The Institute of Medicine (IOM) of the National Academy of Sciences (NAS) collaborated in this study with the Board on Maternal, Child, and Family Health Research of the Commission on Life Sciences of the National Research Council (NRC) to determine methodologies needed to evaluate current childbirth settings in the United States. Although the proportion of non-hospital births runs as high as 4.4 percent annually in Oregon, insufficient data exist to permit complete evaluation of the various birth settings. The application of good research methods should lead to scientific findings that provide the basis for informed, rational decision making about alternative settings for childbirth. A committee of 11 experts was appointed to review current knowledge, provide background knowledge, and identify the kinds of research designs useful for assessing such matters as the safety, quality of maternity care, costs, psychological factors, and family satisfaction of different birth settings. The committee was also charged with preparing a report that could be used to solicit, evaluate, and fund proposals for studies on childbirth settings. The committee did not design specific studies to be carried out, but rather attempted to point out issues that should be considered by researchers because it believed that the best proposals would arise from investigator-initiated research. Gaps in research could be filled by requests for proposals developed by agency staff and the agency peer review committee. In addition, IOM staff members and several consultants provided background papers for the committee's consideration. The research that results from this report will be useful to policymakers and to consumers searching for information to aid in making decisions about birth settings. Research Issues in the Assessment of Birth Settings summarizes the study. Table of Contents <ul>
<li>Front Matter</li>
<li>Introduction</li>
<li>Summary and Recommendations</li>
<li>1: Basic Concepts and Descriptive Data</li>
<li>2: Research Strategies for Assessing Childbirth Settings</li>
<li>3: Risk Assessment</li>
<li>4: Variables</li>
<li>Appendix A: Review of the Safety of Maternity Care in Different Birth Locations</li>
<li>Appendix B : Research Issues Concerning Reimbursement for Childbirth Services</li>
<li>Appendix C: Freestanding Birth Centers</li>
<li>Appendix D: Research on Childbirth Settings: The Assessment of Psychological Variables</li>
<li>Appendix E: Review of Obstetrical Risk Assessment Methods</li>
<li>Appendix F: Vital Statistics and Nonhospital Births: A Mortality Study of Infants Born Out of Hospitals in Oregon Between 1975 and 1979</li>
</ul>

Research Issues in the Assessment of Birth Settings: Report of a Study

Medical Books

Commission on Life Sciences

Division of Health Sciences Policy

INSTITUTE OF MEDICINE

National, Research Council

Committee on Assessing Alternative Birth Settings

Administration & Medicine Economics

National Academies Press

The abortifacient RU-486 was born in the laboratory, but its history has been shaped by legislators, corporate marketing executives, and protesters on both sides of the abortion debate. This volume explores how society decides what to do when discoveries such as RU-486 raise complex and emotional policy issues. Six case studies with insightful commentary offer a revealing look at the interplay of scientists, interest groups, the U.S. Congress, federal agencies, and the public in determining biomedical public policy--and suggest how decision making might become more reasoned and productive in the future. The studies are fascinating and highly readable accounts of the personal interactions behind the headlines. They cover dideoxyinosine (ddI), RU-486, Medicare coverage for victims of chronic kidney failure, the human genome project, fetal tissue transplantation, and the 1975 Asilomar conference on recombinant DNA. Table of Contents <ul>
<li>Front Matter</li>
<li>Introduction</li>
<li>Unproven AIDS Therapies: he Food and Drug Administration and ddI</li>
<li>A Political History of RU-486</li>
<li>The Human Genome Project: The Formation of Federal Policies in the United States, 1986-1990</li>
<li>Origins of the Medicare Kidney Disease Entitlement: The Societal Security Amendments of 1972</li>
<li>Deliberations of the Human Fetal Tissue Transplantation Research Panel</li>
<li>Asilomar and Recombinant DNA: The End of the Beginning</li>
<li>Conclusions</li>
<li>Appendix A: The Public and the Expert in Biomedical Policy Controversies</li>
<li>Appendix B: Biographical Notes on the Authors and Commentators</li>
<li>Index</li>
</ul>

Biomedical Politics

Engineering & Transportation

Committee to Study Decision Making

Engineering

Significant advances in brain research have been made, but investigators who face the resulting explosion of data need new methods to integrate the pieces of the "brain puzzle." Based on the expertise of more than 100 neuroscientists and computer specialists, this new volume examines how computer technology can meet that need. Featuring outstanding color photography, the book presents an overview of the complexity of brain research, which covers the spectrum from human behavior to genetic mechanisms. Advances in vision, substance abuse, pain, and schizophrenia are highlighted. The committee explores the potential benefits of computer graphics, database systems, and communications networks in neuroscience and reviews the available technology. Recommendations center on a proposed Brain Mapping Initiative, with an agenda for implementation and a look at issues such as privacy and accessibility. Table of Contents <ul>
<li>Front Matter</li>
<li>Summary</li>
<li>Introduction</li>
<li>Advancing Neuroscience in the Decade of the Brain</li>
<li>Overview of Neuroscience Research: A Closer Look at the Neural Hierarchy</li>
<li>Computer and Information Technology in Biomedical and Neuroscience Research</li>
<li>Building Consensus, Identifying Needs</li>
<li>The Brain Mapping Initiative: Committee Conclusions and Recommendations</li>
<li>Appendix A: Task Force Topics and Rosters</li>
<li>Appendix B: samples of Requests for Opinions</li>
<li>Appendix C: Lists of Speakers and Demonstrators in Symposia and Open Hearings</li>
<li>Index</li>
<li>Color Plates</li>
</ul>

Mapping the Brain and Its Functions: Integrating Enabling Technologies into Neuroscience Research (Iom Publication, 91-08)

Division of Biobehavioral Sciences and Mental Disorders

Committee on a National Neural Circuitry Database

Computers & Technology

The past 20 years have seen a rapid increase in our understanding of the biology of cancer. And, advances in understanding the genetics of cancer are beginning to have an impact on the clinical management of malignant disease. Many of the genetic changes that underlie malignant transformation of cells and/or that distinguish malignant clones can be used as markers to diagnose, monitor, or characterize various forms of cancer. The purpose of this volume is to assess the current status of genetic testing in cancer management both from the standpoint of those tests and genetic markers that are presently available and from the perspective of genetic approaches to cancer testing that are likely to have an impact on cancer management in the near future.

Advances in Understanding Genetic Changes in Cancer: Impact on Diagnosis and Treatment Decisions in the 1990s

Science & Math

Evolution

Transforming biological discoveries into medical treatment calls for a cadre of health professionals skilled in patient-oriented research. Yet many factors discourage talented persons from choosing clinical research as a profession. This new volume lays out the problem in detail, with specific recommendations to the federal government, the biotechnology and pharmaceutical industries, professional organizations, the health care industry, organized medicine, and the nation's universities and academic health centers. The volume explores  How clinical research is conducted, what human resources are available, and what research opportunities lie ahead. Why health professionals become discouraged about clinical research. How the educational system has failed in this area and what programs stand out as models. How funding affects the supply of researchers.  This practical book will be of immediate interest to public and private agencies funding research, research administrators, medical educators, health professionals, and those pursuing a career in clinical investigation.

Careers in Clinical Research: Obstacles and Opportunities

Business & Money

Committee on Addressing Career Paths for Clinical Research

Job Hunting & Careers

There is a growing perception that biomedical research has focused more on the health problems of men relative to those of women and that women have been denied access to advances in medical diagnosis and therapy as a result of being excluded from clinical studies. Women and Health Research, Volume 2, addresses issues connected with women's participation in clinical studies: ethical issues related to recruitment, retention, and the inclusion of pregnant women and other women of childbearing age; legal issues such as liability, compensation for injury, constitutional concerns, and federal regulations; and health consequences associated with exclusion or underrepresentation. The commissioned papers focus on the research participation of women from specific racial and ethnic groups and on whether women have been underrepresented in biomedical research, based on a systematic survey of clinical studies reported in a prominent medical journal. Table of Contents <ul>
<li>Front Matter</li>
<li>1 Women's Participation in Clinical Research: From Protectionism to Access</li>
<li>2 Women in Clinical Studies: A Feminist View</li>
<li>3 Ethical Issues Related to the Inclusion of Pregnant Women in Clinical Trials (I)</li>
<li>4 Ethical Issues Related to the Inclusion of Pregnant Women in Clinical Trial (II)</li>
<li>5 Ethical Issues Related to the Inclusion of Women of Childbearing Age in Clinical Trials</li>
<li>6 Health Consequences of Exclusion or Underrepresentation of Women in Clinical Studies (I)</li>
<li>7 Health Consequences of Exclusion or Underrepresentation of Women in Clinical Studies (II)</li>
<li>8 Recruitment and Retention of Women in Clinical Studies: Theoretical Perspectives and Methodological Considerations</li>
<li>9 Recruitment and Retention of Women of Color in Clinical Studies</li>
<li>10 Recruitment and Retention of Women in Clinical Studies: Ethical Considerations</li>
<li>11 Impact of Current Federal Regulations on the Inclusion of Female Subjects in Clinical Studies</li>
<li>12 Brief Overvew of Constitutional Issues Raised by the Exclusion of Women from Research Trials</li>
<li>13 Liability Exposure for Exclusion and Inclusion of Women as Subjects in Clinical Studies</li>
<li>14 Liability Exposure When Offspring Are Injured Because of Their Parents' Participation in Clinical Trials</li>
<li>15 Compensation for Research Injuries</li>
<li>16 Justice and the Inclusion of Women in Clinical Studies: A Conceptual Framework</li>
<li>17 Women's Representation as Subjects in Clinical Studies: A Pilot Study of Research Published in JAMA in 1990 and 1992</li>
<li>18 Racial Differentials in Medical Care: Implications for Research on Women</li>
<li>19 Health Status of American Indian and Alaska Native Women</li>
<li>20 Ethical and Legal Issues Relating to the Inclusion of Asian/Pacific Islanders in Clinical Studies</li>
<li>21 The Inclusion of Latino Women in Clinical and Research Studies: Scientific Suggestions for Assuring Legal and Ethical Integrity</li>
<li>Appendix: Author Biographies</li>
</ul>

Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies: Volume 2: Workshop and Commissioned Papers

Health, Fitness & Dieting

Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies

Women's Health

Regulatory agencies within the United States and the United Kingdom, among several other countries, have reviewed extensively the safety and efficacy of Halcion (triazolam)--a once commonly used hypnotic drug. Concerns began to emerge about the safety of Halcion when a Dutch physician reported a possible link between it and a syndrome that included such effects as depression, amnesia, hallucinations, and increased anxiety. In addition, in 1991 its manufacturer, Upjohn, noted that "errors had been identified in a report of one of the clinical studies included in the original" application for approval. Since then, the drug has been removed from the market in several countries, whereas in the United States and Canada, the drug's labeling has been modified to reduce the recommended dose and duration of treatment and to heighten awareness of possible side effects. Yet different data and analyses have resulted in conflicting messages that are difficult to reconcile and interpret. In response to a request from the Food and Drug Administration to resolve these controversial issues related to the safety and efficacy of Halcion, this IOM book assesses the adequacy of the drug's clinical trials; the quality and quantity of data on adverse reactions; overall confidence in the data on effectiveness, adverse events, and side effects at different doses; and whether additional studies are needed. Table of Contents <ul>
<li>Front Matter</li>
<li>Executive Summary</li>
<li>Introduction</li>
<li>Assessment of Efficacy Data</li>
<li>Assessment of Safety Data</li>
<li>Additional Comments on Broader Implications</li>
<li>References</li>
<li>Appendix A: FDA Safety Tables</li>
<li>Appendix B: Summary Tables of Literature Reviewed for Safety of Halcion</li>
<li>Appendix C: Glossary</li>
<li>Appendix D: Acronyms</li>
<li>Appendix E: Resources Reviewed by the Committee</li>
<li>Appendix F: Upjohn Consent to Disclosure</li>
<li>Appendix G: Committee and Staff Biographies</li>
</ul>

Halcion: An Independent Assessment of Safety and Efficacy Data

Committee on Halcion: An Assessment of Data Adequacy and Confidence

Mental Health

As the first real contraceptive innovation in over 20 years, and as a long-acting method requiring clinical intervention for application and removal, the implantable contraceptive Norplant has raised a wide range of issues that could offer valuable lessons about the problems to be addressed if other new contraceptive technologies are to enter the marketplace. In April 1997 an Institute of Medicine workshop on implant contraceptives reviewed newly available data on Norplant's efficacy, safety, and use; identified lessons to be learned about the method's development, introduction, use, and market experience; and explored approaches to developing and introducing new contraceptives based on those lessons. This resulting book contains an examination of Norplant's efficacy and safety, its user populations, training for insertion and removal, consumer perspectives (quality of care, informed decisionmaking, and consumer involvement), and new approaches to contraceptive development and introduction. An appendix contains summaries of 17 workshop presentations.

Contraceptive Research, Introduction, and Use: Lessons From Norplant

Committee on Contraceptive Research and Development

The Forum on Emerging Infections was created in 1996 in response to a request from the Centers for Disease Control and Prevention and the National Institutes of Health. The goal of the forum is to provide structured opportunities for representatives from academia, industry, professional and interest groups, and government to examine and discuss scientific and policy issues that relate to research, prevention, detection, and management of emerging infectious diseases. A critical part of this mission has been the convening of a series of workshops. Public Health Systems and Emerging Infections summarizes the fourth in a series of five workshops.  With a focus on our knowledge and understanding of the role of private and public health sectors in emerging infectious disease surveillance and response, the participants explored the effects of privatization of public health laboratories and the modernization of public health care. The issues discussed included epidemiological investigation, surveillance, communication, coordination, resource allocations, and economic support. Table of ContentsFront MatterSummary and Assessment1 Introduction2 Epidemiological Investigation3 Surveillance4 Communication, Coordination, and Education and Outreach5 Strategic Planning, Resource Allocation, and Economic SupportReferencesAppendix A Glossary and AcronymsAppendix B Workshop AgendaAppendix C Emerging Infectious Diseases: Consensus on Needed Laboratory Capacity Could Strengthen SurveillanceAppendix D Forum Member and Staff Biographies

Public Health Systems and Emerging Infections: Assessing the Capabilities of the Public and Private Sectors: Workshop Summary

Forum on Emerging Infections

The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development. Table of Contents <ul>
<li>Front Matter</li>
<li>Editor's Summary</li>
<li>1 Introduction</li>
<li>2 Similarities and Dissimilarities in Physiology, Metabolism, and Disease States and Responses to Therapy in Children and Adults</li>
<li>3 Pharmacokinetics and Pharmacodynamics in Children Versus Adults</li>
<li>4 Extrapolation of Safety and Efficacy Data to Children</li>
<li>5 Raising Awareness of Regulatory, Legal, and Ethical Issues</li>
<li>6 Concluding Remarks</li>
<li>References</li>
<li>Appendix A: Workshop Agenda</li>
<li>Appendix B: Biographies</li>
</ul>

Rational Therapeutics for Infants and Children: Workshop Summary

Politics & Social Sciences

Estabrook, Ronald W.

Bouxsein, Peter

Pitluck, Sarah

Davis, Jonathan R.

Roundtable on Research and Development of Drugs, Biologics, and Medical Devices

Yaffe, Sumner

Social Sciences

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