Westat IRB Approval

Date:	April 11, 2014
To:	Terisa Davis, Project Director
From:	Kerry Levin, Chair Westat IRB
Subject:	Expedited Approval of NCHS Physician Survey, Project Number 8625.08.11 FWA 00005551

As Chair of the Westat Institutional Review Board (IRB), I reviewed the materials submitted for the following: NCHS Physician Survey, Project Number 8625.08.11. The Westat IRB reviews all studies involving research on human subjects. This study is funded by National Center for Health Statistics.

The purpose of this study is to find ways to better support primary care physicians and practices in reducing chronic conditions such as hypertension, high cholesterol and diabetes.

Westat's role will include the following activities:

• Cognitive testing with 9 respondents prior to OMB clearance.

• Cognitive testing with 30 respondents after OMB clearance.

• Screening physicians over the telephone.

• Mailing surveys to screened physicians.

• Calling non-responders to complete the survey over the phone.

IRB regulations permit expedited review of certain activities involving minimal risk [45 CFR pt. 46.110, 404]. This study can be considered minimal risk and is approved under expedited authority. Per [45 CFR 46 117], a waiver of documentation of informed consent is also approved as the research is no more than minimal risk and involves no procedures for which written consent is normally required outside of the research context.

As the Project Director you are responsible for the following:

• Submit this study for a continuing review on or before April 11, 2015.

• In the interim, notify the IRB Office as soon as possible if there are any injuries to subjects as well as problems or changes with the study that relate to human subjects.

cc: Institutional Review Board Nancy Weinfield

Attachment 6b