African American: An American having origins in any of the black racial groups of Africa.
American Indian or Alaska Native: A person having origin in any of the original peoples of North or South America, including Central America, and who maintains
tribal affiliation or community attachment.
Asian: A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent, including,
for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.
Clinical Research/Clinical Study: Includes (1) Patient-oriented research, which is defined as any 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. Examples of patient-oriented research are studies on mechanisms of human disease, therapeutic interventions,
clinical trials, and development of new technologies. In addition, clinical research/studies also include (2) Epidemiologic
and behavioral studies; and (3) Outcomes and health services research.
Clinical Trial: A prospective biomedical or behavioral research study of human subjects to determine whether new or existing biomedical
or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices) are safe
and effective. Research to develop or evaluate clinical laboratory tests (e.g. imaging or molecular diagnostic tests) might
be considered to be a clinical trial if the test is used for medical decision making for subjects in the study (see entries
for Phase III and Preliminary clinical trial).
Health Disparities: Differences in the incidence, prevalence, mortality and burden of diseases and other adverse health conditions that exist
among specific population groups in the United States. For the purposes of this current exercise, the NIH will focus on racial/ethnic
minority populations (African Americans, Asians, Pacific Islanders, Hispanic and Latinos, Native Americans, and Native Alaskans).
Health Disparities Populations: A health disparity population as defined by Public Law 106-525, has a “significant disparity in the overall rate of disease
incidence, prevalence, morbidity, mortality, or survival rates in the population as compared to the health status of the general
population.” NIH has determined that the following populations constitute health disparity groups: (a) racial/ethnic minority,
(2) low-SES, and (3) rural populations. Women and children are not health disparity populations as defined by law.
Health services research: Health services research is the multidisciplinary field of scientific investigation that studies how social factors, financing
systems, organizational structures and processes, health technologies, and personal behaviors affect access to health care,
the quality and cost of health care, and ultimately our health and well-being. Its research domains are individuals, families,
organizations, institutions, communities, and populations.
Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race.
Inclusion in Clinical Studies: The NIH Revitalization Act of 1993 (PL103-43) requires that women and minorities must be included in all of its clinical
research studies. Definitions for all of the terms referenced in human subject inclusion guidelines and policies can be found
Intervention : A procedure whose purpose is to improve health or alter the course of disease. Types may include: biologic, behavioral, surgical,
or other approaches to prevent disease occurrence or progression or to improve outcomes; intervention may be implemented at
the individual level or at an environmental or systems level.
Minority Health Research: as defined by PL 106-525 it includes basic, clinical, and behavioral research on minority health conditions, including research
to prevent, diagnose, and treat such conditions.
Minority Populations: Minorities are defined by statute for the purpose of NIH minority health and health disparities research reports as American
Indians/Alaskan Natives; Asian Americans; Native Hawaiians and other Pacific Islanders; Blacks; and Hispanics.
Native Hawaiian or Other Pacific Islanders: A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.
Phase III trial: A Clinical Trial that is designed to determine the efficacy of a treatment. Such a trial is usually designed to include a control treatment,
some form of investigator and participant blinding, and random allocation to treatment.
- NIH defined Phase III Clinical Trial - usually involving several hundred or more human subjects, designed to evaluate an experimental intervention in comparison
with a standard or control intervention or comparing two or more existing treatments. Often the aim is to provide evidence
leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes
pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy.
Community trials and other population-based intervention trials are also included.
Exploratory (Phase I, II) Trial: A Clinical Trial of a proposed intervention, which could include drugs, biologics, or devices, as well as surgical, behavioral,
or rehabilitation therapies, that contributes to the justification for and provides the data required to design a future trial
to confirm efficacy (i.e., a Phase III trial); exploratory trials are designed to generate data that inform a decision as
to whether to continue further clinical development of the proposed intervention. An exploratory trial may be designed to
assess safety/toxicity, to determine appropriate dosage or treatment parameters, to assess short-term biological activity
of a new compound, or to provide other information to assist in the decision whether to perform further development or trials
of an intervention.
Prevention: Narrowly defined, prevention research includes only that research designed to yield results directly applicable to identification
of risk, and to interventions to prevent the occurrence of disease or the progression of detectable but asymptomatic disease.