Policies and Regulations

While it is generally agreed that institutions are ultimately responsible for the regulation of all forms of experimentation carried out within their jurisdiction, there is no consensus regarding how—or even whether—autoexperimentation should be regulated. The Nuremberg Code tacitly encourages autoexperimentation through the provisions of Article 5: Perilous human experimentation is prohibited "except, perhaps, in those experiments where the experimental physicians also serve as subjects" (Germany [Territory Under Allied Occupation]). The World Medical Association's Declaration of Helsinki does not address autoexperi-mentation directly, but does say that responsibility for the subject always rests with a "medically qualified person," never on the subject (p. 15—16), and that, when the subject is in a dependent relationship with the researcher, informed consent should be obtained by a physician who is not engaged in the investigation and is "completely independent" of the relationship (p. 16). The U.S. National Institutes of Health promulgated a code for self-experimentation "to provide the same safeguards for physician—subjects as for the normal volunteer" (Altman). The Office for Protection of Research Risks of the U.S. Department of Health and Human Services has ruled that autoexperimentation is subject to the same regulations as other human research, including review by institutional review boards (IRB).

Some institutional ethics codes and policies now advise against or even prohibit autoexperimentation, even when it takes the form of "group" autoexperimentation, and involves residents, students, or employees. The IRB Guidebook issued by the Office for Human Research Protections of the U.S. Department of Health and Human Services suggests advertising for subjects, rather than recruiting students directly, and notes that some universities prohibit or severely restrict student participation. The research ethics policy of Massachusetts General Hospital is more stern: "Studies of volunteers in the investigator's own department or who are the investigator's students should be avoided and will usually be disapproved by the Human Research Committee because of the subtle coercive factors that could be present in even the most harmonious situations." The University of Maryland Baltimore County requires IRB approval to enroll students and employees.

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