IRB Memo

ATTACHMENT 6

Westat IRB Memo

Date:	February 6, 2009
To:	Simani Price, Project Director
From:	Kerry Levin; Chair, Westat IRB
Subject:	Initial approval of the Health Protection Management study, Project 8417.02.01 FWA 5551

As Chair of the Westat Institutional Review Board (IRB), I have reviewed the materials submitted for the following: Health Protection management, Project 8417.02.01. The IRB reviews all studies involving research on human subjects. This study is sponsored by the Centers for Disease Control and Prevention.

Westat will develop a core set of health communication and marketing variables that can be used to conduct periodic population surveys on a range of health protection topics across CDC program areas. The first population for this survey will be developed for pandemic flu preparedness. Westat and its subcontractor will conduct field testing of the survey instrument using telephone and web modalities.

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 this study under expedited authority. In addition, per 45 CFR 46 117 (c) a waiver of documentation of informed consent is approved to conduct the interview by telephone and on the internet as the research involves no more than minimal risk and involves no procedure for which written consent is normally required outside of the research context.

It is the Project Director’s responsibility to submit the study for a continuing review on or before February 2010. 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

Karen Della Torre