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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).


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 an analysis of opt out forms

14 Nov, 16 | by miriamwood

Guest Post: Paraskevas Vezyridis

Article: Dissenting from 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; 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 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, 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 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.


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.

The End is Not What it Seems – Feasibility of Conducting Prospective Research in Critically Ill, Dying Patients.

14 Oct, 16 | by miriamwood

Guest Post by Amanda Van Beinum

Re: Feasibility of conducting prospective observational research on critically ill, dying patients in the intensive care unit

Collecting information about how people die in the intensive care unit is important. Observations about what happens during the processes of withdrawal of life sustaining therapies (removal of breathing machines and drugs used to maintain blood pressure) can be used to improve the care of dying patients. This information can also be used to improve processes of organ donation. But when the Determination of Death Practices in Intensive Care Units (DDePICT) research group first proposed to start collecting prospective data on dying and recently dead patients, a common response from other clinical researchers was, “You’re going to do what?” The research community did not believe that prospective research using an informed consent model would be possible in patients dying after withdrawal of life sustaining therapies in the intensive care unit.

While the clinical research community supported the “big picture” idea behind conducting this research, they were skeptical about our prospective research design and our intent to obtain full informed consent from all families prior to the patient’s death. Some also felt that we would have a hard time obtaining institutional ethics board approval or would encounter barriers from research coordinators uncomfortable with approaching families for consent at a difficult and emotional time in the patient’s care. However, the DDePICt group was persistent, and succeeded in their efforts to design the first prospective, observational pilot study in Canada of patients dying in the intensive care unit after withdrawal of life sustaining therapies. As part of the study design, the DDePICt pilot study collected data for an ethics sub-study to investigate how these anticipated challenges were overcome. The ethics sub-study sought an answer to the question; can we conduct ethical, prospective, observational research on a critically ill and imminently dying population in the intensive care unit?


A Eulogy for the UK Donation Ethics Committee

13 Oct, 16 | by miriamwood

Guest Post by David Shaw

Re: The untimely death of the UK Donation Ethics Committee

Most people I know want to donate their organs after they die. Why wouldn’t they? If you have to die, you might as well do your best to save several other lives once you’re gone. But organ donation is a more ethically complex topic than many people realise. From Spring 2014 until April this year I was a member of the UK Donation Ethics Committee (UKDEC), which advised NHS Blood and Transplant and the various UK health departments on the ethics of organ donation and transplantation. The committee included doctors, lawyers, nurses, ethicists like me, and ‘lay’ members – ordinary members of the public. In my JME article, I discuss the committee’s work and why it came to an end.

UKDEC dealt with a wide variety of topics. We advised the Welsh Government on the ethical implications of a switch to ‘deemed consent’ to organ donation in Wales, undertook an analysis of the role of the family in donation, and engaged with ethnic minorities and religious groups to facilitate discourse about donation. Most of all, our work was important because we provided practical ethical guidance to healthcare professionals who were often unsure about the ethics and sometimes the legality of new developments in organ donation. Every year new technologies emerge that can enable donation where it was previously impossible, or which can improve the viability of donated organs. Sometimes doctors would approach UKDEC for our advice on their protocols that wished to make use of these new innovations. One of UKDEC’s final publications was a discussion paper concerning so-called “elective ventilation”, where a patient is placed onto on life support not because it will physically benefit him or her, but in order to facilitate organ donation.

But perhaps the most important contribution UKDEC made concerned organ donation after circulatory death (DCD). Nowadays, over 40% of UK donations involve DCD. But until around a decade ago, almost all organ donation in the UK took place after neurological determination of death – in other words, you had to be “brain-dead” before your organs could be donated and transplanted into recipients. In contrast, DCD involves organ donation after a patient’s heart has stopped beating. This might sound relatively straightforward, but in fact many doctors and nurses objected to DCD because of concerns about the potential reversibility of death, the burden on families and perceived conflicts of interest. Indeed, with the use of new technologies, heart donation after circulatory death is even possible, which might seem paradoxical.


Natal Nativism

12 Oct, 16 | by Iain Brassington

Scene: the boardroom of a large NHS Trust, somewhere in England.

“And so that brings us neatly to the last item on the agenda: passport checks for pregnant women who want a checkup.  The thing is, you see, that it turns out that we’ve been providing obstetric care to some women who aren’t actually UK citizens.  And, clearly, that has to stop.”
“To stop?”
“Well, maybe not stop.  But you know what I mean.  We can’t go providing treatment to anyone who comes knocking at the door!  Why, we’d have a queue from here to Timbuktu, not to mention the cost!”
“Oh, quite.  No, I quite agree that we can’t be the world’s supplier of healthcare.”
“No.  So that’s settled, then.  No more obstetric services to women who can’t demonstrate their eligibility.”
“You don’t look convinced.  What’s the problem?  These women aren’t eligible.”
“Well, no.  But… well, look.  Remember when Dr Smith retired, and when Dr Jones got that transfer to work in the Inner Hebrides?”
“All too well.  Two great losses to the Trust.  What’s your point?”
“Well, I seem to remember that we pooled together to buy them nice leaving presents.”
“We did.  It was the least we could do.”
“I agree.  But, you see, the thing is, they weren’t actually entitled to them.  If you see what I mean.”
“I’m not sure I follow.”
“No.  Well, you see, the thing is, we bought them those presents, and gave them to them, because it’s the decent thing to do.  There’s no rule that says that we have to buy them.  They wouldn’t have been wronged if we hadn’t.”
“Yeeeeeeessssss…  I mean, no.  But yes.”
“But we gave them the presents anyway.  Because the rules set out what’s minimially decent.  Not an upper limit.”
“Well, you see, I was just wondering: might the same apply in other contexts?  Allowing for the obvious differences, of course.”
“You’re losing me again.”
“I thought I might be.  Well, you see, it’s like this.  We’ve been providing treatment to pregnant women without paying attention to whether they’re entitled by the strict letter of the law.  And that law specifies who is entitled to treatment.  But that doesn’t necessarily impose any exclusions.  You see, I wonder if by getting bogged down in the rules, we might… um…”
“Might what?”
“Well, you see, the thing is…”
“Go on…”
“Look: we might end up looking like utter shits.”

Wholly fictional, this, of course.  No such conversation took place.  On the other hand, as reported by the Beeb, here’s a document from St George’s University NHS Trust.  Skip to p80: more…

Victims, Vectors and Villains? Are Those Who Opt Out of Vaccination Morally Responsible for the Deaths of Others?

11 Oct, 16 | by miriamwood

Guest Post by Euzebiusz Jamrozik, Toby Handfield, Michael J Selgelid

Re: Victims, vectors and villains: are those who opt out of vaccination morally responsible for the deaths of others?

Who is responsible for the harms caused by an outbreak for vaccine preventable disease?

Are those who opt out of vaccination and transmit disease responsible for the resultant harms to others?

Suppose that health care systems make vaccines widely available and easily affordable–but some choose not to be vaccinated, resulting in an outbreak. If the outbreak only affected those who could have been safely and effectively vaccinated, but nonetheless opted out, then we might say that those who become infected consented to the risks involved and are thus responsible for their own illness. What should we think, however, about scenarios where harm occurs to those who cannot be safely or effectively vaccinated – e.g. vulnerable groups such as infants and the immunosuppressed? These groups are often at the highest risk of severe harm, and depend upon herd immunity (resulting from high vaccination rates) to protect them from vaccine-preventable infections. Members of such groups bear the burden of others’ freedom to opt out of vaccination, and this can cost them their lives. In 2015, for example, an immunosuppressed woman died in the United States during a measles outbreak made possible by a lapse in local vaccination rates[1].

Our recent article in the Journal of Medical Ethics argues that imposing risks of infection on others without good justification is morally blameworthy–and that individuals who opt out of vaccination are thus morally responsible for resultant harms to others. In defence of this thesis we address numerous important questions, and our answers may have significant implications for public health policy.


Amoral Enhancement

10 Oct, 16 | by miriamwood

Guest Post by Saskia Verkiel

Re: Amoral Enhancement

A reply to Douglas’ reply to Harris’ reply to Douglas regarding the issue of freedom in cases of biomedical moral enhancement

Wouldn’t it be awesome if we could just swallow a pill and become better people?

With many aspects of life, growing numbers of people are embracing biomedical interventions to improve physical or cognitive performance and endurance, whether indicated for those purposes or not. Think doping in sports. Think Ritalin in college. Think beta blockers in stage performers. Think modafinil in pilots and surgeons who have to be alert for long stretches of time.

The funny thing is that when it comes to moral enhancement, we tend to think more in terms of its application to others, who are ‘obviously’ not such good people. Swindlers. Rapists. Basically all kinds of performers of crime.

Thomas Douglas was the first to write an analysis specifying when certain kinds of biomedical moral enhancement would be permissible, in 2008, and he realised that it’s important to make this distinction of whom we want the enhancement for. He focused on voluntarily enhancing the self. It’s a jolly nice read.

This paper triggered a cascade of replies.

To be fair, seeing the replies fly back and forth in this debate is not unlike watching a ballgame, albeit more enlightening (or so I think). Compare with Monty Python’s Philosophers’ Football. There’s team “Let’s put it in the drinking water!” (roughly: Oxford) and there’s team “Hold it, hold it…” (captained by John Harris and including yours truly).


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