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