Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.109

Document information
Reference	USA 21 CFR Part 56 09-Apr-2025
Validity area	USA
Scope(s)	G
Document name	21 CFR Part 56
Version / Revision	09-Apr-2025
Status	Current
Document type	Legal act
Language(s)	EN
Description	Title 21 —Food and Drugs Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter A—General Part 56 Institutional Review Boards https://www.ecfr.gov/current/title-21
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Scope	G
Document part	§ 56.109
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	IRB review of research: requirements and functions

Content

Subpart C—IRB Functions and Operations [..] § 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. [...] (e) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. For investigations involving an exception to informed consent under § 50.24 of this chapter, an IRB shall promptly notify in writing the investigator and the sponsor of the research when an IRB determines that it cannot approve the research because it does not meet the criteria in the exception provided under §50.24(a) of this chapter or because of other relevant ethical concerns. The written notification shall include a statement of the reasons for the IRB's determination.