It's obvious why only men develop prostate cancer and why only women get ovarian cancer. But it is not obvious why women are more likely to recover language ability after a stroke than men or why women are more apt to develop autoimmune diseases such as lupus. Sex differences in health throughout the lifespan have been documented. Exploring the Biological Contributions to Human Health begins to snap the pieces of the puzzle into place so that this knowledge can be used to improve health for both sexes. From behavior and cognition to metabolism and response to chemicals and infectious organisms, this book explores the health impact of sex (being male or female, according to reproductive organs and chromosomes) and gender (one's sense of self as male or female in society). Exploring the Biological Contributions to Human Health discusses basic biochemical differences in the cells of males and females and health variability between the sexes from conception throughout life. The book identifies key research needs and opportunities and addresses barriers to research. Exploring the Biological Contributions to Human Health will be important to health policy makers, basic, applied, and clinical researchers, educators, providers, and journalists-while being very accessible to interested lay readers. Table of Contents <ul>
<li>Front Matter</li>
<li>Executive Summary</li>
<li>1 Introduction</li>
<li>2 Every Cell Has a Sex</li>
<li>3 Sex Begins in the Womb</li>
<li>4 Sex Affects Behavior and Perception</li>
<li>5 Sex Affects Health</li>
<li>6 The Future of Research on Biological Sex Differences: Challenges and Opportunities</li>
<li>References</li>
<li>Appendix A: Data Sources and Acknowledgments</li>
<li>Appendix B: Physiological and Pharmacological Differences Between the Sexes</li>
<li>Appendix C: Glossary</li>
<li>Appendix D: Committee and Staff Biographies</li>
<li>Index</li>
</ul>

Exploring the Biological Contributions to Human Health: Does Sex Matter?

Health, Fitness & Dieting

Board on Health Sciences Policy

INSTITUTE OF MEDICINE

Committee on Understanding the Biology of Sex and Gender Differences

Mental Health

National Academies Press

Amid increasing concern for patient safety and the shutdown of prominent research operations, the need to improve protections for individuals who volunteer to participate in research has become critical. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs considers the possible impact of creating an accreditation system to raise the performance of local protection mechanisms. In the United States, the system for human research participant protections has centered on the Institutional Review Board (IRB); however, this report envisions a broader system with multiple functional elements. In this context, two draft sets of accreditation standards are reviewed (authored by Public Responsibility in Medicine &amp; Research and the National Committee for Quality Assurance) for their specific content in core areas, as well as their objectivity and validity as measurement tools. The recommendations in the report support the concept of accreditation as a quality improvement strategy, suggesting that the model should be initially pursued through pilot testing of the proposed accreditation programs. Table of Contents <ul>
<li>Front Matter</li>
<li>Executive Summary</li>
<li>1 Introduction, Background, and Definitions</li>
<li>2 Models of Accreditation</li>
<li>3 Standards for Accreditation</li>
<li>4 Evaluating HRPPP Pilot Accreditation Programs</li>
<li>References</li>
<li>Appendix A: Data Sources and Methods</li>
<li>Appendix B: PRIM&amp;R Accreditation Standards</li>
<li>Appendix C: VA Human Research Protection Accreditation Program Draft Accreditation Standards</li>
<li>Appendix D: Committee, Expert Adviser, and Staff Biographies</li>
<li>Index</li>
</ul>

Preserving Public Trust: Accreditation and Human Research Participant Protection Programs

Business & Money

Medicine, Institute of

Committee on Assessing the System for Protecting Human Research Subjects

Management & Leadership

Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement. Table of Contents <ul>
<li>Front Matter</li>
<li>Executive Summary</li>
<li>1 Introduction</li>
<li>2 Design of Small Clinical Trials</li>
<li>3 Statistical Approaches to Analysis of Small Clinical Trials</li>
<li>4 General Guidelines</li>
<li>References</li>
<li>Appendix A Study Methods</li>
<li>Appendix B Glossary of Statistical and Clinical Trials Terms</li>
<li>Appendix C Selected Bibliography on Small Clinical Trials</li>
<li>Appendix D Committee and Staff Biographies</li>
</ul>

Small Clinical Trials: Issues and Challenges (Compass Series)

Science & Math

Committee on Strategies for Small-Number-Participant Clinical Research Trials

History & Philosophy

Safe Passage: Astronaut Care for Exploration Missions sets forth a vision for space medicine as it applies to deep space voyage. As space missions increase in duration from months to years and extend well beyond Earthâ€™s orbit, so will the attendant risks of working in these extreme and isolated environmental conditions. Hazards to astronaut health range from greater radiation exposure and loss of bone and muscle density to intensified psychological stress from living with others in a confined space. Going beyond the body of biomedical research, the report examines existing space medicine clinical and behavioral research and health care data and the policies attendant to them. It describes why not enough is known today about the dangers of prolonged travel to enable humans to venture into deep space in a safe and sane manner. The report makes a number of recommendations concerning NASAâ€™s structure for clinical and behavioral research, on the need for a comprehensive astronaut health care system and on an approach to communicating health and safety risks to astronauts, their families, and the public. Table of Contents <ul>
<li>Front Matter</li>
<li>Executive Summary</li>
<li>1 Astronaut Health Beyond Earth Orbit</li>
<li>2 Risks to Astronaut Health During Space Travel</li>
<li>3 Managing Risks to Astronaut Health</li>
<li>4 Emergency and Continuing Care</li>
<li>5 Behavioral Health and Performance</li>
<li>6 Exploring the Ethics of Space Medicine</li>
<li>7 Planning an Infrastructure for Astronaunt Health Care</li>
<li>References</li>
<li>Appendix A Background and Methodology</li>
<li>Appendix B Committee and Staff Biographies</li>
<li>Index</li>
</ul>

Safe Passage: Astronaut Care for Exploration Missions

Committee on Creating a Vision for Space Medicine During Travel Beyond Earth Orbit

Astronomy & Space Science

National Academy Press

Despite many advances, 20 American workers die each day as a result of occupational injuries. And occupational safety and health (OSH) is becoming even more complex as workers move away from the long-term, fixed-site, employer relationship.  This book looks at worker safety in the changing workplace and the challenge of ensuring a supply of top-notch OSH professionals. Recommendations are addressed to federal and state agencies, OSH organizations, educational institutions, employers, unions, and other stakeholders.  The committee reviews trends in workforce demographics, the nature of work in the information age, globalization of work, and the revolution in health care delivery-exploring the implications for OSH education and training in the decade ahead.  The core professions of OSH (occupational safety, industrial hygiene, and occupational medicine and nursing) and key related roles (employee assistance professional, ergonomist, and occupational health psychologist) are profiled-how many people are in the field, where they work, and what they do. The book reviews in detail the education, training, and education grants available to OSH professionals from public and private sources.

Safe Work in the 21st Century: Education and Training Needs for the Next Decade's Occupational Safety and Health Personnel

Committee to Assess Training Needs for Occupational Safety and Health Personnel in the United States

Technology

Racial and ethnic disparities in health care are known to reflect access to care and other issues that arise from differing socioeconomic conditions. There is, however, increasing evidence that even after such differences are accounted for, race and ethnicity remain significant predictors of the quality of health care received. In Unequal Treatment, a panel of experts documents this evidence and explores how persons of color experience the health care environment. The book examines how disparities in treatment may arise in health care systems and looks at aspects of the clinical encounter that may contribute to such disparities. Patients' and providers' attitudes, expectations, and behavior are analyzed. How to intervene? Unequal Treatment offers recommendations for improvements in medical care financing, allocation of care, availability of language translation, community-based care, and other arenas. The committee highlights the potential of cross-cultural education to improve provider-patient communication and offers a detailed look at how to integrate cross-cultural learning within the health professions. The book concludes with recommendations for data collection and research initiatives. Unequal Treatment will be vitally important to health care policymakers, administrators, providers, educators, and students as well as advocates for people of color. Table of Contents <ul>
<li>Front Matter</li>
<li>Summary</li>
<li>1 Introduction and Literature Review</li>
<li>2 The Healthcare Environment and Its Relation to Disparities</li>
<li>3 Assessing Potential Sources of Racial and Ethnic Disparities in Care: Patient- and System-Level Factors</li>
<li>4 Assessing Potential Sources of Racial and Ethnic Disparities in Care: The Clinical Encounter</li>
<li>5 Interventions: Systemic Strategies</li>
<li>6 Interventions: Cross-Cultural Education in the Health Professions</li>
<li>7 Data Collection and Monitoring</li>
<li>8 Needed Research</li>
<li>References</li>
<li>Appendixes</li>
<li>A Data Sources and Methods</li>
<li>B Literature Review</li>
<li>C Federal-Level and Other Initiatives to Address Racial and Ethnic Disparities in Healthcare</li>
<li>D Racial Disparities in Healthcare: Highlights from Focus Group Findings</li>
<li>E Committee and Staff Biographies</li>
<li>Paper Contributions</li>
<li>Racial and Ethnic Disparities in Diagnosis and Treatment: A Review of the Evidence and a Consideration of Causes - H. Jack Geiger</li>
<li>Racial and Ethnic Disparities in Healthcare: A Background and History - W. Michael Byrd and Linda A. Clayton</li>
<li>The Rationing of Healthcare and Health Disparity for the American Indians/Alaska Natives - Jennie R. Joe</li>
<li>Patient-Provider Communication: The Effect of Race and Ethnicity on Process and Outcomes of Healthcare - Lisa A. Cooper and Debra L. Roter</li>
<li>The Culture of Medicine and Racial, Ethnic, and Class Disparities in Healthcare - Mary-Jo DelVecchio Good, Cara James, Byron J. Good, and Anne E. Becker</li>
<li>The Civil Rights Dimension of Racial and Ethnic Disparities in Health Status - Thomas E. Perez</li>
<li>Racial and Ethnic Disparities in Healthcare: Issues in the Design, Structure, and Administration of Federal Healthcare Financing Programs Supported Through Direct Public Funding - Sara Rosenbaum</li>
<li>The Impact of Cost Containment Efforts on Racial and Ethnic Disparities in Healthcare: A Conceptualization - Thomas Rice</li>
<li>Racial and Ethnic Disparities in Healthcare: An Ethical Analysis of When and How They Matter - Madison Powers and Ruth Faden</li>
<li>Index</li>
</ul>

Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care

Politics & Social Sciences

Committee on Understanding and Eliminating Racial and Ethnic Disparities in Health Care

Sociology

The Metropolitan Medical Response System (MMRS) program of the U. S. Department of Health and Human Services (DHHS) provides funds to major U. S. cities to help them develop plans for coping with the health and medical consequences of a terrorist attack with chemical, biological, or radiological (CBR) agents. DHHS asked the Institute of Medicine (IOM) to assist in assessing the effectiveness of the MMRS program by developing appropriate evaluation methods, tools, and processes to assess both its own management of the program and local preparedness in the cities that have participated in the program. This book provides the managers of the MMRS program and others concerned about local capabilities to cope with CBR terrorism with three evaluation tools and a three-part assessment method. The tools are a questionnaire survey eliciting feedback about the management of the MMRS program, a table of preparedness indicators for 23 essential response capabilities, and a set of three scenarios and related questions for group discussion. The assessment method described integrates document inspection, a site visit by a team of expert peer reviewers, and observations at community exercises and drills. Table of Contents <ul>
<li>Front Matter</li>
<li>Executive Summary</li>
<li>1 Introduction</li>
<li>2 Community Emergency Management and Available Federal Assistance</li>
<li>3 Federal Efforts to Increase State and Local Preparedness for Terrorism</li>
<li>4 Metropolitan Medical Response System Program Contracts</li>
<li>5 Measurement and Data Collection in Evaluation</li>
<li>6 Preparedness Indicators</li>
<li>7 Feedback to Office of Emergency Preparedness on Program Management</li>
<li>8 Feedback to Office of Emergency Preparedness on Program Success</li>
<li>9 Closing Remarks</li>
<li>References</li>
<li>Appendix A Committee and Staff Biographies</li>
<li>Appendix B Selected Information about Federal Chemical, Biological, Radiological, Nuclear Consequence Management Response Teams</li>
<li>Appendix C Metropolitan Medical Response System Program Cities</li>
<li>Appendix D 2000 MMRS Contract Deliverable Evaluation Instrument</li>
<li>Appendix E Preparedness Indicators for Metropolitan Medical Response System Program Contract Deliverables</li>
<li>Appendix F Scenarios and Discussion Materials for Use on Site Visits</li>
</ul>

Preparing for Terrorism: Tools for Evaluating the Metropolitan Medical Response System Program

Committee on Evaluation of the Metropolitan Medical Response System Program

Social Sciences

The death of a child is a special sorrow. No matter the circumstances, a childâ€™s death is a life-altering experience. Except for the child who dies suddenly and without forewarning, physicians, nurses, and other medical personnel usually play a central role in the lives of children who die and their families. At best, these professionals will exemplify â€œmedicine with a heart.â€ At worst, familiesâ€™ encounters with the health care system will leave them with enduring painful memories, anger, and regrets. When Children Die examines what we know about the needs of these children and their families, the extent to which such needs areâ€"and are notâ€"being met, and what can be done to provide more competent, compassionate, and consistent care. The book offers recommendations for involving child patients in treatment decisions, communicating with parents, strengthening the organization and delivery of services, developing support programs for bereaved families, improving public and private insurance, training health professionals, and more. It argues that taking these steps will improve the care of children who survive as well as those who do notâ€"and will likewise help all families who suffer with their seriously ill or injured child. Featuring illustrative case histories, the book discusses patterns of childhood death and explores the basic elements of physical, emotional, spiritual, and practical care for children and families experiencing a childâ€™s life-threatening illness or injury. Table of Contents <ul>
<li>Front Matter</li>
<li>Summary</li>
<li>1. Introduction</li>
<li>2. Patterns of Childhood Death in America</li>
<li>3. Pathways to a Child</li>
<li>4. Communication, Goal Setting, and Care Planning</li>
<li>5. Care and Caring From Diagnosis Through Death and Bereavement</li>
<li>6. Providing, Organizing, and Improving Care</li>
<li>7. Financing of Palliative and End-of-Life Care for Children and Their Families</li>
<li>8. Ethical and Legal Issues</li>
<li>9. Educating Health Care Professionals</li>
<li>10. Directions for Research</li>
<li>References</li>
<li>Appendix A: Study Origins and Activities</li>
<li>Appendix B: Prognostication Scores</li>
<li>Appendix C: Assessing Health-Related Quality in End-of-Life Care for Children and Adolescents</li>
<li>Appendix D: Cultural Dimensions of Care At Life</li>
<li>Appendix E: Bereavement Experiences After the Death of a Child</li>
<li>Appendix F: End-of-Life Care in Emergency Medical Services for Children</li>
<li>Appendix G: Education in Pediatric Palliative Care</li>
<li>Appendix H: Progress in Pediatric Palliative Care in New York State--A Demonstration Project</li>
<li>Appendix I: Committee Biographical Statements</li>
<li>Index</li>
</ul>

When Children Die: Improving Palliative and End-of-Life Care for Children and Their Families

Committee on Palliative and End-of-Life Care for Children and Their Families

Diseases & Physical Ailments

The Roundtable on Environmental Health Sciences, Research, and Medicine wanted to address the link between environmental factors and the development of cancer in light of recent advances in genomics. They asked what research tools are needed, how new scientific information can be applied in a timely manner to reduce the burden of cancer, and how this can be flexible enough to treat the individual. Table of Contents <ul>
<li>Front Matter</li>
<li>Summary</li>
<li>1. Charge to Participants and Workshop Objectives</li>
<li>2. Keynote Addresses</li>
<li>3. The Links between Environmental Factors, Genetics, and the Development of Cancer</li>
<li>4. Gene-Environment Interaction in Special Populations</li>
<li>5. Gene-Environment Interaction in Site-specific Cancers</li>
<li>6. Special Address: A Novel Approach to Cancer Treatment Based on Immune Stimulations and Other Environmental Approaches</li>
<li>7. Cancer and the Environment: A View from the Hill</li>
<li>8. Moving Forward</li>
<li>Abstracts of Talks</li>
<li>References</li>
<li>Appendix A Glossary</li>
<li>Appendix B Workshop Agenda</li>
<li>Appendix C Speakers and Panelists</li>
<li>Appendix D Workshop Participants</li>
</ul>

Cancer and the Environment: Gene-Environment Interaction

Roundtable on Environment Health Sciences, Research, and Medicine

Earth Sciences

"Many people say that it is the intellect which makes a great scientist. They are wrong: it is character." -- Albert Einstein Integrity in Scientific Research attempts to define and describe those elements that encourage individuals involved with scientific research to act with integrity. Recognizing the inconsistency of human behavior, it stresses the important role that research institutions play in providing an integrity--rich environment, citing the need for institutions to provide staff with training and education, policies and procedures, and tools and support systems. It identifies practices that characterize integrity in such areas as peer review and research on human subjects and weighs the strengths and limitations of self--evaluation efforts by these institutions. In addition, it details an approach to promoting integrity during the education of researchers, including how to develop an effective curriculum. Providing a framework for research and educational institutions, this important book will be essential for anyone concerned about ethics in the scientific community. Table of Contents <ul>
<li>Front Matter</li>
<li>Executive Summary</li>
<li>1 Introduction</li>
<li>2 Integrity in Research</li>
<li>3 The Research Environment and Its Impact on Integrity in Research</li>
<li>4 Institutional Approaches to Fostering Integrity in Research</li>
<li>5 Promoting Integrity in Research through Education</li>
<li>6 Evaluation by Self-Assessment</li>
<li>7 Concluding Remarks and Recommendations</li>
<li>A Data Sources and Literature Review Findings</li>
<li>B Outcome Measures for Assessing Integrity in the Research Environment</li>
<li>C Developments in Misconduct and Integrity Policies Since Publication of the 1992 COSEPUP Report1</li>
<li>D Additional Resources Regarding Professional Skills</li>
<li>E Committee and Staff Biographies</li>
<li>Index</li>
</ul>

Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct

Division on Earth and Life Studies

Committee on Assessing Integrity in Research Environments

National, Research Council

Philosophy

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