I. United States v. Karl Brandt (Nuremberg Code)
II. Belmont Report--National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research--Guidelines
A. Boundaries Between Practice and Research
B. Ethical Principles
1. Respect for Persons
subjects as autonomous agents
2. Beneficence
"do not harm"
"maximize possible benefits and minimize possible harms"
3. Justice
fairness regarding the benefits and burdens of the research
C. Applications
1. Informed Consent
information
comprehension
voluntariness
no coersion--threat of harm
no undue influence--improper reward
2. Assessment of Risk and Benefits
(anticipated benefit to Ss/society>risk to Ss)
3. Selection of Subjects