Description
FDA’s regulations on human subject protection (21 CFR part 50) and Institutional Review Boards (IRBs; 21 CFR part 56) help to ensure that the rights, safety, and welfare of human subjects participating in FDA-regulated clinical investigations are protected. These regulations generally conform to the Department of Health and Human Services’ (HHS’) Federal Policy for Protection of Human Research Subjects (45 CFR 46, Subpart A; “the Common Rule”), which sets forth requirements for the protection of human subjects involved in research that is conducted or supported by HHS.
Scope & Applicability
Stakeholders
5may sign informed consent on behalf of the participant; provides written consent if the patient is unable to do so
Governs top dose in clinical studies
Bodies responsible for evaluating trial risks and benefits for pregnant participants.; IRBs experienced in this population may advise on compensation.
Guidance for Sponsors, Investigators, and Institutional Review Boards
Assist sponsors in the nonclinical evaluation
Regulatory Context
Attributes
2Criteria used to determine the interval of continuing review
Risk level for exception from informed consent
Related CFR Sections (2)
- 21CFR56.109§ 56.109 IRB review of research.
(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by these regulations.Read full regulation →
- 21CFR56.110§ 56.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
(a) The Food and Drug Administration has established, and published in the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The list will be amended, as appropriate, through periodic republication in the Federal Register.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)
- CHAPTER 48 - 7348.809 Bioresearch Monitoring (Status: Final)
- Frequently Asked Questions About Medical Devices: Guidance For IRBs, Clinical Investigators, and Sponsors (Status: Final)
- IRB Continuing Review After Clinical Investigation Approval: Guidance for IRBs, Clinical Investigators, and Sponsors (Status: Final)
- Exception from Informed Consent Requirements for Emergency Research: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors (Status: Final)
- IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed: Guidance for IRBs, Clinical Investigators, and Sponsors (Status: Final)
- Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (Status: Final)
- Screening Tests Prior to Study Enrollment: Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)
- Protection of Human Subjects: Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure: Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)