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


This will hurt a bit

11 Apr, 14 | by David Hunter

In a piece titled in a fashion to simultaneously win the internet and cause every male reader to wince, Michelle Meyer asks “Whose Business Is It If You Want a Bee To Sting Your Penis? Should IRBs Be Policing Self-Experimentation?

In this piece she describes the case of a Cornell graduate student who carried out a piece of self-experimentation without IRB approval (based on the mistaken belief it wasn’t required) which aimed to assess which part of the body was worst to be stung by a bee on and involved:  ”five stings a day, always between 9 and 10am, and always starting and ending with “test stings” on his forearm to calibrate the ratings. He kept this up for 38 days, stinging himself three times each on 25 different body parts.”

While IRB approval was required and not sought in this case, Meyer argues that this isn’t problematic effectively because in her view regulating researcher self experimentation constitutes an unacceptable level of paternalism:  ”The question isn’t whether or not to try to deter unduly risky behavior by scientists who self-experiment; it’s whether this goal requires subjecting every instance of self-experimentation, no matter how risky, to mandatory, prospective review by a committee. It’s one thing to require a neutral third party to examine a protocol when there are information asymmetries between investigator and subject, and when the protocol’s risks are externalized onto subjects who may not share much or any of the expected benefits. Mandatory review of self-experimentation takes IRB paternalism to a whole other level.”

Perhaps this is just my inherent lack of a distaste for relatively benign paternalism but I don’t quite see this objection to regulating self experimentation working for three reasons.

Firstly the distinction Meyer draws between self and other experimentation assumes a high level of understanding of the risks and benefits on the behalf of the researcher in a way that negates the need for the normal consent process. This is probably right most of the time and so we can assume consent is present. Does this negate the need for external review? I am not sure it does since the researchers understanding is not perfect and they may be self deceiving in regards to the magnitude and level of risk. Meyer notes for example that this project originally involved stings to the eye, until the supervisor of this student pointed out that this risked blindness. So review by external experts regarding risks and benefits of research can and does reduce the levels of risks in research. In Research Exceptionalism James Wilson and I argue that this is a general justification for external research regulation – the ethics and risks and harms of research are complex and unpredictable and hence external regulation helps clarify these risks and ethical issues to enable researchers to fulfil their moral duties. This is of course paternalistic in the case of self-experimentation, but I presume that the student in this case is grateful to his supervisor for saving his vision, so I think it is the kind of paternalism we ought to endorse, since it is in regards to a risk that the person wouldn’t want to run.

Secondly valid consent, doesn’t just consist of having information, it also requires competency and particularly in these types of cases an absence of coercion. This is a graduate student who is to be frank in a vulnerable institutional position (like many of us in academia…) – if they want to improve their standing and move to the next level they need to keep their superiors happy. This makes them vulnerable to self exploitation and risk taking, which external regulation can reduce and remove.

Finally I suspect that what is going on here is a kind of reverse research exceptionalism where the regulation of research is seen as somehow more problematic than the regulation of other aspects of our lives. It is commonplace for health and safety to require us in the course of our employment to to act and not act in particular ways. This is both paternalistic insofar as it protects us, but it is also not paternalistic insofar as it protects both others and the instution we work at. In this case, this student is working in a lab in an institutional context and if something had gone wrong for the student or others in the course of this research then the institution could well have been held liable for damages arising from this. As such it seems perfectly within their rights to me to decide how to regulate these risks to them, and to decide to regulate these via prospective review.

Now as Meyer notes this is an external requirement rather than a choice that Cornell has made, but I don’t think this changes the justification for the regulation – given that we know in markets competition tends to drive towards failures to protect workers and others, there is nothing inappropriate with the state correcting the market failure here via legislation.






Medical Information for Sale?

21 Jan, 14 | by Iain Brassington

Reader Keith emailed me a week or so ago to tip me off about the government’s plans to allow private firms to access medical information.  It’s a story that has subsequently been picked up by  - inter alia - The Guardian.

As with the last post I made here, I’m going to have to cry off from saying much in my own right – I’ve got lectures that need to be written, and I need at least to go through the motions of being competent – but I would draw your attention the Christian Munthe’s take on the matter.

Touch wood, I’ll be able to get back to more frequent blogging soon.

Sex-Selection and Abortion: Is there a Problem?

17 Jan, 14 | by Iain Brassington

This is just a quick post, and it’s mainly to draw your attention to a couple of other posts worth reading elsewhere.

A little background: there’s been a minor fuss* in the media over the last few days concerning sex-specific abortion**, after The Independent reported that

[t]he practice of sex-selective abortion is now so commonplace that it has affected the natural 50:50 balance of boys to girls within some immigrant groups and has led to the “disappearance” of between 1,400 and 4,700 females from the national census records of England and Wales, we can reveal.

Now, there’s something a bit fishy about the article even on its own terms: alarm bells should be got ringing by this:

[O]ur deeper statistical analysis of data from the 2011 National Census has shown widespread discrepancies in the sex ratio of children in some immigrant families, which can only be easily explained by women choosing to abort female foetuses in the hope of becoming quickly pregnant again with a boy.

After all, it does seem to reduce to a claim along the lines that “I can’t think of a better explanation than e for phenomenon p, therefore e obtains” – but that tells us far more about the limits of the speaker’s imagination than about the state of the world.  Besides, while there are good reasons to favour the most simple explanation of p, one ought to keep a distinction between the simple and the simplistic.  Bluntly, an easy explanation isn’t any more likely to be true by dint of being easy.  E=mc2 is simple once you’ve derived it, but its derivation isn’t easy.

But how reliable is the Indy‘s analysis anyway?  I’ve not gone through the data myself, but Unity has, and has a couple of really good posts: the first is here, and the followup is here.

They’re very worth the read – but I recommend that you make yourself a good cup of tea before starting them.  They’re looooooong.  I’d be interested to know what others think, though.


UPDATE: There’s even more.  I think Unity’s enjoying himself with this.


* Minor in the sense that it’s been eclipsed by things like Oscar nominations.

** Here’s Christina Odone, for example, blaming it all on feminism.  Surprised?  You could knock me down with a bulldozer.

Identity and IVF

11 Jan, 14 | by Iain Brassington

It’s good to see that Stephen Latham is blogging again after a short hiatus; and he’s come back with a really thought-provoking post on IVF and problems of identity.

The background is this: apparently, there is evidence that children conceived by IVF are at an elevated risk of health problems compared to kids conceived naturally:

Compared to spontaneously-conceived singletons, singletons from assisted conception were almost twice as likely to be stillborn, more than twice as likely to be pre-term, almost three times as likely to have very low birth weight, and twice as likely to die within the first four weeks after birth. Outcomes varied by type of assisted conception. Very low and low birth weight, very preterm and preterm birth, and neonatal death were “markedly” more common in births from IVF and, to a lesser degree, in births from ICSI. Use of frozen embryos elminated the risks of ICSI, but not of IVF. But frozen embryos also had increased risk of macrosomia.

This is the paper that Stephen mentions; but it’s not the only one to report potential risks associated with IVF.  A rather kneejerk response to this is to go “Eeeep!  This means that IVF is dangerous, and we’re harming kids by conceiving them by this method”.  (I suspect that there’s an element of that in posts like this – though admittedly if that element is there, it’s being deployed merely as a part of a wider attack on IVF, motivated for different reasons.)  But, of course, kneejerk reactions are rarely all that morally insightful, and the conventional response to concerns about IVF is rather more sanguine.

Borrowing heavily from Parfit, the standard response is this: each of us is reliant on a particular egg and a particular sperm having fused in a particular way.  Had that been different, we would not have come into being.  A month later, and it’d've been a different egg; and it could easily have been a different sperm cell.  Any resultant child would be related to us only in the same way as a sibling – except that it wouldn’t be our sibling, because we wouldn’t be there.  This indicates that, if IVF represents a child’s only chance of coming into existence – and it probably is – it is hard to say that the child has been harmed or wronged thereby.  There may be a qualification to add, along the lines that should the child’s life be so bad that non-existence would be preferable, existence may be a harm; but that kind of outcome is probably hyperbolic in practice.  An elevated risk of any congenital characteristic is therefore unlikely to count as a harm.

So, as Stephen points out, we can ask a question: more…

An Attack of the What-Ifs

25 Oct, 13 | by Iain Brassington

Among the comments to the last post, there’s this from Parmenion59:

So…if a cure for lung cancer is found, and the study has been funded through money from a tobacco company…the BMJ won’t publish said study?
Way to go BMJ.

Hmmm.  At least on the face of it, this looks like an important point – one that deserves a bit of unpacking.  We can begin by distinguishing between responses to this particular point, and responses to the general idea behind it.  First things first.

I’m willing to bite the bullet and admit without worrying too much that the policy of not accepting papers funded by the tobacco industry may mean that some research is not publicised.  There’s a small handful of reasons why I’m willing to do that.  One of them – admittedly the weakest of the lot – is based on the idea that it’s not wholly clear that much tobacco money really is directed at finding a cure for lung cancer, rather than firefighting other research about the detrimental properties of tobacco.  But that, as I say, is weak, based on suspicion rather than anything enormously substantial; and even if the hunch is correct, it’s merely empirical rather than anything conceptual.  Still, even if the hunch is wrong, it shouldn’t matter, because there’re stronger reasons.

One is based around the idea that there’s a special providence in the fall of a pipette – or, put another way, you can’t keep a good truth down.  If something is there to be discovered and is worth the effort, then it’ll be discovered sooner or later; if not by Smith, then by Jones.  And, because scientific progress is invariably a matter of the accretion of the work of several teams, all working independently and making minor discoveries, rather than one heroic person who would be solely responsible for The Cure For Cancer ™, the loss of one paper here and there probably won’t make all that much of a difference in the grand scheme of things. If that’s correct, then the idea that we might lose the cure for cancer is not all that compelling – not one about which we should worry too much.

A final reason is that, as I’ve said before elsewhere, I’m not persuaded that research is obligatory: it’s admirable, but not required by duty.  There’s a range of second-order arguments one might present here, but most relevant has to do with the benefits that research might generate.   more…

How to write a crap essay/paper in bioethics – or how to write bioethics to be published in medical journals…

7 Oct, 13 | by David Hunter

I’ve been considering writing a reflective piece about the general quality of bioethics papers in medical journals, focusing on how the medium (the audience and the severe word limits) impacts on the message and its quality – possibly as a bit of a moan since I’ve not yet managed to get a medical journal to accept one of my papers (my favourite rejection from an editor yet being “nice try, but too philosophical – maybe try the journal of medical ethics?”). Furthermore publication pressures tend to select for particular styles of pieces – I’ve remarked to people in the past that the way to get published in the BMJ is to write a piece critical of research ethics review - preferably with an anecdote  Then this morning on twitter I saw this lovely funny piece by James Lenman of the University of Sheffield on how to write a crap essay in philosophy which contains gems such as:

 ”Whenever in any doubt as to what to say about X, say, apropos of nothing in particular and without explanation, that X is extremely subjective.

When that gets boring, try saying that X is all very relative. Never say what it is relative to.”

And I decided to just borrow and extend the idea in this piece. So take James’ rules as given and add these rules to enable the reader to write a crap piece of work in bioethics:

1. Unreflectively copy a piece of work by a philosopher. If they wasted time qualifying their view or noting it only applies in a limited situation make sure you strip that out.

2. Remember if you are a doctor you don’t need good arguments – you have authority… Remember if you are a philosopher you don’t need to know the context to write authoritatively about it.

3. Never use an argument where an anecdote will do. A homily is worth a thousand arguments.

4. Instead of making an argument, say “I will argue”. Then don’t, an assertion will do. No one will notice.

5. Don’t ever make a modest claim when you can make a bold assertion. Only extremes can be correct.

6. According to the OED it is important to define your terms using the dictionary not how they have been defined in the relevant literature.

7. Please do begin your paper with a vaguely relevant quote from “Literature” this shows that you are well read and thus quite clearly correct. As D’Israeli said: “The wisdom of the wise, and the experience of ages, may be preserved by quotation.”

8. If empirical evidence is relevant to your paper make sure you either don’t find any or you just run a google search and then cherry pick the evidence to support your case without considering its quality.

9. Remember the is/ought problem is a philosophical problem not a bioethical problem so you don’t need to worry about it when making grand assertions from tiny bits of empirical evidence.

10. Ad hominem is a valid argument structure.

11. All slopes are slippery. If its bad and it is remotely possible let us assume that it will happen.

12. There are no principles/theories but the four principles.

13. Obviously the four principles approach is the only one worth considering. Make sure you refer to all four principles (but nothing other than them) especially if several of the principles are irrelevant to the situation you are discussing – before concluding that autonomy trumps the others.

14. Remember the more arguments/assertions you can give the better – why waste time on critical reflection and depth when you can squeeze in more arguments/assertions. Especially ensure that there is no methodological or theoretical consistency about the position you advance.

15. If your argument gets into trouble you can save it by referring to Nazi Germany and implying that your opponents view would have been looked on kindly there.

Please suggest more rules in the comments…  

Research Ethics and Ethical Problems

16 Aug, 13 | by Iain Brassington

Noted on Ben Goldacre’s twitter feed a couple of weeks ago was this article in Slate about the recruitment of pregnant women into drug trials.

Essentially, there’s a situation in which there’s a dearth of information about the impact of drugs during pregnancy.  According to the article,

[p]harmaceutical companies are not willing to navigate the legal and ethical minefield of testing drugs on pregnant women, especially because pregnancy lasts only nine months, a short window in which the tests could pay off in additional sales.  As a result, drugs are often prescribed to this population off-label, meaning that they haven’t been specifically approved for pregnant women.

Of course, that doesn’t explain why testing is an ethicco-legal “minefield” to begin with.  Still, it’s not all that hard to come up with at least a skeletal explanation: the whole point of trials is that the effect of a drug is unknown, and this might mean that it’s not safe.  When we’re talking about a volunteer, then it’s important that they know the risks before enrolling; but when a woman is pregnant, another dimension is added: she’s effectively volunteering her unborn child as well.  And it might be problematic to expose another human – even a foetus – to an unknown risk.

But this leaves us with a paradox: more…

Safety First? How the Current Drug Approval System Lets Some Patients Down

15 Aug, 13 | by BMJ

Post by Julian Savulescu

Cross-posted from the Practical Ethics blog, and relating to this paper in the JME.

Andrew Culliford, whose story is featured in the Daily Mail, is one of the estimated 7 in 100,000 people living with Motor Neuron disease, a progressive degenerative disease which attacks muscles, leaving those affected eventually unable even to breathe unassisted. For Andrew, a young father who has a severe form of the disease, it means a two to five year life expectancy.

Like Les Halpin and Jenn McNary, the mother of twins afflicted with a similar rare disease, he has a simple request: earlier access to medicines that might help improve or extend his life.

The US introduced a mandatory pre-approval process for pharmaceutical drugs after over 100 people were killed by an untested drug formulation. Today, each drug must go through a series of strictly controlled trials, including Phase 1 tests on healthy volunteers, followed by Phases 2 and 3 which test the drug and dosages on smaller and then larger patient groups. The process is estimated to cost $500 million per drug and to take 8 – 12 years.

The process is designed to ensure the efficacy of drugs has been scientifically demonstrated to a very degree of confidence, and to ensure that patient safety is sufficiently protected. In many ways it has been a triumph of science and regulation.

But it has been a failure for one small group of patients: those with rare, imminently lethal diseases, for whom there are no existing good treatments. more…

Emmerich on Fitness to Practise

30 Jul, 13 | by Iain Brassington

Having asked out loud whether anyone could explain a couple of odd FtP decisions, I got this from Nathan Emmerich, offering sociological pop at an answer… 

Iain wondered if anyone could explain the morality that underlies a couple of recent Fitness to Practise decisions made by the GMC.  Well, more accurately he wondered if anyone could explain the “public perception” or “public confidence” aspect of the GMC’s Fitness to Practice guidelines.  Never one to shirk a challenge, I thought I would give it a go…

The first thing to note is that one has to change, or perhaps expand, the terms of the debate.  As a discipline applied philosophical bioethics tends to focus on “ethics”, “ethical reasoning” and codified rules over what I (and some others) would call “morality”.  For our present purposes the starkest way to express the idea is by appeal to the historical morality of the UK medical profession, which used to be based on the idea of the British gentleman of a certain class and standing (and, obviously, race and gender).

This morality was uncodified – it had no explicit ethics.  Indeed, more than this, it was held to be uncodifiable both in principle and as a matter of morality.  It was thought it would be wrong to codify gentlemanly (medical) morality as to do so would open the way to, first, individuals who merely followed rules rather than being the correct sort of persons or having the right character.  Second, it would lead to people who did not have the right character or standing attempting to second-guess the decisions of medical professionals or gentlemen.  Such a thing was, of course, intolerable.

There is no denying that there was a lot wrong with this ‘moral culture’, and a range of factors has been influential in the modification of medical morality from this historical position to the one we have today.  However, “medical morality” has vanished completely, indeed, it is impossible for it to do so: the medical profession (indeed any profession or cultural group) has some underlying moral ethos.  Some cultures, like modern medicine, may also have explicitly stated ethical codes and guidelines that may be more or less in line with the underlying moral culture.  Nevertheless the moral culture itself is not obviated by these codes.  Indeed it underpins the existence and application of any such formally stated ethics.

The problem here is that no rule contains the principles of for its own application.   more…

Not in any Way Topical.

22 Jul, 13 | by Iain Brassington

I know, I know.  I keep banging on about the irrelevance of genetics when it comes to families – about why parenthood isn’t a genetic thing.  But, actually, now I think about it – Duchess of Cambridge blah blah baby blah… I wonder what, if any, constitutional implications there’d be if the heir to the throne were infertile and adopted?

Yeah, I know that it’s doubtless happened before without anyone knowing – but just suppose that the new third in line to the throne were, say, an adopted Cambodian orphan instead of a (close) genetic relation to William and Kate.  I can’t think of any moral objection to that being a barrier to succession.  A child raised in those circumstances would, I think, have just as much right to ascend as would a child related by blood; there’s no reason to suppose that he or she wouldn’t be a part of the family in the fullest sense.

Unless, of course, we think that the word “family” in “Royal family” doesn’t mean quite the same as the word “family” in other contexts.  But then, what would it mean?  Why would genes be important in this circumstance?

And just suppose that the people of late mediaeval and early modern England had had the same obsessions about genes.  That’s something that’s been keeping the Abstruse Goose awake.


Readably big version here.

UPDATE: OK, that’s odd.  The site on which the cartoon appears is currently listed as a virus threat.  I have no idea why.

UPDATE 2: Hmmm.  Seems to work on my home computer.  It might just be the UoM servers being twitchy, then.  Oh, I don’t know.

JME blog homepage

Journal of Medical Ethics

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

Latest from JME

Latest from JME

Blogs linking here

Blogs linking here