Att 14_Study Consent

Interactive Comprehensive Lifestyle Interview by Computer (iCLIC) Consent Form
Full Study Title: Interactive Comprehensive Lifestyle Interview by Computer or iCLIC
Conducted by: United States National Institutes of Health, National Cancer Institute, Division of
Cancer Epidemiology and Genetics, Nutritional Epidemiology Branch
Principal Investigator: Arthur Schatzkin, M.D., Dr. PH
Funded by: United States National Cancer Institute
Why is this study being done?
The purpose of the Interactive Comprehensive Lifestyle Interview by Computer (iCLIC) is to
collect information about diet, health, and lifestyle factors using computerized questionnaires.
This study adds onto the NIH-AARP Diet and Health Study that began in 1995 and has
approximately 500,000 persons still participating in follow-up.
The original NIH-AARP Diet and Health Study collects information on diet and health using
paper-based questionnaires sent in the mail. Answers from the questionnaires are combined
with information on cancer and death in participants that comes from state and national
statistics. As a result, researchers have learned more about how health behaviors are related
to cancer and other diseases and over 30 articles have been published in scientific journals.
This new study will invite by email 10,000 AARP members aged 50 and over. The iCLIC study
will evaluate participation in a web-based study and whether participants complete the
computerized questionnaires when they are asked to do them at different times over a few
months. The study will also assess participant responses about diet, daily activities, and overall
health and lifestyle. Information from this study will help researchers determine the best ways
to use computerized questionnaires for research on diet and health.
What does it mean to participate?
If you are willing to participate, you will be asked a few initial questions about who you are and
some identifying information such as your address, telephone number, date of birth, and email
address. Your answers are private and securely encrypted so that no access to this information
is possible except for study purposes. Identifying information is separated from your responses
so that your questionnaire responses cannot be linked to you. You may be contacted regarding
this study or other health studies in the future, and you have the right to choose to participate
or not participate in those studies.
Once you agree to participate, you will be linked to a separate secure internet site where you
will create your own username and password in order to begin the questionnaires. Each time
you are scheduled to complete a new set of questionnaires, you will be sent an email message

from the iCLIC study. If you agree to be contacted by telephone, we will also call you to remind
you about completing a new set of questionnaires. For each set of questionnaires, participants
may be asked to provide information about their daily activities the day before, a lifestyle and
health history survey, and/or a dietary questionnaire about foods eaten over the past year.
Exactly how long it takes you to complete the questionnaires will depend on the questionnaires
you are asked to do at that time and the answers you give in the questionnaires. We estimate
that it will take 20 minutes to 1 hour each time you are asked to complete a set of
questionnaires.
How long is this study?
Participants will be asked to complete computerized questionnaires at the beginning of the
study and two months later. The iCLIC study will end in approximately six months, but
participants who complete the questionnaires the first time they are notified will be finished
with all questionnaires in less than three months.
What are the risks and benefits of participating in this study?
Your participation in this research study is completely voluntary. This research project involves
no more than minimal risk and does not affect your health care benefits or any other benefits
you may receive.
There are no direct benefits to you for participating in this study. The information you provide
may benefit society by increasing researchers understanding of how to best collect information
for research on the role of diet, daily activities, and health and lifestyle factors.
Will the information I give be kept private?
The personal information you provide in this study will be kept private and secure. All personal
identifying information will be securely encrypted and stored separately from the responses
you give on the study questionnaires. Personal identifying information will be stored in a
secure, password protected, and locked data file and only identified by a study number. In
order to protect the privacy of the information you give us, only a study number will be used to
identify you and the information you provide.
The study staff is required to keep your identity private and your name will never be used in
any publications or presentations about this study. All staff working on the study will be
required to sign a statement pledging to maintain the privateity of all data. Access to study
data will be limited to the staff working on the study.
When the study is complete or until the data is no longer required for research, the data will be
archived and/or destroyed.

In becoming a study volunteer, the information you provide to the study comes under the NIH
privacy policy for research participants. This policy is summarized in the previous two
paragraphs. As a study participant, the information you provide will be covered under the NIH
privacy policy and not the AARP's privacy policy.
This means that if you give us your consent to participate in the study by checking the box
below, NIH will not share with AARP any identifiable study information, and AARP will not share
with NIH any identifiable information other than contact information and current AARP
membership status.
What else do I need to know about the study?
Your participation in this study is completely voluntary. If you decide to participate, you may
decide not to answer specific questions or leave the study at any time. The study investigators
will use the information collected from you during the study up until the time you leave the
study. There will be no penalty or loss of benefits to you if you decline to participate in the
study or if you decide to leave the study at any time.
What if I have questions, comments, or concerns?
This consent form explains the research study. If you have any questions, comments, or
concerns about the study or the informed consent process, you may telephone (301) 594-2931
or email the Principal Investigator, Arthur Schatzkin, M.D., Dr. P.H. at schatzka@mail.nih.gov.
If you have any questions about being a research participant, you may contact the study by
email at iCLICStudy@westat.com or call us toll-free at 1-888-302-6672.
Approvals
This study protocol and this informed consent form have been reviewed by the institutional
review boards of the United States National Cancer Institute and other organizations
participating in monitoring the research data. These review committees monitor the safety and
the rights of individuals participating in this research study.
Legal Rights
You are not waiving any of your legal rights by reading this consent form and agreeing to
participate in the study.