The Ethics of Research Involving Human Subjects PDF Download

Author: David B. Resnik
Publisher: Springer
ISBN: 3319687565
Category : Philosophy
Languages : en
Pages : 316

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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: Carl H. Coleman
Publisher:
ISBN: 9780327176930
Category : Human experimentation in medicine
Languages : en
Pages :

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Author: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher:
ISBN:
Category : Human experimentation in medicine
Languages : en
Pages :

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Author: Nancy M. P. King
Publisher: UNC Press Books
ISBN: 0807876062
Category : Medical
Languages : en
Pages : 294

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Book Description
Across a broad range of disciplines--in medicine, social science, and the humanities--researchers, scholars, teachers, and administrators increasingly are looking for new ways to approach ethical issues in research with human subjects. Questions about how relationships between funders and researchers should affect research design, for example, or whether the potential benefits of research can outweigh the importance of its subjects' interests are inadequately addressed by the prevailing, regulation-based research ethics paradigm. This book constitutes a reexamination of research ethics. It combines case studies and commentaries by a multidisciplinary group of scholars and researchers to explore such topics as informed consent, conflict of interest, confidentiality, and research on illegal behavior. All human subjects research takes place within complex social, cultural, and political contexts, the contributors argue. Increased consideration of the relationships between researchers and their subjects, funders, and institutions within these contexts will facilitate research that is sensitive and responsible as well as scientifically fruitful. Beyond Regulations features a keynote essay by Ruth Macklin. Other contributors are Marcela Aracena Alvarez, Jorge Balan, B. Susan Bauer, Alan F. Benjamin, Lynn Blanchard, Allan M. Brandt, J. Pat Browder, Barbara Entwisle, Sue E. Estroff, Renee C. Fox, Lara Freidenfelds, Gail E. Henderson, Nancy M. P. King, Loretta M. Kopelman, Ernest N. Kraybill, Barry M. Popkin, Silvina Ramos, Desmond K. Runyan, Jane Stein, Ronald P. Strauss, Keith A. Wailoo, and Cynthia Waszak. Across a broad range of disciplines--in biomedicine, the social sciences, and the humanities--researchers, scholars, administrators, and teachers increasingly struggle with questions of ethics in research with human subjects. All research takes place in complex social, cultural, political, and economic contexts; yet the prevailing principle-based research ethics paradigm does not adequately account for them. This book reexamines research ethics using a new relationships paradigm. Through in-depth cases, commentaries, and essays, a multidisciplinary group of scholars and researchers addresses informed consent, conflict of interest, confidentiality, and other issues, considering questions like: What relationships should researchers have with their subjects' communities? When researchers and subjects have different views about research, who should have control? How should relationships between funders and researchers affect research design? Can research be so potentially beneficial that its importance outweighs the interests of subjects? Examining the relationships between researchers and subjects, communities, funders, and institutions--including considerations of authority and voice--can facilitate human subjects research that is morally sensitive and responsible as well as scientifically fruitful.

Author: Council for International Organizations of Medical Sciences
Publisher: World Health Organization
ISBN:
Category : Bioethics
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: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309133386
Category : Medical
Languages : en
Pages : 445

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Book Description
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.

Author: Harold Y. Vanderpool
Publisher: University Publishing Group.
ISBN:
Category : Human experimentation in medicine
Languages : en
Pages : 552

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Author:
Publisher:
ISBN:
Category : Medical ethics
Languages : en
Pages :

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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: Adil Shamoo
Publisher: Garland Science
ISBN: 1136276025
Category : Science
Languages : en
Pages : 174

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Book Description
Media headlines about research misconduct in American Universities have focused public attention on the dramatic ethical problems that can arise during the conductof research. In the current atmosphere of accountability, scientific research on humans is now under increased scrutiny by the media, Congress and the public. Ethics of the Use of Human Subjects in Research fills the need for learning materials and strategies providing support for training programs related to the ethics of the use of human subjects in research. It presents a practical introduction to the ethical issues at stake in the conduct of research with human subjects. Beginning with a chapter on research ethics, a total of 10 chapters range in scope from the deveolopment of a protocol for ethical decision making to how to obtain IRB approval, with an emphasis on ethical factors underpinning the IRB process.