556. Reviewer Assignment and Notification

Updated August 31, 2026

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. IRB members or consultants with appropriate expertise will be assigned to perform an in-depth 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 Research Integrity & Security 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 submission types. If an IRB member with the requisite expertise is not available to review a project, Research Integrity & Security 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, Research Integrity & Security 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, Research Integrity & Security 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.

Research Integrity & Security 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

Research Integrity & Security 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, Research Integrity & Security 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 research protection, experience overseeing their own or their students’ human research, service on ethics or scientific review committees, experience as an IRB member, and consultations with the HRPP Manager. 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 HRPP Manager, Research Integrity & Security 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.

IRB members who perceive a conflict of interest may exist for review of any project/package regardless of submission type, should immediately notify Research Integrity & Security 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 Research Integrity & Security 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 Notification

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, Research Integrity & Security 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

Research Integrity & Security staff share access in IRBNet for the IRB member designated for Expedited Review, identifies them 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.

Identifying the Need for a Consultant

The University IRB uses consultants to supplement IRB review when a specific project requires expertise beyond the scope of IRB membership. For example, a project/package may require:

scientific or scholarly expertise or knowledge related to a particular intervention or procedure;
knowledge or experience regarding the characteristics of a research population, including customs, social mores, or religious beliefs;
knowledge of the scientific or scholarly validity specific to the research design;
knowledge or experience specific to a research site or international locale, including local laws;
knowledge or experience related to special requirements to protect participants, including obtaining informed consent, and protecting participant privacy and data confidentiality.

During the preview of a submission to assign a reviewer, Research Integrity & Security staff may determine the review requires scientific or scholarly expertise that is not available through the IRB membership. They will notify the HRPP Manager or IRB Chair of the need for additional expertise. Once the need for a consultant is identified, the HRPP Manager or staff, or IRB Chair consults with other IRB members, or University or Affiliate administrators or faculty to identify individuals who possess the requisite expertise.

If an IRB member assigned to review a project/package decides they require additional expertise for a thorough review, the member contacts Research Integrity staff coordinating the review to discuss the need for and use of a consultant.

In addition, the convened IRB may determine additional expertise is required during review of a project/package.

If the convened IRB determines additional expertise is required before the IRB can approve the research, IRB review and approval are deferred for consultant review and presentation at a subsequent meeting.
If the convened IRB determines the requirements for IRB approval are met but consultation is necessary for finalizing directed changes, the IRB approves the project/package with conditions. The consultant works with the Primary Reviewer or HRPP Manager or staff to confirm the necessary information has been obtained from the Principal Investigator (PI). This may be accomplished using expedited procedures.

Consultant Review

Consultants do not have appointed terms and they do not vote. Their participation is limited to assisting in the review of specific projects/packages.

When asking an individual to consult on the review of a project/package, the HRPP Manager or staff member coordinating the review asks the consultant if they have a conflict of interests that may interfere with or bias the consultation. Conflict of Interest determination applies if there is 1) a competing interest in the project under review; 2) a financial interest that is, could be, or could be perceived to be impacted by the research under review; and 3) a family member that exerts, could exert, or could be perceived to exert an influence on the individual’s professional judgment in exercising the individual’s role as an IRB consultant.

Consultants with a conflict of interests may contribute to the review of projects/packages only under the following circumstances:

the consultant limits their discussion to provide information requested by the IRB;
the consultant’s expertise cannot be obtained elsewhere, they disclose the conflict of interests to the IRB before presenting their comments;
the consultant leaves the meeting room for discussion and voting.

Consultants are provided copies of the materials that are relevant to their review and are asked to provide written documentation of their comments and recommendations. Research Integrity & Security staff attach the consultant’s materials as Board Documents in IRBNet.

When a consultant is involved in assessing a project/package, the IRB or Expedited Reviewer is made aware of the information provided by the consultant through:

the consultant’s presentation at a convened IRB meeting;
summary of the consultant’s findings, considerations, and recommendations presented by the IRB Chair or other IRB member at a convened IRB meeting; or
access to the consultant’s notes in IRBNet.