Evolution of Human Research Ethics

Apr 9, 2025

Protecting Human Subjects in Research

Overview

  • Focuses on responsibilities of health professionals in protecting human subjects in biomedical and behavioral research.
  • Series includes discussions on IRB criteria, ethical principles, and historical evolution toward current practices.

Early Concerns and Evolution

  • 1926: Paul de Kruif's "Microbe Hunters" highlights independent researchers like Louis Pasteur.
  • Shift from sole responsibility to shared oversight due to increased research complexity and subjects.
  • Growing consensus on protecting research subjects and forming ethical review committees.

Institutional Review Boards (IRBs)

  • IRBs consist of scientists and non-scientists reviewing research protocols.
  • Ensure rights and welfare of research subjects are protected.
  • Responsibility shared among clinical investigators, institutions, and government officials.

Historical Context and Key Events

  • 1900: Yellow fever experiments used informed consent forms.
  • 1946: Nuremberg Trials led to the Nuremberg Code, establishing informed consent and ethical guidelines.
  • 1953: University of Chicago recorded jury deliberations. This led to legislation prohibiting recording without consent.

Regulatory Developments

  • 1962: Kefauver-Harris amendments required informed consent in drug testing (thalidomide case).
  • 1963: Jewish Chronic Disease Hospital case highlighted ethical concerns over patient consent.
  • 1964: NIH initiated systematic protection of subjects in research.

Ethical Guidelines and Reports

  • 1966: Dr. Henry K. Beecher criticized unethical research practices in the New England Journal of Medicine.
  • 1972: Tuskegee Syphilis Study exposed lack of informed consent and sparked public outcry.
  • 1974: National Research Act established IRBs and National Commission for Protection of Human Subjects.
  • 1978: Belmont Report outlined ethical principles: respect, beneficence, and justice.

Contemporary Issues

  • Ongoing challenges in regulating research on special populations (prisoners, infants, mentally incapacitated).
  • Debate over legitimacy of behavioral research and need for further regulations.
  • Importance of IRB and researcher conscientiousness in protecting subjects and society.

These notes provide a comprehensive overview of the evolution and current practices in protecting human research subjects, highlighting significant historical events and regulatory milestones.

Full transcript