Institutional Review Board

PURPOSE

The University of Utah Institutional Review Board (IRB) requires that special consideration be given during the review of studies involving genetic research and information, given the potential predictive power of some genetic information, the familial nature of some genetic research and information, and the potential risks associated with genetic information.

SCOPE

This policy applies to human subject research conducted at the University of Utah.

POLICY

The University of Utah IRB requires investigators to provide a plan to ensure the privacy and confidentiality of participants, minimize the risks associated with genetic research, and provide adequate disclosure of genetic results that may be clinically relevant to the participant.

The IRB guidelines regarding genetic research are posted on the IRB website.

Investigators must submit the required information and documents for genetic research in the new study application. The IRB reviews the proposed research, informed consent documents, and additional information, when applicable, to determine whether the plan to ensure the privacy and confidentiality of participants is adequate, the risks associated with genetic research are minimized, and the plan to disclose genetic results or incidental findings to the participant is adequate.

The assigned IRB reviewer(s) may contact a qualified member of the University of Utah Institutional Biosafety Committee and external consultants, as necessary, to provide independent guidance to the IRB.