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.