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Related Experiment Videos

How informed is informed consent? The BHAT experience.

J M Howard, D DeMets

    Controlled Clinical Trials
    |December 1, 1981
    PubMed
    Summary
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    Most heart attack survivors in the Beta-blocker Heart Attack Trial understood the research. However, some participants believed the trial was a treatment program, with awareness linked to education, race, and age.

    Area of Science:

    • Clinical Trials
    • Bioethics
    • Cardiology

    Background:

    • The Beta-blocker Heart Attack Trial (BHAT) aimed to improve informed consent for myocardial infarction survivors.
    • Ensuring participant comprehension is crucial in clinical research ethics.

    Purpose of the Study:

    • To evaluate participant understanding of the BHAT study design, scientific rationale, and drug risks.
    • To identify factors influencing awareness of trial aspects.

    Main Methods:

    • A bioethicist conducted in-depth home interviews with a random sample of 64 BHAT participants.
    • Data collected from participants across 11 geographic areas.

    Main Results:

    • The majority of participants demonstrated good comprehension of the research.
    Keywords:
    Beta-Blocker Heart Attack Trial (BHAT)Biomedical and Behavioral ResearchEmpirical Approach

    Related Experiment Videos

  • 8% of participants mistakenly believed they were in a therapeutic program, not a research study.
  • Education, race, and age were associated with varying levels of participant awareness.

    • Conclusions:

    • While most participants were well-informed, a small percentage misunderstood the research nature of the trial.
    • Demographic factors play a role in participant comprehension of clinical trials.