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

{{ReferenceData
|has_document=Document:USA 21 CFR Part 56 09-Apr-2025
|module=1
|unit=1.5.4
|scope=G
|doc_part=§ 56.109
|language=EN
|entry_by=Florian Adragna
|contributors=
|tags=TAG-00134-Eth-kom ++ TAG-00340-Req-nfo ++ TAG-00018-Inv-die
|tags_display=[[Glossary:TAG-00134-Eth-kom|Ethics committee]], [[Glossary:TAG-00340-Req-nfo|Requirements]], [[Glossary:TAG-00018-Inv-die|Investigator]]
|comment=IRB review of research: requirements and functions
|content=Subpart C—IRB Functions and Operations
[..]
§ 56.109 IRB review of research.
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(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.
}}