Proposed Updates to the Common Rule: An Overview of the NPRM

Recorded On: 10/30/2015

Proposed Updates to the Common Rule: An Overview of the NPRM On September 2, 2015, the Department of Health and Human Services (DHHS) and fifteen other Federal Departments and Agencies announced that a Notice of Proposed Rule Making (NPRM) was put on public display and was published in the Federal Register on September 8, 2015. This NPRM proposes changes to the Common Rule (45 CFR 46 Subpart A) with the goal of better protecting human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. It also includes discussion of many of the comments received in relation to the Advance Notice of Proposed Rulemaking (ANPRM) that was released in July 2011. Included within this 519-page NPRM are approximately 45 major proposals to the Common Rule and 88 questions to which DHHS is requesting comment. Institutions involved in the conduct of human research should be aware that many of the proposals put forth in the NPRM, if implemented, would have profound and long lasting effects on the conduct and oversight of human research in the future with substantial implications for the workload of investigators, IRBs, and institutions. This webinar will provide a summary of the key portions of the NPRM and provide an opportunity for audience questions, feedback and discussion.

Presenters:

Tom Bechert, Director, Huron Consulting Group Tom has 11 years of experience working with research institutions to enhance compliance, maximize the efficiency of research operations, and improve the overall effectiveness of research operations within universities, academic medical centers, cancer centers, and community hospitals.

Madeleine Williams, Senior Director, Huron Consulting Group Maddie has over 15 years of research experience and assists clients with and human research protection program evaluation and accreditation, institutional review board operational support, research biorepository design and development, and regulatory compliance evaluations.

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