Where’s your ethics committee now, science boy? – updated with letter

February 23rd, 2008 by Ben Goldacre in bad science, regulating research | 38 Comments »

Ben Goldacre
The Guardian,
Saturday February 23 2008

People have done some terrible things, over the years, with science, and with their science skills. I’m talking about Zyklon B, electrocuting gay people straight, torturing people in concentration camps, leaving syphillis untreated in large numbers of black men for an experiment (without telling them, in the US, until the 1970s), and more. Stuff where it’s hard to find any humour.

This is why we have research ethics committees, codes of practise, professional bodies, and regulators like the The US Office for Human Research Protections. Sometimes these organisations can cock up quite badly. Let me tell you about two stories which have been unfolding over the past few months.

In New York, a fiendishly clever trial in ITU departments has looked at one of the simplest interventions imaginable: a ticklist for giving IV lines, a helpful little reminder to wash your hands, wear gloves, and so on. Can something as simple as “using a ticklist”, to check if people are doing the right thing, reduce infections and save lives?

This is the bread and butter of medical academic research, which is usually not about pills, or placeboes, or molecules, but about looking pragmatically at whether one thing works better than another. You will remember that homeopaths and various other quacks are philosophically opposed to this process.

The results were spectacular: in 3 months, the incidence of blood infections from these IV lines fell by two-thirds, and over 18 months, the program saved 1,500 lives and an estimated $200 million. Then someone complained to the OHRP, because this was a research study, and they did not have ethics committee clearance. The project was shut down. This week, the OHRP grandly lifted their ban, explaining that now – since it turns out the research bit is over, and the hospitals are just putting the ticklist into practise – they may tick away unhindered.

This is what we might call the “ethical paradox”. You can do something as part of a treatment program, entirely on a whim, and nobody will interfere, as long as it’s not potty (and even then you’ll probably be alright). But the moment you do the exact same thing as part of a research program, trying to see if it actually works or not, adding to the sum total of human knowledge, and helping to save the lives of people you’ll never meet, suddenly a whole bunch of people want to stuck their beaks in.

Hilary Hearnshaw did an elegant study where she pretended to apply to do a medical research project in the Israel, the UK, and 11 other countries in Europe. She said she wanted to do a trial on a leaflet – contain your excitement – which was designed to help older patients get more engaged with their GP.

Only three countries required the project to go through a process of ethical approval, and in the UK, this was more arduous than in any other country. Getting ethical clearance took ten weeks, required two submissions (because they demanded changes), and five full days of administration, during which the proposal had to be reviewed by full committees, some of which required multiple copies of the application paperwork.

This is just the tip of the iceberg (and I would always welcome more examples by email). For one multicentre clinical trial, each of 125 local research ethics committees required between 1 and 21 copies of a protocol. Ethics approval for another trial, involving 51 centres, required over 25 000 pieces of paper, 62 hours of photocopying, and an average of 3.3 hours of investigator time for each centre. You feel like you’re dying when administrators drag their heels. In the case of medical research, when you delay research findings, and deter researchers from even bothering, people really are dying. This wider harm seems to be a blindspot for the ethics committees, captivated by their own mission creep.

But it’s not the only ethical blindspot. These regulations have their roots in the Nuremburg Code. But while the world of clinicians and academics splits ethical hairs, with our eye off the ball, an elephant has walked into the room. February has seen another string of prominent psychologists resigning from their membership of the American Psychological Association, in disgust at its failure to take a stand on “abusive interrogation techniques”, cruel, inhuman and degrading treatment, and other activities which you might consider to be torture. Psychologists are key to these interrogations and other activities, both in designing and enacting what I would rather not call “protocols”, out of compassion for the people on whom they are grimly enacted, in places cameras do not go.

APA members, trained, clinical professionals on their register, who have signed up to their codes of practise, now participate in these activities. The APA’s response has been to specifically bend the codes of conduct to permit their actions, and to obfuscate. Where’s your ethics committee now, science boy?

Bits:

Ken Pope, prominent member of the American Psychological Association (and a former chair of its Ethics Committee), resigned his membership on February 6. He’s the latest of a growing number of professional psychologists who have quit APA in protest of its position on the use of psychologists in government interrogations in the “War on Terror.”

Lots more on the APA and torture at Mindhacks.

EXTRA:

Here’s a nice letter from Hilary Hearnshaw, the researcher who did the study looking at different countries’ ethics committee palaver.

 

Dear Ben Goldacre,

 

I was very pleased to see that in your article on February 23rd, in The Guardian, you had mentioned my research study comparing the ethics approval protocols in several European countries for an actual study (not a pretend one as you described it).  I followed this up with my colleagues, especially students who attempted to conduct research studies for their masters degrees, to gather information on the effect and delays that acquiring approval from research ethics committees (RECs) incurred. 

 

We found that the effects were so great for students that we decided to change the requirements for them to do a research study for their courses, since the approval process usually took longer than the whole course. It would have required students to start their applications before they had done any studying and learning on the course, which was clearly inappropriate (nay stupid).

 

Thus, as your article was making clear, obtaining research ethics approval led to a reduction in the number of research studies conducted by our students (mostly current health care professionals) and hence to a reduction in the research skills and experience of these health professionals.

 

I am pleased to note that the REC requirements are under constant review by the national COREC organisation, which might make them usable eventually. The whole REC process seems to me to be an excellent example of using a sledgehammer to crack a nut (preventing bad, unethical science) and losing any useful part of the nut in so doing.

 

I wish you well in future attempts to prevent bad science.

 

Kind regards

 

Hilary Hearnshaw

 


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38 Responses



  1. David Colquhoun said,

    February 23, 2008 at 7:08 am

    Excellent piece. And not only that. Have you ever tried complaining to a university ethics committee about something that has happened in their university? The few times that I’ve done it, I have encountered nothing but obfuscation and defence of the indefensible.

  2. Paul Crowley said,

    February 23, 2008 at 10:37 am

    Obviously it’s not exactly Guantánamo, but I’m a little surprised that psychologists in this country and others have been allowed to take part in Big Brother without censure, when if they proposed a similar set-up to an ethics committee they would be outraged.

  3. stavros said,

    February 23, 2008 at 11:20 am

    Well said Ben. You know where is the problem with such errors (deliberate or not): the quacks use them to somehow add truth value to their own irrational claims. Argument by elimination: since you’re doing bad stuff then our woo woo works.

  4. Dan Kimberg said,

    February 23, 2008 at 2:21 pm

    While this kind of ethical paradox is a little disturbing, that’s really because we see the intervention (ticklist) as harmless. But I think it’s pretty obvious that, left to their own to decide which interventions are harmless and which are problematic, clinicians and researchers will be overly inclusive. So while it seems a little paradoxical in this case, that’s just because we’ve given the ticklist protocol our own post-hoc review and decided what they did was fine. In general, though, it’s not okay to embark on a research study without approval just because (a) you know you can get away with it under the guise of medical practice or (b) because you believe it would be approved anyway.

    So in my view, there is no paradox — no matter how seemingly benign, if it’s a research study involving patients, it’s reasonable to impose some kind of review. The real issue is simply that review boards don’t have adequate mechanisms for fast-tracking approval of these kinds of studies. Our local IRB has one fast-track category, but it’s too restrictive to include the vast majority of benign research projects.

    IRBs indeed wield too much power, suffer from mission creep, and impose burdensome and unnecessary bureaucratic requirements on scientists, wasting an incredible proportion of very valuable time. This is all simply a consequence of incompetence. They are bad at what they do.

    I can’t top 25,000 pieces of paper for an example of inefficiency, but I do think something’s wrong when we have to give brain-injured and cognitively impaired patients 20+ pages of consent and other forms prior to participation in our studies, especially considering that the information they really need and want could be conveyed in a short paragraph.

  5. Daibhid C said,

    February 23, 2008 at 3:05 pm

    Dan: I’m not a doctor, but if I’m reading Ben correctly the paradox is that if you *don’t* bother with the research, and just decide without any evidence that the ticklist, or giving all your patients 100mls of madeupnameanine, is a good idea, the ethics committee can’t get involved.

  6. Dan Kimberg said,

    February 23, 2008 at 3:36 pm

    I was just pointing out that what this paradox amounts to is the observation that if you don’t apply for approval, you can sometimes get away with it. It seems like a paradox because of the illusion that it’s okay when you get away with it, as long as it’s harmless. But just because the study seems harmless, that doesn’t mean it’s okay to run it without approval, or under the guise of clinical practice. We have review boards for the specific reason that scientists and clinicians don’t always use good judgment.

    Of course, it makes a huge difference if patients are being randomly assigned to treatment groups vs. being given an across-the-board change in clinical practice. The latter can be implemented outside research procedures and evaluated with a research protocol that generally requires only superficial review.

  7. Nick Bland said,

    February 23, 2008 at 4:16 pm

    Dan: i totally agree with you. You can’t just say that a study doesn’t require ethical approval just because to the researchers thinks its benign.
    as a researcher (although biomedical not clinical) i know that you become very close to your subject and objectivity is very difficult. No one would have thought that bypassing the ethical approval was ok if the checklist had caused an increase in infection. its only now that we know that it is beneficial that such safeguards seem excessive.
    an increase in infection or no effect result must have been concievable otherwise the research is pointless.

  8. Ben Goldacre said,

    February 23, 2008 at 6:39 pm

    DocA, i enjoy your melodrama but i have no need for your halo.

    the question is not wheher ethics committees are a good thing: of course they are.

    the issue is one of proportionality.

    there are many ludicrous examples of ethics committee mission creep, and of ethics committees placing serious barriers to research. this itself has serious consequences for patients. i simply believe that the delay of research, and the fact that research will sometimes not get done because of the problems with ethics committees, is something which must be taken into account when judging their own ethical value. it is striking how much resistance there is to this notion.

    i would love to spend a spell on an ethics committee and i’m sure i’ll do so at some stage in the next few decades. it is very striking to me, however, that the most serious ethical issues in medical academic work – where to start, not even with torture – are often not even the types of questions addressed by ethics committees, and we have taken our eye off the ball.

    you suggest that things have changed for the better over the years, as i would hope they have. i note you also doubt the very existence of the examples i gave.

    the 125 applications example i gave did indeed happen, and it happened after the introduction of new systems to improve the problems with ethics committee clearance in multicentre trials.

    Tully J, Ninis N, Booy R, Viner R. The new system of review by multi-centre research ethics committees: prospective study. BMJ 2000;320: 1179-82.

    as i said: between 1 and 21 copies of a protocol were required by each of 125 local research ethics committees, with two thirds of the committees withholding approval until the researchers had made amendments that were unrelated to local circumstances.

  9. Dan Kimberg said,

    February 23, 2008 at 8:25 pm

    Some random comments, as I’m following this discussion. First, I should have mentioned the following earlier in response to Daibhid C. If a clinician decides to simply change clinical practice across the board, for reasons that are not motivated by research interests, but just by what seems to be a good idea, certainly that doesn’t necessarily require review. However, the local rule (I imagine it’s not that unusual) is that if you later want to look at the records (which are observational and not experimental) and ask some kind of scientific question about that policy change, some level of IRB review is required. I imagine part of the reason for this policy is to prevent clinicians from sneaking research studies in the back door without review by pretending they’re just changes in policy.

    Re: DocA’s comments, I’m surprised to hear that things have been getting better in the UK. The same can not be said for the US, where IRBs are violently out of control. I have to support Ben here — it’s possible to believe strongly in the importance of ethical review and still feel the current system is desperately broken. I applaud Ben for pointing out some egregious examples of bad behavior, although I still think the more harmful (but less colorful) effects are in the mundane, everyday examples.

  10. MattJH said,

    February 24, 2008 at 12:20 am

    Regarding the fact that doctors seem to be able to carry out all sorts of experimental treatments and surgery so long as it is clinical practice rather than ‘research’, I find this disturbing.

    Ethical review boards can and do prevent harm coming to patients. If doctors want to try a new treatment on a patient outside an emergency setting, then I think they should get approval from their hospital authorities first. Otherwise they are doing n=1 experiments that are unrecorded and unregulated.

    Treatment case reports are an example of this – the doctors submit a case report to a journal, the journal asks for a statement of ethics approval, and the doctors reply that it wasn’t research. But then it turns out that they decided to try a new treatment on this patient, and oh look, it worked.

    The problem is that nobody but the doctors weighed up the risks of this treatment, and there’s another problem – if the treatment had failed, would the doctors be submitting a case report? No. So this practice distorts the research literature.

    If doctors want to experiment with treatments then they should get prior approval and be obliged to write up the results of all such trials, even in only one patient.

  11. Ben Goldacre said,

    February 24, 2008 at 12:29 am

    MattJH you are, very understandably, imagining a divide between “experimental” and “everyday” which simply does not exist in the way that you think.

    was the checklist an “experimental” treatment? no.

    the point of the “consent paradox”, as it has come to be known, is that you can take two perfectly everyday treatments – say two treatments for epilepsy, where nobody knows which is best – and if you give one or the other to your patients at whim, unsystematically, there’s no problem, it’s just subject to the normal regulation of doctors treating patients; but if you want to find out which is better, randomise your patients, and compare how well each group performed, you are in big trouble, the patients need to go through a huge amount of palaver, as do the doctors, for giving… the exact same treatments in the exact same situation of uncertainty. it’s an interesting paradox.

    you can read much more about this in the excellent Testing Treatments, which i’ll be doing something big on soon, now that it’s free for download.

    www.jameslindlibrary.org/testing-treatments.html

  12. igb said,

    February 24, 2008 at 7:08 am

    “ou can take two perfectly everyday treatments – say two treatments for epilepsy, where nobody knows which is best – and if you give one or the other to your patients at whim, unsystematically, there’s no problem, it’s just subject to the normal regulation of doctors treating patients; but if you want to find out which is better, randomise your patients, and compare how well each group performed, you are in big trouble,”

    Let me give an example (and if you’re reading, Paul, insert any factual corrections).

    A friend of mine studied medicine in the early 1980s, but for various reasons decided not to make a career in it and after his house jobs he made an exit into IT. Time passed, and he and his wife wanted a child. It didn’t happen, and as they approached forty time really was passing, so they had several courses of IVF. Which ended in miscarriages. Finally one course didn’t end in a miscarriage, and shortly after the twelve week “if it’s going to happen, it probably happened by now” line we all sat around making happy noises.

    Two weeks later she was diagnosed with aggressive cancer in her lymph nodes, suspected to be a secondary from breast cancer. The advice — and they say, delivered pretty brutally — was termination and treatment, or death.

    Paul fled to the medschool library, and found small trials — one in Cambridge, one in South America — which showed that chemo was tolerated in the second and third trimesters. By sheer co-incidence his local hospital was where, near twenty years previously, he had done his house jobs, and the oncologist was someone he’d known then. Paul convinced the hospital to take a chance on treatment while pregnant. Unable to use CAT scanning to find the primary a surgeon was convinced to do the lymph surgery, and some technique I didn’t understand was used to confirm that the primary was breast cancer from the biopsy on the secondary. Then she had chemo through the rest of the pregnancy, with a two week break immediately prior to delivery, and then immediately after their son was born she had a CAT scan which showed up nothing of note.

    He says getting the obs/gyne nurse to write “patient started chemo today” into the pregnancy red book was a new experience for everyone.

    The theory was that the hormone load of IVF had triggered the cancer, and the combination of pregnancy and the chemo had reduced it below the level of detectability. Four years later mother and son are glowing with health, and Paul — having had a fairly Damascine experience — has braved a returners course and the MTAS debacle and has made it as far as SpR in Oncology.

    Heart-warming story? In a way. But Paul’s gone back into medicine partly in reaction to what he saw as the arbitrary way they were treated. The option of treatment through pregnancy wasn’t offered, and rarely is, and the need for a termination was given in words of one syllable. There are no good trials of what an angry father, a tough mother and a brave oncologist were prepared to do to salvage what was the last chance at having a child.

    Would any of this get ethics approval? Doubtful: randomising between abortion and not-abortion is going to be tough, and taking risks with unborn children is highly emotive. But there the three of them are: a happy family, who know how lucky they were. But what’s happened to the experience, to the knowledge of what worked? Well, it’s in the head of a consultant Oncologist in one midlands hospital and an SpR Oncologist in another.

  13. ssoldz said,

    February 24, 2008 at 12:08 pm

    I don’t think Ben’s critics are fair. In my experience in the US, IRBs are out of control. When one of my grad students wants to conduct their dissertation research involving only interviews, they have to allow 6 months and many many hours to obtain IRB approval. This is absurd and can’t but help turn students away from future research careers.

    It took 4 months to get approval to conduct a needs assessment survey of veterans. The main issue of the IRB members seemed to be how they could get access to the data for their own projects.

    Of course we all believe that IRBs are needed. But radical reform is needed to expedite approval, especially of the types of unharmful psychosocial research (interviews, questionnaires) that I generally do.

    As for psychology and the APA, Ben didn’t mention the most absurd aspect. When the first news appeared about the horrible roles of psychologists in Bush’s torture regime, the APA formed a task force to examine the “ethics” of psychologists’ participation in these interrogations. For a majority of the PENS task force, they turned to precisely those psychologists accused of participating in the abuses! See the paper I co-authored with Brad Olson and Martha Davis: The ethics of interrogation and the American Psychological Association: A critique of policy and process.

    The essence of the claim of this task force, and of the APA ever since, is that “psychologists help keep interrogations, safe, legal, ethical, and effective.” This phrase came almost verbatim from the DoD directions to the Behavioral Science Consultation Teams [BSCT] at Guantanamo and elsewhere. the DoD member who wrote those instructions, and th e former chief BSCT at GTMO were on the task force. That is organied “ethics” today.

    This week, the APA passed another in its series of “anti-torture” resolutions, but still claim that “psychologists keep interrogations safe and ethical.” They have rediscovered Orwell’s seminal research on language.

  14. Ben Walsh said,

    February 24, 2008 at 12:17 pm

    MattJH also seems to think that case reports require ethics approval, which, kind of by their nature, they don’t.

    As for the compulsory writing up of negative trials, that’s a different matter-not a bad idea, but it might be difficult to find journals to publish them all (I don’t know if the Journal of Negative Results is still going..).

    If we had free internet based journals, of course..

  15. Dan Kimberg said,

    February 24, 2008 at 8:24 pm

    Ben (Walsh), are you sure there are institutions where you can publish human case data without some kind of committee approval? Where I work (a prominent university in the US), you need explicit approval for anything involving human data or samples, even if it’s a retrospective study of archival data. Bypassing the IRB is a good way to lose your job, and depending on the circumstances, to end up in serious legal trouble. I think it’s pretty much like that everywhere in the US.

  16. mjrobbins said,

    February 25, 2008 at 12:54 am

    I have a friend doing her Ph.D. in Information and Library Studies, trying to get approval from an ethics committee to ask a simple questionnaire about search engine usage. I mean, good grief…

  17. danbeck said,

    February 25, 2008 at 2:07 pm

    Having worked as a trainee in both primary care and hospital medicine, I have felt frustration at the difficulty of conducting so-called benign research (i.e. Comparing two treatments or managements commonly used and known to be acceptable and effective). Often junior clinicians, feeling under pressure to ‘get published’ waste countless hours on ill-devised audits under the banner of clinical governance, or conduct statistically troublesome data trawling expeditions.

    Often the CV bolstering motivation of the ‘researcher’ combines with the increasingly burdensome requirements placed on hopspitals and primary care centres to conduct constant clinical governance exercises. The results, as presented in many a soporific (and regrettably sponsored) lunchtime meeting rarely contribute to the advancement of knowledge.

    The advent of a low-level ethics approval process for small-scale projects has, i recall been suggested on these very pages using the argument that research is being lifted out of the reach of clinical establishments and is increasingly becoming the sole reserve of well financed organisations and businesses.

    The need for change like this has been re-emphasised through a different argument here. Many currently wasted hours, jumping through hoops for career progression could be put to good use, especially if help was at hand when clinicians are designing the methodology of their reseach.

  18. emilypk said,

    February 25, 2008 at 3:18 pm

    Ethics committees at institutions I was at had abbreviated and expidited options for low risk procedures. In those cases it is more a matter of keeping a centralised record of everything that is going on, which seems fair enough. If some places don’t have this, IMHO they need to get in with introducing it.

  19. Jellytussle said,

    February 25, 2008 at 5:30 pm

    Case reports in the UK at least generally do not require ethics approval. They must be anonymised, and clinical photographs do require proper patient consent before use (at least from the BMJ. resources.bmj.com/bmj/authors/types-of-article )
    There is a very grey area between clinical audit (which does not require ethical approval in the UK, though it should be registered) and some observational clinical research (which does require clinical approval.) leading to some sometimes cynical re-branding.

    As has been stated above, many organisations sensibly have a fast-track ethical approval process for simple non-interventional clinical studies.

    Re: igb and pregnancy in breast cancer. Not sure when your friend went through this unpleasant experience but there are a number of reasonable case series for this uncommon condition (e.g.Journal of Clinical Oncology, Vol 23, No 18 (June 20), 2005: pp. 4192-4197), and it is generally accepted that chemo can be given reasonably safely in the 2nd/3rd trimesters. you are never likely to see a clinical trial in this setting, ethics or no.

  20. Dan Kimberg said,

    February 25, 2008 at 7:18 pm

    Let me amend what I wrote earlier. I double-checked our local guidelines, and case reports that involve three or fewer cases do not generally require review, although they still would if the treatment was carried out in the context of a research goal.

    Also, I double-checked the federal guidelines here in the US, and the first decision point is whether or not the activity is designed to contribute to generalizable knowledge. So here at least, there is no paradox, but there is of course the opportunity for abuse.

  21. Dr DLD said,

    February 25, 2008 at 11:22 pm

    Excellent article Ben. Just as an aside, I’m a Clinical Forensic Psychologist working in the UK, and I undertake (or at least try to) research with offender populations, as well as individuals with mental health difficulties. During a recent NHS ethics committee meeting, where I was attempting to seek approval for piloting a questionnaire for use with individuals that have committed a sexual offence, I was asked – in all seriousness – what provision I would make if an individual became ‘aroused’ during the interview. In the absence of constructing a masturbatorium in a side room, I was a bit bemused…I’ve worked with probably over 50 such individuals, and I can honestly say most haven’t spontaneously combusted with delight during my clinical interviews, whatever the subject matter. On the serious side, it demonstrates the lack of knowledge LREC can have for certain patient populations, yet they still scupper much needed research based on a flimsy grasp of the research subject. Anyway, that’s my gripe over with…

  22. Ben Walsh said,

    February 26, 2008 at 10:00 am

    Dan,
    Sorry for being so tardy in replying-we definitely don’t need ethics approval for case reports or series in the UK. I’m sure of this ‘cos I’ve done them.
    But it looks like this has already been cleared up..

  23. Delster said,

    February 26, 2008 at 11:12 am

    I think a good question to ask would be why are there 125 (or more) committees?

    I’m fairly sure that having just one to cover the whole country would be a much more economical way to do these things.

    As well as reducing the number of people working on them it would also mean that they could better track all the research being undertaken in each area.

    For example 2 different researchers in seperate locations looking into the same thing could be put in touch with each other with a view to sharing data or methodology.

    Benefits could include things like each study getting twice the sample size.

    Also the amout of work for the researchers would be cut down as there would only be one process to follow even for multi-centre studies.

    and as an added benefit it might save a couple of small forests worth of paper.

  24. Jellytussle said,

    February 26, 2008 at 12:57 pm

    Delster:
    there are lots of large multicentre national and international clinical trials, which are strictly standardised with respect to protocol, trial consent, central laboratory analysis,central data storage and randomisation, central funding, strict vetting of participating centres etc.

    There is still a requirement for inpedendent ehtical approval for each centre in most cases. Where the trials are multinational, this is probably understandable. For national trials this can be inefficient and frustrating. In the UK it is compounded by the fact that there are effectively 4 autonomous health services, and that by the fact that Scotland has a different legal system.

  25. Squander Two said,

    February 26, 2008 at 1:51 pm

    I cannot recommend enough that anyone interested in the “protocols” Ben mentions see this film about waterboarding.

    > APA members, trained, clinical professionals on their register, who have signed up to their codes of practise, now participate in these activities.

    I’m not necessarily condoning their actions (anyone interested in my own inconclusive opinion on the above film can read it here), but I’m not sure how the ethical codes of conduct come into it. Doctors, who have taken the Hippocratic Oath, have been known to join the armed forces in times of war and shoot enemy soldiers dead. There are plenty of valid reasons to condemn them for doing so — opposing the war in question, for instance, or opposing their unit’s tactics — but I don’t think the fact that they’re doing something to enemy soldiers that they wouldn’t be allowed to do to their patients is one of them. The context matters.

  26. zuclopenthixol said,

    February 26, 2008 at 3:16 pm

    A couple of the BMJ Sponsored research ethics committee detractors

    tinyurl.com/22bjx5

    And
    www.bmj.com/cgi/content/full/328/7432/121

  27. Wonko said,

    February 26, 2008 at 3:50 pm

    I know that this blog isn’t keen on social science, however, it seems to me that the various studies of institutions shows that once you create an institution (such as an ethics committee) it will very quickly take on a self-serving purpose beyond that for which it was established. So, something established to prevent harm to patients (eg, by preventing a pharmaceutical company from simply trying out “me-again” uses for drugs) can end up harming patients (eg, by preventing simple questionnaire research into patient opinions or experience of treatment).

    The end winners in this have to be Big Pharma, who can afford the costs of complying with whatever obstacles an ethics committee chooses to throw in front of them.

  28. Ben Goldacre said,

    February 26, 2008 at 5:53 pm

    haha i’m perfectly into social science research, and i think those are two extremely good points, the second of which i made here

    www.badscience.net/?p=487

    It costs £500m to bring a drug to market. Much of that is spent on randomised trials. We have made these trials so spectacularly complicated and expensive that they are beyond the reach of governments, academia, and even small companies: only huge international pharmaceutical corporations can afford to run drugs trials now, and so corporations are in complete control of the information. This is bad, as the problems with Vioxx, SSRI’s, and other drugs have shown.

    We could whinge about that: or, while they’re all on holiday in Provence with their au pairs, we could castrate the ethics committees, on the grounds – ironically – that they do more harm than good. Imagine there are two drugs called Sixofone and Halfadozen. Nobody knows which one is better for treating Sickitis. The drug companies periodically do trials, but funnily their own drug always seems to come out the best.

    In our clinic, the doctor sees 200 patients in a month with Sickitis. If she gives Sixofone or Halfadozen to her patients entirely at random, on a whim, as a reflection of her own indecisiveness, then the regulation is the same as for any prescription: give reasonable verbal information about risks and benefits, thus obtaining informed consent, and so on.

    But let’s say the same doctor, in a spirit of enquiry, recognises that there is massive clinical uncertainty – nobody knows which of these drugs is better after all – and she wants to test her hunches, rather than simply act on them: then she’s in trouble.
    She could run a speculative little trial, giving 100 patients Sixofone, and compare them with the others on Halfadozen; but she’d be struck off, unless she went through so much red tape that the idea becomes entirely unmanageable. After passing through the endless obstructive and bureaucratic hoops of the ethics committees, from each and every patient she would need to obtain elaborate written consent, and give huge amounts of information.

    Remember, nobody knows which is best, and if she wanted to hand over the same drugs, entirely at whim, outside of her “trial”, there’d be no problem. This is a huge double standard, and it costs us knowledge.

    If we ever had a scientist in charge of health, instead of tinkering with payments to big pharma, they would do one simple thing: move hell and high water to collect and collate the best and cheapest evidence on healthcare. First you would give huge amounts of money to the Cochrane Collaboration, which collects and collates data independently on all healthcare interventions (and is quietly one of the most subversive organisations ever to be created, because it blows the lid on false commercial claims). Doctors waste money by irrational prescribing decisions, so give them clean, clear, accessible information, and that will stop.

    But more than that, we are in a unique position to generate data: we have inherited an extraordinary information resource, in this vast monolith of the NHS. Nobody knows what the best treatment for stroke is, but if we randomised every single new stroke patient in the UK, over one week, into a rough trial, we’d have our answers in a couple of years.

    If you have an ethical objection to that, it better be more important than finding out what is best for stroke victims, because the entire health service is like the clinic I described above. Where there is uncertainty, the patients, and their data, are unique national assets: if we can find a way to use them, systematically, efficiently, ethically, as a resource for research and information, then it wouldn’t matter about Big Pharma’s power any more. But as long as knowledge is expensive, multinational corporations will perpetuate their stranglehold on it, and we will be beholden unto them. It’s just an idea for your cornflakes.

  29. Finger waggler said,

    February 26, 2008 at 8:53 pm

    HI Ben,

    An interesting piece, but i wonder if some of the overzealous application of ethical review isn’t as a result of medical snafus of the past (aided by some just slightly sensationalist reporting…). Dare i mention Alder Hey ? I have been involved in applications to ethical review boards to access human tissue for research. And it’s long winded, sometimes arbitrary, and a pain. However, the public have a right to some protection from well meaning medics (or scientists, including me!), who may not see the wood for the trees (and who may have cream cheese for brains). Yes, there will be cock-ups and some crazy rules, but would it be reasonable to scrap the system and say anything goes ?

  30. Dan Kimberg said,

    February 27, 2008 at 3:13 am

    While it sounds superficially reasonable to allow clinicians to carry out clinical research studies without approval if doing so doesn’t affect their clinical judgment, this seems like a textbook case of a potentially harmful conflict of interests. You can’t tell a patient “we would have randomly assigned you to the snake oil treatment even if we didn’t have a research interest in doing so” any more than a stockbroker can tell a customer “I would have recommended that stock even if I didn’t own 50,000 shares personally.” While thought experiments involving perfect clinical indifference (coinciding with the needed experimental randomization) and doctors who are able to perfectly gauge their own potential biases may seem to challenge this view, you don’t want to design a regulatory policy around ideal cases. With the floodgates opened to unreviewed clinical research, the only thing left to protect patients would be the lack of interest many clinicians have in research.

    So of course I have an objection to your stroke study. Although you, as the designer of the study, may be indifferent about the treatment options, the many clinicians who will be asked to implement your study (involving every new stroke patient in the UK for a week) may not be. Some of those clinicians will therefore be treating their patients in ways that, in their view, are not best for their patients. They will be doing so for research and not clinical reasons, and with a population in which the ability to provide informed consent may be not just impaired but difficult even to determine, on a case-by-case basis. If this kind of study
    doesn’t require review, then why review anything?

    And I’m much less optimistic about how much can be accomplished in a few years of massive clinical studies, although if there really were exactly two universal stroke treatments about which all clinicians were perfectly indifferent, I guess I would concede the point.

  31. Delster said,

    February 27, 2008 at 2:51 pm

    Hi Jellytussle,

    I’m not saying the trials themselves should be standardised….as a good trial has internal consistancy anyway.

    It was the gross inefficiency of the multi approvals boards i was getting at.

  32. Quixotematic said,

    February 27, 2008 at 11:45 pm

    Ben, you are at your worst when you are laying into the RECs. This is unworthy of you. You are perfectly free to apply to observe any REC meeting you like, meet the committee and attempt to understand what they actually do (for no remuneration whatsoever). Why not bring your concerns to NRES rather than spouting bile in your blog?

    A REC is required to return an opinion within 60 days of receipt of the application. Their SOPs stipulate six (not 21) copies of a protocol, though many waive this.

    Where a REC requires (not demands) changes, it will be where a researcher has overlooked some salient point relating to the welfare of their study participants or indeed the law of the land. REC committees also offer researchers a great deal of informal advice from a huge range of professional skill sets – for free

    The recent launch of IRAS has eliminated a great deal of duplicate form-filling and constant efforts are underway to further streamline the process.

    No one likes to be told what to do, Ben, but grow up over this issue.

  33. psybertron said,

    February 28, 2008 at 4:05 am

    Interesting stuff Ben.

    Your social science exchange with Wonko interests me. And the pragmatic points earlier.

    Once you have “human institutions” involved in the process, beyond the basic objective empiricism of the research itself, human values involved in their psychology and decision-making come into play.

    Like Wonko, I’d have suspected from earlier encounters that you might not have been sympathetic to this view.

    My agenda in pointing it out is that it is quite simply better to recognise this value-laden issue and ensure such “human nature” is taken into account transparently, and independently of the science itself, rather than somehow denying it and allowing it to distort the picture science ends up with.

    Ian

  34. scs said,

    March 1, 2008 at 7:47 pm

    @MattJH

    “Ethical review boards can and do prevent harm coming to patients”.

    Sure there are examples of this happening – but can you prove that that statement is true in the overall (net) case?

    Do they do more good than harm?

    Who speaks for the people who would have benefited from the outcome of trials which did not go ahead? Or the people who were harmed because the trial was delayed by the bureaucratic process?

  35. MattJH said,

    March 3, 2008 at 11:11 pm

    I’m not a noob unaware of ethics; I’m a journal editor. Of course I know that case reports don’t usually require ethics approval – that’s because they’re observational studies.

    What I don’t like is doctors taking their pet theory on how a therapy might work and trying it out on a guinea pig patient, and then writing it up as a ‘case report’. This is sheer misrepresentation – they need to be honest and admit when they are experimenting.

    I’m horrified by the implication in the thread that we could abandon using ethics committees. Looking at some of the badly designed and ethically suspect research that still gets submitted to journals, plenty of institutions could do with tightening up their processes, not loosening them.

    People seem to think it is easy to work out what research is ethical and what isn’t. Where harm might be caused, and where it won’t be. It isn’t that simple. Researchers will often be too deep into the project to be aware of the risks (unable to see the wood for the trees, as noted above). Take the example of a ‘simple questionnaire’. If this questionnaire happens to include questions about childhood sexual abuse, is it still simple?

  36. jybay said,

    March 22, 2008 at 3:49 pm

    Ethics committees are an illustration of two of the NHS’ dominant absurdities:

    1. The best is the enemy of the good – any basically good idea must be pursued ab absurdam

    2. Once there is a body of people responsible for executing a basically good idea, they will keep themselves in a job even at the expense of actually undermining the job they are supposed to be doing (see also the Resuscitation Council – raison d’etre = to create simple protocols so that everyone knows what to do in an emergency. Actual operating procedure = make continuous clinically irrelevant changes with the protocols till no one knows what to do)

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