Ep 32: Stepping into Research: Inside the NIHR Associate Principal Investigator Scheme

In this episode, we take a deep dive into the NIHR Associate Principal Investigator (API) Scheme, exploring what it really means to step into a research role. Dr Anastasia Madenidou hosts this conversation with James Bluett, Holly Speight, Jill Firth & Tania-Elena Gudu.

From a Research Delivery Network (RDN) perspective, we provide an overview of the scheme which is open to the entire MDT, highlight its purpose in developing the next generation of researchers, and signpost listeners to key API resources. We then hear directly from both sides of the experience: a mentor sharing insights on supporting and shaping emerging investigators, and an API mentee reflecting on the realities, challenges, and rewards of the programme.

Whether you’re considering applying, mentoring, or simply curious about how the NIHR API Scheme builds research capacity, this episode offers honest reflections, practical advice, and inspiration for your next career step.

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BSR is the UK's leading specialist medical society for rheumatology and MSK health professionals. To discover how we can support you in delivering the best care for your patients, visit our website. 

Transcript

You're listening to the Talking Rheumatology podcast brought to you by the British Society for Rheumatology. 

Hello everyone and welcome to the BSR podcast. My name is Anastasia Madenidou and I'm a clinical research fellow at the University of Manchester and I also have the pleasure to chair the BSR trainee committee. Today we're going to learn all about the associate PI scheme. Here with me is James, Jill, Holly and Tania, who will bring their unique perspective. So now I'm going to ask each person to introduce themselves and what perspective they are bringing today. So first of you, James, welcome and tell us a bit about yourself.

Thanks so much, Anastasia, and thanks for the invitation to speak today. I'm a rheumatologist and I'm also the NIHR Research Delivery Network National Specialty Lead for Musculoskeletal and Orthopaedic Specialty. As a specialty lead, I'm always encouraging colleagues to get involved in research and the NIHR Associate PI Scheme is one of the easiest ways to start. It gives you real hands-on experience working on a study with the support of an experienced principal investigator by your side. It's a practical, approachable way to build your research skills while still doing your day-to-day job. And it opens the door to so many future opportunities. I'm here to give a real broad overview of the scheme for your BSR audience today.

Lovely. Thank you, James. And now, Jill, could you please introduce yourself? Thanks for joining us today.

Good afternoon. Yes, my name is Jill Firth and I'm Consultant Nurse in Rheumatology and retired as Director for Service Improvement for Pennine MSK. I have experience of mentoring somebody on the API scheme, which is why I'm here today.

Lovely. Thank you, Jill. And over to you, Tania.

Hello everyone. My name is Tania Gutu. I'm a consultant rheumatologist working at Ipswich Hospital ESNEFT. I'm also a visiting fellow at the University of Essex Department of Psychology and I will bring the unique perspective of an associate PI mentee. I've completed this scheme back in 2022 and I'm really happy to share my experience with all of you.

Lovely. Thank you, Tania. And over to Holly now. Welcome, Holly.

Thank you. Hi, everyone. My name is Holly Speight and I am the Associate Principal Investigator Scheme National Manager. I'm responsible for the operational delivery of the scheme across the whole of the UK. It's available across England, Wales, Scotland and Northern Ireland. And the perspective I'm going to bring today is around the operational side of the Associate Principal Investigator Scheme.

Thank you, Holly, for joining us. And I'll come back to you, James, to give us a bit of an overview of the scheme, because I'm sure not all listeners are familiar with the scheme, which is relevant to all conditions.

Thanks so much, Anastasia. So the NIHR Associate Principal Investigator Scheme is a really great opportunity for BSR members to truly get involved in research. It's a six month in work training programme, so it provides practical experience for health and care professionals being involved in research. The scheme is not only for trainees or doctors, but is open to any healthcare professional. Through the NIHR Associate Principal Investigator scheme, trainees will experience what it means to work on and deliver an NIHR portfolio trial under the guidance and support of a local principal investigator. The programme is there really to help develop doctors, nurses and healthcare professionals to be the principal investigators of the future. And it helps to increase opportunities for patients, which is why we're all here. to be involved in some of this high quality research that we deliver. For BSR members, importantly, it is open to any health and care professional who is not currently fully funded to work in research. What it means as part of this in work programme is that there's a checklist of activities and learning. So the checklist might include activities such as disseminating the study to the department, Ensuring the delegation log has been correctly completed and there's training that's available such as good clinical practice. In terms of time commitment, alumni of the scheme have said that they spend roughly two to three hours per week dedicated to their associate PI scheme over the six month period, but we certainly don't mandate this and different people will learn at different rates. The involvement may occur partially during the setup phase, which for me I think is a really interesting part of a trial, but also during patient follow-up and it also encompasses patient recruitment as well. The programme has been, I think, a really huge success to date. So we've had 234 individuals from the MSK and orthopaedic specialty who signed up to the scheme. and over 5,000 individuals have completed the scheme across all specialties. This is a huge cohort of alumni there. As well as this, there's a good number of NIHR studies that are registered. So currently there's 42 studies that are registered under musculoskeletal and orthopaedics that are accepting associate PI trainees. which does include commercial studies as well as non-commercial. So it gives people the opportunity to gain experience across the spectrum. And it's also important to note that if you have completed it before, you're also able to complete the scheme another time if you found that it was useful, which I hope you have done. Trainees do receive formal recognition of engagement with NIHR portfolio studies. And in completing the scheme, they will get a certificate of associate PI status, which is endorsed by NIHR and also the Royal Colleges. I think it's really important to note that for resident doctors, the associate PI scheme can help to demonstrate research experience, which is helpful for the ARCP process. And additionally, for the principal investigator, so for the people who are mentoring, I think it offers additional support with the delivery of the study so that there's more people on the ground to help support the study. And for patients, it offers increased opportunities to be involved in high quality research. So we want to have as many people as possible to recruit participants to these high quality studies that we're running. And in terms of feedback, so we've undertaken a formal evaluation of the impact of this associate PI scheme. And we've found that for sites within associate PI, we've seen that site set up times are far quicker. recruitment performance was better and we saw sites recruiting much more participants. So there's many benefits for both the trainee, for the sponsor of the study, but also for the principal investigator and for patients for being part of this scheme.

Thank you, James, for the great overview. So my my understanding very briefly is that this is an opportunity for all clinicians, not just medical doctors, to step up and fulfil the duties of API, but in a very structured and supportive way. So my understanding is that this is a great opportunity actually to get involved in research with. So yeah, It sounds really good. And the feedback you said that is very encouraging. So I think it's important to hear the perspective from both of the mentor and mentee. So actually our listeners to have a better understanding of the scheme and the practical aspects. So I'd like now to invite Jill, who has involved as a mentor in the scheme, to give her own perspective in terms of the commitments and actually what I would like to ask why did you decide actually to get involved in this scheme and give some of your valuable time to educate the next generation of researchers?

Thank you, Anastasia. As a nurse, I've been in a very privileged position to undertake a PhD with a scholarship and I have a fairly lifelong interest in encouraging others to engage in research. But very often, particularly for nurses and allied health professionals, but also for doctors, our involvement is often just around recruitment and data collection. So as a research active organisation, we've ensured that we have a portfolio of research that involves and engages a range of clinicians across the organisation. But very often, the exposure to the setup period in particular and all the governance implications that come with good clinical practice and ensuring that we're delivering the research in the best possible way is something that's undertaken by the leaders and not seen by other people. So for me it was a great opportunity to invite one of my allied health professionals to engage with the scheme, somebody who'd had some exposure to recruitment and data collection in research, but really have no idea about the other implications that go with a good conduct of research. So as James mentioned, I think exposure to the setup period was really a crucial aspect of learning for my mentee. It enabled us to go through all the things that need to be in place before you actually approach MD to take part in research. And that was very new for my mentee that that they've got insight and awareness to those things and could practice some decision making under supervision and with support about what was in place, what was necessary and when the study could go live. So that was all really new. And for me as a mentor as well, you're often very busy when you're trying to support and develop your colleagues because you're busy in clinical practice. and you're busy additionally trying to undertake your research alongside your clinical practice. So this did give us a structure to work to and it gave us that some dedicated time where we actually sat down together and we had some structure to what we were going to discuss and how we were going to work through aspects of the research and ensure that the learning was in place. It also, I think, from the point of view of the mentee, was a very positive experience because I was dedicating this time to her. She had the opportunity to ask questions when I was in listening mode and had the time to answer those questions fully. And it was an opportunity for her to really understand some professional development that was going to be captured, recorded, could be used for professional development and revalidation purposes ultimately. But it was also just a really good opportunity for someone to step up to the next level and to learn more about research and to think about further engagement in research in the future and to take away maybe some of the anxieties and fears that we all have as we develop in a new area. And finally, I think it's also when you've been in a role for a long time and you're very comfortable with working in a research environment, it was a lovely opportunity to think about succession planning and how to get colleagues from one step to the next in a supportive manner. So really enjoyed it and we both found it a very positive experience.

Lovely, that's all great. Your story is very inspiring and I hope we inspire more listeners to sign up as mentors to the scheme. And then because, OK, I want to follow up, Jill, on what you said, because all of us are busy. So I don't know, some clinicians may consider signing up as mentors, but they may say, oh, I need to teach to a more colleague, I need to give more of my valuable time. In practical terms, did you also get some help with the study or was it all about teaching?

I think in the longer term we would reap the benefits. I think at the time it was mainly about learning and development. But what I would say is that you are getting somebody in a position where when the next study comes along, they're in a really good place to extend what they do in relation to that research. So, I think it's incremental learning that can then be applied as you build your research portfolio. But also you hope to inspire that person to maybe think about research bits of their own in the future and that they might actually be reaching out to engage in research. So I think you're equipping somebody with some skills to skills of the confidence really to extend the research career.

Lovely. Thank you, Jill. So we've listened now to the mentor perspective and we will move on to the mentee perspective. So I'd like to ask you, Tania, to share your perspective. And firstly, I'd like to ask you, why did you get involved in this scheme and how did you learn about this scheme?

Thank you, Anastasia. Well, actually, I think my career is a bit unique in the UK. So I've trained and completed a PhD in Romania and France, and I moved to the UK in 2019 and I was a research fellow in Cambridge for two years. So I did have an exposure both with academic and commercial studies. And at the end of 2021, I moved to a substantive consultant job. And which is purely a clinical job, but I still wanted to to continue some some research activities. So I went, I met the clinical trial unit, the R&D team, and they were extremely welcoming and friendly and they signposted me to the associate PI scheme. So this is how I've learned about it. I was very keen to be involved there. So I've applied. I think from my perspective, the application process was very simple, very straightforward. Basically, you need three things. One would be the support of the research unit in your hospital, which I had, and then find a good mentor. And it was really lovely to hear Jill's perspective because I always think about my perspective. I never thought about the mentor perspective. And it's really important to find someone that really matches your level of enthusiasm and has the same level of commitment as you, and I was lucky to have that. And then you need to find a study. In my case, the study that we've chosen was taper study, which is a study about tapering biologics in inflammatory arthritis patients in remission, which was led by Professor Anne Barton at the University of Manchester. It was not on the associate PI registry of studies, so we had to, I had to contact the team and ask them if they would be keen to to be part of the scheme and. They were extremely helpful. And again, it went very easily, very smoothly, and everything fell into place quite quickly. So I think for me it was a great experience to begin with. And over the six months, I've learned a lot of things. And what I've appreciated is that I learned it in a very structured and very hands on, hands on approach. And I think reflecting back on it, if I would to be thinking about what tips and what was important for me. I think it's really essential to be very proactive and take initiative as a mentee. And I was lucky enough to have a mentor who gave me the autonomy and independence for me to lead different study activities as if I were PI. And I was also, I keep using the word lucky, but I was really lucky to be involved in the study from the very beginning, from setting up the study, study initiation visit and then going through recruiting patients, consenting, doing the follow up visit and the overall study management. So I think that's really important because if you are able to go through every step of the study, that gives you an overview of what it means to be To lead the study as a as a principal investigator. And then I think it's also important to have a very good mentor that is not just about the guidance and the things that they teach, but also taking the time to sit with you, discuss your questions, your concerns. And we did have, regardless of how busy we were because I was just starting my my new consultant job, we did have a dedicated time. We would sit down every month and we would go through. the study strategies, what was not going well, what else, what kind of support did I need? And also very important, we did go through the checklist because at the end, when you have to submit the checklist, it's really important that you do it from the beginning and do it live and not leave everything at the very end.

Lovely. That's great. You had a great experience and I hope all participants have had your experience because it's a sounds like a great learning opportunity. So but. I'll come back to specific questions, but because I think it's a good opportunity now to bring Holly in because I understand you need to sign up as a mentor, you need to sign up as a mentee, you need to find the right study. If the study is not at the scheme, you can actually register this study. So Holly, if you could please tell us a bit, if you could tell us a bit about the practical aspects, because ok if I want to do it tomorrow. What shall I do?

Of course, yes. So I'll cover first what you should do if you're a study team and then go on to what you should do if you want to be an associate PI. So if you want to register your study, it must first meet our eligibility criteria and it's pretty broad. We want it to be as inclusive as possible. So first your study must be on the NIHR portfolio. It must be open to recruitment for at least six months. We accept both commercial and non-commercial studies and your study must give individuals the opportunity to learn about consenting, be involved in a patient's pathway and have opportunities for the individual, the associate PI trainee to interact with different areas of the research, different points of contact. So how would you then register your study? You meet the eligibility criteria, that's great. So what I would recommend then is you go onto our website and you can find that by searching www..nihr/associate principal investigator scheme. And on there, you can find a website that gives you a really good overview and it has a dedicated study page. So you can find a link on that page to the registration form. And this form should take you no more than 5 to 10 minutes to complete. The form can be completed by any member of the study team, but we will always require sign off from the UK chief investigator and the sponsor as well. So they really need to say that they're happy for the study to go onto the scheme. Once we've got their approval, we then make the study live to accepting associate PIs. And a common question that we get asked is how quickly does that process take? And it really is as quick as people replying to our emails. You know, we can't often turn these applications around in an hour. So it really is making sure that everybody's aware that you're applying, that they're going to be getting an e-mail asking for approval and that can make the process really quick. So now I'm going to move on to what the process is for an associate PI trainee. So an individual that has listened to Tania speaking and is thinking, actually, this sounds like a really good opportunity for me to learn. So the eligibility criteria is any health and care professional, can participate in the scheme and we really do mean any health and care professional. It is open in not only hospital settings, but we're open in non-hospital settings as well, so primary care, community, local authority. And once you have decided that this is for you, and you have then need to find a study. So to find a study, again, if you go onto our website, you will find a dashboard that we've created and it's called the Where Can I Take Part dashboard. And on there, you can type in your postcode, the name of your organisation, and it will bring you up a full list of studies that are registered onto the scheme. Alternatively, if you're aware of studies going on in your department, you could approach the principal investigators or the research teams for those and ask if the study is registered on the scheme. Or if you're fortunate to work in an organisation that has a research and development team, then you can also contact your R&D team and they can provide you with this information as well. So you've found a study that you want to take part in. So the next thing you would want to do is speak to the principal investigator for that study who's going to be mentoring you. And you can find that information on the dashboard as well if that's how you're finding your study. Or alternatively, the R&D can provide you with this. Or if you've already spoken to the PI, then that makes it a lot easier for you. So have a conversation with the PI and they can give you a really good understanding of what's going to be involved in this study, how much time they will want you to dedicate each week to filling in your checklist, going through those activities that we want you to experience. And it really is a decision for yourself whether you have the capacity to do that as well. The only thing that we mandate is the tenure length. We do not mandate how much time each week you spend completing the activities on the checklist, but the PI can give you a really good understanding of how much time you might be expected to give. Once you've had that conversation and the PI has given you the green light, you then fill in the registration form, which again you can find on our website. And if you've got PI approval, there is an option there for you to upload that approval and we can get you started. Or if you don't have any written confirmation, we send an e-mail to that principal investigator asking them to approve it. And again, much like with study teams, we can turn these applications around relatively quickly as long as people reply to those emails from us. So that's a sort of top tip from me, making sure that you're having those applications and letting people know that you're applying if you're an associate PI so they can be aware that they're going to be getting that e-mail soon. Once you've got that, once we've got that approval for you, we then give you access to NIHR Learn and that is where you will be able to review the checklist and see the activities and the framework of learning we want you to go through over the six months and evidence. And we're always here as a national team to support you if you have any questions and you also have your local principal investigator as well.

Lovely, Holly. Thanks for the great overview and it's important to hear that there is flexibility. It's not that we need to have a study open and then. actually sign up for this specific study, we can have our discussions with local PIs and find also a study as a mentee that you're interested in. Also, it's an opportunity to find out if this PI is the right mentor for you, if he's willing to give the time, but also the whole process is very structured.

That's great. And just to add to that, you know, Tania said about when she actually found a study, it wasn't registered onto the scheme. Please do not be put off if that happens. You know, we can have those conversations with the study team. You know, Tanya took that initiative and had that discussion as well, and it prompted the study to register on the scheme. And we do see that that actually people that want to be associate PIs often sometimes prompt a study to go on there. So if you find a study and it isn't on the scheme, don't be disheartened. You can contact us and we can happily reach out to those study teams and encourage them to apply onto the scheme as well.

Oh, that's that's great. That's an alternative option. Lovely. Now we know all about the scheme, how to sign up for the scheme, which is important. So I'd like a bit to discuss the long term benefits of the scheme. So I'm coming back to you, Tania. So You really enjoyed the scheme, but since you completing the scheme, have you continued to stay engaged in research?

Thank you, Anastasia. It's a great question. And yes, I did continue to be involved and I was an API on three studies now and supporting the other studies in the department as a co-investigator or sub-investigator. But that was a great experience and a good learning opportunity for me to step up as a PI further on. And I'm now also involved in a research unit with the University of Essex Department of Psychology, where we have different projects and we have designed an investigator led study that has recently received the HIV approval. So I'm very excited for this.

Lovely, great. And. It's great to hear that that was this associate PI scheme was the starting point for further involvement in research. So it's not like, especially from a trainee point perspective. It's something you can take forward and yeah, be the starting point for a career in research. Lovely. Now, I'd like to ask a question to all of you and whoever is happy to jump in about any tips that you would like to share with mentors or mentees.

It's probably one thing that I was reflecting when I was listening to Tania talking about her experience as a mentee. And I think what really did work for us was the fact that we did at the outset, although it's very flexible and not prescribed in terms of the time that you spend together, we did actually sit down and diaries in regular time every two weeks together. Because I think what often happens when you're busy in clinical practice is you talk about things when they're not going well, or you talk about things when something needs to be done and there's a deadline. And I think with this experience, what was really nice was we used the structure that's set by the scheme to ensure that we sat down every two weeks and we discussed what was happening and the implications of it, what learning points might arise and answered any questions. And indeed, as a mentor, I asked questions as well to appreciate the understanding of the mentee and any additional learning needs. So it was that structure that underpinned the mentorship scheme that actually led to a really positive experience. I would say that probably if you give anybody any advice, it would be that if you're doing well in the scheme, you know, do diaries early on and set some regular meetings together because the six months goes really quickly. But if you're meeting regularly, it's in no way a burden. It's a very positive experience for both individuals.

Lovely. Now we'd like to ask you, James, about any advice you can give us the chief investigator on the scheme.

Yeah, absolutely, Anastasia. So wearing my other hat, I think from a chief investigator perspective, the scheme is fantastic to help increase capacity to deliver a trial. We know that. Hospital sites are under huge amounts of pressure at the moment. And so when we run these trials, recruitment really is at the top of our agenda. So the more people that are trained up to increase capacity to help deliver the trials and make it a success, the better. We've seen some real positive benefits from the scheme for recruitment, for early site setup. But there's also other benefits. So it helps to increase engagement with sites. It helps to increase the amount of publicity we have for our studies as well by having it on the associate principal investigator scheme. So from a chief investigator's perspective, there's lots of benefits having the study registered for the scheme.

And just building on what James has just said, the promotion, to make that as easy as possible for you as a study team, we have created as a national team a resource website. And again, you can find that on the associate PI scheme website. And on there it houses really useful promotional tools for you that really hopefully you'll be able to just lift, shift, localize with your study information to make it as easy as possible to embed the associate PI scheme within your study. So for example, we've got site initiation visit slides. So when you're setting up those sites, you can make them aware as soon as possible and as early as possible that your study is on the scheme. So your principal investigators can be having a think about who colleagues that might be appropriate to be associate PIs and it hopefully becomes more embedded within your study. Just touching on the resource site as well. So it isn't just for study teams. So really do, if you decide you want to be an associate PI, really do check out our resource sites. So we've got toolkits available for you in there. we've got how-to videos in there. We've tried to make it as comprehensive as possible to support you while you are going through the scheme. And we've also tried to work really hard to make sure that the principal investigators that are doing such an amazing job mentoring these individuals also have that same support. And so there are toolkits there for PIs as well. If they're wondering what is expected of me in this role, we've put some guidance together for you. as well. So we've tried to make sure that we've put as much support in there as possible. And for those individuals that complete the scheme, we've also created an associate PI alumni learning package as well. And you can access that via the NIHR Learn learning that we send to you as well. And that has suggested additional learning and also promotes some local connections that you can make. So for example, with our regional research delivery networks as well who have workforce lead managers that can support your learning as well throughout and also after you've finished the scheme.

Lovely. What I'm hearing is that you're well supported and even if you're listening to us now, you're not quite sure if you want to do this, maybe visit this website, go through this toolkits and maybe you get convinced. Lovely. Thank you, Holly.

If today's episode has inspired you to get involved in research, the NIHR Associate Principal Investigator Scheme is a great place to start. Whether you're a healthcare professional looking to build your research experience or a site team keen to support the next generation of PIs, the scheme is open and ready for you. So head to www.nihr.ac.uk and search for the Associate Principal Investigator Scheme to find out more. explore current opportunities, and take your first step into research leadership. Get involved. Your research journey starts here.

Thank you very much, James, Tania, Jill and Holly for joining me today. We had a great overview of the scheme. We are now familiar with the Mentee and Mentor scheme, so it's up now to our listeners to decide to go ahead and try to do this scheme and move on and start, maybe, get more involved in research. And I'd like to thank also listeners. Thank you very much, everyone. Thank you for listening to Talking Rheumatology, brought to you by BSR. Please do rate share and subscribe through your favourite podcast app.