Public Health Surveillance vs. Research

PrintPrintPDFPDF

What is Public Health Surveillance:

Public Health Surveillance is defined as activities that 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 that are conducted, supported, requested, ordered or required (by) and authorized by a Public Health Agency or authority of the United States 45 C.F.R.§ 46.102(l)(2).

The following criteria must be met to qualify as Public Health Surveillance:

  1. the activity must be conducted, supported, requested, ordered, required, or authorized by a public health authority;
  2. the activity must be a public health surveillance activity; and
  3. the activity must be limited to that 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.

 

I.  A Public Health Authority:

The Common Rule defines a public health authority as an: Agency or authority of the United States, 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 agency, including the employees or agents of 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.

OHRP draft guidance specifies that academic institutions such as UC, health care organizations, and non-profit entities, do not constitute public health authorities: OHRP, Activities Deemed Not to Be Research: Public Health Surveillance 2018 Requirements (November 7, 2018) (“OHRP Draft Guidance”).

Public Health Authority (Examples)

Not a Public Health Authority (Examples)

National Institutes of Health Centers for Disease Control

Occupational Safety and Health Administration California Department of Public Health

County public health departments

University of California Other academic institutions Health care organizations Non-profit entities

The following types of involvement from a public health authority may qualify for public health surveillance activity, if conducted by UC:

  • CDC directly participates in UC’s analysis of specimens and uses that analysis to inform CDC’s decision-making
  • NIH funds a UC investigator-initiated project intended to inform NIH of the prevalence of disease in a community
  • CPDH enters into a cooperative agreement with UC to conduct diagnostic testing of asymptomatic individuals to inform its future guidelines on testing

 

II.  Public Health Surveillance Activity:

OHRP’s draft guidance advises that Public Health Surveillance activity:

1.  Must generally involve collecting, testing, analyzing, and using information or biospecimens to improve public health and prevent disease;

Must serve the purpose of informing a public health authority on taking certain action, such as disseminating information to the public, or issuing orders or guidance; and

2.  If the activity is not undertaken with the direct purpose of informing public health decision-making by a public health authority, OHRP does not view it is as a public health surveillance activity (see OHRP Draft Guidance).

Some Examples include: information about the spread and control of communicable diseases, injuries and conditions, population vital statistics, tracking of health risk factors and outcomes, and monitoring of environmental hazards and conditions that threaten access to safe workplaces and housing, and clean air, water, and uncontaminated food sources.

III.  Activity is Limited to That Necessary to Allow the Public Health Authority to Identify, Monitor, Assess, or Investigate

Public health surveillance activities are deemed not to be research only if they are limited to activities necessary to directly 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, and patterns in diseases or injuries).

OHRP describes such activities as:

  • Detecting potential signals, onsets of disease outbreaks, or conditions of public health importance that had not previously been recognized;
  • Maintaining situational awareness of an identified signal, outbreak, or condition, in order to detect changes that warrant further public health action;
  • Evaluating the characteristics of a signal, outbreak, or condition, including its magnitude, prevalence or incidence, and the context in which a signal, outbreak, or condition occurs or has been detected, in order to inform public health action;
  • Investigating an identified or perceived threat to public health, to determine the magnitude of the problem, identify cases, or determine the cause, and to inform appropriate control measures; and
  • Assembling critical information needed to respond to a disease outbreak or other public health emergency in order to provide situational awareness.

The activities above must be carried out to address potential public health signals, onsets of disease outbreaks, or conditions affecting health and safety, such as infectious and chronic diseases, injury, including those related to medical products, and mental health ( see OHRP Draft Guidance).

Research

Surveillance activities are likely to be “research” and subject to the Common Rule when they involve the collection and analysis of health-related data conducted either to generate knowledge that may apply to populations and settings other than the ones from which the data were originally collected, or to contribute to new knowledge about a health condition.

Centers for Disease Control and Prevention (CDC) provides this helpful guidance: “Surveillance systems most easily fit in [research] if they entail longitudinal data collection systems (such as follow-up surveys and registries) that allow for hypothesis testing; if the scope of the data is broad and includes more information than occurrence of a health- related problem; if analytic analyses can be conducted; and if cases are identified in order to be included in subsequent studies.” CDC, Distinguishing Public Health Research and Public Health Nonresearch Policy (July 2010) (accessed May 14, 2020) (“CDC Policy”).

Important Note: While secondary research can be carried out in tandem with a public health surveillance activity, that portion of the project that is not public health surveillance is not subject to the research exclusion. OHRP Draft Guidance.

In such circumstances, the research component of the protocol (for example, the secondary research analysis) should be reviewed separately from the public health surveillance activity.

The table below illustrates how OHRP and public health agencies would likely view various types of activities:

Research

Public Health Surveillance Activity

UC is selected as one of four study sites by CDC to identify and describe cases of Lassa fever. Cases were identified from hospital and outpatient admissions. The purpose of the project was to generate baseline information on the Lassa virus and human clinical Lassa fever in the Republic of Guinea. No public health interventions were planned as part of this project; there was no direct benefit for study participants.

A national diabetes surveillance system is compiled using public use data from several national surveys. Data from the surveillance system are used to describe the burden of diabetes and its complications on a national and state level. The purpose of the surveillance system is to provide information for the development and improvement of national and state public health programs and services for the prevention and control of diabetes. The intended benefits are for those who have diabetes or those who are at risk of developing diabetes. UC is asked by CDC to compile and analyze the data for

this purpose.

UC PI conducts COVID-19 testing of asymptomatic individuals living in specified neighborhoods to ascertain the prevalence of the disease.

CDPH would like to obtain data to inform the development of contact tracing guidelines and asks a UC PI to collect specified data in specific neighborhoods with a high prevalence of COVID- 19 where specific public health concerns have

been raised.

NIH funds a study aimed at addressing the magnitude of tobacco use among families with small children in rural communities, but the UC PI collects additional information regarding health status to study the health impact of second-hand smoke in children.

NIH funds the collection of data by a UC PI to assess the prevalence of tobacco use among families with small children in rural communities. The purpose of the study is to identify the magnitude of tobacco use among this population and assist NIH in developing proper control

measures.

 

In determining whether an activity constitutes public health surveillance or research, the UCSF IRB will determine (based on a submitted application and consultation):

  • 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;
  • Whether there is a direct link between the surveillance activity and the decision-making and action by a public health authority;
  • Whether the public health authority will participate directly in the collection, testing, analysis or use of the information/biospecimens; and
  • Whether the activity will be supported by a public health authority (e.g., through a grant or contract).

Submission Requirements:

  • The UCSF IRB requires submission of an application even if the study team believes its project constitutes Public Health Surveillance activities only and does not require IRB approval under the Common Rule.
  • The primary reason for requiring an application is to determine whether the project involves components requiring IRB approval, and if so, to ensure they are adequately captured, reviewed and approved in accordance with current regulations. The IRB must also ensure that the project does not meet the definition of a clinical investigation as defined by the U.S. Food and Drug Administration (FDA). For example, if UCSF were to partner with a public health agency to engage in diagnostic testing using a test not granted an Emergency Use Authorization, 510(k) clearance, or other marketing approval by the FDA, the administration of the test would constitute a clinical investigation requiring IRB review. If any portion of the project involves a research component a separate application may be required.
  • In addition, we require a submission in order to collect data on COVID-19 related Public Health Surveillance activities for general research enterprise reporting.
  • Before you submit an application email Joanne Mickalian and Cheri Etter with a brief description of the scope of work. The HRPP will provide feedback on the submission process that best fits your activity.

Your Submission should include:

  • Documentation or approval from the Agency (CDC, CDPH, NIH) and/or other agency communications
  • Protocol, if available

Other considerations:

If a project is a public health surveillance activity, the project must still comply with applicable laws and regulations governing the relevant population, such as privacy laws. The public health authority may also require adherence with ethical guidelines for the conduct of the project.