Tag: IRB
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NIH ALERT: New NIH Submission Requirements Effective January 25, 2018
To all Investigators proposing human subjects research to the NIH, For NIH submissions with due dates on or after January 25, 2018, it is imperative to make an accurate determination of whether your study meets the NIH definition of a clinical trial. The NIH has broadly defined a “clinical trial” resulting in stringent requirements—some are…
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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…