21 CFR 56.103: Circumstances in which IRB review is required
Requires that FDA-regulated clinical investigations needing prior submission not begin without IRB approval and ongoing IRB review, lets FDA reject data from unreviewed studies, and leaves other applicable laws in force.
Part 56, Institutional Review Boards · Subpart A, General Provisions
Recent 483s citing 56.103
- Theranos, Inc. · Palo Alto, CaliforniaPart of an investigation was initiated before IRB approval… Aug 18, 2016
- Burzynski Research Institute/ IRB · Houston, TexasA clinical investigation requiring prior submission to the FDA was initiated… Jul 17, 2015
The regulation text
§ 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 remains subject to continuing review by, an IRB meeting the requirements of this part.
(b)Except as provided in §§ 56.104 and 56.105, the Food and Drug Administration may decide not to consider in support of an application for a research or marketing permit any data or information that has been derived from a clinical investigation that has not been approved by, and that was not subject to initial and continuing review by, an IRB meeting the requirements of this part. The determination that a clinical investigation may not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any other applicable regulations to submit the results of the investigation to the Food and Drug Administration.
(c)Compliance with these regulations will in no way render inapplicable pertinent Federal, State, or local laws or regulations.
[46 FR 8975, Jan. 27, 1981; 46 FR 14340, Feb. 27, 1981]
Questions
What does 21 CFR 56.103 require?
Requires that FDA-regulated clinical investigations needing prior submission not begin without IRB approval and ongoing IRB review, lets FDA reject data from unreviewed studies, and leaves other applicable laws in force.
Which sections are cited alongside 56.103?
In the same 483s, investigators most often also cite 56.108 (IRB functions and operations), 56.109 (IRB review of research), 56.115 (IRB records).