IRB NUMBER: 2013-2732

IRB APPROVAL DATE: 10/02/2014

IRB EXPIRATION DATE: 11/14/2014

ALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIVERSITY

DOCUMENTATION OF INFORMED CONSENT AND HIPAA AUTHORIZATION
Introduction
You are being asked to fill out a pre-screening questionnaire to determine your eligibility to
participate in a research study called Investigation of how morning nutrition influences
cognitive performance. Your participation in the pre-screening questionnaire is voluntary -- it is
up to you whether you would like to participate. It is fine to say no now or at any time after you
have started the questionnaire. If you say no, your decision will not affect any of your rights or
benefits.

The researcher in charge of this project is called

the Principal Investigator. His name is John J.
Foxe. You can reach Dr. Foxe at:
Office Address: Albert Einstein College of
Medicine, Van-Etten Bldg., 1st Floor, C-Wing,
1225 Morris Park Avenue
City, State Zip: Bronx, NY 10461
Telephone #: (718) 862-1821
For questions about the research study, or if you
believe you have an injury, contact the Principal
Investigator or the IRB.
___________________________________________

The Institutional Review Board (IRB) of

the Albert Einstein College of Medicine
and Montefiore Medical Center has
approved this research study. The IRB #
is in the stamp in the upper right hand
corner. If you have questions regarding
your rights as a research subject you may
contact the IRB office at 718-430-2253 or
by mail:
Einstein IRB
Albert Einstein College of Medicine
1300 Morris Park Ave., Belfer Bldg #1002
Bronx, New York 10461

Support for this research study is provided by

PepsiCo

Why is this questionnaire being administered?

The goal of the pre-screening questionnaire is to find out whether or not you meet the criteria to
participate in a research study called Investigation of how morning nutrition influences
cognitive performance. Some of the information collected in this questionnaire may also be
used in the main nutrition study.
Why am I being asked to participate?
You are being asked to fill out the pre-screening questionnaire because you have expressed
interest in participating in the main nutrition study. Anyone who is capable of reading and using
a computer can take the questionnaire.
What will happen if I participate in the pre-screening questionnaire?
Completing the questionnaire will take roughly 20 minutes. Some of the questions you will be
asked are personal, such as your history of drug use or pregnancy status. You do not have to
answer all of the questions, but this may disqualify you from the main study. If you meet all of
the criteria for the main nutrition study, you will be contacted by email or phone to schedule your

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IRB NUMBER: 2013-2732

IRB APPROVAL DATE: 10/02/2014
IRB EXPIRATION DATE: 11/14/2014

participation if you are still interested. If you do not meet the requirements for the main nutrition
study, you will still be contacted and thanked for completing the pre-screening questionnaire. If
you do not participate in the main nutrition study, the information you provide in the prescreening questionnaire will not be used.
BECAUSE SOME OF THE QUESTIONS ARE SENSITIVE, WE STRONGLY RECOMMEND
COMPLETING THE QUESTIONNAIRE AT HOME OR WHERE NO ONE CAN SEE YOUR
COMPUTER SCREEN.
Will I be paid for participating in the pre-screening questionnaire?
You will not receive any payment or other compensation for completing the pre-screening
questionnaire. However, the main nutrition study pays participants $320 total for 3 visits.
Will it cost me anything to participate?
There will be no cost to you to participate except for the time it takes you to complete the
questionnaire.
Are there any risks to me?
It is possible that some of the questions may make you feel uncomfortable, but you are free to
stop filling out the questionnaire at any time.
Confidentiality
We will keep your information confidential, however, a risk of taking part in this study is that your
confidential information might be shared accidentally with someone who is not on the study
team and is not supposed to see or know about your information. This is very unlikely, because
the study team takes confidentiality of your information seriously. Your research records will be
kept confidential and your name will not be used in any written or verbal reports. Your
information will be given a code number and separated from your name or any other information
that could identify you. The form that links your name to the code number will be kept in a
locked file cabinet and only the investigator and study staff will have access to the file. All
information will be kept in a secure manner and computer records will be password protected.
Your study information will be kept as long as they are useful for this research.
The only people who can see your research records are:
the research team and staff who work with them
the organization that funded the research
groups that review research (the Einstein IRB, and the Office for Human Research
Protections)
These people who receive your health information, may not be required by privacy laws to
protect it and may share your information with others without your permission, if permitted by
laws governing them. All of these groups have been asked to keep your information
confidential.
Are there possible benefits to me?
You will not experience any direct benefit from completing the pre-screening questionnaire. We
hope you will participate because the main nutrition study will generate important information
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IRB NUMBER: 2013-2732

IRB APPROVAL DATE: 10/02/2014
IRB EXPIRATION DATE: 11/14/2014

about the brain processes involved in attention and how they are affected by morning nutrition.
The main study will not be possible without this pre-screening process.
What choices do I have other than participating in this pre-screening questionnaire?
You can refuse to participate in the pre-screening questionnaire. You may also not answer
questions that you are uncomfortable answering.
Are there any consequences to me if I decide to stop participating?
No. If you decide to take part, you are free to stop participating at any time without giving a
reason. However, some of the information may have already been entered into the study and
that will not be removed.
Please start the questionnaire on the website if you would like to participate in the pre-screening
questionnaire.

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