Protecting Human Subjects of Research: An Analysis on Proposed Amendments to HEW Policy

Abstract

Editor's Note: The Department of Health, Education and Welfare has prepared amendments to regulations governing research on human subjects. The regulations were established in response to recommendations from the National Commission for the Protection of Human Subjects of Biomedicai and Behavioral Research. These regulations are implemented by the institutional review boards established by colleges, universities and research institutes. The intent of the proposed amendments is admirable: to reduce the categories of research coming under federal control and review. But specific amendments could impose restrictions and difficulties upon political scientists conducting research projects or teaching their students to conduct research.The Association's Council's concerns about the proposed regulations was expressed in this resolution passed on August 30:While endorsing the important goal of protecting human subjects of research from abuse or injury, the APSA opposes any existing or proposed regulations or procedures relating to institutional review boards that would represent a threat to academic freedom or research or freedom of speech. The Council asks the Executive Director, in cooperation with other social science associations and higher education associations to prepare and present analysts of the implications of existing and proposed research regulations for political scientists and other social scientists.Ithiel de Sola Pool has prepared the following analysis of the proposed regulations in order to inform colleagues of their possible impact. Political scientists who share his concerns are invited to write to the Executive Director of the APSA and join in forming a Committee of Concern about Institutional Review Board Practices by writing to: Ithiel de Sola Pool, 105 Irving Street, Cambridge, Massachusetts 02138.The “Proposed Regulations Amending Basic HEW Policy for Protection of Human Research Subjects” which were published in the Federal Register of Tuesday, August 14, 1979, represent a substantial improvement over previous rules and draft rules, but are still grossly improper and unconstitutional.