Download or read book Competence and Vulnerability in Biomedical Research written by Philip Bielby and published by Springer Science & Business Media. This book was released on 2008-09-16 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: Enhanced knowledge of the nature and causes of mental disorder have led increasingly to a need for the recruitment of ‘cognitively vulnerable’ participants in biomedical research. These individuals often fall into the ‘grey area’ between obvious decisional competence and obvious decisional incompetence and, as a result, may not be recognised as having the legal capacity to make such decisions themselves. At the core of the ethical debate surrounding the participation of cognitively vulnerable individuals in research is when, if at all, we should judge them decisionally and legally competent to consent to or refuse research participation on their own behalf and when they should be judged incompetent in this respect. In this book, the author develops a novel justificatory framework for making judgments of decisional competence to consent to biomedical research with reference to five groups of cognitively vulnerable individuals - older children and adolescents, adults with intellectual disabilities, adults with depression, adults with schizophrenia and adults with dementia, including Alzheimer’s disease. Using this framework, the author argues that we can make morally defensible judgments about the competence or incompetence of a potential participant to give contemporaneous consent to research by having regard to whether a judgment of competence would be more harmful to the ‘generic rights’ of the potential participant than a judgment of incompetence. The argument is also used to justify an account of supported decision-making in research, and applied to evaluate the extent to which this approach is evident in existing ethical guidelines and legal provisions. The book will be of interest to bioethicists as well as psychiatrists and academic medical lawyers interested in normative questions raised by the concepts of competence and capacity.
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 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 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 Ethical and Policy Issues in Research Involving Human Participants written by National Bioethics National Bioethics Advisory Commission and published by CreateSpace. This book was released on 2015-03-17 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt: Protecting the rights and welfare of those who volunteer to participate in research is a fundamental tenet of ethical research. A great deal of progress has been made in recent decades in changing the culture of research to incorporate more fully this ethical responsibility into protocol design and implementation. In the 1960s and 1970s, a series of scandals concerning social science research and medical research conducted with the sick and the illiterate underlined the need to systematically and rigorously protect individuals in research (Beecher 1966; Faden and Beauchamp 1986; Jones 1981; Katz 1972; Tuskegee Syphilis Study Ad Hoc Advisory Panel 1973). However, the resulting system of protections that evolved out of these rising concerns-although an improvement over past practices-is no longer sufficient. It is a patchwork arrangement associated with the receipt of federal research funding or the regulatory review and approval of new drugs and devices. In addition, it depends on the voluntary cooperation of investigators, research institutions, and professional societies across a wide array of research disciplines. Increasingly, the current system is being viewed as uneven in its ability to simultaneously protect the rights and welfare of research participants and promote ethically responsible research.
Download or read book The Limits of Consent written by Oonagh Corrigan and published by OUP Oxford. This book was released on 2009-01-29 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since its inception as an international requirement to protect patients and healthy volunteers taking part in medical research, informed consent has become the primary consideration in research ethics. Despite the ubiquity of consent, however, scholars have begun to question its adequacy for contemporary biomedical research. The Limits of Consent explores this issue, reviewing the application of consent to genetic research, clinical trials, and research involving vulnerable populations. For example, in genetic research, information obtained from an autonomous research participant may have significant bearing on the interests of family members who have not consented to the study. This casts doubt on the adequacy of consent for such studies. The Limits of Consent also questions the assumptions that informed consent is essential and that it satisfactorily protects the principle of individual autonomy. It reviews recent empirical studies that challenge the possibility of truly informed consent and highlights the extent to which consent is governed by social norms and expectations. It also investigates how consent might be of secondary importance in some circumstances, for example when a research project appears to protect a public or community interest. Building on these observations, the authors make bold attempts to outline constructive solutions to the problems identified with perspectives from medicine, law, philosophy and sociology. This fascinating and provocative exploration of the limits of informed consent will appeal to ethicists, social scientists, health lawyers, clinical researchers, research ethics committee members, policy makers, and others with an interest in bioethics.
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 Cognitive Vulnerability to Depression written by Rick E. Ingram and published by Guilford Press. This book was released on 1998-03-15 with total page 330 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recurrence of depressive episodes is not uncommon, even after successful treatment. What makes some people more vulnerable than others to this devastating disorder? Do depressive individuals have characteristic thinking and reasoning styles? By what means can cognitive antecedents to affective disorders be identified at different stages in the lifespan, and how can the risks they represent be mitigated? An important resource for anyone who seeks to understand or treat depression, this volume synthesizes the most current research and theory on cognitive vulnerability. Covering methodological, theoretical, and empirical issues, the authors review cognitive theories of depression; explicate and assess the vulnerability approach to psychopathology; and formulate an integrative view of the key proximal and distal antecedents of depression in adults.
Download or read book Clinical Trials in Vulnerable Populations written by Milica Prostran and published by BoD – Books on Demand. This book was released on 2018-05-09 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book Clinical Trials in Vulnerable Populations has 12 chapters divided into 4 sections: Minority Patients, Women, Medically Compromised Patients and Clinical Trials. Contributing authors came from several countries, from Serbia to Turkey. The book was edited by Professor Milica Prostran MD, Ph.D., specialist in Clinical Pharmacology. The potential reader is shown a modern approach to clinical trials in vulnerable populations, from different points of view. The chapters deal at length and clarity with their topics. Finally, I believe, that this book I edited and reviewed with dedication will capture the attention of many readers, from medical students to practicing doctors and pharmacists. All of whom must consider this very important field of medicine: clinical trials in vulnerable patients.
Download or read book The SAGE Handbook of Health Care Ethics written by Ruth Chadwick and published by SAGE Publications. This book was released on 2011-02-07 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: The SAGE Handbook of Healthcare Ethics is an influential collection of work by leading scholars on the fundamental and emerging themes which define healthcare ethics. This authoritative Handbook brings together experts with backgrounds in philosophy, sociology, law, public policy and the health professions and reflects the increasing impact of globalization and the dynamic advances in the fields of bioscience and genetics, which keep ethics at the centre of debates about the future direction of healthcare. Combining international and interdisciplinary perspectives, the Handbook provides a cutting-edge account of debates in five key areas: Health Care Ethics in an Era of Globalization Beginning and End of Life Vulnerable Populations Research Ethics and Technologies Public Health and Human Rights
Download or read book Conducting Biosocial Surveys written by National Research Council and published by National Academies Press. This book was released on 2010-10-02 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent years have seen a growing tendency for social scientists to collect biological specimens such as blood, urine, and saliva as part of large-scale household surveys. By combining biological and social data, scientists are opening up new fields of inquiry and are able for the first time to address many new questions and connections. But including biospecimens in social surveys also adds a great deal of complexity and cost to the investigator's task. Along with the usual concerns about informed consent, privacy issues, and the best ways to collect, store, and share data, researchers now face a variety of issues that are much less familiar or that appear in a new light. In particular, collecting and storing human biological materials for use in social science research raises additional legal, ethical, and social issues, as well as practical issues related to the storage, retrieval, and sharing of data. For example, acquiring biological data and linking them to social science databases requires a more complex informed consent process, the development of a biorepository, the establishment of data sharing policies, and the creation of a process for deciding how the data are going to be shared and used for secondary analysis-all of which add cost to a survey and require additional time and attention from the investigators. These issues also are likely to be unfamiliar to social scientists who have not worked with biological specimens in the past. Adding to the attraction of collecting biospecimens but also to the complexity of sharing and protecting the data is the fact that this is an era of incredibly rapid gains in our understanding of complex biological and physiological phenomena. Thus the tradeoffs between the risks and opportunities of expanding access to research data are constantly changing. Conducting Biosocial Surveys offers findings and recommendations concerning the best approaches to the collection, storage, use, and sharing of biospecimens gathered in social science surveys and the digital representations of biological data derived therefrom. It is aimed at researchers interested in carrying out such surveys, their institutions, and their funding agencies.
Download or read book Research Involving Participants with Cognitive Disability and Differences written by M. Ariel Cascio and published by . This book was released on 2019 with total page 305 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This volume provides timely, multidisciplinary insights into the ethical aspects of research that includes participants with cognitive disability and differences. These include conditions such as intellectual disability, autism, mild cognitive impairment (MCI), and psychiatric diagnoses." - Provided by publisher.
Download or read book The Law and Ethics of Dementia written by Charles Foster and published by Bloomsbury Publishing. This book was released on 2014-12-01 with total page 562 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dementia is a topic of enormous human, medical, economic, legal and ethical importance. Its importance grows as more of us live longer. The legal and ethical problems it raises are complex, intertwined and under-discussed. This book brings together contributions from clinicians, lawyers and ethicists – all of them world leaders in the field of dementia – and is a comprehensive, scholarly yet accessible library of all the main (and many of the fringe) perspectives. It begins with the medical facts: what is dementia? Who gets it? What are the current and future therapeutic and palliative options? What are the main challenges for medical and nursing care? The story is then taken up by the ethicists, who grapple with questions such as: is it legitimate to lie to dementia patients if that is a kind thing to do? Who is the person whose memory, preferences and personality have all been transformed by their disease? Should any constraints be placed on the sexual activity of patients? Are GPS tracking devices an unpardonable interference with the patient's freedom? These issues, and many more, are then examined through legal lenses. The book closes with accounts from dementia sufferers and their carers. It is the first and only book of its kind, and the authoritative text.
Download or read book Index to Theses with Abstracts Accepted for Higher Degrees by the Universities of Great Britain and Ireland and the Council for National Academic Awards written by and published by . This book was released on 2007 with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Children s Competence to Consent written by Gary B. Melton and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Ethical Issues in Neurology written by James L. Bernat and published by Lippincott Williams & Wilkins. This book was released on 2008 with total page 552 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by an eminent authority from the American Academy of Neurology's Committee on Ethics, Law, and Humanities, this book is an excellent text for all clinicians interested in ethical decision-making. The book features outstanding presentations on dying and palliative care, physician-assisted suicide and voluntary active euthanasia, medical futility, and the relationship between ethics and the law. New chapters in this edition discuss how clinicians resolve ethical dilemmas in practice and explore ethical issues in neuroscience research. Other highlights include updated material on palliative sedation, advance directives, ICU withdrawal of life-sustaining therapy, gene therapy, the very-low-birth-weight premature infant, the developmentally disabled patient, informed consent, organizational ethics, brain death controversies, and fMRI and PET studies relating to persistent vegetative state.
Download or read book Issues in Biomedical Research Involving Cognitively Impaired Subjects written by and published by . This book was released on 1995 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt:
