557. Using Consultants for IRB Reviews

Updated July 13, 2021

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 staff may determine the review requires scientific or scholarly expertise that is not available through the IRB membership. She/he/they will notify the Research Integrity Director or IRB Chair of the need for additional expertise. Once the need for a consultant is identified, the Research Integrity Director or staff, or IRB Chair talks 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 she/he/they requires 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 Research Integrity director 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 Research Integrity Director or staff member coordinating the review asks the consultant if she/he/they has a conflict of interests that may interfere with or bias the consultation. Consultants with a conflict of interests may contribute to the review of projects/packages only under the following circumstances:

• the consultant limits her/his/their discussion to provide information requested by the IRB; or
• if the consultant’s expertise cannot be obtained elsewhere, she/he/they discloses the conflict of interests to the IRB before presenting her/his/their comments.

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 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.