You might be in a medical experiment and not even know it

The Week, 1 February 2017
Author: Alice Dreger
“In the long view, modern history is the story of increasing rights of control over your body. Medical experimentation is supposed to be following the same historical trend. the Nuremberg Code stated unequivocally that the voluntary, informed consent of the human subject is essential. Every research ethics code since then has incorporated this most fundamental principle. Yet today, more and more medical experimenters in the United States appear to circumvent getting the voluntary, informed consent of those whose bodies are being used for research.”
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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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Why doctors need to speak out against female genital cutting in India

The BMJ Blog, 20 January 2017
Author: Aarefa Johari
“What is a doctor’s responsibility, then, in the face of such a ritual? Two of the most basic pillars of medical ethics are to do no harm and to act in the best interests of a patient. Female circumcision has no health benefits and can potentially harm girls and women. For a patient, it serves no scientific or medical interest. In fact, since khatna is not a medical procedure at all, girls being brought to get cut can hardly be called patients. Besides, a seven-year-old is not capable of giving informed consent to the procedure.”
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France introduces opt-out policy on organ donation

The Guardian, 3 January 2017
Author: Kim Willsher
“France has reversed its policy on organ donations so that all people could become donors on their death unless they join an official register to opt out. The new law presumes consent for organs to be removed, even if it goes against the wishes of the family. Until 1 January, when the legislation took effect, unless the person who had died had previously expressed a clear wish for or against donation, doctors were required to consult relatives who, in almost a third of cases, refused.”
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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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Decision-making on behalf of people living with dementia: how do surrogate decision-makers

J Med Ethics 2017;43:35-40
Authors: Deirdre Fetherstonhaugh, Linda McAuliffe, Michael Bauer, Chris Shanley
“For people living with dementia, the capacity to make important decisions about themselves diminishes as their condition advances. As a result, important decisions (affecting lifestyle, medical treatment and end of life) become the responsibility of someone else, as the surrogate decision-maker. This study investigated how surrogate decision-makers make important decisions on behalf of a person living with dementia.”
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A thousand words in the palm of your hand: management of clinical photography on personal mobile devices

Med J Aust 2016; 205 (11): 499-500.
Authors: Kieran G Allen, Paul Eleftheriou, John Ferguson
“Opportunities to optimise patient care have been enhanced by this immediate transfer of accurate and relevant clinical images. Despite these benefits, photographic documentation of the patient’s condition on PMDs creates a sensitive personal record on inherently insecure devices when the patient is vulnerable. This exposes patients to an ongoing risk of potentially serious consequences and psychological harm in the event of illicit publication. Health care organisations must ensure that security is a paramount concern and that their clinicians obtain consent appropriately to minimise the risk of a breach of patient confidentiality.”
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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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