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    On October 12, 2018, FDA published guidance to clarify the impact of certain provisions of the 2018 Common Rule requirements on FDA-regulated clinical investigations. Clarifications include that:

    • Certain provisions of the 2018 requirements related to informed consent are not inconsistent with FDA’s current policies and guidance; and
    • FDA’s current regulations for expedited review and continuing review must be followed for FDA-regulated studies

    On January 18, 2017, the Federal Policy for the Protection of Human Subjects, or Common Rule, was updated for the first time since its publication in 1991. The explicit goal of these revisions—the result of collaboration between the US Department of Health and Human Services and 15 other Federal Departments and Agencies—is to reduce administrative burden and better protect subjects in the modern research context.

    The implementation date for most provisions of the revised rule is January 21, 2019, leaving research ethics professionals a short window to comprehend the new rule and update their institutional policies and procedures accordingly. Through its Focus on the Revised Common Rule resources and programs, PRIM&R provides you with comprehensive in-person and online education and resources to help you understand the new provisions and what they mean for your human research protections program.