Human subject research requiring full-board IRB review and approval will be assigned by the IRB Office staff to the next scheduled full-board IRB meeting (i.e., subject to the availability of IRB committee members with appropriate expertise as determined by review of IRB Member Rosters). Meeting agendas will typically be limited to no more than 30 protocols with a maximum of 6 to 7 new applications. In rare circumstances, exceptions can be made to these limits by senior IRB staff.
Research submissions will be assigned to a committee where there is sufficient expertise. The schedule for IRB meetings can be found on the IRB website.
Protocols previously voted by the IRB for reconsideration will generally be assigned to the same IRB committee that previously reviewed the initial submission. As necessitated by time constraints, the principal investigator of the research may request reconsideration of the research submission at the next scheduled full-board IRB meeting. If the next available meeting involves a committee which was not involved in the previous review of the submission, the primary IRB reviewers involved in the previous review of the research submission will be given the opportunity to provide written comments regarding the resubmission. The principal investigator will be invited to attend the full-board IRB meeting at which the protocol is being reconsidered.
Protocols previously voted by the IRB for disapproval are required to be submitted as a new protocol and will be assigned to the first available committee with appropriate expertise to review the study.
Audit reports (including modification submissions related to auditing findings), unanticipated problems involving risks to human subjects or others and issues related to serious or continuing non-compliance are assigned to Committee F. All other research submissions will be assigned to one of the general IRB committees. If appropriate, an UP or audit report may be reviewed by an alternative IRB committee with appropriate expertise.
For initial review, three IRB members serve as reviewers (i.e., a primary, secondary, and tertiary reviewer).
For subsequent reviews, studies will be assigned to primary and secondary reviewers. If deemed necessary, a tertiary reviewer will also be assigned.
For research involving primarily biomedical intervention(s), the primary reviewer will be a physician or health care practitioner with adequate expertise in the area of the research; the secondary reviewer will be a scientific member of the committee; and the tertiary reviewer, if applicable, will be a member whose primary responsibility will be review of the consent document to present the perspective of a potential subject.
For research involving primarily psychosocial interventions, the primary reviewer will be a scientific member with adequate expertise in the area of the research; the secondary reviewer will be a scientific member of the committee; and the tertiary reviewer, if applicable, will be a member whose primary responsibility will be review of the consent document to present the perspective of a potential subject.
For research that purposefully requires the inclusion of children with disabilities or individuals with mental disabilities and is funded by the National Institute on Disability and Rehabilitation, the protocol, regardless of level of risk, will be reviewed by at least one individual who is primarily concerned with the welfare of these research subjects. This representative will have the appropriate scientific or scholarly expertise to serve in this capacity and will serve as either a primary or secondary reviewer. In the absence of an appropriate reviewer, the IRB will identify a consultant to serve in this role. This will be documented in the minutes generated by the Full Board RRC.
For the review of research involving prisoners by the convened IRB Committee, the following membership requirements must be met:
the prisoner representative must be listed on the Committee roster as a voting member if a protocol involving prisoners is on the agenda;
one or more individuals who are prisoners or prisoner representatives must be present (in person, by phone, video-conference or webinar) at the meeting during the discussion and vote of the proposed research study or the study cannot be reviewed or approved;
the prisoner representative must be assigned as a reviewer on research studies involving prisoners and should focus on the requirements of Subpart C;
the prisoner representative will have access to the same materials as all Committee members as outlined under “Distribution of Materials;”
the prisoner representative must present his/her review orally at the convened meeting of the IRB when research involving prisoners is reviewed;
a majority of the IRB must have no association with the prison involved, apart from their membership on the IRB.