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Informed consent process review under revised Common Rule requirements

Jennifer E. Elko (jelko@strategicm.com) is a Senior Consultant at Strategic Management Services, LLC in Alexandria, VA.

On January 19, 2019, most provisions of the revised Federal Policy for the Protection of Human Subjects, also known as the Common Rule, went into effect, including new requirements related to the informed consent process for clinical research studies. The Common Rule sets forth guidelines for the protection of human subjects involved in clinical research. The Common Rule was published in 1991 and adopted by 15 federal departments and agencies, including the Department of Health and Human Services (HHS).[1] The Common Rule also sets forth processes for review of all human subjects research by an institutional review board (IRB). A revised Common Rule was published in the Federal Register on January 19, 2017, which set forth changes to many human subjects research requirements, including revisions and enhancements to the informed consent process.[2] Although certain requirements were delayed following publication of the revised Common Rule, the majority of provisions went into effect on January 21, 2019, including the informed consent-related requirements.

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