International Ethical Guidelines for Health-Related Research Involving Humans
International Ethical Guidelines for Health-Related Research Involving Humans

Author: Council for International Organizations of Medical Sciences (CIOMS)

Publisher: World Health Organization

Published: 2017-01-31

Total Pages: 0

ISBN-13: 9789290360889

DOWNLOAD EBOOK

"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.

International Ethical Guidelines for Biomedical Research Involving Human Subjects
International Ethical Guidelines for Biomedical Research Involving Human Subjects

Author: Council for International Organizations of Medical Sciences

Publisher: World Health Organization

Published: 2002

Total Pages: 116

ISBN-13:

DOWNLOAD EBOOK

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.

The Belmont Report
The Belmont Report

Author: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Publisher:

Published: 1978

Total Pages: 614

ISBN-13:

DOWNLOAD EBOOK

International Ethical Guidelines for Biomedical Research Involving Human Subjects
International Ethical Guidelines for Biomedical Research Involving Human Subjects

Author: Council for International Organizations of Medical Sciences

Publisher:

Published: 2002

Total Pages: 62

ISBN-13:

DOWNLOAD EBOOK

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.

Double Standards in Medical Research in Developing Countries
Double Standards in Medical Research in Developing Countries

Author: Ruth Macklin

Publisher: Cambridge University Press

Published: 2004-05-27

Total Pages: 292

ISBN-13: 9780521541701

DOWNLOAD EBOOK

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.

Field Trials of Health Interventions
Field Trials of Health Interventions

Author: Peter G. Smith

Publisher:

Published: 2015

Total Pages: 479

ISBN-13: 0198732864

DOWNLOAD EBOOK

This is an open access title available under the terms of a CC BY-NC 4.0 International licence. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. Before new interventions are released into disease control programmes, it is essential that they are carefully evaluated in field trials'. These may be complex and expensive undertakings, requiring the follow-up of hundreds, or thousands, of individuals, often for long periods. Descriptions of the detailed procedures and methods used in the trials that have been conducted have rarely been published. A consequence of this, individuals planning such trials have few guidelines available and little access to knowledge accumulated previously, other than their own. In this manual, practical issues in trial design and conduct are discussed fully and in sufficient detail, that Field Trials of Health Interventions may be used as a toolbox' by field investigators. It has been compiled by an international group of over 30 authors with direct experience in the design, conduct, and analysis of field trials in low and middle income countries and is based on their accumulated knowledge and experience. Available as an open access book via Oxford Medicine Online, this new edition is a comprehensive revision, incorporating the new developments that have taken place in recent years with respect to trials, including seven new chapters on subjects ranging from trial governance, and preliminary studies to pilot testing.

Adjusting the Focus
Adjusting the Focus

Author: Angela Ballantyne

Publisher:

Published: 2019

Total Pages: 0

ISBN-13:

DOWNLOAD EBOOK

This paper contends that a research ethics approach to the regulation of health data research is unhelpful in the era of population-level research and big data because it results in a primary focus on consent (meta-, broad, dynamic and/or specific consent). Two recent guidelines - the 2016 WMA Declaration of Taipei on ethical considerations regarding health databases and biobanks and the revised CIOMS International ethical guidelines for health-related research involving humans - both focus on the growing reliance on health data for research. But as research ethics documents, they remain (to varying degrees) focused on consent and individual control of data use. Many current and future uses of health data make individual consent impractical, if not impossible. Many of the risks of secondary data use apply to communities and stakeholders rather than individual data subjects. Shifting from a research ethics perspective to a public health lens brings a different set of issues into view: how are the benefits and burdens of data use distributed, how can data research empower communities, who has legitimate decision-making capacity? I propose that a public health ethics framework - based on public benefit, proportionality, equity, trust and accountability - provides more appropriate tools for assessing the ethical uses of health data. The main advantage of a public health approach for data research is that it is more likely to foster debate about power, justice and equity and to highlight the complexity of deciding when data use is in the public interest.

Practical Aspects of Signal Detection in Pharmacovigilance
Practical Aspects of Signal Detection in Pharmacovigilance

Author: Council for International Organizations of Medical Sciences (CIOMS)

Publisher: Cioms

Published: 2010

Total Pages: 0

ISBN-13: 9789290360827

DOWNLOAD EBOOK

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.

The Ethics of Research with Human Subjects
The Ethics of Research with Human Subjects

Author: David B. Resnik

Publisher: Springer

Published: 2018-01-09

Total Pages: 320

ISBN-13: 3319687565

DOWNLOAD EBOOK

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.