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Compensating persons injured in human experimentation.

C C Havighurst

    Science (New York, N.Y.)
    |July 10, 1970
    PubMed
    Summary

    Ethical research requires financial protection for subjects, not just informed consent. New mechanisms for compensation and insurance are needed to safeguard participants in clinical research.

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    Area of Science:

    • Bioethics
    • Clinical Research Ethics
    • Research Subject Protection

    Background:

    • Current ethical guidelines for research primarily focus on informed consent and supervision.
    • Historically, research subjects have lacked adequate financial protection, relying on institutional goodwill or unclear legal recourse.
    • Existing regulatory bodies have not fully ensured conditions for clinical research that adequately protect subject rights.

    Purpose of the Study:

    • To assert the ethical imperative for investigators to provide financial protection to research subjects.
    • To highlight the inadequacy of current mechanisms for compensating injured research subjects.
    • To call for the development of new systems for insurance or indemnification for research participants.

    Main Methods:

    • Ethical analysis of research subject protection.
    • Review of historical practices in research subject compensation.
    • Identification of gaps in current regulatory frameworks.

    Main Results:

    • Ethical principles extend beyond informed consent to include financial protection for research subjects.
    • The absence of established mechanisms has led to insufficient financial safeguards for participants.
    • Research institutions, sponsors, and regulatory agencies share responsibility for implementing protection.

    Conclusions:

    • Financial protection for research subjects is an ethical requirement for investigators.
    • Development of insurance or indemnification mechanisms by research institutions and sponsors is crucial.
    • Urgent study is needed to implement compensation arrangements for injured research subjects, with regulatory bodies needing to fulfill their responsibilities.

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