The National Institutes of Health (NIH) is informing the research community of its implementation of a provision in the 2018 Requirements for the Federal Policy for the Protection of Human Subjects (“the revised Common Rule”) under which public health surveillance activities may be deemed not to be research for the purposes of the regulation (45 CFR 46.102(I)(2)).
The revised Common Rule identifies certain public health surveillance activities as being excluded from applicability of the Common Rule, “including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.” In November 2018, the Office for Human Research Protections (OHRP) provided draft guidance on this exclusion, Activities Deemed Not to Be Research: Public Health Surveillance 2018 Requirements, which identifies NIH as a public health authority (45 CFR Part 46.102(k)) for the purposes of this provision. On October 20, 2020, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) recommended the exclusion be interpreted narrowly to avoid the inappropriate application of the exclusion to research that should be subject to the Common Rule in its Interpretation of Public Health Authority and Public Health Surveillance Activities, 45 CFR Part 46.102(k), 46.102(l)(2).
Given the importance of the protections provided by the revised Common Rule for research participants and acknowledging that exclusions from these requirements and protections should be made cautiously, NIH, as a public health authority, will solely make all determinations as to whether an NIH-supported or -conducted study qualifies as a public health surveillance activity for purposes of the Common Rule definition of research.
Please note: applicable definitions from the revised Common Rule (45 CFR 46.102):
“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. 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 authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.”
Important things for applicants to keep in mind, if you think your NIH funded project would meet this exclusion:
- Write your funding application and plan your budget as though the exclusion request will not be approved.
- Notify your NIH Program Official/Program Director if you intend to submit the public health surveillance exclusion request as early as possible. You will have the opportunity to submit a compelling justification for this exclusion during the just-in-time (JIT) process. Your justification must address specific points, outlined by NIH.
- NIH will “solely make” the determination, and they have stated that they intend to apply this exclusion narrowly.
Please see the following links for more detail: