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Related Experiment Videos

Informed consent by proxy. An issue in research with elderly patients.

J W Warren, J Sobal, J H Tenney

    The New England Journal of Medicine
    |October 30, 1986
    PubMed
    Summary

    Proxy consent for nursing home research is crucial. Nearly half of proxies refused participation for elderly patients, highlighting a significant barrier to clinical studies in this growing population.

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    Area of Science:

    • Gerontology
    • Clinical Research Ethics
    • Health Services Research

    Background:

    • The elderly population in nursing homes is increasing, necessitating clinical studies.
    • Mentally incompetent patients cannot provide informed consent, requiring proxy decision-making.
    • Proxy consent is essential for conducting research in nursing home settings.

    Purpose of the Study:

    • To investigate proxy decision-making for nursing home patient participation in minimal-risk clinical studies.
    • To identify factors influencing proxy consent or refusal for elderly patients in research.

    Main Methods:

    • A study involving 168 nursing home patients and their proxies (primarily family members).
    • Proxies decided whether patients could participate in a minimal-risk study.

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  • Statistical analysis was used to identify associations with refusal.

    • Main Results:

    • 46% of proxies refused consent for patient participation.
    • Refusal was linked to beliefs about nursing home research, patient disturbance, and proxy's own willingness to participate.
    • Even when proxies believed patients would refuse, 31% still gave consent.

    Conclusions:

    • Proxy refusal represents a significant obstacle to conducting research with elderly, incompetent nursing home residents.
    • Further research is needed to understand proxy selection and decision-making criteria.
    • Addressing proxy concerns may facilitate essential clinical research in this demographic.