ABSTRACT

Federal regulations to protect human subjects contain an implicit model of the research process. The definition of a subject, of the relationship between subject and experimenter, of what risk is and when it occurs, and what potential benefits might be, are clear, even when they are not clearly spelled out. Experimental subjects are characterized by a relative deficiency of power within the research situation: they are subject to the control of the investigator. No matter how humane the experimenters and how responsible their treatment of subjects, the basic interest is the process under study, with people conceptualised primarily as vehicles for, or carriers of, this process. A more serious possibility occurs at a later date when the research data are made available to a larger public. Human subject regulations are designed to guard subjects from risks which occur during the interaction between subject and experimenter, rather than risks which occur at a later date.