Helen

Age at interview: 53

Brief Outline:

Helen has worked as a research nurse for 22 years. She is now the Lead Research Nurse and the Clinical Trials Manager for her Trust, with oversight for a team of research nurses and allied health professionals.

Background:

Helen is the lead research nurse and clinical trials manager for her Trust. She is married and has children. Her ethnic background is White British.

More about me...

Helen has worked as a research nurse for 22 years. She has a background in oncology and was “headhunted” by a consultant for a research nurse post. Helen had no official training or induction when she started and was “just thrown into it”, but had good support from her manager (who was an experienced research nurse) and shared an office with other research nurses. Helen is now the Lead Research Nurse and the Clinical Trials Manager for her Trust. The roles involve managing a research team of around 23 full-time equivalent staff, but she still has patient contact as this is very important to her. She enjoys her job and finds that “every day is different, a new challenge”.

Across her career, Helen has seen the roles and responsibilities of research nurses change in a number of ways. For example, when she first started, consenting patients to studies was not a task that research nurses undertook. Instead, she was involved in other activities to support patients through studies – including collecting toxicities, giving medications, and conducting follow-ups. Now, Helen and many of the research nurses or allied health professionals in her team take informed consent from patients and this is “a part of the role that I enjoy probably the most”. Other components of being Lead Research Nurse and Clinical Trials Manager include screening for eligible patients, teaching Good Clinical Practice, attending clinical governance meetings, liaising with study teams, and undertaking reviews of ongoing studies. Helen has managerial responsibilities for research health professionals in her team. Most research staff are now on permanent contracts but some are fixed-term; it can be a “tense time” when contract renewals loom, subject to funding. There is currently a hiring freeze in Helen’s Trust which means she has not been able to replace research staff who have left.

Helen is passionate about raising the profile of health research and research nursing. She thinks there has long been a perception that research nurses have little to no contact with patients and sit at a desk entering data all day. Helen acknowledges that research nurses spend a portion of their time on paperwork but that this is “relevant paperwork – it’s all to do with the patient and it’s valuable”. She feels there’s now more appreciation for the importance of research and that research nurses are “the glue that keeps it all together”, although this recognition continues to be a “drip, drip, drip” process. Helen has worked hard to develop good relationships with clinical staff, including Clinical Nurse Specialists with whom she sees some role similarities, meaning that, “where there aren’t enough Clinical Nurse Specialists, we most certainly plug that gap”.

Helen feels that there remain obstacles around research to overcome with patients and clinical staff alike. For example, the word ‘trial’ can conjure up negative connotations and so she encourages her research team to use ‘study’ instead. Talking about ‘placebos’ can also be confusing. She worries that such terminology can be off-putting for patients and a barrier to becoming truly informed about a study to make a decision – whether that be to take part or decline. She thinks it is important that research nurses find ways to check understanding but to do so in a way which doesn’t make the patient feel they are being tested. Helen cautions against clinical staff gatekeeping research nurses away from certain patients. She emphasises that research nurses are trained and knowledgeable about patient distress, and that it should be up to the patient to choose if they want to take part in studies. Helen thinks it is good that research nurses in her Trust now wear the Clinical Nurse Specialist uniform because it highlights research as their speciality, helps others to recognise them as part of the clinical team (whilst differentiating them from ward staff), and reinforces their identities as nurses.

Helen comments that research nurses should have good communication skills, motivation, belief in the value of research, and the ability to prioritise tasks and work autonomously. She encourages student nurses to engage with research teams to understand what they do. She doesn’t recommend that student nurses go straight into research after qualifying, and suggests they should gain broader experience first, but highlights ways that they can support research as well. For example, she encourages clinical nurses to be aware of studies taking place and respond positively when patients say they are participating in one. Helen feels that, with increased awareness about research nurses, there have been improved career pathway options. She hopes to become a nurse prescriber which would be beneficial in running drug trials.

There are many ways that Helen and her colleagues have tried to raise the profile of research and how it contributes to improving healthcare.

Yeah, it’s something I feel so strongly about, really strongly about. So the, the sort of things to raise the profile, I mean we do do quite a lot in the Trust. I mean obviously we’re limited with time and we have been subject to funding cuts so we are, you know, quite thin on the ground but we, well we do celebrate International Clinical Trials Day so we go round the hospital. We, the last time we did that, last May we actually took a cake trolley round, that was much better than actually having displays in certain areas in the hospital but I think the patients and public don’t always wanna come up to a display particularly if there is a few people standing by it so the, the coffee and the cakes, that went down really, really well and I think we did raise the profile. We’ve done a few interviews on our local radio station, we go out to-, myself and my colleague go out to schools to talk when we can. We present at charity events, Rotary, things like that where we can. And for about the past four years, I pushed but I managed to get myself onto the student nurse the undergraduate training course so and I’m trying to get more student nurses to come and spend some time with us as part of one of their placements. And that wasn’t easy because even getting the clinical placement facilitators, I don’t know what their job title is now, to understand that our role was like a CNS [Clinical Nurse Specialist] and to try and encourage student nurses-, and we did have a student nurse who came in quite recently and really enjoyed it.

Helen and her research team recently started wearing Clinical Nurse Specialist uniforms. She thinks this has been beneficial.

I know in some places research staff don’t wear uniforms but I feel quite strongly that we do wear uniforms because I think that I’m a nurse and in fact in the past we had lots of discussions with my manager at the time about perhaps we all just wear the same, the same uniform and it’s a specific research uniform. And I’m a nurse and I’ve trained to be a nurse, I’m a Sister and I don’t want that taken away from me because that’s how I identify myself and that’s what I want to be. So to me, your uniform is very important and also by wearing a uniform I think you are seen as part of the clinical team. When all my Band 6’s wore the CNS [Clinical Nurse Specialist] uniform they suddenly found it a lot better as well because I think what was happening before that was they were going onto wards and they-, obviously the ward staff would all be everywhere and then, you know, the doctor would come on or relatives would come on and start asking questions and we’d always feel we were going, “Oh sorry, I don’t know, I don’t know”, and actually now we’ve got the CNS uniforms the doctors know that we’re not part of the ward team because we’re CNS’s so we’re, you know, we’re coming in and doing what we need to do and then we’re going out, so that’s actually helped quite, quite a bit. But I do feel quite strongly about, about uniforms because I think it identifies us. 

Helen, a lead research nurse and clinical trials manager, talked about there being a variety of roles for research nurses.

Okay, so I guess the research role, research nurse role is very different across the board so, you know, you could go to a clinic-, phase 1 clinical trials unit where you’ll have the nurses actually giving the drugs and things. So we, we’ve, our roles evolved here, so when I first started here back in 2000 I was one of those nurses up giving the chemotherapy but then I realised that actually that wasn’t, that wasn’t my area of expertise, my area of expertise was the research, was understanding about randomisation, reading protocols and understanding about novel therapies and things. So what I try to impress on my team, and it’s particularly difficult for generic research nurses who are perhaps involved in 15, 16 different specialties perhaps none of which are their-, might have been their speciality that, you know, your skills are research that, that’s your, you’re a research specialist so and we try and, we’ve done a bit of work on that at our sort of away-day and things like that.

Helen found patients were more receptive to hearing about research opportunities when their consultant’s name was mentioned by research NMAHPs.

Just another little thing that we do as well is we don’t just sort of come in and, you know, see patients and say, you know, “I’m, I’m part of the research team,” what we always say is “I work with your consultant and he or she has asked me to come and see you today.” And that’s made quite a big difference because we had a study several years ago now where we just went up and saw patients and we were getting quite a, quite a high, patients were declining and then we changed our tack a little bit and then we started saying oh, you know, “Your consultant, Dr A, has asked us to come and see you today,” and straight away you’ve got that, “Oh, okay, is that, alright, okay,” and then, you know, and it was an observational study but recruitment increased [laugh] significantly just because, because of that.

Research nurses didn’t take consent for studies when Helen was first in post. She felt the responsibility has “evolved” over time and that it can be very beneficial as well as personally rewarding.

Yeah so in the time that I’ve been in my current post are the Trust that I work for now very much supports research healthcare professionals receiving consent from patients, even into drug trials, because they feel that actually the consent process is very thorough [laughs]. So obviously a Principal Investigator Consultant would confirm eligibility but for most studies a Band 6, 7 or 8a then we receive consent. And we’ve got SOPs [Standard Operating Procedures] and we’ve got, you know, a whole process and training etc. But it, it gives us-, it makes the job more interesting I think, it makes it a little bit easier for the doctors because we can arrange to bring the patients in at a time that suits them and not necess-, and easier for the patients, it’s not a time that, they don’t have to be booked into clinic to see the consultants. And it’s a part of the role that I enjoy probably the most, actually.

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.

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.

Helen talked about fostering good working relationships with Clinical Nurse Specialists in particular. She felt it was important to convey that research was about ultimately about patient choice and benefit.

I think we have very good relationships with like the CNS’s [Clinical Nurse Specialists] and the ward staff, I put that down to the, you know, the, the lovely working relationships that my team have because we are always going in, you know, can sometimes be at an inconvenient time. We had a situation a little while ago where some of the CNS’s, there was a few CNS’s and one CNS or a couple of CNS’s would be absolutely fine about us going in to see patients just on the day they’d had, in clinic at the point they’d had their diagnosis and you’d find a little bit of, you know, cherry-picking or gatekeeping and I did a little bit of work around speaking to that, the resisters, I call them resisters, you know, it’s not, it’s not us wanting to put a patient into a study it’s the consultant feels the patient may benefit from going onto that study, may benefit, but also we, we’re experienced nurses and we are experienced and we do know how to approach patients. You know, most of my team have got a lot of experience in the area in which they’re doing the research so yeah, we know that patients might be upset, we know our patients are vulnerable but we know how to handle that. And what we don’t want happening is, you know, three or four years down the line, patients talking and one patient had access to a study, the other patient didn’t have access to the study and that patient, you know, patient perhaps has relapsed so, “Why didn’t I get access to that study?” and, you know, “Because we were told that we couldn’t come and see you because you’d be too upset,” and we can’t be paternalistic, you know, patients have to make those decisions themselves.

Helen explained a bit about the funding arrangements for research NMAHPs in her team.

None of us are funded by the Trust at all and we get what’s called Activity Based Funding Units so we have a target that we set ourselves in many ways but it is also given to us by the Network, Clinical Research Network that we’re affiliated to in this area. And then we have to recruit really a number of, a certain number of patients so if it’s an interventional study then you get 11 ABFU [Activity Based Funding Unit] points, if it’s a non-interventional study with less than 10,000 patients you get 3.5 and if there’s more than 10,000 patients you get one ABFU, so that equates to anywhere between £65 and £85. So half of our funding in my department comes from ABFU funding but that doesn’t really cover the costs of the staff, all of the staff. We get some funding then from supporting and facilitating commercial studies so and one of the high level objectives in the Department of Health is to recruit and open more commercial studies.

Helen’s team worked flexibly to recruit patients from waiting list initiative clinics which were often outside of their core working hours.

Shift patterns, I have core hours so I, for my team so anywhere between 8 in the morning and 6 o’clock in the evening and I think we’re very, very fortunate in the fact that our hours are quite flexible. And I think it’s quite a tough world out there on the wards and in other departments and we are, we are quite fortunate with regards to hours and the level of flexibility but on the back of that then if staff need to stay late there is an expectation that they would, you know, if they can they will stay late because, you know, what we’re finding because clinics are so busy at the moment you’ve got lots of waiting list initiative clinics so some of the clinics start at 8 in the morning so we’ve gotta cover those clinics, some clinics go on until 7, 8 at night, we have weekend clinics so where possible if we’re available, we’ll-, none of us are, our contracts are all Monday to Friday but if we have to come in at weekends and people can cover it then they will and then they just, we don’t have the money to pay for them but what we do is give them time and half back. So yeah, it and I’ve sort of started to warn the staff that things will change, that we will, that, you know, when we develop as a team further and have more funding then because in many ways a lot of patients are missing out, you know, if they’re coming in after 6 o’clock they’re not, might not be offered those emergency studies that may benefit them.

Which is a shame.