iv. Role of Consultants

The University of Iowa IRBs may invite scientists or non-scientists from within or outside the University of Iowa, who have special expertise, to function as consultants and ad hoc reviewers of a project application.  These individuals have access to all documents submitted to the University of Iowa IRB relevant to the specific project under review, may participate in the deliberations and make recommendations on the project, but may not vote.  At the time of preliminary review of a project application, the University of Iowa IRB Chair or Primary Reviewer may decide that the study requires further review by a consultant with expertise outside of the current University of Iowa IRB membership.  This determination may be made based on the scientific design of the study, the ethical issues of the study, the potential risks, or benefits of the study, specific privacy and confidentiality concerns, or considerations relative to a particular study population or other reasons.

Upon identifying the need for a consultant review, the Chair and/or Primary Reviewer in consultation with the Chair will identify a consultant based on the particular issues to be addressed.  The Chair will determine that the consultant does not have a conflict of interest based.  A signed confidentiality agreement will be required from the consultant prior to completing the review process.  For issues requiring only simple clarification, a written set of questions will be developed for submission to the consultant or the completion of a primary reviewer checklist may be required of the consultant.  The consultant’s written response to these questions will be provided to the full University of Iowa IRB for review at the time of the convened meeting. 

For issues requiring more than simple clarification, the consultant may also be asked to review the project application in its entirety, complete a primary reviewer checklist, and attend the full board meeting during the review of that particular study.  The consultant will leave prior to the final vote by the University of Iowa IRB.  Documentation of the discussion with the consultant will be included in the meeting minutes.