The Belmont Report draws on a fundamental belief about what persons are in order to state how they ought to be treated. Human beings are autonomous, i.e., they are capable of self-determination by comprehending information and making considered judgments based on their own preferences. In ordinary life, this leads to the ethical principle that human beings should be respected by being given maximum freedom to make their own choices. In research, this same principle recognizes research participation as elective and that research subjects, with full information and comprehension, make a voluntary choice to participate. Voluntariness must be maintained; i.e., subjects are free to withdraw at any time. Informed consent includes all the processes leading up to and maintaining the voluntariness of the choice to participate in research, both before and during the research. It is not just the signed consent form or even the act of signing it.
Persons' abilities to receive and comprehend information, relate it to their own preferences, and then make a decision are sometimes limited. Their own immaturity or disability can limit free choice. So also can some feature of the environment in which the consent process takes place. Respect for persons requires that we protect from harm those whose self-determination is diminished. At the extreme, it may require overriding the individual's judgment in order to do what is in that person's best interests. Still, the first duty of respect is to honor the autonomy of persons. Research with older subjects can test the richness of this principle as an analytical framework. Some older adults are well able to make their own decisions; others may require accommodation or assistance in making decisions; and some cannot make their own decisions even with assistance. We will return to this topic. There are other implications to respect for autonomy. The duty to protect confidentiality has its roots not just in agreements made but in respect for persons; controlling disclosure of intimate knowledge concerning oneself is a way of preserving one's own autonomy.
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