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Nurses, midwives & allied health professionals in research

Recruitment activities by research nurses, midwives and AHPs in research delivery roles

Recruiting patients to studies was described as the “bread and butter work” by Melanie, and this was the case for many nurses, midwives and allied health professionals (NMAHPs) in research delivery roles*. Recruitment usually involved several steps: identifying eligible patients, approaching them, discussing the study, and consenting them to take part in the study.
 
Identifying eligible patients
 
Identifying eligible patients for recruitment into a study was done in many different ways, including:
  • screening hospital records and patient databases (online and/or paper-based);
  • going onto clinics and wards, and in response to Accident and Emergency (A&E) Department admission alerts;
  • being informed by clinical staff* (clinicians, nurses, midwives) of any patients they come across who might be eligible;
  • attending multidisciplinary team (MDT) meetings;
  • attending NHS-run information sessions/programmes (for newly diagnosed patients, for example);
  • attending other illness-related support groups; 
  • via social media; and
  • hosting stands at public events (e.g. regional festivals).
 

Osi found that being a physical presence on the ward and encouraging staff to tell her about potentially eligible patients was the best approach for some studies.

Osi found that being a physical presence on the ward and encouraging staff to tell her about potentially eligible patients was the best approach for some studies.

Age at interview: 27
Sex: Female
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So the best way I would say is literally when I'm-, I go to the ward. Each day they’ve got their own handover sheet, so I walk onto the ward. I'm usually like, "Morning guys," and they're like, "Oh, what-," go like, "There's no blood pressure ladies here for you," ‘cos that was one of the main studies that I was always looking for. But then I-, I'd say, at the same time when I'm looking at like the handover sheet, I'm always ex-, I'm explaining to them that I'm also looking for pre-term ladies and everything else. So as well as myself screening for them-, so they actually know that now it's blood pressure ladies, but now hopefully, in time they’ll be like, "Oh yes, we've got premature ladies- labour ladies as well for you," and stuff like that. So, I would say not only shall I say, just screening the actual physical paper, but just every-, I'm like-, I walk on and they’ll know that I've came on to the ward today [laugh]. And then talking to doctors – so, thankfully now the doctors actually flag up when they’ve seen a patient. For example, in clinic they're like, "Oh Osi, we saw a-, I saw a lady in clinic," and they can remember their names, it's usually great. They’ll give that to me and then I can source out that lady - when's the next time she's coming in or what-, maybe she's actually ineligible and stuff like that. We've-, we've had a commercial study which was looking at fibroids and reducing heavy menstrual bleeding, and within that study we-, I -, ‘cos-, so there's many clinics where they could potential-, there wasn’t a set clinic for fibroid ladies, it's fibroids are usually found in the secondary problem. So I just introduced like a screening sheet and I left it with the head nurse on the clinic, and just said to her that every-, "If you guys remember," ‘cos the information leaflet was right by it, so I said, "When you guys take an information leaflet to give to the lady, if you can just pop her name down and her number and then I can get in contact with her on a future date", or they can give me a call and if I'm around I come up and speak to them directly. 
 

Jo described the main ways she identified potential participants and approached them with information about studies.

Jo described the main ways she identified potential participants and approached them with information about studies.

Age at interview: 49
Sex: Female
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I would usually go, I would either do it in two different ways, I work with the neurologist and with another consultant who does care for the elderly and they either suggest patients or CC me into the bottom of clinic letters that they think may be suitable for whichever study or I’ll screen a clinic and I’ll pick up patients that I think are gonna be suitable and then run it past them, if they’re happy for me to approach that patient. And then I usually send them like the patient information leaflet and then ask them to contact me either by telephone or e-mail if they wanna take it further or if they wanna ask any further questions. Or I might catch up with them at a clinic visit if I see they’re coming in for a routine visit I’ll pop and see them and introduce myself and say you know, “I’ve got this study that you may be interested in taking part, this is a brief outline, take the information home with you if you think you’d like to have like to have a think about it take it further then get in contact with me and we’ll discuss again.” And very often you get a positive response, more, I’d say 8 out of 10 times you get a positive response. 
 

Nikki felt that some of the paper-based systems used to screen for potential eligible participants would be improved by being made electronic.

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Nikki felt that some of the paper-based systems used to screen for potential eligible participants would be improved by being made electronic.

Age at interview: 34
Sex: Female
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In critical care, we screen everybody every day for, you know, the number of studies that we have. Surgical patients tend to be a bit more difficult, in terms of you know, trying to- It sounds crazy but they still make paper lists for surgical patients. Which is just baffling to me, why it's not done electronically on an electronic system. But literally, the surgeon will make a paper list and hand it to the booking clerk, who then books all these patients. So we have to sort of somehow get hold of a list, so that we can then screen for patients. So, that's been a bit of a, a nightmare. Emergency patients are weirdly easier to find out about than the elective. Which to my mind is just a bit crazy, but anyway. So yeah, so we'll come up with a system of, of screening patients and making sure that we're not missing patients. And then we'll approach.
In some teams, the screening for eligible patients was carried out by the research NMAHPs themselves. Other times, there were people employed as data managers/support who did these tasks.
 
Many studies involved identifying and recruiting patients from healthcare settings, such as hospitals and GP clinics. This could be challenging in terms of fitting around other clinical activities and finding appropriate spaces to talk to eligible patients. Some research NMAHPs emphasised the importance of being confident when approaching potential participants and having a strong grasp of what the study entailed. Sarah, a research midwife, said it was important “to be really, really confident about your eligibility criteria, and to understand a bit about the patient that you're going to see, and where they've come from today”.
 
The recruiting/screening arrangements were usually documented in the study protocol but, if recruitment was a struggle, it was sometimes possible to try new approaches. Sandra recalled a study where “recruitment was very poor and so I contacted a research nurse from another [site]” who recommended attending multidisciplinary team (MDT) meetings to flag potential participants: “so then I started going to some of the MDT meetings for that study and that did yield a better increase”.
 
Some studies did not permit looking for potential participants outside of NHS settings; as such, non-NHS support groups, social media and public events. These were not common avenues used in the clinical research studies by most of the people we spoke to. Libby felt there was sometimes a lot of unnecessary “red tape” around recruitment.
 
Identifying potential participants in some settings, such as care homes and hospices, could have extra challenges. Gavin had led* a randomised controlled trial about fall-prevention which required a two-step approach to recruitment: firstly seeking approval from care homes to approach residents and then from individual residents. Carrying out research in these different settings also required NMAHPs to adapt in various ways, for example there could be different practices and paces of working involved.
 
Whilst it could be a successful strategy to enlist clinical non-research staff in helping identify potential participants that they had cared for and to seek their advice on how best to approach, some research NMAHPs found gatekeeping was an issue. This meant that some individuals blocked access to potential participants, usually by telling the research NMAHP that they ‘shouldn’t’ or ‘couldn’t’ approach the patient about a study. Helen saw it as paternalistic and worried it compromised equal access to study opportunities: “[a patient might ask] “Why didn’t I get access to that study?” “Because we were told [by clinical staff] that we couldn’t come and see you because you’d be too upset””.
 

In the context of paediatric intensive care studies, Julie felt it was helpful to talk to ward staff about patient suitability. Communication within the research team was important too.

In the context of paediatric intensive care studies, Julie felt it was helpful to talk to ward staff about patient suitability. Communication within the research team was important too.

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So we time our - sort of liaison with the clinicians and the bedside nurses so that it’s post things like ward rounds – we’re not adding pressure to them. So we try and time it well. That we try and discuss with them if a patient is eligible for a study, particularly if, for example, they, there may be a reservation but also as well whether it’s about the dynamics in a family, so things like ‘whose got parental responsibility?’, ‘actually this is a head injury’, ‘is there a sensitivity around it’s a non-accidental injury’, you know, some of those issues that can perhaps make the consent process more, more tricky. 

So I think it’s about liaising with them, not just about the clinical details but also about the family set up and the support structure that’s there. So on a day-to-day basis we try and liaise with the clinical team regularly, but we also make sure that our communication amongst ourselves is good, because the last thing that they want is to be badgered by us as well. And we’ve had this where we’ve got say three or four studies going on and a patient could be eligible for three or four studies, and you may need to prioritise which study. And so we can’t have our team going an asking them, and then someone else coming and asking them, and then someone else coming and asking them, and ‘cos we alienate not only the families but we alienate the staff who are quite protective of the families. 

So we, we make sure that our communication is good amongst ourselves to reduce that.
Telling patients about the study
 
Once potential participants were identified, the next step was usually to contact them and tell them about the studies. There were a number of ways research NMAHPs did this:
  • going to meet the patient before, during or just after an already-scheduled appointment (for example, whilst the patient was in the waiting room);
  • sending out postal invites (sometimes a few lines about study opportunities were added to an appointment letter); and
  • telephoning the patient (sometimes to set up a visit to the patient’s home or to arrange for the patient to come into the GP clinic or hospital).
In approaching patients, the aim was to give them more information about the study and see if they were interested in taking part. Sometimes patients had to be seen by consultants and receive a diagnosis or other information before a research NMAHP could approach them, as was the case in a heart study James worked on.
 
Conversations to introduce studies to eligible patients usually had to fit around their other clinical appointments, which could make the discussions disjointed. Layla had a study in which she approached patients waiting for antenatal appointments and found she often lost the opportunity to finish speaking to them: “what often happens as well is we'll start the recruitment process and then they get called into their scan. So you have to wait for them to finish. I've had a few who, by the time they've finished their scan, are just like 'nah, not going to', and they don’t come back”.
 
A vital part of the research NMAHP role is supporting patients to make an informed decision about whether to take part in a research study or not. This included telling potential participants if and when they would need to have follow-up visits, what activities (e.g. interventions, tests) would be involved, and any possible disadvantages and risks. Helen, a lead research nurse, said that discussing any health/travel insurance implications was important too. As Libby explained of one study she recruited to, “[if] someone is going to commit to you [to go into a study] for two and a half to three years, the very least you can do is give them time and information and support to make that decision”. The amount of time patients had to decide whether or not to participate varied. Some studies were very time-sensitive (for example, within a window of a few hours of a medical event such as arriving to hospital with chest pains), whilst others had more flexibility.
 
As a general rule, Sandra said research NMAHPs should use “simple, clear, plain language as much as possible”. Many recognised it was important to tailor the way they communicated to help patients understand. Some people had approaches they used for particular studies or groups of patients, including children and young people. Tabitha “pared it down” when explaining the technology being used in an antenatal study she recruited for, as she felt “it would have been really inappropriate” to explain “everything behind it”.
 

Paul drew on his nursing skills when telling patients about studies and checking their understanding.

Paul drew on his nursing skills when telling patients about studies and checking their understanding.

Age at interview: 47
Sex: Male
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The patient information leaflets come from the trials. But it’s, it’s your own communication skills it comes with, I’ve been nursing for 15 years now, it’s something you learn to do, and you work off their cues, their verbal cues, their non-verbal cues. And you talk in a language that they can understand. Some people are, are very, very knowledgeable and they tell you that this, and you’re discussing them and they take you off on a tangent about some other trial that was on. And some people just really don’t know very much about it and just need it in very plain basic English, and some people don’t want to know anything about it. They’re happy to take part, they know that it’s going to be a chemotherapy drug but they don’t really want to know too much. So, it’s all about the conversation that you’re having with the patient. It’s all about the discussion. And there’s no set rules or set laws, you have to gain an understanding that they know what’s going to be happening to them, and actually what they’re consenting to. But that level of knowledge you have to discern as a nurse to say that I have to sign to say that I am sure that they’re aware of what they’re doing.

And that’s just through conversation.
 

Melanie thought it was important to clearly explain expectations and any extra commitments involved in study participation.

Melanie thought it was important to clearly explain expectations and any extra commitments involved in study participation.

Age at interview: 43
Sex: Female
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And I always try and make sure that they understand the impact on their lives. So, often people might be quite interested, especially if it's a new drug that they think might have a wonderful effect, and they're very keen to be part of the study. I do just try and make sure that, OK yes, it might, but you're also going to have to come for 20 appointments, and you might be here all day on some days, and sometimes it's really boring and, you know, we try and make it as pleasant for people as we can, but you know, the nature of the work that we do there's a bit of hanging about and waiting for pharmacy.
 
So, I just try and tell people that upfront cos I don’t like -, I wouldn’t -, I wouldn’t want to be part way through a study and, you know, have a nasty surprise, or think, 'Oh well, you know, I can't do this anymore,' or 'I'm too busy or work's too much,' or whatever, and we do try to be really flexible and accommodating and, you know, have an appointment when, when people can come in, cos I appreciate people work and they’ve got families and all the rest of it. So, I guess it's just trying to be as honest and upfront with people as early as possible.
 
And then they’ll have a conversation with the consultant as well as us, and yeh, we can go back and forwards as many times as they want really till they're happy to take part, or not, whichever.
 

Abi recruited participants from a stroke club for her PhD on aphasia. In this, and when she was previously employed in a research delivery role, she drew on her communication skills as a speech and language therapist.

Abi recruited participants from a stroke club for her PhD on aphasia. In this, and when she was previously employed in a research delivery role, she drew on her communication skills as a speech and language therapist.

Age at interview: 37
Sex: Female
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So meeting face-to-face is, is a really useful way of, of getting that process started.
 
Then when somebody has shown that they might be interested in hearing more I would go to visit them at home, and talk them, talk to them individually, away from the bustle and noise of the group, and talk to them individually about the specifics of the project. Exactly what it would entail, and I’d do that accompanying the consent form, so that they can read the consent form at the time, or they could follow it, but I’d read it aloud word for word so that they were getting the same written information as they were getting auditory information. And then I would pause and emphasise different bits as they go along. I would check and ask for questions. So, I’d use my kind of I’d monitor somebody’s facial expression or whatever, if they went, or you know where I’d check to say, “You know, have you understood what that is? Do you, do you get that?” And we’d talk about somebody’s specific situation.
 
And at that point I would say, “Okay, so that’s the information,” I’ve given them the opportunity to ask any questions, and so as I say I’d support any questions with a writing or reading or you know you can see I use gesticulation a lot, tone of voice changing re-wording things if they’re too complicated, using plain language, and then give them the time to think about it, and say when I’ll come back. If you’re happy for me to come back, so I would never do consent straightaway. There’s the time to think about it and you know be with others and if, if the person wants somebody else to be with them for that and to support them in that exercise then that’s great, we’re very happy for them to do that. But equally I feel very strongly that it’s important that it’s the person who’s taking part in the research, and critically it is the case that people with aphasia have capacity, to make these decisions but that the information needs to be delivered and presented to them in an accessible way.
 
Yeah.
 
So I think historically there might have been, it might have been easier to you know defer to a carer or a significant other, to explain things and to you know check that they’re alright with it, but my preference very much is to have the conversation directly with the person who’s got aphasia, and check that they understand it and then and then similarly with the consent form, I would, I wouldn’t just give it to them and let them read it, I’d say, “Okay so what you’re agreeing to here, this says, are you happy with that?” and then they can give a tick or whatever. And then even things like writing down their name at the end, on the bottom of the, on the consent form I would, if they’re not able to do it by themself I would write it down for them so that they could copy it, so there’s layers of different little support things. But that’s very much drawing on my clinical experience to do that.
Explaining certain concepts could be challenging, such as randomisation (when patients are randomly allocated to one option of several options within a study) and placebos (when patients are given a ‘dummy’ treatment). Although most research NMAHPs found it helpful to describe the randomisation process as being a computer-based one, Rachel X thought this sounded “very impersonal”. Barbara also struggled with this: “it is a good metaphor, if you will, to say, “It's rolling a dice”. However, when you're talking about people's health and survivability of a condition, that's a pretty cold and calculating, callous way of expressing things”. With studies that have a control arm (when the treatment or care for one group of participants does not change as part of the study), Christine felt it was important to make these participants “feel equally as valued, that one’s not any more valuable than the other, because we need both sides of the coin to tell us what is best”.
 
Many research NMAHPs talked about how important it was to convey that taking part in research was a voluntary and separate activity to the ‘normal’ clinical care that a patient would receive. Opportunities for patients to ask questions were important and many people said that, if they didn’t know the answer, they would try to find out. As Dawn explained, “if they ask questions that I haven’t got the answer for… then I would suggest coming back to see the consultant or I’ll get the consultant to come and speak to them”.
 
Pressures to recruit to ‘time and target’ were described as a major source of stress. For some, this pressure came from PIs (Principal Investigators) and study centres. Others, such as Layla, felt there was “pressure that I put on myself”. Many expressed concern about funding being suspended or future study opportunities being lost because of recruitment difficulties. This was particularly a concern for those employed by the Clinical Research Network (where funding was based on ‘activity units’) and those who were running commercial studies. In general, the focus on high recruitment numbers could make research NMAHPs feel uncomfortable and, as Ginny said, like they were doing a “sales job”. Libby felt it was crucial to keep “sight of why we’re doing the research and who it’s for, and the fact that the human beings behind it are the important people, not the numbers on the page”.
 
The reasons why recruitment was difficult varied across studies. Research NMAHPs sometimes asked for advice and shared tips with those at other study sites. This could be very helpful if the suggestions to boost recruitment could be put into place. Whilst some factors for recruitment difficulties were unpredictable, it was frustrating for those research NMAHPs who felt the targets had been unrealistic from the start and that there was nothing they could do to increase it. Sometimes this was because the recruitment targets were higher than eligible patients seen, other times the likely consent rates of patients had been significantly overestimated.
 

When recruitment for a study was a struggle, Sandra found it useful to get advice from research nurses at another site.

When recruitment for a study was a struggle, Sandra found it useful to get advice from research nurses at another site.

Age at interview: 43
Sex: Female
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Yes so we had a study that was looking at pain relief and recruitment was very poor and so I contacted a research nurse from another Trust, and said we’ve got the same study as you, but we’re not managing to recruit people, what are you doing that’s to increase your yield of patients coming through? And she said she had started going to the multi-disciplinary team meetings, sat in the meetings and then could just be like a big red flag that, to point people to the study. So what was happening was they would be seen in MDT [Multi-Disciplinary Team], they would discuss everything that needed to be discussed, but because there wasn’t a member from the research team there they would almost forget about the research, or they might remember later, and it was a bit too late. So she used to attend the meeting and then she could record potential participants and then she would be able to go back to the consultants afterwards and say, “you mentioned this person, it sounds like they might be suitable for this study,” and that, so then I started going to some of the MDT meetings for studies, for that study, and that did yield a better increase, yeah.
Many people highlighted that, despite pressures to recruit, it is important patients feel able to say ‘no’ to study participation. They valued that part of their research NMAHP role was to support patients to make decisions for themselves, including whether to enrol or stay in studies. Although a patient might be eligible, there could be many other life circumstances and factors to consider. Helen suggested that, although research NMAHPs shouldn’t ask patients “why they declined unless they offer it, …if you get an inkling that they don’t really understand but they’ve just declined it then it’s worth exploring a little bit more with no pressure, just to make sure that they have got the right idea [about the study]”.
 

Nicky had previously been under pressure to recruit patients to studies, but felt that voluntary participation was important.

Nicky had previously been under pressure to recruit patients to studies, but felt that voluntary participation was important.

Age at interview: 52
Sex: Female
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There is quite a lot of pressure to get patients into studies. I mean obviously, if you kind of decide on a target at the beginning, I mean I think just personally you quite like to do what you said you’re gonna do, so that’s one thing. But you do get, I mean there is a certain amount of pressure to meet those targets anyway. I think we, I would say mostly when we get patients on studies in [City] we do generally keep them on the study, we do have quite a good record of sort of, once people are on it, they stay on it. But then we do sometimes struggle to recruit, but then I think perhaps because we’re not pushing people that perhaps aren’t necessarily appropriate for the study, then we’re getting the right people, and then they are staying on the study throughout. But I think, I mean I think that’s one of the hardest things in research is recruiting [laugh] people, recruiting people to studies because you don’t want, you don’t want to persuade people to do something, you know. You, I think especially as a nurse, you want to be an advocate for that person and, you know, if someone has got reservations about it then you don’t want to, you know, you don’t want to push them to do something that isn’t really right for them [cough] for whatever reason. So it’s sort of finding a balance between sort of, you know, trying to sort of be positive about the study but equally not, not forcing people to do something they don’t want to do.
 

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

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

Age at interview: 53
Sex: Female
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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.
 

Michael said he used his nursing skills and values in supporting eligible patients to make informed decisions about research participation.

Michael said he used his nursing skills and values in supporting eligible patients to make informed decisions about research participation.

Age at interview: 29
Sex: Male
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And that in essence is the art of being a research nurse. It’s not all science because you know on paper this person might have a performance score of zero, they might have good social support, and they might feel physically not too bad, but if after three weeks of a clinical trial they’re exhausted and, you know, they might have bad venous access and their arms are getting really sore from repeated cannulations, and they don’t want a PICC [Peripherally Inserted Central Catheter] line. Then you have to decide ‘well actually it’s probably not appropriate because this is affecting your quality of life’. 

And I think as a nurse no matter where you are, no matter what ward you’re on, or whether you’re a research nurse or a nurse, you are primarily the patient’s advocate, you are there to look at the psycho-social holistic care, “How are you managing with life?” And if that’s becoming compromised it’s your job, I feel, to bring up that conversation of, “How is your quality of life? Is this something you want to continue?”
Taking consent
 
If a patient is willing to enrol in a study, they will then usually go through a consent process before they can take part. This often involved patients reading and signing paper documents, and their records being updated to say that there are on a study. In one of the studies Layla recruited to, participants had a sticker put on their maternity notes. Participants enrolled in brain surgery research wore wristbands at the hospital where Jisha worked.
 
For some studies and in some places, research NMAHPs took consent from patients. In other circumstances, and particularly for CTIMP (Clinical Trials of an Investigational Medicinal Product) studies, consent was taken by consultants. Most research NMAHPs had attended training [specifically for taking consent in research. Julie thought that often “people [who design/timeline research plans] underestimate the amount of time it takes to consent a study”, but emphasised it was important “to do these things properly”.
 

In Julie’s research team, Band 5 research nurses took consent for observational studies. She thought it was important to consider the family unit when consenting for paediatric intensive care studies.

In Julie’s research team, Band 5 research nurses took consent for observational studies. She thought it was important to consider the family unit when consenting for paediatric intensive care studies.

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So obviously a core part of our role is actually taking informed consent for patients to go into a study. As I say, a lot of our studies are defined as low risk observational studies, so we do actually take consent and we use Band 5 nurses and Band 6 nurses to do that. And a core thing of what we teach them is about the fact that you, obviously giving them the information in the form of the participant information sheet but it’s also about you conveying in the language that when you speak to them that this something they can choose to do. And it’s about recognising when a family looks like they’re struggling to make that decision, and I think it’s whether or not they might need you to come and talk to their parents, so grandparents. And okay, we don’t need to take an informed consent from a grandparent but actually if a parent feels that they want you to explain it to other people, then that’s what we would do. So we want to help them, we want to facilitate them making that decision, and if that’s involving speaking to other people, then actually we can do that. 

If it’s, it may be speaking to the child and young person ourselves as well, obviously sadly when they’re on intensive care a lot of our patients are already sedated, so it’s hard to involve them. But we do actually consent for some studies, almost pre-operatively before they come to the unit, so where possible we try and speak to the child or young person as well. So I think it’s about seeing what the family need and trying to meet that. If it’s that they’re concerned and they want to see that you’ve spoken to their cardiac surgeon or their nurse specialist, then we can facilitate that as well. But also recognising that there’s no-, there’s no pressure and it’s absolutely their right to withdraw or, you know, to not even take part in the first place, that they don’t have to take part. And that it will not affect their clinical management otherwise.
 

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.

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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.

Age at interview: 53
Sex: Female
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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.
 

Ellen couldn’t take consent from patients in all of the studies she worked on. Even so, she sometimes had a role informally translating the information in simpler terms after doctors had explained the study.

Ellen couldn’t take consent from patients in all of the studies she worked on. Even so, she sometimes had a role informally translating the information in simpler terms after doctors had explained the study.

Age at interview: 50
Sex: Female
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The emergency one, that was always them [doctors – taking consent from patients]. I was, you know, it was too much of , it was a CTIMP [Clinical Trial of an Investigational Medicinal Product] and, you know, quite an important one - you could kill somebody with it. So that was always them, I was just there helping. So for that one, I would be doing-, you know, what it's like, the doctor explains to the patient and then they go away and the patient says, “What do they mean?”

So I’d be doing that bit, which I was used to [laughs] as a nurse. Doing a simple explanation. And paperwork. And that sort of thing. And I also helped administer the drug. Because I'd come from an area-, you worked in chemotherapy and I was used to working with drugs, and. And things like that. And the ward staff actually, it was quite new, thrombolysis, then. And the ward staff were quite- a lot of them were quite under-confident about it, so I brought my previous nursing skills to that. I was more confident in a way.

And then the other trial, the one that was acute but not emergency, you could- that was a CTIMP [Clinical Trial of an Investigation Medicinal Product] but they allowed nurse consent. So for that one then, yeah. Within a few weeks I was probably recruiting. And the other one was just to do with a medical device, but not a drug.
Paul described a study where it was possible to use “non-witness consent” (when the researcher is not present when a consent document is signed): “I can identify them in MDT [Multidisciplinary Team meetings], the clinical nurse specialist gives them a brief overview at their next appointment, then I ring them and we discuss the trial. If they’re happy, I send them a pack out with a consent form and demographics form [to complete and return]”. 
 
Different models of consent
 
Patients are not always able to give consent themselves and relatives or carers might give consent on their behalf (for example, for studies involving newborn babies and unconscious patients). Graham and Imogen talked about research studies in emergency settings, and how different models of consent were often used. Some of the brain surgery studies Jisha worked on also allowed professional consent if patients were incapable of making the decision themselves (e.g. if unconscious). With elderly participants at risk of dementia, it was sometimes necessary to assess cognitive decline and re-consent at each follow-up visit.
 

Imogen described some studies in emergency medicine with different approaches to consent.

Imogen described some studies in emergency medicine with different approaches to consent.

Age at interview: 32
Sex: Female
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So, we work on say a study called [trial name] which is looking at the benefits of having a more rapid CTCA [computed tomography coronary angiography] for patients who come in with moderate risks, sort of ACS [acute coronary syndrome], and they, we’re comparing having that scan versus standard care. So, with this study we’ve got up to 24 hours to consent our patients, so we can give them a little bit more time to have a quick think, to have, have their think about it, and ask questions and consult their family members before they make their decision. But then we also run a study start-, [trial name] which has been running for a number of years now, and this is looking at trauma patients who have come in with a traumatic head injury, and it’s looking at giving them tranexamic acid or a placebo within the first three hours of, of injury. So, patients in this study are quite often unable to give consent, quite often don’t have family members with them because they’ll have been flown into the hospital or come in by ambulance and the family members aren’t there. So, we have to use a professional consent or a waiver of consent in order to put these patients into the studies. And then we try and obtain retrospective consent as soon as they regain capacity. And for this study I think the patients, I mean they tend to have pulled through when we’re asking them for consent, and we’re talking to them about what happened when they first came, came in, so 99.9% of these patients have been quite happy to keep their data in the study and happy to have participated.
 

Graham described how consent tended to work in paramedic studies.

Graham described how consent tended to work in paramedic studies.

Age at interview: 40
Sex: Male
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Consent is a tricky issue for us. The traditional model of consent is based on patients being in hospital, having time to consider the study, you know, read a patient leaflet, I understand and things, you’ve got 24 hours or more to consider it. That doesn’t work for us [laughs]. We don’t give people 24 hours to think about what we’re going to do. So, and I think this is one of the reasons why pre-hospital research is a fairly relative, is a relatively new thing because the models of consent didn’t really exist until relatively recently to let us do that type of research. So, for us, consent is often a delayed-, it’s either a very shortened consent, so in our situation a very short, “We’re doing this, this is the situation, are you happy to be involved? Yes or No.” And then we go down whatever route, and we follow that patient up later on and take a more informed consent. So often the consent is either implied or shortened in our setting, in the emergency setting, but then followed up later on with a more informed consent. And it’s often the option to either have the data, the patients’ data, included or excluded from the study. Some of the situations we work in, such as the cardiac arrests and some of the stroke research we’re doing now, informed consent is impossible. Due to the nature of the conditions we’re studying, at the time. So then there’s other forms of consent in terms of delayed consent or family consent, or there’s various models that have been looked at. But they, they’re again recent developments. So it depends on the study, it depends on the condition, it depends on the patient that we’re talking about. But we do-, they’re all set up to give the patients the options to be included or excluded or to have their data included or excluded. But we have to adapt them to the situation we’re talking about.
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).
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