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Suggested Citation:"Introduction." Institute of Medicine. 1994. Fetal Research and Applications: A Conference Summary. Washington, DC: The National Academies Press. doi: 10.17226/4797.
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Introduction

Research involving human fetuses and fetal tissues has been a subject of national debate and rancor for more than two decades. Despite the many demonstrated medical benefits of such research and the issuance of guidelines by various governmental and private ethics advisory bodies, federal support of this research has been severely curtailed. The only research so funded has been that which involved potential therapeutic benefit to the fetus, or involved no more than minimal risk to the fetus even if potential benefit to the mother could be demonstrated. Thus, scientific investigation in this area has depended almost exclusively on funds provided by pharmaceutical companies, private foundations, university budgets, and patient fees. The effects of federal restrictions, in addition to restricting the amount of research done, include the lack of a national, consensus-derived research agenda, absence of organized peer review of proposed research protocols, and advance of the clinical practice of medically assisted conception without the benefit of a robust scientific knowledge base.

In 1988 and 1989, about the time a three-year federal moratorium banning research on a fetus that involved more than minimal risk was scheduled to expire, reports were issued by the U.S. Congress Office of Technology Assessment and the Association of American Medical Colleges on biotechnology, infertility, and fetal research and fetal tissue research.1 The Institute of Medicine (IOM) also issued a report in 1989 that contained policy recommendations and a re-

1  

U.S. Congress, Office of Technology Assessment, New Developments in Biotechnology: Ownership of Human Tissues and Cells, OTA-BA-337, U.S. Government Printing Office, Washington, D.C., March 1987. U.S. Congress, Office of Technology Assessment, Infertility: Medical and Social Choices, OTA-BA-358, U.S. Government Printing Office, Washington, D.C., May 1988. Association of American Medical Colleges, Summary, Fetal Research and Fetal Tissue Research, Washington, D.C., 1988.

Suggested Citation:"Introduction." Institute of Medicine. 1994. Fetal Research and Applications: A Conference Summary. Washington, DC: The National Academies Press. doi: 10.17226/4797.
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search agenda for increasing the science base underlying medically assisted conception.2 This report dealt exclusively with issues related to in vitro fertilization (IVF), but its recommendations regarding the development of research policy and practice oversight, the establishment of research programs coordinated by the National Institutes of Health, multicentered data collection, and improvements in communication among researchers and clinical practioners could apply to other aspects of fetal research and fetal tissue research as well. Yet, until President Clinton lifted the federal moratorium (which had been extended following controversy about fetal tissue transplantation research) in January 1993 (58 FR 7468), nothing changed.

In 1992, following the recommendation of the IOM Program Committee, the National Academy of Sciences and the Institute of Medicine decided to support with their own funds a project, proposed by the IOM Board on Health Promotion and Disease Prevention, to examine the current state of fetal research and fetal tissue research. The IOM convened a committee to plan a conference on the topic. This report is the result of the committee's efforts.

The initial aim was to help inform private funders, who often lack the formalized peer review systems used by government funding agencies, about new and promising areas of research in the field and, thus, to serve as an outside assessment of research priorities. The committee, formed in 1992, was comprised of senior scientists, broadly knowledgeable in the field, but not themselves directly involved in human fetal studies. Although time and funds did not permit full elaboration of a detailed research agenda, the conference did provide an overview of current research and a forum for discussion of key questions for the future: What are the important problems in fetal research that can be approached with current or developing technology? What are the ethical boundaries?

The conference, organized into four sessions and involving 24 speakers, was held June 20–22 in Irvine, California. The first session introduced some of the ethical and legal issues of research with fetuses and fetal tissues; the following sessions on preembryo research, fetal research, and fetal tissue transplantation formed the main scientific portion of the conference (Appendix A). Discussion periods encouraged interaction among the speakers and conference participants, including other scientists, physicians, and bioethicists, as well as governmental advisers and public health and health industry representatives (Appendix B).

This report begins with an overview of fetal research and research with fetal tissue, followed by a short history and background regarding the regulatory and legislative actions governing this research over the past 30 years. These sections are provided to add breadth for the reader unfamiliar with the field and its complicated legislative history. The main body of the report summarizes the conference presentations and discussions. A glossary of terms is included and all

2  

Institute of Medicine, Medically Assisted Conception: An Agenda for Research, National Academy Press, Washington, D.C., 1989.

Suggested Citation:"Introduction." Institute of Medicine. 1994. Fetal Research and Applications: A Conference Summary. Washington, DC: The National Academies Press. doi: 10.17226/4797.
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sections are written with a wide audience in mind, including lay persons and policymakers, as well as scientists and science administrators. Although there are no policy recommendations offered in this report, conclusions given by individual speakers and discussed by conference participants are emphasized. Further, Appendix C contains the summary of the recommendations and research agenda provided in the 1989 Institute of Medicine report on medically assisted conception to allow readers to put these recommendations in context with suggestions and topics discussed at the 1993 conference.

The prospect of federal funding for this area of research now seems brighter. Although some areas will remain controversial, even divisive, there are ample opportunities for progress where ethical consensus is possible. Greater attention is being brought to this field by changes in the political climate, the advance of technology, and the increasing concern among often polarized public constituencies. Dramatic evidence of these concurrent forces blazed recently across the nation's front pages with the news that human embryos could now be cloned.3 The committee hopes that the background given and the research summarized here will provide insights for future progress and contribute to a fuller understanding of the social and ethical issues involved.

3  

Gina Kolata, "Cloning Human Embryos," New York Times, October 26, 1993.

Suggested Citation:"Introduction." Institute of Medicine. 1994. Fetal Research and Applications: A Conference Summary. Washington, DC: The National Academies Press. doi: 10.17226/4797.
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Page 1
Suggested Citation:"Introduction." Institute of Medicine. 1994. Fetal Research and Applications: A Conference Summary. Washington, DC: The National Academies Press. doi: 10.17226/4797.
×
Page 2
Suggested Citation:"Introduction." Institute of Medicine. 1994. Fetal Research and Applications: A Conference Summary. Washington, DC: The National Academies Press. doi: 10.17226/4797.
×
Page 3
Next: Setting the Stage: Fetal Research, Fetal Tissue Research, and Historical Timeline of Regulation and Legislation »
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Research involving human fetuses and fetal tissue has been a subject of national debate and rancor for more than two decades. Despite the many demonstrated medical benefits of such research and the issuance of guidelines by various governmental and private ethics advisory bodies, federal support of this research has been severely curtailed. In 1993 the Institute of Medicine (IOM) sponsored a conference on fetal research and applications. This book examines the current state of fetal research and fetal tissue research. It contains an overview of research in the field and a short history on the regulatory and legislative actions governing the field. The bulk of the volume centers on ethical and legal issues of fetal research, preembryo research, fetal research, and fetal tissue transplantation. The volume also contains a full reprinting of the summary from the 1989 IOM book Medically Assisted Conception: An Agenda for Research, including the recommendations and research agenda suggested in that volume. Readers can therefore view that information in context with the suggestions and topics discussed at the conference. The background and research summarized in Fetal Research and Applications should provide insights for future progress and contribute to a fuller understanding of the social and ethical issues involved in this field.

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