CTSA national evaluation exemption

Date:

March 4th, 2009

To:

Debra Rog, Project Director

From:

Kerry Levin, Chair Westat IRB

Subject:

Exemption of CTSA Process Evaluation, Project 8668
FWA 5551

As Chair of the Westat Institutional Review Board (IRB), I have reviewed the materials submitted
for the following: CTSA Process Evaluation, Project 8668. Pursuant to 45 CFR pt. 46, the IRB
reviews all studies involving research on human subjects. This project is funded by the National
Center for Research Resources.
Westat will conduct an evaluation for the Clinical and Translational Science Awards program.
This process evaluation will focus on the implementation of the National CTSA programs and the
national Consortium. Westat will develop the evaluation framework and data collection
instruments as well as develop and implement the protocol for data collection.
Per 45 CFR 46 101 (b) (5) and based on the information provided, this project is exempt from
IRB review because the research is determined to be minimal risk and is designed to be a research
or demonstration project (program evaluation) that studies or evaluates a service program.
If activities change, please contact the IRB Office to ensure that the status is accurately reflected
in our records. You are only required to submit the study for a continuing review on or before
March 4, 2010 if activities change for this project. 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
Ann Bennett