University of Pittsburgh logo
  1. Policies & Procedures

Meeting Assignment and Review

Meeting Assignment

  1. Human subject research requiring full-board IRB review and approval will be assigned by an IRB Coordinator to the next scheduled full-board IRB meeting with appropriate expertise.  Meeting agendas will typically be limited to no more than 25 items with a maximum of 4 to 5 new applications. In rare circumstances, exceptions can be made to these limits by HPR leadership.
  2. 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.
  3. Protocols previously voted by the IRB for deferral will generally be assigned to the same IRB committee that reviewed the initial submission.   As necessitated by time constraints, the principal investigator of the research may request review 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 may be invited to attend the full-board IRB meeting at which the protocol is being reviewed.
  4. A protocol previously voted by the IRB for disapproval is required to be submitted as a new application and will be assigned to the first available committee with appropriate expertise to review the study.
  5. Audit reports (including modification submissions related to audit findings), Reportable New Information, and issues related to serious or continuing non-compliance are assigned to the Executive Committee (Committee F). All other research submissions will be assigned to one of the general IRB committees. If appropriate, Reportable New Information or an audit report may be reviewed by an alternative IRB committee with appropriate expertise.

Reviewer Assignment

  1. For initial review, three IRB members serve as reviewers (i.e., a primary, secondary, and tertiary reviewer).
  2. For subsequent reviews, studies will be assigned to a primary reviewer.  If deemed necessary, a secondary and tertiary reviewer will also be assigned.
  3. 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.
  4. For research involving primarily social and/or behavioral 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
  5. 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, Independent Living and Rehabilitation Research, 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  IRB Coordinator.
  6. For the review of research involving prisoners by the convened IRB Committee, the following membership requirements will 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.

5/4/2021