The Office for Human Research Protections (OHRP) has published a draft guidance document to “help entities determine whether a planned activity constitutes a public health surveillance activity deemed not to be research under the 2018 Requirements” (i.e., the revised Common Rule). The draft guidance reminds entities that while the revised Common Rule does not prescribe any specific requirements for who determines whether projects do or do not constitute public health surveillance activities under 45 CFR 46. 102(I)(2), such decisions should be thoughtful and deliberate. The revised Rule does, however, set forth three criteria that must all be satisfied for a public health surveillance activity to be deemed “not research”:
• Is the activity a “public health surveillance activity”?
• Is the activity being conducted or supported in any way by a “public health authority”?
• Is the activity necessary to allow a public health authority to accomplish their mission of protecting and maintaining the health of the population in which they are responsible for?
The draft guidance explores these criteria and provides examples of public health surveillance activities that OHRP considers not to be research under 45 CFR 46. 102(I)(2). Importantly, OHRP also calls out that:
• The explicit exclusion of these public health surveillance activities from the definition of research does not mean that all other types of public health activities are necessarily research; and
• An activity may include multiple components, some of which are not public health surveillance, and that only those components that “serve to enable a public health authority to carry out one or more public health surveillance objectives should be considered potentially eligible for the public health surveillance activity exclusion…”