Considerations When Transferring Clinical Investigation Oversight to Another IRB: Guidance for IRBs, Clinical Investigators, and Sponsors

Description

This guidance discusses the regulatory responsibilities of institutional review boards (IRBs), clinical investigators, and sponsors when oversight of a previously approved, ongoing clinical investigation under FDA’s jurisdiction is transferred from one IRB to another IRB. This guidance also addresses questions that have been previously raised concerning procedures and processes that are required and/or recommended by FDA when such oversight is transferred. FDA encourages individuals to contact the agency directly to discuss any unusual circumstances.

Scope & Applicability

Regulatory Context

• 21CFR56.102§ 56.102 Definitions.

  As used in this part:Read full regulation →

• 21CFR812.150§ 812.150 Reports.

  (a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports:Read full regulation →

• 21CFR312.30§ 312.30 Protocol amendments.

  Once an IND is in effect, a sponsor shall amend it as needed to ensure that the clinical investigations are conducted according to protocols included in the application. This section sets forth the provisions under which new protocols may be submitted and changes in previously submitted protocols maRead full regulation →

• 21CFR56.103§ 56.103 Circumstances in which IRB review is required.

  (a) Except as provided in §§ 56.104 and 56.105 , any clinical investigation which must meet the requirements for prior submission (as required in parts 312, 812, and 813) to the Food and Drug Administration shall not be initiated unless that investigation has been reviewed and approved by, and remaiRead 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 →

• 21CFR812.35§ 812.35 Supplemental applications.

  (a) Changes in investigational plan —Read full regulation →

• 21CFR56.108§ 56.108 IRB functions and operations.

  In order to fulfill the requirements of these regulations, each IRB shall:Read full regulation →

• 21CFR312.66§ 312.66 Assurance of IRB review.

  An investigator shall assure that an IRB that complies with the requirements set forth in part 56 will be responsible for the initial and continuing review and approval of the proposed clinical study. The investigator shall also assure that he or she will promptly report to the IRB all changes in thRead full regulation →

• 21CFR56.120§ 56.120 Lesser administrative actions.

  (a) If apparent noncompliance with these regulations in the operation of an IRB is observed by an FDA investigator during an inspection, the inspector will present an oral or written summary of observations to an appropriate representative of the IRB. The Food and Drug Administration may subsequentlRead full regulation →

• 21CFR56.121§ 56.121 Disqualification of an IRB or an institution.

  (a) Whenever the IRB or the institution has failed to take adequate steps to correct the noncompliance stated in the letter sent by the agency under § 56.120(a) , and the Commissioner of Food and Drugs determines that this noncompliance may justify the disqualification of the IRB or of the parent inRead full regulation →

• 21CFR56.115§ 56.115 IRB records.

  (a) An institution, or where appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following:Read full regulation →

• 21CFR312.31§ 312.31 Information amendments.

  (a) Requirement for information amendment. A sponsor shall report in an information amendment essential information on the IND that is not within the scope of a protocol amendment, IND safety reports, or annual report. Examples of information requiring an information amendment include:Read full regulation →

• 21CFR50.24§ 50.24 Exception from informed consent requirements for emergency research.

  (a) The IRB responsible for the review, approval, and continuing review of the clinical investigation described in this section may approve that investigation without requiring that informed consent of all research subjects be obtained if the IRB (with the concurrence of a licensed physician who is Read full regulation →

• 21CFR56.113§ 56.113 Suspension or termination of IRB approval of research.

  An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for Read full regulation →

• 21CFR50.25§ 50.25 Elements of informed consent.

  (a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to each subject: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 →

• In Vivo Bioavailability-Bioequivalence Studies – Clinical

  Maria A. Carballosa, M.D.

  2025-12-23

• Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)

  Celularity, Inc

  2025-12-09

• Sponsor/Investigator

  Verdure Sciences, Inc.

  2025-11-18

• Clinical Investigator (Sponsor)

  Pamela K. Den Besten, DDS, MS

  2025-09-30

• Clinical Investigator/Sponsor

  Ralph A. DeFronzo, M.D.

  2025-09-23

• Clinical Investigator

  Shirish M. Gadgeel, M.D.

  2025-09-09

• Clinical Investigator

  Mark J. Savant, M.D

  2025-07-15

• Clinical Investigator

  Peter Michael, M.D.

  2025-07-01

• Clinical Investigator (Sponsor)

  American Behavioral Research Institute, LLC

  2025-06-10

• Bioresearch Monitoring Program

  Amy Lightner, MD

  2025-06-03

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• Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff (Status: Final)
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