Exempt Human Subjects Research: Pathway to Approval.

Exempt Human Subjects Research: Pathway to Approval.

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Oftentimes, there is confusion surrounding with Exempt research and the requirements for IRB or institutional review. This is perfectly understandable, particularly given that the Common Rule has been revised in recent years and more research involving human subjects may fall into an exempt category.

Although federal regulations do not require IRB review of exempt research, federal agencies have issued guidance recommending that exempt determinations should be made by an individual that is not otherwise affiliated with the research. In other words, institutions should not permit study investigators to make exempt determination for their own projects.

To ensure that exempt determinations are issued by individuals that are not directly involved with the research, MedStar Health Research Institute policy states that exempt determinations must be made by either an IRB member or qualified / trained / designated members of the ORI staff.

In order to make these determinations, a formal submission is required through the Huron system. As with all other Human Subjects Research projects the formal determination must be issued before any research activities may begin.

If you have any questions regarding this process, please contact MHRI’s ORI Director, Jim Boscoe, at James.H.Boscoe@medstar.net.

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