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Agencies Extend Comment Period on Proposed Changes to Clinical Research Rules

Those wishing to comment on revisions to the Federal Policy for Protection of Human Subjects (known as the “Common Rule”) could add a 30-day comment period extension to the things they were grateful for at this year’s Thanksgiving dinner. On Wednesday, November 25th, the 16 federal agencies involved in updating the Common Rule announced an extension of the comment period for the September 8, 2015, notice of proposed rulemaking (“NPRM”). The agencies granted the 30-day extension based on requests for additional time to fully review the NRPM and provide comments.

As we’ve previously reported, the NPRM makes some significant changes to the Common Rule. The changes include:

• expanding the scope of the applicability of the Rule to cover all clinical trials conducted at U.S. institutions that receive federal funding for non-exempt human subjects research (even if the research itself is not federally funded);
• updating the IRB review process to a more risk-based framework;
• creating new exemptions from the Common Rule for certain types of research; and
• improving and streamlining the informed consent process.

The Department of Health & Human Services has provided a succinct summary the changes and the Office of Human Subject Research Projections has created a six-part webinar series available on YouTube with more detail about the changes (links to all webinars are available here).

Persons interested in commenting on the NPRM must now submit comments by January 6, 2016.

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