PREFACE

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was established by Title II of the National Research Act (Public Law 93-348) to study the ethical principles underlying biomedical and behavioral research on human subjects and to make recommendations to the Secretary, DHEW, and to Congress, for the protection of these subjects. This report was prepared in response to a section of the Act that required the Commission to "conduct an investigation and study of the nature and extent of research involving living fetuses, the purposes for which such research has been undertaken, and alternative means for achieving such purposes" (Section 202 (b)).

This volume, Report and Recommendations: Research on the Fetus, contains the Commission's Recommendations, the underlying Deliberations and Conclusions, a dissenting statement and an additional statement by Commission members, and summaries of materials presented to the Commission. An appendix volume contains the complete texts of reports and papers prepared for the Commission on the ethical, legal and medical aspects of research on the fetus and other material reviewed by the Commission in its deliberations.

THE MANDATE

The National Research Act (P.L. 93-348) established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and gave the Commission a mandate to investigate and study research involving the living fetus, and to recommend whether and under what circumstances such research should be conducted or supported by the Department of Health, Education, and Welfare. A deadline of four months after the members of the Commission took office was imposed for the Commission to conduct its study and make recommendations to the Secretary, DHEW. The priority assigned by Congress to research involving the fetus indicates the concern that unconscionable acts involving the fetus may have been performed in the name of scientific inquiry, with only proxy consent on behalf of the fetus.

The members of the Commission determined at the outset to undertake a careful study of the nature and extent of research on the fetus, the range of views on the ethical acceptability of such research, and the legal issues involved, prior to formulating their recommendations. To this end, the Commission has accumulated an extensive body of information, held public hearings, questioned a panel of distinguished ethicists, and conducted lengthy deliberations. In the course of these activities, the Commission has given close scrutiny to many important questions that surround research on the fetus, for example: What are the purposes of research on the fetus? What procedures have been employed in such research? Are there alternatives to such research? Can appropriate consent to such research be obtained by proxy? Under what conditions may research be done on a fetus that is to be aborted, or a nonviable delivered fetus? What review of proposed research should be required?

In the remainder of Section I, the background and activities of the Commission are summarized, and the definitions used in this report are set forth. Reports, papers and testimony that were prepared for or presented to the Commission are summarized in Sections II to VII of this report. The Commission's own