Answer to Question 1
TRUE
Answer to Question 2
The horrific and senseless nature of German experiments on prisoners prompted the development of the Nuremberg Code (1947), which established directives for experimentation with human subjects. This code specifies that voluntary consent is absolutely essential for clinical research. Consent must not be coerced, and participants should know the nature, duration, and purpose of the research, together with its methods and means and all inconveniences and hazards that could be reasonably expected as a result of participation. The experiment must be conducted by qualified individuals, and the participant must be allowed to discontinue participation at any time.
A second document developed as a result of Nazi atrocities is the Declaration of Helsinki, first adopted by the World Medical Assembly in 1964 and reaffirmed on subsequent occasions. This document also sets forth basic guidelines for the conduct of research, including the need for clearly formulated experimental procedures, a careful assessment of risks compared with benefits, and the provision of adequate information to the participants including the aims, methods, benefits and risks, and the freedom to withdraw. It is important to note that the Declaration of Helsinki does not specifically state how these principles are to be implemented; that is left to federal, state, and local governments and professional organizations.
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