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LRPs for NIH Employees - Intramural Programs
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 sequelae, 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.
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