International Ethical Guidelines For Biomedical Research Involving Human Subjects

Author : Council for International Organizations of Medical Sciences
Publisher : World Health Organization
Page : 116 pages
File Size : 54,8 Mb
Release : 2002
Category : Bioethics
ISBN : UOM:39015061025931

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International Ethical Guidelines for Biomedical Research Involving Human Subjects by Council for International Organizations of Medical Sciences Pdf

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 : Anonim
Publisher : Unknown
Page : 128 pages
File Size : 52,7 Mb
Release : 1994
Category : Electronic
ISBN : OCLC:257107218

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International Ethical Guidelines for Biomedical Research Involving Human Subjects by Anonim Pdf

Author : Council for International Organizations of Medical Sciences (CIOMS)
Publisher : World Health Organization
Page : 0 pages
File Size : 54,7 Mb
Release : 2017-01-31
Category : Bioethics
ISBN : 9290360887

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International Ethical Guidelines for Health-Related Research Involving Humans by Council for International Organizations of Medical Sciences (CIOMS) Pdf

"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.

Author : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher : Unknown
Page : 614 pages
File Size : 45,9 Mb
Release : 1978
Category : Human experimentation in medicine
ISBN : UCSD:31822000897728

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The Belmont Report by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Pdf

Author : Robert J. Levine,Samuel Gorovitz,James Gallagher
Publisher : World Health Organization
Page : 312 pages
File Size : 48,8 Mb
Release : 2000
Category : Bioethics
ISBN : UOM:39015051312711

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Biomedical Research Ethics by Robert J. Levine,Samuel Gorovitz,James Gallagher Pdf

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 : Zbigniew Bańkowski,Robert J. Levine
Publisher : World Health Organization
Page : 314 pages
File Size : 53,6 Mb
Release : 1993
Category : Bioethics
ISBN : UOM:39015032442181

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Ethics and Research on Human Subjects by Zbigniew Bańkowski,Robert J. Levine Pdf

Not the issue: W.K. Mariner

Author : Ruth Macklin
Publisher : Cambridge University Press
Page : 292 pages
File Size : 54,8 Mb
Release : 2004-05-27
Category : Law
ISBN : 0521541700

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Double Standards in Medical Research in Developing Countries by Ruth Macklin Pdf

Recent international developments show that essential medications can be made affordable and accessible to developing countries, and that double standards need not prevail. This is the first book to examine these issues, drawing the bold conclusion that double standards in medical research are ethically unacceptable."--BOOK JACKET.

Author : United States. National Bioethics Advisory Commission
Publisher : Unknown
Page : 166 pages
File Size : 49,9 Mb
Release : 2001
Category : Clinical trials
ISBN : IND:30000078894023

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Ethical and Policy Issues in International Research by United States. National Bioethics Advisory Commission Pdf

Author : United States. National Bioethics Advisory Commission
Publisher : Unknown
Page : 174 pages
File Size : 46,6 Mb
Release : 2001
Category : Bioethics
ISBN : UOM:39015042253453

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Ethical and Policy Issues in International Research: Report and recommendations of the National Bioethics Advisory Commission by United States. National Bioethics Advisory Commission Pdf

Author : James V. Lavery
Publisher : Unknown
Page : 401 pages
File Size : 51,6 Mb
Release : 2007
Category : Medical
ISBN : 9780195179224

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Ethical Issues in International Biomedical Research by James V. Lavery Pdf

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 : Sana Loue
Publisher : Springer Science & Business Media
Page : 256 pages
File Size : 48,7 Mb
Release : 2007-05-08
Category : Medical
ISBN : 9780306468391

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Textbook of Research Ethics by Sana Loue Pdf

This textbook provides a brief history of human experimentation and reviews various theories of ethics from which the principles and rules that govern this research are derived. All relevant international documents and national regulations, policies and memoranda are referred to extensively to assist in addressing issues that regularly arise during the course of research involving human subjects. It includes case examples and exercises and is of interest to students and experienced researchers.

Author : Patricia A. Marshall,Patricia Loomis Marshall
Publisher : World Health Organization
Page : 89 pages
File Size : 46,6 Mb
Release : 2007
Category : Medical
ISBN : 9789241563383

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Ethical Challenges in Study Design and Informed Consent for Health Research in Resource-poor Settings by Patricia A. Marshall,Patricia Loomis Marshall Pdf

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 : Zbigniew Bankowski,Council for International Organizations of Medical Sciences
Publisher : Unknown
Page : 206 pages
File Size : 40,6 Mb
Release : 1991
Category : Bioethics
ISBN : CORNELL:31924059266316

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Ethics and Epidemiology by Zbigniew Bankowski,Council for International Organizations of Medical Sciences Pdf

Author : Dr. Jane Barrett
Publisher : Inst of Clinical Research
Page : 76 pages
File Size : 52,5 Mb
Release : 2006
Category : Clinical medicine
ISBN : 9781905238026

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Ethics in Clinical Research by Dr. Jane Barrett Pdf

Until recently there has been no formal law covering many aspects of clinical research, making the ethical and scientific guidelines more important. Rapidly changing law gives researchers challenges when deciding research policies. There is relatively little teaching on the ethics of clinical research and this monograph intends to trigger thought and discussion as well as provide guidance in decision-making.

Author : Aurora Plomer
Publisher : Routledge
Page : 335 pages
File Size : 47,9 Mb
Release : 2013-03-04
Category : Law
ISBN : 9781135338329

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The Law and Ethics of Medical Research by Aurora Plomer Pdf

The growing globalization of medical research and the application of new biotechnologies in morally contested areas has forced a revision of international ethical guidelines. This book examines the controversies surrounding biomedical research in the twenty-first century from a human rights perspective, analyzing the evolution and changes in form and content of international instruments regulating the conduct of biomedical research. The approach adopted is comparative and includes an evaluation of human rights and UK and US law on embryonic stem cell research, the HIV/AIDS trials in the developing world, the Alder Hey Inquiry and the human radiation and nerve gas experiments on human subjects in the US and the UK. This is the first book to analyze some of the major issues in biomedical research today from an international, comparative human rights perspective.