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The 2018 Requirements (also referred to as the revised Common Rule (rCR)) consider public health surveillance activities "not research" solely for the purposes of the regulations (45 CFR 46.102(I)(2)).
Public health surveillance activities are defined as those "including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority 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, patterns in diseases, or increases in injuries from using consumer products). Such 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)."
Public Health Surveillance Exclusion Requests
Exclusion requests submitted for applications with due dates on or after January 25, 2022, contract solicitations issued on or after this date, and NIH Intramural Research Program (IRP) studies in which the first participant is intended to be enrolled on or after January 25, 2022, must receive NIH Office of the Director (OD) approval. This includes competing applications submitted for due dates on or after January 25, 2022.
NIH anticipates it will be extremely rare for NIH-funded activities to qualify for a public health surveillance exclusion. In the rare event that an NIH applicant or offeror submits a public health surveillance exclusion request, the NIH application or proposal must be under consideration for funding.
Grant applicants should first notify their NIH Program Officer/Program Director before submitting an exclusion request for public health surveillance.
Applicants or offerors should not assume that the exclusion request will be approved, so all associated research costs for conducting the activity without an approval of the exclusion request must be included in the budget. In addition, the PHS Human Subjects and Clinical Trials Information Form must be completed with the NIH application.
Applicants, offerors, and/or IRP investigators must ensure that requests meet the required criteria as specified in (NOT-OD-22-001). Incomplete requests and requests that do not meet the exclusion request requirements will be rejected (see the Investigator Instructions Workflow (PDF - 366 KB) for additional information on exclusion requests).
Notices & Statements
- NOT-OD-22-001 - NIH Implementation of the Revised Common Rule Provision Regarding Public Health Surveillance Activities Deemed Not to Be Research