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Full Board Review
Published on Jun 15, 2022 · Last Updated 1 year 2 months ago
Human subjects research that is not Exempt or eligible for Expedited Review must be reviewed at a convened meeting of the IRB. Full board review usually involves research that is greater than minimal risk but also includes minimal risk research that does not meet one or more of the Expedited Review Categories. If the full board determines that the research is indeed minimal risk, then all subsequent reviews may use Expedited Review procedures.
In addition to new studies and continuing review of and amendments to previously approved research, the full board reviews events that represent possible unanticipated problems related to research involving risks to subjects or others and cases which might meet the criteria for serious or continuous non-compliance (IRB SOP 901).
Amendments to greater than minimal risk research might require full board review. However, minor amendments that involve changes that are no more than minimal risk and do not alter the IRB's prior risk-benefit determination may be reviewed using Expedited Review procedures.
IRB Committee Meeting Dates
- The committee meetings for IRB A occur on the First and Third Wednesdays of each month.
- The smaller meetings of the Executive IRB (IRB D) occur on alternating weeks of each month.
45 CFR 46.107 IRB membership
(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.
(b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes,so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.
(c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
(d) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
(e) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
(f) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB
Frequently Asked Questions
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When does a submission need to be received in order to placed on the agenda?
To be ensured that a study will be reviewed at a convened meeting, it must be received by the IRB by Tuesday in the week prior to the scheduled meeting. It is often not possible add items to the agenda that are received after this deadline.
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Do all studies that require full board review have to go back to the full board for subsequent reviews?
No. Some studies are determined by the full board to be minimal risk. These are reviewed using expedited procedures for all future reviews. Many amendments to full board studies involve minor changes that do not affect risk to subjects and these may also be reviewed using expedited procedures. Finally, studies whose only remaining procedures involve follow-up or data analysis usually do not require full board review.
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What about new studies or amendments that are urgent and can't wait for the next full board meeting?
The CHOP IRB also includes a rapid action IRB, officially titled the CHOP Executive IRB, that can be convened with one or two days notice to review items that are emergencies or urgent matters. In the event that there is insufficient time for this IRB to meet and if the emergency involves an FDA-regulated investigational test article, the investigator may exercise the emergency exemption from prior IRB review. They should call the IRB to confirm whether or not the IRB is able to review the submission prior to the proposed use.