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What is clinical research?

Clinical research is defined by the NIH 

National Institutes of Health (NIH)
the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage.
as:

  1. Patient-oriented research. Research conducted with human subjects 
    Human Subject
    Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction 
    Interaction
    any communication or other interpersonal contact between an investigator and a human subject. For more information, go to definitions in 45 CFR 46.102 and full 45 CFR 46.
    or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA.
    (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 

Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities.
or contract mechanism.  A grant is primarily an award 
Award
provision of funds by NIH, based on an approved application and budget or progress report, to an organizational entity or an individual to carry out a project or activity.
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 

Proposal
a written offer by an individual or non-federal organization to enter into a contract, consisting of a technical and a business proposal which includes a description of the project and its costs, and the methods, personnel, and facilities to carry it out.
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 
Contract
award instrument establishing a binding legal agreement between NIH and an award recipient for products or services. The Office of Acquisition 
Office of Acquisition (OA)
OA is part of the NHLBIs Division of Extramural Research Activities. OA provides support during the planning, negotiation, award and administration of research contracts. (Not be confused with the NIH Office of Acquisition Management and Policy)
Management and Policy (OAMP) web site provides additional information
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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