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Regulatory Definitions

October 2004

For IRB review purposes, the DHHS and FDA definitions are applied:

DHHS: Research is:

"a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."

FDA: Does not define research. FDA regulations defines Clinical Investigation:

"...any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration."

DHHS: A human subject is:

"...a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information."

FDA: A Human Subject is:

"...an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient."

DHHS Intervention:

"...includes both physical procedures by which data are gathered, and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject."

DHHS: Identifiable private information is:

...information for which "the identity of the subject is or may readily be ascertained by the investigator or associated with the information."

DHHS & FDA: Minimal risk is:

"The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."

A useful glossary of terms can be found at http://www.hhs.gov

Clinical Practive Vs. Clinical Investigation

The IRBs are 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. In cases where the distinction remains unclear, the IRB will consult with the Department Chair 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 clinical 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 investigation clear. We urge all faculty to review this document carefully.


AAHRPP

 

 

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