Description
This guidance is intended to assist institutional review boards (IRBs) in complying with the new requirement for IRB registration. (See 74 FR 2358 (Jan. 15, 2009)) This requirement is an amendment to Part 56, Institutional Review Boards, (21 CFR 56.106), that requires each IRB in the United States (U.S.) that reviews FDA-regulated studies to register. IRB registration information is entered into an Internet-based registration system maintained by the Department of Health and Human Services (HHS). This system is a modification of the one used by the Office for Human Research Protections (OHRP) for registration of IRBs that are designated by institutions under Federalwide Assurances (FWAs). OHRP has issued a similar rule requiring IRBs designed under FWAs to register or update their registration information at this modified site. (See 74 FR 2399 (Jan. 15, 2009))
Scope & Applicability
Product Classes
6Subject to mandatory recall provisions
Medical products for the treatment of SLE.; Requires at least two adequate and well-controlled trials
development program for drug and biological products
IVD device clinical studies conducted on de-identified specimens
Device studies that may be conducted with only IRB approval
Drug trials conducted under an IND
Stakeholders
4Veterinarian responsible for selecting anesthetic regimens and conducting field studies
Entity responsible for submitting applications under section 524B
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.
Regulatory Context
Attributes
1November 20, 2024
Related CFR Sections (2)
- 21CFR20.63§ 20.63 Personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal privacy.
(a) The names or other information which would identify patients or research subjects in any medical or similar report, test, study, or other research project shall be deleted before the record is made available for public disclosure.Read full regulation →
- 21CFR56.106§ 56.106 Registration.
(a) Who must register? Each IRB in the United States that reviews clinical investigations regulated by FDA under sections 505(i) or 520(g) of the act and each IRB in the United States that reviews clinical investigations that are intended to support applications for research or marketing permits forRead full regulation →
Related Warning Letters (10)
- 2025-12-23
In Vivo Bioavailability-Bioequivalence Studies – Clinical
Maria A. Carballosa, M.D.
- 2025-12-09
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
Celularity, Inc
- 2025-11-18
Sponsor/Investigator
Verdure Sciences, Inc.
- 2025-09-30
Clinical Investigator (Sponsor)
Pamela K. Den Besten, DDS, MS
- 2025-09-23
Clinical Investigator/Sponsor
Ralph A. DeFronzo, M.D.
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-07-01
Clinical Investigator
Peter Michael, M.D.
- 2025-06-10
Clinical Investigator (Sponsor)
American Behavioral Research Institute, LLC
- 2025-06-03
Bioresearch Monitoring Program
Amy Lightner, MD
See Also (8)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- CPG Sec. 100.950 International Partnership Agreements for Compliance Activities (Status: Final)
- Guidance for Industry: Pre-Petition Consultations for Food Additives and Color Additives (Status: Final)
- Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Status: Final)
- Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use (Status: Final)
- French Translation of Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry (Questions et Réponses relatives au Registre des aliments à signaler) (Status: Final)
- Small Entity Compliance Guide: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Transportation, and Storage (Status: Final)
- Orientación preliminar de la industria: Preguntas y respuestas sobre el Registro de productos sanitarios en productos agroalimentarios, según establecido por la Ley de Enmiendas a la Alimentación y Medicamentos (FDA), 2007 (Edición 2) (Status: Draft)