Ethical and Policy Issues in International Research Clinical Trials in Developing Countries

Ethical and Policy Issues in International Research Clinical Trials in Developing Countries

Author: Harold T. Shapiro

Publisher:

Published: 2002-02-01

Total Pages: 373

ISBN-13: 9780756713553

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The companion volume to a report by the Nat. Bioethics Advisory Commission that discusses the ethical issues that arise when research subject to U.S. regulations is sponsored or conducted in developing countries. Papers in this volume include: the challenge of equivalent protection; attitudes and experiences of U.S. and developing country investigators regarding U.S. human subjects regulations; the relevance of culture for informed consent in U.S.-funded international health research; comparative analysis of international documents addressing the protection of research participants; and international perspectives on protecting human research subjects.


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:

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Ethical Considerations for Research Involving Prisoners

Ethical Considerations for Research Involving Prisoners

Author: Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research

Publisher: National Academies Press

Published: 2007-01-22

Total Pages: 284

ISBN-13: 0309164605

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In the past 30 years, the population of prisoners in the United States has expanded almost 5-fold, correctional facilities are increasingly overcrowded, and more of the country's disadvantaged populations—racial minorities, women, people with mental illness, and people with communicable diseases such as HIV/AIDS, hepatitis C, and tuberculosis—are under correctional supervision. Because prisoners face restrictions on liberty and autonomy, have limited privacy, and often receive inadequate health care, they require specific protections when involved in research, particularly in today's correctional settings. Given these issues, the Department of Health and Human Services' Office for Human Research Protections commissioned the Institute of Medicine to review the ethical considerations regarding research involving prisoners. The resulting analysis contained in this book, Ethical Considerations for Research Involving Prisoners, emphasizes five broad actions to provide prisoners involved in research with critically important protections: • expand the definition of "prisoner"; • ensure universally and consistently applied standards of protection; • shift from a category-based to a risk-benefit approach to research review; • update the ethical framework to include collaborative responsibility; and • enhance systematic oversight of research involving prisoners.


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

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"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.


Ethics of the Use of Human Subjects in Research

Ethics of the Use of Human Subjects in Research

Author: Adil Shamoo

Publisher: Taylor & Francis

Published: 2021-03-05

Total Pages: 160

ISBN-13: 1136276033

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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.


Ethical Challenges in Study Design and Informed Consent for Health Research in Resource-poor Settings

Ethical Challenges in Study Design and Informed Consent for Health Research in Resource-poor Settings

Author: Patricia A. Marshall

Publisher: World Health Organization

Published: 2007

Total Pages: 89

ISBN-13: 9241563389

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This review considers ethical challenges to research design and informed consent in biomedical and behavioral studies conducted in resource-poor settings. A review of the literature explores relevant social, cultural, and ethical issues in the conduct of biomedical and social health research in developing countries. Ten case vignettes illustrate ethical challenges that arise in international research with culturally diverse populations. Recommendations for researchers and policy-makers concerned about ethical practices in multinational studies conducted in resource-poor settings are also listed.


Ethical and Policy Issues in Research Involving Human Participants

Ethical and Policy Issues in Research Involving Human Participants

Author: National Bioethics National Bioethics Advisory Commission

Publisher: CreateSpace

Published: 2015-03-17

Total Pages: 282

ISBN-13: 9781508819585

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Protecting the rights and welfare of those who volunteer to participate in research is a fundamental tenet of ethical research. A great deal of progress has been made in recent decades in changing the culture of research to incorporate more fully this ethical responsibility into protocol design and implementation. In the 1960s and 1970s, a series of scandals concerning social science research and medical research conducted with the sick and the illiterate underlined the need to systematically and rigorously protect individuals in research (Beecher 1966; Faden and Beauchamp 1986; Jones 1981; Katz 1972; Tuskegee Syphilis Study Ad Hoc Advisory Panel 1973). However, the resulting system of protections that evolved out of these rising concerns-although an improvement over past practices-is no longer sufficient. It is a patchwork arrangement associated with the receipt of federal research funding or the regulatory review and approval of new drugs and devices. In addition, it depends on the voluntary cooperation of investigators, research institutions, and professional societies across a wide array of research disciplines. Increasingly, the current system is being viewed as uneven in its ability to simultaneously protect the rights and welfare of research participants and promote ethically responsible research.