If a participant is below 80% adherence within this 6-week period and 
their adherence is stable, meaning that there is no increasing trend in their 
adherence level, they will be randomly assigned to either a 6-week, 8- week or 
10-week baseline. Participants who were assigned 6- week baseline, will now be 
eligible to start the intervention, those in the 8-week will complete two more 
weeks of baseline prior to the intervention, and those in the 10-week will 
complete four more weeks of baseline prior to the intervention *.  
*Participants must be considered stable based on their pill counts to continue to 
the intervention period. For this study stability will be defined as no increasing 
trend (3 data points) in their adherence level. If a participant was assigned to a 
group but is not stable during that time period, they will be assigned to the next 
group (if disqualified for 6-week they will go to the 8-week and so on). 
Assessment Sessions: 
Participants will complete the major life events assessment and a variety of 
assessments pertaining to executive function/memory. Similar to the 
screening/baseline session, these measures will all be administered via Zoom. 
Some of these tasks may only be administered in certain assessment sessions 
(e.g., the initial and/or final). 
The types of tasks participants may complete are: 
• Prospective memory tasks  
• A working memory task 
• An impulsive choice task 
Participants will also have their height/weight taken, and the research staff will 
obtain self-report and objective measures of medication adherence (e.g., 
information such as data from MEMS caps, pill counts, reasons for non-
adherence, and reasons for opening medication bottles). 
Intervention Sessions: 
During the Covid-19 Quarantine All intervention sessions will be conducted via 
zoom. 
During each intervention meeting, the research staff will obtain self-report and 
objective measures of medication adherence, and participants will either complete 
EFT or IC activities, dependent on group assignment. Pill counts and MEMS data 
may be obtained by a staff member that is not acting as the interventionist for 
EFT/IC activities, so as to reduce the total time the participant must be in the lab. 

 
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Participants assigned to EFT will be asked to generate episodic cues, similar to 
the tasks used in our previous studies on EFT’s effect (Daniel et al., 2013); unlike 
in prior studies, however, cues will be specific to instances of taking one’s 
medication and/or positive events resulting from successful medication 
adherence. The episodic component of the thinking task occurs while the 
participants are asked to describe the perceptual details of the medication-taking 
(e.g., taking medication at home on a typical day, or while out of town on 
vacation) or medication-outcome event (feeling better and more energetic after 
medication, etc.). Participants will be asked open-ended questions to prompt more 
detail (such as what they are seeing, hearing, smelling, feeling), and to identify 
what successful adherence may look like if the initial event description does not 
go as planned (e.g., if you normally take your medication when you make coffee, 
what would successfully taking your medication look like on a day when you run 
out of time to make it?). Participants may record their EFT events into audio cues, 
so that they can practice using EFT using different modalities at home. 
Participants assigned to IC will be asked to generate cues about newly-learned 
health information. For this activity, the research staff will provide participants 
with a weekly learning module that will consist of presenting information on 
relevant health-related topics (e.g., information about diagnosed conditions that 
made them eligible for participation), which may include brief quizzes, 
informational videos, and other learning-oriented activities that may help with 
information retention (e.g., playing a memory game incorporating information 
about glucose metabolism). Participants will be asked to generate cues about the 
course content which may include imagining different ways the information could 
be useful, how it could be applied in different contexts, with different people, etc. 
As in EFT, participants will be asked open-ended questions as needed to prompt 
more details, and IC participants may also audio record their cues.  
Participants will be asked to rate their cues on different dimensions (e.g., 
vividness, usefulness, valence, salience), which will be used to calculate a 
richness score (average of dimension ratings).  
EFT participants may be provided the same information that IC participants are 
provided, to ensure both groups are equally knowledgeable on the topics; this 
information may be provided in a different format for ease of use/reference 
outside of the laboratory (e.g., on a study website, pamphlet, or booklet). 
Participants will be trained to use EFT/IC outside of the lab using the ecological 
momentary intervention (EMI) computer based program that we have developed: 
the Mobile Audio Management and Response Tracker (MAMRT). This program, 
which is part of the study website, can be accessed by smartphone, tablet or 
computer. This application stores participants’ EFT/IC cues, prompts their use 
(e.g., reminder text message, reminder email), asks questions about use of their 
cues, and records their use. Participants will be instructed to practice using 
EFT/IC daily. The MAMRT software was previously approved in 
STUDY00000936, and appears in Sze, Daniel, Kilanowski, Collins, and Epstein, 
2015. In addition to the above, the MAMRT website may also be used to provide 
health information (i.e., that provided to the IC group), and other activities such as 

 
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completing quizzes to assess mastery of educational materials, with multiple 
versions of quizzes on each module available to account for those who need or 
desire additional practice. The website will also contain password protected 
sections that are for internal use by study personnel. The website will not contain 
protected health information. 
 
Because use of the EMI is not incentivized in any way, staff will conduct walk-
throughs by phone with the participant to ensure that the participant is using the 
intervention outside of the lab. These walk-through calls will consist of guiding 
the participant through the use of their EFT/IC cues; calls will last about 15 mins, 
and will be scheduled with participant. Check-ins (practice and reminders) may 
occur both during the intervention weeks and during the study follow-up period 
prior to the final assessment. Participants may also receive reminder 
texts/email/or phone calls to use their EFT/IC cues. 
 
During CDC recommended travel restrictions due to flu, respiratory illness or 
coronavirus, we are enacting preventative measures to ensure both participants 
and employees limit exposure. 
(1)  Participants will be asked during reminder calls/emails/text 
messages/scheduling contacts questions regarding their health and their 
child’s health before in-person meetings.  This language can be used in any 
contact of scheduling participants such as, in-person or phone, email, text, 
letter,etc 
Example of ..”With the current situation involving the flu, respiratory illnesses, 
and the coronavirus, the Imagine to Remember Study team are enacting some 
preventive measures to keep everyone healthy. The Imagine to Remember Study 
Team wants to ensure the safety of all staff and our participants. While we 
understand that there are areas with confirmed cases of the virus and your area 
may or may not be affected, we would like to help prevent the possible spread by 
asking a few questions prior to your appointment.” 
1.      -”Have you or your child traveled in the last 14 days? If so, where? (effected 
confirmed areas are changing daily) 
2.      -Are you or your child experiencing or showing any symptoms related to the 
flu, or other respiratory illnesses such as the coronavirus, including fever, cough 
or shortness of breath?  
If new information about symptoms is found, we will follow CDC 
guidelines/recommends 
https://www.cdc.gov/coronavirus/2019-ncov/about/symptoms.html 
3.      -Have you had any potential contact with someone who has tested positive 
for any of the above illnesses? 

 
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This information is not data but can be used to determine if an in-person meeting 
can be scheduled or if an alternative should be scheduled at least 14 days from the 
date of incident (or the current CDC/health department time recommendations).  
If necessary, attempts will be made to administer study materials and measures 
remotely. This may include administering surveys that are already used in current 
study materials online, as well as conducting phone calls in lieu of face to face 
meetings as needed. 
In the event a participant/staff member tests positive for coronavirus, we will 
work with Erie County Health department to provide any information they need; 
including names, address and phone numbers, of potential contacts as per the 
Health department policies. NYS law indicates that it is mandatory to provide this 
information in the case of an identified infectious disease: 
INFORMATION FOUND HERE: 
https://regs.health.ny.gov/content/section-210-reporting-cases-or-suspected-cases-
or-outbreaks-communicable-disease-physicians 
 
 
For all session types above, the tasks and procedures may be completed in an 
order different from that outlined as feasibility and efficiency warrants.  
 
12.2 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 audio recordings of participants cues; recordings of the sessions, 
demographic measures; delay discounting; prospective, and working memory; 
substance use/consumption; pregnancy status; medication adherence (pill counts, 
pharmacy refill records, MEMS-provided medication adherence, self-report 
measures); and participants’ heights and weights recorded during the 
experimental sessions, in addition to medical history and details about past 
medication use. 
 
12.3 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, “Measures.docx”. Additional questionnaires 
may be added a later time via modification. 

 
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Recordings: Intervention sessions will be recorded for to review EFT/IC fidelity 
and provide feedback to Interventionists/research staff. 
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, and medical history. 
Medication Use and Adherence: We will obtain pill counts, reasons for non-
adherence, intent to take medication, and motivation to adhere to medications, as 
well as medication adherence data as recorded by the MEMS caps and 
prescription refill history. 
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, or just prior to 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. 
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). 
Cue Measures: Rating scales assessing dimensions of the cues (e.g., vividness of 
imagining, or recalling the info, attentiveness to cues) and cue use (e.g., vividness, 
usefulness) will be administered at cue generation and when cues are accessed via 
our software program. Cues will be rated on numerical and/or ordinal scales; e.g., 
on a scale of 1 to 5, where 1 indicates “not at all” and 5 indicates “very much”.   
Delay Discounting (DD): 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 hypothetical money available immediately or a 
larger amount of hypothetical money available later.  
Du, W., Green, L., & Myerson, J. (2002). Cross-cultural comparisons of 
discounting delayed and probabilistic rewards. Psychological Record, 
52(4), 479–492. https://doi.org/https://doi.org/10.1007/BF03395199 
o Those assigned to the EFT (IC) group may be asked to visualize 
future events (health information) while completing the DD task. 
 
Memory tasks: Different types of memory processes may be involved in the 
intervention effects; these include working memory, prospective memory, 
retrospective memory and episodic memory, which will be measured using 
computerized tasks or paper/pencil measures. The tasks we will use are the 
following: 

 
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• The “Virtual Week” (Rendell et al., 2007; Rose et al., 2010) is a measure 
of Prospective Memory (PM) and Retrospective Memory (RM). The task 
is styled as a board game, with each round (movement across the board) 
representing one day. Throughout a single day, participants are instructed 
to complete different tasks either as different events occur (e.g., when 
someone comes to the door), at different times of day (e.g., when it is 
4:00pm), or after different durations of gameplay. The game begins with a 
training round, so that the participant learns what is expected through the 
task. While completing the training round, the participant will be provided 
with any necessary instructions from the study personnel to help them 
complete the task correctly. After the training round, all participants will 
complete test rounds of the “Virtual Week.”  
o Those assigned to the EFT group may be asked to visualize 
completing the daily tasks prior to starting each round (e.g., close 
their eyes and imagine everything that would be involved with 
calling a fictional person in the game at a certain time). 
Rendell, P. G., Jensen, F., and Henry, J. D. (2007). Prospective memory in 
multiple sclerosis. J. Int. Neuropsychol. Soc. 13, 410–416. doi: 
10.1007/s00213-008-1408-0 
Rose, N. S., Rendell, P. G., McDaniel, M. A., Aberle, I., and Kliegel, M. 
(2010). Age and individual differences in prospective memory during a 
“Virtual Week”: the roles of working memory, vigilance, task regularity, and 
cue focality. Psychol. Aging 25, 595–605. doi: 10.1037/A0019771 
 
• Working memory, measured as the ability to remember sequences of items 
(e.g., letters, numbers, symbols, or locations), with and/or without 
distractors present, and potentially in different orders (e.g., 
forwards/backwards).  
• Prospective Memory Task, measured as the ability to remember to do to 
an extra task (e.g., clicking the mouse, certain keys on the keyboard, 
typing in a text box), while finding target word’s in a word list 
Cheng, H. , Yang, Z. , Dong, B. , Chen, C. , Zhang, M. , Huang, Z. , Chen, Z. 
and Wang, K. (2013), Chemotherapy‐induced prospective memory 
impairment in patients with breast cancer. Psycho‐Oncology, 22: 2391-
2395. doi:10.1002/pon.3291 
• Royal Prince Alfred Prospective Memory Test is a measure of time and 
event based prospective memory designed to assess retention over both 
long and short intervals (e.g. 15 minutes to a few days)  
Radford, K.A., Lah, S., Say, M.J., & Miller, L.A. 2011). Validation of a New 
Measure of Prospective Memory: The Royal Prince Alfred Prospective 
Memory Test, The Clinical Neuropsychologist, 25, 127-140; 
DOI:10.1080/13854046.2010.529463. 
•  

 
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12.4 Describe any source records that will be used to collect data about subjects 
(e.g. school records, electronic medical records). 
Response:  
Electronic medical records and pharmaceutical records will be used. These will 
include records from patients at UBMD and additional records provided through 
the use of i2b2/TriNetX and Urban Family Practice. 
 
12.5 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:  
We will not be administering any diagnostic tests, and as such will not be sharing 
results with participant’s physicians. 
 
12.6 Indicate whether or not study results will be shared with subjects or others, 
and if so, describe how these will be shared. 
Response:  
Full study results will not be shared with subjects. Findings based on group data 
may be presented at conferences and published in scientific journals.  
 
13.0 
Study Timelines* 
13.1 Describe the anticipated duration needed to enroll all study subjects. 
Response:  
We anticipate it will take up to 6 months to recruit all participants. 
13.2 Describe the duration of an individual subject’s participation in the study. 
Include length of study visits, and overall study follow-up time. 
Response:  
Participants will be in the study for approximately 15 weeks, from the time of the 
initial online screening survey is completed, and until the final study assessment 
is completed. An outline of the approximate duration of each session type and 
corresponding study week is provided below. 
 

 
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13.3 Describe the estimated duration for the investigators to complete this study 
(i.e. all data is collected and all analyses have been completed). 
Response:  
We anticipate the study will take approximately 1 year to complete. 
14.0 
Setting 
14.1 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), in the the 
Division of Behavioral Medicine Research Labs, located in G56, G58, G90, G96 
and 151 Farber Hall, University at Buffalo South Campus. 
 

 
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14.2 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:  
☒ 
N/A:  This study is not conducted outside of UB or its affiliates. 
15.0 
Community-Based Participatory Research 
15.1 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. 
16.0 
Resources and Qualifications 
16.1 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. 
 

 
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Describe other resources available to conduct the research.  
16.2 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 Principal Investigator will devote approximately 5-8 hours per week to meet 
with staff, oversee data safety and discuss recruitment and study specific 
information. 
The Project Coordinator will spend approximately 30% of their time training and 
supervising staff, including conducting weekly project meetings, 20% 
coordinating the scheduling of appointments for staff and prospective subjects, 
10% coordinating and assisting in the test sessions, and 10% overseeing the 
development of study materials. 
Research Assistants/Interventionists will spend approximately 50% of their time 
training and running participants, 20% recruiting subjects, 20% developing 
project materials, including questionnaires, surveys, and forms, and 10% entering 
data and quality control of the data collected during the study. 
 
16.3 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:  
We do not anticipate a need for medical or psychological resources stemming 
from the research procedures. However, if during any of the visits, the participant 
discloses occurrences of recent life events that appear to cause the participant a 
high degree of distress (e.g., the participant is crying, appears in shock, etc.) the 
project coordinator and PI will be notified. These participants will be provided 
with a list of resources. Additionally, we will follow up with the participant 
within the next 24 hours of said occurrence. 
 
16.4 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 

 
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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. 
 
17.0 
Other Approvals 
17.1 Describe any approvals that will be obtained prior to commencing the 
research (e.g., school, external site, funding agency, laboratory, radiation 
safety, or biosafety). 
Response:  
☒ 
N/A:  This study does not require any other approvals. 
18.0 
Provisions to Protect the Privacy Interests of Subjects 
18.1 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. In sessions, participants will only interact with project research staff 
and sessions will take place in a private laboratory room that may include 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. 
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. 
 

 
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In regards to the CDC procedures mentioned in the Procedures section: 
In the case of a positive test of an infectious disease, any contact with the Person 
Under Investigation (PUI) will be disclosed to the Erie county health department 
as requested/required.  
Erie county Department of Health, Epidemiology and Disease control includes 
forms for identifying reportable infectious diseases and contact information for 
the appropriate person at the Health department to discuss any personally 
identifiable information. 
http://www2.erie.gov/health/index.php?q=epidemiology-amp-disease-control 
 
18.2 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 from this database 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 (i2b2, TriNetX, Urban Family Practice), 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 and pharmacists at their 
preferred pharmacy to confirm eligibility after participants have completed 
consent/HIPAA/medical/pharmacy release forms. 
Any information through recruitment from Trialfacts will be deleted from there 
servers upon completion of the study and all information will be transferred to a 
secure database of interested participants maintained by the Division of 
Behavioral Medicine and approved for use by previous IRB committees. Potential 
participants from this database will be contacted if they had indicated that they are 
willing to be contacted for participation in studies and thus control their own 
participation. 
 
19.0 
Data Management and Analysis* 
19.1 Describe the data analysis plan, including any statistical procedures.  This 
section applies to both quantitative and qualitative analysis.  
Response:  

 
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Pill count and MEMS data displayed as a percentage of doses taken will be 
displayed graphically to enable visual analysis of changes in means and trends of 
dependent variables across the different phases of the study.  
Borckardt, J., & Nash, M. (2014). Simulation modelling analysis for small sets of 
single-subject data collected over time. Neuropsychological Rehabilitation, 24(3-
4), 492–506. https://doi.org/10.1080/09602011.2014.895390 
 
Kratochwill, T., Hitchcock, J., & Chezan, L. (2015). What Works Clearinghouse 
Standards and Generalization of Single-Case Design Evidence. Journal of 
Behavioral Education, 24(4), 459–469. https://doi.org/10.1007/s10864-015-9224-
1 
 
19.2 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:  
A power analysis is not applicable to this multiple baseline design. We are 
collecting weekly data from participants and will have enough data points to 
ensure we will be able to achieve the study objectives. The results of this study 
will be analyzed graphically as well as assessing the degree of change from 
baseline to treatment across the three replications. For an example of a study that 
utilized a multiple baseline design, see:  
Spaulding, S., Devine, K., Duncan, C., Wilson, N., & Hogan, M. (2012). 
Electronic Monitoring and Feedback to Improve Adherence in Pediatric Asthma. 
Journal Of Pediatric Psychology, 37(1), 64–74. 
https://doi.org/10.1093/jpepsy/jsr059 
19.3 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 UB IRB 
and other required offices/agencies. Materials will be checked to make sure that 
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. 
 
20.0 
Confidentiality* 

 
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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.   
 
20.1 
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. 
Urban Family Practice patient data will be protected by only accessing 
identifiable contact information remotely. Urban Family Practice will send us an 
encrypted file, containing this contact information that will be stored on a 
password protected server that only the research staff will have access too. 
Trialfacts recruitment data will be protected by only accessing survey information 
remotely. Trialfacts will send us an encrypted file/ Google spreadsheet, containing 
this information that will be stored on a password protected server that only the 
research staff will have access too. 
Potential participants who have filled out the online screening 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 screening 
survey responses they will be de-identified and stored in a locked filing cabinet in 
a locked room (G96/G56 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 (that may 
include forms such as: medical release/ pharmacy release forms and other study 
materials) 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. 
 
20.2 
A.  How long will the data be stored? 
Response:  

 
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All study 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. Any identifiable information from participants (i.e. medical release 
forms/ pharmacy release forms) 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. Information about potential 
participants provided to us by Urban Family Practice and Trialfacts will be 
deleted upon completion of the study. 
 
20.3 
A.  Who will have access to the data? 
Response:  
Only the principal investigator and research staff associated with the study will 
have access to the data. 
 
20.4 
A.  Who is responsible for receipt or transmission of the data? 
Response:  
The principal investigator takes primary responsibility for the data. 
 
20.5 
A.  How will the data be transported? 
Response: 
Data will be transported in password protected/encrypted files via email. 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 21.0) 
 
20.6 
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 and urine samples will be analyzed during session it is collected or 
immediately after the appointment and will not be saved (i.e., stored). Specimens 
will not be banked for future use. 

 
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20.7 
B.  How long will the specimens be stored? 
Response:  
N/A, specimens will not be stored 
20.8 
B.  Who will have access to the specimens? 
Response:  
Research staff conducting appointments will have access to the specimens during 
or immediately after the appointment. However, specimens will not be stored. 
 
20.9 
B.  Who is responsible for receipt or transmission of the specimens? 
Response:  
N/A, there is no receipt or transmission of the specimens. 
 
20.10 B.  How will the specimens be transported? 
Response: 
N/A, the specimens will not be transported. 
 
21.0 
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. 
 
21.1 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 and may work with a Data Safety Officer 
consistent with our NIH DSMP. 
 

 
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21.2 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. 
 
21.3 Describe any safety endpoints. 
Response:  
This study poses no greater than minimal risk; therefore, there are no safety 
endpoints. 
 
21.4 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 
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. 
 
21.5 Describe the frequency of safety data collection. 
Response:  
Data will be reviewed weekly and secured in G56 and 252A 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. 
 
21.6 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. 

 
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21.7 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. 
 
21.8 Describe the statistical tests for analyzing the safety data to determine 
whether harm is occurring. 
Response:  
N/A, there are no discontinuing criteria. 
 
21.9 Describe any conditions that trigger an immediate suspension of the 
research. 
Response:  
N/A, there are no discontinuing criteria. 
 
22.0 
Withdrawal of Subjects* 
☐ 
N/A:  This study is not enrolling subjects.  This section does not apply. 
 
22.1 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 
instructions, possible reasons for removal include nonsystematic responding to 
questionnaires. 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. 
 
22.2 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:  

 
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Participants will be debriefed about the nature of the study and the reason for their 
removal. No additional follow-up is needed. 
 
22.3 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. 
 
23.0 
Risks to Subjects* 
23.1 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. 
Breach of confidentiality is another potential risk. 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.  
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. 
 
23.2 Describe procedures performed to lessen the probability or magnitude of 
risks, including procedures being performed to monitor subjects for safety. 
Response:  

 
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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 relevant research staff and participant will be present in the 
room during sessions. 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.  
Should an emergency situation occur, access to further 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 (if 
trained) and call on campus emergency services or police as necessary. 
4. If the subject is conscious – continue to observe subject. 
 
23.3 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. 
 
23.4 If applicable, indicate which research procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
Response:  
N/A, we will not be enrolling pregnant participants. 
23.5 If applicable, describe risks to others who are not subjects. 
Response:  
N/A, no foreseeable risks to others who are not subjects. 
 
24.0 
Potential Benefits to Subjects* 
24.1 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. 

 
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Response:  
Participants may benefit from improved health due to better adherence to their 
prescribed medication(s). Participants may also learn about the experimental 
research process and their health. 
25.0 
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.   
 
26.0 
Economic Burden to Subjects 
26.1 
Describe any costs that subjects may be responsible for because of 
participation in the research.   
NOTE:  Some examples include transportation or parking. 
Response:  
Participants will be responsible for transportation to/from the laboratory for their 
scheduled sessions. If participants do not have their own personal mode of 
transportation, they may be reimbursed in the amount of standard bus/train fare. 
Participants will not incur parking fees at our laboratory. 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
27.0 
Compensation for Participation 
27.1 
Describe the amount and timing of any compensation to subjects, 
including monetary, course credit, or gift card compensation. 
Response:  
Participants will receive $35 for completion of each assessment session ($35 x 3 = 
$105), and will receive additional compensation bonuses if they (a) complete all 
three assessment sessions ($25), and (b) return the MEMS cap ($20). The total 
possible compensation for participation in the study is $150. 
 
28.0 
Consent Process 
28.1 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 29.0. 
☒ 
Yes 
(If yes, Provide responses to each question in this Section) 
☐ 
No 
(If no, Skip to Section 29.0) 
 

 
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28.2 Describe where the consent process will take place.  Include steps to 
maximize subjects’ privacy. 
Response:  
Online/Phone Screening 
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. electronically signing) online 
(see Phone Script for related details). Screening consent will be obtained prior to 
asking any contact or eligibility questions.  
In-Lab Screening/Assessment 1 
Documented informed consent will be obtained in a private room at the Division 
of Behavioral Medicine Research Lab during the scheduled laboratory 
appointment. 
 
28.3 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 
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.  
 
28.4 Describe any process to ensure ongoing consent, defined as a subject’s 
willingness to continue participation for the duration of the research study.   
Response:  
Participants will be seen both weekly and monthly at different points of the 
intervention; after initial consent, participants will have the ability to discontinue 
the study at any time. 
28.5 Indicate whether you will be following “SOP: Informed Consent Process for 
Research (HRP-090).” Pay particular attention to Sections 5.4-5.9. 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 

 
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• 
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 28.8) 
Cognitively Impaired Adults 
☒ 
N/A:  This study will not enroll cognitively impaired adults.   
(Skip to Section 28.9) 
Adults Unable to Consent 
☒ 
N/A:  This study will not enroll adults unable to consent.  
(Skip to Section 28.13) 
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 29.0) 
 
29.0 
Waiver or Alteration of Consent Process 
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. 
 
29.1 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. 
 
30.0 
Process to Document Consent 

 
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☐ 
N/A:  A Waiver of Consent is being requested.   
(Skip to Section 31.0) 
30.1 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:  
☒ 
We will be following “SOP:  Written Documentation of Consent” 
(HRP-091). 
31.0 
Multi-Site Research (Multisite/Multicenter Only)* 
☒ 
N/A:  This study is not an investigator-initiated multi-site study.  This 
section does not apply. 
 
32.0 
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. 
32.1 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:  
We do not plan to use the data collected for future research.