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Ethical principles and informed consent: an NIMH perspective

D Shore1

  • 1Division of Clinical and Treatment Research, National Institute of Mental Health, Rockville, MD 20857, USA.

Psychopharmacology Bulletin
|January 1, 1996
PubMed
Summary

Ensuring state-of-the-art informed consent is crucial for advancing clinical research, especially for severe mental disorders. Updated procedures and subject education are vital for ethical and effective scientific progress.

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Area of Science:

  • Clinical Research Ethics
  • Mental Health Research
  • Informed Consent

Background:

  • Current informed consent procedures and documents may not meet contemporary standards.
  • Effective informed consent is essential for the ethical conduct of clinical research.
  • Protecting human subjects, particularly those with severe mental disorders, is paramount.

Purpose of the Study:

  • To emphasize the need for updated informed consent processes in clinical research.
  • To highlight the importance of educating researchers and participants on informed consent.
  • To advocate for continued clinical research involving individuals with mental disorders.

Main Methods:

  • Review of current standards and practices in informed consent.
  • Identification of available resources for improving informed consent education.

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  • Discussion of the necessity of research on competency and understanding in the consent process.

    • Main Results:

    • Existing consent procedures may be outdated and require modernization.
    • Numerous resources exist to support informed consent education for all stakeholders.
    • Further research is needed to bridge the gap between explained and understood information in consent.

    Conclusions:

    • Clinical researchers must update consent procedures to be state-of-the-art.
    • Enhanced education and resources are available to improve informed consent practices.
    • Prohibiting competent individuals with mental disorders from research participation is detrimental to scientific advancement and treatment improvement.