January 30, 2025 – Westat, Inc.

Dear Dr. Royal:

The U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) conducted an evaluation of Westat, Inc.’s Human Research Protections Program (HRPP) on August 9, 2022, and from September 12 through September 16, 2022. The review was conducted as part of OHRP’s program to evaluate Westat, Inc.’s compliance with the HHS protection of human subjects regulations at 45 CFR part 46.  OHRP makes no determinations of noncompliance with the 2018 Requirements for the protection of human research subjects.

This evaluation was conducted by an OHRP team.  It involved the review of nine active HHS-funded study records, the institutional review board (IRB) written procedures including checklists, and IRB meeting minutes. We also observed the convened IRB meeting on August 9, 2022. OHRP was pleased to observe that continuing education was provided during this IRB meeting. The IRB staff provided excellent and prompt support for the IRB members during the meeting.

The OHRP team interviewed the signatory official, the human protections administrator, IRB chairpersons, IRB members, Quality Assurance (QA) staff, and other support staff with various responsibilities during the site visit. Each person interviewed by the OHRP team displayed a sincere commitment to the work of Westat, Inc.’s HRPP.

We acknowledge that Westat, Inc. updated its IRB written procedures, checklists, and forms to include more operational details based on OHRP’s observations. This evaluation is complete. We appreciate Westat, Inc.’s continued commitment to protecting human research subjects. Please do not hesitate to contact me should you have any questions.

Sincerely,

LCDR Paul E Lees, MPH, MS
Compliance Analyst
Division of Compliance Oversight

CC (email only):
Ms. Sharon Zack, Human Protections Administrator, Westat, Inc.
Ms. Winifred Meeker-O’Connell, Director, Office of Clinical Policy, Food and Drug Administration (FDA)
Dr. Michelle Bulls, Director, OPERA, Office of Extramural Research, National Institutes of Health (NIH)
Dr. Pamela Kearney, Director, Division of Human Subjects Research, Office of Extramural Research, NIH
Dr. Adam Berger, Director, Division of Clinical and Healthcare Research Policy, Office of Science Policy, NIH
Ms. Lydia Kline, Team Lead, Clinical Research Policy, Division of Clinical and Healthcare Research Policy, Office of Science Policy, NIH
Center for Devices and Radiological Health (CDRH) IRB: BIMO-CDRH@fda.hhs.gov
Center for Biologics Evaluation and Research (CBER): CBERBIMONotification@fda.hhs.gov
Office of Regulatory Affairs (ORA): orabimoinspectionpoc@fda.hhs.gov
Center for Drug Evaluation and Research (CDER): BIMO-CDEROSI@fda.hhs.gov