In Pausing Human Research On Zika, Medical Ethicists Acknowledge A Dark Past

Wbur, 21 March 2017
Author: Paul C. McLean
“This was the proposal: Deliberately infect a small group of consenting adults with the Zika virus to learn about the disease and speed up the search for a vaccine. The need is clear. Zika is an emerging global threat to public health. The NIH called for an ethics consultation and asked two essential questions: Can a Zika “human challenge” study be ethically justified? If so, under what conditions? The panel’s answer, in short, was this: The research could be justified, but conditions must be met. Their assessment epitomizes both the grand purpose of bioethics and the broad frustration with it.”
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Scope of practice largely undefined

MJA Insight, 20 March 2017
Author: Sue Ieraci
“Most people working in medicine are familiar with the term “scope of practice”, but many of us may not have thought much about how guidelines are developed or regulated. As more intra- and inter-professional problems occur, however, we may find that the structures for doing so are not as robust as we may hope.”
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Pelvic mesh devices hit by allegations of research fraud, experimental surgery on thousands of women

SMH, 14 March 2017
Author: Joanne McCarthy
“Pelvic devices developed in Australia from the 1980s and 1990s are at the centre of a global medical scandal that includes regulatory failure, and allegations of research fraud and experimental surgery on women in multiple countries.”
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Ethics panel blocks proposed Zika vaccine research

Statnews, 28 February 2017
Author: Helen Branswell
“A federally appointed ethics panel has rejected an application from a team of scientists to deliberately infect people with the Zika virus, a decision that threatens to further slow the search for an effective vaccine. The panel’s report said it would not currently be ethical to conduct the study because of the risk to potential volunteers and their sexual partners and because there are other possible study approaches.”
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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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Is Consent Based on Trust Morally Inferior to Consent Based on Information?

Bioethics.2017 doi:10.1111/bioe.12342
Authors: Kongsholm, N. C. H. and Kappel, K.
“Informed consent is considered by many to be a moral imperative in medical research. However, it is increasingly acknowledged that in many actual instances of consent to participation in medical research, participants do not employ the provided information in their decision to consent, but rather consent based on the trust they hold in the researcher or research enterprise.”
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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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