1. Beyond Regulations: Ethical Considerations in Research
HRPP 201
March 2009
Beyond Regulations: Ethical Considerations in Research
Presented by:
Marisue Cody, PhD
Deputy Director, PRIDE
Beyond Regulations: Ethics in Human Subject Research

2. HRPP 201
March 2009
Objectives
Describe the ethical underpinnings of human subjects protection
Discuss how regulations do not address all concerns regarding human subjects protection
Beyond Regulations: Ethics in Human Subject Research

3. Timeline of historical events
HRPP 201
March 2009
Timeline of historical events
Beyond Regulations: Ethics in Human Subject Research

4. HRPP 201
March 2009
Nazi experiments
Used unconsenting concentration camp victims as subjects and subjected them to great pain, suffering, disfigurement, and death
These were not therapeutic trials.
Beyond Regulations: Ethics in Human Subject Research

5. HRPP 201
March 2009
The Nuremberg Code
Set of ethical principles developed by U.S. military tribunal post WWII (1949)
Consent
Right to withdraw
Weighing of risks and benefits
Beyond Regulations: Ethics in Human Subject Research

6. HRPP 201
March 2009
Thalidomide tragedy
Use in pregnant women resulted in thousands of babies born with digits or limbs
Lead to 1962 Drug Amendments Act – prove efficacy not just safety
Beyond Regulations: Ethics in Human Subject Research

7. The Declaration of Helsinki
HRPP 201
March 2009
The Declaration of Helsinki
Issued by the World Medical Association (1964, amended 5x, 2000 most recent)
Well-being of the human subject should take precedence over the interests of science and society
Physician’s responsibility is to safeguard the health of the people
Medical research should be subject to review, approval, and oversight of an independent ethics committee
Beyond Regulations: Ethics in Human Subject Research

8. Studies identified by Henry Beecher
HRPP 201
March 2009
Studies identified by Henry Beecher
NEJM 1966 – review of 22 unethical published studies including:
Jewish Chronic Disease Hospital case: injected live cancer cells into patients without informing them
Willowbrook case: injected isolated strains of hepatitis into institutionalized mentally retarded children to understand the natural history of the disease and effects of gamma globulin
Beyond Regulations: Ethics in Human Subject Research

9. U.S. PHS syphilis study at Tuskegee
HRPP 201
March 2009
U.S. PHS syphilis study at Tuskegee
40-year research study designed to gain an understanding of the natural history of untreated latent syphilis
During course of study, penicillin was identified to be effective treatment but subjects denied access to treatment
Beyond Regulations: Ethics in Human Subject Research

10. National Research Act Mandated regulations to protect human subjects
HRPP 201
March 2009
National Research Act
Mandated regulations to protect human subjects
Created National Commission to examine ethical issues
Beyond Regulations: Ethics in Human Subject Research

11. The Belmont Report National Commission 1979:
HRPP 201
March 2009
The Belmont Report
National Commission 1979:
Respect for persons, operationalized by obtaining informed consent
Beneficence, minimizing possible harms and maximizing possible benefits
Justice, fair or equitable selection of subjects
Beyond Regulations: Ethics in Human Subject Research

12. Guideline for GCP from ICH (1996)
HRPP 201
March 2009
Guideline for GCP from ICH (1996)
Joint effort of the European Union, Japan, and the U.S. to develop a common approach to research leading to approval of new drugs
Beyond Regulations: Ethics in Human Subject Research

13. HRPPP (Human Research Participant Protection Programs)
March 2009
HRPPP (Human Research Participant Protection Programs)
Institute of Medicine report 2001
Preserving the Public Trust
Broader system with multiple functional elements
Advocated accreditation of the HRPPP
Beyond Regulations: Ethics in Human Subject Research

14. Ethics Cases HRPP 201 March 2009
Beyond Regulations: Ethics in Human Subject Research

15. HRPP 201
March 2009
QUESTIONS
Beyond Regulations: Ethics in Human Subject Research