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

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.