Protection of participants and experimental design in clinical abuse liability testing.

The protection of participants in clinical abuse liability testing requires adherence to the basic practices of respect for persons, beneficence and justice. Informed consent procedures must ensure protection of confidentiality, specification of potential risk and benefits, and careful explanation of the nature of the research project and the procedures of the study. All participants should be assured that their participation is voluntary, and that they may freely decline or withdraw from the study. The selection of subjects for participation in clinical abuse liability testing should involve consideration of social and behavioral factors which may co-vary with risk for substance abuse. Protection of participants also involves attempts to achieve excellence in the design and conduct of the research in order to enhance the contribution of such studies to science and humanity.