Glossary

Glossary
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  • Abuse-Liable
    Pharmacological substances that have the potential for creating abusive dependency. Abuse-liable substances can include both illicit drugs (e.g., heroine) and licit drugs (e.g., methamphetamines).

    Adjuvant Therapy
    Therapy provided to enhance the effect of an primary therapy; auxiliary therapy.

    Adverse Effect (from OHRP IRB Guidebook)
    An undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention (e.g., headache following spinal tap or intestinal bleeding associated with aspirin therapy).

    Adverse Drug Experience (Life-threatening, Serious, Unexpected)
    21 CFR 312.12

    Adverse Experience (Life-threatening, Serious, Unexpected)
    21 CFR 600.80

    Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA)
    Alcohol, Drug Abuse, and Mental Health Administration; reorganized in October 1992 as the Substance Abuse and Mental Health Services Administration (SAMHSA). ADAMHA included the National Institute of Mental Health (NIMH), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute on Drug Abuse (NIDA), the Office for Substance Abuse Prevention (OSAP), and the Office for Treatment Intervention (OTI). NIMH, NIAAA, and NIDA are now part of the National Institutes of Health (NIH).

    Approved with Limited Modifications (ALM)
    Refers to status of reviewed protocols. See the IRB Guidebook Section 6 for more.

    Assent
    Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research.

    Assurance
    A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved [Federal Policy §___.103].

    Authorized Institutional Official
    An officer of an institution with the authority to speak for and legally commit the institution to adherence to the requirements of the federal regulations regarding the involvement of human participants in biomedical and behavioral research.

    Autonomy
    Personal capacity to consider alternatives, make choices, and act without undue influence or interference of others.

    Autopsy
    Examination by dissection of the body of an individual to determine cause of death and other medically relevant facts.