Sensitization of the Reinforcing Value of Food as a Predictor of Weight Change in Adolescents
Conditions: Obesity, Adolescent, Adolescent Behavior
Sponsor: State University of New York at Buffalo

 
 
Official Title: 
Study of Nutrition and Activity in Kids 
NCT number: 
NCT04027608 
Document Type:  
Study Protocol 
Date of the 
Document: 
September 02, 2020 
 
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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 
PROTOCOL TITLE : Study of Nutrition and Activity in Kids (SNAK) 
 
Page 1 of 44 
 
 
INSTRUCTIONS: Complete Research Protocol (HRP-503) 
• Depending on the nature of what you are doing, some sections 
may not be applicable to your research.  If so, you must provide 
the reason why the section is not applicable for the response.  For 
example, most behavioral studies would answer all questions in 
section 30 with words to the effect of “drugs and medical devices 
are not used in this study.” 
• When you write a protocol, keep an electronic copy. You will 
need to modify this copy when making changes. 
• Do not remove the italics instructions or headings. 
• If you are pasting information from other documents be sure to 
use the “Merge Formatting” paste option so that the formatting 
of the response boxes is not lost.  If information is presented 
outside of the response boxes, it will not be accepted.  
• If this study involves multiple participant groups who participate 
in different research procedures, consent processes, etc., be 
certain to provide information in each applicable section for 
each participant group and clearly label each participant group 
within a section or subsection.  
 
 
PROTOCOL TITLE: 
Include the full protocol title. 
Response: Study of Nutrition and Activity in Kids (SNAK)  
 
PRINCIPAL INVESTIGATOR: 
Name   Jennifer Temple 
Department -Exercise and Nutrition Sciences 
Telephone Number -716-829-5593  
 
Email Address- jltemple@buffalo.edu 
Response:  
 
VERSION NUMBER: 
Include the version number of this protocol. 
Response: 17 

 
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Revised: January 5, 2023 
 
DATE: 
Include the date of submission or revision. 
Response:  Sept 2020 
 
Grant Applicability: 
Describe whether or not this protocol is funded by a grant or contract and if so, 
what portions of the grant this study covers. 
Response: This Study is funded by a grant from NIH- NIDDK R01-
DK106265 
 
 

 
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Revised: January 5, 2023 
Table of Contents 
1.0 
Objectives ...................................................................................................................................... 4 
2.0 
Background .................................................................................................................................. 4 
3.0 
Inclusion and Exclusion Criteria .......................................................................................... 5 
4.0 
Study-Wide Number of Subjects (Multisite/Multicenter Only) ............................... 8 
5.0 
Study-Wide Recruitment Methods (Multisite/Multicenter Only) .......................... 8 
6.0 
Multi-Site Research (Multisite/Multicenter Only) ........................................................ 9 
7.0 
Study Timelines ....................................................................................................................... 10 
8.0 
Study Endpoints ...................................................................................................................... 10 
9.0 
Procedures Involved .............................................................................................................. 10 
10.0 Data and Specimen Banking ............................................................................................... 23 
11.0 Data Management ................................................................................................................... 23 
12.0 Provisions to Monitor the Data and Ensure the Safety of Subjects ..................... 25 
13.0 Withdrawal of Subjects......................................................................................................... 27 
14.0 Risks to Subjects ...................................................................................................................... 27 
15.0 Potential Benefits to Subjects ............................................................................................ 29 
16.0 Vulnerable Populations ........................................................................................................ 30 
17.0 Community-Based Participatory Research................................................................... 31 
18.0 Sharing of Results with Subjects ....................................................................................... 31 
19.0 Setting ......................................................................................................................................... 31 
20.0 Resources Available ............................................................................................................... 32 
21.0 Prior Approvals ....................................................................................................................... 34 
22.0 Recruitment Methods............................................................................................................ 34 
23.0 Local Number of Subjects .................................................................................................... 36 
24.0 Confidentiality .......................................................................................................................... 36 
25.0 Provisions to Protect the Privacy Interests of Subjects ........................................... 37 
26.0 Compensation for Research-Related Injury ................................................................. 38 
27.0 Economic Burden to Subjects ............................................................................................ 38 
28.0 Consent Process ...................................................................................................................... 38 
29.0 Process to Document Consent in Writing...................................................................... 42 
30.0 Drugs or Devices ..................................................................................................................... 43 
 

 
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Revised: January 5, 2023 
1.0 
Objectives 
1.1 Describe the purpose, specific aims, or objectives. 
1.2 Response: The purpose of this study is to measure the reinforcing 
value of a preferred health snack food and an unhealthy snack 
food. We will also look at the reinforcing value of exercise and how 
these values may lead to long term weight gain in adolescents.  
 
1.3 State the hypotheses to be tested. 
Response:   
We hypothesize that sensitization to HED food will be 
associated with greater weight at the time of testing as well as greater 
weight gain over time, while sensitization to LED food will be associated 
with lower BMI percentile at the time of testing in adolescents.   
2.0 
Background 
2.1 Describe the relevant prior experience and gaps in current 
knowledge. 
Response: While a substantial body of research suggests that RRV is 
related to obesity, there is very little research on factors that contribute 
to the RRV of food, particularly how patterns of eating can increase or 
decrease the motivation to eat specific foods.   Our previous work has 
demonstrated that a subset of obese individuals show increases in RRV 
of food after repeated consumption of large portions of HED snack 
foods, which we have conceptualized as sensitization.  Our preliminary 
data suggest that sensitization of the RRV of HED food is a predictor of 
weight gain over time.  However, more work needs to be done to address 
this relationship using a planned, prospective study design, using 
adolescent research subjects, and examining potential moderators of 
this relationship. 
 
2.2 Describe any relevant preliminary data.  
Response:  
 
We have strong preliminary data to suggest that increases in the RRV of 
food after repeated administration of LED and HED snacks meet the criteria for 
sensitization.  Furthermore, sensitization to HED food is associated with greater 
weight at the time of testing as well as greater weight gain over time, while 
sensitization to LED food is associated with lower BMI percentile at the time of 
testing in adolescents.  Finally, the relationship between sensitization to repeated 
food intake and BMI percentile is moderated by Delay Discounting, supporting 
previous work suggesting that reinforcement pathology is a risk factor for obesity 
32.  Our work and that of others from the past decade provides the foundation for 
this theoretical approach.  The proposed studies will allow us to determine the 

 
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extent to which sensitization of the RRV of snack foods is predictive of weight gain 
and the development of obesity in adolescents.  In addition, our preliminary data in 
adolescents suggest that sensitization to LED food may protect against weight gain.   
 
2.3 Provide the scientific or scholarly background for, rationale for, 
and significance of the research based on the existing literature 
and how will it add to existing knowledge. 
Response: This line of research will allow us to not only identify factors that 
increase risk for weight gain, but may also allow us to determine factors that 
protect against weight gain and obesity.  If sensitization to LED food confirmed as a 
protective factor against weight gain in adolescents, future studies may focus on 
determining ways in which to sustain long-term increases the RRV of LED foods in 
order to promote LED food consumption and reduce weight gain.  Finally, the 
proposed studies will also examine the independent and moderating effects of the 
RRV of physical activity to include a more comprehensive understanding of energy 
balance.  If RRV of physical activity moderates the impact of sensitization of the 
RRV of HED food on weight change over time, developing strategies to increase the 
RRV of physical activity may provide an alternate pathway to prevent obesity 
among adolescents who do not find LED foods very reinforcing.   
 
2.4 Include complete specific citations/references.  
Response:  
 
3.0 
Inclusion and Exclusion Criteria 
3.1 Describe the criteria that define who will be included or excluded 
in your final study sample.  
Response: Two hundred twenty-six participants (113 boys, 113 girls) 
ages 12 – 16 will be studied.   
Part 1: 
INCLUSION:  
-between 12-14yoa (male and female)  
-zBMI: -1.5 to +2.0 (*determined by Height/weight measurement at 
Visit 1) 
-neutral or higher liking of the study foods 
EXCLUSION: 
-Under/over age 12-16 
-metabolic or endocrine disorder 

 
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- use of medications known to effect appetite (Ritalin, Adderall, 
Concerta, Wellbutrin, Prednisone, etc) 
-Unwilling to complete the study visits 
-allergy to study foods 
-dislike of study foods (*determined via Preference for Study foods 
forms at Visit 1) 
-parent report that child reads below 4th grade reading level 
-parent report that child cannot complete light physical activity 
without assistance 
-No English Speaking parent or legal guardian (therefore cannot 
provide consent in English nor answer questionnaires for this study) 
* all other exclusion criteria are assessed from Survey monkey 
screening in advance of the first appointment vis parental report. At 
the first appointment the child is directly asses for height, weight, and 
The linking of study foods. 
 
Part 2: Any subject completing V9 of part one who signed an 
addendum giving permission for future contact, will be invited to 
participate in Part 2 of the SNAK study. All interested former 
participants will be eligible to participate until age 18. 
Part 3: Any subject completing V12 of part two who signed an 
addendum giving permission for future contact, will be invited to 
participate in Part 3 of the SNAK study.  
At the age of 18 they may still participate, but will then be consented 
as an adult (rather than assented). If their parents are willing, they 
can accompany the participant to the appointment for collection of 
parent data (surveys, height/weight) or the forms can be sent to the 
parent for submission remotely. 
 
 
3.2 Describe how individuals will be screened for eligibility. 
Response: A survey monkey questionnaire “SNAK Screening Survey 
6.25.18.pdf” will be used to screen all participants. This screening 
begins with a consent process prior to screening. The online screening 
(or phone screening when someone discloses that they do not have 
internet access) inquires about child date of birth, height/weight, 
liking of study foods, health conditions, allergies, and current use of 
medications. A participant is not eligible if they are allergic to a critical 
mass of the study foods, they are on medications effecting their eating. 

 
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At the first appointment the child is directly asses for height, weight, 
and The linking of study foods. They must like at least one of the 
health and one of the junk foods 50% or more in order to participant. 
Additionally the BMI z score must fall into the range of -1.5 to 2.0 in 
order to stay in the study after Visit 1. For those that qualify at the end 
of Visit 1, they will not be reassessed for these criteria after Visit 1. 
Therefore the only exclusion criteria after visit 1 will be ability to 
schedule and attends study appointments. 
 
3.3 Indicate specifically whether you will include or exclude each of 
the following special populations: (You may not include members 
of these populations as subjects in your research unless you 
indicate this in your inclusion criteria.) 
• 
Adults unable to consent 
• 
Individuals who are not yet adults (infants, children, 
teenagers) 
• 
Pregnant women 
• 
Prisoners 
Response: Including individuals who are not yet adults. 
 
3.4 Indicate whether you will include non-English speaking 
individuals.  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.  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: e.g., pilot studies, small unfunded studies with 
validated instruments not available in other languages, numerous 
questionnaires, and some non-therapeutic studies which offer no 
direct benefit.)  
 
Response: This study will not include children that do not speak 
English, while we may be able to include families where English is the 
second language of the parent.  This study is longitudinal and requires 
many questionnaires that have been validated in English, so it is a 
requirement that the participant speak English.  

 
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Revised: January 5, 2023 
 
 
4.0 
Study-Wide Number of Subjects (Multisite/Multicenter Only) 
4.1 If this is a multicenter study, indicate the total number of subjects 
to be accrued across all sites. 
Response: n/a 
 
5.0 
Study-Wide Recruitment Methods (Multisite/Multicenter Only) 
If this is a multicenter study and subjects will be recruited by methods not 
under the control of the local site (e.g., call centers, national advertisements) 
describe those methods.  Local recruitment methods are described later in the 
protocol. 
5.1 Describe when, where, and how potential subjects will be 
recruited. 
Response: Part 1: Upon approval, we will email a description of the 
screening survey along with a hyperlink to the survey to our contact 
database. We will also post flyers up on UB campus’, in the community 
and distribute flyers to local schools, ever few months until all 226 
participants have had their initial appointments. Facebook may be 
utilized for recruitment by simply posting our approved 4x6 refer a 
friend flyer on Facebook and asking people to like and share the flyer 
image. 
 
5.2 Describe the methods that will be used to identify potential 
subjects. 
Response: Part 1: Passive advertising via flyers and emails to our lab’s 
consented contact database. We will also distribute flyers to schools 
and after school programs who have approved distribution of the 
study materials. 
Part 2: Those that gave permission for future contact, should the 
SNAK study be extended, will be invited to participate in Part 2 of the 
SNAK study via email and phone script (attached).   
Part 3: Those that gave permission for future contact, should the 
SNAK study be extended, will be invited to participate in Part 3 of the 
SNAK study. At this time, we will schedule their follow up 
appointment at the end of their previous appointment and only call 
families to notify them if the study is NOT extended (NIH grant 
extension not funded). 

 
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Those currently enrolled in the SNAK Part 1 will receive a flyer 
announcement about the future opportunity. 
 
5.3 Describe materials that will be used to recruit subjects. (Attach 
copies of these documents with the application. For 
advertisements, attach the final copy of printed advertisements. 
When advertisements are taped for broadcast, attach the final 
audio/video tape. You may submit the wording of the 
advertisement prior to taping to preclude re-taping because of 
inappropriate wording, provided the IRB reviews the final 
audio/video tape.) 
Response: Email recruitment and flyers to schools will be the main 
form of recruitment used for this study.   
 
6.0 
Multi-Site Research (Multisite/Multicenter Only) 
6.1 If this is a multi-site study where you are the lead investigator, 
describe the processes to ensure communication among sites, such 
as: 
• 
All sites have the most current version of the protocol, 
consent document, and HIPAA authorization. 
• 
All required approvals have been obtained at each site 
(including approval by the site’s IRB of record). 
• 
All modifications have been communicated to sites, and 
approved (including approval by the site’s IRB of record) 
before the modification is implemented. 
• 
All engaged participating sites will safeguard data as 
required by local information security policies. 
• 
All local site investigators conduct the study appropriately. 
• 
All non-compliance with the study protocol or applicable 
requirements will reported in accordance with local policy. 
Response: n/a 
 
6.2 Describe the method for communicating to engaged participating 
sites: 
• 
Problems. 
• 
Interim results. 
• 
The closure of a study 
Response: n/a 
 

 
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Revised: January 5, 2023 
7.0 
Study Timelines 
7.1 Describe the duration of an individual subject’s participation in the 
study. 
Response: Part 1: The participant will participate in 9 visits over 2 
years.  
 
Part 2: Participants completing part 1 will be invited to take place in 
Part 2. This may include up to 3 visits; 1 every 9 months (up to a total 
of 3 appointments) prior to the participant turning 18 yoa. Should a 
scheduled appointment occur after the participant’s 18th birthday, 
they will be given a new consent process, upon arrival, for the legal 
adult participant. 
 
7.2 Describe the duration anticipated to enroll all study subjects. 
Response: We expect that it will take 3 years to enroll all participants 
in part 1 of the study.   
 
7.3 Describe the estimated date for the investigators to complete this 
study (complete primary analyses) 
Response: We expect that Part 1 of this study will be completed 5 
years from the start date (approximately 2021). 
Those that complete Part 1 in early 2021 and elect to participate in 
Part 2, may be participating until early 2023. 
8.0 
Study Endpoints 
8.1 Describe the primary and secondary study endpoints. 
Response: The primary endpoint is enrolling all 226 participants, and 
the secondary endpoint is completing all of their follow up visits for 
each participant. 
 
8.2 Describe any primary or secondary safety endpoints. 
Response: n/a 
 
9.0 
Procedures Involved 
9.1 Describe and explain the study design. 
 

 
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24 hours before the scheduled appointment participants will be called to ask COVID 
screening questions. Parents will be spoken to unless the child has research age 18 
and has signed consent to participate in the study as an adult. Should no one 
respond to our call, and automated email will be set to the email address on file and 
a redcap survey will administer the COVID screening survey. Staff will review 
responses and reschedule families if anyone in the household has had symptoms in 
the past 14 days. (see attached survey) 
Upon arrival for a scheduled appointment, participants will ring the door bell and a 
staff member in PPE will meet them for touchless temperature screening and COVID 
screening questions. A Yes to any of the questions or recording a temperature >100 
on Parent or child will lead to suggesting the family call their health care provider 
immediately and rescheduling of the appointment to a date 14days+ after symptoms 
have subsided for anyone in the household. 
Only one family will be scheduled at a time. Appointments will be separated by 30 
min to allow for deep cleaning and sanitation. 
 
SNAK STUDY PART 1 (Visits 1-9) 
Appointment 1 (2.5-3 hrs) (TODAY) 
• Consent and Assent Process 
• Parent/guardian and child will answer some questions separately.  Including, 
completing a pubertal assessment of child’s current development, as well as a 
food security survey.  
• Parents/guardians will then complete a Demographic Questionnaire and a 
Child Feeding Questionnaire and have their own height and weight measured. 
• The child will: 
1. answer a stress questionnaire, a risk taking questionnaire, food 
consumption, and a healthy eating questionnaires 
2. have their body composition measured in the BODPOD 
3. have their heart rate and blood pressure measured 
4. be asked to exercise on a variety of gym equipment for a few minutes  
5. be asked to rate a variety of snack foods 
6. provide a recall previous 24-hour diet and physical activity  
 
Appointment 2 (30-45min) 
The child will: 
1. be asked not to eat or drink anything other than water for 2 hours prior to 
the appointment 
2. be asked to eat a granola bar and play a computer game for a small snack food 
reward or activity time 
3. provide a recall of previous 24-hour diet and physical activity  
4. sent home with 2-weeks’ worth of snacks and asked to eat a snack each day  
5. be instructed to answer 7 short survey questions via email, text or online survey 
each evening 

 
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Revised: January 5, 2023 
 
Appointment 3 (30-45min) 
The child will: 
1. be asked not to eat or drink anything other than water for 2 hours prior to 
the appointment 
2. be asked to eat a granola bar and then play a computer game for a snack food 
reward (30g each) or activity time 
3. provide a recall of same day diet and physical activity and fill out a short online 
survey  
4. be sent home with a watch that tracks activity and asked to wear it for 1 week, 
without removing it, until their next appointment 
5. be instructed to keep track of their food and beverage intake during the week 
using a provided booklet 
 
Appointment 4 (30-45min) 
The child will: 
1. be asked not to eat or drink anything other than water for 2 hours prior to 
the appointment 
2. be asked to eat a granola bar and play a computer game for a small snack food 
reward or activity time 
3. provide a recall of previous 24-hour diet and physical activity  
4. sent home with 2-weeks’ worth of snacks and asked to eat each day  
5. be instructed to answer 7 short survey questions via email, text or online survey 
each evening 
 
Appointment 5 (30-45min) 
The child will: 
1. be asked not to eat or drink anything other than water for 2 hours prior to the 
appointment 
2. be asked to eat a granola bar and then play a computer game for a snack food 
reward activity time  
3. provide a recall of same day diet and physical activity and fill out a short online 
survey  
4. Parent and child will be paid for your first wave of participation (Appointments 
1-5).  
 
 
 
FOLLOW UP VISIT 
Appointment 6 (90min, 6 months after initial appointment) 
The Parent will: 
1. complete the pubertal assessment, eating questionnaires, child feeding 
questionnaires, a health change form, and have their height and weight 
measured. 
The child will:    

 
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Revised: January 5, 2023 
1. complete the pubertal assessment, stress questionnaire, and eating 
questionnaires 
2. have their body composition measured 
3. have their heart rate and blood pressure measured 
4. provide a recall of previous 24-hour diet and physical activity  
5. be paid for their follow up visit participation 
 
Appointment 7 (90min, 15 months after initial appointment) 
The Parent will: 
1. complete the pubertal assessment, eating questionnaires, child feeding 
questionnaires, a health change form, and have their height and weight 
measured. 
The child will:    
1. complete the pubertal assessment, stress questionnaire, eating questionnaires, 
and adolescent risk questionnaire 
2. have their body composition measured 
3. have their heart rate and blood pressure measured 
4. provide a recall of previous 24-hour diet and physical activity  
5. be paid for their follow up visit participation 
 
Appointment 8 (75-90min, 24 months after initial appointment) 
The Parent will: 
1. complete the pubertal assessment, eating questionnaires, child feeding 
questionnaires, a health change form, a contact form and have their height and 
weight measured 
The child will:    
1. be asked not to eat or drink anything other than water for 2 hours prior to the 
appointment 
2. complete the pubertal assessment, stress questionnaire, eating questionnaires, 
and adolescent risk questionnaire 
3. have their heart rate and blood pressure measured 
4. be asked to play a computer game for a snack food reward or activity time  
5. provide a recall previous 24-hour diet and physical activity  
6. be sent home with a watch (and log book) that tracks activity asked to wear it 
for 1 week, without removing it, until their next appointment 
7. be instructed to keep track of their food and beverage intake during the week 
using a provided booklet 
 
Appointment 9 (75-90min, 24 months + 1 week after initial appointment) 
The parent will: 
1. be presented with a consent addendum regarding future contact. 
The child will:    
1. be asked not to eat or drink anything other than water for 2 hours prior to the 
appointment  
2. have their body composition measured 
3. provide a recall previous 24-hour diet and physical activity  

 
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Revised: January 5, 2023 
4. answer questionnaires about sleep and physical activity 
5. be asked to play a computer game for a snack food reward or activity time 
6. be paid for their follow up visit participation 
 
SNAK STUDY PART 2 (VISITS 10-12) 
 
Appointment 10 (90min, ~33 months after initial appointment, ~ 9 months from visit 
9) 
The Parent will: 
1. Complete the pubertal assessment, eating questionnaires, child feeding 
questionnaires, a health change form, a contact form, and have their height 
and weight measured. 
The child will:    
1. complete the pubertal assessment, stress questionnaire, eating questionnaires, 
physical activity questionnaire, sleep questionnaires, and adolescent risk 
questionnaire 
2. have their body composition measured 
3. have their heart rate and blood pressure measured 
4. provide a recall of previous 24-hour diet and physical activity  
5. be paid for their follow up visit participation 
 
Appointment 11 (90min, ~42 months after initial appointment, ~ 9 months from visit 
10) 
The Parent will: 
1. Complete the pubertal assessment, eating questionnaires, child feeding 
questionnaires, a health change form, and have their height and weight 
measured. 
The child will:    
1. be asked not to eat or drink anything other than water for 2 hours prior to the 
appointment 
2. complete the pubertal assessment, stress questionnaire, eating questionnaires, 
physical activity questionnaire, sleep questionnaires, and adolescent risk 
questionnaire 
3. have their body composition measured 
4. have their heart rate and blood pressure measured 
5. provide a recall of previous 24-hour diet and physical activity  
6. be asked to play a computer game for a snack food reward or activity time  
7. be paid for their follow up visit participation 
 
 
Appointment 12 (90min, ~51 months after initial appointment, ~ 9 months from visit 
11) 
The Parent will: 
1. Complete the pubertal assessment, eating questionnaires, child feeding 
questionnaires, a health change form, a contact form, and have their height 
and weight measured. 

 
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Revised: January 5, 2023 
The child will:    
1. complete the pubertal assessment, stress questionnaire, eating questionnaires, 
physical activity questionnaire, sleep questionnaires, and adolescent risk 
questionnaire 
2. have their body composition measured 
3. have their heart rate and blood pressure measured 
4. provide a recall of previous 24-hour diet and physical activity  
5. be paid for their follow up visit participation 
 
SNAK STUDY PART 3 (VISITS 13-16) ~ 9 months from previous visit 
 
We anticipate SNAK part 3 visits looking the same as SNAK part 2 visits. At this 
time, we are only requesting approval to ask Participants if they would like to be 
contacted for SNAK Part 3 should the study be extended with further NIH 
Funding, between the time of their V12 and when they would be due for their 
next follow up appointment (~9-11 months later). 
 
 
*Should the child turn 18 during the course of the study (SNAK Part 2 or Part 3) and 
provide consent to continue participation, parent components for Appointments 10-12 
will have the option to be completely remotely (surveys and self-report weight) at the 
discretion of the consenting adult participant. 
**Parents will be offered to complete surveys remotely prior to the appointment time if 
desired. 
 
 
 
9.2 Provide a description of all research procedures being performed 
and when they are performed, including procedures being 
performed to monitor subjects for safety or minimize risks. 
Response:  
 
 
MEASURES  
 
Additionally, all survey instruments, other than the Tanner and Pubertal, will be 
administered online, via Survey Monkey (for SNAK Part 1) and REDCap (for SNAK 
parts 2/3), from a laboratory computer in a private experimental room.  In response 
to COVID 19 and in an effort to make more study aspects accessible via online 
formats, rather than paper-based, RedCap will be used to administer from surveys 
and tasks for Visit 7-9 (SNAK part 1). 
 
Reinforcing Value TASK:  The reinforcing value of the exercise will be tested on the 
first visit.  Also, RRV of snack food will be tested at baseline and again after the two 

 
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Revised: January 5, 2023 
weeks of exposure to the food. Later they will complete this task again for another 
food type versus reading time. Upon 2-year follow-up, the task will be implemented 
once again. This task provides an empirical measure of the amount of work 
individuals are willing to perform to gain access to these foods (Epstein et al., 2008).  
Participants will then be instructed in the use of the computer task where they will 
respond for an assigned snack food on one computer and reading time on the other. 
The task is similar to a slot machine where every time the mouse button is clicked, 
the shapes rotate and change color.  When all of the shapes match, the participant 
receives a point.  For every 5 points, they will receive a 30g portion of the snack food 
for which they are playing. Participants may go back and forth between computers 
per their preference of rewards they would like to earn.  The schedule of 
reinforcement will be a progressive, variable ratio schedule of: VR4, VR8, VR16, 
VR32, VR64, VR128, VR256, VR512, VR1024 and VR2048.  The session will end 
when the participant no longer wishes to earn points for either reward. At the end 
of the session, participants will be given the portions of food that they earned during 
the game. 
 
Child and Parent Food availability and Scarcity Questionnaires (FIQ): The 
survey module and the associated Food Security Scale were developed by 
researchers at the National Center for Health Statistics and Centers for Disease 
Control and Prevention. It has been shown to identify food-insecure households and 
households with very low food security with reasonably high specificity and 
sensitivity and minimal bias. The surveys are phrased differently to address the 
separate perspectives of parent/guardian and child, with the child form being 5 item 
and the adult containing 24 items.  The VFS will also be administered which has 
more questions related to the child experience. 
 
Healthy Eating self-efficacy questionnaire (SEHE): Self-efficacy to make healthy 
food choices will be measured using a nine-item scale developed for use with American 
adolescents (French, Story, Neumark-Sztainer, Fulkerson, & Hannan, 2001).  The self-
efficacy scale was used to assess participants’ self-confidence for making healthy food 
choices in social situations (e.g., with friends), in emotional situations (e.g., bored) and 
in normal situations (e.g., at family dinner).  Responses are rated on a six-point scale 
ranging from “not at all sure” to “very sure.” 
 
Demographic: Parents will complete a demographic questionnaire providing 
information about household income, education, profession, and race/ethnicity for 
themselves and a secondary caregiver, if applicable. The parent will also be asked to 
self-report the current stature of the child’s secondary care giver, as well as any 
other adult caregivers that the child lives with.   
 
Tanner Stage Evaluation:  Boys and girls will be given line drawings of the 5 stages 
of pubertal development and asked to circle the one that looks most like them.  Girls 
will be given drawings of breast development and boys will be given drawings of 
genital and pubic hair development.  Parents will independently be given the same 

 
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drawings and asked to circle the one that they feel best resembles their children.  
The average of the self and parental reports will be taken.  These drawings will be 
given to the children in an envelope and they will be given verbal instructions to 
circle the picture that looks most like how they look and to return the questionnaire 
to the envelope.  The experimenter will leave the room and return 2 minutes later.  
Self-assessment of pubertal stage has been shown to be accurate and an acceptable 
substitute when physical examinations are not feasible. Parents will no longer be 
asked to complete the Tanner after Visit 8. 
 
Pubertal Development Questionnaire –modified (PDQ):  This questionnaire asks 
questions about secondary sex characteristics for boys (growth of body hair, 
changes in voice, acne, and height) and girls (breast development, menstruation, 
and acne).  This will be given along with the Tanner Stage drawings and will be used 
as a secondary measure of pubertal development. This questionnaire will be given 
to both child and parent, and the scores will be averaged together. A 6th question has 
been added to this questionnaire in order to assess child self-assessed perception of 
stature as well as the parent’s assessment of the child’s stature. The parent and child 
will independently be asked to circle one same-sex drawing from a series of nine 
somatotypes introduced by Stunkard (1983). 
 
Hypothetical Delay Discounting Task (Delay Discounting Task): 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. In the delay discounting task, participants will make choices between a 
fixed reward available after a time delay and an immediate reward whose 
magnitude will be adjusted in specific dollar increments in either ascending or 
descending order. The task will be administered by the experimenter using paper 
cards.  Cards that depict different hypothetical dollar amounts will be placed two at 
a time on a table in front of the participant.  The card set depicting the delayed, fixed 
rewards will be placed to the participant's left and the card set depicting the 
immediate rewards will be located on the participant's right.   
 
The values of the delayed (fixed) amounts will be about $50.  The immediate 
reward value cards will depict 30 values ranging from 0.1 to 100% of the delayed 
reward with which they are compared. The trials will be presented across a series of 
time delays (e.g., 1 day, 1 week, 2 weeks, 1 month, 6 months, 1 year and 2 years).  
Participants will indicate their desired reward (either immediate or delayed) by 
pointing to the appropriate card.  Upon making two choices for the opposite reward, 
an indifference point is determined by taking the average of the immediate reward 
values immediately prior to and immediately following a switch in choice to the 
other reward. As the amount of the immediate reward decreases, the participant 
may decide when he/she is willing to wait for the specified delay (i.e., one week) to 
receive the larger amount. 
 
Adjusting Amount Discounting Task (Minute Task). Participants will complete 
the DD task for money. Computerized administered assessments will provide 
participants with choices between a smaller amount available immediately or a 

 
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larger amount available later. The magnitude of the immediate commodity is 
adjusted until it is subjectively equivalent to the later larger amount. Subjective 
equivalence will be obtained at delays such as; 1 day, 1 week, 1 month, 3 months, 6 
month, and 1 year.  
 
Adjusting Amount Discounting task (web based) DD will be measured using the 
adjusting-amount task, which involves making choices between different amounts 
of money over different amounts of time. The participant will be presented with two 
choices on the computer screen and asked to choose which one they would prefer if 
they were going to actually get the amounts shown. The delayed amount will be $50. 
The delay increases from 1 day to 2 years through the task. The immediate amount 
will vary through the task, adjusting based on the participants' choices in order to 
estimate the point of indifference between delayed and immediate amounts. * A link 
to this task will be emailed or texted to participants the day before their visit for 
remote completion. The completion should take <1 minute total. 
 
The Child Feeding Questionnaire (CFQ): Parent feeding practices will be assessed 
using the Structure the Child Feeding Questionnaire (CFQ). The CFQ is the most 
widely used instrument to assess parent feeding practices and has been used in 
numerous studies with children across the age spectrum. 
 
Perceived Stress Scale (PSS-10): Previous research has shown a positive 
association between childhood cumulative stress and BMI as well as decreased self-
regulatory behavior (Evans, 2003).  The inclusion of the c will allow us to control for 
the influence of general stress on BMI outcomes (Terzian, Moore, & Nguyen, 2010).  
We will also examine it as a potential moderator in the relationship between 
impulsivity and adolescent BMI.   
 
Adolescent Risk taking Questionnaire (ARA): This questionnaire has been 
designed to assess the frequency of risk taking by the study population.  The 
adolescent version will be administered to ensure that the questions asked are age 
appropriate.  Adolescents (12-16 yoa) are asked 60 questions about the frequency 
of engaging in substance use, violence, and other risk taking behaviors over the past 
12 months. This questionnaire has been updated to include some rewording and 
new questions from Youth Behavioral Risk surveillance Survey (from which it is 
based) 2019. 
Dutch Eating Behavior Questionnaire (DEBQ): At the end of the sequence 
of visits, participants will complete an eating questionnaire that assesses 
knowledge about dieting practices and dietary restraint measurements. 
 
Power of Food Scale (PFS): The Power of Food Scale (PFS) assesses the 
psychological impact of living in food-abundant environments. It measures appetite 
for, rather than consumption of, palatable foods, at three levels of food proximity 

 
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(food available, food present, and food tasted). It is comprised of 15 statements 
pertaining to the availability, presence, and taste of food.  Examples of statements 
include: “If I see or smell a food I like, I get a powerful urge to have some.”  The 
aggregate PFS score suggests degree of vulnerability to the various aspects of an 
obesogenic food environment, one that is filled with readily available, high-kilojoule, 
highly palatable food.  
Hunger, Thirst Rating Scale: Participants will be asked to rate their degree 
of thirst, hunger, liking of the study foods and desire to eat the study foods on 
a 100mm analog scale ranging from “not at all” to “extremely”. This rating 
will be performed at three different time points during each RRV visit.  
24-hour food and exercise recall:  At each visit, the child (with the 
assistance of the parent) will recall his/her dietary intake and physical 
activity for the previous 24 hours and current day.  Any participant who has 
not complied with the study protocol will be rescheduled.    
Dietary habit books:  During the course of the study participants will 
engage in two, separate weeks of wash out where they will not participate in 
any lab activities, but will be asked to wear an ACTi graph activity monitor 
for 1 week. During that week the participant will be asked to record their 
dietary history.  Participants will be asked to indicate the time of day, portion 
sizes and brands of foods and beverages consumed. 
Weight, height, and BMI: Youth and Parent/Guardian weight will be 
assessed by use of a digital scale (SECA). Height will be assessed using a SECA 
stadiometer.  On the basis of the height and weight data, BMI, and BMI 
percentile is calculated using the CDC Child (or Adult) BMI Calculator 
according to the following formula: (BMI = kg/m2).   
Body Composition: Body composition will be calculated using air 
displacement plethysmography in the child only. The device used is called a 
Bod Pod. The BOD POD technology is fundamentally the same as underwater 
(hydrostatic) weighing, but uses air instead of water. The BOD POD measures 
the volume of air a person's body displaces while sitting inside a comfortable 
chamber, rather than measuring how much water his or her body displaces 
when dunked in a tank. The BOD POD itself is a dual-chambered, fiberglass 
plethysmograph that determines body volume by measuring changes in 
pressure within a closed chamber. Children will be asked to wear 
standardized athletic clothing for each BOD POD measurement over time. 
Liking of Exercise and Seated Activities: Participants will be asked to use 
each piece of exercise equipment for 1 minute and they will have 3 minutes 
to explore the desk activities.  They will be asked to rate how much they like 
each of these on a 100mm VAS scale.  
Adolescent Sleep Hygiene Scale (ASHS) comprehensively assesses sleep hygiene 
through 8 subscales: physiological, behavioral arousal, cognitive/emotional, sleep 
environment, sleep stability, daytime sleep, substances, and bedtime routine. Six tier 

 
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frequency measure in which each increase in response suggests a 20% increase in 
frequency. Questions are asked about behaviors during the previous month.  
 
Cleveland Adolescent Sleep Questionnaire (CASQ) This is meant to measure 
excessive daytime sleepiness in adolescents. The survey includes various statements 
about alertness and sleepiness, which the participant rates from 1-5 (never to 
almost every day).  
 
The International Physical Activity Questionnaires (IPAQ) – short form is 
comprised of 7 items to assess self-report physical activity. The purpose of the 
questionnaire is to provide common instruments that can be used to obtain 
internationally comparable data on health–related physical activity. IPAQ-S will be 
used to assess the types and intensity of physical activity and inactivity in daily life 
to estimate total activity in MET-min/week and time spent sitting “over the past 7 
days.”  
 
SNAK Part 2 only –Survey Additions 
 
The Consideration of Future Consequences (CFC) scale measures the extent to 
which people consider the potential distant outcomes of their current behaviors and 
are influenced by those potential outcomes.  The CFC is a 12- item scale using 5- 
point ratings.  (1 = extremely uncharacteristic to 5 = extremely characteristic). For 
example, participants rate the statement “I consider how things might be in the 
future, and try to influence those things with my day to day behavior. 
 
The French Weight Loss Scale (FWLS) was validated for use with adolescents and 
has been used with children, adolescents, and adults. It asks participants to report 
their use of various weight control behaviors over the past 9 months. 
 
The Parent Encouragement of Child Weight Loss (PEWL) scale assesses parent-
reported use of various strategies that can be used to both indirectly and directly 
encourage their child to lose weight Parents are asked to rate how they feel about 
questions from 1 (not) to 5 (definitely).  The scale has primary been used with 
parents of female children, but the questions are appropriate for both boys and girls.  
 
The Weight Concerns Scale (WCS) was validated in a sample of female 
adolescents, but has been used with both adolescent boys and girls. It asks 5 
questions that all address different aspects of the importance of weight and body 
shape.  
 
Measures timeline: 
 
Visits 
Survey Measure 
1, 6, 7, 8, 10, 11, 12 
Pubertal (child self report) 

 
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1, 6, 7, 8, 10, 11, 12 
Tanner (child self report) 
1, 6, 7, 8, 10, 11, 12 
Pubertal (parent) 
1, 6, 7, 8 
Tanner (parent) 
1, 8, 10, 12 (currently 1, 6, 7, 
8, 10, 11, 12) 
Demographic (Parent) 
1, 6, 7, 8, 10 
Child Feeding Questionnaire (CFQ) 
1, 6, 7, 8, 10, 11, 12 
Food Insecurity Q (FIQ-Parent)  
 
 
1, 2,3,4,5, 6, 7, 8, 10, 11, 12 
Self Efficacy for Healthy Eating (SEHE) 
1, 6, 7, 8 
Power of Food Scale (PFS) 
1, 6, 7, 8, 10,11 
Dutch Eating Behavior-Hill (DEBQ) 
1, 6, 7, 8, 10, 11, 12 
Eating Disorder Evaluation (EDE-Q) 
1, 6, 7, 8, 10, 11, 12 
Child FIQ (FIQ-C)  
1, 6, 7, 8, 10, 11 
Venezuela Food (VFS) 
1, 6, 7, 8, 10, 11, 12 
Perceived Stress Scale (PSS) 
1,  8, 12 
Adolescent Risk Assessment (ARA) 
7, 8, 10, 12 
Contact Information Update (parent) 
9, 10, 12 
Adolescent Sleep Hygiene Scale (ASHS) 
9, 10, 12 
Cleveland Adolescent Sleep (CASQ) 
10, 11, 12 
Consideration of Future Consequences Scale (CFC) 
10, 11, 12 
The French (FWLS) (Child) 
10, 11, 12 
The French (FWLS) (Parent) 
9, 10, 11, 12 
Physical Activity Q (IPAQ-S) 
10, 11, 12 
Weight Concerns Scale (WCS) 
10, 11, 12 
Parent Encouragement of  Weight Loss (PEWL) (Parent) 
Visits 
Task/Assessment 
1, 6, 7, 8, 10, 11, 12 
Height/Weight (Child & Parent) 
1, 6, 7, 8, 10, 11, 12 
Blood pressure/Heart Rate (Child) 
1, 6, 7, 9, 10, 11, 12 
Body Composition-Body Fat % 
1, 2, 4, 6, 7, 8, 9, 10, 11, 12 
24 hour dietary recall 
1, 2, 4, 6, 7, 8, 9, 10, 11, 12 
24 hour physical activity recall 
1, 6, 7, 9, 10, 11, 12 
Minute Task 
1, 6, 7, 9, 10, 11, 12 
Delay Discounting Task 
1 
RRV PA 
2, 3, 4, 5, 8, 9, 11 (HED only) 
RRV HED/LED 
 
 
9.3 Describe procedures performed to lessen the probability or 
magnitude of risks. 
Response: The level of risk encountered by the participants in this experiment is no greater 
than minimal.  We have taken several steps to mitigate any potential or perceived risk. First, 
the questionnaires are completed using survey monkey and redcap, which contains no 
personal identifying information and uses only a code that is maintained on a password 
protected computer.  Second, the participants are told that they do not have to answer 
questionnaires that they are not comfortable answering. Finally, participants are reminded 
that none of the information that they provide will be shared with anyone, including parents 
or the authorities.  Using these procedures, we have good response rates on our 

 
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questionnaires and have not had participants report feelings of discomfort in answering 
questions of this nature.   
 
The only people who will have access to the questionnaire data are study staff.  It will be 
entered by the participant directly into the secure, password protected Survey Monkey™ or 
redcap program.  If the participant is uncomfortable answering the questionnaires, he/she 
does not have to complete them and can still participate in the remainder of the 
experimental sessions. In addition, if at any time the participant wishes to stop the 
experiment, he/she can do so without question and will be compensated for the time 
completed.   
 
There is minimal risk associated with reporting of Tanner Stage & Pubertal Development 
Questionnaire.  The children may feel embarrassed reporting about the stages of their 
genital and breast development.  In order to minimize this, the experimenter will leave the 
room while the child completes the questionnaire and they will be given a folder to place 
the questionnaire into to give back to the experimenter. Furthermore, the Adolescent Risk 
Questionnaire and Eating Disorder Examination Questionnaire are administered (as with all 
surveys) are administered in a private room. We make clear in the directions that there are 
no right or wrong answers and that their responses will be kept confidential. These 
instruments are not meant to be diagnostic in the manner in which they are being 
administered and are being used in the context of the research to understand how desire to 
regulate food intake and engage in various forms of risk behavior and dieting may interact 
with our study measures to influence weight change over time.  See section 14.1 for more 
discussion on this. 
Furthermore, at the end of Visits 10-12 we will hand out a resource sheet which can 
provide information about how to get help regarding many concerns.  
 
9.4 Describe all drugs and devices used in the research and the 
purpose of their use, and their regulatory approval status. 
Response: n/a 
 
9.5 Describe the source records that will be used to collect data about 
subjects. (Attach all surveys, scripts, and data collection forms.) 
Response: (see above) 
 
9.6 What data will be collected including long-term follow-up. 
Response:  
Pubertal ratings, self-efficacy, height/weight/body compositions, scarcity 
ratings, risk taking propensity, impulsivity, child feeding practices and food 
frequency will all be assessed at visits 6, 7, 8 (6, 15, and 24 month follow up).  
Pubertal ratings, self-efficacy, height/weight/body compositions, scarcity 
ratings, risk taking propensity, impulsivity, child feeding practices, physical 
activity and sleep  will all be assessed at follow up visits 10, 11, 12. 

 
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9.7 For HUD uses provide a description of the device, a summary of 
how you propose to use the device, including a description of any 
screening procedures, the HUD procedure, and any patient follow-
up visits, tests or procedures. 
Response: n/a 
 
10.0 Data and Specimen Banking 
10.1 If data or specimens will be banked for future use, 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. 
Response: Data will be stored for up to 3 years after data collection.  No 
specimens will be collected.  
 
10.2 List the data to be stored or associated with each specimen. 
Response: Data will be stored in a password protected database. The data 
will not contain any identifying information.  No information will be removed 
from the laboratory.  
 
10.3 Describe the procedures to release data or specimens, including: 
the process to request a release, approvals required for release, 
who can obtain data or specimens, and the data to be provided 
with specimens. 
Response: n/a 
 
11.0 Data Management 
11.1 Describe the data analysis plan, including any statistical 
procedures. 
Response:  
Response: The data will be analyzed using SPSS and SYSTAT software once 
collection is complete. 
 
2 Way ANOVAS with  
Inde: Sex and BMI as predictors 
Dep: Food reinforcement 
Cov: SES 
 

 
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Revised: January 5, 2023 
Variables of interest include: 
BMI% pre/post 
Sex 
SES 
Food reinforcement pre/post 
Other analyses: 
Assigned snack food  
Self efficacy scores for health eating 
 
11.2 Provide a power analysis. 
Response: 3 level Dependent, 2-2level Independents. 
Able to detect effect size of 0.25, 0.5, 0.75, 1.00, or 1.25 at alpha 0.05  
>90                                    0.826  0.999  1.000  1.000  1.000 
N>90 used to see small/medium to large effects and also have an even 
number of participants to evenly split recruitment groups (N= 226, 113 male, 
113 female) 
 
 
11.3 Describe the steps that will be taken to secure the data (e.g., 
training, authorization of access, password protection, encryption, 
physical controls, certificates of confidentiality, and separation of 
identifiers and data) during storage, use, and transmission. 
Response:  The Principal Investigator, Dr. Jennifer Temple, will be 
responsible for ensuring data integrity and safety monitoring for human 
subjects who are involved in the research by training all staff to abide by 
appropriate protocols, including data security, password protection, and 
GRP/CITI training. The project coordinator will monitor these training steps. 
All data that are collected by the investigators are stored in password 
protected databases or in locked filing cabinets, where the information is 
only associated with a numeric identifier and not a subject’s personal 
information. 
11.4 Describe any procedures that will be used for quality control of 
collected data. 
Response: Quality control checks are used for all calculations and 
manual data inputs. At least two experimenters will check all values 
via double data entry. Data collected via survey monkey or redcap will 
be downloaded. 
 
11.5 Describe how data and specimens will be handled study-wide: 

 
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Revised: January 5, 2023 
Response: Data will be stored in a password protected database. The data 
will not contain any identifying information.  No Information will be removed 
from the laboratory.  
 
11.6 What information will be included in that data or associated with 
the specimens? 
Response: ID number associated with height and weight data. No specimens 
collected. 
 
11.7 Where and how data or specimens will be stored? 
Response: Data will be stored in a password protected database. The data 
will not contain any identifying information.  No information will be removed 
from the laboratory.  
 
11.8 How long the data or specimens will be stored? 
Response: 3 years 
 
11.9 Who will have access to the data or specimens? 
Response: PI, research coordinator, Approved research assistants on the 
project will have access to the data. 
 
11.10 Who is responsible for receipt or transmission of the data or 
specimens? 
Response: n/a 
 
11.11  How data and specimens will be transported? 
Response: n/a 
 
12.0 Provisions to Monitor the Data and Ensure the Safety of Subjects 
12.1 Describe the plan to periodically evaluate the data collected 
regarding both harms and benefits to determine whether subjects 
remain safe.   
Response: The Principal Investigator, Dr. Jennifer Temple, will be responsible 
for ensuring data integrity and safety monitoring for human subjects who are 
involved in the research. The project coordinator will bring any concerns or 

 
Page 26 of 44 
Revised: January 5, 2023 
comments from the participants or research assistants to the attention of the 
PI.  
This study asks students to answer a variety of surveys asking about their risk 
taking and eating behaviors. Because the questionnaires used in this study are 
not meant to be diagnostic and because the measures examine common, 
subclinical eating behaviors, we do not take any action in children who score 
high on disordered eating behavior.  We lack the qualifications and the 
authority to perform diagnostic screening.  Additionally, because we aim to 
protect privacy and confidentiality of our participants, we are not willing to 
share their response information with parents. We have added a notification at 
the end of the Adolescent Risk Questionnaire which provides contact 
information for the Crisis Services hotline, so that students may anonymously 
seek that support if they are interested. Furthermore, we will supply a resource 
sheet to all participants at the end of visits 10, 11, 12, should they participate in 
SNAK Part 2. 
 
12.2 Describe what data are reviewed, including safety data, untoward 
events, and efficacy data. 
Response: participant comments will be reported 
 
12.3 Describe how the safety information will be collected (e.g., with 
case report forms, at study visits, by telephone calls with 
participants). 
Response: n/a 
 
12.4 Describe the frequency of data collection, including when safety 
data collection starts. 
Response: n/a 
 
12.5 Describe who will review the data. 
Response: n/a 
 
12.6 Describe the frequency or periodicity of review of cumulative data. 
Response: For the proposed project the data will be reviewed at 1 month and 2 
months. For the previously conducted research, approximately every 6 
months the data was reviewed by the PI. 
12.7 Describe the statistical tests for analyzing the safety data to 
determine whether harm is occurring. 

 
Page 27 of 44 
Revised: January 5, 2023 
Response: n/a 
 
12.8 Describe any conditions that trigger an immediate suspension of 
the research. 
Response: n/a 
 
 
 
13.0 Withdrawal of Subjects 
13.1 Describe anticipated circumstances under which subjects will be 
withdrawn from the research without their consent. 
Response: Anyone unable to attend their appointments or a participant that 
frequently canceled appointments will be withdrawn due to the time-
sensitive nature of the data collection. Should they drop out or be withdrawn 
from the study, they will be asked to answer a 4-5 question exit survey about 
their experience.  
 
13.2 Describe any procedures for orderly termination. 
Response: N/A 
 
13.3 Describe procedures that will be followed when subjects withdraw 
from the research, including partial withdrawal from procedures 
with continued data collection. 
Response: Anyone that is withdrawn from the study will be paid for their 
time. They will not be contacted for future data and their data will be coded 
as a withdraw. Their data will stay on file for the study term, unless they ask 
for their data to be withdrawn. 
 
14.0 Risks to Subjects 
14.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related the subjects’ participation in 
the research. Include as may be useful for the IRB’s consideration, 
a description of the probability, magnitude, duration, and 
reversibility of the risks. Consider physical, psychological, social, 
legal, and economic risks. 
Response:  

 
Page 28 of 44 
Revised: January 5, 2023 
The level of risk encountered by the participants in this experiment is NO 
GREATER THAN MINIMAL.  There are no invasive techniques being used or 
substances that are potentially harmful. There is a low probability of risks from 
completing some of our study instruments, including risk of disclosure of 
information outside the context of the research study. Sub-clinical disordered 
eating behavior, such as dieting and food restriction, is assessed on our 
instruments, such as the DEBQ and the EDE-Q.  These instruments are not meant 
to be diagnostic in the manner in which they are being administered and are 
being used in the context of the research to understand how desire to regulate 
food intake and engage in various forms of dieting may interact with our study 
measures to influence weight change over time.  These are commonly used 
measures in this population and are not known to cause physical, psychological, 
social, legal or economic harm.  Food scarcity is being assessed using two 
instruments in this study (VFS and FIQ).  It is critical that we gather information 
about the child’s perceived food scarcity, as we have preliminary data showing 
that the child’s perception is more strongly related to weight change than the 
parent’s perception.  The child may feel some embarrassment from answering 
questions about their food scarcity, but all other risks (physical, social, legal, and 
economic) remain extremely low probability.  
Finally, the participants in our study complete the ARA questionnaire.  This 
questionnaire is modeled from the Youth Behavioral Risk Surveillance study 
questionnaire which has been used in tens of thousands of adolescents from 
across the country for over a decade.  There are no known or reported risks from 
the administration of this questionnaire.  The participants are told that their 
answers will be kept confidential, including not being reported to their 
parents.  They are at no legal risk from reporting this activity.  It is common for 
studies of adolescent substance use to provide this type of disclaimer to 
participants completing questionnaires of this nature in order to encourage 
honesty and reduced undue concern from the participant that there will be 
punishment for their answers. We have added a pop up containing contact 
information about a local mental health hotline (Crisis Services) at the end of the 
ARA survey, so that any student has access to this confidential line if they are 
interested. Furthermore, we will supply a resource sheet to all participants at the 
end of visits 10, 11, 12, should they participate in SNAK Part 2 or 3.  
Despite these surveys not being clinical assessments we will attempt to notify 
parents/guardians of potential ongoing high risk eating behaviors and mental 
health responses of their teenagers. Data from the EDE-Q and ARA will be 
reviewed at the end of SNAK Part 2 visits (Visits 10-12).  Should responses 
indicate recent purging behavior, suicidal ideation or attempt, the 
parent/guardian of the child will be contacted using the “Parental Contact due to 
EDE or ARA Phone Script” based on the following assessment plan. 
The EDE Q survey data will be reviewed by research assistant at the end of SNAK Part 2 
(Visits 10, 11, 12).  If an individual scores an average > 4.0 globally (average of EDE-Q 

 
Page 29 of 44 
Revised: January 5, 2023 
items #1-12 and 19-28), and endorses >2 on #16 (vomiting) or >2 on #17 (laxative use), 
the PI, Jennifer Temple, will call the parent/guardian of the child to suggest they talk to 
their child about their risky eating habits and consider seeking medical evaluation 
following the “Parental Contact due to EDE or ARA Phone Script” within one week.  
 
The ARA survey data will be reviewed by research assistant at the end of SNAK Part 2 
(Visit 12). Should a participant endorse thoughts of suicide (#15) greater than "once or 
twice" or any endorsement of "suicide attempt" (#16) in the past 12 months, the PI, 
Jennifer Temple, will call the parent/guardian of the child to suggest they talk to their 
child about their mental health and consider seeking medical evaluation following the 
“Parental Contact due to EDE or ARA Phone Script” within one week. 
 
The “Parental Contact due to EDE or ARA Phone Script” will not specifically disclose the 
child’s questions or responses, but will convey the nature of the concern as “high risk 
eating behaviors” or “mental health.” The PI will make 3 documented phone calls 
attempts to parents over 3 weeks. If no contact is made, the research coordinator will 
mail a letter using the indicated script and include the “Resource letter” along with it. 
 
Individuals will not be contacted for data from appointments that they have previously 
consented/assented to. The SNAK Part 2 Consent and Assent forms will include a 
statement about potential disclosure. Those that have already signed a SNAK Part 2 
Consent will be provided a Consent/Assent Addendum notifying them of the change 
prior to the start of their next scheduled appointment. The child will not be dismissed 
from the study based on these survey responses. 
14.2 If applicable, indicate which procedures may have risks to the 
subjects that are currently unforeseeable. 
Response: n/a 
 
14.3 If applicable, indicate which procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
Response: n/a 
 
14.4 If applicable, describe risks to others who are not subjects. 
Response: n/a 
 
15.0 Potential Benefits to Subjects 
15.1 Describe the potential benefits that individual subjects may 
experience from taking part in the research. Include as may be 
useful for the IRB’s consideration, the probability, magnitude, and 
duration of the potential benefits. 

 
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Response: The participants may find the compensation to be a benefit to 
their participation.  
Also, in order to support the involvement of families that may not have 
personal transportation available, we will reimburse the public travel cost of 
the parent, participant, and any siblings under 16 years of age that must 
travel with the parent to the appointment. The travel must be completed via 
NFTA bus or rail, on the date of appointment, and a receipt must be rendered 
in exchange for cash reimbursement for the fare.  Those that have unlimited 
monthly NFTA passes will not reimbursed. 
 
15.2 Indicate if there is no direct benefit. Do not include benefits to 
society or others. 
Response: no direct benefit  
 
16.0 Vulnerable Populations 
16.1 If the research involves individuals who are vulnerable to coercion 
or undue influence, describe additional safeguards included to 
protect their rights and welfare. 
• 
If the research involves pregnant women, review 
“CHECKLIST: Pregnant Women (HRP-412)” to ensure that 
you have provided sufficient information. 
• 
If the research involves neonates of uncertain viability or 
non-viable neonates, review “CHECKLIST: Neonates (HRP-
413)” or “HRP-414 – CHECKLIST: Neonates of Uncertain 
Viability (HRP-414)” to ensure that you have provided 
sufficient information. 
• 
If the research involves prisoners, review “CHECKLIST: 
Prisoners (HRP-415)” to ensure that you have provided 
sufficient information. 
• 
If the research involves persons who have not attained the 
legal age for consent to treatments or procedures involved in 
the research (“children”), review the “CHECKLIST: Children 
(HRP-416)” to ensure that you have provided sufficient 
information. 
• 
If the research involves cognitively impaired adults, review 
“CHECKLIST: Cognitively Impaired Adults (HRP-417)” to 
ensure that you have provided sufficient information. 
• 
Consider if other specifically targeted populations such as 
students, employees of a specific firm or 
educationally/economically disadvantaged persons are 
vulnerable to coercion or undue influence.  The checklists 

 
Page 31 of 44 
Revised: January 5, 2023 
listed above for other populations should be used as a guide 
to ensure that you have provided sufficient information.  
Response:  
This study is recruiting children who have not yet reached the age of consent. 
In order to ensure they are aware of all of the study parameters, obligations, 
and any risks, the child will be present during the Parental Consent process. 
Furthermore, the child will be provided with an age-appropriate Assent form 
along with explanation of expectations.  The families will be given a private 
moment to discuss their child’s participation before signing any forms. Also, 
the research assistant will insist that any question be asked and answered 
before signing the consent and assent forms. Finally, the families are notified 
that they are able to withdraw from the study at any time without penalty.  
 
17.0 Community-Based Participatory Research 
17.1 Describe involvement of the community in the design and conduct 
of the research. 
Response: none 
 
Note: “Community-based Participatory Research” is a 
collaborative approach to research that equitably involves all 
partners in the research process and recognizes the unique 
strengths that each brings. Community-based Participatory 
Research 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. 
18.0 Sharing of Results with Subjects 
18.1 Describe whether or not results (study results or 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 physicians) and if so, describe how 
it will be shared. 
Response: None. We will do our best to prevent subjects from learning their 
body fat % during our testing, so that it does not influence behavior. No 
survey information will be disclosed to parents and we will not comment on 
any survey responses made by parent or child. 
 
19.0 Setting 
19.1 Describe the sites or locations where your research team will 
conduct the research.  

 
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Revised: January 5, 2023 
Response: UB South Campus, G62 Farber Hall, And Nutrition and Health 
Research lab, Farber G03, and Bod Pod Room (Kimball 119/120) 
 
19.2 Identify where your research team will identify and recruit 
potential subjects. 
Response: All participants will be those that completed studies in our 
laboratory in the past who have asked to be placed on our email list or are 
those that have seen a flyer for our study. 
 
19.3 Identify where research procedures will be performed. 
Response: UB South Campus, G62 Farber Hall, And Nutrition and Health 
Research lab, Farber G03 and Bod Pod Room (Diefedorf Annex Room G19 or 
Kimball 119/120) 
 
19.4 Describe the composition and involvement of any community 
advisory board. 
Response: n/a 
 
19.5 For research conducted outside of the organization and its 
affiliates describe: 
• Site-specific regulations or customs affecting the research for 
research outside the organization. 
• Local scientific and ethical review structure outside the 
organization. 
Response: n/a 
 
20.0 Resources Available 
20.1 Describe the qualifications (e.g., training, experience, oversight) of 
you and your staff as required to perform their role. 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 people 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 person meets the qualifications described to 
fulfill their roles. 

 
Page 33 of 44 
Revised: January 5, 2023 
Response: PI, Jennifer Temple has extensive experience with this type of 
research. All lab staff been trained by the research Coordinator and PI to take 
height and weight measurements in accordance with those use for the 
NHANES national data collection. 
 
Describe other resources available to conduct the research: For 
example, as appropriate: 
20.2 Justify the feasibility of recruiting the required number of suitable 
subjects within the agreed 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: We have access to the contact information of over 2000 
individuals that completed other studies in previous years. Additionally, have 
previously been approved to send flyers to local public schools in large 
numbers.  Therefore, we believe we will be able to attain n=226 nonsmoking 
youth within the given 3-year period. 
 
20.3 Describe the time that you will devote to conducting and 
completing the research. 
Response: Table 3. Planning for enrollment of participants from baseline (B) 
through three follow-up periods every 6 months (F)   
 
Study Months 
 
0-6 6-12 12-18 
18-24 
24-30 
30-36 
36-42 
42-48 
48-54 
54-60 
IRB, pilot 
testing, staff 
10 
 
 
 
 
 
 
 
 
 
Finish 
data 
collection
, data 
analysis 
and 
manuscri
Enroll 1-58 
 
B 1- F 1–45 F 1 - 45 F 1 - 45 
 
 
 
 
Enroll 58 - 116 
 
 
B 46-
F 46-90 F 46-90 
F 46-90 
 
 
 
Enroll 116 - 
 
 
 
B 91-
F 91-135 F 91-135 F 91-135 
 
 
Enroll 174 - 
 
 
 
 
B 136-
F 136-180 F 136-
F 136-
 
Enroll 232 - 
288
 
 
 
 
 
B 181-226 F 181-
226
F 181-
226
F 181-
226
Total/6 
10 
45 
90 
135 
180 
180 
135 
90 
45 
Study Year 
01 
02 
03 
04 
05 
Total 
Assessments/y
55 
225 
360 
225 
45 
B = baseline data collection; F = Follow-up weight re-checks 
 
 
20.4 Describe your facilities. 
Response: We are a research laboratory with many rooms, including a full kitchen 
and two study rooms. A third study room is located directly across the hall. All 

 
Page 34 of 44 
Revised: January 5, 2023 
height and weight measurements will be taken within G62 Farber Hall, UB South 
Campus. Exercise will Occur in Farber G03 and BODPOD measurements will be 
taken in Diefendorf Annex G19. 
 
20.5 Describe the availability of medical or psychological resources that 
subjects might need as a result of an anticipated consequences of 
the human research. 
Response: n/a 
 
20.6 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 research assistants are CITI human ethics and GRP certified 
and have gone through rigorous training and observation by managers in the 
Nutrition and Health Research lab prior to working autonomously. 
 
21.0 Prior Approvals 
21.1 Describe any approvals that will be obtained prior to commencing 
the research. (E.g., school, external site. funding agency, 
laboratory, radiation safety, or biosafety approval.) 
Response:  
 
22.0 Recruitment Methods 
22.1 Describe when, where, and how potential subjects will be 
recruited. 
Response: n/a 
 
22.2 Describe the source of subjects. 
Response: see above 
 
 
22.3 Describe the methods that will be used to identify potential 
subjects. 
Response: see above 
 

 
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Revised: January 5, 2023 
22.4 Describe materials that will be used to recruit subjects. (Attach 
copies of these documents with the application. For 
advertisements, attach the final copy of printed advertisements. 
When advertisements are taped for broadcast, attach the final 
audio/video tape. You may submit the wording of the 
advertisement prior to taping to preclude re-taping because of 
inappropriate wording, provided the IRB reviews the final 
audio/video tape.) 
Response: see above 
 
22.5 Describe the amount and timing of any payments to subjects. 
SNAK PART 1: 
After these 5 visits the child will be paid $55, and as long as all materials have 
been completed along the way, they will receive a bonus of $45, for a total of 
$100.  This “bonus” is a compilation of money earned for doing activities 
outside of the laboratory. Children earn $1 per day for eating their snack and 
then completing their daily survey about the food. They also earn $1 per day 
for wearing their activity monitor and writing down their dietary intake in 
their habit book. Should more than 4 days snacking be missed in a 2 week 
periods, $1 will subtracted from their earnings per missed day. Once the 
child completes the first 5 visits, the parent will be entered into a drawing to 
win a $100 check. The drawing will occur once per every 10 families that 
complete the study. 
 
Six months after the first appointment, they will come back into the lab, so 
that the child can have their body composition measured and to answer 
some questionnaires. The parent will also be re-weighed. The participant will 
be paid $25 for this appointment (90min). Another 9 months later, the child 
will be asked to come in again for another 90 min appointment. For this visit, 
the child will earn $30, and the parent/guardian will receive $10 to help 
offset the cost of transit. 
 
Finally, 24 months after the first appointment, the child will be asked to come 
to the lab for 2 appointments (75-90 min each) again to answer questions, 
eat a granola bar, play the computer game, and to have their body 
composition measured. There will be a 1 week break in between the 
appointments when the child will again wear the activity monitor watch and 
record their diet. The child will come in for their last appointment and be 
paid $55 more, with an additional $15 parent compensation. Over the course 
of the study the child will earn up to $210. The parent may receive a total of 
$25 to help offset the cost of travel. 
 
Those currently enrolled in SNAK Part I who have not yet completed visit 9 
will be provided an updated SNAK infographic at their next appointment to 

 
Page 36 of 44 
Revised: January 5, 2023 
inform them of both child and parent compensation increases at Visits 7 and 
9. 
 
SNAK Part 2: 
 
For the second phase of the study, families that have consented to be contacted for 
continuation (contingent upon further grant funding) will be called and offered to 
participant in Part II of the SNAK study. Should they choose to participate, we 
will be attempt to schedule 90min follow up appointments every 9 months until 
the child turns 18. For most children this would be amount to 3 follow up 
appointments (3 appointments maximum) but for children that enrolled in the 
program near age 15, they may be more likely to have only one follow up 
appointment prior to age 18. The first scheduled appointment after a participant 
turns 18 will involve a new consent process for the legal adult participant. If they 
would like to continue their participation in the study, the parent components will 
become optional.  
 
Payment will be the same for each appointment regardless of how many follow up 
appointments a particular participant completes. Visit 10 (33months) -90min- $30 
to the child and $10 transit to parent/guardian. Visit 11 (42 months) -90min- $30 
to the child and $10 transit bonus to parent/guardian. Visit 12 (51 months) -
90min- $30 to the child and $10 transit bonus to parent/guardian.  
 
 
 
23.0 Local Number of Subjects 
23.1 Indicate the total number of subjects to be accrued locally. 
Response: all- n =226 
 
23.2 If applicable, distinguish between the number of subjects who are 
expected to be enrolled and screened, and the number of subjects 
needed to complete the research procedures (i.e., numbers of 
subjects excluding screen failures.) 
Response: n/a 
 
24.0 Confidentiality 
Describe the local procedures for maintenance of confidentiality. 
24.1 Where and how data or specimens will be stored locally? 
Response: Information will be treated in strict confidence to the extent 
provided by law. The child’s identity will be coded and will not be associated 
with any published results. A child’s answers to sensitive questionnaires will 

 
Page 37 of 44 
Revised: January 5, 2023 
not be released to anyone, including a parent or guardian, except under very 
rare circumstances in which his/her answers suggest a danger to 
him/herself or to another person.    We control access to the computer files 
that hold this information. The connection between name and accession 
number will be kept in separate files and will be destroyed after the study is 
completed and published.  
 
24.2 How long the data or specimens will be stored locally? 
Response: 3 years after the end of all data collection. 
 
24.3 Who will have access to the data or specimens locally? 
Response: PI, research coordinator, assigned research assistants 
 
24.4 Who is responsible for receipt or transmission of the data or 
specimens locally? 
Response: Assigned research assistants. 
 
24.5 How data and specimens will be transported locally? 
Response: n/a 
 
25.0 Provisions to Protect the Privacy Interests of Subjects 
25.1 Describe the steps that will be taken to protect subjects’ privacy 
interests. “Privacy interest” refers to a person’s desire to place 
limits on whom they interact or whom they provide personal 
information. 
Response: Only research assistants will know the identity of participants. They will 
not share the participation status or any information with anyone outside the 
research team. Additionally, all participant information will be attached via numeric 
code, and will not be linked to an individual name. 
 
25.2 Describe what steps you will take to make the subjects feel at ease 
with the research situation in terms of the questions being asked 
and the procedures being performed. “At ease” does not refer to 
physical discomfort, but the sense of intrusiveness a subject might 
experience in response to questions, examinations, and procedures. 
Response: Response: We describe our confidentiality and privacy 
policies prior to consent. Subjects will complete the questionnaires 

 
Page 38 of 44 
Revised: January 5, 2023 
online in an environment that makes them most comfortable. All 
subjects will be told that all responses will be confidential. 
 
25.3 Indicate how the research team is permitted to access any sources 
of information about the subjects. 
Response: Participants have given their permission to be screened and also 
consented to participate in the outlined procedures. All have also indicated 
that they would like to be contacted for future studies. During the consent 
process they granted permission for their information to be connected to a 
unique identifier, and not associated to their name. The research team can 
access participant data by ID number only through participant folders and 
computer databases. 
 
26.0 Compensation for Research-Related Injury 
26.1 If the research involves more than Minimal Risk to subjects, 
describe the available compensation in the event of research 
related injury. 
Response: n/a 
 
26.2 Provide a copy of contract language, if any, relevant to 
compensation for research-related injury. 
Response: n/a 
 
27.0 Economic Burden to Subjects 
27.1 Describe any costs that subjects may be responsible for because of 
participation in the research. 
Response: n/a 
 
28.0 Consent Process 
28.1 Indicate whether you will be obtaining consent 
Response: Yes, all subjects will be 12-16 at the time of enrollment so they 
will be providing assent while their parents provide consent for their 
participation. Age will be verified by asking the subject’s date of birth. 
28.2 Describe where  the consent process take place 
Response: Online, before the subject starts the research survey and then 
officially G62 Farber Hall, South Campus, Closed participant room 

 
Page 39 of 44 
Revised: January 5, 2023 
28.3 Describe any waiting period available between informing the 
prospective subject and obtaining the consent. 
Response: The time between scheduling the appointment and appointment 
date. 
28.4 Describe any process to ensure ongoing consent. 
Response: n/a 
 
28.5 Describe whether you will be following “SOP: Informed Consent 
Process for Research (HRP-090).” If not, describe: 
• 
The role of the individuals listed in the application as being 
involved in the consent process. 
• 
The time that will be devoted to the consent discussion. 
• 
Steps that will be taken to minimize the possibility of 
coercion or undue influence. 
• 
Steps that will be taken to ensure the subjects’ 
understanding. 
Response: Yes, will be following HRP-090 procedure.  
 
Non-English Speaking Subjects  
28.6 Indicate what language(s) other than English are likely to be 
spoken/understood by your prospective study population or their 
legally authorized representatives. 
Response: n/a 
 
28.7 If subjects who do not speak English will be enrolled, describe the 
process to ensure that the oral and written information provided 
to those subjects will be in that language. Indicate the language 
that will be used by those obtaining consent. 
Response: n/a 
 
Waiver or Alteration of Consent Process (consent will not be 
obtained, required information will not be disclosed, or the 
research involves deception) 
28.8 Review the “CHECKLIST: Waiver or Alteration of Consent Process 
(HRP-410)” to ensure you have provided sufficient information for 
the IRB to make these determinations. Provide any additional 
information necessary here: 

 
Page 40 of 44 
Revised: January 5, 2023 
Response: n/a 
 
28.9 If the research involves a waiver 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 
 
Subjects who are not yet adults (infants, children, teenagers) 
28.10  Describe the criteria that will be used to determine whether a 
prospective subject has not attained the legal age for consent to 
treatments or procedures involved in the research under the 
applicable law of the jurisdiction in which the research will be 
conducted. (E.g., individuals under the age of 18 years.) For 
research conducted in NY state, review “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013)” to be aware 
of which individuals in the state meet the definition of “children.” 
Response: self-report birthdate and parental confirmation 
 
28.11  For research conducted outside of NY state, provide information 
that describes which persons have not attained the legal age for 
consent to treatments or procedures involved the research, under 
the applicable law of the jurisdiction in which research will be 
conducted. One method of obtaining this information is to have a 
legal counsel or authority review your protocol along the 
definition of “children” in “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).” 
Response: n/a 
 
28.12  Describe whether parental permission will be obtained from: 
• 
Both parents unless one parent is deceased, unknown, 
incompetent, or not reasonably available, or when only one 
parent has legal responsibility for the care and custody of the 
child. 
• 
One parent even if the other parent is alive, known, 
competent, reasonably available, and shares legal 
responsibility for the care and custody of the child. 

 
Page 41 of 44 
Revised: January 5, 2023 
Response: one parent or guardian 
 
28.13 Describe whether permission will be obtained from individuals 
other than parents, and if so, who will be allowed to provide 
permission. Describe the process used to determine these 
individuals’ authority to consent to each child’s general medical 
care. 
Response: We will be following the HRP013 Standard Operating 
procedure for LAR, Children, & Guardians, thus it is possible that a LAR 
may provide consent in this study. The consent forms ask that the parent 
or guardian indicate their relationship to the child on the consent form.  
 
28.14  Indicate whether assent will be obtained from all, some, or none 
of the children. If assent will be obtained from some children, 
indicate which children will be required to assent. 
Response: yes, all 
 
28.15 When assent of children is obtained describe whether and how it 
will be documented. 
Response: Child Assent form (see attached) 
 
Cognitively Impaired Adults 
28.16 Describe the process to determine whether an individual is 
capable of consent. The IRB sometimes allows the person 
obtaining assent to document assent on the consent document and 
does not automatically require assent documents to be used. 
Response: n/a 
 
Adults Unable to Consent 
When a person is not capable of consent due to cognitive impairment, a 
legally authorized representative should be used to provide consent and, 
where possible, assent of the individual should also be solicited. 
28.17 List the individuals from whom permission will be obtained in 
order of priority. (e.g., durable power of attorney for health care, 
court appointed guardian for health care decisions, spouse, and 
adult child.)  For research conducted in NY state, review “SOP: 
Legally Authorized Representatives, Children, and Guardians 
(HRP-013)” to be aware of which individuals in the state meet the 

 
Page 42 of 44 
Revised: January 5, 2023 
definition of “legally authorized representative.”  The list in the 
consent template signature section corresponds to the priority list 
for NYS.   
Response: n/a 
 
28.18  For research conducted outside of NY state, provide information 
that describes which individuals are authorized under applicable 
law to consent on behalf of a prospective subject to their 
participation in the procedure(s) involved in this research. One 
method of obtaining this information is to have a legal counsel or 
authority review your protocol along the definition of “legally 
authorized representative” in “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).” 
Response: n/a 
 
28.19  Describe the process for assent of the subjects. Indicate whether: 
• 
Assent will be required of all, some, or none of the subjects. If 
some, indicated, which subjects will be required to assent and 
which will not. 
• 
If assent will not be obtained from some or all subjects, an 
explanation of why not. 
• 
Describe whether assent of the subjects will be documented 
and the process to document assent. The IRB allows the 
person obtaining assent to document assent on the consent 
document and does not routinely require assent documents 
and does not routinely require subjects to sign assent 
documents. 
Response: n/a 
 
28.20  For HUD uses provide a description of how the patient will be 
informed of the potential risks and benefits of the HUD and any 
procedures associated with its use. 
Response: n/a 
 
29.0 Process to Document Consent in Writing 
 
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 

 
Page 43 of 44 
Revised: January 5, 2023 
required outside of the research context, the IRB will generally waive the 
requirement to obtain written documentation of consent. 
(If you will document consent in writing, attach a consent document. If you will 
obtain consent, but not document consent in writing, attach a consent script. 
Review “CHECKLIST: Waiver of Written Documentation of Consent (HRP-411)” 
to ensure that you have provided sufficient information. You may use 
“TEMPLATE CONSENT DOCUMENT (HRP-502)”to create the consent document 
or script.) 
29.1 Describe whether you will be following “SOP: Written 
Documentation of Consent (HRP-091).” If not, describe whether 
and how consent of the subject will be obtained including whether 
or not it will be documented in writing. 
Response: yes, following 
 
30.0 Drugs or Devices 
30.1 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. 
Response: n/a 
 
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: 
30.2 Identify the holder of the IND/IDE/Abbreviated IDE. 
Response: n/a 
 
30.3 Explain procedures followed to comply with FDA sponsor 
requirements for the following: 

 
Page 44 of 44 
Revised: January 5, 2023 
 
Applicable to: 
FDA Regulation 
IND Studies 
IDE studies 
Abbreviated 
IDE studies 
21 CFR 11 
X 
X 
 
21 CFR 54 
X 
X 
 
21 CFR 210 
X 
 
 
21 CFR 211 
X 
 
 
21 CFR 312 
X 
 
 
21 CFR 812 
 
X 
X 
21 CFR 820 
 
X 
 
Response: n/a