556. Reviewer Assignment and Notification
Updated Oct. 4, 2019
The membership of the University IRB is sufficiently diverse to allow compliant review of the types of research in which University/Affiliate investigators commonly engage including social behavioral, psychological, educational, and biomedical research (including clinical trials).
The University IRB uses a primary reviewer system for Full Committee Review and designates a qualified IRB member for Expedited Review. This system applies to reviews of new projects, continuing review and amendment packages, and quality assurance reviews or problem reports requiring IRB review for potential serious or continuing noncompliance or unanticipated problems involving risks to participants or others. At the discretion of RI staff or upon recommendation by the IRB Chair, another IRB member may be assigned as a secondary reviewer for Full Committee or Expedited Review of any of the aforementioned submission types. If an IRB member with the requisite expertise is not availableto review a project, RI staff will engage the services of a qualified consultant.
The primary/expedited reviewer is responsible for
- conducting a comprehensive review;
- completing the primary and relevant supplemental review worksheets;
- presenting a summary of the research and review findings at the convened meeting ( Full Committee Review only); and
- in the Reviewer Comments page in IRBNet, noting additional comments, selecting a Recommendation, and attaching the completed review worksheets.
When a project involves populations likely to be vulnerable to coercion or undue influence, RI staff ensures that at least one IRB member or consultant knowledgeable about or experienced in working with the target population will be present at the meeting. For research funded by the National Institute on Disability and Rehabilitation Research, RI staff ensure the availability of an IRB member or consultant with the knowledge and expertise to evaluate the specific concerns of children or adults with disabilities, including mental disabilities.
RI staff verify that a prisoner or prisoner representative is present at a convened meeting when prisoner research will be reviewed.
Selection of Primary and Expedited Reviewers
RI staff use IRB members’ CVs or comprehensive IRB rosters to assess for scientific and scholarly knowledge and expertise; knowledge or expertise involving specific populations; and organizational affiliation of IRB members when designating reviewers for action items at convened IRB meetings, and for projects/packages eligible for review by expedited procedures.
For expedited review assignments, RI staff also verify the IRB member is listed among those qualified to conduct expedited reviews (per delegation of authority memo from the IRB Chair). Qualifications for IRB members to conduct expedited reviews include prior training related to human research protection, experience overseeing their own or their students’ human subject research, service on ethics or scientific review committees, experience as an IRB member, and consultations with the RI Director and staff. When research involving prisoners is eligible for review by expedited procedures, it is assigned to the IRB prisoner representative (see “prisoner” in the online Policy Manual Definitions).
If the RI Director, RI staff, IRB Chair, or the primary reviewer determine other types of expertise or knowledge are required to conduct an in-depth review of the protocol, another faculty member or expert in the field may be asked to provide a consultant review to complement but not replace the designated IRB member’s review. See IRB policy for consultant reviews.
IRB members who perceive a conflict of interest may exist for review of any project/package regardless of submission type, should immediately notify RI staff of the conflict so another IRB member may be designated to conduct the review.
Use of Secondary Reviewers
Secondary reviewers are generally assigned for new projects submitted for Full Committee Review for research posing greater than minimal risk and for clinical investigations, but may be used when a second IRB member has expertise that is relevant to the research, or when substantive ethical considerations are raised by the research.
Secondary reviewers may be assigned for projects/packages reviewed by expedited procedures when the primary reviewer or RI staff determine an augmented review would complement the determination.
Secondary reviewers may be asked to assist the primary reviewer in evaluating the consent materials (preferred for research involving clinical trials) and may complete all or a subset of the applicable review worksheets.
Secondary reviewers report their findings and render their determinations separately and in addition to those of the primary reviewer.
Rarely are secondary reviewers used for projects reviewed by expedited procedures.
Reviewer No tification
Notification of Full Committee Review Assignments
At least one week before the scheduled meeting, the meeting agendas are published in IRBNet and IRB members are notified the agenda is available. The agenda includes primary and secondary review assignments for projects/packages submitted for Full Committee Review.
For action items on the agenda, RI staff share access in IRBNet with the IRB members who will be attending the meeting, and assign primary and secondary reviewers. Shared access allows the members to review the current and archived materials for the project/package. IRBNet displays primary and secondary reviewer designations.
Notification of Expedited Review Assignments
RI staff share access in IRBNet for the IRB member designated for Expedited Review, identifies her/him as the primary reviewer, and selects the option to notify the member of the expedited review assignment. Shared access allows the primary member to review the current and archived materials for the project/package.