What is the definition of clinical research?
• To prevent confusion, the NIH definition of “clinical research” will be used to determine which studies should be entered in Study Manager. That definition is: • Research which falls into one of the following categories: (1) Patient-oriented research. Research conducted with human subjects (or on a material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that strictly utilize human tissue. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies. (2) Epidemiologic and behavioral studies. (3) Outcomes research and health services. Be sure to note the underlined exclusion.
The NIH definition of clinical research includes all NIH supported biomedical and behavioral research involving human subjects. Applications for support of clinical research studies should address the policy by providing a description and justification of the study population. Research is a continuum of studies from basic laboratory to observational to clinical. Assessment of differential effects of an intervention or therapy on women, men, or members of minority groups and their subpopulations requires fundamental information on such groups. Therefore, at the earliest stages of research, investigators are expected to include individuals (or tissues) of both genders and diverse racial and ethnic groups in order to generate information necessary for the rational design of appropriate Phase III clinical trials. Investigators are expected to report results on all participating gender and minority groups, as appropriate. (See Section VB. and VI A. in the NIH Guidelines) • Question: What is
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