attachment_10_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
28th, 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