Description
This guidance provides the current recommendations of the Food and Drug Administration (FDA) concerning Institutional Review Boards’ (IRB) review and approval under 21 C.F.R. Part 56 of stand-alone authorizations that are created by covered entities (or by third parties), pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule, and that are provided to research subjects prior to enrolling in clinical investigations after April 14, 2003, to obtain their permission to use and/or disclose their health information for research. A stand-alone HIPAA authorization (for research) is a document that is used to obtain permission from an individual for a covered entity to use and/or disclose the individual’s identifiable health information for a research study, and that is not combined with an informed consent document to participate in the research study itself. The Privacy Rule refers to a HIPAA authorization that has been combined with an informed consent document as a “compound authorization.” IRBs would be required to review the HIPAA authorization in a “compound authorization” because IRBs are required, with certain exceptions, to review and approve informed consent documents. See 21 C.F.R. Part 56.
Scope & Applicability
Stakeholders
4Entity responsible for submitting applications under section 524B
Responsible for maintaining the coding key in clinical research
requiring clinical investigators to disclose the financial interests and arrangements of their same-sex spouses.
Health plans, health care clearinghouses, and certain health care providers subject to the Privacy Rule.
Regulatory Context
Attributes
1Individually identifiable health information protected under the Privacy Rule
Related CFR Sections (2)
- 21CFR56.108§ 56.108 IRB functions and operations.
In order to fulfill the requirements of these regulations, each IRB shall:Read full regulation →
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
Related Warning Letters (10)
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2025-03-25
Clinical Investigator
Americo F. Padilla, M.D.
- 2024-11-05
Institutional Review Board (IRB)
Armstrong County Memorial Hospital
- 2024-10-22
Clinical Investigator
Namita A. Goyal, M.D.
- 2024-10-08
Institutional Review Board (IRB)
Louisiana State University Health Science Center IRB
- 2024-07-16
Bioresearch Monitoring Program/IRB
Massachusetts Institute of Technology MIT
- 2024-06-18
Clinical Investigator (Sponsor)
Angela D. Ritter, M.D.
- 2024-03-26
Institutional Review Board (IRB)
New York State Psychiatric Institute IRB
See Also (8)
- IRB Continuing Review After Clinical Investigation Approval: Guidance for IRBs, Clinical Investigators, and Sponsors (Status: Final)
- Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs (Status: Final)
- Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Sponsor - Investigator - IRB Interrelationship: Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)
- Non-local IRB Review : Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)
- Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Chapter 48 7348.809A Radioactive Drug Research Committee (Status: Final)