The USA’s Food and Drug Administration and informed consent

By Hugh Davies The Food and Drug Administration’s (FDA) initiative Over the last three decades seeking consent of patients or volunteers to join a medical research study has become dominated by an increasingly lengthy, opaque and Participant Information Sheet (PIS), shielding the researcher from liability. The FDA argues that Informed consent documents are often long, […]

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Simulated empathy in surgical informed consent: Should AI comfort patients or just inform them?

By Pranab Rudra. The use of AI in healthcare is rapidly expanding, raising critical ethical questions about its role in informed consent, a process that relies not only on clear, accurate information but also on genuine human connection. This focus is crucial because informed consent is both an informational and an emotional interaction, and any […]

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Medical research with human samples and health data—why ‘dynamic’ consent is not the solution

By Andreas Bruns and Eva C Winkler. Informed consent is a central principle of medical research ethics. Traditionally, consent is required to respect the autonomy of human research subjects—their right to make their own, informed decision about whether or not to participate in medical research. However, this principle has come under significant pressure with the […]

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Interdisciplinary collaboration to identify and address ethical issues arising from the development of irreversible, high risk medical treatments

By Alex Harris & Frederic Gilbert. There are increasing numbers of clinical trials assessing high risk, irreversible treatments.  While a clinical trial aims to assess the safety and efficacy of a clinical intervention, participants enrolled in trials of high risk, irreversible treatments may be left with significant ongoing or emerging burdens after exiting the trial. […]

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Martha’s rule: rebalancing power dynamics between patients or families and clinicians to improve patient outcomes

By Ilaria Bertini. UK media outlets have reported the upcoming implementation of Martha’s Rule within NHS foundation trusts, starting from April 2024. This rule will enable swift second medical opinions for patients, healthcare practitioners, or families who express concerns regarding the patient’s response to care provided. This new pathway takes its name from a 13-year-old […]

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Voicing the realities of patient consent to unplanned obstetric interventions

By Frances Hand*, Morganne Wilbourne*, Sophie McAllister, Louise Print-Lyons, and Meena Bhatia. Approximately 46% of primiparous women using NHS facilities undergo an obstetric intervention during their labour. For women with a planned intervention (usually a caesarean birth) conversations regarding consent are mostly straightforward and occur during the pregnancy. Where an intervention is unplanned, current practice […]

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Mindless consent

By Edwin Jesudason. How could consent be mindless, if it’s about our choosing to give permission?  We could suggest at least two ways, the first familiar, the second – and the topic of this blog – perhaps less so. The first is habitual: the mindless ‘consent’ many of us give, with a passing click or […]

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