International Ethical Guidelines For Health Related Research Involving Humans

Author : Council for International Organizations of Medical Sciences (CIOMS)
Publisher : World Health Organization
ISBN 13 : 9789290360889
Total Pages : 0 pages
Book Rating : 4.87/5 ( download)

DOWNLOAD NOW!

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.

Author : Council for International Organizations of Medical Sciences
Publisher : World Health Organization
ISBN 13 :
Total Pages : 116 pages
Book Rating : 4.31/5 ( download)

DOWNLOAD NOW!

Download or read book International Ethical Guidelines for Biomedical Research Involving Human Subjects written by Council for International Organizations of Medical Sciences and published by World Health Organization. This book was released on 2002 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher :
ISBN 13 :
Total Pages : 614 pages
Book Rating : 4.28/5 ( download)

DOWNLOAD NOW!

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:

Author : Council for International Organizations of Medical Sciences
Publisher :
ISBN 13 :
Total Pages : 62 pages
Book Rating : 4.43/5 ( download)

DOWNLOAD NOW!

Download or read book International Ethical Guidelines for Biomedical Research Involving Human Subjects written by Council for International Organizations of Medical Sciences and published by . This book was released on 2002 with total page 62 pages. Available in PDF, EPUB and Kindle. Book excerpt: Content: Ethical justification and scientific validity of biomedical research involving human subjects -- Ethical review committees -- Ethical review of externally sponsored research -- Individual informed consent -- Obtaining informed consent : essential information for prospective research subjects -- Obtaining informed consent : obligations of sponsors and investigators -- Inducement to participate -- Benefits and risks of study participation -- Special limitations on risk when research involves individuals who are not capable of giving informed consent -- Research in populations and communities with limited resources -- Choice of control in clinical trials -- Equitable distribution of burdens and benefits in the selection of groups of subjects in research -- Research involving vulnerable persons -- Research involving children -- Research involving individuals who by reason of mental or behavioural disorders are not capable of giving adequately informed consent -- Women as research participants -- Pregnant women as research participants -- Safeguarding confidentiality -- Right of injured subjects to treatment and compensation -- Strengthening capacity for ethical and scientific review and biomedical research -- Ethical obligation of external sponsors to provide health-care services -- Appendix 1: items to be included in a protocol (or associated documents) for biomedical research involving human subjects -- appendix 2: the Declaration of Helsinki -- Appendix 3 : the phases of clinical trials of vaccines and drugs.

Author : Ruth Macklin
Publisher : Cambridge University Press
ISBN 13 : 9780521541701
Total Pages : 292 pages
Book Rating : 4.00/5 ( download)

DOWNLOAD NOW!

Download or read book Double Standards in Medical Research in Developing Countries written by Ruth Macklin and published by Cambridge University Press. This book was released on 2004-05-27 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Publisher : World Health Organization
ISBN 13 :
Total Pages : 314 pages
Book Rating : 4.81/5 ( download)

DOWNLOAD NOW!

Download or read book Ethics and Research on Human Subjects written by Zbigniew Bańkowski and published by World Health Organization. This book was released on 1993 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: Not the issue: W.K. Mariner

Author : National Health and Medical Research Council (Australia)
Publisher :
ISBN 13 : 9780648464426
Total Pages : 0 pages
Book Rating : 4.23/5 ( download)

DOWNLOAD NOW!

Download or read book National Statement on Ethical Conduct in Human Research 2023 written by National Health and Medical Research Council (Australia) and published by . This book was released on 2023 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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 : Peter G. Smith
Publisher : Oxford University Press, USA
ISBN 13 : 0198732864
Total Pages : 479 pages
Book Rating : 4.60/5 ( download)

DOWNLOAD NOW!

Download or read book Field Trials of Health Interventions written by Peter G. Smith and published by Oxford University Press, USA. This book was released on 2015 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: "IEA, International Epidemiological Association, Welcome Trust."

Author : Council for International Organizations of Medical Sciences (CIOMS)
Publisher : Cioms
ISBN 13 : 9789290360827
Total Pages : 0 pages
Book Rating : 4.28/5 ( download)

DOWNLOAD NOW!

Download or read book Practical Aspects of Signal Detection in Pharmacovigilance written by Council for International Organizations of Medical Sciences (CIOMS) and published by Cioms. This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309133386
Total Pages : 445 pages
Book Rating : 4.88/5 ( download)

DOWNLOAD NOW!

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.