Author: James V. Lavery Publisher: ISBN: 0195179226 Category : Medical Languages : en Pages : 401
Book Description
Ethical Issues in International Biomedical Research is the definitive book on the ethics of research involving human subjects in developing countries. Using 21 actual case studies, it covers the most controversial topics, including the ethics of placebo research in Africa, what benefits should be provided to the community after completion of a research trial, how to address conflicts between IRBs in developed and developing countries, and undue inducement of poor people in developing countries. Each case is accompanied by two expert commentaries, written by many of the worlds leading experts in bioethics as well as new voices with research experience in developing countries. No other volume has this scope. Students in bioethics, public and international health, and ethics will find this book particularly useful.
Author: Matti Häyry Publisher: Rodopi ISBN: 9042021799 Category : Medical Languages : en Pages : 279
Book Description
This book deals with the international assessment and regulation of biomedical research. In its chapters, some of the leading figures in today's bioethics address questions centred on global development, scientific advances, and vulnerability. The series Values In Bioethics makes available original philosophical books in all areas of bioethics, including medical and nursing ethics, health care ethics, research ethics, environmental ethics, and global bioethics.
Author: Baruch A. Brody Publisher: Oxford University Press, USA ISBN: 9780195090079 Category : Medical Languages : en Pages : 412
Book Description
Examines the many ethical issues related to biomedical research, including the use of animals in research, research on human subjects, clinical trials, international research ethics policies, and other related topics.
Author: National Academies of Sciences, Engineering, and Medicine Publisher: National Academies Press ISBN: 0309676630 Category : Medical Languages : en Pages : 133
Book Description
On February 26, 2020, the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine hosted a 1-day public workshop in Washington, DC, to examine current and emerging bioethical issues that might arise in the context of biomedical research and to consider research topics in bioethics that could benefit from further attention. The scope of bioethical issues in research is broad, but this workshop focused on issues related to the development and use of digital technologies, artificial intelligence, and machine learning in research and clinical practice; issues emerging as nontraditional approaches to health research become more widespread; the role of bioethics in addressing racial and structural inequalities in health; and enhancing the capacity and diversity of the bioethics workforce. This publication summarizes the presentations and discussions from the workshop.
Author: Robert J. Levine Publisher: World Health Organization ISBN: Category : Bioethics Languages : en Pages : 312
Book Description
Records the papers and commentaries, with an edited discussion, presented at an international consultation convened by the Council for International Organizations of Medical Sciences (CIOMS) to guide revision of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The Guidelines, first issued in 1982 and then revised in 1993, are being updated and expanded to address a number of new and especially challenging ethical issues. These include issues raised by international collaborative trials of drugs in developing countries, especially expensive drugs, and the use of placebo controls in randomized clinical trials. Others arise from the complexity of research in human genetics, including stem-cell research, and in reproductive biology. Throughout, particular attention is given to the difficult questions that arose during the heated debate over trials in developing countries, of short-duration zidovudine (AZT) therapy to reduce perinatal transmission of HIV. The International Ethical Guidelines for Biomedical Research Involving Human Subjects set out a code of research ethics that is widely used by ethical review committees and other bodies responsible for reviewing and overseeing the ethical design of studies and conduct of research. The revision of the Guidelines is being coordinated by CIOMS, in collaboration with WHO. The consultation centered on seven specially commissioned papers, authored by international experts that explore some of the more difficult issues in depth. Each is followed by an invited commentary, often expressing opposing views, and a summary of the issues or conclusions that emerged during the subsequent debate. The first paper, on justice in international research, deals with the question of whether proposals for research to be conducted in a developing country should make provision for future access of the population involved to the interventions under investigation. Also considered are questions that arise when research uses populations in developing countries to investigate interventions that will be of exclusive benefit to the industrialized world. Case studies of recent drug trials and their research protocols are discussed to illustrate circumstances in which use of populations in developing countries is justified or constitutes exploitation. Ethical challenges of the randomized controlled trial are considered in the second paper, which includes a discussion on the equitable distribution of benefits and risks, the use of placebo for controls, and the obligation to ensure that the participation of controls does not compromise their medical care or endanger their health. A paper on informed consent in international health research considers how cultural factors influence communication and language in the informed-consent process and respect for privacy and confidentiality in the research. Subsequent papers address issues in genetics research and reproductive biology, including the moral status of fetuses and the use of embryos in research, and examine the contribution which international human rights instruments can make in the application of the general principles of ethics to research involving human subjects. The final paper gives an overview of capacity building and the role of communities in international biomedical research.
Author: Patricia A. Marshall Publisher: World Health Organization ISBN: 9241563389 Category : Medical Languages : en Pages : 89
Book Description
This review considers ethical challenges to research design and informed consent in biomedical and behavioral studies conducted in resource-poor settings. A review of the literature explores relevant social, cultural, and ethical issues in the conduct of biomedical and social health research in developing countries. Ten case vignettes illustrate ethical challenges that arise in international research with culturally diverse populations. Recommendations for researchers and policy-makers concerned about ethical practices in multinational studies conducted in resource-poor settings are also listed.
Author: Ronald M. Green Publisher: OUP Oxford ISBN: 0191563021 Category : Philosophy Languages : en Pages : 368
Book Description
Medical care and biomedical research are rapidly becoming global. Ethical questions that once arose only in the narrow context of the physician-patient relationship in relatively prosperous societies are now being raised across societies, cultures, and continents. For example, what should be the "standard of care" for clinical trials of medical innovations in poorer countries? Are researchers obligated to compare new therapies or drugs with the best known ones available, or can they use as a benchmark the actual treatments (or lack of treatments) available to poor people? Should pharmaceutical companies seeking to lower the costs of new drug trials be allowed to enrol citizens of less developed countries in them even when those individuals cannot afford and will not be eligible for the resulting drugs? More generally, should the norms of medicine and research be the same across cultures or can they adapt to local social, economic, or religious conditions? Global Bioethics gathers some of the world's leading bioethicists to explore many of the new questions raised by the globalization of medical care and biomedical research. Among the topics covered are the impact of globalization on the norms of medical ethics, the conduct of international research, the ethics of international collaborations, challenges to medical professionalism in the international setting, and the relation of religion to global bioethics.
Author: Council for International Organizations of Medical Sciences Publisher: World Health Organization ISBN: Category : Bioethics Languages : en Pages : 116
Book Description
The present text is the revised/updated version of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. It consists of 21 guidelines with commentaries. A prefatory section outlines the historical background and the revision process and includes an introduction an account of earlier instruments and guidelines a statement of ethical principles and a preamble. An Appendix lists the items to be included in the research protocol to be submitted for scientific and ethical review and clearance. The Guidelines relate mainly to ethical justification and scientific validity of research; ethical review; informed consent; vulnerability - of individuals groups communities and populations; women as research subjects; equity regarding burdens and benefits; choice of control in clinical trials; confidentiality; compensation for injury; strengthening of national or local capacity for ethical review; and obligations of sponsors to provide health-care services. They are designed to be of use to countries in defining national policies on the ethics of biomedical research involving human subjects applying ethical standards in local circumstances and establishing or improving ethical review mechanisms. A particular aim is to reflect the conditions and the needs of low-resource countries and the implications for multinational or transnational research in which they may be partners.
Author: James V. Lavery
Author: Matti Häyry
Author: United States. National Bioethics Advisory Commission
Author: Baruch A. Brody
Author: United States. National Bioethics Advisory Commission
Author: National Academies of Sciences, Engineering, and Medicine
Author: Robert J. Levine
Author: Patricia A. Marshall
Author: Ronald M. Green
Author: Council for International Organizations of Medical Sciences