A principal element of Informed Consent is the statement of purpose of the research. In most cases it is possible to be completely open and forthright about this. In a few circumstances, however, including both medical and behavioral science research, a full knowledge of the research will affect the responses the human subjects provide. In these circumstances the researcher and the IRB must determine what constitutes an appropriate respect for the autonomous decision-making authority of the subject.
It is also true that the activities of the researcher will have an effect on research results. Accordingly, the research community has developed ways to insure against either the subject or the researcher having undesired effects on the results. Blind, double-blind, placebo and control parameters are often implemented. It is usually possible to make a full disclosure of the purposes of research when these additional controls are necessary. When this is not the case, as in certain kinds of behavioral research, it is important that the research and the IRB have done their best to respect individual autonomy, to have weighed the risks and benefits accurately, and to have insured that a fair burden is placed on classes and groups of persons.
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