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    NEW!Latest News

    On July 20, 2018, the Office for Human Research Protections (OHRP) made available three draft guidance documents that relate to the three burden-reducing provisions in the revised Common Rule. Institutions may choose to implement these three provisions during the delay period for general compliance with the revised Common Rule (July 19, 2018 through January 20, 2019). The three draft guidance documents are now available on OHRP’s website:

    (1) Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements

    (2) When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019: 2018 Requirements

    (3) Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements

    The draft guidance documents and instructions for how to submit comments are now available. There is a different docket for each draft guidance document in which the public can submit comments during the comment period of July 25 - August 24, 2018.

    For more information on implementing these provisions during the delay period, see PRIM&R's blog post.

    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 July 19, 2018, 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.