Definitions of Research Compliance Terms

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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.)

Equitable – Fair or just, used in the context of selection of subjects to indicate that the benefits and burdens of research are fairly distributed.

Exemptions – Federal code permits some research activities that are less than minimal risk and that fall into any of six federally mandated categories to be exempted from continuing review of the IRB. The PI must still submit an application to the Office of Research Compliance for exemption certification.

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 a designated reviewer rather than by the entire IRB. Federal rules permit expedited review for certain types of minimal risk research.

Experimental – Term often used to denote a therapy (drug, device, procedure, etc.) that is unproven or scientifically unvalidated 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.

Experimental Study – A true experimental study is one in which subjects 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).