Section IV:

IRB Panel Organization, Composition, and Responsibilities

WPP #: IV-5

Title 5:

Use of Consultants for IRB Review

Effective Date:

9-24-13

Revision History:

09-04-13

Policy Statement

In order to facilitate thorough review of human subjects research at VCU, IRB members are encouraged to use consultants to aid in the review process.

Procedures and Guidance

Informal Consultation:

IRB members are encouraged to seek informal consultation as a normal part of their review process. Informal consults may occur with IRB members from any VCU IRB panel as well as other members of the University community providing that the individual has the appropriate expertise. If the consultation is done as an informal discussion, the formal steps (below) do not apply. However, care should be taken regarding confidentiality and conflict of interest issues.

Formal Consultation:

At its discretion, an IRB panel may invite scientists or non-scientists from within or outside the University, who have special expertise, to function as consultants and ad hoc reviewers of a research protocol application. These individuals are considered guests to the IRB meeting (see WPP#: III-3) and have access to all documents submitted to the IRB relevant to the specific project under review, may participate in the deliberations and make recommendations on the project, but may not vote.

A consultant may not participate in the Panel's review of any project in which the consultant has a conflicting interest, except to provide information requested by the Panel. A consultant is considered to have a conflicting interest when the consultant, the consultant’s spouse or partner, or any of the consultant’s dependent children have a non-financial interest in the design, conduct, or reporting of the research, or have any financial interest in the research as defined in the Office of Research Conflict of Interest Policy.

Consultants having a conflict of interest shall:

  • Announce the conflict and disqualify themselves from participation before review of that research project except to provide information on request, and
  • Leave the meeting during the discussion and the vote on any motion to approve, require changes, or disapprove the research in question.

Office of Research Subject Protection (ORSP) staff, Chairperson, or primary/secondary reviewer may evaluate a protocol and make their own determination that additional expertise is needed. If this decision is made by any one of these individuals, a consultant will be provided in accordance with the following procedures:

  1. Payment of consulting fees should be pre-arranged through the ORSP Director.
  2. It should be determined if the consultant needs to sign a confidentiality agreement. If unclear, contact the ORSP Director for assistance.
  3. If the consultation will include a review of the protocol and Investigator Brochure information, the consulting reviewer should receive these materials in a timely manner. A timeline for the consultation should be included, so that the consulting reviewer will have an appropriate amount of time prior to the scheduled presentation for discussion of the review with the Panel reviewer and/or panel.
  4. The assigned Panel reviewer may decide that the presence of the consulting reviewer at the Panel meeting where the research is presented would be of value to the review or may simply request the consultant to provide written comments. In either case, the consulting reviewer may be invited to attend the meeting in person or remotely as a guest. Written comments provided by the consultant will be entered into the IRB minutes as part of the IRB deliberations as deemed appropriate and necessary for the specific protocol.
  5. The requesting Panel reviewer is not obligated to follow a consultant recommendation, but should present the information to the Panel, with an explanation of the review.

If a consulting reviewer requests contact with the sponsor or investigator for more information, this request must be managed by the Panel reviewer involved in the consultation. It may be done as a conference call with the consultant and assigned Panel reviewer. There should not be individual sponsor contact by the consulting reviewer.

In addition to securing additional scientific or contextual consultation, the IRB reviewer together with the IRB Chairpersons and/or Panel may determine the necessity for consultation by legal counsel. In such cases, the VCU Office of the General Counsel may be consulted directly by the IRB Leadership for information and/or clarification regarding matters of state law applicability or to request a legal opinion pertaining to the review of a protocol. The opinion and/or information offered by legal counsel will be entered into the IRB minutes as a part of the IRB deliberations for the specific protocol.

References

WPP # III-3: Meeting Guests