Ethics: of the unethical variety


This post is based on a comment on an article promoting informed consent for experiments. I don’t seem to have got a response from the author, so in case others wished to discuss, I thought I’d post it here.

While most of the examples used were ones where I would have agreed with the judgement of the author, the way in which ethics approval is clogging up our system with red-tape is really very serious. I’ve written up a few such ways in ‘ethics’ rules like the need to obtain consent does active harm in some of these links.

The earlier commenter “Former user” showed how farcical the bureaucratic/legal requirement for consent in difficult and expert circumstances is. He wrote this:

As a physician with over 25 years experience, I have performed the exercise of ‘informed’ consent on a daily basis. Ethically, it is a meaningless exercise. There is no informed consent except from a legal standpoint, as most patients are so emotionally overwhelmed that it goes unheard. It is no more effective than trying to explain the national debt to an adult, or Darwin’s theory of evolution to a creationist. A large portion of the adult population still are not convinced the world is round. Under the circumstances, we who are informed must act benevolently, and do what is best for the individual and society as a whole. Consent has never been in trouble nor does it really exist. We are all volunteers in the experiment called life.

Whenever you go to a doctor now, you sign such consents. And they’re not really consents to anything because as Former User says, the possible side-effects of all treatments are endless as are the possible side-effects of doing nothing. So it makes no practical sense. I always feel completely disempowered when being put through a consent procedure. I know it’s driven by lawyers and bureaucrats. It’s not engaging me in anything but a take-it-or-leave it exercise designed to legally protect the practitioner.

But leave that to one side. My basic problem is that these kinds of rules are absolute. But life is full of subtleties and distinctions. Let’s say you’re trying to reduce malaria in Africa and you vary your approaches as you go to refine your efficacy. This is experimenting – as firms do A/B testing to see what works. Are you supposed to get consent to them all? You can say ‘yes’ but 1) that could impose huge costs and other logistical obstacles enough to stop you doing it. So you go on doing what you’re doing without learning to be better. 2) I doubt the community being ‘experimented’ on would agree.

These are not just debating points. I recently chaired The Australian Centre for Social Innovation which did an evaluation on its wonderful Family by Familyprogram. We couldn’t get a university evaluation done on the effects of the program on children because it was too hard to get ethics approval. Is that ethical? To go on spending millions of dollars on a program on the seat of your pants without straining every fibre to give it the best possible impact on kids?

None of this is to decry the significance of ethical concerns in research or anywhere else.

But the author is promoting – relatively uncritically if I might respectfully say so – a particular formula which is a bureaucratic formula. She wants to impose a rule fit for all circumstances. But there is no rule fit for all circumstances. Can I suggest an alternative? Get a randomly selected group of users together and ask them to advise on what they are and are not happy with and take what they say seriously. That would bring about real world ethical engagement between the ‘experimenters’ and those they ‘experiment’ on – where the two groups share strong common interests.

Postscript: from the Q&A on the site from which I got the diagram above:

Are there any fees associated with ethics approval or site authorisation?
There are fees for ethics review and site authorisation of commercially sponsored research and research conducted by private institutions. The fee for submission of a research project with full industry sponsorship is $3300 and the fee for subsequent amendments is $550, excluding minor administrative changes. The Site Specific Assessment fee is $3300 per site for research projects with full industry sponsorship. HREC fees for the addition of sub-studies to research projects with full industry sponsorship will be determined on a case-by-case basis (typically $1665 or, in some cases, the full fee of $3300). All prices are inclusive of GST.

How long will it take for my project to be approved?
The benchmark for receipt of an ethical decision is 60 days from receipt of a valid ethics application. The benchmark for site authorisation is 25 days from receipt of a valid Site Specific Assessment form.

Low or negligible risk research studies are typically reviewed out of session of the HREC with a response received within 4 weeks of submission. For studies requiring HREC review, you should expect to receive a response within 2 weeks of the HREC meeting date. Site authorisation is typically received within 2 weeks of submission of a valid Site Specific Assessment form.

To reduce delays associated with incomplete Site Specific Assessment submissions, researchers are encouraged to make early contact with the relevant Research Governance Officer and undertake completion of the Site Specific Assessment form in parallel with ethical review.

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11 Responses to Ethics: of the unethical variety

  1. Douglas Hynd says:

    Getting approval for semi-structured elite interviews with senior management & board of welfare agencies was a nightmare. Approval was structured with the presumption of vulnerability in the way the questions were framed. In this case the power relationship ran the other way. It was a highly frustrating exercise.

  2. john Walker says:

    When my Anne was doing her Masters in Art history, many of her cohort chose to research and write about , long dead artists- the ‘Catch 22 ‘ drawnout process of getting approval from the Human Ethics Committee needed in order to write about ,living artists was too hard and simply too incomprehensible for most.

  3. Nicholas Gruen says:

    I was a bit concerned about putting up the post as Troppo only has a relatively small budget for counselling people whose childhood traumas are triggered by reading our posts. The imaginary car trips are really an elaborate ruse to distract attention from this possibility.

  4. Moz of Yarramulla says:

    I like the idea of requiring ethics committee approval for the null hypothesis test. It might also point out the ridiculous nature of the process, especially when it’s declined. “In declining approval to perform the experiment you failed to give us permission to do nothing. What should we do?”

    The other one is politicians – I assume that by being born as subject we’ve given “informed consent” to be legislated upon? If not, is that perhaps a useful model for a lot of other consents. By going to the doctor I’ve given consent to be treated. Although one consideration there is that consent checks actually also serve as a sanity check. I’ve “refused consent” in the past when someone wanted to intubate the arm that was about to be operated on. I can imagine the check also catching a whole bunch of similar errors.

  5. Chris Lloyd says:

    I have long thought that Universities should completely abandon ethics applications for research. Instead, they should have a list of principles of ethical research and make it clear that those who break them stand a chance of being fired. Outrageous you say? No, this is exactly how we conduct teaching every term. I do not need to fill out an ethics application stating that I will not grope, racially abuse or otherwise mistreat the students and I am pretty clear that I will be fired if I do. Works fine … so far anyway.

  6. Nicholas Gruen says:

    We do the same here at Troppo, but we believe in carrots as well as sticks. If you write the wrong thing on Troppo we send people in white coats out to take you through an ethics program of reintegration to the community. If you win one of our comps you get the first class flight to London and exclusive possession of the imaginary Merc Sports for the week. How else could we keep up the quality of the content?

  7. conrad says:

    You’re lucky Chris. At my university we do have to do various workshops (approximately 10 different ones every two years or so — luckily most of which are now online), that make sure we understand what we shouldn’t do. When we used have to listen to someone tell us these things I remember asking about endemic discrimination against women, which the person didn’t want to answer despite fairly blatant examples I could think of where I work. So that seems fine (it is probably very hard to sue for it), unlike putting my hands in places I shouldn’t. Indeed, I believe we’re not supposed to touch people at all.

  8. Nicholas Gruen says:

    Back on the thread the author defends her ‘intentions’, but alas, not her argument.

    We don’t disagree that the systems that exist, particularly in the U.S., are failing everyone. That said, I’m not advocating bureaucracy, I’m advocating a basic morality – which is that if we are going to use people for experiments, we need to tell them that. Consent doesn’t have to be as complicated as we make it, and if we did real consent more in medical practice, then patients would not find consent to research nearly as confusing and off-putting as they might otherwise. But we have built a system that is largely about those in power making decisions, and we have to think about how to fix that. And in the meantime, people being experimented on have the right to know that. Thanks very much for your comments.

    To which I replied:

    Thanks for the response Alice, but I was hoping to press you – because I think you’re wrong about this and it’s important to try to argue such things through. As I said, I don’t think you’re wrong in intent – but your response only defends your intent. Your article insists that the Nuremberg Code means that “voluntary, informed consent of the human subject is essential”. You then say you’re just after morality – not bureaucracy. Well it turns out that trying to operationalise the code has generated a blizzard of bureaucracy and a great deal of it is somewhere between making no sense and being seriously counterproductive.

    I think you need to tell us what you’d recommend in the scenarios I’ve painted. A/B testing – which can hugely improve outcomes – is experimenting. Does your commitment to the Nuremburg code require that we get informed consent for all such testing? If it does a lot of experimenting – of the kind I outlined – won’t be economic. So people will die in developing countries of diseases that might be handled by appropriate health measures. Is that ethical?

    But no more news.

    • Paul Frijters says:

      ha, that is nothing. If you take informed consent literally, you can close down most labs in the world, particularly in economics and psychology. You know the ones where you do silly games for an hour and then get paid 20 bucks? They basically never tell the subjects the true intent of the experiment beforehand. Would you believe it? No full informed consent!

      And what to make of the statistical offices gathering inflation data or on traffic behaviour. Again, shock horror, no consent! And then they blatantly publish their findings without full attribution in things like the GDP figures, aweful!

      Don’t forget that a seminar is a place where learning might take place, sensitivities might get ruffled (or is that feathers?), all without written consent and a help line for post-seminar stress.

      And, truly worst of all, think of the millions of shops we have in the world, shamelessly and openly experimenting on us with offering all kinds of new products and means to get our attention. Quite often not just without asking consent, but where consent would certainly not have been given.

      Please, don’t get me started on the world of religion! Thoughts that might change your life and make you see yourself differently, without prior approval and full disclosure? It would never go through a committee.

      Thank got we now have over 300 committees in Australia to sort this mess out.

  9. Peter WARWIck says:

    On the subject of ethics, there are none. Ethics (but lets suppose it exists) is simply a matter between parties (who may be known or unknown to each other) to arrive at some nebulous position where the parties agree not to screw each other to the wall. Forget the “informed” bit. The parties are playing draw poker, discarding crappy cards and hoping improving cards will be dealt.

    I was involved (in part) with the negotiations between Exxon Mobil and the resource owners in Papua New Guinea. Rest assured, Exxon Mobil had at their base, a plan to extract as much gas as they can, at the cheapest price. They negotiated hard with the resource owners, who were flummoxed by the large figures involved, and the guvman was no better (but had Ks rolling in their eyes).

    Exxon Mobil touted their usual ethical and moral approach to everything, but underlying everything was a burning push to maximize their position, and the resource owners had to work through what they thought was a deal. They were not sure of the cards they were dealt.

    Paul F is right. This “informed consent” is simply a product of managerialism, and as he has said, there are plenty of management committees, who are kept in full employment pondering the whole subject.

  10. Nicholas Gruen says:

    Here’s my favourite story about ethics processes.

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