Attachment 4 IRB

attachment 4

IRB Exception Memo

TO: Charles Carusi October 31, 2005

Project Director

FROM: Thomas W. McKenna

Chairman, Institutional Review Board

SUBJECT: Review of Questionnaire for Federally Funded Studies

Evaluation of HHS Tobacco CQI

Project 8214

As Chairman of the Westat Institutional Review Board (IRB), I have reviewed the Questionnaire for Federally Funded Studies for the following: Evaluation of HHS Tobacco CQI, Project 8214.

Based on the information provided, the project does not require IRB review because the study does not involve research on human subjects [45 CFR 46.102(f)].

If the project changes, please contact the IRB Office to ensure that the status is accurately reflected in our records.

Thank you.

Cc: Institutional Review Board

Miriam Aiken

Diane Cadell

A5-1