MacDoctor March 2, 2009

Unethical Ethics

Have you ever noticed how the word unethical seems to take on the same meaning as politically correct? There’s a great illustration of this in the Herald today. Dr. Shaun Holt writes our ethics system for approval of new research is now so unwieldy, it is preventing perfectly legitimate research from being done. Shaun recounts his experience:

“As an experienced medical researcher and an ex-member of an ethics committee, I am likely to know about the ethical requirements of medical research. Last year I submitted an application for a simple study to see if honey could help treat a common skin infection in children that is otherwise very difficult to treat. Only 15 children were required for the study, and all the caregivers had to do was to apply the honey, cover with a dressing and see if it seemed to help.

“In order to apply to the ethics committee, I had to consult a Maori health provider to make sure there were no cultural issues if any Maori children took part and see a justice of the peace to sign a statutory declaration.

“The application itself needed around 9000 words to complete and over 350 pages had to be submitted. For a study which could not be any simpler and had almost no chance of causing any harm, the application process took longer than doing the study would have.

“The study was rejected by the committee and around 40 points were raised, most of which were either wrong or not relevant to the ethics of the study. For example, I was told to consult at least two more Maori health providers and to have systems in place for interpreters, even though the study was to be undertaken by a few GPs who would ask their own patients with this condition if they wanted to take part.”

Here is a fine example of political correctness encroaching on the word ethics. In general, the ethicality of most research projects is dead easy. There is already a requirement to get written permission from each participant, so there is an inbuilt requirement to ensure that the participant understands what s/he is signing up for. Anything beyond this is politically correct nonsense. This particular piece of research is a simple GP-driven pilot. to require this sort of thing to go through a tortuous and politically driven process is madness, and is one of the causes of the deleterious state of medical research in this country (the other is lousy funding, but that’s another issue).

I see this sort of thinking in many other places besides the Ethics Committee. I have seen the words “unethical practice” used to describe actions where the user of the phrase clearly meant “does not coincide with my world-view”.  I recall being called unethical because I would not allow more than two members of a Whanau in to see a patient at the same time. I have been called unethical because, against a families wishes, I told a patient they were dying of cancer – because the patient asked me directly if this was so.

Politics determines that it is unethical to tell a family the results of their 14 year old daughters pregnancy test and it is unethical to tell a wife her husband’s blood test results, despite the husband giving verbal permission over the phone. I have been told it would be unethical to tell a patient my deep misgivings about the Gardasil vaccine and I was told the same when I expressed my doubts about the meningococcal campaign.

Ethics is something that is based on shared values rather than political diktat. Values, in turn, should be based on principles of right and wrong rather than whatever is the prevailing opinion. When we allow our notion of ethics to be subverted by the current flavour of political opinion, we are staring into the same abyss that allowed Hitler to murder six million Jews, Stalin to starve millions of cossacks, MacCarthy to destroy lives on mere suspicion and Pol Pot to kill based on his notion of a good society.

Hindering research is probably the least of our problems.

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14 Comments

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  • You gotta be careful with honey. Imagine if one of the patients *ate* it.

    You never thought of that.. did you!

    JC

  • JC: Imagine if one of the patients *ate* it.

    Ate honey that had been placed on a sloughy wound!? Ewwwww.
    :-)

  • I see your point, Dr Mac…but really, comparing some beaurcratic red-tape with Pol Pots genocide is a bit much, even for you….

    Not comparing, Millsy, just suggesting that PC masquerading as ethics is the top of that famous “slippery slope”

  • MacDoctor – thanks for blogging about my article, I agree with your comments. I’ve had 100% support so far, and other people have told me of their experiences which I’ll write up as a follow-up article in the NZMJ. Cheers.

    Will await your article with interest, Shaun. Thanks for commenting.

  • Are the people who stung this honey of a study paid to come up with this nonsense?

    They are indeed, HP.

  • Yes, its around $400 for each monthly meeting. 2 of the 12 members must be Maori and at least 6 members must be laypeople.

  • as a doc involved with running clinical trials i absolutely agree with shaun’s comments. the ethics committes are populated by the usual suspects who (with a few notable exceptions) have no understanding of the commercial imperative (indeed, actively disdain it) under which these studies operate. trials often operate internationally with competitive recruitment and we often find ourselves frustratingly cooling our heels for weeks waiting for ethics to pronounce on some arcane and irrelevant cultural matter while south africa and australia are up and running – and pinching our export dollars. private ethics committees, operating to international guidelines (which are well defined),are the obvious answer.

  • Hi Wally – thanks for that, agree totally. I’m writing a follow-up article for the NZMJ where I will be discussing some of the feedback I’ve had such as yours. It would be great if you could email any comments to me at holtshaun@gmail.com and they can either be on the record, or anonymous. Cheers.

  • Who does the ethics committee report to? Where’s their report, eh? Let the bloggers run their rule of ridicule through it.

  • Hi Will – they’re part of the Ministry of Health

    http://www.ethicscommittees.health.govt.nz/

    I have received a lot of stories from people who have had terrible problems and am writing a follow-up report for the NZ Medical Journal.

    Cheers

  • Will:

    They report to the Minister:

    Here is their Annual Report for 2007

    Note the 62 pages of blissful bureaucratic nothingness.

    Now you know.

  • Ah. Thank you. I think… :-)

    I quite like the bit about ethical values for a pandemic:

    “Considering ethical issues as part of pandemic planning will better equip us to react to a pandemic by acting on shared values using common sense and imagination, even when we have little time.”

    This is seriously deadpan stuff.

    I particularly like the bit about using common sense… :-)

  • Mac Doc was that McArthur or McCarthy you referred to in your last para,

    Sorry that was McCarthy, of course. Have changed it. Thanks.

  • Just out of interest what were the 40 things listed, obviously some of these as illustrated were PC nonsense but what I’m thinking of is that protection of study participants is really important, if you think of situations like the TGN1412 study, our own ‘unfortunate experiment’ into cervical cancer or Wakefield and MMR/Autism study on 12 children that sparked off a vaccine scare. Subsequently it was recently found to have basically have been made up and too boot unethical – the children were apparently put through invasive procedures to suit an agenda paid by lawyers looking to litigate and not for clinical reasons. It might not be that this proposed study is going to have this effect, but my examples indicate just how badly things can go wrong.

    I’m thinking things like that a treatment being studied should have a strong biological basis for it’s use, and should at least be predicted to be beneficial to study participants. That control groups need to be used, can you really measure the effect of something without seeing whether it’s better or worse than standard treatment. How are you going to measure things, is it subjective or objective measurements like in this case healing time or measurements of size or it is that it looks better. Removal of bias by blinding, so that observer bias doesn’t creep in and affect results with the intervention being reported more positively. What groups are being studied, and what is being done to protect them – children are a special group, more vulnerable because they won’t be consenting for themselves. How the treatment is going to be standardised and whether the size of a study is big enough to get a valid result. What is being done to screen for or manage risk, like if a person turns out to have a allergic reaction to the product that could and should have been predicted. Informed consent, is it sufficient so that people know what is going on with the study and what it’s measuring? There are a number of issues there, even privacy – I know it’s noted that in the opinion piece it’s said that it’s unethical to give information over the phone or that parents be given information on their pregnant daughter suggesting this is wrong but the issue is privacy…but can you positively identify anyone over the phone? Should in the sticky issue of sexual behaviour of teenagers should parents have that level of control that the daughter has to face her parents going ballistic because she’s lost control over when and how she’s going to deal with the results of her actions (stupid or not)? I’d prefer myself that my medical information is given to me only and not to others even if they are concerned parties. Even with vaccines, we have to be careful that the ‘concerns’ are valid and evidence based and that scepticism isn’t misplaced. It’s important that evidence isn’t discarded in favour of pseudoscepticism where information is discarded just because of suspicion about motives of various groups, given the effects on public health of vaccine scares (MMR in the 90′s or DPT back in the 70′s being a good examples).

    I wouldn’t know from the reports made whether this issue consists of valid ethical concerns about the study compared with nit-picking at details, but at the same time I would say protection of research subjects is absolutely critical. Commercial imperatives might apply but I don’t think it trumps making sure the study being proposed is solid and does an adequate job of protecting the participants.

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