The Changing Moral Focus of Newborn Screening: An Ethical Analysis by the President's Council on Bioethics

Preface

The Changing Moral Focus of Newborn Screening is a white paper of the President's Council on Bioethics. The Council was established on November 28, 2001, to advise the President on bioethical issues related to advances in biomedical science and technology. In connection with its advisory role, the Council undertakes fundamental inquiry into the human and moral significance of developments in biomedical and behavioral science and technology, with the aim of fostering greater understanding and public discussion of bioethical issues.

The subject of this white paper is a type of genetic screening that is widely practiced in the United States—and yet little understood, especially by the parents of the nearly four million newborns who are screened every year. In the last few years, both the practice and the moral focus of newborn screening have begun to change, also in ways that are little understood or publicly discussed. With the hope of promoting discussion and understanding of these changes, among policymakers and the public at large, the Council undertook the inquiry that now culminates in the publication of this white paper.

The origins of this inquiry date back to December 2005, when the Council began to consider the topic of children and bioethics; in September 2006, the Council also took up the topic of ethical issues in genetic research and technology. This white paper began to take shape at the confluence of these two broader streams of inquiry. It reflects a careful study of the published literature on the ethics, policy dimensions, and technologies of newborn screening. The ideas and arguments presented herein were initially developed in working papers authored by the Council staff and in discussions among the Council members themselves.

The ideas and arguments in this white paper have been shaped in significant ways by presentations at Council meetings by some of the leading experts and scholars in the field: Duane Alexander, director of the National Institute of Child Health and Human Development; Jeffrey R. Botkin of the University of Utah School of Medicine; Francis Collins, former director of the National Human Genome Research Institute; Norma n Fost of the University of Wisconsin School of Medicine and Public Health; Kathy Hudson, director of the Genetics and Public Policy Center; Michael S. Watson, executive director of the American College of Medical Genetics; and Nancy Wexler, president of the Hereditary Disease Foundation. (Transcripts of their remarks are available online at www.bioethics.gov.) The Council extends its thanks to these individuals and to Michele A. Lloyd-Puryear, chief of the Genetic Services Branch of the Maternal and Child Health Bureau at the Health Services and Resources Administration, U.S. Department of Health and Human Services, and Kevin Fitzgerald, the David Lauler Professor of Catholic Health Care Ethics at Georgetown University, who met with the Council staff to discuss ethical issues confronting the practice of newborn screening today.

Finally, the Council is grateful to the following experts for their willingness to read and offer criticism of earlier drafts of portions of this white paper: Duane Alexander, Jeffrey R. Botkin, Wylie Burke of the University of Washington, Ellen Wright Clayton of Vanderbilt University Law School, Thomas Murray of The Hastings Center, Lainie Friedman Ross of the University of Chicago, and Benjamin S. Wilfond of the University of Washington School of Medicine.