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NIH Policy on Implementing the Revised Common Rule’s Public Surveillance Exception

Posted By:  CITI Program Staff October 20, 2021

The revised Common Rule identifies certain public health surveillance activities, “including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority,” as being excluded from applicability of the Common Rule.

“NIH Implementation of the Revised Common Rule Provision Regarding Public Health Surveillance Activities Deemed Not to Be Research,” a notice issued by the Office of the Director of the National Institutes of Health (NIH), states that justification for exclusion must include information that demonstrates all three of the following:

  1. The proposed activity is limited to that necessary for NIH to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, or patterns in diseases).
  2. The activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
  3. The activities will directly inform NIH public health decision making or action.

All requests for NIH-funded research – whether conducted or supported – including competing applications submitted for due dates on or after January 25, 2022, contract solicitations issued on or after January 25, 2022, applications for awards issued under Other Transactions Authorities (OTAs) on or after January 25, 2022, and NIH Intramural Research Program (IRP) studies in which the first participant is intended to be enrolled on or after that date – must receive approval by NIH to be considered as a public health surveillance activity deemed not to be research under 45 CFR Part 46.102(k), 46.102(l)(2).
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