Guidance: Determining Public Health Practice from Public Health Research
The JHSPH IRB must review submissions involving evaluations of public health projects and determine whether those projects meet the definition of “human subjects research.” The IRB will consider the following factors in making its decision on a case-by-case basis.
1.Making the Practice v. Research Determination
General Attributes of Public Health Research: The intent of the project is to generate generalizable knowledge in a systematic way to improve public health practice beyond the scope of the population involved. “Generalizable knowledge” means new information that has relevance beyond the population or program from which it was collected, or information that is added to the scientific literature. The intended benefits of the project may or may not apply directly to study participants, but always extend beyond the study participants, usually to a broader population or community. Generalizable, for purposes of defining research, does not refer to the statistical concept of population estimation or to the traditional public health method of collecting information from a sample to understand health in the population from which the sample came.
General Attributes of Public Health Practice: The intent of the project is to identify and control a health problem or improve a public health program or service for a specific population. The intended benefits of the project are primarily or exclusively for the participants (or clients) or the participants’ community. Data collected are needed to assess and/or improve the program or service, the health of the participants or the participants’ community, and the knowledge that is generated does not extend beyond the scope of the activity. Project activities are not experimental.
Some hallmarks of public health practice, as opposed to public health research, include:
1)The JHSPH faculty are working closely in concert with a public health authority or non-governmental organization.
2)The activities arise from a “fee for service” contract (as opposed to a more open-ended (research-type) grant) between the public health authority and the JHSPH.
3)The JHSPH faculty have no intent to generalize the results of the activities beyond the scope of use defined in the contract (e.g., may not publish beyond the scope of internal documents produced for, or by, the sponsoring agency.)
4)The activities use only standard methodologies and/or proven interventions.
With respect to (1) and (2), public health practice activities are almost always performed in close collaboration with a public health authority, and are usually supported by highly prescriptive contracts rather than open-ended funding arrangements.
With respect to (3), public health practice activities usually result in only restricted dissemination of the results, because those results are so specific to the program, population, and environment in question. If broader dissemination is envisioned or occurs (e.g., presentation of the results at a national or international meeting or publication in a peer-reviewed journal), it almost always implies a degree of generalizability that signals research.
With respect to (4), according to CSTE (Council of State and Territorial Epidemiologists), research (as opposed to practice) “involves testing new, unproven treatments or strategies that are not known to be efficacious. As such, research entails the design of a study to enable rigorous monitoring of potential adverse, unexpected consequences to selected human subjects in the application of new, often unproven interventions.”
2.Public Health Research Determinations
If the IRB determines a project to be “research”, the IRB must then decide whether the project meets the criteria for exemption, or if it requires review by one of the two Boards. This determination will be made in accordance with JHSPH policy.
Important Note: A public health practice (i.e., non-research) project may generate generalizable knowledge after the project is undertaken, even though generating this knowledge was not part of the original, primary intent. In this case, since the primary intent was not to generate or contribute to generalizable knowledge, the project is not classified as research at the outset. However, if subsequent analysis is desired to generate or contribute to generalizable knowledge, the analysis constitutes human subjects research that requires JHSPH IRB review, and a new protocol application (for secondary data analyses) must be submitted, and approval obtained before the subsequent analysis can be undertaken.
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