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Legal liability to volunteers in testing new drugs

W F BOWKER

    Canadian Medical Association Journal
    |April 6, 1963
    PubMed

    Insights

    Drug trial volunteers may recover damages if harmed, provided proper consent and no negligence occurred. Legal recourse depends on disclosure, consent validity, and the roles of scientists, physicians, and drug makers.

    Area of Science:

    • Medical Law
    • Clinical Trials
    • Drug Safety

    Background:

    • Drug testing involves inherent risks to volunteers.
    • Legal frameworks govern volunteer protection in clinical trials.

    Purpose of the Study:

    • To analyze Canadian legal recourse for drug trial volunteers harmed during testing.
    • To determine liability of scientists, physicians, and drug manufacturers.

    Main Methods:

    • Legal analysis of volunteer rights under Canadian law.
    • Examination of consent requirements and negligence standards.

    Main Results:

    • Scientists are protected if risks are disclosed and consent is obtained.
    • Guardian consent may not shield scientists for minors or those of unsound mind.
    • Physician and manufacturer liability depends on active negligence or misleading information.

    Conclusions:

    • Volunteer protection in drug trials hinges on informed consent and absence of negligence.
    • Specific legal protections vary based on the role of the involved parties and the nature of the harm.
    Keywords:
    DRUGSJURISPRUDENCEREFLEX

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