The Nuremberg Trials (1945-1946) - ANSWERSDeveloped into:
Nuremberg Code
• Ethical conduct of medical experimentation
1. Requirements for informed consent,
voluntary
2. Benefits to society
3. Avoid Risk
4. Scientifically Qualified
The Declaration of Helsinki - ANSWERSJune of 1964 - revised six times •
Built upon the Nuremberg Code •
Recommendations:
- Research with humans should be based on laboratory & animal experimentation
- Research should be conducted by medically/scientifically qualified individuals
- Risks should not exceed benefits
• 1975:
- independent review of protocols & provided requirements for informed consent
The Syphilis Study at Tuskegee (1932-1972) - ANSWERSDeveloped into:
Regulatory Guidance
• National Research Act 1974
- Commission for the Protection of Human Subjects of Biomedical & Behavioral Research.
- Identify the basic ethical principles that should underlie the conduct of biomedical and behavioral
research involving human subjects
, Belmont Report (1979) - ANSWERSInfluenced by Nuremberg Code & Declaration of Helsinki
• Based on three ethical principles
Three Ethical Principles - ANSWERS1. Respect for persons
- Individuals should be treated as autonomous agents
- Persons with diminished autonomy are entitled to protection
2. Beneficence
- Human Subjects should not be harmed
- Research should maximize possible benefits & minimize possible harm
Assessment of risks and benefits
- The nature and scope of risks and benefits must be assessed in a systematic manner
3. Justice
- The benefits and risks of research must be distributed fairly
Selection of Subjects
- There must be fair procedures and outcomes in the selection of research subject
Informed Consent - ANSWERSSubjects, to the degree that they are capable, must be given the
opportunity to choose what shall or shall not happen to them
- The consent process must include three elements:
• Information • Comprehension • Voluntariness
The Common Rule - ANSWERSAssuring compliance by research institutions
• Requirements for the obtaining and documenting of informed consent
• Requirements for IRB • Protections for vulnerable subjects
45 CFR 46 - Basic DHHS Policy for the Protection of Human Research Subjects
Office of Human Research Protection (OHRP) - ANSWERSentity within the Department of Health and
Human Services (DHHS) in charge of implementing the regulations.
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