May 2020

The Revised Common Rule (RCR) promulgated by the U.S. Office of Human Research Protections (OHRP) explicitly deems “public health surveillance activities” not to be human subjects research, and thus not governed by the regulatory requirements of 45 CFR 46.

Although the RCR does not define “public health surveillance” (PHS), it states that those activities must:

• Be conducted, supported, requested, ordered, required, or authorized by a public health authority; and,
• Be 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)
• Provide timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters) [1]

PHS activities can involve collection and testing of information or biospecimens.

Because we are currently in the midst of the COVID-19 pandemic, a crisis that threatens public health, we are updating this information to provide further guidance to investigators. To be considered a PHS activity, the activity must fulfill the criteria listed above. In addition the JHM IRBs also require consideration of the World Health Organization’s Ethical Guidance on Public Health Surveillance and Ethical Issues in Management of Infectious Disease Outbreaks.

Specifically, although there are many situations in which obtaining informed consent from participants in PHS activities is impossible, the WHO recommends that “Whenever possible, individuals should be involved in decisions that affect them. In some cases, individuals should be free to make their own choices.” Despite there being no official legal requirement for informed consent in PHS, it ought to be considered when possible. Because that consent is not governed by the Common Rule, information can be provided and consent can be obtained in whatever method makes the most sense to respect the rights of participants in the particular project.

The collection of biological specimens used for PHS in the midst of the current pandemic is extremely important for future research aimed at understanding and controlling the virus. The WHO Guidance for Managing Ethical Issues in Infectious Disease Outbreaks provides guidance about the long-term storage of biological specimens collected during infectious disease outbreaks, and similarly recommends a process of informed consent: “Before individuals are asked to provide biospecimens during an infectious disease outbreak, they should be given access to information about the purpose of the collection, whether their samples will be stored and, if so, the ways in which their specimens might be used in the future. When feasible and consistent with public health objectives, individuals should be asked to provide informed consent or be given the opportunity to opt out of the long-term storage of their specimens. Seeking informed consent is particularly important if there is any possibility that the specimens may later be used for research purposes.”

Finally, there are many situations when it is advantageous to combine a research activity with a PHS activity. In those cases, the Office of Human Research Protection (OHRP) provides guidance that “If an activity is composed of multiple components, some of which are not public health surveillance, OHRP’s view is 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 under 45 CFR 46.102(l)(2).”

At Johns Hopkins University, the IRB will make the determination of whether an activity constitutes a PHS activity because, as the OHRP guidance acknowledges, “the line between public health surveillance activities and research activities can be difficult to draw.” If the JHU IRB makes a “public health surveillance/not research” determination, it may also advise the investigator to adhere to relevant ethical guidelines for the conduct of the surveillance activity (such as the WHO Guidelines).

The IRBs will require investigators submit specific information to determine whether the activity qualifies as a public health surveillance activity. This may include:

• Whether the activity is necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onset of disease outbreaks, or conditions of public health importance. (Note: It is unlikely that an activity meeting the definition of “clinical trial” would fall into this category.)
• Whether there is a direct link between the surveillance activity and the decision-making and action by a public health authority.
• Whether the activity will be conducted by a public health authority [e.g. the public health authority will participate directly in the collection, testing, analysis or use of the information/biospecimens].
• Whether the activity will be supported by a public health authority [e.g. through a grant or contract].
• Confirmation that the relevant public health authority is responsible for public health matters as part of its official mandate.

Definitions from the 2018 OHRP Guidance:

Public Health Authority: An agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, a foreign government, or a person or entity acting under a grant 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.

Please Note: The definition of a “public health authority” requires that an agency’s official mandate include the responsibility for public health matters. The mandate can be responsibility for public health matters, generally, or it can be for specific public health programs. Furthermore, an agency’s official mandate does not have to be exclusively or primarily for public health. Therefore, to the extent a government agency is responsible for public health matters as part of its official mandate, OHRP considers that, for purposes of this guidance, it qualifies as a public health authority.

Public Health Surveillance Activity:

There is no formal regulatory definition for public health surveillance activities.

In general, public health surveillance involves collecting, testing, analyzing, and using information or biospecimens to improve public health and prevent disease. It provides timely and useful evidence, and it enables public health authorities to be more effective in their efforts to protect and promote public health. Thus, public health surveillance is an important element of public health practice.

Public health surveillance uses information and biospecimens from a variety of sources, including mandatory reporting of certain conditions, routine monitoring, vital records, medical records, medical billing records, clinical specimens, and public health investigations. Further, it often uses the same analytical and laboratory techniques as epidemiological research. However, the difference between public health surveillance and research in this context is that the purpose of the surveillance is to inform the decisions or actions that must be made by a public health authority.

The direct link to decision making and action by a public health authority is a hallmark of public health surveillance. In the context of public health surveillance, the collection, management, analysis, and interpretation of surveillance information or biospecimens is designed to inform a public health authority, and generally is followed by public health action or by the dissemination of information to public health programs and others to stimulate public health action.

Surveillance activities that are not undertaken for the purpose of directly informing public health decision making or action generally will not be considered public health surveillance, even if they might be considered surveillance for other purposes.

Conducted by a Public Health Authority:

An activity is “conducted” by a public health authority when the public health authority participates directly in the collection, testing, analysis, or use of the information or biospecimens, or funds these uses through a contract.

Supported by a Public Health Authority:

An activity is supported by a public health authority when the activity is funded through a grant or cooperative agreement. Activities that are requested, ordered, required, or authorized by a public health authority also may be considered to be “supported by a Public Health Authority”, even if they are carried out by an entity that is not a public health authority (e.g., academic institutions, health care organizations, nonprofit entities).

 

[1] https://www.hhs.gov/ohrp/draft-guidance-public-health-surveillance-activities.html