The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research ended its work by substantially endorsing the status quo which places primary reliance on local Institutional Review Boards for subject protection. This was predictable because of the Commission's researcher-dominated composition which permitted it to assume that (1) research is good; (2) experimentation is almost never harmful to subjects, and (3) researcher-dominated IRBs can adequately protect the interests of human subjects. The successor Presidential Commission can learn much by re-examining these premises.

At the outset of his “Report on the National Commission,” Professor Annas quotes a satire on federal commissions. He then hastens to add that the quoted passage is an unfair and untrue characterization of the National Commission for the Protection of Human Subjects. This could be said of Annas' entire article. His central theme — that the Commission was biased in favor of research — is supported by poor evidence, and contrary evidence is neglected. For an accurate description of the Commission and its work, readers must turn elsewhere. We would suggest starting with the Commission's own reports, which include detailed explanations of the bases for its recommendations as well as the data that were considered by the Commission in arriving at the recommendations.

During the last half of 1980, health systems agencies (HSAs) throughout the country will be conducting appropriateness reviews for the first time. For many HSAs, this will be their initial venture into reviewing existing institutional health services, as distinguished from their reviews of proposed capital expenditures and new institutional health services under the authority of Section 1122 of the Social Security Act or state certificate of need (CON) laws. The scope, content, and effect of appropriateness reviews present numerous areas of uncertainty, some of which this article will examine.

Appropriateness review was enacted originally as part of the National Health Planning and Resources Development Act of 1974 (the “Act”). It was a compromise. The concept originated among health planners who were dissatisfied with their inability to initiate changes in the health care delivery system. This weakness resulted from their essentially reactive posture in reviewing new projects proposed by existing facilities.