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 research normally has the intent to publish the results in a scientific journal.
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. Customarily, faculty investigators must seek IRB review for human research projects, but the Organization does not require them to seek IRB approval for clinical practice activities or public health interventions.
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 Activities
The Organization recognizes that surveillance, emergency responses, and program evaluations do not meet the DHHS definition of research. These activities constitute public health activities the primary intent of which is to prevent disease in a particular population, to improve a public health program, or to provide emergency disaster relief and do not meet the DHHS definition of research. Therefore, these activities do not have to be reviewed by an IRB.
In cases where it is not clear whether an activity falls into clinical practice or public health activities, faculty should request an IRB opinion on whether an activity is research requiring IRB review. The request for opinion should be sent by a letter addressed to an IRB chair. The final determination of the question of whether the activity is or is not a research project is the responsibility of the IRB.