attach_6_irb and OHSR determination

Attachment 6

Date:	January 28, 2010
To:	Steve Riordan, Project Director
From:	Kerry Levin, Chair Westat IRB
Subject:	Expedited Initial Approval of Cancer Trials Support Unit, Project Number 8339 FWA 0551

As Chair of the Westat Institutional Review Board (IRB), I reviewed the materials submitted for the following: Cancer Trials Support Unit, Project Number 8339. The Westat IRB reviews all studies involving research on human subjects. This project is funded by the Cancer Therapy Evaluation program at the National Cancer Institute.

Westat will collect three customer satisfaction surveys; for the Help Desk, website, and patient registration. Particpants are invited by email and directed to an automated system to complete the surveys. Incentive gift cards will be distributed randomly to 10 selected participants in the study.

The 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 and is approved under expedited authority. A request for a waiver of documented informed consent was also approved (45 CFR 46 117 c. 2) as the study is minimal risk and involves no procedure for which written consent is normally required outside of the research context.

If activities change, please contact the IRB Office to ensure that the status is accurately reflected in our records. You are required to submit the study for a continuing review on or before January 28^th, 2011. In the interim, you are responsible for notifying the IRB Office 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

Jennifer Bryant