Contains Nonbinding Recommendations
Any IRB that reviews an emergency research study must be able to ascertain the acceptability of the
proposed research in terms of institutional commitments and regulations, applicable law, and standards
of professional conduct and practice; therefore the IRB needs to include persons knowledgeable in these
areas (21 CFR 56.107).
The IRB that is responsible for finding and documenting that community consultation and public
disclosure will take place (as required by 21 CFR 50.24(a)(7)) should be knowledgeable about local
conditions in order to evaluate the community consultation and public disclosure plans. A central IRB
may want to obtain input from an IRB at the institution where the research is to be conducted, to ensure
that local concerns are addressed. The institution’s IRB may have additional insights or knowledge
about local or State laws or regulations pertaining to emergency research studies, the demographics of
the area in which the study will take place, the need to translate the informed consent document,
community consultation or public disclosure materials into other languages, practices of emergency
medical services in the area, etc.
Responsibility for these studies should not be delegated to another IRB unless the institution agrees to
the transfer. Any such agreements to allow review using a centralized IRB process or an IRB other than
the institution’s IRB should be in writing.
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Copies of any agreements should be provided to all parties
involved in conducting the research (e.g., the institution, the institution’s IRB, the central IRB, clinical
investigator(s)).
50. How should an IRB document its review of an emergency research study?
IRB meeting minutes must be in sufficient detail to show attendance at the meetings, actions taken by
the IRB, the vote on these actions, the basis for requiring changes in or disapproving research, and a
written summary of the discussion of controverted issues and their resolution (21 CFR 56.115(a)(2)).
FDA anticipates that a study in which informed consent is not obtained for all subjects is by its very
nature controversial. Therefore IRBs must summarize their discussions and decisions regarding the
required elements for these studies (21 CFR 50.24(a)) in the IRB’s written meeting minutes. For
example, the IRB would document its discussion of issues raised during community consultation
activities, particularly discussions of community opposition to, or concern about, the emergency
research study. If the IRB approves the study despite the objection of some part(s) of the community,
the IRB should also document this, and provide its reason(s) for doing so.
51. What is meant by “licensed physician concurrence”?
The IRB m
ust have the concurrence of a licensed physician, both initially and at the time of continuing
review, that the criteria of 21 CFR 50.24 are met (21 CFR 50.24(a)). The licensed physician must be “a
member of or consultant to the IRB and . . . not otherwise participating in the clinical investigation” (21
CFR 50.24(a)). Where the licensed physician member(s) cannot participate in the deliberation and
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In the preamble to the proposed rule, FDA said that the agency anticipates that research involving an exception from
informed consent will usually be performed at an institution with an IRB. However, any duly constituted IRB can ensure that
the rights and welfare of research subjects are protected by fulfilling the requirements of part 56 (21 CFR part 56) and §
50.24, including § 50.24(a)(7) requiring public disclosure to and consultation with the communities from which the subjects
will be drawn. FDA recognizes that independent IRBs can also review such studies, or institutions can enter into agreements
to use a centralized IRB review process. Any agreement delegating review responsibilities to an independent IRB or using a
centralized IRB Review process should be documented in writing. See 61 Fed. Reg. 51504 (Comment #18).
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