Accountability for reasonableness in an institutional setting

Gry Wester, Postdoctoral Fellow, University of Bergen

Many countries have adopted a practice whereby designated institutions play a key role in making decisions about health care priority-setting. The appropriate procedure by which such bodies should make their decisions in order to ensure legitimacy and fairness has been much discussed.  In particular, Daniels and Sabin’s influential framework for procedural justice, ‘Accountability for Reasonableness’ (AFR), has been prominent in the debate [1]. The AFR specifies four conditions that a decision-making procedure must meet in order to be fair and legitimate: the Publicity Condition, the Relevance Condition, the Revisions and Appeals Condition, and the Regulative Condition. While the strengths and weaknesses of the framework have been widely discussed, the question of how well the framework lends itself to use in a real-world institutional setting has received much less attention. There is often an implicit expectation of a higher standard of reasoning or deliberation in such public decision-making institutions – yet decision-making in a real-world institutional setting may be subject to a range of constraints and challenges that typically do not apply in the context of private reasoning. It is worth considering, therefore, how well the conditions set out in the AFR, and the concerns that they embody, map on to or capture the complexities of practice.

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Accountability for reasonableness in an institutional setting

What are we talking about? Clarifying calls for “public discussion” about emerging technologies

Matthew McCoy, Postdoctoral Fellow in Advanced Biomedical Ethics, Penn University

Earlier this year, an expert committee convened by the U.S. National Academies of Science and Medicine published a report on the science, ethics, and governance of human genome editing. Peppered throughout the report’s 200-plus pages were repeated references to the need for more “public discussion” about ethical issues raised by human genome editing.[1]

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What are we talking about? Clarifying calls for “public discussion” about emerging technologies

What is ‘necessary training’ in health-related research ethics?

Kristine Bærøe, Associate Professor at the Department of Global Public Health and Primary Care, University of Bergen

A couple of months ago a new Research Ethics Act was implemented in Norway. The rationale for replacing the preceding regulation was to strengthen legal responsibilities of researchers and institutions for promoting acceptable research [1]. According to the new regulation, researchers are held legally responsible for ensuring that they ‘act with caution to ensure that all research is conducted according to recognised research ethical norms’ [2]. At the same time ‘institutions are responsible for: a) necessary training of candidates and employees in recognised research ethical norms and b) that everyone who conducts or participates in the research is familiar with recognised research ethical norms’ [2]. The lawmakers have explicitly left it to the researcher community to define what is covered by ‘recognised norms’ [1], but implicitly the community will also have to define what should go into ‘necessary training’.

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What is ‘necessary training’ in health-related research ethics?

Gene Patents & Access to Health: Speaking at but not to each other

Dr Aisling M. McMahon, Lecturer Newcastle Law School, and our Caroline Miles visiting Scholar in March this year

Recent international developments in gene patenting raise questions again about how bioethical concerns surrounding the grant of patents on health-related technologies are addressed or engaged with by patent law. In 2013 and 2015, the Supreme Court of the United States[1] and the Australian High Court[2], respectively, delivered judgments rejecting the patentability of isolated genes. Both disputes involved Myriad’s patents on BRCA1 and BRCA2 genes. Subsequently, in March 2016 a Canadian case involving the Children’s Hospital of Eastern Ontario’s (CHEO) challenge to patents on genes related to Long QT Syndrome (LQTS) (a condition that can potentially cause irregular and chaotic heartbeats[3]) was settled. The settlement provided a licence to CHEO to test for the syndrome and this has appeared to quell public concerns.[4]

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Gene Patents & Access to Health: Speaking at but not to each other

Winter School @Ethox: “A most exciting experience!”

Suzanne Metselaar, Dept. of Medical Humanities, VU University Medical Center, Amsterdam, and Gerben Meynen, Dept. of Philosophy, VU University, Amsterdam

Since 2013, a one-week Winter School at the Ethox Center is part of our master programme Philosophy, Bioethics, and Health (PBH). PBH is an interdisciplinary, two-year MA-programme of the Dept. of Philosophy of VU University in collaboration with the Dept. of Medical Humanities of VU University Medical Center in Amsterdam. Students describe the visit to Ethox as a great learning experience: it is seen as the highlight of our Master programme. And the beautiful scenery and history of Oxford are certainly a great bonus!

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Winter School @Ethox: “A most exciting experience!”

‘Donate to charity for cash prizes!’

Kate Sahan, The Ethox Centre, Nuffield Department of Population Health, University of Oxford

Said one breathless charity rep who knocked at my door on a peculiar evening in late September. A grubby pamphlet was unfurled, designed to dazzle with pound signs, money fans, and testimonials. The charity reps, propping themselves up on the dodgy adjoining brick wall, were clearly at the end of another punishing day of pounding Oxford’s mean pavements. So my resistance to their win-win money-making idea was treated as just another of their usual street-side heckles: I blurted out something about perverse incentives, about how it would encourage gambling. I screwed up my face in a don’t-get-it-and-feels-icky kind of way.

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‘Donate to charity for cash prizes!’

It’s an emergency: should we ‘rescue’ vulnerable emergency care patients from research?

 pulpfiction

Kate Sahan, The Ethox Centre, Nuffield Department of Population Health, University of Oxford

A current emergency medicine trial, Paramedic2, which randomizes patients to adrenaline versus saline in cardiac arrest has put emergency medicine research (EMR) back under the spotlight. There are concerns that a ‘totally useless placebo’ will be more harmful than the standard adrenaline shot given during the resuscitation protocol. However, the history of EMR has taught us that some emergency interventions rest on an insufficiently-explored and updated evidence base[1]. For example, up until the early 2000s, corticosteroids were given to tens of thousands of severe head trauma patients in the belief they were medically beneficial. But it took a systematic, placebo-controlled research study of their use called CRASH to make an unwholesome discovery: steroids had no benefit, and caused actual harm by killing or severely brain-damaging more patients than placebo.

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It’s an emergency: should we ‘rescue’ vulnerable emergency care patients from research?