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What is clinical research?

Clinical research is defined by the NIH as:

  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. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes:
    • mechanisms of human disease,
    • therapeutic interventions,
    • clinical trials, or
    • development of new technologies.
  2. Epidemiologic and behavioral studies.
  3. Outcomes research and health services research.

Clinical research may be conducted via a grant or contract mechanism. A grant is primarily an award of financial assistance transferred to a recipient to carry out a project, program or training. This website will address the conduct of clinical research primarily through a grant mechanism. However, many of the same principles apply to contracts as well.

A contract is a written proposal by an individual or non-federal organization, usually in response to a request for proposals. It consists of a technical and a business proposal, including a description of the project and its costs, and the methods, personnel, and facilities to carry it out. Please go to Contract Opportunities and Procedures for more detail on writing a contract proposal.

Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov

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