21 CFR 312.66: Assurance of IRB review
Investigators must ensure a compliant IRB handles initial and ongoing review of the study, promptly report changes and unanticipated risk problems to it, and make no changes without IRB approval except to eliminate immediate hazards.
Part 312, Investigational New Drug Application · Subpart D, Responsibilities of Sponsors and Investigators
Recent 483s citing 312.66
- Hennepin County Medical Center, Dept Of Emergency Medicine · Minneapolis, MinnesotaNot all changes in research activity were approved by an Institutional Review Board… Apr 26, 2019
- Lauren R. Klein, MD, MS, Sponsor-Investigator · Minneapolis, MinnesotaNot all changes in research activity were approved by an hlstitutional Review Board… Apr 23, 2019
- Kang Zhang, M.D., Ph.D · La Jolla, CaliforniaFailure to assure that an IRB was responsible for the initial and continuing review… Aug 1, 2016
- Stanislaw R Burzynski, M.D · Houston, MarylandFailure to report promptly to the IRB all unanticipated problems involving risk to… Mar 15, 2013
- Form 483 · FEI 3006750659 · Centennial, ColoradoFailure to report promptly to the IRB all unanticipated problems involving risk to… May 7, 2008
The regulation text
§ 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 the research activity and all unanticipated problems involving risk to human subjects or others, and that he or she will not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects.
[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 67 FR 9586, Mar. 4, 2002]
Questions
What does 21 CFR 312.66 require?
Investigators must ensure a compliant IRB handles initial and ongoing review of the study, promptly report changes and unanticipated risk problems to it, and make no changes without IRB approval except to eliminate immediate hazards.
Which sections are cited alongside 312.66?
In the same 483s, investigators most often also cite 312.60 (General responsibilities of investigators), 312.62 (Investigator recordkeeping and record retention), 50.20 (General requirements for informed consent), 50.23 (Exception from general requirements).