PRINCIPLISM AND THE ETHICAL APPRAISAL OF CLINICAL-TRIALS

For nearly two decades, the process of reviewing the ethical merit of research involving human subjects has been based on the application of principles initially described in the U.S. National Commission's Belm ont Report, and later articulated more fully by Beauchamp and Childres s in their Principles of Biomedical Ethics. Recently, the use of ethic al principles for deliberating about moral problems in medicine and re search, referred to in the pejorative sense as ''principlism'' has com e under scrutiny. rn this paper we argue that these principles can pro vide a foundation for the source of ethical appraisal of human researc h, but are not themselves wholly adequate for this purpose. Therefore, we further propose that (1) principles should be understood as heuris tics that can be ''specified'' as described by DeGrazia (1992), and (2 ) that the principle-based approach should be supplemented by formally incorporating ''sensitivity to context'' into the evaluation of clini cal trials.