Rebecca J. Cook, Bernard M. Dickens, and Mahmoud F. Fathalla
- Published in print:
- 2003
- Published Online:
- October 2011
- ISBN:
- 9780199241323
- eISBN:
- 9780191696909
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780199241323.003.0025
- Subject:
- Philosophy, Moral Philosophy
This chapter outlines the provisions of the World Medical Association's Declaration of Helsinki, which was developed as a statement of ethical principles to provide guidance to physicians and other ...
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This chapter outlines the provisions of the World Medical Association's Declaration of Helsinki, which was developed as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data.Less
This chapter outlines the provisions of the World Medical Association's Declaration of Helsinki, which was developed as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data.
Onora O'Neill
- Published in print:
- 2010
- Published Online:
- May 2010
- ISBN:
- 9780195325195
- eISBN:
- 9780199776412
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195325195.003.0007
- Subject:
- Philosophy, Moral Philosophy, General
Contemporary work on research ethics often points to Nazi inhumanity and abuse of research subjects as a prelude to arguing that research on human subjects requires their fully informed consent. By ...
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Contemporary work on research ethics often points to Nazi inhumanity and abuse of research subjects as a prelude to arguing that research on human subjects requires their fully informed consent. By contrast, the Nuremberg Code of 1947 demanded more robustly that fundamental obligations not to force, deceive, or use duress be respected, in order to ensure that research participation would be voluntary. Subsequent codes, such as the Declaration of Helsinki, set more exacting regulatory requirements aimed at securing highly specific and explicit consent. This supposed improvement may be neither feasible nor ethically superior.Less
Contemporary work on research ethics often points to Nazi inhumanity and abuse of research subjects as a prelude to arguing that research on human subjects requires their fully informed consent. By contrast, the Nuremberg Code of 1947 demanded more robustly that fundamental obligations not to force, deceive, or use duress be respected, in order to ensure that research participation would be voluntary. Subsequent codes, such as the Declaration of Helsinki, set more exacting regulatory requirements aimed at securing highly specific and explicit consent. This supposed improvement may be neither feasible nor ethically superior.
Adil E. Shamoo and David B. Resnik
- Published in print:
- 2009
- Published Online:
- May 2009
- ISBN:
- 9780195368246
- eISBN:
- 9780199867615
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195368246.003.0012
- Subject:
- Biology, Disease Ecology / Epidemiology, Biochemistry / Molecular Biology
This chapter discusses the history of human experimentation, with special attention to cases that have helped to shape ethical guidelines and policies. It discusses important codes, such as the ...
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This chapter discusses the history of human experimentation, with special attention to cases that have helped to shape ethical guidelines and policies. It discusses important codes, such as the Nuremberg Code and the Declaration of Helsinki, and it provides an overview of U.S. federal regulations. The chapter also addresses some key concepts and principles in human research, such as informed consent, risk/benefit ratios, minimal risk, and research versus therapy.Less
This chapter discusses the history of human experimentation, with special attention to cases that have helped to shape ethical guidelines and policies. It discusses important codes, such as the Nuremberg Code and the Declaration of Helsinki, and it provides an overview of U.S. federal regulations. The chapter also addresses some key concepts and principles in human research, such as informed consent, risk/benefit ratios, minimal risk, and research versus therapy.
Ezekiel J. Emanuel
- Published in print:
- 2012
- Published Online:
- May 2015
- ISBN:
- 9780195379907
- eISBN:
- 9780190267711
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:osobl/9780195379907.003.0008
- Subject:
- Philosophy, Moral Philosophy
This chapter discusses the continuing debate on research ethics in developing countries. The Declaration of Helsinki—one of the foremost documents in bioethics—is often cited to justify a standard of ...
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This chapter discusses the continuing debate on research ethics in developing countries. The Declaration of Helsinki—one of the foremost documents in bioethics—is often cited to justify a standard of care for research subjects undergoing scientific study. The opposing position finds this too idealistic, and the Declaration too outdated, to be relevant in the standards of global justice. A middle ground between these positions is proposed—pragmatic cosmopolitanism and beneficent statism—both of which may provide a solution to the debate.Less
This chapter discusses the continuing debate on research ethics in developing countries. The Declaration of Helsinki—one of the foremost documents in bioethics—is often cited to justify a standard of care for research subjects undergoing scientific study. The opposing position finds this too idealistic, and the Declaration too outdated, to be relevant in the standards of global justice. A middle ground between these positions is proposed—pragmatic cosmopolitanism and beneficent statism—both of which may provide a solution to the debate.
Alexander Morgan Capron
- Published in print:
- 2014
- Published Online:
- January 2015
- ISBN:
- 9780262027465
- eISBN:
- 9780262320825
- Item type:
- chapter
- Publisher:
- The MIT Press
- DOI:
- 10.7551/mitpress/9780262027465.003.0013
- Subject:
- Biology, Bioethics
Informed consent is usually thought of as the ethical cornerstone of research with human beings yet over the past thirty years a largegap has opened between informed consent as an object of ...
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Informed consent is usually thought of as the ethical cornerstone of research with human beings yet over the past thirty years a largegap has opened between informed consent as an object of veneration and its actual role as a governing concept in research with human subjects. This chapter argues that our failure to recognize that gap—and to make necessary policy adjustments—should be on the minds of the drafters of any proposal to reframe the federal regulations for research with human beings.Such attention would be particularly fitting because the federal rules themselves bear much of the responsibility for the diminishing importance of informed consent in research.Less
Informed consent is usually thought of as the ethical cornerstone of research with human beings yet over the past thirty years a largegap has opened between informed consent as an object of veneration and its actual role as a governing concept in research with human subjects. This chapter argues that our failure to recognize that gap—and to make necessary policy adjustments—should be on the minds of the drafters of any proposal to reframe the federal regulations for research with human beings.Such attention would be particularly fitting because the federal rules themselves bear much of the responsibility for the diminishing importance of informed consent in research.
Alex John London
- Published in print:
- 2022
- Published Online:
- December 2021
- ISBN:
- 9780197534830
- eISBN:
- 9780197534861
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/oso/9780197534830.003.0002
- Subject:
- Philosophy, Moral Philosophy
This chapter traces the practical and conceptual origins of eight problematic commitments including the perception that there is an inherent moral dilemma at the heart of research with humans and the ...
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This chapter traces the practical and conceptual origins of eight problematic commitments including the perception that there is an inherent moral dilemma at the heart of research with humans and the tendency to conceptualize research as a private transaction between researchers and participants without clear connections to the requirements of a just social order. It introduces readers who are new to research ethics to key cases and documents relating to domestic and international research and illustrates how they gave rise to the problematic views that produce conceptual and practical tensions in the field. The chapter frames the questions that will be addressed in subsequent chapters, including issues about research risk; the role of paternalism in research ethics; and requirements relating to responsiveness to host community health needs, the standard of care, and post-trial access in international research.Less
This chapter traces the practical and conceptual origins of eight problematic commitments including the perception that there is an inherent moral dilemma at the heart of research with humans and the tendency to conceptualize research as a private transaction between researchers and participants without clear connections to the requirements of a just social order. It introduces readers who are new to research ethics to key cases and documents relating to domestic and international research and illustrates how they gave rise to the problematic views that produce conceptual and practical tensions in the field. The chapter frames the questions that will be addressed in subsequent chapters, including issues about research risk; the role of paternalism in research ethics; and requirements relating to responsiveness to host community health needs, the standard of care, and post-trial access in international research.
