Diabetologist and former journal editor faces charges of data fabrication

BMJ 2017; 356: j1348
Author: Clare Dyer
“At a four week hearing of the Medical Practitioners Tribunal Service that opened on 13 March, the GMC accuses Grant of a catalogue of research misconduct, including forging the signatures of coauthors, listing doctors who had not significantly contributed to papers as coauthors, and fabricating data.”
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Informed Consent

N Engl J Med 2017; 376:856-867
Authors: Jeffrey M. Drazen, David P. Harrington, et al
“In the classic interaction in which informed consent is obtained for research, an investigator presents the potential participant with information regarding a new therapeutic, diagnostic, or prophylactic intervention and then asks the participant to read and sign a detailed written consent document. This traditional prototype is becoming outdated. Informed consent, which is ethically essential in most clinical research, respects persons’ rights to decide whether participation in the research is compatible with their interests, including their interests in protection from exploitation and harm. Required by ethical guidelines and regulations unless explicitly waived by institutional review boards, informed consent is thus a means of protecting the rights and welfare of participants while they contribute to the advancement of knowledge.”
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Tribunal reprimands medical researcher for professional misconduct

Medical Board of Australia, 22 February 2017
“The Medical Board of Australia referred Mr Nicholas Melhuish to the tribunal on the grounds that his multiple breaches of the Privacy Act 1988 and the Health Records (Privacy and Access) Act 1997 (ACT) as well as breaches of Good medical practice: a code of conduct for doctors in Australia (the Code of Conduct), the National Health and Medical Research Council’s Australian Code for Responsible Conduct of Research 2007 (the NHMRC Code) and the ACT Health Research Practice Policy amounted to professional misconduct.”
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How to Keep HIV Cure-Related Trials Ethical: The Benefit/Risk Ratio Challenge

JME Blog, 20 February 2017
Author: Nir Eyal
“While high or unknown risks are a mainstay of early-phase trials in areas like cancer research, cure study participants typically have a safe and efficacious alternative to those risks: remaining on antiretrovirals. Can we justify asking patients who are doing well on antiretrovirals to accept the risk and uncertainty of many HIV cure-related trials? If we cannot, we might need to give up on the hope of curing HIV, or of achieving controlled remission.”
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Health incentive research and social justice: does the risk of long term harms to systematically disadvantaged groups bear consideration?

Journal of Medical Ethics 2017;43:150-156.
Authors: Wild V, Pratt B
“The ethics of health incentive research—a form of public health research—are not well developed, and concerns of justice have been least examined. In this paper, we explore what potential long term harms in relation to justice may occur as a result of such research and whether they should be considered as part of its ethical evaluation.”
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Ethical framework for the detection, management and communication of incidental findings in imaging studies, building on an interview study of researchers’ practices and perspectives

BMC Medical Ethics 2017 18:10
Authors: Eline M. Bunnik, Lisa van Bodegom, Wim Pinxten, Inez D. de Beaufort, Meike W. Vernooij
“As thousands of healthy research participants are being included in small and large imaging studies, it is essential that dilemmas raised by the detection of incidental findings are adequately handled. Current ethical guidance indicates that pathways for dealing with incidental findings should be in place, but does not specify what such pathways should look like.”
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A New Day For Oversight Of Human Subjects Research

Health Affairs Blog, 6 February 2017
Author: Holly Fernandez Lynch
“On January 19, 2017—President Obama’s last day in office—the Federal Register published a Final Rule to amend the Federal Policy for the Protection of Human Subjects, the set of regulations applicable to most human subjects research conducted or supported with federal funds, and more typically referred to as the “Common Rule.” This rule change had been a long time coming, with an Advance Notice of Proposed Rule Making (ANPRM) published in July 2011 and a Notice of Proposed Rule Making (NPRM) published in September 2015. The seriousness of its impact on the research community, patients, and the public is evidenced by the more than 3,300 public comments submitted during the rulemaking process. So what changed?”
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