Podcast – Behind the Approval: Research Ethics and Consent

Voice Over:

The Dementia Researcher Podcast. Talking about careers, research conference highlights, and so much more.

Rebecca Williams:

Hello, and welcome to the Dementia Researcher Podcast. Today we explore a crucial, yet often under-discussed aspect of conducting research, and that is navigating the complex world of ethics approvals and participant consent.

Hello, my name’s Rebecca Williams and I’m a PhD student here at the University of Cambridge. And I spend a lot of my time with patients, with data, and with ethics. But I haven’t actually had to navigate my way through an ethics application yet, though I’m sure that will soon change. So, when Dementia Researcher invited me to chat with experts on the topic, I jumped at the chance. And helping me today to get to grips with ethics and consent are three experts who have gone through the process themselves, researched the topics, and even led an ethics panel. And with that, I’m delighted to announce Dr. Anna Volkmer, Dr. Victoria Shepherd, and Danielle Wilson. Hi, everyone.

Danielle Wilson:

Hi.

Dr Victoria Shepherd:

Hello.

Dr Anna Volkmer:

Hi.

Rebecca Williams:

Hello. So, let’s meet our guests.

Anna, I know our listeners have met you lots of times before, so why don’t you go first and introduce yourself?

Dr Anna Volkmer:

Thank you very much, Rebecca. So, my name is Dr. Anna Volkmer. I’m a speech and language therapist by background, but I’m also a senior research fellow at UCL. And I focus my research on developing interventions for people with rare language-led dementias, and other types of dementia. And really focus on supporting them to communicate and interact with them, their loved ones and the people around them.

Rebecca Williams:

Fantastic. Super interesting research. Victoria, I’ll bounce over to you now. Can you tell us a bit about yourself?

Dr Victoria Shepherd:

Hi, I’m Vicki Shepherd. I’m a senior research fellow at the Centre for Trials Research at Cardiff University, and a nurse by professional background. And in Cardiff I lead a program of research exploring the inclusion in research, with a particular focus on people who might have additional capacity and communication needs. Exploring the kind of ethical, legal and practical challenges around involving those groups in research. I’m also a member of a research ethics committee.

Rebecca Williams:

Fantastic. The right person to have on this panel then. And Danielle, last but certainly not least, can I come over to you?

Danielle Wilson:

Thanks, Rebecca. I manage the UK Dementia Research Institute’s Care Research and Technology Centre based at Imperial College London. I’m also a new member of Genomic England’s Access Review Committee. We provide an independent examination of those who wish to access the National Genomic Research Library. And I’m a chair and longstanding member of a health research authority research ethics committee. Very much looking forward to speaking about it today.

Rebecca Williams:

Wonderful. Well, thanks so much everyone. Just before we get started, I should acknowledge that I know that many of our listeners are from outside the UK, and what we’re going to be talking about today is the UK system. So, whilst the regulations where you are might be slightly different, hopefully the advice we have will be useful no matter where you are.

Now, I must confess that I’m rather scared of ethics and consent. Whenever you hear about ethics reviews being discussed, I feel it’s always in quite a negative light. And I’m not specifically talking about ethical research, but rather the requirement for research to have ethical approval. I’m hoping that you can all help set the record straight today, and also calm me down. And rather than discussing the issues, instead I thought we’d have a chat about what it takes to get that all-important favorable decision for ethics.

Starting with the basics, Danielle, could you maybe give us an introduction to ethics in terms of research? When is it needed? Is it always needed? Why do I need it? All those kinds of things.

Danielle Wilson:

Yeah, sure. Hopefully by the time we reach the end of the podcast, Rebecca, you’ll feel a lot more confident, or at least have our email addresses to hand when you are putting together your ethics application. I guess the first thing I’d say is ethics is everywhere, and it doesn’t just happen in ethics committees at a certain time of the day. It’s a really fluid process in how we act, probably all of the time. But when we’re talking about research ethics, at a very high level we’re talking about the moral principles that govern how we as researchers should carry out our work.

And to set the scene, which is a good opening question, we must first determine whether the project is research. I won’t go into the detail of that, because the devil is always in the detail of what your project entails. But I will direct you to the HRA, that’s the Health Research Authority’s website, and I’ll talk about them in just a second. And they have a really good tool that you can use to help determine whether your project is actually research, and then what kind of approval you will need going forward. As I said, the HRA, the Health Research Authority’s website is helpful for determining if your project’s research, and what approvals you need. Because you may need HRA approval but not REC approval and they will be able to take you through and help you determine that.

But before we go on, I’ll explain a little bit about the HRA, the Health Research Authority. They are an arm’s-length body of the Department of Health and Social Care, which means the government has devolved some of the responsibilities to them. And it’s important to note as you did at the top of the podcast, Rebecca, that the HRA functions apply to research undertaken in England. Although the HRA worked closely with other countries in the UK to provide a UK-wide system. And the HRA’s vision is really for high quality health and social care research that improves people’s health and wellbeing, with the core aim to protect and promote the interests of patients from the public in health and social care research.

It’s probably also important to say that I don’t work for the HRA. I’m chair of one of their RECs, or research ethics committees, and then in my day job I’m employed by Imperial College London. Everyone that sits on a research ethics committee is a volunteer giving up their time to review their studies and give their opinion.

Rebecca Williams:

That’s really fascinating. Thanks so much for that intro. Can I ask, one of the things that always freaks me out is what happens if a study changes? So many changes over the course of research, if your study changes, do you have to reapply to those ethics boards?

Danielle Wilson:

It depends on what the change is. You don’t have to reapply, but you might apply for an amendment. And that amendment could be a small amendment or a larger amendment. But you will submit, again, not the full document pack, but whatever’s changed. And the HRA has streamlined that and made it a lot easier for people to do that. And then that will be reviewed again, probably not at a formal research ethics committee meeting, it might be done by email by a couple of members. But you certainly will have to let the research ethics committee review what your changes might be that you’d like to make.

Rebecca Williams:

Makes sense. Can I ask, you mentioned sometimes needing approval through the HRA but not a REC. What is the difference between those two things? Are they the same? How do they compare?

Danielle Wilson:

Yeah, absolutely. It’s sometimes quite a tricky definition. I won’t profess to explain right now, but if you take a look at the HRA website, they will tell you whether a study just needs HRA approval, needs REC approval, or doesn’t, and you can go via your university. And as I was doing a bit of research for this podcast, at Imperial we have three research ethics committees. I only knew about one of them, so again, always learning about things. They are studies that either are health related, non-health related, or for educational purposes that don’t need HRA or REC approval. Again, the devil’s really in the details. Look at the HRA website, look at your institution’s website, and there are loads of resources and decision trees that can help you make that.

Rebecca Williams:

Fantastic. Anna, you had something to add on there.

Dr Anna Volkmer:

Yeah, I also wanted to add that, because many of our listeners might be based in National Health Service settings or even outside the UK, that sometimes you can also apply for a service evaluation approval rather than a full ethical approval. Having myself worked in Australia as well, I know they have similar systems there within their healthcare organisations. Having done that kind of work even in the UK with some large charities, some large charities also have those kinds of internal ethical and service evaluation bodies that you can apply to instead.

What’s really wonderful on the HRA website, is they have a decision tool. I think that can really help take you through some basic questions. And sometimes it can really help you understand what you need to be anticipating, and where you need to judge, how big an application or what organization you need to apply for. It’s just a really handy tool, actually.

Rebecca Williams:

Amazing. I think worth having in mind. Vicky, did you want to add something on the end?

Dr Victoria Shepherd:

Yeah, just to highlight as well, of course some research it’s conducted in social care settings. I guess care homes might be a good example of that. And again, depending on the type of research that might go through a social care research ethics committee or might be part of a NHS Health Research Authority committee. And it also depends the type of people you are including as well. In England and Wales, if you’re involving people who lack capacity to consent to the research, it needs to go through the Health Research Authority ethics committee. It can’t go to an institutional ethics committee, even if it doesn’t involve the NHS in any way.

Rebecca Williams:

That’s really valuable. Thank you. Talking about different types of people giving consent, people with perhaps decisional capacity giving consent, what about not people at all? Do fundamental scientists also need ethics? I’ll leave that open to anyone.

Danielle Wilson:

I’ll jump in and give a very unhelpful answer of saying they may, or they may not. It really depends what are you looking at, where might you be getting your samples from? All kinds of questions that I think you’ll really only know if you talk about your specific project. But again, the decision tree that we alluded to earlier and on the HRA website, will absolutely steer you through the questions and will give you a very clear answer as to what to do next.

Rebecca Williams:

Wonderful. I think that’s a good start of when do you need ethics? I guess the next natural thing, I’m going to leave it open to the floor, is what are the broad steps involved in an ethics application and when should you start thinking about them? I know from seeing colleagues go through this, sometimes it feels like it can take years to get ethics through. Why is that, what are those steps, and when should you start thinking about it? Anna?

Dr Anna Volkmer:

I’m just going to get in with an easy answer, and say you should think about it straight away. And I would say because, from a very practical level, Rebecca, if you’re putting together a study, actually the ethics application will take you through that process. It’s actually a really useful investment of time, because generally you have to write a protocol describing what you’re going to do, thinking really thoroughly about your inclusion criteria, about the exact protocol that you’re going to do, how long it’s going to take. It’s actually a really useful piece of work. If you frame it in terms of, and find out and think about your ethics straight away, it’s a good investment for the rest of your project.

Rebecca Williams:

Yeah, that definitely makes sense. I found that writing pre-registrations as well for the open science framework, having it all written down I find is incredibly useful. You mentioned a protocol there. Is there anything else that is included in an ethics application? Or I guess what goes into a protocol is another question?

Dr Anna Volkmer:

I don’t mind starting off, but I think it probably depends where you are submitting your application to. And so I’ve submitted service evaluation applications through the NHS trust that I’ve worked with. I’ve also submitted low level ethics applications through the university ethics that I’m part of at UCL. And I’ve submitted ethics applications to the HRA, to HNS, and for NHS ethics. And the forms describe the amount of information you need. For example, in the NHS trust I’ve applied for a service evaluations information. It’s literally a form, and they tell you what you need to fill in with just titles. Whereas in the low level ethics, they’ll ask you for subsections on describe what your aim is, who your participants are, and where you’re going to find them, and your protocol.

And then there’s a separate subsection saying, now think about where you’re going to store your IT information. And that’s actually all on the form. Whereas when I’ve submitted a protocol for an NHS ethics I had to use a much bigger protocol proforma, with a lot more in-depth information, and I had to have that approved by my organization in my department first, then the wider university, then it was submitted to the HRA, before it went to an ethics board. So it just depends what level you’re going for, but the forms will direct you in the right direction to how much detail you need to give. But perhaps I should hand over to somebody else to flesh that out a bit.

Rebecca Williams:

Yeah. Coming back to something you said, Danielle, it’s the devil’s in the details, I suppose is the thing of reading those forms. Have you got anything to add on there?

Danielle Wilson:

Yeah, sure. Anna, thank you for outlining that process so eloquently. It is a process. The ethics committee part of it is only one part of that. And before that you would engage with your institution because you always need a sponsor for your study, and doing that early is really key. But once you submit the application to the HRA and you book in your slot with the research ethics committee, we have quite strict timelines that we have to follow. So that part of the process is quite heavily and tightly controlled for timelines. But I would say everything before that and everything after it isn’t. The HRA, as you can imagine being a government body, they have timelines that they strictly adhere to. But it’s just one part of the process, I think.

And coming back to what the research ethics committee can see, we have the protocol as you’ve mentioned, we have your patient facing documents, so that might be a consent form, an information sheet, it may be a video that you want to recruit people via, or adverts that you want to go out to social media or stick on a clinic room wall. And then the HRA are always evolving how the process and what information we get as a research ethics committee, we see. Just lately within our packs, we have got a participant information sheet checklist. So have you included all this information? If you haven’t, go back and maybe check. I feel that they are always continually trying to improve the process, so that researchers don’t miss out a key bit of information. And then you must look at that after you’ve attended the committee meeting.

Rebecca Williams:

Yeah, I find checklists incredibly useful. Anna, you have something to add on?

Dr Anna Volkmer:

Well, just given this is an informal podcast and we’re just chatting, I was going to take the opportunity to ask Danielle, in your checklist, does it say anything about information sheets and consent forms being accessible? Because of course as a speech and language therapist, I should have said it in the introduction, but that’s part of what I’m always interested in, is making things accessible for people who’ve got communication or cognitive difficulties so they can participate in research. And oftentimes, all the information that’s required to be in a consent form or a participant information sheet is so complex, so legalistic. And that’s actually, we should divulge our relationship. Victoria and I are jointly interested in consent and capacity, and have done some work in it. But I’m just curious on your checklist, does it say accessibility?

Danielle Wilson:

Vicki, you probably know this more than me. I’ve only seen a couple of them. It’s a good question. Vicki, I’ll hand it over to you.

Dr Victoria Shepherd:

It’s a really good question, and it doesn’t talk about accessibility. There’s a lot of emphasis on public and patient involvement, and I’m sure that’s something that we can talk about in a bit more detail. But essentially involving when you design your research, when you develop the materials that a participant will see, it’s essentially good practice to involve people like those groups as you’re developing those materials. There’s a very strong focus on public and patient involvement, and I think the assumption is that that inevitably will make them more accessible in terms of the language use, so English language, that’s accessible to the wider population. But of course there are bigger issues, aren’t there, around accessibility? The format the information is provided in, not just the readability age of the information, but the concepts and how they’re presented. And whether the use of alternative formats, the use of images, potentially the use of easy read formats, non-written formats, audio, visual, and how those together can help someone be supported to understand the information about a study.

I would say research ethics committees are probably moving much more towards the idea of a layering of information being a much more person-centered approach. Perhaps not having all the information in a participant information sheet that a participant gets as their first port of call for information about a study, but perhaps presenting a shorter summary for people that is accessible, and then building on that to give the full information sheet. There is a requirement to include information, for example, about data protection, and where people’s data will be stored and who will have access to that in the full information sheet. But by layering it, you can make the information that people really need upfront accessible, and then they could move on to that much more detailed information perhaps in an appendix, or later on in the information sheet. Very much that kind of layering approach, I think.

Rebecca Williams:

That’s really interesting. I think we’ll definitely move on to talk about that decisional capacity aspect and consent more in just a second. I was just curious before you moved on, is there any pre-reading or training that you would recommend before filling in your first ethics application? Or is the best approach to ethics applications just to do them as many as you can?

Danielle Wilson:

I’ve really begged up the HRA website, and they’ll probably see a huge influx of traffic after this goes out. I would absolutely take a look there, take a look at your institution’s webpages, but also see if you can find the IRAS form, which is the form that is used and sent to the REC within your site file, if you’re working on studies now. It’ll be a little different to the protocol, but it will capture most of the questions that you’ll probably be required to complete.

I would speak to as many people as you can that have gone through the process before, and disregard the horror stories, because everybody has those horror stories. I think processes are continuously improving. I’d probably just plug, the only way to change the process is to get involved. If you’re interested, come and shadow, or observe a research ethics committee meeting. Anybody can do that, and anybody can join a research ethics committee. We have a good mixture of laypeople and experts. I think if you tick off each one of those things, and are interested and curious, I think it will make your own ethics application a lot easier to compile.

Rebecca Williams:

Yeah. I certainly find it really enlightening when reading the ethics documents for the studies that are currently running. I think it’s fascinating to look through all the details included in there. Amazing.

In that case, we’ll shift tangents slightly over to you, Vicki. I know ethics applications and panels will give obviously a lot of consideration to how we take consent from participants. And we’ve already talked about those issues of accessibility and decisional capacity. I know it’s something I’ve had to think very carefully about when collecting my data as someone who works with patients. Can you maybe talk to us a bit more about this, and how this factors into ethics decisions?

Dr Victoria Shepherd:

It very much follows on from thinking about ensuring that the information is accessible. And one additional resource I think that people might find quite helpful when thinking about involving people living with dementia in research, is online you can find the DEEP Network. Who are a group of researchers who are primarily people living with dementia, who co-produce guidelines, including about how to make information accessible, and including about the kind of ethical principles that researchers could follow. Drawing on those kind of resources when developing a study, and particularly developing that kind of participant information sheet.

But essentially the principles of consent, I guess we’ve skipped through to that point. But essentially this is a fundamental principle in research, isn’t it? That ensuring that anyone taking part in a study are aware of what involvement would require, and make a fully informed decision about whether they wish to take part or not, that’s free of coercion. And researchers must use that principle when developing any kind of research. But of course, that requires people to fully understand the information about what would be involved in taking part in a study, and some people living with dementia, and of course other conditions, even when supported to make a decision and to access accessible information, may not have capacity to consent to that particular study. And of course, capacity is very much a fluctuating situation and people may have capacity to make some decisions and not others.

When it comes to consent for research, if a participant potentially doesn’t have capacity to consent, there are processes where that needs to be assessed, formally documented. And then there are alternative processes laid out for the arrangements to include people who are not able to give their own consent to take part in research. In the UK, that varies depending on what part of the UK you’re in, and what type of research, whether it’s a clinical drug trial or not. And that varies across the world as well, depending on the kind of jurisdiction you’re working in. And there will be arrangements that people need to follow, depending on where they are based.

But ordinarily, it probably involves involving someone close to that person to help make a decision about whether they take part or not in research. But very much involving a person living with dementia in that decision, to the extent that they’re able to do so. And then of course, revisiting consent throughout a study where capacity may change over time, and revisiting that. And ensuring that at each time point, perhaps when re-approaching a participant for another follow-up appointment for example, that that process is reconsidered about whether there might be changes in their capacity at any time point. There’s lots of information on the website where I collect resources, called capacityconsentresearch.com. And if people do have good examples, they can always contact me through that website as well.

Rebecca Williams:

Fantastic. I know the idea of consent being dynamic and ongoing, is something that in our neuroimaging studies with patients, we see. Checking in with them is something I do so regularly because I really want them to enjoy being there, but sometimes it just isn’t happening. Another thing you mentioned of how to keep consent and patient or participant facing documents accessible is with public and participant involvement. I was curious of how exactly can we involve the public and participants in our research, but particularly our ethics? Has anyone got any examples or experience with that? Anna?

Dr Anna Volkmer:

Well, I was just going to mention, first, that Vicki and I have been collaborating with another researcher. We recently did a survey of researchers who work in the field of dementia, about how confident they feel around assessing the capacity for somebody to participate in a research study. We’ve basically found that there’s not a lot of specific training for researchers who are working with people with dementia. A lot of the training around capacity judgments in research is very general, or it’s not specific to dementia. And we feel, as you’ve highlighted about this idea of checking in, that there’s lots of specific dementia related issues, like fluctuating capacity, like whether people really understand what’s being said, that can be an issue. Watch this space, because we’re moving forward and thinking about what that could mean for some training and whatnot.

But in terms of PPI, I’ve actually found PPI to be one of the most valuable ways of informing an ethics application, developing consent forms. For example, I developed several consent forms for a study that I was doing. And when the ethics committee asked me some questions about why, I’d say for example, I was planning to use the same picture-based, accessible, readable consent form for both people with dementia and their partners. They said, “Why are you using the same one? Why don’t you just use a text-based version for the partners?” I said, “Well, my PPI group said that everyone can access the accessible version, so we should treat everybody in the same way.”

And this then resonated with the ethics committee. And they said, “Yes, of course that makes total sense.” But it was really, useful to have gone through with the PPI group, why we were collaboratively making these decisions. And that really showed that we were making ethical decisions with people with dementia, rather than for people with dementia. I think in terms of the broader idea of ethics, it just makes it much more ethical. And it made me feel, on a very personal note, much more confident about what I was saying. I think PPI can be extremely useful just in terms of what you say and how you feel about what you’re saying, but also making sure we are being ethical researchers.

Rebecca Williams:

Yeah, absolutely. Being clear and accessible, I think is something all researchers can always do better at. I think we assume a level of knowledge sometimes that just isn’t there for a lot of our participants. Even as you say, Anna, even perfectly healthy controls. Speaking of Anna, you’ve obviously led a number of studies, you’ve applied for ethics, gone through the whole rollercoaster. Are there any lessons that you’ve learned, and can you give us maybe some examples of how your studies have changed to get approval?

Dr Anna Volkmer:

The biggest lesson that I keep learning, is keep an eye on the details. And that’s talking the broadest sense about ethical applications, because you need to provide precise information, answer every question. You need to really make sure that on an ethics application, you’re storing your data in the right way, in the right place. I use a lot of video data of people, which can be considered quite confronting, and is ethically challenging, making videos of people with dementia, and how you’re going to store that to be identifiable, and all of that complex stuff. I must provide a lot of detail about what I’m going to do with that data, and how I’m going to store it, how I’m going to share it.

I would say sometimes I will miss a box even when I think I’ve done a fair few of these. And I think one thing is about being rigorous, going back over and back over. That’s probably a very personal one. Don’t cut corners, really make sure that you’ve been precise. And then I think my second top tip is something we’ve covered already, and is about putting PPI at the center of your application and your study. Because that makes sure… it ensures what you’re doing is ethical because doing it with people. And it’s very difficult to argue that you have designed a study with people with dementia and their family members, and that that wouldn’t be ethical, because they’ve said it’s a great idea.

I guess that I’ve found that really useful, and I think that’s motivated me, in the words of Daniel saying get involved, is what’s motivated me to get involved. I sit on a couple of groups, like the Alternative and Complex Consent Pathways group for trials. I’ve been on the NICE guideline committee, where we wrote the NICE guideline around decision-making mental capacity, which is mainly for health and social care, but also includes a bit on research. It made me very passionate about that, and it made me understand it more.

Rebecca Williams:

Amazing.

Dr Anna Volkmer:

I know I’ve spoken a lot. Sorry. I always do that.

Rebecca Williams:

No. Vicky, any other top tips for us?

Dr Victoria Shepherd:

Yeah, I was just going to add to that, that of course a health research authority, research ethics committee will have lay-members as part of the committee. There are very strict guidelines around the makeup of a research ethics committee so that people, patients, members of the public are very much at the heart of that approvals process, as well as contributing as a public involvement contributor as well. Ensuring that your research is explained clearly in lay language is essential to get that kind of approval. Often as researchers, as clinicians, as scientists, we’re not very good at that. So having public involvement can help us describe our research in very clear terms, and that in turn will help the research ethics committee to understand the information and to give good advice as part of that approvals process.

There isn’t a shortcut. I think you will need to have that public and patient involvement. And as Danielle I’m sure will be able to tell us, the HRA are moving towards an even stronger position where it’s required in all types of research. We can’t just say that because we’re not involving patients or people living with dementia, that we don’t have to have any aspect of public involvement anymore. Ensuring that’s embedded right from the outset will be really key to smoothing that process through approvals.

Rebecca Williams:

Absolutely. I’ll just ping over to you Danielle, and I’ll come back to you in just a second, Anna. Can you maybe talk us through, Danielle, are there any particularly common mistakes that people make in ethics applications?

Danielle Wilson:

Yeah, no, really good question. And I would absolutely echo what Anna and Vicki have said. You begin to see the protocols, the patient information sheets, they become obvious when they haven’t had that involvement of people that are affected by dementia, in this case. And we always go back and ask that these information sheets are read by people who have the condition that they’re aiming to recruit. That is definite rule number one, and the HRA are absolutely, big agenda to push this.

I would say the other thing is we don’t only want the best ethical standards for the participants being recruited, but we also want to know that the researchers doing the research are supported as well. And it’s really useful when, if you’re doing a project for your PhD or master’s, that your supervisor comes along to support you. You can share the questions that we might ask you at the research ethics committee, but we want to know that you are being supported with the research that you’re carrying out.

And I will just touch on something that is sometimes controversial. We receive ethics applications where the student carrying out the research would like to be the chief investigator. And again, there is guidance and rules around that, but we take that on a case by case basis. How sensitive is your research? Who are the participant group that you are aiming to recruit in the study? And do we think that someone with the experience and background, so we assess your CV as well, should be and could take all of the responsibility for this research study? That’s worth exploring and thinking about when you are putting together your research application. It’s not that we don’t think that that person has the expertise or skills, but we want to ensure that they are supported to carry out the study, and that they then develop and grow within their research career. It doesn’t all have to be done within that one study. They’re definitely my top tips, I would say.

Rebecca Williams:

Fantastic. Thanks so much for that. And Anna, coming back around to you.

Dr Anna Volkmer:

I was just going to reflect on international studies. I suddenly was thinking about our podcast listenership, and the fact that I’ve recently done a study involving collaborators in 17 different countries, and I had to ask each collaborator in each country respectively to apply for their own ethics. And in some countries what we were doing was required full ethical approval. And some countries, it didn’t require any approval ethically, and people were told it’s just PPI. It was very variable.

And I’ve also had experiences in that project where I shared a sample consent form that we co-developed. It was accessible, and it had lots of pictures, and simplified information. And some ethics organisations wouldn’t accept it, so they asked people to amend them. I guess I’m mindful that what we are saying, and certainly I know with my PPI hat on, that the idea of patient and public involvement is very commonly talked about in the UK, and in Australia a lot as well. And kind of in the states, but not as much.

And in many countries, people, although I call it PPI, they weren’t using this idea of PPI, they were just told, oh, you don’t need ethics for that. That’s just asking people’s opinion, it’s fine. This idea of PPI is also something that perhaps isn’t common internationally. We’ve been very much talking about studies being undertaken within English Welsh legislative regions, or Scottish, or UK. But actually when we go internationally, I don’t understand all the different regions, but it’s certainly been a really interesting experience to try and think about how different cultural values have influenced their ethical approval processes.

Rebecca Williams:

Yeah. Surely there’s studies in and of themselves into how ethics is done in various countries. I’m sure we could write a paper on that on its own. Yeah, that’s all super interesting. Thank you so much. Danielle, to come back to you again. In my future research, I might want to use some kind of new technology. I’m already using ChatGPT to help me code, it’s amazing. But what are the ethical implications of using these kind of emerging technologies where we might not quite know all the details yet, such as AI, in dementia research?

Danielle Wilson:

Again, in researching that for this podcast, I did reach out to the HRA. Because this is an area where I didn’t find the website to be too helpful. Hopefully, I can send the links and people listening to this podcast can access them. But as you say, it’s a new and evolving area, and it’s an area where we need other expertise to sit on our research ethics committees, and training for our existing members.

In the center that I work in, we are care, research and technology. We have a mixture of clinicians, AI, machine learning experts, software engineers, we are bringing that all together. Yet five years ago, if you had told me that I would be working in a center where you had all those different disciplines, I probably wouldn’t have believed you. I wouldn’t have understood how they would all work together to solve the complex issues that people with dementia face.

It is an emerging area, it is tricky, and I think everyone’s really aware of that. The Turing are doing amazing work. The HRA, the MHRA are partnering so that we can discuss the issues, make sure the research ethics committees have the training. And again, it goes back to the issue of consent. If I consent to something today that’s using AR or machine learning, what does that mean for tomorrow? What does that mean for the next five years? I’m not sure we know as yet. Yeah, I think there’s a lot of work to do, a lot of guidance to be written.

Rebecca Williams:

Yeah, absolutely. We see ethics evolving to adapt to new technologies, we see ethics evolving to include more PPI. Opening the floor, are there any other ways that we are seeing ethics evolve over the years, or any ways you’d like to see it evolve? Vicki?

Dr Victoria Shepherd:

Yeah. I think inclusivity is a really key move at the moment as well. As researchers, as research ethics committees’ members, we’ve often taken an approach where actually as long as participants are coming into the study, everyone is happy. But traditionally, we’re underserving some groups when we think about research. There are people we exclude from our research, either advertently or inadvertently. We need to make sure that research is accessible for everyone and that we’re including the right groups in research.

And again, coming back perhaps to people who may have additional issues around capacity and consent, traditionally they’ve been excluded from a lot of research through a move towards thinking about their protection, that kind of gatekeeping or safeguarding. But it means that we have less evidence for those groups than we do have for other groups. I think moving towards thinking about inclusion is very important. And that includes people perhaps from underserved groups, so ethnic minority groups for example. And again, on research ethics committees we have a lot of training now around equality, inclusivity and diversity as well. The same kind of principles apply to research ethics as they do to other aspects towards moving a more inclusive approach.

Rebecca Williams:

Fantastic. It’s great to see these kinds of strides that ethics is taking. I think we often see ethics as quite a stagnant monolith, and it’s really interesting to hear your opinions and how it’s actually evolving in real time. I think that’s coming to the end of our session is coming now, so I’m going to ask you all for one last thing, which is what do you think is the most important takeaway about ethics and consent? And I’m going to be mean and start with you, Anna.

Dr Anna Volkmer:

The most important thing for me is using PPI to make things accessible and doing things with them. I think that’s it. Does it make grammatical sense?

Rebecca Williams:

Yeah, absolutely. Bringing people into ethics applications. Absolutely. Vicki, what about yourself?

Dr Victoria Shepherd:

Yeah. I think we need to change our way of thinking, that ethical approval isn’t something that we have to get, that actually it’s thinking about how it makes us more ethical as researchers. Focusing on person-centered approaches to research, not so much on achieving the process, not being process-driven.

Rebecca Williams:

Absolutely. Yeah, that’s a really interesting take on it. Danielle, last but certainly not least?

Danielle Wilson:

Yeah. I would say if you were curious, come and observe an ethics committee. And if you are even more curious, fill in an application and join a research ethics committee. Because I think the only way we can change, evolve, and do things better is by being involved in the process. That would be my plea to anybody interested.

Rebecca Williams:

Well, thank you all so much. This has been incredibly helpful for me. As someone who does quite a bit of outreach and engagement, I’d somehow never put together that that is in any way useful for an ethics application. Thank you all so much. This has been wonderful.

I am afraid that is all we have time for today. If you just can’t get enough of this topic, visit the Dementia Researcher website, where you’ll find a full transcript, link to the resources that were mentioned and biographies on our lovely guests. If you have any questions for our panel or some tips of your own, please post them in the comment section below. I would like to thank our amazing guests, Dr. Anna Volkmer, Dr. Vicki Shepherd, and Danielle Wilson. I’m Rebecca Williams, and you’ve been listening to the Dementia Researcher Podcast. Goodbye, everyone.

Dr Anna Volkmer:

Bye.

Dr Victoria Shepherd:

Bye.

Danielle Wilson:

Bye.

Voice Over:

The Dementia Researcher Podcast was brought to you by University College London, with generous funding from the UK National Institute for Health Research, Alzheimer’s Research UK, Alzheimer’s Society, Alzheimer’s Association, and Race Against Dementia. Please subscribe, leave us a review, and register on our website for full access to all our great resources, dementiaresearcher.nihr.ac.uk.

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