Research Definitions

Definition of Clinical Research

The NIH Panel's Definition of Clinical Research

Early in its deliberations the Panel realized the importance of reaching a consensus on a working definition of "clinical research" for all its tasks, particularly for tracking and monitoring funding activities. The Panel's three-part definition is:

1. Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. This area of research includes:
   • Mechanisms of human disease
   • Therapeutic interventions
   • Clinical trials.
   • Development of new technologies
2. Epidemiologic and behavioral studies
3. Outcomes research and health services research.

Excluded from this definition are in vitro studies that utilize human tissues but do not deal directly with patients. In other words, clinical or patient-oriented research is research in which it is necessary to know the identity of the patients from whom the cells or tissues under study are derived. Therefore funding for research that is concerned with examining patients has been the area of concern for the Panel and its subcommittees, not funding for basic studies. However, mixed grant applications, as in program projects in which one element of the proposal is an animal model and one is a human model, were classified as clinical research for the purposes of the Panel's activities.

The Panel recognizes that there is no definition of clinical research upon which there is total agreement. The Panel's definition has been criticized for being too inclusive; some commentators prefer a narrower definition confined to patient-oriented research in which the physician and patient interact directly. Nevertheless, the definition above is the one upon which the Panel has based its recommendations. Furthermore, the Panel recommends that henceforth, the NIH use this definition as its standard for all analyses.

Biostatistician Definition

A biostatistician by definition specializes in the development and application of statistical theory and methods for the study of phenomena arising in the life sciences. In effect, a biostatistician works to discover answers to difficult questions by examining data under a special type of magnifying glass. A biostatistician has primary expertise in building inferences using data and so may also be thought of as a special kind of architect.

A biostatistician researches in a broad range of areas, some of which include health, medicine, agriculture, biology, genetics, biochemistry, biophysics, demography, epidemiology, health promotion, and psychology. Biostatisticians therefore enjoy collaborating with all kinds of investigators, from university faculty and staff, to community professionals, on a broad range of activities that will advance research enterprise and research quality.

Definition of a KUSM-W Investigator

A KUSM-W Investigator is a local KU faculty member, usually full time, whose funded research is managed by KURI.

Definition of an Outside Investigator

An Outside Investigator is any other investigator other than a local KU faculty member, usually full time, whose funded research is managed by KURI.

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Last Modified: October 12, 2005