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Intramural Programs Appendix III: Definition of Qualified Research
Definition of Clinical Research
Clinical research is patient-oriented research that is conducted with human subjects,
or research on the causes and consequences of disease in human populations involving
material of human origin for which an investigator or colleague directly interacts
with human subjects in an outpatient or inpatient setting to clarify a problem in
human physiology, pathophysiology or disease, or epidemiologic or behavioral studies,
outcomes research or health services research, or developing new technologies,
therapeutic interventions, or clinical trials (Public Law 106-505).
Activities Constituting AIDS Research*
The following parameters define whether a proposed research assignment meets the criteria for
coverage under the NIH AIDS Research Loan Repayment Program - that is, whether
the incumbent will be "primarily" engaged in AIDS research. "Primarily" engaged
in AIDS research is defined as AIDS research activities that constitute at least 80% of a
researcher’s time. Clinical Associates, whose intent is to primarily engage in AIDS research,
must engage in qualified AIDS research for at least three months in the first year of their
program, with a total of fifteen months of qualified AIDS research during their two-year contract.
AIDS researchers include registered nurses who are principal or associate investigators in AIDS research studies.
- AIDS research includes studies of the human immunodeficiency virus (HIV),
the pathophysiology of HIV infection, the development of models of HIV infection
and its sequelae, cofactors predisposing to HIV infection and AIDS, or its
equelae, and the development of vaccines and therapeutics. More specifically, the following research activities are included:
- Studies of HIV and related retroviruses;
- Studies of the mechanism(s) by which HIV and related retroviruses establish infection and infect host cells;
- Studies of the mechanism(s) by which HIV and related retroviruses cause disease,
including studies of the immune deficiency induced by HIV and related retroviruses;
- Studies of the pathophysiology of host response to HIV infection;
- Studies of in vivo or in vitro models of human HIV infection and its sequelae;
- Epidemiologic studies of HIV and related retrovirus infection;
- Clinical trials involving prophylaxis or therapy for HIV infection or its sequelae;
- Preclinical studies aimed at the development of therapy for or prevention of HIV
infection and the immunodeficiency caused by HIV infection and its sequelae;
- Cofactors predisposing to acquiring HIV infection and/or the progression of HIV-related disease;
- Basic studies and clinical trials involving vaccines, or other immunological or chemotherapeutic
interventions for the prevention of HIV infection and its sequelae;
- Studies into the transmission of HIV involving high risk behaviors and research concerning
the interruption of transmission by behavioral change and pharmacologic intervention; and
- Basic studies of the societal impact of and response to the HIV/AIDS epidemic, including subgroups within the population.
- AIDS researchers include scientists who are intellectually engaged in the process of
providing scientific direction and guidance in programs of original AIDS research, specifically,
epidemiologists, statisticians, and others who are involved in the design and conduct of research
studies. The duties of such scientists may include the generation and design of studies and collation and
analysis of data; and/or the preparation and publication, as author or co-author, of studies in peer-reviewed journals.
- AIDS researchers include physicians and registered nurses who are providing care for HIV-infected
individuals that are subjects of HIV-related research. (See
http://www.cc.nih.gov/nursing
for information on eligibility and application process for RN's employed by the Clinical Center.)
* Adopted by the Loan Repayment Committee on November 19, 1993.
Date Last Updated: October 1, 2010
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