Glossary

Glossary
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  • Emancipated Minor
    A legal status conferred upon persons who have not yet attained the age of legal competency as defined by state law (for such purposes as consenting to medical care), but who are entitled to treatment as if they had by virtue of assuming adult responsibilities such as being self-supporting and not living at home, marriage, or procreation. (See also: Mature Minor.)

    Embryo
    Early stages of a developing organism, broadly used to refer to stages immediately following fertilization of an egg through implantation and very early pregnancy (i.e., from conception to the eighth week of pregnancy). (See also: Fetus.)

    Epidemiology
    A scientific discipline that studies the factors determining the causes, frequency, and distribution of diseases in a community or given population.

    Equitable
    Fair or just; used in the context of selection of participants to indicate that the benefits and burdens of research are fairly distributed [Federal Policy §___.111(a)(3)].

    Ethics Advisory Board
    An interdisciplinary group that advises the Secretary, HHS, on general policy matters and on research proposals (or classes of proposals) that pose ethical problems.

    Ethnographic Research
    Ethnography is the study of people and their culture. Ethnographic research, also called fieldwork, involves observation of and interaction with the persons or group being studied in the group's own environment, often for long periods of time. (See also: Fieldwork.)

    Expanded Availability
    Policy and procedure that permits individuals who have serious or life-threatening diseases for which there are no alternative therapies to have access to investigational drugs and devices that may be beneficial to them. Examples of expanded availability mechanisms include Treatment INDs, Parallel Track, and open study protocols.

    Expedited Review
    Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research [Federal Policy §___.110].

    Experimental
    Term often used to denote a therapy (drug, device, procedure) that is unproven or not yet scientifically validated with respect to safety and efficacy. A procedure may be considered "experimental" without necessarily being part of a formal study (research) to evaluate its usefulness. (See also: Research.)

    Experimental Study
    A true experimental study is one in which participants are randomly assigned to groups that experience carefully controlled interventions manipulated by the experimenter according to a strict logic allowing causal inference about the effects of the interventions under investigation. (See also: Quasi-Experimental Study).