NATIONAL ACADEMY PRESS
2101 Constitution Avenue, NW Washington, DC 20418
NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competencies and with regard for appropriate balance.
This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.
The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education.
Support for this project was provided by the National Institute of Child Health and Human Development (contract no. NO1-HD-9-2926) and the Centers for Disease Control.
Library of Congress Catalog Card No. 90-63689
International Standard Book Number 0-309-04428-6
Additional copies of this report are available from:
National Academy Press
2101 Constitution Avenue, N.W. Washington, D.C. 20418
S270
Printed in the United States of America
The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatlichemuseen in Berlin.
First Printing, January 1991
Second Printing, September 1991
COMMITTEE ON PRENATAL AND NEWBORN SCREENING FOR HIV INFECTION
MARIE C. McCORMICK (chair),
Joint Program in Neonatology, Harvard Medical School, Boston, Massachusetts
LORI B. ANDREWS,
American Bar Foundation, Chicago, Illinois
MOLLY J. COYE,
Division of Public Health, Johns Hopkins University School of Hygiene and Public Health, Baltimore, Maryland
ROBERT A. DERZON,
Lewin/ICF, Inc., San Francisco, California
NORMAN C. FOST,
Department of Pediatrics, University of Wisconsin School of Medicine, Madison
LAURENCE R. FOSTER,
Office of Epidemiology and Health Statistics, Health Division, Oregon Department of Human Resources, Portland
RODNEY HOFF (government liaison member),
Epidemiology Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland
MICHAEL M. KABACK,
Department of Pediatrics, University of California, San Diego
BARBARA J. SABOL,
Human Resources Administration, New York, New York
A. EUGENE WASHINGTON,
Center for Reproductive Health Policy Research, Department of Obstetrics, Gynecology, and Reproductive Sciences, and Institute for Health Policy Studies, School of Medicine, University of California, San Francisco
STAFF
LESLIE M. HARDY, Project Director
GAIL GELLER, Consultant
LEAH MAZADE, Staff Editor
GAlL SPEARS, Administrative Assistant
ROBIN WEISS, Director, AIDS Activities
PREFACE
Policymakers face special challenges in formulating rational human immunodeficiency virus (HIV) testing and screening policies for women and children. Incomplete data and complex medical, social, and ethical questions confound the decision-making process. Moreover, decisions must be made and policies implemented in a continually changing environment as the epidemic of HIV infection and acquired immune deficiency syndrome (AIDS) evolves and the development and refinement of diagnostic technology and medical therapy proceed apace.
In recent months policymakers have come to appreciate the extent and seriousness of the problem of HIV disease among women and children, and this perception has brought proposals for screening pregnant women and newborns for HIV. The prospect of HIV screening among these populations engenders spirited debate in many arenas. In particular, public policy discussions attempt to grapple with determining what constitutes an acceptable balance between the medical and public health benefits and the consequent personal and societal costs of such screening.
In light of this ongoing debate (and the potential for damaging ad hoc recommendations), the National Institute of Child Health and Human Development and the Centers for Disease Control requested that the Institute of Medicine assemble an expert committee to offer direction to policymakers and to examine the myriad questions that frame the development of sound perinatal HIV screening policy. Specifically, the committee's charge was to assess the appropriateness, at this time, of screening pregnant women and newborns for HIV infection, to consider the criteria that should be satisfied when such screening is introduced, and to reflect on possible advances in treatment and HIV diagnostic capability (particularly for neonates) that might necessitate policy modifications.
As part of its deliberations, the committee convened a public conference on May 14-15, 1990, to explore the salient technical, medical,
legal, and ethical aspects of HIV screening proposals for pregnant women and newborns. Appendix A contains the program of the conference and a summary of its activities. Such a summary cannot, of course, fully capture the richness and breadth of the panelists' presentations and subsequent discussions, but it does provide a synthesis of the major issues raised and the concerns expressed during the conference. It also reflects the subjective views of the speakers, which do not necessarily coincide with the conclusions reached by the committee. These differences of opinion mirror the controversy inherent in perinatal HIV screening policy development and serve as a reminder that many policy decisions in this area are to some extent based on judgment. Indeed, the evolving nature of the HIV epidemic and current gaps in knowledge, as well as changing technology, often require that informed judgment supplement incomplete data.
The conference greatly enriched the committee's deliberations, and committee members and staff extend their thanks both to the speakers, for their informative, provocative presentations, and to those who attended, for their constructive, lively contributions to the discussions. In particular, the committee acknowledges the thoughtful commentary of the final panelists: Neil Holtzman, Edward Connor, Sheldon Landesman, Kristine Gebbie, and Ronald Bayer. Their discussion of the considerations that should inform the development of prenatal and newborn HIV screening policy as well as their policy judgments helped to crystallize the committee's conclusions and recommendations. Because this final panel by design reiterated many of the themes that surfaced throughout the conference, a discrete synopsis of their discussion does not appear in the summary.
This report presents the committee's collective judgment about whether screening pregnant women or newborns for HIV infection is currently appropriate and discusses the process by which screening policy should be developed and implemented. It is intended to offer direction to state policymakers faced with decisions about instituting publicly sponsored prenatal or newborn HIV screening programs and consequently focuses primarily on their design and implementation. All statements and recommendations within the report are specific to the United States. Nevertheless, the guidance provided in the committee's recommendations may also be applicable to other settings in which screening policy might be developed.
Finally, the committee was continually reminded of the broader implications for other population groups (e.g., nonpregnant adolescents and adults) of its recommendations for HIV screening of pregnant women. The committee's charge did not include the examination of HIV screening policy for other individuals of reproductive age who might also benefit from the early diagnosis of infection and medical intervention. The