IRB Letter

MEMORANDUM
FDA Human Subject Protection Program Management Staff

DATE:

12/14/2023

FROM:

Human Subject Protection (HSP) Executive Officer, Office of the Chief Scientist (OCS)

TO:
CC:

Jill Settle, CDER, FDA Project Lead
Jill Brown, CDER, HSP Liaison

SUBJECT:

FDA Protocol Number: 2024-CDER-027

STUDY TITLE:

Exploring Barriers to Buprenorphine Access for Opioid Use Disorder

SUBMISSION TYPE: Exempt Research Determination

Based on the information submitted, the research study title “Exploring Barriers to Buprenorphine
Access for Opioid Use Disorder” does not require FDA IRB review and approval because it is exempt
from the requirements of 45 CFR Part 46 (45 CFR 46.104(d)(2)(ii)). If changes are proposed to ongoing
human subjects research that could affect its exempt status, the HSP Liaison, in collaboration with the
FDA Project Lead, must complete a new exemption determination form with supporting information to
request confirmation of that determination from the HSP Executive Officer. Although this research
activity is exempt from FDA IRB oversight, all of FDA’s human subjects research activities, regardless of
whether the research is subject to regulation under the Common Rule or FDA regulations, will be guided
by the ethical principles of respect for persons, beneficence, and justice, in accordance with the Belmont
Report.
For applicable FDA Standard Operating Policies and Procedures and Staff Manual Guide 9001.4 refer to
the SharePoint site for Human Subjects Research Conducted or Supported by the FDA at:
https://fda.sharepoint.com/sites/OC-intranet-OC-OCS-Human-Subject-protection/.

If you have questions, or would like further information, please do not hesitate to contact the Human
Subject Protection Program Management Staff in the Office of the Chief Scientist by email at
HSPPMS@fda.hhs.gov.