You don't need to be signed in to read BMJ Blogs, but you can register here to receive updates about other BMJ products and services via our Group site.

Resource

Patient Views about Consent, Confidentiality & Information-Sharing in Genetic Medicine.

29 Apr, 16 | by BMJ

Guest post by Sandi Dheensa, Angela Fenwick and Anneke Lucassen

Imagine you’re a clinician in genetic medicine.  For a while, you’ve been seeing Joe Bloggs, a patient with a mutation in a gene that’s caused a hereditary form of colon cancer.  As is your standard practice, you help Joe identify who in his family is also at risk and spend some time talking about how he’ll tell them.  The Bloggs’ are a large bunch: Joe has children, siblings, nieces, nephews, aunts, uncles, and cousins, all of whom might have the mutation.  Anyone who tests positive would be eligible for regular bowel screening, which – while not pleasant – makes it much more likely that any cancer will be caught at a  treatable stage.  Unfortunately, despite all this, you’ve reason to believe that Joe hasn’t told his relatives anything and now you’re unsure what to do.

What are your options?  You might say Joe’s confidentiality and autonomy are paramount: it’s up to him what he does, and, as his doctor, you’ve done your part by telling him the cancer is heritable.  Or you might argue that Joe’s family needs to know – but how  and when?  The GMC says you can share a patient’s personal information without consent if the benefit of doing so outweighs the risk: does the situation meet this criterion?  What if you share the information and Joe sues you for breaching his confidentiality?  But what if you don’t say anything and a relative develops a cancer that could’ve been prevented?  Won’t their trust in the health service be shaken if they knew you’d chosen not to share?  Indeed, the UK and Netherlands have recently seen cases where relatives  questioned the health service’s non-disclosure of relevant information.

Taking a “joint account” view of confidentiality from the outset would’ve avoided these situations.  The joint account involves viewing genetic and personal information as distinct: the possible inheritance of cancer is common to the whole Bloggs family, but that Joe has stage III bowel cancer is personal.  If genetic information is confidential to the family, not just the tested patient, you’d have told Joe upfront, before even drawing his blood, that you’d look into sensitive and appropriate ways to let his relatives know the information if they might benefit from it.  Later down the line, when it materialised he hadn’t told his family, it would’ve been easier to negotiate what to do.

In our recent JME paper, we explored the views of people affected by hereditary cancer and other conditions regarding the distinction between genetic and personal information, the levels of confidentiality afforded respectively, and healthcare professionals’ roles and responsibilities toward their patients’ relatives.

In line with the joint account approach, our interviewees considered their signs, symptoms, and diagnoses as personal, but thought genetic risk was familial and that their relatives needed to know about it. more…

Recent Attempts to Restrict the Abortion Law in Poland: A Commentary

25 Apr, 16 | by BMJ

Guest post by Dr Atina Krajewska, University of Sheffield

A couple of weeks ago news hit the headlines about attempts to introduce a total ban on abortion in Poland.  The legislative proposal that caused outrange among women’s rights organisations has been drafted by a citizen’s initiative, “Stop Abortion”, and is the fourth attempt to restrict abortion access to have been given a parliamentary hearing in Poland in the last 5 years.  The proposal must be supported by 100 000 signatures before it can be voted in Parliament.  However, as this threshold has been easily met in the past, it is worth reflecting on its causes and possible legal and social consequences for Poland and Europe.

Current law

Poland is well known for its conservative approach towards reproductive rights.  The current Act on Family Planning, from 1993, extends the protection of the right to life to the prenatal phase of human life.  It allows doctors to perform lawful abortions in only three sets of circumstances: when a) the pregnancy constitutes a danger to the life or health of the mother; b) prenatal tests suggest a high risk of a serious and irreversible abnormality or a severe life-threatening illness of the foetus; c) there is a justified suspicion that the pregnancy is a result of a criminal act (rape or incest).  A lawful termination can take only place within the first 12 weeks of pregnancy.  The Act has been often criticised as one of the most restrictive in Europe.

Nevertheless, despite popular belief, it is not the current law that seems to lie at the root of the problem.  The reason for the limited access to abortion services for women is not the restrictive legislation, but its highly limiting and narrow interpretation and incorrect implementation.  Poland has recently lost three major cases before the European Court of Human Rights (Tysiac, R.R., and P & S) due to the lack of adequate procedures guaranteeing the full exercise of statutory rights and medical practice substantially limiting access to lawful abortions.  For the first time in the abortion context, the Court found that the actions of Polish authorities and medical professionals have met the threshold of inhumane and degrading treatment, set in Article 3 of the European Convention on Human Rights. Poland is the best example of how social, historic and political circumstances led to the bifurcation of different forms of legality, i.e. to discrepancies between formal and informal rules, between law and other – ethical and social – norms.

The new proposal

The new bill “on the general protection of human life and preparation for family life” defines “prenatal life” as starting from the moment of conception, which is described as “the fusion of the female and male gametes”.  The same definition applies to the term “conceived child”, used in the Polish criminal code.

Crucially, the Bill proposes to delete all three conditions under which lawful abortion is currently permitted.  This, of course, constitutes a dramatic departure from the current legal framework, and converts the current legislation into an administrative tool setting general directions for (limited) sexual education and social care necessary for families affected by the new regulation.  At the same time, and more importantly, the new proposal sets out changes to the Polish criminal code, according to which ‘the causation of the death of a conceived child’ would carry a sentence between 3 months and 5 years of imprisonment.  The same sanction would apply if someone were to assist with, or incite, abortion.

There is only one exception. more…

How We Feel about Human Cloning

7 Apr, 16 | by BMJ

Guest post by Joshua May

Suppose you desperately want a healthy child to build a family of your own.  As is increasingly common, however, you can’t do it naturally – whether from infertility, a genetic disease you don’t want to pass on, or a non-traditional relationship.  If you seek a genetic connection with the child, there are some limitations to the main alternatives: adoption, surrogacy, and in vitro fertilization.  You may yearn for more options.

How would you feel about cloning?  Take the nucleus of a cell from yourself or a loved one, then put it into an egg that will eventually develop into a baby that shares nearly all the genes of the donor cell.  The resulting baby will simply be a kind of ‘delayed twin’ of the donor.

Most people believe this is immoral.  There’s a bit more support for therapeutic uses that merely create new tissue, for example.  But, at least in the US and UK, people overwhelmingly condemn cloning for the purposes of creating new human lives.  In fact, a recent poll suggests there is little disagreement in America over this issue, where human cloning is among the most widely condemned topics (alongside polygamy and infidelity).

That’s what people think, but how do they feel?  Controversial bioethical issues often generate intense feelings.  Some bioethicists treat cloning in particular as a line in the sand that we mustn’t cross, for fear of sliding down a slippery slope to a dystopia.

Consider Leon Kass, who played a major role in public policy as chair of George W. Bush’s President’s Council on Bioethics.  Kass argues that there is wisdom in repugnance toward human cloning, allowing us to ‘intuit and feel, immediately and without argument, the violation of things that we rightfully hold dear’.  As opposed to mere unease or sadness, Kass and some others have argued that disgust is such a powerful and distinctive emotion that we should take it seriously as a moral guide when deliberating about ethical issues.

An empirical claim lurks.  Such bioethicists assume that people in general share their reaction of repugnance. Besides, if we can uncover the emotional reactions people tend to feel toward disputed moral issues, then we can better understand why they hold the beliefs they do.  Does the prospect of cloning humans make us sick?  Scared?  Sad?  Angry?  Excited?  At ease?

In my paper, I provide some initial evidence that people (at least in the States) feel primarily anxious and curious about human reproductive cloning.  These were the most frequently self-reported negative and positive emotions, not disgust, fear, sadness, anger, excitement, amusement, comfort, or joy. more…

Why Brits? Why India?

3 Apr, 16 | by Iain Brassington

Julie Bindel had a piece in The Guardian the other day about India’s surrogate mothers.  It makes for pretty grim reading.  Even if the surrogates are paid, and are paid more than they might otherwise have earned, there’s still a range of problems that the piece makes clear.

For one thing, the background of the surrogates is an important factor.  Bindel writes that

[s]urrogates are paid about £4,500 to rent their wombs at this particular clinic, a huge amount in a country where, in 2012, average monthly earnings stood at $215.

It’s tempting, at first glance, to look at the opportunity to be a surrogate as a good thing in this context: these women are earning, by comparative standards, good money.  But, of course, you have to keep in mind that the standard is comparative.  If your choice is between doing something you wouldn’t otherwise do and penury, doing the thing you wouldn’t otherwise do looks like the better option.  But “better option” doesn’t imply “good option”.  So there’s more to be said there; more questions to be asked.  Choosing x over y because y is more awful doesn’t mean that x isn’t.  It might be a good thing; but it might not be.  There might be economic – structural – coercion.  Choosing to become a surrogate might be a symptom of there being no better alternative.

A related question is this: are the women really making a free choice in offering their reproductive labour even assuming that the terms are economically just?  Possibly not:

I have heard several stories of women being forced or coerced into surrogacy by husbands or even pimps, and ask Mehta if she is aware of this happening.  “Without the husbands’ [of the surrogates] consent we don’t do surrogacy.”

Note (a) the non-denial, and (b) the tacit acceptance that it’s the husband’s decision anyway.  That’s not good.

(In a wholly different context, I’ve recently been reading David Luban’s Lawyers and Justice, and – in a discussion about lawyers cross-examining complainants in rape cases, he makes this point:

([H]ere we have two people who are confronted by powerful institutions from which protection is needed.  The defendant is confronted by the state [that is: in any criminal trial, the defendant does need protection from the power of the state – IB], but the victim is confronted by the millennia-long cultural tradition of patriarchy, which makes the cliché that the victim is on trial true.  From the point of view of classical liberalism, according to which the significant enemy is the state, this cannot matter. But from the point of view of the progressive correction of classical liberalism, any powerful social institution is a threat, including diffuse yet tangible institutions such as patriarchy. (p 151)

(The sentiment would seem to apply here.  A view of human agency that sees liberty as being mainly or only about avoiding state interference is likely to miss all kinds of much more subtle, insidious pressures that are liberty-limiting.  Economic factors are such pressures.  The idea of the wife as property is another.)

I do wonder if readers of this blog might help out with answering one more question, though. more…

Mature Content?

27 Feb, 16 | by Iain Brassington

There’s an aisle at the supermarket that has a sign above it that reads “ADULT CEREALS”.  Every time I see it, I snigger inwardly at the thought of sexually explicit cornflakes.  (Pornflakes.  You’re welcome.)  It’s not big, and it’s not clever: I know that.  But all these years living in south Manchester have taught me to grab whatever slivers of humour one can from life.

Anyway…  A friend’s FB feed this morning pointed me in the direction of this: a page on Boredpanda showing some of the best entries to the 2016 Birth Photography competition.  (Yeah: I know.  I had no idea, either.)

I guess that birth photography is a bit of a niche field.  The one that won “Best in Category: Labour” is, for my money, a brilliant picture.  Some of the compositions are astonishingly good – but then, come to think of it, childbirth isn’t exactly a surprise, so I suppose that if you’re going to invite someone to photograph it, they’re going to have plenty of time to make sure that the lighting is right.

A second thought that the pictures raise is this: no matter how much people bang on about the miracle of birth… well, nope.  Look at the labour picture again.  I can’t begin to express how glad I am that that’s never going to happen to me; and I’m even more convinced than I was that I don’t want to play any part in inflicting that on another person.

But my overriding response is something in the realm of astonishment that some of the pictures are blanked out as having “mature content”.

I mean… really? more…

A Tool to Help Address Key Ethical Issues in Research

22 Feb, 16 | by BMJ

Guest post by Rebecca H. Li and Holly Fernandez Lynch

One of the most important responsibilities of a clinical project lead at a biotech company or an academic research team is to generate clinical trial protocols. The protocol dictates how a trial will be conducted and details background information on prior research, scientific objectives, study rationale, research methodology and design, participant eligibility criteria, anticipated risks and benefits, how adverse events will be handled, plans for statistical analysis, and other topics. Many protocol authors use as a starting point a “standardised” protocol template from their funder or institution. These templates often provide standard language, and sections for customisation, sometimes with various “pick-and-choose” options based on the nature of the research. They inevitably cover each of the key topics listed above, but often fail to include ethical principles and considerations beyond the regulatory requirement of informed consent. Indeed, the process of protocol writing has traditionally focused on scientific detail, with ethical analysis often left to institutional review boards (IRBs) and research ethics committees (RECs); unfortunately, robust discussion of specific ethical issues is often absent from clinical trial protocols.

When IRBs and RECs convene to review protocols, they are expected to evaluate whether the study will adequately protect enrolled participants. When the protocol fails to address potential ethical concerns explicitly, reviewers are left to speculate: did the investigator consider the concern, but dismiss it as not relevant in this particular context; did the investigator fail to understand the concern; does the investigator have an appropriate plan in place to resolve the concern, but has left it unstated in the protocol? This uncertainty can contribute to delays as reviewers debate among themselves, and can require lengthy back-and-forth with researchers, including series of protocol revisions and re-reviews until clarity is established. In some cases, it may also be that reviewers with less experience or expertise fail to identify an ethical concern that has not been brought to their attention in a protocol. more…

Making the Jump to a Medico-Legal Career

15 Jul, 15 | by BMJ

Guest Post by Daniel Sokol

On a number of occasions, I have been asked by early career ethicists about the move from ethics to law, or the wisdom of seeking a legal qualification to supplement their ethical knowledge. In the UK, this can be achieved remarkably quickly. This blog post is an answer to those questions, based only on my own experiences.

In 2008, I was a lecturer in medical ethics and law at St George’s, University of London. I had no legal training, and felt uncomfortable teaching law to medical students. Some of the graduate students were former lawyers and it must have been obvious to them that the limits of my legal knowledge extended no further than the PowerPoint slide.

That year, an old school friend, a solicitor, encouraged me to become a lawyer. “I can imagine calling you ‘My learned friend‘ in court”, he said. And so the seed was planted, and with each soul-sapping marking session, and each article published and quite unread, the seed grew until, in 2009, I resigned from my lectureship to study on the law conversion course, now called the Graduate Diploma in Law (GDL). more…

Eating Disorders and Ramadan

6 Jul, 15 | by Iain Brassington

One of those things that’d simply never occurred to me before was highlighted a few days ago in a story on Buzzfeed: how do you reconcile Ramadan fasting with recovery from an eating disorder?  Indeed: can you reconcile them at all?

“Food is obviously a big part of the holy month,” Sofia says. “Usually after breaking fasts, my family have bigger meals than usual, my mum cooks a lot of extravagant Pakistani dishes for iftar. It’s also a time when my extended family tend to visit more, or we go to the mosque and eat there.

“It’s really difficult to eat in public, especially because I’m still uncomfortable around a lot of foods. And what people usually don’t understand is how seeing all that food can make you feel so pressured. Last Ramadan I remember having to force myself to eat because everyone kept telling me to – and I couldn’t say no to them. When we came back from the mosque, I spent most of the night crying, because I felt I had no control.”

[…]

She adds: “I know in my head that I need to stick to the diet and do what my doctor says. But it’s still uncomfortable preparing food while my family aren’t allowed to eat or drink.” At times she “feels guilty while she’s eating”, she says, and there are moments when she’s tempted to go back to fasting again.

 

How central is the not-eating to Ramadan?  I mean: I know that there’re exemptions for things like medical conditions; but is there a mechanism for people not so much to be exempted, but to make an equivalent sacrifice?  Is fasting valued in itself, or because of what it symbolises?  If the latter, than some sort of substitution would seem possible without that counting as an exception.  If the former, then that wouldn’t be so clear.

Either way, the article suggests that part of the problem here is that there simply isn’t the support.  Inasmuch as that anorexic Muslims will be a minority of a minority, I suppose that that’s not surprising – and it’s compounded by apparent misunderstanding in south Asian communities.  But it’s no less worth noting for that.

What should Investigators be Doing with Unexpected Findings in Brain Imaging Research?

22 Jun, 15 | by BMJ

Guest Post by Caitlin Cole

Incidental findings in brain imaging research are common. Investigators can discover these unexpected findings of potential medical significance in up to 70% of their research scans. However, there are no standards to guide investigators as to whether they should actively search for these findings or which, if any, they should return to research participants.

This complex ethical issue impacts many groups in brain imaging: participants and parents of child participants who may desire relevant health information, but alternatively may suffer from anxiety and financial burden; investigators who must ethically grant their participants autonomy, but who also may suffer from budget and personnel restrictions to manage the review and report of these findings; Institutional Review Board (IRB) members who must provide ethical oversight to imaging research and help mandate institutional standards; and health providers who must interface with their patients and assist with follow up care when necessary.

Our research study shows these groups share some ideas on the ethics of returning incidental findings – the researcher has an ethical responsibility or obligation to tell a subject that there’s something there, however they do it, but just inform the subject, even though it’s not part of the research” – yet also acknowledge the inherent risk in reporting medical research information. As one of our IRB members commented, I mean [in regards to withholding findings] one reason would be to protect the patient from doing something stupid about them.

When participants are asked about incidental findings, they consistently state that they want to receive all information pertinent to their health. Research participants want to make their own medical decisions and feel investigators have a responsibility to keep them informed.

However, it is clear from our research that participants do not always understand the difference between a brain scan for research purposes and a clinical scan. The incidental finding reports that they receive include personal health information, written in medical jargon, discovered during a clinical procedure that may have immediate or long term medical significance. Because of this crossover between conducting research and sharing health information, participants may overestimate the clinical utility of the reported research information. This is a challenge for investigators whose role is to conduct research, not to diagnose participants or offer findings with clinical certainty. Participant assumptions otherwise have the potential to cause downstream legal complications for the research institution.

It is necessary to understand the impact on all parties involved in the process of disclosing incidental findings to determine appropriate management policy. This challenging task should not be underestimated as these groups think differently about the balance between risk and benefit based on their role in this process, whether they be a research participant, a research investigator, an IRB member or a health provider. Overall there is an ethical demand to manage and report unexpected findings discovered in brain imaging research; finding a way to do this while minimizing negative impact for all involved is important.

Read the full paper here.

Animals in US Laboratories: Who Counts, Who Matters?

21 Mar, 15 | by BMJ

Guest post by Alka Chandna

How many animals are experimented on in laboratories? It’s a simple question, the answer to which provides a basic parameter to help us wrap our heads around the increasingly controversial and ethically harrowing practice of locking animals in cages and conducting harmful procedures on them that are often scary, painful, and deadly. Yet ascertaining the answer in the United States – the world’s largest user of animals in experiments – is surprisingly difficult.

In the eyes of the US Animal Welfare Act (AWA) – the single federal law that governs the treatment of animals used in experimentation – not all animals are created equal. Mice, rats, and birds bred for experimentation, and all cold-blooded animals – estimated by industry to comprise more than 95 percent of all animals used – are all unscientifically and dumbfoundingly excluded from the AWA’s definition of “animal”. Orwell cheers from his grave while Darwin rolls in his.

Leaving aside the question of whether mice and rats should be categorized as vegetable or mineral, the exclusion of these animals from the AWA also results in a dearth of data on the most widely used species, as the only figures on animal use in US laboratories that are systematically collected, organized, and published by the government are on AWA-regulated species. more…

JME blog homepage

Journal of Medical Ethics

Analysis and discussion of developments in the medical ethics field. Visit site



Creative Comms logo

Latest from JME

Latest from JME

Blogs linking here

Blogs linking here