Informed consent and medical device registries

By Daniel B. Kramer, Elizabeth Roe and Efthimios Parasidis. Regulators charged with evaluating new medical devices face several unenviable trade-offs. Extensive pre-market evaluation may delay market entry for useful technology, but a rushed assessment may fail to identify important safety concerns. Rigorous post-market studies may help balance these competing concerns, but must also weigh the […]

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Who should get to choose their surrogates?

By Mark Christopher Navin, Jason Adam Wasserman, Devan Stahl, and Tom Tomlinson, Clinical ethics consultants regularly witness something like the following progression: A patient is determined to lack decision-making capacity (DMC). In the absence of an Advanced Care Planning document that names a surrogate decision maker (e.g. a Durable Power of Attorney for Health Care), […]

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Altered vaccination schedules and informed consent

By Jennifer O’Neill. According to the General Medical Council (GMC) publication Good Medical Practice, medical treatments should be provided “…based on the best available evidence” with a favourable balance between benefit and risk. Legal principles of informed consent and shared decision-making recognise the patient’s right to be informed of the risk-benefit profile of a treatment […]

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Open future or an informed present? Cancer predispositions testing in children

By Sapna Mehta, Dennis John Kuo. Teenagers, and indeed all children to various extents, live in a world that does not recognize their independence fully.  In various situations, they find their rights being exercised by and interests being defined by parents as well as other authorities such as physicians, teachers and the state to a […]

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Vulnerable adults can be autonomous. Assuming that they are not is wrong and harmful.

By Jonathan Lewis. With the establishment of the Mental Capacity Act (“MCA”) 2005 in England and Wales, the days of court interventions into the lives of adults with mental capacity seemed numbered. If you were an adult with capacity, then you were legally recognised as able to give genuine consent to care and medical treatments. […]

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“We think you may be at risk of a genetic disease”. Should direct-to-consumer genetic testing companies contact at-risk relatives?

By Philip E Baker and Jordan A Parsons. Direct-to-consumer (DTC) genetic testing is becoming increasingly popular. However, with genetic testing comes the possibility of discovering mutations that confer increased risk of genetic diseases not only to the tested individual (the proband), but also their genetic relatives. This raises the challenging ethical question of what should […]

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Why do we need to distinguish ‘valid’ and ‘informed’ consent to medical treatment?

By Emma Cave. Common law and ethics require that consent is voluntary, that it is made by a person with capacity and that it is sufficiently informed. But it does not follow that consent that is insufficiently informed will necessarily be considered in law to be invalid. Since Montgomery in 2015, the requirement of informed […]

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Refusal redux: Revisiting debate about adolescent refusal of treatment

By Dominic Wilkinson. Last month, in an emergency hearing, the High court in London heard a case that characterises a familiar problem in medical ethics. A 15 year old adolescent (known as ‘X’) with a long-standing medical condition, sickle cell disease, had a very low blood count and required an urgent blood transfusion. However, X […]

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