There were a range of research colleagues that research nurses, midwives and allied health professionals (NMAHPs)* spoke about. These included Principal Investigators (PIs), Chief Investigators (CIs), staff at study centres, and fellow research NMAHPs. Whilst these individuals sometimes overlapped as clinical colleagues* (including Principal Investigators who were often clinicians), this section describes their working relationships in the context of research.
Principal Investigators (PIs), Chief Investigators (CIs) and study centres
The UK Health Research Authority (HRA) make a distinction between PIs and CIs, although in practice the terms were sometimes used interchangeably by the NMAHPS we spoke to. The HRA defines PIs as individuals with responsibility for the study being run at a particular site. Often the PIs were clinicians but some were NMAHPs by background. Indeed, Claire, Karen, Gavin and Nicky had all been PIs (or co-PIs) themselves. CIs have ultimate responsibility for the study being run across all study sites. Some research NMAHPs we interviewed, such as Nikki, worked in departments or units where the CIs were based. Many research NMAHPs had worked with study centres – this usually meant a team of people, including CIs and trial managers, with overarching responsibility for coordinating the study.
Some research NMAHPs worked very closely with PIs/CIs and study centres, whereas others had less contact and felt more distant. This situation often depended on the scope and scale of the research, including whether it was an academic or commercial study. For example, whether a study was being run locally at one or two sites by a small team, versus many sites (regionally, nationally, internationally) with a large research team located elsewhere.
Nicky described her experiences of the relationships between Principal Investigators (PIs) and research nurses.
Nicky described her experiences of the relationships between Principal Investigators (PIs) and research nurses.
Age at interview: 52
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
You do work really very independently in research, so, usually have a PI [Principal Investigator] for the study, a Principal Investigator, so but often that Principal Investigator is a clinician, so particularly in, where I work, I mean [cough] the Principal Investigators there, they’re consultants, they’re out you know busy in the clinical area. So really, I would say we kind of pretty much, as nurses, pretty much coordinate and run the studies. So you do have to be able to work very much, you know, take on board a lot of the responsibility. Obviously they’ve got the overall responsibility and you have to, again you have to be able to pick out what are the things, you know, you have to make sure you’re constantly communicating with them to feed everything back, and make sure they’re kind of aware of what’s going on the study and if there’s any issues with patients, then they’re aware of it. But actually, you are making a lot of the decisions. And actually there are a couple, well one study where I’m the PI myself. And I think that’s happening a lot more now, that nurses are becoming PI’s for more studies. So again on that study, you know, it is just me, I’m kind of the person that’s in charge of it, and obviously I’ve got people on my team working on it.
Nikki had varied experiences with the amount of engagement from Chief Investigators (CIs) or Principal Investigators (PIs) and study centres.
Nikki had varied experiences with the amount of engagement from Chief Investigators (CIs) or Principal Investigators (PIs) and study centres.
Age at interview: 34
Sex: Female
HIDE TEXT
PRINT TRANSCRIPT
I think it depends on the study. I think-, I'm sure probably most people find this, that if you've got a CI [Chief Investigator] on site you tend to have much-, it's a much more sort of two-way, probably much more frequent conversation isn't it, about what's going on, and what's happening. And if you're a site delivering someone else's study, it's probably less so. Because you're just, just much more remote aren't you, from that I think. And I think it, I think it depends on the, on the CI, as well. And, and the site. You know, I've certainly had studies where you feel much more engaged, you know, the CI often checks in with you, or checks in with the site. He's, “How are you going?”, and sending newsletters, gives you updates. And that's quite- it's quite motivating. Whereas I've had some studies, you're literally given the information to start up, and then check back in in a year's time, and- It feels quite disengaging, I think, from a research delivery team point of view. It feels like you've been forgotten about. Which I'm sure isn't the case.
But I quite- I find it- I find it a better experience if they are the types that engage with you as you sort of go along.
Christine said research nurses need “to get on with people across a broad spectrum of networks”. This included trying to motivate consultants engaged in research who are often under a lot of clinical pressures.
Christine said research nurses need “to get on with people across a broad spectrum of networks”. This included trying to motivate consultants engaged in research who are often under a lot of clinical pressures.
Age at interview: 54
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
Optimistic, organised, methodical, a good listener, able to get on with people, across a broad spectrum of networks really. Because you're dealing with, you know, academics and, like yourself, from universities. Or you're dealing with businesses. And you're dealing with consultants. You're trying to motivate consultants. That's quite challenging, sometimes. It's just like, I'm, I'm sort of go on the principle of a bull in a china shop, must be it's my Taurus. But I'm very much of 'I just need you to do this, is there any chance you could get this done?' and I'm very much a face to face. If I email, if I don't get a response, I'm like 'do you know what, I'll just go and see them'. So I know I've always got to put myself out there a little bit more, you know. And you know, within the first few weeks, I very quickly realised they do need- You know, they're very busy. They've massive clinical load. So as regards research, it's, it's there, but it, it will always take a second to the clinical needs. Which is obvious. But, so things like reminding them when they need to do the GCP [Good Clinical Practice] training, when they need to do it, sending that reminder. And actually giving them the link to-, you actually, there's a lot of, you know, really pushing that side of that relationship to support them, to do, to help you do what you need to do.
So, yeah. I think it's about not always taking no for an answer. Being able to push past that. And, and finding ways to see solutions to problems. So, yeah. A bit more lateral thinking helps.
Sometimes it was the PIs who first introduced studies to patients and took consent; other times, this was done by research NMAHPs. This depended on the type of study and context (e.g. if eligibility depended on consultants making a diagnosis). Often though PIs had delivered some form of training on recruitment and other data collection activities to research NMAHPs. Helen felt it was important to hear them talk about studies to get tips on explaining the information to patients before starting recruitment. At times, clinical workload pressures made it difficult for PIs/CIs to also stay on top of research activity, so some research NMAHPs saw part of their role being to make this as seamless as possible.
There were inevitably occasional disagreements between PIs/CIs and research NMAHPs. In some situations, research NMAHPs felt under a lot of pressure to follow PI instructions. Some people felt able to stand their ground and that their views on important matters would be taken into consideration. Ellen described having worked with some “keen” PIs who “just don’t always get the little grey areas” of balancing recruitment numbers with advocating for patient choice. Ginny found some PIs/CIs were remote and quite uninvolved. When she was first in post, Osi struggled to rally enthusiasm from some PIs whose research had fizzled out a bit and become ‘out of sight, out of mind’.
Contact with study centres included activities like Site Initiation Visits (SIVs) and monitoring; both Ellen and Osi learnt a lot from these processes when they were new to research. Michael felt strongly about the importance of SIVs: “it’s a great opportunity and they go through everything in detail”.
Helen talked about Site Initiation Visits. These meetings went best when attended by representatives from all teams and departments who would be involved in the study at that site.
Helen talked about Site Initiation Visits. These meetings went best when attended by representatives from all teams and departments who would be involved in the study at that site.
Age at interview: 53
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
Yeah, yeah well I think many, many years ago, your Site Initiation Visits, the sponsor would come up to the hospital but I think with cutbacks and you know, perhaps reduced funding and things like that quite a lot of them are done over the telephone now. So we’ve got a telephone Site Initiation Visit tomorrow and we’ll gather together all the research staff who will be involved in the study. Myself I’ll be there, it’ll be the Principal Investigator and the co-investigators and we’re also getting some of the CNS’s [Clinical Nurse Specialists], because they’re actually gonna be delivering the CTIMP [Clinical Trials of an Investigational Medicinal Product]. So it will be a dial-in with the slides and it’s just a great opportunity to go through the protocol and ask all those questions that you’re just not quite sure about and how you’re going to do the training and, you know, who’s gonna be trained, you know, are they gonna need GCP [Good Clinical Practice] training, how are you gonna run the study, where are you gonna store the drug. Pharmacy aren’t attending tomorrow but they’re attending a separate Site Initiation Visit.
So an ideal Site Initiation Visit would be that I would invite as many people as possible because I think if you get engagement at the very start with the CNS’s as well and support services if they’re ever able to come, then that would be great because they understand about the study form the very beginning. But in reality that doesn’t always happen, that everyone gets involved, but I do, I would invite everybody who I thought might want to be there. And then the ideal would be that they would go through the protocol at the very beginning and everybody was there and ask any questions and that might take about an hour and then at that point all the clinical team, the non-research staff can all go because they don’t wanna go through the Case Report Forms and the electronic CRF and, you know, all the sample handling and things, so that would be-, you know, we’d probably carry for about another hour and then yeah that would be, but that’s a great opp-, I take loads and loads of notes and then from that I start working out the work instructions for the study and how we’re gonna run the study.
In practice.
Sandra highlighted the importance of good working relationships with Principal Investigators. She also encouraged engagement with study centres, especially if there are uncertainties or problems in studies.
Sandra highlighted the importance of good working relationships with Principal Investigators. She also encouraged engagement with study centres, especially if there are uncertainties or problems in studies.
Age at interview: 43
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
So obviously the PI, the Principal Investigator, always work very closely with them. Make sure that they know what’s going on, where we’re at with the study. Have there been any changes? Do, you know we have regular meetings just to check in and see where we’re at, cos obviously they’re responsible for the study, I’m not, I’m responsible for my patients. They’re responsible for the study. So, they need to know everything that’s going on, and making sure that they’re aware. Working with the study teams, it’s really important to have really clear conversations, and if you’re not sure about something ask, I’ve never met a study team that have gone, “Phew what are you asking that for?” No, they always, always willing to help, I’ve never had any problems with my study teams. I don’t know whether I’ve just been lucky or whether that’s the case for everybody but they, we’re here to help them do their study, and they can’t get their results without us, and actually if we’ve got results but we don’t give it to them nothing’s going to happen with it. So again, it’s that partnership working, but yeah always go back to them and ask them questions, if I’ve got any concerns. There are study teams that are very new to research and actually I probably know a lot more about research than they do, so sometimes if I read something and I think, “Oh I’m not really sure that that’s quite right,” I’ll go back to them and say, “ it’s just a query, I’ve worked on studies before and this bit doesn’t really make sense to me. Can you explain to me how that works?” Or, “Are you considering changing that bit at all?”
Asking the question cos sometimes it changes and especially in palliative care, the time frames nearly always have to be extended because it takes longer to achieve the results than we’re expecting. And that happens in lots of studies not just in palliative care but because we don’t know, and you’re kind of thinking, “Oh yeah, can do this, this and this,” and because they take a timeline, but patients don’t conform to timelines. They conform to whatever path they’re on, so it depends where you intercept with them and is that going to work. So just keeping really clear, if you’re having any problems going back to the study team and say, “The patients are saying this, this is the reason I’m not-” so screening logs, and keeping that information as to why people say ‘no’, can be just as important as why they say ‘yes’.
Jo found that study centres were not always aware of how research was likely to work on the ground and so there was sometimes a negotiation of expectations.
Jo found that study centres were not always aware of how research was likely to work on the ground and so there was sometimes a negotiation of expectations.
Age at interview: 49
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
And particularly I think that you know a lot of the study centres I mean it’s not the same that the PI’s [Principal Investigators] do know obviously but a lot of the study centres they don’t have that idea of what it actually is or how a hospital operates and sometimes I’ll look and, you know, and think oh well why can’t you just get that information, you know, and things don’t all, you know. Things don’t always happen that way and things will always be different to how they anticipate that they will be because of, you know, different reasons than the clinical environment. And that as well it’s about them understanding that-, you understanding what they want but they also understand, they have to understand how, how you’re gonna get that and that might not fit into every box, every time [laughs].
In some cases, there was frequent communication from data managers at study centres/within research teams. They might contact research NMAHPs to ask for updates on participant recruitment and retention or with queries or requests about missing data and updates. Rachel X emphasised that it was important to respond in a timely manner. However, this communication was sometimes felt to be too much. Louise felt there was quite a lot of pressure on her when she first started in a research midwife role. At the other end of the research lifespan, some people felt that the findings of studies were not forthcoming or given promptly enough to research NMAHPs (and/or to patients).
Michael praised the data management teams. At times, the queries had seemed finicky but he appreciated the importance of quality data.
Michael praised the data management teams. At times, the queries had seemed finicky but he appreciated the importance of quality data.
Age at interview: 29
Sex: Male
SHOW TEXT VERSION
PRINT TRANSCRIPT
So typically you’ll have data teams, who are administrative staff who will go through your notes scrupulously and ask you, “Why did you not write the date here?” “You scored that out and didn’t sign it.” And there can on occasions be a little bit of tension when you’re new to research, because you get really busy and you’re clinically very busy with often very unwell patients, so the last thing you’re thinking at that time is to-, when you score something out to sign it the correct way that the data team want it. And then the next day when they’ve gone through your notes, they come and grab you and say, “Can you fix this? Can you correct this?” You know, “This is illegible, and you haven’t written this, can you clarify that?” And you get to the point where you’re like, “Do you know what, I’m so busy, I’ve got the patient, just leave me alone, it doesn’t matter.” But of course, in research it does matter. But you learn that as you go along, the more experience you get with the clinical trial, you know that it’s easier in the long run to document it well at the time, and that becomes second nature after a couple of months, you get used to what the expectation is, cos it is different from a ward setting in terms of documentation. So you pick that up and then it becomes fine. The data team are fantastic. I don’t envy them in many respects because they trawl through doctors writing, which is notoriously difficult to read on occasion. And they’re the ones who really will make sure your data is exact and correct, and so they’re a real big support.
In her current researcher role, Mary liaised a lot with data managers. She saw parallels with the importance of building good relationships in her other role as a health visitor.
In her current researcher role, Mary liaised a lot with data managers. She saw parallels with the importance of building good relationships in her other role as a health visitor.
Age at interview: 58
Sex: Female
HIDE TEXT
PRINT TRANSCRIPT
For example, in the study-, the trials that I’m currently working on, we’re using quite a lot of routine maternity data, so data collected by clinicians in their role as clinicians, held by the NHS Trusts but, you know, we’re accessing it for research purposes. And in theory it’s a much easier way of collecting data than collecting it fresh, as a research team, but in practice it’s got all kinds of difficulties around it. You know, around completeness and access to that data, and all the rest of it. And one of the things the people who deal with that data-, that’s their day job, are data managers and analysts sitting in Trusts, that’s what they do. So, in order as a research team to access that data you have to work with those data analysts.
And while in theory you’re talking about a spreadsheet worth of data, you know, ‘send us the data’, what you’re actually doing is building relationships with those people so they understand what our needs are, we understand what their needs and pressures are, and you establish trust, even though I don’t speak their language, they don’t really know or particularly care about my precious research study. 90% of what’s involved is me building a good relationship with them, so that they feel valued, they understand what it’s for, I understand their pressures, I know when to ask them for things, when not to ask them for things. Making it as simple as possible for them to achieve what I need them to achieve, and given-, and making it in some way reciprocal so that I gain but they also gain something from it. A satisfying, maybe slightly different angle to their working day.
And I think as a health visitor that, you know, you’re, you’re constantly trying to encourage people to access the service, you are, you have to be humble because you’re a guest in their homes a lot of the time, just in the way that when I’m working with data analysts I’m wanting something from them, they don’t have to give me if they don’t want to. They don’t have to give me. So it’s about respecting people’s-, the different pressures on people and being able to assess-, read people and assess situations quickly.
Ginny found it “very patronising and also really irritating” being asked frequently for updates on study recruitment numbers.
Ginny found it “very patronising and also really irritating” being asked frequently for updates on study recruitment numbers.
Age at interview: 53
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
I’m sure I’m not the only person to say this but I find the e-mails and things that I get from the people who are co-coordinating, managing whatever there’s loads of them all seem to be doing the same thing who seem to spend a lot of time asking ‘Ginny, you know, how many dah dah dah have you done this month?’ or going ‘Oh well done’ and I find it very patronising and also really irritating having that all the time.
Because I’m quite self-motivated I think so I would do that anyway so I’ll, I’ll recruit people because I want to and because I’m interested in doing that, I don’t find it very helpful having somebody kind of doing targets like that.
For those research NMAHPs jointly employed as study coordinators, fostering good relationships with study sites was important. This sometimes reflected a recognition that they wanted to be a support rather than burden. Carole clarified to a study site she was due to visit that “I wasn't a threat, I wasn't there to shadow them, I wasn't there to be heavy-handed, I'm there to help”.
In his trial coordinator and research physiotherapist role, Carlos felt it was important to establish good relationships with study sites from the outset.
In his trial coordinator and research physiotherapist role, Carlos felt it was important to establish good relationships with study sites from the outset.
Age at interview: 26
Sex: Male
HIDE TEXT
PRINT TRANSCRIPT
Also communication and needs to be a lot of communication and team working, either with your own team, with your trial team and with the, with the site, or with the sites. So as long as there is communication, you’re pretty much always aware of what’s going on, so we don’t, you, when you find out there’s something serious or something that needs addressing happened, you find it quite early on and don’t allow it to build it up [laughs].
Oh so yeah, so I think it starts from the very beginning. So making them feel comfortable and so making them feel that you’re a point of support. It’s a learning curve for everyone, especially in the beginning. So I think making them feel okay so, “I can, I can call, I can call him if I need something”, I think that’s a good point to start with. And then all the rest comes naturally.
Other research NMAHPs
Some people worked with other research NMAHP colleagues – either on the same project(s), in shared offices, or in the same team/department. A few people also had colleagues without health professional backgrounds who were in research delivery roles (e.g. often titled Clinical Trials Officers/CTOs). However, a number of people did not have any research NMAHP (or CTO) colleagues when they first started in their post; this could be quite isolating, and it could make the adjustment into their role more difficult.
There were several advantages to having research NMAHP colleagues. For example, if a research NMAHP was on (annual, sick) leave or otherwise overwhelmed with work, their colleagues could sometimes help out. Having fellow research NMAHPs was often a valuable source of information and advice on a range of topics, including overcoming recruitment barriers. Meeting research NMAHPs from other contexts and sites was appreciated, whether this was through a networking event, study meeting or as a research champion (a role appointed to raise awareness of the importance of clinical research in a particular area or profession, e.g. midwifery).
Jisha encouraged all research nurses in her team to attend Site Initiation Visits so that they had an understanding of the study and could help if their colleagues were on leave.
Jisha encouraged all research nurses in her team to attend Site Initiation Visits so that they had an understanding of the study and could help if their colleagues were on leave.
Age at interview: 39
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
With my team, I will always tell them-, when there is an SIV [Site Initiation Visit] coming up- even if they are not the main lead nurse, I invite everyone to attend that. Because it will be better for them to know what's going on in their team. Rather than 'oh, I don't know that study at all'. If someone comes and ask, or maybe a patient relative sees a leaflet and asks, “What is that trial?” it would be really foolish to say, “Sorry, I don't know”. But I will tell them- even if you don't know the in-depth of the study and each steps, just to have a brief idea of what the study's all about. And also, they will be on the delegation log, attending all the trainings. For example, if someone is on leave or someone has gone on sick leave, there is always a buddy nurse to look after that study. So the study won't be struggling and the participants also won't be struggling. So, that's how I manage my team [laughs]. And it, it is working well. Because if someone is struggling and really busy one day, there is another person who is not the lead nurse, can, you know, come in and help them to recruit that patient. And do the steps, yeah.
Christine had supportive colleagues, which helped when she started her research job.
Christine had supportive colleagues, which helped when she started her research job.
Age at interview: 54
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
And I think the team were amazing. Because everybody just said they had no-, you know, they just said, “Don't expect anything, just be a sponge, just see as much as you can, ask what you can, if you don't understand just ask”. And they had no expectation to put pressure on me for any length of time, until you felt ready to do it really.
So I think it was- and that was difficult, because in a ward, you know, we're not quite so patient when a new nurse comes on the ward [laughs]. Because you're like 'come on, really need you to go and do that admission, and we need that admission done really efficiently and really quickly because there's another one needs doing'. And that, that- there wasn't that. That certainly was not the atmosphere. It was a very supportive, and just you know, “Just take as long as you need”, there's no, you know, “You've just got to,” you learn this as you do it really.
Research-related services
Although not generally viewed as part of the research team, many research NMAHPs liaised with research support services in the course of their jobs. This included ‘Research and Development/Innovation’ teams, ethics committees and sometimes IT services.
Karen had seen increases and changes in the research governance structures across her career. Going through ethics processes could be “paralysingly slow” and “bureaucratic”.
Karen had seen increases and changes in the research governance structures across her career. Going through ethics processes could be “paralysingly slow” and “bureaucratic”.
Age at interview: 55
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
Well I mean now if it’s a biggish study and you want it supported by one of the clinical trials unit, you are following acres of paperwork, of SOP’s [Standard Operating Procedures] and this, and that and the other, and you know there’s no avoiding it, you’ve just got to suck it up and do it really. I don’t think it’s actually made the research any better than what we did before when we had so much less, but you know it’s, things are different nowadays, I mean governance matters, you’ve just got to follow it.
You know it is, it is paralysingly slow sometimes, and ethics, well actually if you get, if you ever get to an ethics committee it’s fine, it’s getting it through R&D [Research & Development], checking it, changing it, changing it, and it’s very much sometimes about one person’s slant on things versus another. I mean it drives me demented when you have to put things to R&D, and they’ve changed the wording of your letter. You know, you know, for god’s sake, you know, I’ve been doing this for 30 years, I know how to write a letter to a patient. You may have phrased it differently, but what I did was not unintelligible. But, but yeah, it’s just one of the irritants of doing research.
It is quite, quite bureaucratic.
Footnotes
*The people interviewed for this website were mostly research NMAHPs (i.e. those employed in a research delivery role). However, we also interviewed some NMAHP researchers (i.e. those leading research as independent researchers). The latter group included people who were undertaking or had completed academic research qualifications, such as PhDs, and many had previously been in (or continued to also be in) research delivery roles. For more information about the distinctions between these roles and the sample of NMAHPs interviewed for this project, please see the Introduction section.
*Many research NMAHPs and NMAHP researchers felt strongly that they continued to be clinical within their research roles. As such, the wording of ‘research’ NMAHPs/staff and ‘clinical’ NMAHPs/staff can be problematic for implying that research is not also clinical activity. Where the wording ‘clinical staff’ is used on the website, we mean for this refer to non-research clinical staff (i.e. those who are not currently employed to carry out research or enrolled to pursue research through an academic qualification).
Copyright © 2024 University of Oxford. All rights reserved.
