PROCEDURE

IRB Responsibilities

An individual IRB member may:

• Request the Chair to appoint a consultant whenever the member determines the assigned protocol requires expertise in a special area in which (s)he is unable to review a protocol adequately.
• Recommend a person whom (s)he contacted for information related to the research to serve as a consultant.

The IRB:

• May decide during the review discussion if a consultant is needed to assist in the review of the protocol.
• Authorizes the Chair to appoint consultants subject to later ratification by the IRB.
• Ratifies appointment of a consultant by the Chair.

The Chair (or designee):

• Examines the agenda for each meeting to determine if a consultant is needed for:
  • Scientific expertise.
  • Representation of vulnerable populations.
    • Research funded by Department of Education (National Institute on Disability and Rehabilitation Research) which purposefully includes children with disabilities or individuals with mental disabilities as research participants, will undergo review by at least one person primarily concerned with the welfare of these participants.
  • Understanding of local context.
  • Other issues.
• Appoints consultants as necessary for research protocols to receive adequate review;

Consultant Responsibilities

The Consultant:

• Receives POL009 on IRB member and consultant conflicting interest.
• Certifies in writing that (s)he has no conflicting interest.
• Receives all documents submitted to the IRB for review and after consultation returns them.
• Presents opinions on the protocol either by oral presentation at the time of convened IRB review or by written summary.
• If present at the meeting, departs convened meeting before the final IRB deliberation and vote on the research protocol on which (s)he gave consultative input.

OIRB Responsibilities

Senior staff:

• Assists the Chair in review of the agenda for each meeting, if needed.
• Assists the Chair in identifying and contacting potential consultants.
• Communicates with consultants on matters pertaining to IRB review and scheduling of assigned protocol review.

OIRB administrative support staff:

• Distributes materials to consultants, including certification form of no conflicting interest.
• Distributes written summary of consultant, if provided, to IRB members with convened review materials.
• Documents in the IRB minutes key information provided by consultant during oral presentation.
• Attaches consultant’s written summary and/or any written presentation materials to the minutes and files in the protocol record. 

Approved on March 10, 2010, by:

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director