What is an Institutional Review Board (IRB)?»
Under FDA regulations, an IRB is an appropriately constituted group that has been
formally designated to review and monitor biomedical research involving human subjects.
In accordance with FDA regulations, an IRB has the authority to approve, require modifications
in (to secure approval), or disapprove research. This group review serves an important
role in the protection of the rights and welfare of human research subjects.
The purpose of IRB review is to assure, both in advance and by periodic review, that
appropriate steps are taken to protect the rights and welfare of humans participating
as subjects in the research. To accomplish this purpose, IRB uses a group process
to review research protocols and related materials (e.g., informed consent documents
and investigator brochures) to ensure protection of the rights and welfare of human
subjects of research.
The fundamental purpose of IRB review of informed consent is to assure that the rights
and welfare of subjects are protected. A signed informed consent document is evidence
that the document has been provided to a prospective subject (and presumably, explained)
and that the subject has agreed to participate in the research. IRB review of informed
consent documents also ensures that the institution has complied with applicable regulations.
Who are the members of IRB?»
The FDA regulations [21 CFR 56.107(a)] require that, as part of being qualified as
an IRB, the IRB must have "... diversity of members, including consideration of race,
gender, cultural backgrounds and sensitivity to such issues as community attitudes
....The IRB regulations [21 CFR 56.107(e)] prohibit any member from participating
in the IRB's initial or continuing review of any study in which the member has a conflicting
interest, except to provide information requested by the IRB. In accordance with IRB
regulations [21 CFR 56.108(c) and 21 CFR 56.107(a)], IRB must include one or more
members not affiliated with the institution.
No ad hoc substitutes for the IRB members are accepted by the FDA. Only formally appointed
and listed in the membership roster may substitute, provided that the IRB's written
procedures describe the appointment and function of alternate members. However, an
absent member may participate by video- or phone conference. Such members may vote
and be counted as part of the quorum.
21 CFR 56.107(c) requires at least one member of the IRB to have primary concerns
in the scientific area and at least one to have primary concerns in the non-scientific
area, including physicians and Ph.D. level physical or biological scientists. When
an IRB encounters studies involving science beyond the expertise of the members, the
IRB may use a consultant to assist in the review, as provided by 21 CFR 56.107(f).
Is my project considered research?»
All of the following activities may be considered research:
Pilot studies (research development)
Medical chart reviews
Case studies (involving more than three individuals or a regulated investigational
drug or device)
Analysis of identifiable, existing data.
What is expedited review?
Expedited review is a procedure through which certain kinds of research may be reviewed
and approved without convening a meeting of the IRB.
The IRB regulations [21 CFR 56.110] permit an IRB to review certain categories of
research through an expedited procedure if the research involves no more than minimal
risk. A list of categories
The IRB may also use the expedited review procedure to review minor changes in previously
approved research during the period covered by the original approval. Under an expedited
review procedure, review of research may be carried out by the IRB chairperson or
by one or more experienced members of the IRB designated by the chairperson. The reviewer(s)
may exercise all the authorities of the IRB, except disapproval. Research may only
be disapproved following review by the full committee. The IRB is required to adopt
a method of keeping all members advised of research studies that have been approved
by expedited review.
[See Conditions for IRB Use of Expedited Review - Federal Register: November 9, 1998
(Volume 63, Number 216), Notices]
Do I need to report completion of my research?
Yes. Procedural requirements [21 CFR 56.108(a)(3)] requires ensuring "prompt reporting
to the IRB of changes in a research activity." The completion of the study is a change
in activity and should be reported to the IRB. Although subjects will no longer be
"at risk" under the study, a final report/notice allows IRB to close its files and
use provided information in the evaluation and approval of related studies.
To report your research completion, submit the IRB Form B to firstname.lastname@example.org.