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IRB Case: Public health practice vs. research

Is it research or practice?

Julius Landwirth

The key issue in this case study is the differentiation between public health practice and research. The background section summarizes attempts by both professional and government bodies to establish criteria that facilitate this differentiation. Why is this important and why has it been so difficult?

The constitutionally-based legal authority of public health agencies is to conduct activities that serve to assure the conditions for people to be healthy. The tools of public health practice involve systematic study of events and trends, data collection, including personal health information, surveillance, and data analysis leading to conclusions that can be generalized to be of benefit to the entire population. This authority is supported by state and federal police powers to constrain individual liberties for the public good.

At its core, public health ethics strives to provide guidance toward reasonable balance between legally and socially mandated activities to promote and protect the health of the entire population while respecting the rights and interests of individuals.

Whether an activity is judged to be practice or research will strongly influence the direction of that balance and whether formal review for compliance with Common Rule regulations should be required. Because IRB review is often a costly and lengthy process, the distinction is of considerable practical importance to public health practitioners

In many cases, such as in mass vaccination efficacy studies, this distinction is relatively straightforward.  In other cases, however, public health practices that involve systematic design to yield information that can be generalized for the potential benefit of a larger population, beyond those individuals bearing the potential risks, may begin to overlap with the Common Rule definitions of research.

This was the problem confronting the Dept of Public Health IRB that reviewed the case under discussion here.

The stated goal of the proposed project was to develop a local surveillance system in a local community for a specific disease, and to study its natural history and health care resource utilization demands that could be expanded to cover the entire state population.

Although the case write-up describes the committee’s review of 4 aspects of the proposal, the concern that runs through the discussion is whether the proposal represents primarily public health practice or research.  The submitted protocol indicated that the project incorporated both. The reviewers acknowledged they had difficulty differentiating the research from practice activities. They ultimately concluded that the projects contained elements “that met criteria for both public health research and public health practice, approximately 60% research and 40% practice.” It is not clear from the narrative whether this distribution referred to categorization of specific elements or whether some elements were seen as blends of research and practice.

The Council of State and Territorial Epidemiologists, in its report Public Health vs. Practice (cited in the narrative) provides a checklist designed to resolve this question with some degree of consistency.

According to the checklist a project may be categorized as public health practice, and not research, if:

  • it is to be conducted by a public health official, agent or agency;
  • there is  legal authorization;
  • it involves the acquisition and analysis of identifiable health data for the purpose of protecting the health of  a particular community;
  • it is primarily designed so that the benefits and risks accrue to that community;
  •  the activity conducted with oversight by a governmental public health authority accountable to the public;
  • it involves persons who must participate and from whom voluntary informed consent is not requested; and
  • the specific intent of the project to protect the health of a particular community (rather than to test an hypothesis and generalize the knowledge beyond the activity’s participants).

The first of the 4 areas of the project that were central to the committee’s review related to the research design. Elements of this design included intent to collect demographic data, create a specific disease surveillance system, understand the burden of chronic disease, and long term follow up of the natural history of the disease. In determining which of these activities were practice or research the committee relied primarily on the extent to which anticipated benefits would accrue to the local risk-bearing population versus general non-risk-bearing populations. However, it seems to this writer that judgments about potential range of accrued benefits are incomplete without a concurrent assessment of potential risks. Since public health practice involves inherently generalizable activities, whether benefits to non-participants in a local program are ethically justifiable depends in large part on the level of potential risk for the participants. If these risks are sufficiently minimized, the activity might fall within the scope of public health practice even if the benefits are widely disseminated.

The second area relates to privacy in the collection and use of personal health information.

Disclosure of such information for standard public health practice purposes can be done without consent, but requires waiver of consent from an IRB when used for research purposes. The Committee determined that since the researcher was acting as a DPH agent, request for waiver of consent was unnecessary.  The narrative also cites, however, regulations covering situations when, as here, the information sought would be used for both practice and research,  in which case researchers may proceed “either under the research provisions or the public health provisions, as appropriate.”  Perhaps a more prudent approach might be to follow public health ethics principles of minimization of harm and proportionality and establish a presumption of need for waiver of consent absent specific justification.

The third area reviewed by the Committee dealt with participant recruitment including asking physicians for permission to contact patients, and obtaining informed consent from the patients. The Committee categorized this as a research maneuver, rather than practice. This is also for legitimate public health purposes consistent with permission, so should there be an assessment of how recruiting in this way might compromise the results of the work.

  

In the fourth area the Committee examines the potential benefits and risk of harms related to various activities in the protocol that are clearly research. The Committee suggested a number of modifications that would offer better assurances of fair distribution of benefits and harms in accord with research ethics guidelines.

This section presents an opportunity to point out a possible moral hazard created by focusing too sharply on distinguishing public health practice from research if it results in the implication that distinctly different ethical principles apply. In fact, the principles of respect for individuals, minimization of harm and fairness in distribution of benefits and risks apply as well to public health professionals or agents acting under specific legal authority in the conduct of standard public health practice.

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