Tag Archives: Common Rule

Common Rule Delay and Single IRB Requirement for Federally Supported Studies

On January 17, 2018, changes to the common rule that were scheduled to be effective on January 19, 2018, were delayed 6 months.  The new effective and compliance date is July 19, 2018.  This will allow time for the regulatory agencies to develop more guidance around the 2018 Common Rule, and they will also work […]

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Important News About NIH-Funded Human Subjects Research

NIH Policy for NIH-Funded Human Subjects Research Effective October 1, 2017, all new and ongoing NIH-funded research meeting certain criteria is deemed to be issued a Certificate of Confidentiality (CoC) via a new NIH policy. This policy results from a directive in the 21st Century Cures Act. For more information about the change in policy, please see this notice. Previously, researchers […]

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The Common Rule is Revised – but under temporary moratorium

DHHS’s revised “Common Rule” governing human subjects research was finally published, and will become effective January 19, 2018 (except for the single-IRB requirement for cooperative research, which is two years later). However, there is a 60 day moratorium in effect at the moment. For summaries of the very significant changes (including removal of continuing review […]

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