Ethics part 2: The Wobbly Step

image: https://www.thespruce.com/garden-path-ideas-8620749

Trigger warning: later in this article, there is a fictional account of someone with autism trying to seek medical help. If you have had any similar experiences, you may wish to stop reading at the point where a thin dividing line appears.

A couple of weeks ago I wrote a post looking at the process for ethical approval in research studies and some of the speed bumps I’ve encountered whilst setting up my small research project – which is now a service evaluation (an internal piece of work) rather than ‘research’. (If you read the previous post this will make more sense!)

Anyway, in the course of my pondering on ethics in healthcare research, I have begun to form some theories. Firstly, the process of seeking and awarding ethical approval seems to be based on some assumptions* – and one of those assumptions seems to be that ‘one size fits all’ when it comes to ethics for research. However, healthcare research is a very diverse world with all sorts of different study areas, methods and approaches ranging from ‘first in human’ medicine trials, to questionnaires about appetite in older people. So research is clearly not ‘one size’ and perhaps a more nuanced approach would be helpful?

*not all of those assumptions are bad, by the way. The assumption that we should seek informed consent (an active willingness to take part) from participants before they get involved in a study, is a good thing. The assumption that they should be provided with information about the study in a way that they can understand, so that they can make that decision, is also a really good thing.

NHS England’s Research Toolkit explains: “Ethical practice in research means ensuring your research participants are not exposed to risk as part of your project, protecting their right to anonymity and confidentiality, and that your project has merit.” That’s certainly a good thing. As I understand it, seeking ethical approval means that you’re being transparent and accountable about what you want to do and how you want to do it, to people who are impartial, in order that the participants will be protected.

That’s all good in theory but what happens if your project is drawing ‘outside the lines’ a bit? I’m not talking about doing anything unethical or harmful, but what if you want to do collaborative research for example, where the people participating in your project are also researchers? This kind of approach is called Participatory Action Research, where both the researchers and the participants plan and take part together in the study, without the traditional dividing line with researchers on one side and participants on the other.

I’ve spoken to a number of people in research circles and they’ve all said similar things: that sometimes the ethics process can be a bit rigid and committee members get stuck on a certain way of thinking. Although the intention is to prevent harm, sometimes it can prevent progress too. And then you might get the kind of situation where a project is turned down because of the perceived reputational risk to the organisation; this is where ethics becomes a tool to protect the organisation rather than working through the potential issues with more finesse.

I imagine it a bit like a garden path (like the one in the picture at the top of the page). Ethics applications are fairly systematic: you need to have the right set of documents and fill in the right forms, and this is to make sure the process is rigorous and that all the basics have been covered. So far so good.

But then, if your project is one of those ‘outside the lines’ ones, you hit the wobbly step.

This is the part of the process which is less familiar to the committee members. Maybe it’s a new approach or the processes aren’t widely used. The committee walks up to the wobbly step on the path and then says something like: “Well naturally, the researcher will need to do this…” and they step over it.

“Clearly this won’t be possible, so instead, this ought to happen…” and they step over it.

“It won’t be practical to allow this to happen. We would recommend this…” and they step over it.

The committee doesn’t engage with the wobbly step – perhaps because they haven’t had the training or experience to see how to do it? Or perhaps because they’ve spent their working life practising in a certain way (as researchers or clinicians themselves) and simply reject something which is unfamiliar? Or maybe they’re worried about what might go wrong and the negative consequences, so they reshape the research into something more acceptable…but it loses it’s heart in the process.

You see, to either side of the wobbly step are new research paths, methods and processes which haven’t been explored, because the research community has been stepping over the wobbly step, and avoiding the challenging and discomforting experience of wrangling with new and different ways of working…and to be honest, I get it. There’s a lot at stake – participants wellbeing for starters, but also their confidence in a system which should have their best interests at its’ heart. We’ve all seen how disinformation about routine vaccinations has caused an entire generation to become vulnerable to childhood diseases such as mumps, measles and whooping cough, which had been all but eradicated a generation previously. If that’s how people react when the evidence of vaccine safety is abundant, how might they react to something which looks or feels very different to conventional research?

And yet…there are also a lot of really good projects that either got significantly altered at the wobbly step in order to get past it, or frankly got stuck there, never to move again. If research is meant to be at the forefront of learning and innovation, then we as a community of practitioners (including ethics committee members) need to be willing to sit with the discomfort of something new and unfamiliar, in order to allow progress along these new paths and therefore potentially open up research and healthcare to more people who might not be able to access it.

For example: let’s imagine you’re neurodivergent. You have high-functionning autism, which means you cope pretty well with the day-to-day of life, and you have good strategies that help you manage when things feel a bit stressful or overwhelming. Unfortunately, in the past, you haven’t had a great experience with medical professionals who didn’t understand why you found it hard to keep eye-contact, and they interpreted your need to fidget or tap repeatedly on your phone, as being disinterested or dismissive.

They asked you questions you weren’t sure how to answer, so rather than cause offence, you stayed silent instead. (You’d learnt the hard way that saying aloud what seemed obvious to you, was upsetting to other people, so your strategy for that issue was staying silent.) They asked you why you weren’t taking the medication they’d prescribed and when you tried to explain that it tasted funny, they were impatient with you, and said that medicines sometimes tasted odd, but that you were an adult and you should just get on with it. “Don’t you want to get better?” Well, yes of course you did, but because of your autism the taste of the tablets wasn’t a mild inconvenience, but a sensory overload where the taste kept repeating itself in your mouth over and over again for hours.

After several similar experiences with medical professionals who seemed to not understand you – or want to understand you, and then get cross, frustrated or frankly blame you for being ill (“If you’d done what I’d told you to, we wouldn’t be in this position and other people could have this appointment instead.”) you just stopped going. You still weren’t well, and the symptoms were having an impact on your sleep, your energy levels and your mood, but the thought of going back to ask for help again and be turned down just wasn’t an option. It was too stressful, too demoralising, too depressing, too…everything. Going past medical places, seeing adverts about medical things or research or even TV shows was upsetting and triggered those bad memories. Why wasn’t there someone who could just listen to you and help?

In this context, and with this history, the likelihood of someone with autism attending regular research appointments in a hospital is slim to none. But the expectations of some types of research is that they can only happen in certain locations such as a hospital and during normal working hours, when it’s busy and full of people. A clinical research study which suggested offering appointments ‘out of hours’ and in a non-clinical setting such as a community centre, simply wouldn’t be allowed. But it’s exactly that kind of ‘novel’ approach, which could enable more people to get involved in research – or frankly just access routine medical treatment. The ethics committee’s concerns would quite rightly be: what if there was a medical emergency? What if they needed a crash cart (emergency resuscitation equipment) or if the medicine had to be stored in very specific conditions in order to be safe?

These are challenging things to be sure, but they’re not insurmountable, with a bit of creativity and ingenuity. Yes, I fully accept that in a resource-starved NHS, having mobile emergency units seems like a pipe-dream, and where’s the logic of holding a clinic off-site when we already have everything we need in one place? And yet…

And yet, I can’t help thinking that if we were to take some time to sit with the discomfort and uncertainty which the wobbly step can bring, we might be able to open up some amazing, yet simple innovations which could enable some research areas to take a real leap forward…

Thoughts?

Authors note: I have tried to represent something close to what an autistic person might experience when they seek medical help. This fictional account is based on some first-hand accounts I have heard from people with autism, however I accept that each individual with autism is unique, and not all their needs or experiences will be the same. I apologise sincerely if my story has caused offence, or upset in any way.