Time Restricted Feeding and Its Potential Effect on Weight Loss

Principal Investigator: Lauren Timmerman

Participating Facilities: University of Connecticut

April 19, 2017

AH 6306

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3. Abstract (150-200 words)

The severity of the obesity epidemic stresses the need for effective approaches

for treatment, specifically weight loss. Caloric restriction and excess energy

expenditure through exercise are popular forms of treatment, however

alternatives are still being investigated (1). Intermittent-fasting, and more

specifically, time-restricted feeding have been studied in rodents, however

research in humans is lacking (1). This study will look at the correlation between

time-restricted feeding and weight loss in 20 women, ages 18-23 years old.

Time-restricted feeding will not restrict calories or leave those at risk for nutrient

deficiencies, it simply controls for the amount of time a person eats, and then

fasts- usually overnight (2). Positive results for weight-loss have been shown in

rodent studies for time-restricted feeding. If similar results that are shown in

rodents appear in human subjects, then this may pose as a feasible, sustainable,

and relatively straightforward method for weight-loss that most healthy, obese

individuals can participate in (1).

4. Introduction

Obesity is diagnosed as having a BMI over 30 (3). This condition is

currently an widespread, affecting more than 78 million Americans (3). Obesity

not only decreases a persons lifespan, but also raises the risk for many

illnesses, including heart disease, Type 2 Diabetes, and cancer (3). There are

many causes of obesity, which includes genetics, overeating, physical inactivity,

and a multitude of diseases (3). Since it continues to be a growing issue in the

United States, research is constantly being conducted in order to search for

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additional treatment and alternative preventative measures. Two of the leading

treatment and preventative therapies are caloric restriction and increasing

energy expenditure through physical activity (3). Although these have been

successful in some regards, alternate methods continue to be explored.

Recently, the concept of intermittent fasting has been tested as a possible

method to decrease an individuals weight (2).

Intermittent Fasting is an umbrella term that can encompass many

different methods of food consumption and restriction such as: alternate day

feeding, 5:2 feeding, and time-restricted feeding (4). Alternate day feeding is

when one only eats every other day over a 7-day (1 week) period of time (4). The

5:2 method is when there is 2 full days of fasting, followed by 5 days of eating

(4). While these two methods have been tested and shown successful weight

loss in humans, they are not sustainable as a long-term diet lifestyle (4).

However, time-restricted feeding (TRF) is performed on a daily basis where food

intake is limited within a short window of time and extending the length of the

daily fasting interval, usually about 12 hours (2,4). This method of eating is

hypothesized to be relatively more sustainable for the average person to adhere

to, compared to other intermittent eating patterns (4). However, research in the

adherence and success of TRF for weight loss is mostly conducted in rodent and

is lacking in human subjects (1).

The research regarding TRF in rodent subjects have shown promising

outcomes (1). Time-restricted feeding has shown beneficial results that include

improved insulin sensitivity, decrease in adipose tissue, and improved

cardiovascular health even after following an obesogenic diet (1). Which is why it

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is crucial to take the next step and apply this research to more human models.

Most studies that have tested human time-restricted feeding have small sample

sizes and have also shown mixed results related to glucose and insulin

sensitivity and weight loss (2,4,5,6,7,8) . Continuing TRF research in human models

increases the possibility of an additional alternative treatment for obesity (4).

5. Purpose

Obesity is an epidemic that continues to affect many Americans (3). There

are multiple therapeutic methods, medications, and dietary methods that are

available for prevention and treatment (3). However, obesity still continues to be

a growing problem (3). The purpose of this study is to understand if time-

restricted feeding may possibly increase weight loss in obese individuals and

become a possible treatment method for obesity. Time-restricted feeding only

manipulates the variable of when food is ingested; it does not include calorie

restriction (1,4). If successful, then individuals looking to lose weight will not

have to focus on adhering to strict dietary intake, but simply limit their food

intake to a 12 hour time-frame to promote weight loss.

6. Objectives/ Specific Aims:

The main objective of this study is to find an additional method that will

contribute to weight loss in healthy, obese individuals in order to help

combat the obesity epidemic that is affecting the United States.

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 The specific aim is to understand if time-restricted-feeding limited to a 12

hour-fast, 12 hour-feed will contribute to weight loss in obese women at

UConn ages 18-23 years old.

This study will also be compared to the recent published research: Time-

Restricted Feeding Increases Fat Oxidation and Reduces Swings in

Appetite Levels in Humans by Peterson et.al., that looks at participants

whom consumed all of their food within a 6-hour window and fasted for 18

hours (2).

7. Hypotheses:

Null Hypothesis: There will be no change in weight in the test group at the

end of the 4-month study.

Alternative Hypothesis: The test group will weigh less than their initial weight

at the end of the 4 month study due to adhering to consuming all food within

the 12 hour window.

8. Review of Literature

A. Time-restricted feeding is a preventative and therapeutic

intervention against diverse nutritional challenges. (1)

Purpose: Current therapeutics for obesity is limited and offers only modest

improvements. Preventing obesity with time-restricted feeding is promising, yet

the ability to combat preexisting obesity is unknown. This study evaluates the

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effectiveness of time-restricted feed against different diet types, eating

patterns, and existing obesity.

Method: 392 twelve-week-old male rodent mice were exposed to different

feeding regimens. The mice were split into two groups, short term, and long-

term duration. The short-term (13-weeks time-restricted feeding and cross over

to 12 week ad libitum feeding) gained weight rapidly during the 12-week ad

libitum feeding. Then they were transferred to strictly only time-restricted-

feeding. The long-term mice (26 week time-restricted feeding and 12 week ad

libitum diet) also had an increase in weight when switching to the ad libitum

diet, however the weight stabilized at 106% body weight increase.

Results: When both short-term and long-term mice followed strictly a TRF diet,

they both dropped weight. The short-term mice showed a modest drop in

weight (about 2 g) and maintained new body weight until the end of the study.

The long-term mice lost about 6 g. TRF showed to efficiently protect against

body weight gain even when animals were subjected to diverse nutritional

challenges, such as increasing caloric intake. It also promoted weight loss and

efficient weight stabilization when used as a therapeutic intervention on pre-

existing diet induced obesity.

B. High caloric intake at breakfast vs. dinner differentially influences

weight loss of overweight and obese women. (5)

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Purpose: There is a limited amount of research that tests the association of

time-of day of nutrient intake and metabolic syndrome. The main goal of this

study is to compare weight loss while following an isocaloric diet that varied with

an increase in calories at varying times of the day. It compared a high caloric

intake during breakfast versus a high caloric intake at dinner in order to see if

there is a difference in success of weight loss.

Method: This was a randomized study that occurred over duration of 12 weeks.

Women who were overweight or obese and diagnosed with metabolic syndrome

were randomly placed into two groups, both with an isocaloric (~1400 kcal)

weight loss group. The difference was the split of calories where either breakfast

would be 700 calories, or dinner would be 700 calories.

Results: The high caloric intake at breakfast group showed larger weight loss

and waist circumference reduction. In both groups, there was a reduction in

glucose, insulin, and ghrelin. However, in the breakfast group all of these

variables in addition to HOMA IR was decreased significantly. Mean

triglyceride levels decreased by 33.6% in breakfast group, but increased by

14.6% in the dinner group.

C. Time-Restricted Feeding Increases Fat Oxidation and Reduces

Swings in Appetite Levels in Humans (2)

Purpose Time restricted feeding is a known approach as a dietary intervention

that involves eating within a small window of time. In rodent studies, time-

restricted feeding has shown to decrease chance of weight gain by increasing

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energy expenditure. This study tests this in 10 overweight and obese humans to

see if time-restricted feeding will favorably alter energy metabolism by changing

energy expenditure, appetite, or macronutrient oxidation.

Method: A mixture of ten overweight and obese subjects, ages 20-45 years old

with no chronic diseases participated in a 1-week randomized crossover study.

Participants were asked to keep a regular sleep schedule and ate either between

8 am and 2 pm (6 hour feed, 18 hour fast) or 8 am and 8 pm (12 hour feed, 12

hour fast). Participants metabolism was then tested in a 24-hour respiratory

chamber after eating 3 identical meals. Appetite was measured using VAS.

Results: Eight participants completed the study. Linear mixed models showed

that time-restricted feeding did not affect overall 24-hour energy expenditure.

However, time-restricted feeding did decrease the respiratory quotient of all the

patients showing that there is an increase in fat oxidation and protein oxidation.

It was also shown that there was a difference in daily swings in appetite during

the day.

D. Restricting nighttime eating reduces daily energy intake in healthy

young men: a short-term crossover study. (6)

Purpose: It has been hypothesized that young adults in particular are at a

higher risk for poor dietary habits and significant weight gain. This is why the

participants of this study are young men. Anecdotal weight management

suggests limiting food consumption at night, however there is few experimental

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data that support this suggestion. This study focuses on short-term trends of

energy intake results from eliminating nighttime eating. The hypothesis is that

restricting nighttime eating will be associated with lower total daily energy

intake compared to the control group.

Method: This study adheres to the guidelines set by the Declaration of Helsinki

and procedures involving human subjects. The participants were recruited

through the various means of fliers, Facebook, and posted advertisements. All

participants were 18-26 years of age, healthy, non-smokers, and abstained from

alcohol. They had an average BMI of 24.4 (normal), and a mean age of 20.9.

This study used a crossover design, had 29 total participants, and initiated a 2-

week night eating restriction intervention, which included fasting from 7 pm to 6

am. It was then followed by a 2-week control condition that was separated with

a 1-week washout period. Individuals were also screened and excluded if they

were diagnosed with night-eating syndrome, which is defined as one consuming

more than half their daily intake after 7 pm.

Results: Of the 29 who started the study, 2 participants dropped out and 27

participants completed the study. There was reported decrease in kilocalorie

intake of 2,663 vs. 2,609 for the nighttime control. There was an average of 0.4

kg decrease in weight and an average of 0.1 decrease of BMI. During the

control condition there was a reported 0.6 kg increase in weight. There was a

reported increase in hunger upon waking, however no recorded increase of

breakfast intake compared to the control. Overall, participants lost a small

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amount of body weight during the restriction condition and gained a small

amount of body weight during the control condition. This study presents a small

amount of evidence that nighttime restriction may be beneficial in weight loss

and preventing weight gain without restricting caloric intake. However, in order

to prove beneficial a study would need to be conducted long term in order to

provide sufficient evidence of sustainability of the diet and weight loss.

9. Need and Significance of the Study

There is limited research regarding the benefits of time-restricted-feeding

in humans. As of date, there are an increasing amount of rodent studies with

positive results highlighting the success of time restricted feeding and the

positive effects it has on weight-loss (1). However, in order to make it applicable

to combatting the obesity epidemic in the United States, it requires more

substantial and conclusive research in human subjects. Currently, there is mixed

results involving human subjects due to uncontrollable confounding variables

(2,4,5,6,7). Hence the need for more human-based studies in order to gain support

and reliability of the time-restricted feeding and fasting lifestyle. This study will

help increase the weight of evidence behind TRF for weight loss. If results are

positive and the null hypothesis is rejected, it will possibly enhance the

opportunity for TRF to be used as an additional method to combat weight gain

and obesity, without the excessive use of calorie restriction and/or increasing

energy expenditure.

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 10. Methods:

a) Subjects: 20 UConn women ages 18-23 who have a BMI of >30 (obese).
I. Control group: Ten subjects whom will simply track their calories

and sleep habits.

II. Test group: Those who will consume all calories in 12-hour window

and restrict calories during nighttime hours. These subjects will also

record their caloric intake and sleep habits.

b.) Design: This study is designed to be a true experimental design with a

single-factor and
match-pair (8). This will allow for a structure for evaluating the cause-and-

effect relationships between a set of independent and dependent

variables (8). The independent variable is time-restricted-feeding (12 hour

feed, 12 hour fast), and the dependent variable is weight-loss. Certain

intrinsic factors that are classified as extraneous variables will be the

participants sleeping and exercise habits. In order to control for these

variables, participants who exercise as well as those who have poor sleep

habits will be evenly distributed between the control and the test group.

Having a relatively even amount of these participants between the control

and test groups will help control for the confounding variables.
c.) Procedures: To help increase inter-subject variability, participants will be

placed using a
match-pair design (8). This will be accomplished by screening subjects

about for exercise and sleep habits. Those who participate in moderate to

vigorous exercise more than 3 times per week for 150 minutes or more

will be randomized and placed in either the control or test group. Those

with poor sleep patterns, including erratic sleep, or sleeping less than 6

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 hours per night will be randomized and placed in either the control or test

group.
d.) Data Analysis: Multiple types of data will be collected daily throughout the

study. Daily
data collected will include: daily intake, daily sleep patterns, and if the

participant participated in any exercise. Weekly data collection will

include a fasted, morning weigh-in every Saturday. Once the study is

concluded, all of the information will be analyzed during the evaluation

stage that will take place in March through April. Items that will be

controlled for will be participant exercise routines and sleep patterns. A

linear regression will be the main type of analysis to determine is there is

a relationship between 12-hour energy restriction and weight loss.

e.) Limitations:
Hawthorne Effect: this may increase the subjects in the control group due

to the novelty of tracking their intake and sleep habits and the fact they

are participating in an experiment (8).

John Henry Effect: the control group may know that they are not receiving

the experimental treatment; therefore it may alter their regular eating

habits since they are required to track their progress (8).

Additional limitations: small subject pool in a specific age group which

limits the reproducibility of the study and results in order to apply to other

age, gender, and racial groups. Other factors that may affect the results

are: the subjects sleep duration, differences in dietary and nutrient

intake, and the rate of excess energy expenditure.

8. Time, Space and Availability of Equipment

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The recruitment phase of this project begins in August and continues

through October. The study will be conducted November through

February. The evaluation will then begin in March and end in April.

Fortunately, not much space is needed to complete this study. There will

only need to be two rooms, one for initial recruitment meetings and then

the other. The equipment needed is a highly accurate scale, and the

phone-tracking app for food intake and sleep.

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 9. Budget (Cost Analysis)
The overall expenses for this will include hiring a Graduate assistant to

help conduct research, participant compensation, overall recruitment

materials (such as posters, email crafting, etc.), and then an accurate

scale for weekly measurement. Overall, the total amount needed will be

~$40,000.
10. Possible Funding Agency
In order to fund this research, there are a few grants by the National

Institute of Health (NIH) that would provide sufficient funds. A few grants

that would be applied for would be Exploratory/Developmental Clinical

Research Grants in Obesity (R21). Within the participating organization

(NIH) these additional components support this particular grant: the

National Institute of Diabetes and Digestive and Kidney Diseases, the

National Cancer Institute, Eunice Kennedy Shriver National Institute of

Child Health and Human Development, and the Office of Dietary

Supplements.

10. References (Arrange and number the references as they appear in

the text)

1. Chaix A, Zarrinpar A, Miu P, Panda S. Time-restricted feeding is a

preventative and therapeutic intervention against diverse nutritional
challenges. Cell Metab. 2014 Dec 2;20(6):991-1005.
2. Courtney Peterson, Eleonora Poggiogalle, Robbie, Beyl, Daniel Hsia, Eric
Ravussin. Time-Restricted Feeind Increases Fat Oxidation and Reduces Swings in
Appetite Levels in Humans. Obesity Society. 2016 Nov. 3. Oral Abstracts
3. L. Kathleen Mahan, S. E.-S. (2017). Krauses Food & the Nutrition Care

Process (14thed. ) St. Louis, Missouri: Elsevier Inc.

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4. Antoni R, Johnston KL, Collins AL, Robertson MD. Investigation into the acute

effects of total and partial energy restriction on postprandial metabolism among

overweight/obese participants. Br J Nutr. 2016 Mar 28;115(6):951-9.

5. High caloric intake at breakfast vs. dinner differentially influences weight loss

of overweight and obese women. Obesity (Silver Spring). 2013 Dec;21(12):2504-

12

6. LeCheminant JD, Christenson E, Bailey BW, Tucker LA. Restricting night-time

eating reduces daily energy intake in healthy young men: a short-term cross-

over study. Br J Nutr. 2013 Dec 14;110(11):2108-13.

7. Antoni R, Johnston KL, Collins AL, Robertson MD. Investigation into the acute

effects of total and partial energy restriction on postprandial metabolism among

overweight/obese participants. Br J Nutr. 2016 Mar 28;115(6):951-9.

8. Faghri, P. (2017,) Measurement. [PowerPoint slides]. Retrieved from

https://lms.uconn.edu/webapps/blackboard/execute/content/file?

cmd=view&content_id=_1317404_1&course_id=_24475_1

11. Informed Consent (use Application for the Use of Human Subjects

by University of Connecticut)

Internal office use only:

Full Board __
Expedited __

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(IRB-1) Protocol Application for the Involvement of Human Participants in Research
Institutional Review Board, Research Compliance Services

SECTION I: General Information

Nature of Study:
(Place an X in the
column. Check only
one.)
Faculty Research Graduate Research
Dissertation Undergraduate Research
Masters Thesis Staff Research

Study Title:
________________________________________________________________

Study Objective (2-3 sentence summary of study):

_________________________________
____________________________________________________________________________
_____
____________________________________________________________________________
_____

PI, Student Investigator, Correspondent Information:

Principal Investigator Student Investigator Correspondent (primary
(PI) (only for Student Initiated point of contact for
Research) correspondence, if applicable)
Name (First, Last,
Degree):
Department:
Mailing Address:
Preferred Phone #:
Emergency Phone #
(Required Full Board,
More than Min. Risk
only):
Preferred E-Mail Address:

Very Important: Complete and attach the Appendix A form to list all UConn key
personnel engaged in research and other non-UConn investigators.

Section II: Collaborating Institutions/Facilities and Other IRB Reviews

Will the research be conducted only at Storrs and/or the five regional campuses, School of Law, or School
of Social Work with no involvement of a collaborating institution? ___ Yes ___ No (If yes, skip to
Section III)

Collaborating Institutions with a Collaborative Agreement with UConn-Storrs

UConn has formal agreements with the University of Connecticut Health Center (UCHC), Hartford
Hospital (HH) and the Connecticut Childrens Medical Center (CCMC) that authorize one IRB to take the
lead with some research protocols. This decision is made by the IRBs involved, but the PI may request
which IRB he/she prefers to be the IRB of record. See the IRB website for additional information. If you
are collaborating with one of the institutions listed below, place an X in the appropriate cell to indicate
which institution, based on the preponderance of expected enrollment, you are requesting serve as the

16
IRB of record or that independent IRB approval will be sought from each applicable site. If you request
that UConn-Storrs be the IRB of record, place an X in the appropriate cell.

Institution Name % to be Requested IRB of Independent IRB

enrolled/consented Record Review
UConn Health Center
Hartford Hospital
Connecticut Childrens
Medical Center
UConn Storrs
Provide additional comments as needed:

If the PI, Student Researcher or other Key Personnel has an affiliation/appointment with an Institution
listed above, please explain:
______________________________________________________________

Other Collaborating Institutions/Facilities

If you are collaborating with other sites, provide the name of each institution/facility (e.g. other university,
K-12 school, nursing home, tribal affiliation, etc.) and describe the type of involvement of each institution
(e.g. recruitment, enrollment/consenting, study procedures, follow-up, data analysis). Indicate if IRB
approval/site permission is attached (indicate yes, no, or pending). You will need to obtain IRB approval
from every collaborating institution that has an IRB before you can initiate research there.
Note: tabbing out of the bottom right cell will insert another row if needed.

Name of Institution Describe Involvement IRB Approval/Site Permission

Attached?

Provide additional comments as needed:

If the PI, Student Researcher or other Key Personnel has an affiliation/appointment with an Institution
listed above, please explain:
______________________________________________________________

International Research
Will any aspect of the study take place outside of the United States? ___ Yes ___ No
(If yes, complete table below)

NOTE: You may need to obtain IRB approval in the country where the research is taking place and/or a Federal-wide
Assurance with the Office of Human Research Protections (OHRP). Please see the IRB website for additional
information.

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Institution/Facility and/or Site Permission
Attached?

Provide additional comments as needed:

17
If the PI, Student Researcher or other Key Personnel has an affiliation/appointment with an Institution
listed above, please explain:
______________________________________________________________

SECTION III: Funding

It is the responsibility of the Principal Investigator to notify the IRB via an Amendment (IRB-3) or at Re-
Approval, on an IRB-2 form if the funding source changes in any way.

Funding Source: Departmental Funds Human Rights Institute

(Place an X in the
column next to the
funding source.)
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Award

For Internal, UConn Funded Studies:

If the research is supported either in whole or in part by internal funds (Internal Program Support, Office of
Undergraduate Research, Research Incentive Accounts, etc) one COMPLETE copy of each grant
application (if applicable) must be included with this application.

Name of Internal/UConn Funding Source:

Principal Investigator:
Grant Title (if applicable and if different from
protocol title):
KFS Account Number (if known and only
applicable for Faculty Large and Small Grants
funded by Internal Program Support)
Proposal Number (if applicable, e.g. PD00-0000):
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Provide any additional comments as needed:

Note: If there is more than one funding source, copy the table format and add the additional funding
source.

For Externally Funded Studies:

If the research is supported either in whole or in part by external funds (federal, state or private), one
COMPLETE copy of each grant application or contract must be included with this application.

For each funding source, please identify the following:

NOTE: If the PI on the grant/contract is not the PI on this IRB protocol, submit an e-mail with this application in which the PI who is
receiving the grant acknowledges use of this protocol under the grant.

Name of Funding Source I (if UConn is the

recipient of a subaward, list the institution
providing the funding then list the primary source
of funds):
Principal Investigator of Contract/Grant:
Contract/Grant Title:
(if different from protocol title)

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 KFS Account Number:
OSP Proposal Number:
Grant/Contract Status:
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Will funds from this contract/grant be awarded to an individual or institution (via a PSA or subcontract) that
will be engaged in human participant research? ___ Yes ___ No
If yes, indicate the name of the institution: ______________________________________
Provide any additional comments as needed:

Name of Funding Source II(if UConn is the

recipient of a subaward, list the institution
providing the funding then list the primary source
of funds):
Principal Investigator of Contract/Grant:
Contract/Grant Title:
(if different from protocol title)
KFS Account Number:
OSP Proposal Number:
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(i.e., pending/awarded)

Will funds from this contract/grant be awarded to an individual or institution (via a PSA or subcontract) that
will be engaged in human participant research? ___ Yes ___ No
If yes, indicate the name of the institution: ______________________________________
Provide any additional comments as needed:

Note: If there are more than two funding sources, copy the table format and add the additional funding
source.

SECTION IV: Conflict of Interest (only required for externally funded research)
At the time of proposal submission to the Office for Sponsored Programs (OSP), all investigators and key
personnel are required to submit a Significant Financial Interest Review Form to OSP. For more
information, please go to the Conflict of Interest Committee website,
http://www.compliance.uconn.edu/conflict.cfm.

Is any investigator listed on this protocol required to submit the follow-up form, supplemental
Significant Financial Interest Review Form? ___ Yes ___ No

If yes, please identify each individual:

______________________________________________________

SECTION V: Human Participants

Place your responses BELOW, not within, the box containing each items description.

How many participants will be enrolled?

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If you are enrolling more than one population describe the total enrollment for each. Note: Participants
are generally considered to be enrolled when they sign the consent form or have gone through an oral
consent process. Therefore, be sure to account for attrition in your enrollment number.

If applicable, how many potential participants will be screened?

When screening procedures are conducted as part of the consent process, participants that fail to screen
will be counted as being enrolled in the study.

Participant Population(s):
Describe the participant population(s) including gender, ethnicity, age range, income, level of education,
and language spoken.

Recruitment:
Describe the recruitment process including who will recruit, when and where recruitment will take place
and how participants will be identified and recruited (e.g., direct recruitment by study team in person, on
the phone, by mail/email/internet, random sampling, referrals from other participants, snowball sampling
and/or healthcare providers). Attach copies of all advertisement/recruitment materials for IRB review
including phone scripts, web postings, newspaper advertisements. If recruiting at off-campus sites,
written permission and/or local IRB approval may be required.

Special Population(s):
Identify any special participant population(s) that you will be specifically targeting for the study.

Check all that Minors Economically/Educationally Disadvantaged

apply: (Place an Prisoners Members of the Armed Forces
X in the column
Pregnant Women/Neonates Non-English Speaking
next to the name of
the special Decisionally Impaired Individuals Living with AIDS/HIV
population.) UConn Students Other (Please identify):
UConn Employees

UConn Students or Employees:

Are you recruiting students who are in a class you teach or for which you have responsibility? ___ Yes
___ No
Are you recruiting employees who report to you? ___ Yes ___ No

If Yes, explain why this population is necessary to the study and indicate precautions taken by the
researchers to minimize potential undue influence or coercion:
____________________________________________________________________________________
_____
____________________________________________________________________________________
_____

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SECTION VI: Drugs/Devices, Genetic Testing, Radiation and Biological Samples
Drug/Device Use
Does the study involve the use of any of the following (check all that apply)?
An FDA approved drug or medical device ___ Yes ___ No
An investigative/unapproved drug, supplement or medical device ___ Yes ___ No
A non-medical device ___ Yes ___ No
A proprietary product ___ Yes ___ No
A biological agent ___ Yes ___ No

If yes, please complete the Drug/Device Supplemental Form (IRB-1A) and attach it to this application.

Biological Samples
Does the study involve the use of biological samples?
(Either banked or prospectively obtained) ___ Yes ___ No
If Yes, you will need to obtain approval from the Biosafety Officer before the study can be initiated. Please attach a
copy of the approval letter if approval has already been granted from the BSO.

Genetic Testing
Does the study involve the genetic testing of biological samples? ___ Yes ___ No
If yes, please complete the Genetic Testing Supplemental Form (IRB-1B) and attach it to this application.

Radiation or Radioisotopes
Does the study involve the use of radiation or radioisotopes? ___ Yes ___ No
If yes, you will need to obtain approval from the Radiation Safety Officer before the study can be initiated. Please
attach of copy of approval letter if approval has already been granted from the RSO.

SECTION VII: Research Plan

Purpose
State the reason for the study, the research hypothesis, and the goals of the proposed study as related to the
research question(s).

Introduction
Provide a clear and succinct summary description of the background information that led to the plan for this project.
Provide references as appropriate and, when applicable, previous work in animal and/or human studies. Provide
previous UConn protocol number, if applicable.

Design, Procedures, Materials and Methods

Describe the study design, including the sequence and timing of all study procedures. Indicate expected start and
completion dates. Include screening procedures, if any. The IRB strongly suggests that investigators incorporate

21
flexibility into the study design to accommodate anticipated events (i.e. explain how missed study appointments can
be made up by participants). If the research involves study of existing samples/records, describe how authorization
to access samples/records will be obtained. If the study involves use of deception explain the reason why this is
necessary. If applicable, describe the use of audiotape and/or videotape and provide justification for use. If this study
offers treatment for the participants condition, complete the Treatment Study Supplemental Form (IRB-1C) and
attach it to this application for review. If the study includes measures, survey instruments and questionnaires,
identify each and, if available, provide references for the measures. Describe what they intend to measure (relate to
purpose/hypothesis) and their psychometric properties (e.g., reliability and validity). Identify any that were specifically
created for the study.

Justification of Sample Size/Data Analysis

Justification of Sample Size: For qualitative and pilot studies, describe how the proposed sample size is appropriate
for achieving the anticipated results. For quantitative studies, provide a power analysis that includes effect size,
power and level of significance with references for how the sample size was determined. Explain the rate of attrition,
with references as appropriate. Data Analysis: For all studies, provide a description of the statistical or qualitative
methods used to analyze the data.

Inclusion/Exclusion Criteria
List major inclusion and exclusion criteria. Any proposed exclusion criterion based on gender (women
of childbearing potential), age, or race must include justification for the exclusion. Describe the
conditions under which participants may be removed from the study, i.e., noncompliance with study
rules, study termination, etc.

Risks and Inconveniences

Describe the potential risks to participants (and secondary participants, if applicable) and steps taken to minimize
risks. Assess the likelihood of the risk occurring and, if it were to occur, the seriousness to the participant. Types of
risks to consider include: physical, psychological, social, legal, employment, and financial. Also describe any
anticipated inconveniences the participants may experience (time, abstention from food, etc.).

Benefits
Describe anticipated benefits to the individual participants. If individual participants may not benefit directly, state so
here. Describe anticipated benefits to society (i.e., added knowledge to the field of study) or a specific class of
individuals (i.e., athletes or autistic children). Do not include compensation or earned course credits in this section.

Risk/Benefit Analysis
Describe the ratio of risks to benefits. Risks to research participants should be justified by the anticipated benefits to
the participants or society. Provide your assessment of anticipated risks to participants and steps taken to minimize
these risks, balanced against anticipated benefits to the individual or to society.

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Economic Considerations
Describe any costs to the participants or amount and method of compensation that will be given to them. Describe
how you arrived at the amount and the plan for compensation; if it will be prorated, please provide the breakdown.
Experimental or extra course credit should be considered an economic consideration and included in this section.
Indicate when participants will receive compensation.

Data Safety Monitoring

This is a prospective plan set up by the study investigators to assure that adverse events occurring during studies are
identified, evaluated, and communicated to the IRB in a timely manner. Although the investigators initially propose a
Data Safety Monitoring Plan (DSMP), the IRB must approve the plan and may require revision of the plan. A DSMP
is required for all human studies at the University of Connecticut except for studies determined to be exempt from
continuing IRB review. For studies that present more than minimal risk to participants, the IRB will review and
determine on a case-by-case basis whether a data safety monitoring board is most appropriate. Please refer to the
IRBs policy regarding data safety monitoring before completing this section -
http://irb.uconn.edu/irb_sop/IRBSOP_submission.html#data_safety_monit.

Issues that should be addressed in the DSMP include the following:

1) frequency of the monitoring
2) who will conduct the monitoring (Under UConn policy a student cannot be the sole person responsible for
monitoring the data and safety of the protocol procedures. )
3) what data will be monitored
4) how the data will be evaluated for problems
5) what actions will be taken upon the occurrence of specific events or end points
6) who will communicate to the IRB and how communication will occur

Sample response to issues listed above for minimal risk/slight increase over minimal risk Survey results will be
monitored by the PI in conjunction with the student investigator once every two weeks (items 1, 2 and 3). Survey
responses will be reviewed to monitor for clarity (i.e., the same question is skipped by 5 or more participants). In that
case, the question will be revised and an amendment will be submitted to the IRB (items 4, 5 and 6).

Privacy/Confidentiality
Explain how the privacy interests of participants will be maintained during the study (note that privacy pertains to the
individual not to the data). Describe procedures for protecting confidentiality of data collected during the study and
stored after study closure. Describe how data will be coded. Describe plans for storage and security of electronic
data (plan must comply with the Universitys Policy on the Security Requirements for Protecting University Data at
Rest). If identifiable, sensitive information (illegal drug use, criminal activity, etc.) will be collected, state whether a
Certificate of Confidentiality will be obtained. Be sure to state whether any limits to confidentiality exist and identify
any external agencies (study sponsor, FDA, etc.) that will have access to the data. If participants will be screened,
describe the plans for storage or destruction of identifiable data for those that failed the screening.

SECTION VIII: Informed Consent

As PI, you are responsible for taking reasonable steps to assure that the participants in this study
are fully informed about and understand the study. Even if you are not targeting participants
from Special Populations as listed on page 4, such populations may be included in recruitment

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efforts. Please keep this in mind as you design the Consent Process and provide the information
requested in this section.

Consent Setting
Describe the consent process including who will obtain consent, where and when will it be obtained, and how much
time participants will have to make a decision. Describe how the privacy of the participants will be maintained
throughout the consent process. State whether an assessment of consent materials will be conducted to assure that
participants understand the information (may be warranted in studies with complicated study procedures, those that
require extensive time commitments or those that expose participants to greater than minimal risk).

Capacity to Consent
Describe how the capacity to consent will be assessed for participants with limited decision-making capacity,
language barriers or hearing difficulty. If a participant is incapable of providing consent, you will need to obtain
consent from the participants legal guardian (please see the IRB website for additional information).

Parent/Guardian Permission and Assent

If enrolling children, state how many parents/guardians will provide permission, whether the childs assent will be
obtained and if assent will be written or oral. Provide a copy of the script to be used if oral assent will be obtained.

Documentation of Consent
Specify the forms that will be used for each participant population, i.e., adult consent form, surrogate consent form,
child assent form (written form or oral script) or an information sheet. Copies of all forms should be attached to this
application in the same format that they will be given to participants (templates and instructions are available on the
IRB website).

Waiver or Alteration of Consent

The IRB may waive or alter the elements of consent in some minimal risks studies. If you plan to request either a
waiver of consent (i.e., participants will not be asked to give consent), an alteration of consent ( e.g., deception) or
a waiver of signed consent (i.e., participants will give consent after reading an information sheet), please answer
the following questions using specific information from the study:

Waiver (i.e. participants will not be asked to give consent) or alteration of consent (e.g. use of deception in
research):

Why is the study considered to be minimal risk?

How will the waiver affect the participants rights and welfare? The IRB must find that
participants rights are not adversely affected. For example, participants may choose not to

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 answer any questions they do not want to answer and they may stop their participation in the
research at any time.

Why would the research be impracticable without the waiver? For studies that involve
deception, explain how the research could not be done if participants know the full purpose of
the study.

How will important information be returned to the participants, if appropriate? For studies that
involve deception, indicate that participants will be debriefed and that the researchers will be
available in case participants have questions.

Waiver of signed consent (i.e. participants give consent only after reading an information sheet):

Why is the study considered to be minimal risk?

Does a breach of confidentiality constitute the principal risk to participants? Relate this to the
risks associated with a breach of confidentiality and indicate how risks will be minimized
because of the waiver of signed consent.

Would the signed consent form be the only record linking the participant to the research?
Relate this to the procedures to protect privacy/confidentiality.

Does the research include any activities that would require signed consent in a non-research
setting? For example, in non-research settings, normally there is no requirement for written
consent for completion of questionnaires.

HIPAA Authorization
On the Storrs campus, the following sites are covered entities under the Health Insurance Portability and
Accountability Act:

1. Nayden Rehabilitation Clinic (outpatient physical therapy)

2. Speech and Hearing Clinic
3. Emergency Medical Services (EMS, Ambulance)

If research participants are recruited through these entities, it may be necessary to obtain a Waiver of Authorization to
allow you to access records for recruitment and an Authorization to use and disclose Protected Health Information
(PHI). Contact the Office of Research Compliance at 860-486-8802 for additional information. Note: Student Health
Services is not covered by HIPAA; however, FERPA regulations apply.

Principal Investigator Certification

I understand the University of Connecticuts policies concerning research involving human participants
and I agree:

1. To comply with all IRB policies, decisions, conditions, and requirements;

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 2. That this study has been designed, to the best of my knowledge, to protect human participants
engaged in research in accordance with the standards set by the University of Connecticut, the
United States Department of Health and Human Services, the Food and Drug Administration, and
any other sponsoring agency;
3. To obtain prior approval from the IRB before amending the research protocol or the approved
consent/assent form;
4. To report to the IRB in accordance with IRB policy, any adverse event(s) and/or unanticipated
problem(s) involving risks to participants;
5. To submit the Re-Approval/Completion Form as needed;
6. That my participation and the participation of any co-investigators does/do not violate the
University of Connecticut policy on Individual Conflicts of Interest in Research;
7. That each individual listed as study personnel in this application has a) completed the required
human subjects training, and b) are knowledgeable of the study procedures described in the
protocol;
8. That each individual listed as study personnel in this application possesses the necessary training
and experience for conducting research activities in the role described for them in this research
study.

Furthermore, by signing below, I also attest that I have appropriate facilities and resources for conducting
the study.

Original Signature of Principal Investigator Date

Original Signature of Student Investigator Date

(Only for Student-Initiated Research)

Original Signature of Medical Monitor Date

(Required for all studies that will be monitored by a
Physician)

Department Head Certification

This is to certify that I have read the protocol and believe that there is value in
asking and answering these research questions using the approach described in this
application. To the best of my knowledge, the researcher(s) have the time, facilities,
and expertise to conduct this study.

Original Signature of Department Head Date

(Required for ALL studies, unless grant application/contract
is attached; see Section III)

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