Revised_Att 14_iCLIC Consent Form_11-25-08

Interactive Comprehensive Lifestyle Interview by Computer (i CLIC)
Consent Form
Full Study Title: Interactive Comprehensive Lifestyle Interview by Computer or i CLIC
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
(i CLIC) is to collect information about diet, health, and lifestyle factors using
computerized questionnaires. This study adds onto the National Institutes of Health
(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 50 articles have been published in scientific journals.
This new study will invite 5,000 current participants in the NIH-AARP Diet and Health
Study and 10,000 newly invited persons who are AARP members age 50 and over.
The i CLIC study will evaluate how much participation there is 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, email
address, and sometimes social security number. Your answers are confidential 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
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questionnaires. Each time you are scheduled to complete a new set of questionnaires,
you will be sent an email message from the study. If you agree to be contacted by
telephone or by text message, we will also contact you by these means to send you
notification about completing a new set of questionnaires. For each set of
questionnaires, participants may be asked to complete information about foods they’ve
eaten the day before, 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?
Most participants will be asked to complete computerized questionnaires at the
beginning of the study and two months later. Some participants will also be asked to
complete a questionnaire one month after they start the study and then again, at two
months and three months after they start the study (four times altogether). Participants
selected to participate in the study are being asked to complete questionnaires at
different time periods in order to see the best pattern for completing questionnaires.
The i CLIC study will end in seven months, but most participants will be finished with all
questionnaires in less than four 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 confidential?
The personal information you provide in this study will be kept confidential 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 confidentiality 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 confidential 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 confidentiality 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.
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In becoming a study volunteer, the information you provide to the study comes under
the NIH confidentiality 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 confidentiality 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 iCLICcontactUs@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.

This part will be outside the box and on the screen itself.

I have read this informed consent information and agree to participate in the study.

I have read the informed consent information above and do not want to participate
in the study.

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