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

Women and Health Research

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

By: Institute of Medicine,Division of Health Sciences Policy,Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies

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Women and Health Research

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

By: Institute of Medicine,Division of Health Sciences Policy,Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies

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.

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261

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National Academies Press

Published Date

ISBN 10

0309176867

ISBN 13

9780309176866

Women and Health Research

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

By: Institute of Medicine,Division of Health Sciences Policy,Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies

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Women and Health Research

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

By: Institute of Medicine,Division of Health Sciences Policy,Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies

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262

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National Academies Press

Published Date

ISBN 10

0309050405

ISBN 13

9780309050401

Ethical Considerations for Research on Housing-Related Health Hazards Involving Children

By: Institute of Medicine,National Research Council,Division of Behavioral and Social Sciences and Education,Board on Children, Youth, and Families,Committee on Ethical Issues in Housing-Related Health Hazard Research Involving Children, Youth, and Families

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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children

Ethical Considerations for Research on Housing-Related Health Hazards Involving Children explores the ethical issues posed when conducting research designed to identify, understand, or ameliorate housing-related health hazards among children. Such research involves children as subjects and is conducted in the home and in communities. It is often conducted with children in low-income families given the disproportionate prevalence of housing-related conditions such as lead poisoning, asthma, and fatal injuries among these children. This book emphasizes five key elements to address the particular ethical concerns raised by these characteristics: involving the affected community in the research and responding to their concerns; ensuring that parents understand the essential elements of the research; adopting uniform federal guidelines for such research by all sponsors (Subpart D of 45 CFR 46); providing guidance on key terms in the regulations; and viewing research oversight as a system with important roles for researchers, IRBs and their research institutions, sponsors and regulators of research, and the community.

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216

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National Academies Press

Published Date

ISBN 10

0309164923

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9780309164924

Women and Health Research

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

By: Institute of Medicine,Division of Health Sciences Policy,Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies

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Women and Health Research

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

By: Institute of Medicine,Division of Health Sciences Policy,Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies

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262

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National Academies Press

Published Date

ISBN 10

0309050405

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9780309050401

Women and Health Research

Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers

By: Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies,Institute of Medicine

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Women and Health Research

Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers

By: Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies,Institute of Medicine

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262

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National Academies Press

Published Date

ISBN 10

030958650X

ISBN 13

9780309586504

The Human Radiation Experiments

By: United States. Advisory Committee on Human Radiation Experiments

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The Human Radiation Experiments

By: United States. Advisory Committee on Human Radiation Experiments

This book describes in fascinating detail the variety of experiments sponsored by the U.S. government in which human subjects were exposed to radiation, often without their knowledge or consent. Based on a review of hundreds of thousands of heretofore unavailable or classified documents, this Report tells a gripping story of the intricate relationship between science and the state.Under the thick veil of government secrecy, researchers conducted experiments that ranged from the mundane to such egregious violations as administering radioactive tracers to mentally retarded teenagers, injecting plutonium into hospital patients, and intentionally releasing radiation into the environment. This volume concludes with a discussion of the Committee's key findings and guidelines for changes in institutional review boards, ethics rules and policies, and balancing national security interests with individual rights. Ethicists, public health professionals and those interested in the history of medicine and Cold War history will be intrigued by the findings of this landmark report.

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655

Publisher

Oxford University Press

Published Date

ISBN 10

0195107926

ISBN 13

9780195107920

Methodological Challenges in Biomedical HIV Prevention Trials

By: Institute of Medicine,Board on Global Health,Committee on the Methodological Challenges in HIV Prevention Trials

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Methodological Challenges in Biomedical HIV Prevention Trials

By: Institute of Medicine,Board on Global Health,Committee on the Methodological Challenges in HIV Prevention Trials

The number of people infected with HIV or living with AIDS is increasing at unprecedented rates as various scientists, organizations, and institutions search for innovative solutions to combating and preventing the disease. At the request of the Bill & Melinda Gates Foundation, Methodological Challenges in Biomedical HIV Prevention Trials addresses methodological challenges in late-stage nonvaccine biomedical HIV prevention trials with a specific focus on microbicide and pre-exposure prophylaxis trials. This book recommends a number of ways to improve the design, monitoring, and analysis of late-stage clinical trials that evaluate nonvaccine biomedical interventions. The objectives include identifying a beneficial method of intervention, enhancing quantification of the impact, properly assessing the effects of using such an intervention, and reducing biases that can lead to false positive trial results. According to Methodological Challenges in Biomedical HIV Prevention Trials, the need to identify a range of effective, practical, and affordable preventive strategies is critical. Although a large number of promising new HIV prevention strategies and products are currently being tested in late-stage clinical trials, these trials face a myriad of methodological challenges that slow the pace of research and limit the ability to identify and fully evaluate effective biomedical interventions.

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270

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National Academies Press

Published Date

ISBN 10

0309114306

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9780309114301

Vaccine Safety Research, Data Access, and Public Trust

By: Institute of Medicine,Board on Health Promotion and Disease Prevention,Committee on the Review of the National Immunization Program's Research Procedures and Data Sharing Program

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Vaccine Safety Research, Data Access, and Public Trust

By: Institute of Medicine,Board on Health Promotion and Disease Prevention,Committee on the Review of the National Immunization Program's Research Procedures and Data Sharing Program

The Vaccine Safety Datalink (VSD) is a large, linked database of patient information that was developed jointly by CDC and several private managed care organizations in 1991. It includes data on vaccination histories, health outcomes, and characteristics of more than 7 million patients of eight participating health organizations. Researchers from CDC and the managed care groups have used VSD information to study whether health problems are associated with vaccinations. The subsequent VSD data sharing program was launched in 2002 to allow independent, external researchers access to information in the database. In this report, the committee that was asked to review aspects of this program recommends that two new oversight groups are needed to ensure that the policies and procedures of the VSD and its data sharing program are implemented as fairly and openly as possible.

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152

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National Academies Press

Published Date

ISBN 10

0309165245

ISBN 13

9780309165242

Society's Choices

Social and Ethical Decision Making in Biomedicine

By: Committee on the Social and Ethical Impacts of Developments in Biomedicine,Institute of Medicine

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Society's Choices

Social and Ethical Decision Making in Biomedicine

By: Committee on the Social and Ethical Impacts of Developments in Biomedicine,Institute of Medicine

Breakthroughs in biomedicine often lead to new life-giving treatments but may also raise troubling, even life-and-death, quandaries. Society's Choices discusses ways for people to handle today's bioethics issues in the context of America's unique history and culture--and from the perspectives of various interest groups. The book explores how Americans have grappled with specific aspects of bioethics through commission deliberations, programs by organizations, and other mechanisms and identifies criteria for evaluating the outcomes of these efforts. The committee offers recommendations on the role of government and professional societies, the function of commissions and institutional review boards, and bioethics in health professional education and research. The volume includes a series of 12 superb background papers on public moral discourse, mechanisms for handling social and ethical dilemmas, and other specific areas of controversy by well-known experts Ronald Bayer, Martin Benjamin, Dan W. Brock, Baruch A. Brody, H. Alta Charo, Lawrence Gostin, Bradford H. Gray, Kathi E. Hanna, Elizabeth Heitman, Thomas Nagel, Steven Shapin, and Charles M. Swezey.

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560

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National Academies Press

Published Date

ISBN 10

0309598532

ISBN 13

9780309598538

Halcion

An Independent Assessment of Safety and Efficacy Data

By: Institute of Medicine,Division of Health Sciences Policy,Committee on Halcion: An Assessment of Data Adequacy and Confidence

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Halcion

An Independent Assessment of Safety and Efficacy Data

By: Institute of Medicine,Division of Health Sciences Policy,Committee on Halcion: An Assessment of Data Adequacy and Confidence

Regulatory agencies within the United States and the United Kingdom, among several other countries, have reviewed extensively the safety and efficacy of Halcion (triazolam)â€"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.

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177

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National Academies Press

Published Date

ISBN 10

0309059763

ISBN 13

9780309059763

Integrating Clinical Research into Epidemic Response

The Ebola Experience

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Board on Global Health,Committee on Clinical Trials During the 2014-2015 Ebola Outbreak

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Integrating Clinical Research into Epidemic Response

The Ebola Experience

The 2014â€"2015 Ebola epidemic in western Africa was the longest and most deadly Ebola epidemic in history, resulting in 28,616 cases and 11,310 deaths in Guinea, Liberia, and Sierra Leone. The Ebola virus has been known since 1976, when two separate outbreaks were identified in the Democratic Republic of Congo (then Zaire) and South Sudan (then Sudan). However, because all Ebola outbreaks prior to that in West Africa in 2014â€"2015 were relatively isolated and of short duration, little was known about how to best manage patients to improve survival, and there were no approved therapeutics or vaccines. When the World Heath Organization declared the 2014-2015 epidemic a public health emergency of international concern in August 2014, several teams began conducting formal clinical trials in the Ebola affected countries during the outbreak. Integrating Clinical Research into Epidemic Response: The Ebola Experience assesses the value of the clinical trials held during the 2014â€"2015 epidemic and makes recommendations about how the conduct of trials could be improved in the context of a future international emerging or re-emerging infectious disease events.

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343

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National Academies Press

Published Date

ISBN 10

0309457793

ISBN 13

9780309457798

Women's Health Research

Progress, Pitfalls, and Promise

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Women's Health Research

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Women's Health Research

Progress, Pitfalls, and Promise

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Women's Health Research

Even though slightly over half of the U.S. population is female, medical research historically has neglected the health needs of women. However, over the past two decades, there have been major changes in government support of women's health research-in policies, regulations, and the organization of research efforts. To assess the impact of these changes, Congress directed the Department of Health and Human Services (HHS) to ask the IOM to examine what has been learned from that research and how well it has been put into practice as well as communicated to both providers and women. Women's Health Research finds that women's health research has contributed to significant progress over the past 20 years in lessening the burden of disease and reducing deaths from some conditions, while other conditions have seen only moderate change or even little or no change. Gaps remain, both in research areas and in the application of results to benefit women in general and across multiple population groups. Given the many and significant roles women play in our society, maintaining support for women's health research and enhancing its impact are not only in the interest of women, they are in the interest of us all.

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438

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National Academies Press

Published Date

ISBN 10

0309153891

ISBN 13

9780309153898

Ethical Conduct of Clinical Research Involving Children

By: Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children

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Ethical Conduct of Clinical Research Involving Children

By: Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children

In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

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445

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National Academies Press

Published Date

ISBN 10

0309133386

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9780309133388

Responsible Research

A Systems Approach to Protecting Research Participants

By: Institute of Medicine,Committee on Assessing the System for Protecting Human Research Participants

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Responsible Research

A Systems Approach to Protecting Research Participants

By: Institute of Medicine,Committee on Assessing the System for Protecting Human Research Participants

When 18-year-old Jesse Gelsinger died in a gene transfer study at the University of Pennsylvania, the national spotlight focused on the procedures used to ensure research participants' safety and their capacity to safeguard the well-being of those who volunteer for research studies. Responsible Research outlines a three-pronged approach to ensure the protection of every participant through the establishment of effective Human Research Participant Protection Programs (HRPPPs). The approach includes: Improved research review processes, Recognition and integration of research participants' contributions to the system, and Vigilant maintenance of HRPPP performance. Issues addressed in the book include the need for in-depth, complimentary reviews of science, ethics, and conflict of interest reviews; desired qualifications for investigators and reviewers; the process of informed consent; federal and institutional oversight; and the role of accreditation. Recommendations for areas of key interest include suggestions for legislative approaches, compensation for research-related injury, and the refocusing of the mission of institutional review boards. Responsible Research will be important to anyone interested in the issues that are relevant to the practice of using human subjects as research participants, but especially so to policy makers, research administrators, investigators, and research sponsorsâ€"but also including volunteers who may agree to serve as research participants.

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313

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National Academies Press

Published Date

ISBN 10

0309084881

ISBN 13

9780309084888

Ethical Considerations for Research on Housing-Related Health Hazards Involving Children

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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children

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217

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National Academies Press

Published Date

ISBN 10

0309097266

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9780309097260

Book's by Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies

Women and Health Research

Women and Health Research

Women and Health Research

Women and Health Research

Ethical Considerations for Research on Housing-Related Health Hazards Involving Children

Ethical Considerations for Research on Housing-Related Health Hazards Involving Children

Women and Health Research

Women and Health Research

Women and Health Research

Women and Health Research

The Human Radiation Experiments

The Human Radiation Experiments

Methodological Challenges in Biomedical HIV Prevention Trials

Methodological Challenges in Biomedical HIV Prevention Trials

Vaccine Safety Research, Data Access, and Public Trust

Vaccine Safety Research, Data Access, and Public Trust

Society's Choices

Society's Choices

Halcion

Halcion

Integrating Clinical Research into Epidemic Response

Integrating Clinical Research into Epidemic Response

Women's Health Research

Women's Health Research

Ethical Conduct of Clinical Research Involving Children

Ethical Conduct of Clinical Research Involving Children

Responsible Research

Responsible Research

Ethical Considerations for Research on Housing-Related Health Hazards Involving Children

Ethical Considerations for Research on Housing-Related Health Hazards Involving Children

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