Notes on Human Subject Protection in Biomedical and Behavioral Research

Overview

• Series of videotapes for health professionals on responsibilities for protecting human subjects in research.
• Programs cover:
  • Criteria used by Institutional Review Boards (IRBs) for research review.
  • Application of basic ethical principles.

Historical Context

• 1926: Paul Dick Rife's Microbe Hunters discusses early researchers like Louis Pasteur and Walter Reed.
• Transition from individual researchers to large-scale research by mid-20th century.
• Increased complexity in research raised concerns about protecting subjects from risks.

Evolution of Ethical Concerns

• Independent committees of researchers formed to review proposed ethical research.
• Acknowledgment that human subject protection is a shared responsibility among:
  • Clinical investigators
  • Institutions
  • Government officials
  • IRBs

Early Consent Forms

• 1900: Consent form used in Walter Reed's yellow fever experiments indicates early ethical practices.
• Ethical concerns rooted in the principle of "do no harm" attributed to Hippocrates.

Key Historical Events

1. Nuremberg Trials (1946): Medical professionals from Nazi Germany prosecuted for unethical experiments; led to the Nuremberg Code.

   • First internationally recognized medical research ethics code.
   • Key principles include:
     • Voluntary informed consent is mandatory.
     • Experiments should avoid unnecessary suffering.
     • Researchers must be qualified professionals.
     • Subjects can withdraw anytime.

2. Wichita Jury Study (1950s): Ethical issues regarding recording jury deliberations without consent.

   • Resulted in laws protecting juror privacy.

3. Thalidomide Incident (1962): Drug caused birth defects; led to amendments requiring informed consent and transparency about experimental drugs.

4. Sloan-Kettering Incident (1963): Injecting cancer cells into patients without informing them. Public outcry led to criticism of trust between patients and researchers.

5. Public Health Service Syphilis Study (Tuskegee Study, 1932-1972): Followed untreated syphilis in Black men without consent or treatment. Resulted in hearings and the National Research Act (1974) creating IRBs and the National Commission for the Protection of Human Subjects.

The Belmont Report (1978)

• Issued by the National Commission summarizing basic ethical principles:
  • Respect for Persons: Informed consent without coercion.
  • Beneficence: Maximize benefits while minimizing harms.
  • Justice: Fair distribution of research risks and benefits.
• Discusses application of principles to informed consent and subject selection.

Ongoing Concerns

• Uneasy balance in research ethics continues to provoke study and debate:
  • Special populations (prisoners, infants, mentally incapacitated) face unique ethical considerations.
  • Ongoing dialogue regarding legitimacy of various behavioral research methods.
  • Continuous need for refining IRB processes and regulations.

Conclusion

• The improvement of human subject protections is an ongoing effort. The conscientiousness of IRBs and researchers is crucial for ensuring safety and ethical treatment in research.