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ALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIVERSITY

DOCUMENTATION OF INFORMED CONSENT AND HIPAA AUTHORIZATION

IntroductionYou 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 influencescognitive performance. Your participation in the pre-screening questionnaire is voluntary -- it isup to you whether you would like to participate. It is fine to say “no” now or at any time after youhave started the questionnaire. If you say “no,” your decision will not affect any of your rights orbenefits. 

The researcher in charge of this project is calledthe “Principal Investigator.” His name is John J.Foxe. You can reach Dr. Foxe at:Office Address: Albert Einstein College ofMedicine, Van-Etten Bldg., 1st Floor, C-Wing,

1225 Morris Park AvenueCity, State Zip: Bronx, NY 10461Telephone #: (718) 862-1821For questions about the research study, or if youbelieve you have an injury, contact the PrincipalInvestigator or the IRB.

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Support for this research study is provided byPepsiCo 

The Institutional Review Board (IRB) ofthe Albert Einstein College of Medicineand Montefiore Medical Center hasapproved this research study. The IRB #is in the stamp in the upper right hand

corner. If you have questions regardingyour rights as a research subject you maycontact the IRB office at 718-430-2253 orby mail:

Einstein IRB Albert Einstein College of Medicine1300 Morris Park Ave., Belfer Bldg #1002Bronx, New York 10461

Why is this questionnaire being administered?

The goal of the pre-screening questionnaire is to find out whether or not you meet the criteria toparticipate in a research study called Investigation of how morning nutrition influencescognitive performance. Some of the information collected in this questionnaire may also beused 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 expressedinterest in participating in the main nutrition study. Anyone who is capable of reading and usinga 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 beasked are personal, such as your history of drug use or pregnancy status. You do not have toanswer all of the questions, but this may disqualify you from the main study. If you meet all ofthe criteria for the main nutrition study, you will be contacted by email or phone to schedule your

IRB NUMBER: 2013-2732

IRB APPROVAL DATE: 10/02/20

IRB EXPIRATION DATE: 11/14/2

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participation if you are still interested. If you do not meet the requirements for the main nutritionstudy, you will still be contacted and thanked for completing the pre-screening questionnaire. Ifyou 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 YOURCOMPUTER 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-screeningquestionnaire. 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 thequestionnaire.

Are there any risks to me?

It is possible that some of the questions may make you feel uncomfortable, but you are free tostop filling out the questionnaire at any time.

ConfidentialityWe will keep your information confidential, however, a risk of taking part in this study is that yourconfidential information might be shared accidentally with someone who is not on the studyteam and is not supposed to see or know about your information. This is very unlikely, becausethe study team takes confidentiality of your information seriously. Your research records will bekept 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 informationthat could identify you. The form that links your name to the code number will be kept in alocked file cabinet and only the investigator and study staff will have access to the file. Allinformation 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 toprotect it and may share your information with others without your permission, if permitted bylaws governing them. All of these groups have been asked to keep your informationconfidential.

Are there possible benefits to me? 

You will not experience any direct benefit from completing the pre-screening questionnaire. Wehope you will participate because the main nutrition study will generate important information

IRB NUMBER: 2013-2732

IRB APPROVAL DATE: 10/02/20

IRB EXPIRATION DATE: 11/14/2

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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 areason. However, some of the information may have already been entered into the study andthat will not be removed.

Please start the questionnaire on the website if you would like to participate in the pre-screeningquestionnaire.

IRB NUMBER: 2013-2732

IRB APPROVAL DATE: 10/02/20

IRB EXPIRATION DATE: 11/14/2