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IRB NUMBER: 2013-2732 IRB APPROVAL DATE: 10/02/2014 IRB EXPIRATION DATE: 11/14/2014 ALBERT EINSTEIN COLLEGE OF

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:

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

Office Address: Albert Einstein College of Medicine, Van-Etten Bldg., 1 st 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.

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

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 pre- screening 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

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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