Informed Consent in Research & Medical Treatment- week 7 lecture

Informed Consent in Research & Medical Treatment

Why Conduct Research?

• Fundamental moral commitment to:
  • Advancing human welfare
  • Gaining knowledge and understanding
  • Examining cultural dynamics
• Tri-Council Code: Research must serve a purpose.
• Can have negative impacts; e.g., a drug for chronic symptoms potentially used as a truth serum.

Importance of Research Ethics

• Major Reasons for Research Ethics:
  1. Correct past problems and abuses.
  2. Prevent new problems and abuses.
  3. Law alone is insufficient.

Historical Context of Research Ethics

• Two Major Atrocities Leading to Current Ethics:
  1. Nazi Science:
  • Inhumane experimentation involving hypothermia induction and oxygen deprivation.
  1. Tuskegee Institute Study:
  • Conducted by Dr. T. Clark in Alabama from 1932-1972, observing untreated syphilis in 399 African American men historical significance of treating patients ethically.
  • No treatment was provided even when available; focused on disease progression until death.

The Nuremberg Code (1947)

• Key Principle: "The voluntary consent of the human subject is absolutely essential."
• Critique on following the code, particularly towards marginalized groups.

Declaration of Helsinki (1964)

• Advocated for distinction between:
  • Research aimed at treatment vs. purely scientific goals.
• Addressed conflict of interest when physicians also conduct research, emphasizing clear communication about the nature of studies.

Tri-Council Policy Statement (TPS)

• Joint commitment by three councils in Canada to ethical research involving human subjects.
• Key Point: Abiding by the TPS is necessary for public funding of research.

Ethical Principles of the Tri-Council Code

• Four Basic Principles (1997):
  1. Respect for Persons
  2. Non-Maleficence
  3. Beneficence
  4. Justice

Guiding Ethical Principles (1999)

• Principles include:
  1. Human Dignity
  2. Free and Informed Consent
  3. Vulnerable Persons
  4. Privacy and Confidentiality
  5. Justice and Inclusiveness
  6. Balancing Harms and Benefits
  7. Non-Maleficence
  8. Minimizing Harm
  9. Maximizing Benefits

Consent in Medical vs. Research Context

• Patients’ right to consent must be respected whereas researchers scrutinize consent because participation isn't guaranteed as a right.
• Researchers must determine if any coercion exists in consent.
• Consent in research can be rejected if coercion is discovered.

Coercion, Inducement, and Vulnerable Populations

• Example Cases:
  1. Inmates: May volunteer for research to receive good behavior nominations for parole.
  2. HIV Research: Researchers in areas with high infection rates often induce participation that may lead to ethical conflicts.
• Coercion: Involuntary participation due to threats or pressure.
• Inducement: Participation based on rewards; must be ethical and not induce undue risk.

Voluntariness in Consent

• Addressing coercion: Assess if participation would still occur without adverse consequences.
• Kirkwood's Case Study on Ethics:
  • Explores "No Choice" situations where lack of decent alternatives impacts true voluntariness in participation for vulnerable individuals; highlights potential ethical issues.