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The ethics process: Favourable opinion granted!

The Get Real with Meeting Centres project has now been given the green light by an external ethics committee. Six months into the project this may seem rather late – and it is a little later than we originally envisaged, but not by much (see below!)

When I was first plotting out the timeline of this project, way back in 2020 when it was still an as-yet-to-be-funded apple in the eye of our research team, I blocked out a few months at the start for gaining ethical approval without much of a concrete idea of what exactly this would entail (Note: I am an early career researcher). We’d gather together our planning documents, I thought, fill out a form, answer a couple of questions with some panel or other and we’d be on our way. How difficult could it be? After all we’re not giving people drugs or experimenting on human tissue samples like some studies (Note again: I am an early career researcher!)

Make no mistake, making a formal ethics application to an external, professional health and social care Research Ethics Committee (REC) is a major undertaking and a significant amount of work. It is serious business and a major milestone in the progress of a research project, if you have to do it. It also requires getting your head around more acronyms than a season of Line of Duty (REC, SCREC, NIHR, HRA, IRAS, the list goes on… all will hopefully become clear!)

So here’s a few thoughts on our experience of navigating the process, which perhaps might help others understand what to expect.

Why we had to go through this process

Early on, there was some debate as to whether we would need external approval from a health and social care REC to proceed (there are lots of these RECs under the NHS Health Research Authority, or HRA – told you there were lots of acronyms!), or whether the ethics side of things could be dealt with “in-house” by the University’s own ethics committees.

On the one hand, our study is funded by the NIHR (National Institute for Health Research), a national government agency responsible for funding health and social care research, most of which involves NHS and statutory social care services, so it’s usual for them to expect ethics to be dealt with by a formal, health-related REC for research that they fund. But on the other hand, Meeting Centres are not NHS and nor are they even formal social care services (i.e. provided by Local Authorities) – they are a grass roots form of social support, typically led by the community together with voluntary/charity groups. Meeting Centres do not typically even like to be called a “service”, as they see themselves more as a social club where those who attend have a say in what happens and how. So if our research was not with an NHS or formal social care service, why would we need to go to a formal NHS HRA REC for approval?

The answer lay in what we were seeking favorable ethical opinion for. The main ethical issue in Get Real is that we intend to include people living with dementia as participants in our research, as their voices will be essential to our study. However, it means that we cannot guarantee that every participant will be able to give informed consent to take part in the usual sense – in that some, though they may be happy to take part and able to offer valuable insights, may not be able to fully understand and retain knowledge of the what the whole of the research is about during their participation. University ethics committees do not typically have the authority to grant the go-ahead for research on this particular issue – but HRA RECs do. So an application to a HRA REC it would be!

Why it took so long

Firstly, the application itself is not something you can simply rattle off in an afternoon, especially if you’re not used to making them. The first inkling I got that this might be a little more in-depth than I was expecting was when I logged onto the online system to do the form and was encouraged to sit through an entire training module on how to fill out the application form. You apply through something called IRAS – or Integrated Research Application System. This online portal is quite ingenious in that you first answer a few questions so that it can determine what form or forms you might need to fill in, then it puts all the possible questions for all the possible forms in one place. You click through and fill out details to these questions (which can vary from having to write 1,000 plus words to just a line or two), and it then takes those answers and slots them into the appropriate place on the form(s) you need to fill out, so that you don’t have to duplicate work filling out multiple forms. Ingenious, but still intimidatingly complex for a first time applicant.

If you think you’ll just be able to cut and paste bits out of your already-drafted project protocol/plan, think again – the level of detail required is sobering, there will be things you have not even considered that you need to give a definitive answer on, and it all has to be in plain English (i.e. NOT in scientific jargon like your protocol most probably is!) It’s more likely you will end up updating/re-writing bits of your protocol as you go through the IRAS application, as it makes you think things through and prompts you to make decisions you hadn’t yet got to when planning the project thus far.

Secondly, you will need to include a range of well-developed project materials in your application. I advise finding the checklist of documents on your IRAS application early on, so there are no nasty surprises. I had expected to include drafts of participant information sheets and consent forms but these need to be final versions as changing them afterwards will be difficult. You will also need finalized or near-finalized versions of any interview schedule or questionnaire that you are planning to use. For us, this significantly put back our ethics application submission as we needed to do a good degree of consulting with stakeholders to develop both. In the end the committee agreed we could submit an updated version of the questionnaire for rubber stamping AFTER the rest of the project had been given approval, as the questionnaire is still developing and needs to be piloted. But all the same, the version we included with the application needed to be close to what the final version will be, more a workable questionnaire to be tweaked rather than a rough draft. Drafting my project Gantt chart in 2020, I admit I did not foresee this, and scheduled questionnaire development and piloting through the summer and into the autumn of 2021, completely independently of any thought about submitting the project for ethical opinion – that was a rookie error!

Navigating RECs

Finally, though, we had everything we needed, developed to a high enough degree, to go ahead with the ethics application by the end of May. Now we had to find a REC to review our application – which doesn’t just mean sending them the form, but also scheduling a meeting with them to discuss the application. At the risk of sounding like a broken record, in my naivete I initially assumed this too would be simple but – no! There is not just one REC to apply to, and not even just one REC per region, but multiple ones per region all specializing in different areas – and it’s up to you, the applicant, to choose the appropriate one.

In the event we applied to one of the Wales RECs because it was the best fit for our research that we could get a hearing with quickly. We found we would have to wait a further month to get a meeting with the London-based SCREC (Social Care Research Ethics Committee), and there were no available meeting dates for the near future for West Midlands-based RECS. The Wales REC we applied to however was a good fit as their areas of expertise included research involving adults lacking capacity and qualitative research, plus one of our research study sites is in mid-Wales. As for gaining favorable ethical opinion, any appropriate REC in England of Wales can grant it if your research is based in England and Wales (at time of writing at least) – the region does not matter so much. If you are in doubt as to whether a REC is appropriate for your study, you can also contact them by email or telephone (as listed on the HRA website) – which is exactly what I did when faced with the need to make a quick decision on a REC to submit to when submitting our form. The REC representative was extremely helpful in answering all my questions and enabling me to set up the meeting.

The result and why it’s a major milestone

Following our meeting we received a list of items to change or clarify, to which we responded, and favorable ethical opinion was confirmed on June 11. The reason this is such a cause for celebration is that, until this milestone was met, we could not proceed with getting the actual study done. Now we can get on with the business of recruiting participants and actually sitting down with them in interviews and group discussions. Any further delay would have put the study behind given our timescale, so it’s also a relief to be where we are – and reinvigorating to be able to wrap up the planning phase of this study and re-orient our focus toward the practicalities of data gathering, which is what will be our main focus for the next 6-12 months. Onwards we go!

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