ABSTRACT
One of the most important achievements of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was to begin the process of correcting the conceptual and semantic errors that had undermined virtually all previous attempts to develop rational public policy on research involving human subjects. The Commission developed satisfactory definitions of research and practice; abandoned the distinction between therapeutic and nontherapeutic research; clarified the concept of risk; and identified the different purposes of informed consent and the consent form. The term "mere inconvenience" is used in Recommendation in the Commission's report on prisoners. The Commission concludes that when research is designed to evaluate a practice, the entire activity—research and practice components—should be reviewed by an Institutional Review Boards. In the 1975 revision of this Declaration, "medical research combined with professional care" is designated "clinical research," while "nontherapeutic biomedical research involving human subjects" is designated "non-clinical biomedical research".
