Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Women and Health Research written by Institute of Medicine and published by National Academies Press. This book was released on 1994-02-01 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the nineteenth century some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning. Yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues. Women and Health Research examines the facts behind the public's perceptions about women participating as subjects in medical research. With the goal of increasing researchers' awareness of this important topic, the book explores issues related to maintaining justice (in its ethical sense) in clinical studies. Leading experts present general principles for the ethical conduct of research on womenâ€"principles that are especially important in the light of recent changes in federal policy on the inclusion of women in clinical research. Women and Health Research documents the historical shift from a paternalistic approach by researchers toward women and a disproportionate reliance on certain groups for research to one that emphasizes proper access for women as subjects in clinical studies in order to ensure that women receive the benefits of research. The book addresses present-day challenges to equity in four areas: Scientificâ€"Do practical aspects of scientific research work at cross-purposes to gender equity? Focusing on drug trials, the authors identify rationales for excluding people from research based on demographics. Social and Ethicalâ€"The authors offer compelling discussions on subjectivity in science, the evidence for male bias, and issues related to race and ethnicity, as well as the recruitment, retention, and protection of research participants. Legalâ€"Women and Health Research reviews federal research policies that affect the inclusion of women and evaluates the basis for researchers' fears about liability, citing court cases. Riskâ€"The authors focus on risks to reproduction and offspring in clinical drug trials, exploring how risks can be identified for study participants, who should make the assessment of risk and benefit for participation in a clinical study, and how legal implications could be addressed. This landmark study will be of immediate use to the research community, policymakers, women's health advocates, attorneys, and individuals.
Download or read book Compensating for Research Injuries written by United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research and published by . This book was released on 1982 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Ethics Dumping written by Doris Schroeder and published by Springer. This book was released on 2017-12-04 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book provides original, up-to-date case studies of “ethics dumping” that were largely facilitated by loopholes in the ethics governance of low and middle-income countries. It is instructive even to experienced researchers since it provides a voice to vulnerable populations from the fore mentioned countries. Ensuring the ethical conduct of North-South collaborations in research is a process fraught with difficulties. The background conditions under which such collaborations take place include extreme differentials in available income and power, as well as a past history of colonialism, while differences in culture can add a new layer of complications. In this context, up-to-date case studies of unethical conduct are essential for research ethics training.
Download or read book Women and Health Research written by Anna C. Mastroianni and published by . This book was released on 1994 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Compensating for Research Injuries Appendices written by United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research and published by . This book was released on 1982 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Workplace Injuries and Diseases written by Karen Roberts and published by W.E. Upjohn Institute. This book was released on 2005 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: The chapters in this volume were originally presented at a conference to honor Terry Thomason,held at the University of Rhode Island in March, 2004. It is about workplace safety and health and issues related to prevention and compensation for occupational injuries and illnesses, a topicto which Terry devoted much of his research life. The volume is intended to serve as a detailedintroduction to the workers' compensation novice but also provide insights to those more familiarwith the area.
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Download or read book Review of the Fialuridine FIAU Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 1995-03-14 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: In June 1993 a clinical trial of fialuridine (FIAU), a promising new medication for hepatitis B, was abruptly terminated when one of the 15 out-patients participating in the National Institutes of Health (NIH) study was suddenly hospitalized with liver failure. Although all the remaining patients were contacted and told to stop taking their medication, six more subsequently developed severe toxicity. Five patients died, and two others were probably saved from death only by having liver transplants. In response to a request from the Secretary of the Department of Health and Human Services, the IOM committee has analyzed the FIAU clinical trials, making recommendations for additional safeguards for the conduct of future clinical trials. This evaluation included the review of documents pertaining to investigational new drug submissions, protocols and consent forms from other clinical trials, as well as information available from other clinical and preclinical experience with compounds related to FIAU and its parent drug, fiacitibine (FIAC), which is metabolized to FIAU. The committee does not seek to affix responsibility for the adverse outcome of this NIH trial, but instead focuses on whether any rules or procedures governing the clinical trials process itself need to be changed, and if so, what burdens or costs such changes might place on future clinical trials.
Download or read book The Oxford Textbook of Clinical Research Ethics written by Ezekiel J. Emanuel and published by OUP USA. This book was released on 2011-02 with total page 848 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students.
Download or read book Returning Individual Research Results to Participants written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-08-23 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.
Download or read book The Belmont Report written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1978 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book A Measure of Malpractice written by Paul C. Weiler and published by Harvard University Press. This book was released on 1993 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Measure of Malpractice tells the story and presents the results of the Harvard Medical Practice Study, the largest and most comprehensive investigation ever undertaken of the performance of the medical malpractice system. The Harvard study was commissioned by the government of New York in 1986, in the midst of a malpractice crisis that had driven insurance premiums for surgeons and obstetricians in New York City to nearly $200,000 a year. The Harvard-based team of doctors, lawyers, economists, and statisticians set out to investigate what was actually happening to patients in hospitals and to doctors in courtrooms, launching a far more informed debate about the future of medical liability in the 1990s. Careful analysis of the medical records of 30,000 patients hospitalized in 1984 showed that approximately one in twenty-five patients suffered a disabling medical injury, one quarter of these as a result of the negligence of a doctor or other provider. After assembling all the malpractice claims filed in New York State since 1975, the authors found that just one in eight patients who had been victims of negligence actually filed a malpractice claim, and more than two-thirds of these claims were filed by the wrong patients. The study team then interviewed injured patients in the sample to discover the actual financial loss they had experienced: the key finding was that for roughly the same dollar amount now being spent on a tort system that compensates only a handful of victims, it would be possible to fund comprehensive disability insurance for all patients significantly disabled by a medical accident. The authors, who came to the project from very different perspectives about the present malpractice system, are now in agreement about the value of a new model of medical liability. Rather than merely tinker with the current system which fixes primary legal responsibility on individual doctors who can be proved medically negligent, legislatures should encourage health care organizations to take responsibility for the financial losses of all patients injured in their care.
Download or read book International Ethical Guidelines for Health Related Research Involving Humans written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2017-01-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.
Download or read book Redress Schemes for Personal Injuries written by Sonia Macleod and published by Bloomsbury Publishing. This book was released on 2017-11-30 with total page 731 pages. Available in PDF, EPUB and Kindle. Book excerpt: This ground-breaking book takes a fresh look at potential non-litigation solutions to providing personal injury compensation. It is the first systematic comparative study of such a large number – over forty – of personal injury compensation schemes. It covers the drivers for their creation, the frameworks under which they operate, the criteria and thresholds used, the compensation offered, the claims process, statistics on throughput and costs, and analysis of financial costings. It also considers and compares the successes and failings of these schemes. Many different types of redress providers are studied. These include the comprehensive no-blame coverage offered by the New Zealand Accident Compensation Corporation; the widely used Patient, Pharmaceutical, Motor Accident and Workers Compensation Insurance systems of the Nordic states; the far smaller issue-focused schemes like the UK Thalidomide and vCJD Trusts; vaccine damage schemes that exist in many countries; as well as motor vehicle schemes from the USA. Conclusions are drawn about the functions, essential requirements, architecture, scope, operation and performance of personal injury compensation systems. The relationships between such schemes, the courts and regulators are also discussed, and both calls and need for reforms are noted. Noting the wide calls for reform of NHS medical negligence litigation within the UK, and its replacement with a no blame approach, the authors' findings outline options for future policy in this area. This major contribution builds on general shifts from courts to ADR, and from blame to no blame in regulation, and is a work that has the potential to have a major impact on the field of personal injury redress. With contributions by Raymond Byrne, Claire Bright, Shuna Mason, Magdalena Tulibacka, Matti Urho, Mary Walker and Herbert Woopen.
Download or read book Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings written by Dobrochna Bach-Golecka and published by Springer Nature. This book was released on 2021-05-16 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book discusses compensation mechanisms and other non-judicial means that offer alternatives to court proceedings, designed and provided for within national legal regimes. Such schemes are primarily of a civil or administrative character and are mainly intended to supplement criminal liability for medical negligence. As such, the book focuses on medical malpractice and prospective medical harm from a civil law perspective. It examines the contemporary perspective of a patient-physician relationship, which has evolved from a relation of a quasi-patrimonial character into a partnership of quasi-equal parties, dealing with a medical treatment procedure as a scientific endeavor. It also reviews the extra-legal conditions that are taken into account in compensation arrangements, particularly the need to satisfy a psychological urge for conciliation and empathy on the part of medical personnel. Lastly, the book explores the responsibility of public authorities and healthcare providers to guarantee access to healthcare that is of a sufficient quality, based upon standards provided for in international (and European) law.
Download or read book Compensating for Research Injuries Report written by United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research and published by . This book was released on 1982 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt:
