Comment on Pool' Analysis

Extract

In the Fall 1979 issue of PS, Ithiel Pool presented an analysis of the recently-proposed HEW regulations on the protection of human subjects of behavioral and biomedical research. He expressed three major criticisms of the proposals. The first is that the draft regulations “extend federal authority … to policing some practices in private research which should in a free society be guided by private research which should in a free society be guided by private and professional decisions.” Second, he objects to the proposal that Institutional Review Boards (hereinafter “IRB's”) should determine that “the research methods are appropriate to the objectives of the research and the field of study.” Finally, he argues that the proposed regulations are an unconstitutional prior restraint on free speech.

We have serious reservations about all three of Pool's arguments, most particularly the third. We are concerned that the issues raised be seriously considered and widely discussed in the profession, especially given the quasi-official way in which Pool's statement was presented in PS (see the Editor's Note, p. 452) as well as the fact that it was announced in December 1979 (in IRB: A Review of Human Subjects Research) that a committee of social scientists headed by Pool has “challenged the constitutionality of the DHEW proposed regulations.” (The article listed such notables as Gabriel Almond, George Homans and Charles Lindblom as “among the more than forty prospective members of the Committee,” p. 7).