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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Destroying research embryos within 14 days limits chance of medical breakthroughs

The Conversation, 30 January 2017
Author: Patrick Foong
“Primarily due to moral considerations, stem-cell scientists have to work within many limitations placed on their research. One of these is the 14-day rule that outlaws research on pure human embryos over two weeks old. It is encoded in laws in at least 12 countries, including the US, UK, Australia and New Zealand.”
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How to keep high-risk studies ethical: classifying candidate solutions

J Med Ethics 2017;43:74-77
Author: Nir Eyal
“This article lays out a wide spectrum of candidate ethical solutions for the challenge on which this JME symposium focuses: the benefit:risk ratio challenge to some early-phase HIV cure and remission studies. These candidate solutions fall into four categories: ones that seek to reduce risks in early-phase HIV cure and remission studies, ones that enhance the benefits for these studies’ participants (or show that those were adequate in the first place), ones that focus on participants’ free and informed consent to participate and ones according to whom the large benefits to non-participants can defeat considerations about individual participant net risks. In so doing, this article also structures the rest of the symposium.”
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Dynamic Consent: a potential solution to some of the challenges of modern biomedical research

BMC Medical Ethics 2017 18:4
Authors: Isabelle Budin-Ljøsne, Harriet J. A. Teare, Jane Kaye, Stephan Beck, Heidi Beate Bentzen et al
“Innovations in technology have contributed to rapid changes in the way that modern biomedical research is carried out. Researchers are increasingly required to endorse adaptive and flexible approaches to accommodate these innovations and comply with ethical, legal and regulatory requirements. This paper explores how Dynamic Consent may provide solutions to address challenges encountered when researchers invite individuals to participate in research and follow them up over time in a continuously changing environment.”
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Feasibility of conducting prospective observational research on critically ill, dying patients in the intensive care unit

J Med Ethics 2017; 43: 47-51
Authors: Amanda van Beinum, Laura Hornby, Sonny Dhanani, Roxanne Ward, Jane Chambers-Evans, Kusum Menon
“Studying patients during the end of life is important, as it has the potential to lead to improvements in care for the dying. For patients who die after a controlled withdrawal of life-sustaining therapies in the intensive care unit, information about the natural history of death and the process of removing life support has additionally led to advances in practice for deceased organ donation. However, this unique population of severely critically ill and imminently dying patients has been difficult to study, largely due to assumptions made by research teams and ethics boards alike about the logistical difficulties of obtaining consent and completing research procedures before or during the process of withdrawal of life-sustaining therapies. In this paper, we describe the ethics substudy of the first prospective observational research study in Canada to obtain consent and collect clinical data on patients during the process of withdrawal of life-sustaining therapies in the intensive care unit.”
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Two urologists conducted research without consent or ethics approval

BMJ 2016; 355: i6677
Author: Clare Dyer
“Two senior consultant urologists at St Bartholomew’s Hospital in London conducted research without obtaining patients’ permission or ethics committee approval, a medical practitioners tribunal has found. Niels Buchholz and Junaid Masood should each have known that their work on percutaneous nephrolithotomy comparing outcomes in randomised patients constituted clinical research that required full consent, the tribunal concluded.”
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Are Chiropractors Backing The Anti-Vaccine Movement?

Forbes, 10 December 2016
Author: Bruce Y Lee
“Today Andrew Wakefield was a keynote speaker at the International Chiropractors Association’s Annual Conference on Chiropractics and Pediatrics in Maui, Hawaii. Yes, the same Andrew Wakefield, who in 2010 was stripped of his medical license in the United Kingdom for ethical violations and failure to disclose potential financial conflicts of interest, The same Wakefield who published a subsequently discredited and retracted study in The Lancet linking vaccines to autism that the British Medical Journal (BMJ) described as an “elaborate fraud”. The same Wakefield who produced and directed an anti-Vaccine “documentary” film ‘Vaxxed: From Cover-Up to Catastrophe’ that pushed conspiracy theories about the Centers for Disease Control and Prevention (CDC) and vaccines. The same Wakefield who has not been able to provide scientific evidence to support his claims. Is this really the best way for a professional association and a conference to gain scientific legitimacy?”
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Therapeutic appropriation: a new concept in the ethics of clinical research

J Med Ethics 2016; 42:805-808
Authors: Rosalind McDougall, Dominique Martin, Lynn Gillam, Nina Hallowell, Alison Brookes, Marilys Guillemin
“In this paper, we describe a new concept—therapeutic appropriation. Therapeutic appropriation occurs when patients, or clinicians, actively reframe research participation as an opportunity to enhance patients’ clinical care, while simultaneously acknowledging the generalised research aims. To illustrate the concept of therapeutic appropriation, we draw on data from an interview study which we conducted to investigate the experiences of patients and general practitioners involved in clinical trials in primary care. We argue that therapeutic appropriation has two key elements: comprehension that the research project is not necessarily aiming to benefit participants and the deliberate use of incidental features of the research for personal therapeutic benefit of various kinds.”
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Introduction to the article collection ‘Translation in healthcare: ethical, legal, and social implications’

BMC Medical Ethics 2016 17:74
Authors: Michael Morrison, Donna Dickenson, Sandra Soo-Jin Lee
“New technologies are transforming and reconfiguring the boundaries between patients, research participants and consumers, between research and clinical practice, and between public and private domains. From personalised medicine to big data and social media, these platforms facilitate new kinds of interactions, challenge longstanding understandings of privacy and consent, and raise fundamental questions about how the translational patient pathway should be organised.”
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