The Nuremberg Code 70 Years Later Moreno, Jonathan D; Schmidt, Ulf; Joffe, Steve
JAMA : the journal of the American Medical Association,
09/2017, Volume:
318, Issue:
9
Journal Article
Ethics in human experimentation has a long history and The Uses of Humans in Experiment draws on examples from the early modern period to illustrate how humans have been both subjects and instruments ...over the past four centuries.
This volume brings together the contributions of a group of scholars from different countries and various academic disciplines. It examines Japan's wartime medical atrocities and their postwar ...aftermath from a comparative perspective and inquires into perennial issues of historical memory, science, politics, society and ethics elicited by these rebarbative events. The volume's central ethical claim is that the failure to bring justice to bear on the systematic abuse of medical research by Japanese military medical personnel more than six decades ago has had a profoundly retarding influence on the development and practice of medical and social ethics in all of East Asia. The book alsom includes an extensive annotated bibliography selected from relevant publications in Japanese, Chinese and English. --Book Jacket.
Prior to and during the Second World War, the Japanese Army established programs of biological warfare throughout China and elsewhere. In these "factories of death," including the now-infamous Unit 731, Japanese doctors and scientists conducted large numbers of vivisections and experiments on human beings, mostly Chinese nationals. However, as a result of complex historical factors including an American cover-up of the atrocities, Japanese denials, and inadequate responses from successive Chinese governments, justice has never been fully served. --
The legal implications of conducting clinical research and trials are becoming more complex. Everyone involved in clinical research increasingly needs to be aware of not only the ethical issues at ...stake but also how the law affects medical practice and research. Much of clinical research and trial law and litigation is comparatively recent and researchers need to ensure current compliance on a wide range of issues. Including: standards and duty of care informed consent conflicts of interest research contracts establishing clinical trials the disclosure and withholding of clinical trial results Clinical Research and the Law comprehensively discusses these topics and provides the answers to the legal questions and potential pitfalls encountered in medical research. It is an up-to-date, practical guide for clinical investigators and their institutional administrators, particularly risk managers and research administrators, as well as healthcare administrators and members of institutional review boards. This book is also a key resource for medical students, postgraduate research students, practicing attorneys and counselors for teaching hospitals and institutions undertaking clinical research and contract research organizations.
There are situations in which the requirement to obtain conventional written informed consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, ...including some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived, the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived in its entirety. Using the same threshold for a partial or complete waiver limits the options available to institutional review boards as they seek to optimize a consent process. In this article, we argue that new standards are necessary in order to enable important pragmatic clinical research while at the same time protecting patients’ rights and interests.
Ethics in field experimentation McDermott, Rose; Hatemi, Peter K.
Proceedings of the National Academy of Sciences - PNAS,
12/2020, Volume:
117, Issue:
48
Journal Article
Peer reviewed
Open access
In 1966, Henry Beecher published his foundational paper “Ethics and Clinical Research,” bringing to light unethical experiments that were routinely being conducted by leading universities and ...government agencies. A common theme was the lack of voluntary consent. Research regulations surrounding laboratory experiments flourished after his work. More than half a century later, we seek to follow in his footsteps and identify a new domain of risk to the public: certain types of field experiments. The nature of experimental research has changed greatly since the Belmont Report. Due in part to technological advances including social media, experimenters now target and affect whole societies, releasing interventions into a living public, often without sufficient review or controls. A large number of social science field experiments do not reflect compliance with current ethical and legal requirements that govern research with human participants. Real-world interventions are being conducted without consent or notice to the public they affect. Follow-ups and debriefing are routinely not being undertaken with the populations that experimenters injure. Importantly, even when ethical research guidelines are followed, researchers are following principles developed for experiments in controlled settings, with little assessment or protection for the wider societies within which individuals are embedded. We strive to improve the ethics of future work by advocating the creation of new norms, illustrating classes of field experiments where scholars do not appear to have recognized the ways such research circumvents ethical standards by putting people, including those outside the manipulated group, into harm’s way.
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