ETHICAL RESEARCH WITH THE DEVELOPMENTALLY DISABLED

The developmentally disabled constitute a vulnerable population in the context of nontherapeutic experimentation. Their vulnerability is cha racterized by diminished decision-making capacity and by susceptibilit y to coercive situations that may bring voluntariness into question. T he international consensus is that research involving this population should be permitted, but only if the consent of a legal guardian is ob tained and appropriate safeguards are introduced. Therefore, legislati on regulating the ethical conduct of research should be enacted includ ing provision for substituted consent in the research context. Althoug h researchers seeking the participation of a developmentally disabled individual in a protocol must presume the person to be capable of part icipating in the decision, they must conduct competency assessments if the person's ability to make such a decision is in doubt. Information must be presented in such a way as to maximize the individual's contr ibution, and capacity must be reevaluated on an ongoing basis. In addi tion, research on the developmentally disabled presents specific chall enges to establish competency, the selection of subjects, the characte ristics of the decision maker, and the model to be used in making subs tituted decisions.