International Ethical Guidelines for Health-Related Research Involving Humans PDF Download
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Author: Council for International Organizations of Medical Sciences (CIOMS)
Publisher: World Health Organization
ISBN: 9789290360889
Category : Bioethics
Languages : en
Pages : 0
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Book Description
"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 (CIOMS)
Publisher: World Health Organization
ISBN: 9789290360889
Category : Bioethics
Languages : en
Pages : 0
Get Book Here
Book Description
"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:
Category : Law
Languages : en
Pages : 116
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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: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher:
ISBN:
Category : Ethics, Medical
Languages : en
Pages : 614
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Book Description
Author: David B. Resnik
Publisher: Springer
ISBN: 3319687565
Category : Philosophy
Languages : en
Pages : 320
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Book Description
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: Zbigniew Bańkowski
Publisher: World Health Organization
ISBN:
Category : Medical
Languages : en
Pages : 314
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Book Description
Not the issue: W.K. Mariner
Author: Graeme Laurie
Publisher:
ISBN: 1108576095
Category : Law
Languages : en
Pages : 444
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Book Description
The definitive reference guide to designing scientifically sound and ethically robust medical research, considering legal, ethical and practical issues.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241547723
Category : Medical
Languages : en
Pages : 212
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Book Description
I. Defining "research"--II. Issues in study design . -- III. Harm and benefit -- IV. Voluntary informed consent -- V. Standard of care -- VI. Obligations to participants and communities -- VII. Privacy and confidentiality -- VIII. Professional ethics.
Author: Council for International Organizations of Medical Sciences (CIOMS)
Publisher: Cioms
ISBN: 9789290360827
Category : Drug monitoring
Languages : en
Pages : 0
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Book Description
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: M. Elizabeth Halloran
Publisher: Springer Science & Business Media
ISBN: 0387686363
Category : Medical
Languages : en
Pages : 397
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Book Description
As well as being a reference for the design, analysis, and interpretation of vaccine studies, the text covers all design and analysis stages, from vaccine development to post-licensure surveillance, presenting likelihood, frequentists, and Bayesian approaches.
Author: Ron Iphofen
Publisher: Springer
ISBN: 9783030167585
Category : Philosophy
Languages : en
Pages : 0
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Book Description
This handbook is a ‘one-stop shop’ for current information, issues and challenges in the fields of research ethics and scientific integrity. It provides a comprehensive coverage of research and integrity issues, both within researchers’ ‘home’ discipline and in relation to similar concerns in other disciplines. The handbook covers common elements shared by disciplines and research professions, such as consent, privacy, data management, fraud, and plagiarism. The handbook also includes contributions and perspectives from academics from various disciplines, treating issues specific to their fields. Readers are able to quickly source the most comprehensive and up-to-date information, protagonists, issues and challenges in the field. Experienced researchers keen to assess their own perspectives, as well as novice researchers aiming to establish the field, will equally find the handbook of interest and practical benefit. It saves them a great deal of time in sourcing the disparate available material in these fields and it is the first ‘port of call’ for a wide range of researchers, research advisors, funding agencies and research reviewers.The most important feature is the handbook’s ability to provide practical advice and guidance to researchers in a wide range of disciplines and professions to help them ‘think through’ their approach to difficult questions related to the principles, values and standards they need to bring to their research practice.
