During the peer review of the trial, this aspect will be considered in the evaluation. Finally, it is expected that the investigators will perform the necessary analyses and include the results in submitted publications. The following series of questions and answers are intended to assist you in preparation of research applications in accordance with the NIH Guidelines. 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. Investigators are expected to report results on all participating gender and minority groups, as appropriate. For the purposes of the NIH policy, it is a broadly based prospective Phase III clinical trial that is designed to evaluate an experimental intervention in comparison with a standard or control intervention or to compare two or more existing treatments. Often the aim of such investigations is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacological, nonpharmacological, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy.