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Informed Consent Forms for Research with Human Subjects: Time to End the Charade.

Leonard H Glantz1

  • 1Boston University School of Public Health, Boston, MA, USA.

American Journal of Law & Medicine
|March 24, 2025
PubMed
Summary

Informed consent forms are crucial for protecting human research subjects. Decades of experience highlight the importance of carefully crafted consent documents in ethical research practices.

Keywords:
bioethicsconsent formshuman subject researchinformed consent

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Area of Science:

  • Bioethics
  • Human Subject Protection
  • Legal Aspects of Research

Background:

  • Established in 1974, the Center for Law and Health Sciences provided legal background papers on informed consent to the National Commission for the Protection of Human Subjects.
  • These papers, authored by George J. Annas, Barbara F. Katz, and the narrator, were foundational in human research ethics.
  • The author's fifty-year career includes extensive involvement with Institutional Review Boards (IRBs) and the FDA's Pediatric Research Advisory Board, focusing on human subject protection.

Purpose of the Study:

  • To reflect on the evolution of human research ethics and the role of informed consent.
  • To examine the complexities of protecting the rights and welfare of research subjects.
  • To critically evaluate the effectiveness of consent forms in ensuring thorough subject information.

Main Methods:

  • Review of legal background papers on informed consent provided to the National Commission.
  • Analysis of the book "Informed Consent to Human Experimentation: The Subject's Dilemma."
  • Personal reflection on fifty years of experience with IRBs and human subject protection activities.

Main Results:

  • The initial project provided critical legal background for the National Commission.
  • The author's extensive experience led to a long-held assumption about the efficacy of consent forms.
  • Significant time was dedicated by IRB members to reviewing and debating the precise wording of consent forms.

Conclusions:

  • The author's early work contributed to the foundational understanding of informed consent in research.
  • Fifty years of practice highlight the central role of Institutional Review Boards and regulatory bodies in human subject protection.
  • There is an ongoing need to ensure that consent forms effectively inform subjects about research aspects.