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  • Paternalism
    Making decisions for others against or apart from their wishes with the intent of doing them good.

    The agreement of parent(s) or guardian to the participation of their child or ward in research [45 CFR 46.402(c)].

    The scientific discipline that studies the action of drugs on living systems (animals or human beings).

    Phase 1, 2, 3, 4 Drug Trials
    Different stages of testing drugs in humans, from first application in humans (Phase 1) through limited and broad clinical tests (Phase 3), to postmarketing studies (Phase 4).

    The physical manifestation of a gene function.

    Some clinical studies compare an experimental treatment to another treatment. The non-experimental treatment is sometimes referred to as a "placebo," a word that comes from the Latin for "I shall please."

    Originally, placebos were drugs that were thought to have no medicinal effect (positive or negative). Such "drugs" were given to appease people who had physical or mental complaints of no known cause. In this context, placebos came to be known as "sugar pills."

    More recently, the word placebo has come to mean different things to different people. In the context of clinical trials, a "placebo treatment" often refers to treatment that is indistinguishable from the treatment that is under investigation. Most commonly, this would be a pill of capsule of the same size and color but containing a harmless, inactive substance.

    Participants have the right to know (a) whether they may be assigned to a placebo group and the probability of that assignment and (b) the nature of the placebo treatment.

    Portable Document Format (PDF)
    Computer file format used with programs like Adobe Acrobat and Adobe Acrobat Reader

    Possibly Related (used with Adverse Event Report)
    There is a reasonable possibility the adverse event may have been caused by the drug, device, or intervention; or it is possible that the adverse event may have been caused by the drug, device, or intervention, but there is insufficient information to determine the likelihood of this possibility.

    Postamendments Devices
    Medical devices marketed after enactment of the 1976 Medical Device Amendments.

    Preamendments Devices
    Medical devices marketed before enactment of the 1976 Medical Device Amendments.

    Preclinical Investigations
    Laboratory and animal studies designed to test the mechanisms, safety, and efficacy of an intervention prior to its applications to humans.

    Predicate Devices
    Currently legally marketed devices to which new devices may be found substantially equivalent under the 510(k) process.

    The period of time from confirmation of implantation of a fertilized egg within the uterus until the fetus has entirely left the uterus (i.e., has been delivered). Implantation is confirmed through a presumptive sign of pregnancy such as missed menses or a positive pregnancy test [45 CFR 46.203(b)]. This "confirmation" may be in error, but, for research purposes, investigators would presume that a living fetus was present until evidence to the contrary was clear. Although fertilization occurs a week or more before implantation, the current inability to detect the fertilization event or the presence of a newly fertilized egg makes a definition of pregnancy based on implantation necessary.

    Premarket Approval
    Process of scientific and regulatory review by the FDA to ensure the safety and effectiveness of Class III devices.

    President's Commission
    President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. An interdisciplinary advisory group, established by congressional legislation in 1978, which was in existence until 1983, and which issued reports on ethical problems in health care and in research involving human subjects.

    Principal Investigator
    The scientist or scholar with primary responsibility for the design and conduct of a research project. (See also: Investigator.)

    An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution [45 CFR 46.303(c)].

    Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.

    The person whose case serves as the stimulus for the study of other members of the family to identify the possible genetic factors involved in a given disease, condition, or characteristic.

    Preventive or protective; a drug, vaccine, regimen, or device designed to prevent, or provide protection against, a given disease or disorder.

    Prospective Studies
    Studies designed to observe outcomes or events that occur subsequent to the identification of the group of participants to be studied. Prospective studies need not involve manipulation or intervention but may be purely observational or involve only the collection of data.

    The formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective participants and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data.

    Public Health Service (PHS)
    Part of the U.S. Department of Health and Human Services, it includes FDA, NIH, CDC, SAMHSA, and HRSA.

    The relative absence of extraneous matter in a drug or vaccine that may or may not be harmful to the recipient or deleterious to the product.