International Ethical Guidelines For Health Related Research Involving Humans

Author : Council for International Organizations of Medical Sciences (CIOMS)
Publisher : World Health Organization
Page : 0 pages
File Size : 47,5 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 : Council for International Organizations of Medical Sciences
Publisher : World Health Organization
Page : 116 pages
File Size : 52,9 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 : 40,8 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 : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher : Unknown
Page : 614 pages
File Size : 46,5 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 : Ruth Macklin
Publisher : Cambridge University Press
Page : 292 pages
File Size : 41,8 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 : Zbigniew Bańkowski,Robert J. Levine
Publisher : World Health Organization
Page : 314 pages
File Size : 40,7 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 : National Health and Medical Research Council (Australia),Australian Research Council,Universities Australia
Publisher : Unknown
Page : 0 pages
File Size : 53,8 Mb
Release : 2023
Category : Human rights
ISBN : 0648464423

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National Statement on Ethical Conduct in Human Research 2023 by National Health and Medical Research Council (Australia),Australian Research Council,Universities Australia Pdf

"The purpose of the National Statement is to promote ethically good human research. Fulfilment of this purpose requires that participants be accorded the respect and protection that is due to them. It also involves the fostering of research that is of benefit to the community. The National Statement is therefore designed to clarify the responsibilities of: institutions and researchers for the ethical design, conduct and dissemination of results of human research ; and review bodies in the ethics review of research. The National Statement will help them to meet their responsibilities: to identify issues of ethics that arise in the design, review and conduct of human research, to deliberate about those ethical issues, and to justify decisions about them"--Page 6.

Author : Zbigniew Bankowski,Council for International Organizations of Medical Sciences
Publisher : Unknown
Page : 206 pages
File Size : 54,5 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 : Robert J. Levine,Samuel Gorovitz,James Gallagher
Publisher : World Health Organization
Page : 312 pages
File Size : 55,9 Mb
Release : 2000
Category : Bioethics
ISBN : UOM:39015050529257

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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 : Peter G. Smith,R. H. Morrow,Richard H. Morrow,David A. Ross
Publisher : Oxford University Press, USA
Page : 479 pages
File Size : 49,5 Mb
Release : 2015
Category : Medical
ISBN : 9780198732860

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Field Trials of Health Interventions by Peter G. Smith,R. H. Morrow,Richard H. Morrow,David A. Ross Pdf

"IEA, International Epidemiological Association, Welcome Trust."

Author : Council for International Organizations of Medical Sciences
Publisher : World Health Organization
Page : 0 pages
File Size : 44,6 Mb
Release : 2009
Category : Bioethics
ISBN : 929036081X

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International Ethical Guidelines for Epidemiological Studies by Council for International Organizations of Medical Sciences Pdf

This 2009 text supersedes the 1991 International Guidelines for Ethical Review of Epidemiological Studies. Its core consists of 24 guidelines with commentaries. A section outlines the historical background and the revision process, and includes an introduction, an account of earlier instruments and guidelines and a statement of general ethical principles. An Appendix lists the items to be included in a research protocol to be submitted for epidemiological research involving human subjects. Also included in the appendices is the World Medical Association's 2008 Declaration of Helsinki. [Ed.].

Author : Council for International Organizations of Medical Sciences (CIOMS)
Publisher : Cioms
Page : 0 pages
File Size : 52,6 Mb
Release : 2010
Category : Drug monitoring
ISBN : 9290360828

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Practical Aspects of Signal Detection in Pharmacovigilance by Council for International Organizations of Medical Sciences (CIOMS) Pdf

In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems. Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled.

Author : David B. Resnik
Publisher : Springer
Page : 316 pages
File Size : 51,5 Mb
Release : 2018-01-09
Category : Philosophy
ISBN : 9783319687568

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The Ethics of Research with Human Subjects by David B. Resnik Pdf

This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust. It explains how trust is important not only between investigators and subjects but also between and among other stakeholders involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. The book argues that trust should be viewed as a distinct ethical principle for research with human subjects that complements other principles, such as autonomy, beneficence, non-maleficence, and justice. The book applies the principle of trust to numerous issues, including informed consent, confidentiality, risk minimization, risks and benefits, protection of vulnerable subjects, experimental design, research integrity, and research oversight.This work also includes discussions of the history of research involving human subjects, moral theories and principles, contemporary cases, and proposed regulatory reforms. The book is useful for undergraduate and graduate students studying ethical policy issues related to research with human subjects, as well as for scientists and scholars who are interested in thinking about this topic from the perspective of trust.

Author : Anonim
Publisher : Unknown
Page : 218 pages
File Size : 51,7 Mb
Release : 2014
Category : Human experimentation in medicine
ISBN : 1100254730

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Tri-council Policy Statement by Anonim Pdf

This document is a joint policy of Canada's three federal research agencies, the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada. This updated version replaces the TCPS 2 (2010) as the official human research ethics policy of these agencies.

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories
Publisher : National Academies Press
Page : 399 pages
File Size : 42,8 Mb
Release : 2018-09-23
Category : Medical
ISBN : 9780309475174

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Returning Individual Research Results to Participants by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories Pdf

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.