Random reviews of IRB protocols to begin

The Office of Research Compliance and Ethics has established a committee for random reviews of approved IRB studies to support quality assurance efforts for the protection of human subjects.

Review of human subjects research protocols approved by the IRB in 2010 will begin next week. Principal investigators will receive a letter from the Protocol Review and Education Program (PREP), notifying them that their study has been randomly selected for post-approval review. The letter will include details on how to schedule the review, the names of the committee member to contact, and what the review will involve.

PREP conducts not-for-cause reviews, therefore protocols are not selected on the basis of suspicion that the investigator is or is not in compliance with IRB regulatory standards. Results of the reviews are reported in aggregated format unless an issue requires a report to the federal Department of Health and Human Services.

Dr. Robin Liles serves as chair of the committee and can be reached at 336 285-4390 or by email.

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