January 2019

Research is defined by DHHS regulations as the systematic investigation, including development, testing and/or evaluation, designed to develop or contribute to generalizable knowledge.  In the context of these issues, generalizable knowledge is held to be knowledge related to health that can be applied to populations outside the population being studied.  That is, participants in a research project may or may not benefit directly from the study, but a larger group is expected to gain from the knowledge obtained in the study.  The investigator conducting may often have the intent to publish the results in a scientific journal or otherwise disseminate them.

The FDA regulates research (clinical investigations) involving drugs or devices, other than the use of approved drugs or devices in the course of medical practice, and all research in which data will be submitted to or held for inspection by the FDA. 

When an activity is research, or a clinical investigation, it is subject to review and approval by an Institutional Review Board (IRB) before the work may be undertaken. 

Clinical Practice vs. Clinical Investigation

The Organization is aware that research conducted in an academic setting can often result in an overlap between clinical practice designed to take care of a specific patient's medical needs and clinical investigation designed to collect generalizable knowledge to advance standards of care. This distinction can be particularly confusing in clinic-based research where contact with patients and clinical investigators may extend over long periods of time.

The decision as to what constitutes clinical practice in a department is made by the Department Director. However, in those grey areas where one may be unsure about whether an activity is clinical practice/patient care or research, we encourage faculty to contact the IRB in writing for an opinion. This will avoid any future confusion should the question arise in the course of an application for funding or review of a submitted manuscript for publication of case results (See Policy 102.3 “Single Case Reports and Case Series”). In cases where the distinction remains unclear, the IRB will consult with the Department Chairman before a decision is made as to which category the activity belongs.

In general, patients believe that the physicians, nurses and other health professionals caring for them make decisions that directly impact on their medical problem; that is, any decision or institution of a specific therapy, program, or course of treatment is made on an individualized patient basis. In addition, patients expect that information provided during the course of a clinic or hospital visit will be part of their medical record for consultation by health care providers who are part of their management team, not for use by researchers.

The agenda for the conduct of research is, however, very different from this assumption. While one of the goals for clinical investigation may be an impact on a patient's medical care, a research study is not conducted with strictly personal patient benefit in mind and data collected is shared with the research team and/or a sponsor of the study. Therefore, the aim of research is to produce new knowledge which can be used to support or negate a theory or practice.

We call your attention to The Belmont Report. In that Report, the section entitled "A. Boundaries Between Practice and Research" makes these distinctions between practice and research/clinical investigation clear. We urge all faculty to review this document carefully.

Public Health Surveillance Activities

Public health surveillance activities are specifically deemed “not to be research” under the DHHS regulations.  These activities may include the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority [1].  They are 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.  Because the distinction between public health surveillance activities that are “not research” and public health activities that require IRB oversight is not easy to make, a JHM IRB must make these determinations.  Public health activities that do not require IRB review must adhere to ethical standards appropriate to the conduct of those activities.

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[1] “Public Health Authority” is defined in 45 CFR 46.102(k) as “an agency or authority of the United States, a state, 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 form 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.”