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Who is afraid of the big broad bioethics? A dialogue between authors of “Highlights in bioethics through 40 years”

6 Dec, 16 | by miriamwood

Guest Post: Pingyue Jin and Mark Hakkarinen

Article: Highlights in bioethics through 40 years: a quantitative analysis of top-cited journal articles

Dear readers of the JME’s blog, we hope this short dialogue below may prompt your interest to join us in this journey that explores the depth and width of the field of bioethics.

Everything starts from somewhere…

Pingyue: I think it all started with a blog post. Around May 2015, I found this webpage “Top 50 Bioethics Journals and Top 240 Most Cited Bioethics Articles Published Since 2009”, and I thought to myself: “What a fantastic idea! I wish I could have started with these papers when I first came to this field.” After that, this idea of identifying seminal bioethics papers lingered in my mind for weeks. Finally I picked up all my courage and wrote to the author of that post, Mark, who was then a total stranger and now a good friend. In the end of the email, I cautiously mentioned if I could join him in a project (funded only by our enthusiasm) to examine the part of bioethics represented by these highly-cited articles. Luckily, he said yes.

Mark: Though using top journals and most-cited articles was a preliminary idea, it is the very foundation of our work. My original approach was to retrieve the top 1,000 cited articles from bioethics-related journals, which covered 100 journals and 52,000 articles. After some discussion, we decided to focus on the top 20 articles each year, which we boldly refer to as the “highlights of bioethics”.

We are aware that citation count is a popular yet controversial indicator, and we refrain from associating citation counts with quality. Instead, we are more comfortable with the idea that citation counts can partly reflect the “influence” or “impact” of the article to its discipline. Citation in a sense indicates peer recognition (positive or negative), researchers cite others either to agree or disagree, to build on predecessors’ idea or to refute it and establish a new one. Either way, those top cited articles have research significance to both the field and the community.

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Mind the Gap: Ethical Failures in the Treatment of Chronic Fatigue Syndrome

6 Dec, 16 | by miriamwood

Guest Post: Charlotte Blease & Keith Geraghty

Article: Epistemic injustice in healthcare encounters: Evidence from chronic fatigue syndrome by Blease, Carel, & Geraghty

Some illnesses are uncool.

That might sound like an inflammatory comment – especially for a medical journal, yet perhaps the biggest concealed fact in medicine is that hierarchies of diseases exist among patients and healthcare professionals. A caste system of illness influences how patients perceive their health complaints, whilst health professionals also hold biases that influence how they treat and rank patients in the medical pecking order.

When it comes to hierarchies of illness, evidence shows that chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME), features at the bottommost end of the medical “favoured” list. In the 1980s, newspapers helped coin the dismissive label “yuppie flu”; today, ME/CFS sufferers are still being referred to psychotherapists to work on their “faulty” illness beliefs. The truth about CFS/ME is that it is a medically contested illness; the NHS and NICE guidelines acknowledge that there are massive gaps in our current understanding around the illness, its cause and its impact on patients. CFS/ME is also illness that can devastate lives, leaving many housebound, bedbound and isolated, not just from society but also in terms of medical support.

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The Moral Agency of Institutions: Effectively Using Expert Nurses to Support Patient Autonomy

5 Dec, 16 | by miriamwood

Guest Post: Sonya Charles

Article: The Moral Agency of Institutions: Effectively Using Nurses to Support Patient Autonomy

When you think of nurses, what do you think of?

Florence Nightingale? Nurse Ratchet?

A sassy, but competent woman in scrubs?

Popular culture has not always been kind to nurses and, even when it has, it rarely gives an accurate depiction of what nurses actually do. We might shrug off the misrepresentation of nursing as popular culture rarely gives an accurate depiction of many areas of life. Unfortunately, unlike other professions, these misconceptions of nursing spill over into nurses work environment as well.

In this paper, I consider how traditional views of nurses still undermine nurses’ professional autonomy. Certainly, those who work in modern hospitals have a better sense of what nurses do; however, the hospital, as an institution, is still set-up with a traditional hierarchy in mind. I argue that we need to shift hospital policies and power hierarchies such that nurses can achieve professional autonomy (both as a profession and as individual practitioners). Not only is this good for nurses, but it is also good for patients.

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The Ethics Liaison Program: Building a Moral Community

2 Dec, 16 | by miriamwood

Guest Post: Sarah Bates
Article: The Ethics Liaison Program: Building a Moral Community

As challenges to health care delivery increase over time, it is becoming more and more important for hospitals to maintain a strong institution-wide moral culture. But the common model of employing one or a few “ethicists” can lead to the misconception that ethics is the responsibility of those individuals alone, rather than that of all staff throughout the hospital. Meanwhile, staff members who lack dedicated time for ethics-related work, but who are interested in contributing to that work to the extent that their schedules permit, lack a means by which to do so.

The Ethics Liaison Program at Beth Israel Deaconess Medical Center (BIDMC) helps to address those problems at our institution. The 75-plus Liaisons represent clinical and nonclinical areas throughout BIDMC. They spread awareness of Ethics Programs throughout the medical center, communicate between the three ethicists and colleagues in their own work areas, and take on ethics-related projects connected to their work. By “Ethics Programs,” we mean the three-person Ethics Support Service (who conduct ethics consults) and the Ethics Advisory Committee that oversees them, as well as the Liaison Program itself.

The Liaison Program is a win-win for both the Liaisons and BIDMC Ethics Programs. Liaisons join a supportive community that meets monthly to discuss the ethics consults conducted that month, as well as a related journal article. In addition to those monthly meetings, Liaisons can take advantage of educational opportunities, at BIDMC and beyond: monthly Ethics Case Conferences open to all BIDMC staff; ethics-related events and presentations at affiliated institutions; and an annual three-day bioethics course through the Harvard Medical School Center for Bioethics. Liaisons also benefit from mentorship and support to complete their projects. The Liaison Program facilitates as much ethics-related work as the Liaisons have time and inclination to complete.

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LECTURE: Rebalancing Empowerment and Protection: Evolving Legal Frameworks for Impaired Capacity

28 Nov, 16 | by Iain Brassington

Thursday 8 December 2016, 18:00 – 19:00

UCL Gustave Tuck Lecture Theatre, Wilkins Building, Gower Street, London WC1E 6BT

Speaker: Professor Mary Donnelly (University College Cork)
Chair: TBC
Accreditation: This event is accredited with 1 CPD hour with the SRA and BSB

Admission: Free, Registration required (here)

 

The past decade has seen a notable evolution in the normative context for law’s response to people with impaired capacity. Driven by a range of factors, including greater recognition of human rights (perhaps most notably through the Convention on the Rights of Persons with Disabilities) and better empirical understandings, a rhetoric of inclusion and empowerment has replaced traditional approaches centred on control and protection.  Law reform projects in various jurisdictions (Australia, Canada, Ireland, Northern Ireland) have attempted to develop legislative frameworks to give effect to these emerging norms. Yet there is also another narrative. Concerns are expressed (perhaps most commonly by frontline professionals: healthcare professionals, lawyers, social workers and sometimes by family members of people with impaired capacity) that something important may be lost where there is a devaluation of protective norms. There is also a dissonance between the abstract ideals of human rights on the one hand and on the other, the complex corporeal, economic, family, phenomenological and social context within which people with impaired capacity, and those who care for/about them, live.

Tensions between empowerment and protection norms and between abstract, rights-based and contextual, evidence-based policy drivers are inevitable by-products of law’s evolution and they play a necessary role in the development of the law in this area. Rebalancing is a process and not a once-off event. And, of course, as revealed by even a minimal consideration of earlier legal responses to impaired capacity, there is a good deal of room for evolutionary wrong-turns and for unexpected and undesirable consequences. Placing current debates about how law should respond to impaired capacity within an evolutionary context, this paper identifies and evaluates the range of ways in which contemporary tensions may be resolved.

About the speaker:

Mary Donnelly is a Professor in the Law School, University College Cork. Her books include Consent: Bridging the Gap Between Doctor and Patient (Cork: Cork University Press, 2002); Healthcare Decision-Making and the Law: Autonomy, Capacity and the Limits of Liberalism (Cambridge: Cambridge University Press, 2010) and The Law of Credit and Security (Dublin: Round Hall Thomson Reuters, 2011; 2nd ed, 2015) and she is co-author of End-of-Life Care: Ethics and Law (Cork University Press, 2011) and Consumer Law: Rights and Regulation (Dublin: Round Hall Thomson Reuters, 2014) and co-editor of Ethical and Legal Debates in Irish Healthcare: Confronting Complexities (Manchester University Press, 2016).

She has collaborated on projects funded by the European Commission, the Irish Research Council for the Humanities and Social Sciences, the National Children’s Office and the Irish Hospice Foundation and has acted as consultant for public agencies and legal firms.  She is/has been a member of the Expert Group to review the Mental Health Act 2001 and of the HSE National Consent Advisory Group and the HSE National Assisted Decision Making Steering Group.

Are Single Men in the UK Entitled to have a Baby using Fertility Treatment?

22 Nov, 16 | by Iain Brassington

Guest post by Atina Krajewska, Rachel Cahill-O’Callaghan, and Melanie Fellowes

The World Health Organisation is currently considering a change in the definition of infertility according to which, it has been reported, “single men and women without medical issues [would] be classed as ‘infertile’, if they do not have children but want to become a parent.”  Although the WHO has not to date officially confirmed these reports, the possible changes have been considered controversial and provoked heated responses in other UK media.  One of the main points of contention was the possibility of opening fertility treatment to single men.  Before we engage in discussions about the new WHO standards concerning fertility treatment, which – it should be stressed – have not yet been officially announced or adopted, it is important to shed some light on the legal situation of single men in the UK, who wish to become single fathers using fertility treatment.   This entry is aiming to exactly that.  (In respect of single women, see this.)

A single man wishing to have a child will have to use a surrogate and will either use the surrogate’s ovum and his sperm, or she will carry an embryo created by his sperm and a donated egg.  The HFE Act 1990 (as amended by the HFEA 2008) and the Surrogacy Arrangements Act 1985 will therefore be the two most relevant pieces of legislation governing the area.  Neither of these Acts expressly mentions single men as a separate class of patients.

The Human Fertilisation and Embryology Act 1990 has never prevented single persons from accessing ARTs.  The Act and the Human Fertilisation and Embryology Authority’s 8th Code of Practice refers to a “woman”, a “couple”, and an “individual”, and the latter opens up the possibility for single men to access treatment.  Consequently, should they be adopted, the new WHO guidelines would not affect the fundamental principles of the HFE Act 1990 (2008), which does not engage with questions of rationing and access to publicly funded treatment.  It is also unlikely that it could affect the interpretation of these provisions of the Act that may be seen as creating invisible obstacles for single persons.  (More here and here.)

A look at the 2008 HFE Act suggests that the legal position of single men is arguably weaker than that of single women (excluding women using surrogacy, who seem to constitute the most vulnerable and least protected group of patients).  The amended version of s 13 (5) of the HFE Act 2008, which replaced “the need for a father” with the “need for supporting parenting” in the welfare of the child assessment, refers only to a woman and is now silent about the man.  This change was rightly welcomed as enhancing equality and promoting alternative family structures in the context of ARTs.  However, it has paradoxically weakened the position of single men.  A surrogate woman who gives birth to a child would be recognised as a legal mother under the HFE Act and would only need to show evidence of a supportive network of family and friends.  At the same time, the wording of s 13(5) weakens the claims of single men wishing to become parents by accessing fertility treatment.

The biggest challenge single men face in this context is the establishment of legal parenthood.  Interestingly, the only situation in which a single man could be regarded as the legal father of the child would occur when he is the biological father, the surrogate mother is unmarried and not in a civil partnership, and no one chooses otherwise.  (This rule is inferred from s 42, 43, and 44 HFE Act 2008, although none of these provisions mentions single men.)  The realities of surrogacy will rarely allow for such a set of circumstances to occur.  On top of this, the single male might also struggle to satisfy the requirement under s. 54(8) HFEA 2008 that no money or other benefit has been given or received for surrogacy, as the majority of arrangements will involve third parties who are not family members, and will usually involve a financial component.  This is one of the reasons why most surrogacy arrangements involving single men will take place abroad.  In these cases, the single man whose child was born as a result of a surrogacy arrangement through IVF/IUI will have to apply for a parental order or adoption. more…

A Hot Take on a Cold Body

21 Nov, 16 | by Iain Brassington

It’s good to see Nils’ post about the recent UK cryonics ruling getting shared around quite a bit – so it should.  I thought I’d throw in my own voice, too.

About 18 months ago, Imogen Jones and I wrote a paper musing on some of the ethical and legal dimensions of Christopher Priest’s The Prestige.  One dimension of this was a look at the legal status of the bodies produced as a result of the “magic” trick – in particular, the haziness of whether they were alive or dead; the law doesn’t have any space for a third state.  The paper was something of a jeu d’esprit, written to serve a particular function in a Festschrift for Margot Brazier.  If I say so myself, I think it’s a pretty good paper – but it’s also meant to be fun, and is clearly rather less serious than most ethico-legal scholarship (or anything else in the book, for that matter).

coldlazarus5

Not quite “Cold Lazarus”, but close enough…

So it’s a bit of a surprise to see relevantly similar themes popping up in the news.  If we’re freezing people in the hope of curing terminal illness in the future, what’s the status of the bodies in the meantime (especially if the death certificate has been signed)?  There’s a load of questions that we might want to ask before we get too carried away with embracing cryonics.

Right from the start, there’s a question about plausibility.  For the sake of what follows, I’m going to treat “freezing” as including the process of defrosting people successfully as well, unless the context makes it clear that I mean something else.  Now, that said, the (moral) reasons to freeze people rely on the plausibility of the technology.  If the technology is not plausible, we have no reason to make use of it.  It wouldn’t follow from that that using it’d be wrong – but since the default is not to act in that way, it’s positive reasons that we need, rather than negative ones.  Neither could we really rely on the thought that we could cryopreserve someone in the hope that the freezing-and-thawing process becomes more plausible in future, because we’d have no reason to think that we’d chosen the right version of the technology.  We can only cryopreserve a person once: what if we’ve chosen the wrong technique?  How would we choose the best from an indefinitely large number of what we can at best treat as currently-implausible ones?

So how plausible is it to put a body on ice, then revive it many years later?  It’s been pointed out by some that we currently do preserve embryos without apparent ill-effect, with the implication that there’s no reason in principle why more developed humans couldn’t be frozen successfully.  However, whole humans are a wee bit more complex than embryos; it’s not at all clear that we can extrapolate from balls of a few cells to entire humans.  Even the admittedly limited experimental evidence that it’s possible to freeze whole organs won’t show us that, since we’re systems of organs.  One can accept that an organ is a system, too; but all that means is that we’re systems of systems – so we’ve squared the complexity.  And, of course, the timescales being considered here are tiny compared with the kind of timescales envisaged in cryonic fantasies. more…

Justice Cryogenically Delayed is Justice Denied?

18 Nov, 16 | by BMJ

Guest Post by Nils Hoppe

Re JS (Disposal of Body) [2016] EWHC 2859 (Fam)

This unusual and sad case concerns a court application by a 14 year old girl, JS.  In 2015 she was diagnosed with a rare form of cancer which proved terminal and, at the time of her application, she was receiving palliative care as an in-patient at a hospital.  The other parties involved in the application were JS’s parents, who were acrimoniously divorced.  JS had no direct contact with her father after 2008.

Knowing that she would soon die, JS carried out online research into commercial cryogenic preservation techniques, defined in the judgment as “the freezing of a dead body in the hope that resuscitation and cure may be possible in the distant future”.  Such techniques are not uncontroversial, being regarded with scepticism by the majority of the medical and scientific community.  They are also not cheap: the judgment describes the costs associated with the basic cryopreservation package as being in the region of £37,000, or, as Mr Justice Peter Jackson put it, “about ten times as much as an average funeral”.

Of most significance to the court application was the fact that the proposed procedure required the cooperation of the hospital in which JS was a patient.  This concern was described in the following terms by the judge:

The body must be prepared within a very short time of death, ideally within minutes and at most within a few hours.  Arrangements then have to be made for it to be transported by a registered funeral director to the premises in the United States where it is to be stored.  These bridging arrangements are offered in the UK for payment by a voluntary non-profit organisation of cryonics enthusiasts, who are not medically trained.  Evidently, where the subject dies in hospital, the cooperation of the hospital is necessary if the body is to be prepared by the volunteers.  This situation gives rise to serious legal and ethical issues for the hospital trust, which has to act within the law and has duties to its other patients and to its staff. (at paragraph 12)

JS, described as bright, intelligent and articulate, decided that she wanted her body to be cryopreserved after her death.  Her mother supported this wish: her father did not initially, though his views changed.  By the time the matter went to court, JS’s father was prepared to agree to what she wanted, subject to certain conditions, including that he be permitted to see her body after her death (which was objectionable to JS), and that he not be financially liable for the cryopreservation process.

In these circumstances, Mr Justice Peter Jackson was asked to make an order permitting JS’s mother to make arrangements for the cryopreservation of JS’s body after her death and, conversely, preventing her father from intervening.  In doing so, he considered a range of legal and ethical issues.

The whole concept of halting decay after death in order to wait for a miracle cure is predicated on the potential for future scientific progress.  At the same time, it was clearly right for Mr Justice Peter Jackson to work on the basis of science as it stood at the time the matter came before him.  The cessation of the JS’s life is, in the current scientific context, irreversible and fulfils the criteria we use to diagnose death in a legally meaningful way.  The question of what is then done with her body is at this stage of secondary importance only.  She may request to be interred in a family tomb, be incinerated, or donate her body for scientific purposes.  In this case, she would like to be cryopreserved.  The court ought to only engage with this issue in detail if the proposed use of the body after death raises issues which touch on public morals, such as Lord Avebury’s memorable attempt to bequeath his body to Battersea Dogs’ Home, or Jeremy Bentham’s installation as an autoicon.  Her wish to place a very expensive bet on an unknown future technology becoming available is her business alone and may even be a fully acceptable, if unusual, desire with which a court ought not interfere.  Her bet also extends to that new technology permitting her successful resuscitation.  It extends to her mental faculties surviving the procedure so she can meaningfully engage with her surroundings post-resuscitation.  And it also extends to a cure having been found for the condition which caused her first ‘death’.

Any one of these bets is so risky as to be legitimately thought of as unlikely.  In sum, they are sufficiently unlikely to not raise a significant problem in the proceedings before Mr Justice Jackson: If he thought that her death was, on the balance of probabilities, reversible at a future point in time, would he be entitled to decide this issue on the basis that she is dead?  Most jurisdictions, including England and Wales, are clear that the death of the individual must be ‘irreversible’ to be normatively meaningful.  Where this is the case, what is done with the body afterwards is very much a matter for the concerned individual and her family.  There is only a reserve right for public institutions to intervene if the proposed use is deemed so inappropriate as to negate her right to decide what to do with her body after her own death.

Indeed, where the discussion at some point centres upon what the best interests of JS are it seems clear that it must be ever so slightly more in her interest to preserve an opportunity of resurrection, albeit enormously remote, than it is to be interred and decay irreversibly.  It seems clear that there is very little sensible argument which would allow the Court to deny her final wish.  The mere fact that we feel the promises made by the cryopreservation industry amount to a most grievous form of quackery is insufficient to justify an interference, just as we do not have to like or agree with the reasons why adherents to some religions used to refuse blood transfusions.

The Court was required to work on the basis of what is scientifically possible at this point in time, and be agnostic as to any future developments.  Mr Justice Jackson did so, and he did so with commendable sensitivity to the subject matter before him.  The decision is the right one to reach.  The theoretical question of what becomes of all those cryopreserved in facilities across the world if technology advances to the point where they can effectively be rescuscitated remains for another time.  But there is an exciting point here: unless the law is changed ex ante, cryopreservation companies will suddenly have custody of hundreds of comatose patients, rather than dead bodies – with all of the entailing legal and moral obligations.

Dissenting from care.data: an analysis of opt out forms

14 Nov, 16 | by miriamwood

Guest Post: Paraskevas Vezyridis

Article: Dissenting from Care.data: An Analysis of Opt-out Forms

In our article, which is part of a wider project examining the technical, social and ethical challenges of big data in primary care, we simply wanted to explore how varied opt out forms can be when there is no standardised form available. We took as our case study opt out forms from care.data; the highly controversial (scrapped in July 2016) programme of work by NHS England and the Health and Social Care Information Centre (HSCIC) to extract and link (in one central database) healthcare information from GP practices and other NHS and social care services for all sorts of administrative and research purposes. This was an important research question for us since wordings, available options and even design layouts could influence the decision of patients whether to allow the sharing of their GP record for the care.data programme.

While it relies on the individual’s inertia (and often lack of awareness) an opt out is usually considered a more practical and valid approach to consent when compared to an opt in, particularly for low risk, population level studies where highly representative samples are required. For care.data, two types of opt outs were possible: data would either not be extracted from GP records and/or shared outside of the HSCIC in any identifiable form. However, there was no standardised opt out form released, like with the Summary Care Records (SCR). GPs had to come up with their own forms to register patients’ dissent. We searched websites of GP practices to retrieve around 100 unique forms. We did not examine the information provided on GP practices’ websites. While there are around 8,000 GP practices in England, we believe that our sample was big enough to study any evident variability and make a point about the need to standardise these forms so that everyone, from GPs to patients, is on the same page.

What was striking for us was that, while the majority of these forms provided patients with the 2 types of objection, there were some forms that provided only one option (opt out from care.data altogether). There was also variability in other information provided: who was responsible for this programme (HSCIC and NHS England), what was it about and it was important for the NHS and researchers, where patients could have found more information, how data was to be protected, who could had access to this data and whether the programme had any support, for example, by a healthcare professional association.

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Randomised Placebo-Controlled Trials of Surgery: Ethical Analysis and Guidelines

25 Oct, 16 | by miriamwood

Guest Post by Karolina Wartolowska

Re: Randomised placebo-controlled trials of surgery: ethical analysis and guidelines [open access]

Surgical placebo-controlled randomised controlled trials are, in many ways, like placebo-controlled drug trials. Like in case of drug trials, sometimes, a placebo-controlled design is necessary so that the results are valid and unbiased. Placebo control is usually necessary when a surgical trial has only subjective outcomes. This is often the case, because many surgeries are done to relieve pain and improve function. Validating the efficacy of a surgery in a well-designed trial helps to improve clinical practice. If the procedure is ineffective it should be discontinued and less risky treatment should be used instead. It also demonstrates the need for new effective interventions. But if the surgery is effective the resources should be allocated to the better intervention. If efficacy of intervention is never tested, many patients may be exposed to risks associated with a surgery but do not get any real benefits.  They also do not get other treatment, which may provide similar benefits without the risks and costs associated with surgery.

Surgical placebo-controlled randomised controlled trials may be undertaken in an ethical way. Firstly, there needs to be “equipoise”. In other words, there should be uncertainty, lack of strong evidence and lack of agreement among the clinicians whether the investigated surgery is effective or whether it is better than conservative treatment.  If there is equipoise, there is no true “best treatment” which can be recommended to the patient. Secondly, there should be some preliminary evidence that the surgery works (form animal studies, open-label trials). There is no point undertaking a surgical trial if it fails to show any improvement in the surgical arm. Thirdly, the risks associated with a surgical trial should not be disregarded. To be justified, such trials should have high scientific and clinical value and a potential to change clinical practice. Moreover, the risks of harm in both trial arms should be as small as possible. This is particularly important in the placebo/sham arm. The placebo mimics the active surgery but it also omits the surgical element which is the key part of the active surgery. So some procedures necessary in the surgical arm, for example anticoagulants or antibiotics, may be avoided in the placebo arm or can be replaced with a saline injection.  Ideally, the placebo/sham procedure should benefit the patients, for example as a diagnostic procedure. And last but not least, it is important that there is an uncertainty about the treatment allocation but there is no actual deception. Patients should understand which procedures are or are not performed and what are the associated risks in each trial arm.

Surgery is inherently risky but it is important to know whether it is also effective and worth taking these risks.

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