Institutional Review Board

An institutional review board (IRB), also known as an independent ethics committee, is a select group of people formally designated to weigh risks versus benefits of participation in research and to protect the rights and welfare of research participants. Key goals are:

• Protecting human subjects from physical or psychological harm by reviewing research protocol and related material
• Assuring prospective research subjects are fully informed about the study and the voluntary nature of their participation

In the United States, IRBs are guided by the regulations applied to all research involving humans as set forth by the U.S. Office of Human Research Protections and the U.S. Food and Drug Administration.

The Genesys Health System IRB operates under a domestic Federal Wide Assurance for the Protection of Human Subjects granted by the U.S. Department of Health and Human Services (FWA #00006799).

The Ascension Genesys Hospital IRB has the following authority:

• To ensure that research has scientific integrity and is conducted in such a manner that it protects the rights and welfare of all participating subjects
• To review all research protocols involving human subjects performed under the auspices of all Ascension ministry locations
• To approve, require modification, suspend or disapprove all research activities that fall within its jurisdiction.

The Ascension Genesys Hospital IRB may have relationships and agreements with other IRBs. However, any research that has been previously approved by another IRB may still be subject to an Ascension Genesys Hospital IRB review. The Ascension Genesys Hospital IRB has final authority over research conducted within the Ascension Genesys Hospital jurisdiction, regardless of any previous other or central IRB approvals.

It is Ascension policy that all research involving human subjects must be reviewed and approved by the IRB prior to beginning research.