Glossary

Glossary
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  • In Vitro
    Literally, "in glass"; used to refer to processes that are carried out outside the living body, usually in the laboratory, as distinguished from in vivo.

    In Vivo
    Literally, "in the living body;" processes, such as the absorption of a drug by the human body, carried out in the living body rather than in a laboratory (in vitro).

    Independent Variables
    The conditions of an experiment that are systematically manipulated by the investigator.

    Informed Consent
    A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, participants may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence [Federal Policy §116; 21 CFR 50.20 and 50.25].

    Institution (1)
    Any public or private entity or agency (including federal, state, and local agencies) [Federal Policy §___.102(b)].

    Institution (2)
    A residential facility that provides food, shelter, and professional services (including treatment, skilled nursing, intermediate or long-term care, and custodial or residential care). Examples include general, mental, or chronic disease hospitals; inpatient community mental health centers; halfway houses and nursing homes; alcohol and drug addiction treatment centers; homes for the aged or dependent, residential schools for the mentally or physically handicapped; and homes for dependent and neglected children.

    Institutional Review Board for Human Use (IRB)
    A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research [Federal Policy §§___.102(g), ___.108, ___.109].

    Institutionalized
    Confined, either voluntarily or involuntarily (e.g., a hospital, prison, or nursing home).

    Institutionalized Cognitively Impaired
    Persons who are confined, either voluntarily or involuntarily, in a facility for the care of the mentally or otherwise disabled (e.g., a psychiatric hospital, home, or school for the retarded).

    Investigational Device Exemption (IDE)
    Exemption from certain regulations found in the Medical Device Amendments that allow shipment of unapproved devices for use in clinical investigations [21 CFR 812.20].

    Investigational New Drug (IND)
    A drug permitted by FDA to be tested in humans but not yet determined to be safe and effective for a particular use in the general population and not yet licensed for marketing.

    Investigator
    In clinical trials, an individual who actually conducts an investigation [21 CFR 312.3]. Any interventions (e.g., drugs) involved in the study are administered to participants under the immediate direction of the investigator. (See also: Principal Investigator.)