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Related Experiment Videos

Understanding informed consent.

R Macklin1

  • 1Department of Epidemiology and Social Medicine, Albert Einstein College of Medicine, the Bronx, New York 10461, USA.

Acta Oncologica (Stockholm, Sweden)
|March 25, 1999
PubMed
Summary
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Bioethics·2002

Informed consent is a vital communication process between researchers and subjects, documented by consent forms. Ensuring true voluntariness and clarity in research ethics remains a challenge.

Area of Science:

  • Bioethics
  • Research Ethics
  • Clinical Research

Background:

  • Informed consent is a cornerstone of ethical research, serving as a communication process between researchers and subjects.
  • The informed consent form documents this crucial discussion.
  • International research ethics codes emphasize the importance of informed consent.

Purpose of the Study:

  • To review the role of informed consent in international research ethics.
  • To discuss historical violations of informed consent.
  • To explore ongoing challenges and unanswered questions in the informed consent process.

Main Methods:

  • Review of leading international codes of research ethics.
  • Discussion of prominent historical violations of informed consent.
Keywords:
Biomedical and Behavioral Research

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  • Analysis of persistent issues in informed consent procedures.

    • Main Results:

    • Informed consent, even when understood, presents challenges regarding information disclosure and ensuring voluntariness.
    • The 'therapeutic misconception,' where subjects believe research is beneficial treatment, is a significant problem.
    • Complexity of technical language in consent forms is a remediable issue.

    Conclusions:

    • Effective informed consent requires clear communication and addressing issues like therapeutic misconception.
    • Simplifying technical language in consent forms can improve subject understanding.
    • Ongoing vigilance and ethical consideration are necessary to uphold informed consent principles in research.