Appendix H_IRB exempt

Appendix H
IRB Exemption Memo

TO:

Susan Crystal-Mansour
Project Director

April 26, 2006

FROM:

Thomas W. McKenna
Chairman, Institutional Review Board

SUBJECT:

IRB Review and Approval
Health Information National Trends Survey (HINTS) III (HINTS 2007)
Contract No. N02-PC-61300
Project 8137.04
FWA 5551

As Chairman of the Westat Institutional Review Board (IRB), I have reviewed the materials
submitted for the following: Health Information National Trends Survey (HINTS) III (HINTS
2007), Contract No. N02-PC-61300, Project 8137.04. Pursuant to 45 CFR pt. 46, the IRB reviews all
studies involving human research. This study is funded by the National Cancer Institute (NCI).
HINTS created the first administration of an ongoing, cross-sectional survey to provide estimates
of the prevalence of cancer-relevant knowledge, attitudes, and behaviors in the U.S. adult population.
HINTS collects nationally representative data about the American public's use of cancer-related
information. The survey provides updates on changing patterns, needs, and information opportunities in
health; identifies changing communications trends and practices; assesses cancer information access and
usage; provides information about how cancer risks are perceived; and offers a test bed to researchers to
test new theories in health communication. HINTS was first conducted in 2003 and was a purely
telephone study. HINTS was conducted again in 2005 and collected information from both a phone and
web-based survey.
The priorities for HINTS 2007 are to preserve the methodological integrity of the survey and to
experiment with alternative and combinations of modes of questionnaire administration. Westat is
planning a mixed-mode data collection design employing dual sampling frames, providing a nationally
representative sample in each. We are planning to use a random digit dialing (RDD) telephone survey and
a mail questionnaire. No identifying information is retained on individual participants. Adults 18 years or
older who either comprehend English or Spanish are eligible to participate.
IRB regulations permit expedited review of certain activities involving minimal risk [45 CFR pt.
46.110 (b)(1)]. This study can be considered minimal risk.
I am therefore approving the study under expedited authority. However, you must send copies of
the finalized study questionnaire(s) and consent materials to the IRB before beginning to contact study
participants. Completion of the questionnaire provides implied consent, and I am therefore waiving the
requirement of documentation of informed consent. You are required to submit the study for an annual
review on or before April 26, 2007. In the interim, you are responsible for notifying the Office of
Research Administration as soon as possible if there are any injuries to the subjects, problems with the
study, or changes to the study design that relate to human subjects.
Cc:

Institutional Review Board
Paul Hurwitz
Jeanne Rosenthal

H-1