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Ethical, professional, federal, and campus guidelines for human subject research all require voluntary participation of subjects. The Nuremberg Code, developed by the International Military Tribunal that tried Nazi physicians for the "experiments" they performed on non-consenting inmates of concentration camps, was the first widely recognized document to deal explicitly with the issue of voluntary and informed consent. The first principle of the code states:
The voluntary consent of the human subject is absolutely essential. This means that the person involved should:
This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the:
The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
Therefore, each subject must give her or his agreement to participate in the research based upon adequate knowledge and understanding of relevant information, under circumstances that minimize the possibilities of coercion or undue influence.
Information about the research or what they should expect if they participate should not be withheld, especially if withholding it would influence a reasonable person's decision to participate or would damage his or her subsequent self-esteem. Information about risks shall never be withheld for the purpose of eliciting cooperation, and truthful answers should always be given to questions about the research. Certain groups, such as the economically disadvantaged, the very sick, and the institutionalized, may have compromised autonomy and should be protected against danger of being involved in research solely for administrative convenience or because they can be relatively easily manipulated. No coercion, explicit or implicit, should be used to obtain or maintain cooperation. Subjects must feel completely free to decline to participate and to withdraw their participation at any time. As established by the National Commission for the Protection of Human Subjects and documented in the Belmont Report:
Unjustifiable pressures usually occur when persons in positions of authority or commanding influence -- especially where possible sanctions are involved -- urge a course of action for a subject. A continuum of such influencing factors exists, however, and it is impossible to state precisely where justifiable persuasion ends and undue influence begins. But undue influence would include actions such as manipulating a person's choice through the controlling influence of a close relative and threatening to withdraw health services to which an individual would otherwise be entitled.