Twenty-seven participants were interviewed. Interviews were predominantly conducted via Zoom (n = 24) with a mean duration of 38 mins (range 26–53 mins). Participant characteristics are shown in Table 1 below.
Table 1
Characteristics of interview participants
| Participant characteristic | n = 27 (%) |
| Gender | |
| Female | 21 (78) |
| Male | 6 (22) |
| Prefer to self-describe | 0 |
| Age | |
| 18–24 | 1 (4) |
| 25–34 | 5 (19) |
| 35–49 | 6 (22) |
| 50–64 | 10 (37) |
| 65+ | 5 (19) |
| Geographical location | |
| England | 17 (63) |
| Wales | 8 (30) |
| Scotland | 1 (4) |
| Northern Ireland | 1 (4) |
| Ethnicity | |
| White | 23 (85) |
| Asian / Asian British | 1 (4) |
| Black / African / Caribbean / Black British | 1 (4) |
| Mixed / Multiple ethnic groups | 0 |
| Other ethnic group (self-described) | 2 (7) |
| Stakeholder group (primary) | |
| Researcher | 7 (26) |
| Clinician | 4 (15) |
| Family member/friend of someone with an impairing condition | 6 (22) |
| Member of the public | 6 (22) |
| Experience of living with a condition affecting memory/understanding | 2 (7) |
| Other | 2 (7) |
| Area of interest^ | |
| Dementia | 15 (56) |
| Parkinson’s disease | 4 (15) |
| Stroke | 5 (19) |
| Palliative or end of life care | 5 (19) |
| Care of older people | 2 (7) |
| Care homes | 2 (7) |
| Other (e.g Persistent Disorders of Consciousness, intellectual disability, emergency care, Huntington’s disease, REC) | 5 (19) |
| ^Participants could select more than one option |
Participants were very supportive of advance research planning (ARP) as a concept, whilst recognising that it may take various different forms or include a range of activities in practice. Views about the feasibility of ARP varied depending on these different contexts. Six main themes were identified which describe their views about ARP, the purpose of ARP and the processes involved, and the barriers and enablers to its implementation: 1) Planting a seed – creating opportunities to initiate or engage with ARP; 2) One part of the puzzle – using preferences expressed through ARP to inform decisions about participation; 3) Finding the sweet spot – optimising the timing of ARP; 4) More than a piece of paper – finding the best mode for recording and documenting preferences; 5) Not shutting the door on an opportunity – minimising the risk of unintended consequences; 6) Navigating with a compass – principles underpinning ARP to ensure safeguarding and help address inequalities. A number of sub-themes were also identified.
Participants also recognised the complexities and implementation challenges that might be encountered in real world settings, and proposed a number of facilitative strategies that might help address them.
Theme 1: Planting a seed – creating opportunities to initiate or engage with ARP
ARP as a promising contribution to research
Whilst ARP was a new concept to almost all participants, there were strong levels of interest in enabling people to express their preferences about future research participation. ARP was viewed as having a valuable role in both supporting advance planning arrangements and maintaining opportunities to be involved in research.
‘I am working in the palliative and end of life research world, and I was struck by how brilliant a concept that was. We are making great strides in trying to advance people’s forward planning when it comes to their own death. So, things like research and the ability to be useful and have some kind of utility and impact, either whilst you're dying or incapacitated or after your death. Certainly, from a personal point of view I would love to have something like that in place so that I can continue to be useful in some way’ [ID 06, researcher]
Participants reported examples of ARP already occurring, including people who were actively seeking opportunities to express their continued willingness to take part in research, and research teams who had introduced conversations about future research participation. This included opportunities which had arisen organically with patients who were seriously ill during the COVID-19 pandemic, and more formal arrangements that formed part of consent processes in some palliative and end of life care studies.
‘I eventually got round to .. [completing my own]… Lasting Power of Attorney, and under the statement about “Is there any specific wishes?” the only wish that I have put is that if there is a research opportunity then I want the opportunity [to be considered]. If the doctors think it’s in my best interests or they are happy that I would be a participant, then just do it’ [ID 09, member of the public]
‘Down on the wards [during COVID-19 pandemic] we were asking people, “If you were to deteriorate, become unwell, and the doctors needed to put you to sleep with a tube to help you breathe, would you reconsider research at that point?” and we started documenting that in patients notes, so there was some kind of guide for the ICU team to go off. I don’t know how helpful it was or how much they were looking at it, but it felt like we were doing something directly to try and protect people’s kind of rights and what they wanted’ [ID 01, clinician]
Participants described how conversations about future preferences about care and treatment were often avoided in society due to cultural attitudes towards serious illness and death. Participants viewed conversations about research preferences as also being important, but voiced the view that they were even less likely to occur than conversations about other aspects of future planning. Some researchers reported seeing the impact of this lack of prior discussion in practice, describing how family members can find themselves in a situation where they are unable to draw on a previous discussion to help them to make a decision about research participation.
‘It’s again a huge part of our problem that we don’t have these conversations about end-of-life care, emergency care, what happens if I lack capacity …. and then when you do ask a consultee, they’re like ‘well we never talked about it, we never had this conversation’ …. certainly no one’s having chats about research, your general public are not having these conversations’ [ID 11, researcher]
Opportunities to initiate ARP discussions
Rather than ARP being viewed as a one-off opportunity or a single event, participants thought it was important to consider how to maximise opportunities for people to have conversations about their research preferences. Having opportunities to start initial conversations about future research was seen as key, although participants recognised that it could be a potentially distressing topic for people to discuss, particularly if it was in the context of having been diagnosed with a condition that may affect their decision-making ability in the future.
‘The vast majority of people haven’t really even thought about it. So, it just plants a seed there, and the seed may well come to fruition; it may not. Hopefully it wouldn’t, because I wouldn’t get anything that needs studying, but it’s just there, it gets the discussion going’ [ID 14, family member]
Opportunities for ARP could take the form of an introductory discussion with the person and their family members, led by a member of their clinical care team such as a GP or another practitioner. This might lead to more formal processes such as creating a documented record of the discussion and the person’s preferences should those involved wish to do so.
‘I think pragmatically, for me, it would be more about having a discussion with family, and … obviously people can write it down if they wish’ [ID 05, researcher]
Additionally opportunities to have discussions about ARP might arise when people are engaging in other future planning activities (e.g organ donation, Lasting Power of Attorney arrangements, funeral preferences, wills), research related activities (e.g taking part in a specific study, signing up to a research registry or a biobank) or other altruistic acts (e.g donating blood), as well as being embedded in communications that come from charities and other organisations (e.g condition-specific organisations such as Alzheimer’s Society, peer support groups, or community initiatives such as Park Run).
‘If you give people as many opportunities to engage with the process the better ….. because most people don't want to think about advanced things to do with their death and dying until they're right up there confronted with it’ [ID 06, researcher]
‘There is a place for it within peer groups, within third sector groups, within charities and national foundations to sort of signpost people to the idea of doing it’ [ID 12, HCP]
Key areas for opportunities to introduce the concept of ARP and signpost to more information are summarised in Fig. 1 below.
< Figure 1. Opportunities for engaging with and initiating advance research planning>
Participants suggested that ARP could also be embedded in processes offering care and support for people with a specific condition such as peer support groups or post-diagnostic support or advertised through GP practices or hospitals (e.g posters in waiting rooms or on websites). Some also described how opportunistic events might also have a role in initiating ARP discussions, such as impromptu conversations with someone who has been involved in research, or arising from high profile media coverage which might raise awareness about the importance of research (e.g COVID) or the impact of capacity-affecting conditions (e. diagnosis of a celebrity).
‘Because if you get some big megastar who’s got dementia, I’m sure there’ll be a lot more people who’ll be involved in the research, and then it sort of ebbs and flows. It’s how to nurture that and, again, you’re just open to almost like the tides really. You can’t control them but maybe harvest them’ [ID 14, family member]
Communication and addressing informational and support needs about ARP
Participants stressed the need for all those involved (or likely to be involved) in ARP discussions to be provided with accessible information about research and ARP, which should be available in multi-media formats (e.g online, leaflet, video) and may need to be tailored for different audiences to account for their informational needs and role in the process. Most participants suggested that a coordinated media campaign would be particularly useful to help raise awareness with both the general public and professional audiences.
‘Maybe like a scheme, a campaign like ‘Do you know what your loved ones would want? Have a conversation about it’. And maybe start with like that first and ease people in before writing the form’ [ID 27, family member]
‘I think Research Ethics Committees, people who already work in research, everybody would need more information about the process and what documentation to expect. People with a condition and family members. I think it should all focus on opportunity’ [ID 09, member of the public]
Participants expressed a range of views about whether engaging in ARP would be a self-directed process or take place within a healthcare consultation or other supported conversation or could be either of these options depending on the context, for example whether the person had been diagnosed with a condition that could affect their capacity in the future. Where ARP discussions would involve health care practitioners or other personnel, participants thought it important that they have the skills, knowledge, and time to enable them to do so effectively.
‘It would require very good communication skills to introduce it as a topic, because it’s part of the bigger context of what’s going to be happening with that person’s condition, and illness’ [ID 05, researcher]
However, participants recognised the challenges of including it in consultations as an additional activity within an already pressurised health and care system. As a result, some participants thought that non-clinical settings may be better placed to provide the time and support that would be needed.
‘Like all these things, it needs to be done with time and explanation and accessibility and that’s where I’d have concerns about who was going to do that conversation and how much time they’d actually have to do it in’ [ID 11, researcher]
‘Maybe peer to peer support groups and other community support groups where they’re back every week they can be introduced as a topic and then as a talking point and then, people can come back to when they’ve had real proper time for reflection …. it’s a complex idea and a complex thought and I’m not sure that, that a clinical setting is necessarily always the best place to go through that’ [ID 12, HCP]
Given the potential complexities involved, participants thought that ARP discussions might be more effective if they included the family member(s) being nominated as a consultee/representative, where possible. This would ensure that they were aware of the presence of any document detailing the person’s preferences, could use the conversation to help them to contextualise and later interpret those wishes, and could provide continuity in the event of a loss of capacity (e.g if the person was being cared for in a different setting at that later timepoint).
‘I think it's finding engaging ways to make the information really explicit because I suppose the differences are so key, and having some kind of way of ensuring whoever is the named representative for that person engages with the process as well’ [ID 06, researcher]
Theme 2: One part of the puzzle – using preferences expressed through ARP to inform decisions about participation
Outputs of ARP are general sentiments rather than specific decisions
Participants expressed a range of views about how binding they thought preferences expressed through ARP should be. These views were often shaped by whether they were primarily thinking about treatment related research such as clinical trials, or less overtly invasive research such as observational studies, and also how generic or specific those preferences are and how recently they had been expressed.
‘Are you then looking at the more general sentiments rather than specific decisions. It’s more a general sense of what I would prefer rather than it being legally binding or having that much weight - it’s more of an advisory document that says this is what I would like’ [ID 07, researcher]
Some participants thought that preferences expressed through ARP could not be considered ‘decisions’ as it would not be possible to foresee the potential range of circumstances that might apply. This placed the emphasis on people being supported to discuss their general preferences through ARP rather than making specific decisions.
‘Because essentially, you’re kind of saying make a decision on every and any medical procedure I currently have available to me and things that I haven’t yet thought of – that’s kind of a mind-blowing thing to try and think about whether you’re happy for that to happen to you, not just today but in the future too’ [ID 07, researcher]
‘It’s not about making the decision, it’s more prompting the discussions’ [ID 23, member of the public]
However, some clinicians saw greater utility in more specific documented preferences that could be said to constitute informed consent for a study. This was thought to be particularly valuable in circumstances where consent requirements were perceived as creating a barrier to inclusion, for example in emergency situations such as stroke trials, and for observational studies involving routinely collected data.
‘I think that's probably a situation where advance consenting would probably be a lot more helpful, from a research perspective anyway’ [ID 10, HCP]
However, other clinicians felt that the range of potential trials, the evolution of clinical trial design, and the speed of developing new interventions meant that it would be difficult to specify what future types of studies and interventions a person would be willing to participate in and receive. This might be particularly relevant if the aims or outcomes of the study might not be what matters most to the person at that point in time. This was particularly stark for those involved in research into conditions where the precipitating event was entirely unexpected, and where clinical outcomes were particularly uncertain, such as in prolonged disorders of consciousness. Participants described the unlikeliness of being able to capture this nuance in ARP.
‘The treatment turns out not to be very effective so you’ve still gone through the procedure, and yet your outcome is still poor and you’ve only consented on the proviso that, or you’ve only put in your advanced plan, this would be a quality of life enhancing treatment and actually all it’s done potentially is preserved your life but with poor quality of life’ [ID 07, researcher]
Some participants suggested that preferences expressed through ARP might not be binary in nature, so that rather than establishing either generic or specific preferences, a layered or tiered approach might be preferable. In this situation, people would be able to express their general preferences about the opportunity to be involved in research, with the ability to specify more detailed preferences should they wish, or if they are in a position to do so. This was thought to better align with other types of advance decisions such as organ donation, recognising that these processes encounter similar challenges.
‘I think maybe stepped kind of consent would be a better idea or stepped permissions because not everybody wants to go for everything. I mean it’s the same with emergency [care] planning, like there are some things that people just never want, the same with [organ] donation isn’t it’ [ID 11, researcher]
Weighing of ARP preferences when decisions are being made
When it comes to how ARP preferences should be used in participation decisions, most participants thought that preferences expressed through ARP would supplement the current process of consulting someone else on the person’s behalf, rather than be considered as a binding decision that ‘bypasses’ the need for an alternative decision-maker.
‘I hope that it would kind of be a parallel process that would eventually inform the consultee process, rather than something that would replace it’ [ID 07, researcher]
Under this view, decisions about participating in a study would be made by someone caring for the person based on their preferences expressed though ARP, but also informed by their current circumstances and involving the person themselves in the decision as much as possible. Honoring the person’s preferences about research, and helping them to fulfil their wishes, was considered to be part of the caring role.
‘The carer knows the person the best. Nine times out of ten [they] would have been there when they signed the form, the carer should have their best interests at heart, the carer would have lived with them probably, the carer would know what they want …. The person has indicated during their good days that they want to take part in research, the carer will help them honour that. The researcher should just talk to the carer and the person, because they may have lucid moments, or good days or bad days’ [ID 13, person living with a condition that may affect capacity]
However, one participant cautioned that, whilst the family member’s view about their current situation is important, the person’s previously expressed preferences should be given a greater weighting.
‘Maybe you need provision for somebody close to actually give an opinion of what they think the person might feel, but you’d have to have a way of not giving that same weight as the person themselves’ [ID 22, member of the public]
Whilst the involvement of an alternative decision-maker was seen as a safety check by some, other participants felt that where the person was adequately informed (and sufficiently specific) when expressing their views through ARP, their preferences should not be overridden by a family member.
‘No, I think it should be legally binding. That’s how I would rationalise it, in essence, that these are the wishes of this person. If I’m giving unconditional support to the research and signing a document, that is my wish’ [ID 17, person living with a condition that may affect capacity]
‘If you express a preference to take part in certain research and then your consultee comes along and says ‘no’, they’re undermining your wishes but at the same time having that secondary check when the context is known feels like a relief to me…’ [ID 11, researcher]
Opting into research versus opting out
There was also a view from some participants that a person’s wish to not be included in research should carry more weight than a wish to be included. Although some participants thought that even when a wish to be included has been expressed, it should always be ‘double-checked’ by another person who would be able to reduce the level of participation if they felt it wasn’t appropriate given their current condition.
‘If they’ve said that they don’t want to do something, that’s probably considered a binding contract. But then the agreement to opt in ….. you should just always seek consent from that person’s power of attorney or whatever, because that person’s wishes and feelings may well have changed over time and someone else is better informed to say’ [ID 06, researcher]
‘Unless there was anything you want to take off, for instance if you no longer thought it appropriate for them to take part in scans because their fear of going to scans would now be too great, then I could see it working that way. So, you’d say no to some things but definitely not the other way, saying yes to something that they had originally said they wouldn’t want to take part in’ [ID 24, family member]
This contributory or supplementary role of ARP, and its value in emergency situations where participation decisions need to be made quickly and by clinicians who are not familiar with the patient, was recognised by some participants. Having access to previously expressed preferences about research though ARP was thought to be particularly useful in circumstances where a family member was not immediately available to provide their opinion about whether the person should be involved in the study or did not feel able to make a decision.
‘I think it's a very good adjunct and a good way if you can't find any family, which is not uncommon in the emergency sense, and also if the family are there and they’re dithering a little bit … but I don’t think you should change your approach because the form’s there’ [ID 10, AHP]
‘I see it totally working for a family member who’s a consultee, because it’s basically the person’s wishes laid out, so they would have no reason to question them… but yeah, I think it would definitely remove that kind of lack of confidence that clinicians have in certain contexts, including emergency medicine … everybody’s so cautious, then if you have this group who have something written down, everyone will breathe a sigh of relief’ [ID 11, researcher]
One participant expressed the view that ARP could play an important role in helping to overcome barriers caused by gatekeeping behaviours and paternalistic views about studies involving people with impaired capacity to consent. This might include families, but also clinicians and research ethics committees (RECs).
‘They can make certain ethics committees feel quite uncomfortable, and maybe put things in place which actually make it even more challenging to recruit. It’s protection, it’s this idea that people are vulnerable and that having them involved in research is burdensome, but it’s not. Clinician gatekeeping is a real issue in palliative care research’ [ID 05, researcher]
Theme 3: Finding the ‘sweet spot’ – optimising the timing of ARP
Need to align motivation and opportunity
One of the challenges identified by participants was how to align the opportunity for people to express their preferences about future research with their motivation to do so. Many participants recognised the challenges of people being motivated to undertake any form of advance planning, despite this being widely advocated.
‘One of the big challenges with advance care planning is that culturally we don’t think a lot these things are going to happen to us, and it’s this idea that you’re tempting fate by having these discussions’ [ID 05, researcher]
Participants also noted that taking part in research isn’t on most people’s radar currently, let alone thinking about taking part in research at some distant time point in the future should they lose capacity to express their own views. Enabling research to seem more relevant to people was described as being the ‘first hurdle’ to overcome.
‘People just don’t think about being in research, it doesn’t feel like something that you do as a normal person, maybe it feels like something that old people do’ [ID 08, researcher]
Alongside research needing to seem relevant to people, participants described how the circumstances under which they might not be able to provide their own consent to take part would also need to seem relevant in order for people to engage with ARP. As one participant noted, ‘it’s not their problem until it’s their problem’ [ID 03, HCP]. However, they also noted the difficult nature of these conversations and the challenge of getting the timing right.
‘I think people should be encouraged to think about this, but people are so scared of their own mortality and their own death. If you ask people too early, they're just going to be like ‘what are you talking about?’ like, ‘I'm never going to die, I'm never going to get dementia’, so it has to be at the sweet spot’ [ID 08, researcher]
Impact of delaying opportunities to engage with ARP
Participants with experience of caring for people with neurodegenerative conditions such as dementia also highlighted the need to balance this with not leaving future planning discussions until a point in time where the person was not able to engage fully in the conversation.
‘Although they may be distressed, distraught, or whatever because of a life-threatening illness they would be capable of making a decision, have the mental capacity I suppose … but down the line you need to have already made the decision, otherwise it’s too late’ [ID 26, member of the public]
However, opportunities for timely discussions could be impacted by wider systemic issues of people experiencing delays in receiving a diagnosis of a capacity-affecting condition such as dementia, and a lack of healthcare support even once diagnosed. This was a view commonly shared by people with lived experience from across the UK, although it was not raised by clinicians.
‘You really are left alone just to do your own thing. So, they don’t go to the doctors unless they’re ill. Getting to the memory clinic is, you’re lucky, you’re on a waiting list, you get one visit and that’s it’ [ID 24, family member]
‘He attended the memory clinic …. and he has an appointment like once a year …. and anything can happen within that year’ [ID 16, family member]
Theme 4: More than a piece of paper – finding the best modes for recording and documenting preferences
Best format to facilitate expression of wishes about research
There were mixed views from participants about the best way to record ARP conversations, and the preferences that were expressed. This often focused on whether a template ‘advance research directive’ document would be helpful in facilitating people to express their wishes, how detailed it should be with respect to specific conditions or types of research, and how it might align with other relevant documents that people might already complete and need to retain.
‘It gives you something physical to keep with your professional documents, you know, important papers that should somebody need to be checking through your information, at any point, just as a reminder to them to use that as well’ [ID 20, member of the public]
Participants often drew parallels with other processes for documenting advance decisions, including those recording altruistic-based wishes such as organ donation, and those relating to their future care or treatment. Some participants suggested that mirroring the format of other advance directive documents such as ReSPECT forms (Recommended Summary Plan for Emergency Care and Treatment) [36] would be helpful, for example containing a list of options to select from rather than having only open ended text boxes. This similarity in format was thought to help with completing the document and be helpful when it is later used to inform a participation decision.
‘If you had a list of bullet points on the form that said ‘I'm happy to take part in the following studies, observational, pharmaceutical, device, and so on’ then it …. would be easier rather than it being a block of text … and makes it less ambiguous’ [ID 10, researcher].
‘I think for it to be of best benefit it would need to be mostly generic, mostly a tick box, that takes away ambiguity, it’s easier for people to understand, and less of the free text. I think that would protect both sides better and a broader range of people’ [ID 21, family member]
However, other participants thought a template with various options to select could seem overly burdensome and deter people from considering research all together. Some thought it would be too restrictive and preferred to have the ability to personalise their response using free text or use audio or video recordings which they thought would allow them to better express their own voice in the process.
‘I just feel that detailed questions may put some people off taking part altogether because they go into too much detail and they start to sound really scary …. whereas some research is not invasive in any way.’ [ID 23, member of the public]
‘I wonder if there is a way for me to be able to write a paragraph on my thoughts and opinions, in my tongue, my words, and my vernacular, that is making it actually reflective of what I want, instead of just legalese tick boxes that, isn’t reflective of what I want. Or it is reflective of what I want, but it doesn’t sound like what I want’ [ID 01, HCP]
One participant suggested that another briefer format such as a wallet-sized card to carry would be more effective, particularly in emergency situations, which would state that if the person lost capacity they would still like to take part in medical research.
Digital versus paper options – challenges for recording, storing and accessing ARP documents
Linked to this, there were also a range of views about how advance research directive documents should be completed and stored in order for them to be accessible to families, clinical/research teams and to the person themselves. Both paper and digital formats would be affected by issues around access to personal documents once a person had lost capacity affected, but in differing ways. For example, digital formats were considered more secure but couldn’t be accessed without knowing the person’s passwords and might be affected by technological advances whereas paper documents might be more easily accessed but could be lost or become untraceable over time.
‘We don’t have any documentation because before she came to live with us, she was posting stuff off all over the place and getting rid of things. If all of her identification documents were online our life would have been much, much easier’ [ID 24, family member]
‘If we were to lock [away] information like this about someone who has dementia on a digital system, it may be really difficult to get that information without Power of Attorney …. And even if you have Power of Attorney it doesn’t do anything for the password’ [ID 23, member of the public]
The need for digital versions to keep pace with changes to technology and information governance over time was highlighted by some participants. Ensuring that people discussed their research preferences with families, and informed them about that they had completed an advance research directive, was thought to be the best way to reduce the impact of these challenges.
‘Whatever happens online, I feel it's going to get overtaken by legislation and IT developing and everything …. whatever documents that are finally agreed about research, [it is important to] stress that you need to talk to your family about this’ [ID 14, family member]
The difficulties of being able to access up to date ARP documents, particularly in urgent situations when an enrolment decision is time-sensitive, were frequently raised by participants. Some reported that even accessing electronic health records between different healthcare organisations was impossible in some settings. Several participants referred to the difficulties they already encountered with accessing other forms of future planning, such as LPA documents and advance directives, or even being aware that they had been completed. Communication about the existence of an ARP document was seen as key, along with integrating ARP into existing pathways.
‘The NHS is getting better at IT, but actually the LPA, unless somebody comes into the hospital waving it you’ve often got no indication that the person has one in place’ [ID 09, member of the public]
‘It’s the same as the ReSPECT form, does anybody know you’ve got it, is anybody going to look at it. Because if you get a new form as part of a process it has to be integrated into a kind of treatment pathway’ [ID 11, researcher]
Theme 5: Not shutting the door on an opportunity – minimising the risk of unintended consequences
Impact of uninformed and misinformed decisions about research
Whilst there were high levels of support for ARP, there was recognition that introducing ARP is not without unintended consequences, particularly if peoples’ preferences about participating in research or not were insufficiently informed. This was linked to the view that levels of awareness and understanding about research are relatively low in the general population.
‘It would be a travesty if loads of people said they didn’t want to take part in research, especially if that was because they didn’t understand the nature of research, like, what kind of research they were opting out from versus opting into’ [ID 08, researcher]
One participant described an example where patients at an outpatient clinic had misunderstood the invitation to express their general interest in taking part in research when asked via an electronic screen as part of routine booking in procedures. Patients often clicked different ‘yes’ or ‘no’ responses at each clinic appointment. It demonstrated the difficulties around interpreting binary ‘yes or no’ answers, including where there were inconsistencies in their responses when being asked the same question on multiple occasions. It also highlighted the importance of having contextualized discussions about research rather than just replying on one-way electronic communication.
Some participants drew parallels with existing ‘opt out’ arrangements such as organ donation, and highlighted the negative consequences of any shift towards the view that researchers could only include people who had ‘opted in’ through prospectively expressing a wish to be included in research. Participants were particularly concerned about the impact this would have in terms of exacerbating inequalities in access to research that are experienced by some groups, and thus further reducing inclusivity and diversity in research.
‘Potentially you're missing out on huge swathes of people that would not have signed something for whatever reason. Just because people that tend to sign up or are in positions to make advanced care plans, might just have less chaotic lifestyles. You know, it's all that kind of the social and economic drivers and determinants of health generally’ [ID 06, researcher]
There were concerns about how relevant the wishes expressed in an advance research directive could be considered if a long period of time had elapsed since its completion. Particularly as there would, by definition, have been changes to the person’s health status during that time which resulted in a loss of capacity.
‘I think that’ll be very challenging …. if it’s put in a drawer for ten years and things have changed massively since then how much weight are we, as a care team, as the researchers, going to put in that document when we’re representing the person as they are now, ten years later’ [ID 07, researcher]
Some participants were concerned that the passing of time might also affect peoples’ recall of discussions about ARP, or even that any discussions had taken place. More fundamentally, ARP would rely on the attitudes towards research held by those responsible for making a decision about research and whether they were trying to make an authentic decision based on the person’s wishes or based it on their own personal views about research.
‘Those people who are in a place to be more open minded about research participation would be supported by that conversation having had occurred, because they want to be part of it and [are] looking for reasons to do so, to make that more authentic decision. But then there is a really large group for whom, particularly in the early stages, even if that conversation had occurred, it probably wouldn’t be available in their working memory. Because you might approach those same family six or twelve months later’ [ID 03, clinician]
Theme 6: Navigating with a compass - principles underpinning ARP to ensure safeguarding and help address inequalities
Fundamental role of trust in ARP
Trust was thought to play a key role in ARP. Participants described the relationship between the trust people might put in ARP and the process for engaging with it, and the trustworthiness of the source of information about ARP. Participants described how information about ARP that was received through existing trust relationships, such as with a healthcare provider, might help foster trust in ARP itself.
‘There would be quite a lot of people maybe who don’t want to resort to something online, because they’ll not be sure if they can trust it or not. Whereas, maybe information that they’ve acquired at their GP surgery or in the hospital, they will have more faith in that’ [ID 20, member of the public]
However, given the ‘vulnerability’ of this group, there are implications for how organisations involved in ARP might be perceived. Participants thought that ARP should be introduced sensitively, particularly where people have been diagnosed with a capacity-affecting condition, otherwise it risked eroding trust in these existing relationships.
‘I’d worry that if we were forcing stuff on people, whether that would worsen trust in healthcare … if we’re saying, well, no, we’re going to enroll them, because they’ve signed a piece of paper twenty years ago that said that they would love to take part in research’ [ID 01, HCP]
Some participants highlighted that it is important that ARP takes account of particular concerns around trust associated with certain types of research or research activities, or where levels of trust and views about trustworthiness may differ between communities and individuals depending on cultural, historic, and other contextual factors.
‘There's some careful wording where it's human tissue … or there's religious and cultural reasons why they would be absolutely dead against something like that’ [ID 06, researcher]
Safeguarding and protection of interests
The importance of ensuring there are safeguards against harm or exploitation was highlighted by many participants, although a number thought that having consultees or legal representatives involved as part of the process already fulfilled this requirement. This included their view that a consultee/legal representative should be able to advise that a participant should not be involved in a study or should be withdrawn from a study if they are distressed or experiencing harm. This balance between the need to protect them from harm as a result of a particular study and the requirement to honour their prior wish to be included in research more generally was described by one family member as the ‘ethical cut off’ point. This limiting of harm or distress was seen by participants as being part of the role of enacting the person’s wishes as it is unlikely that they would have agreed to participate if it involved such harm.
‘I think I would want a safeguard in place where someone could step in and say actually things have changed to such an extent this would cause distress and actually if this person had capacity, they would acknowledge that themselves and so we don’t think it would be appropriate for them to take part’ [ID 02, researcher]
‘So, I think if it comes to a point where somebody’s health is rapidly declining, because of the research, that’s when there should be that family says, “no, they’re not coming anymore”.’ [ID 21, family member]
Some participants thought that this situation would need to be articulated as part of the person’s preferences about being involved in research, although one recognised that putting caveats around what was acceptable in terms of distress would make the ARP process difficult, and probably end up making it almost impossible to operationalise. Others wondered if a third party organisation could provide an independent review in situations where there were disagreements or concerns, although it was suggested that their role would be supportive or mediation rather than having decision-making authority.
‘I wonder if there was a process for maybe a voluntary service …. where independent advisors go in and review the situations and review what the family are saying or what doctors are saying and make decisions. Could they overrule a next of kin? Probably not. So, like some independent service, that offered support and guidance, in these kind of tense situations, would probably be really good.’ [ID 01, HCP]
Other participants expressed the view that the arrangements in place around the person’s care and treatment will already be playing a role in safeguarding, as someone who lacks capacity to consent will be requiring care and support outside of a research context.
‘There would already be health decisions that’d have to be made outside of just this to have flagged up that this person was particularly vulnerable ….. I’d find it difficult to imagine a position in which they wouldn't already be known to the system as it were.’ [ID 06, researcher]
There was also the view that, unlike other areas such as finance where people may have motives to exploit ‘vulnerable’ people, research participation is unlikely to create the same ulterior motives.
‘There's less immediate material gain in research, so I can't really imagine somebody being able to benefit directly from having control in that way’ [ID 06, researcher]
Participants also highlighted the well-established safeguards that are in place around research conduct, including the requirements for ethical review and existing legal protections in terms of data protection and confidentiality, and the additional safeguards that govern research involving adults who lack capacity to consent. They suggested that communication aimed at raising awareness about ARP should include highlighting that there are existing safeguards in place and that its purpose is not to bypass or subvert these important protections.
Not perfect, but better that the status quo
Despite the complex issues raised, introducing ARP was generally seen as an improvement on the current imperfect situation. It was seen as adding what one participant described as an ‘extra layer of security’ that would make the process ‘ethically safer’ than the current arrangements.
‘I think at the moment using proxy consent is often used as the best way forward, but I think it’s imperfect. I would see something like advanced research planning as an improvement on the current status quo. If our research relates to vulnerable groups who may not be able to give consent, we’re trying very hard to think how we can best respect their dignity by including them earlier on in the conversation, but then have a safeguard whereby their consent can be overridden in very particular circumstances. That would strike the right balance, I think’ [ID 02, researcher]
Importantly, a number of participants stressed the risk of potentially reinforcing existing inequalities in research that would need to be addressed during implementation. These may arise through the routes to implementation that may not reach people from under-served groups, and around issues relating to the accessibility of ARP processes themselves.
‘There’s a huge selection about populations being under-represented by self-selecting to take part in these things and actually they’re the people we get to too late already because their needs are so very complex and we need more research to help them, to get better health outcomes than they currently do’ [ID 12, HCP]
‘Anything that involves digital literacy, online engagement, you’re going to disadvantage certain people. If it’s only located in primary care, you’re going to disadvantage populations like the gypsy and Roma that move a lot and disengage with services. If it’s only done in English. I think most standard strategies, through standard pathways are going to exacerbate the historically excluded groups’ [ID 11, researcher]
There were particular concerns around the impact on inequalities of any ‘ethics creep’, for example if it became a requirement that people with impaired capacity to consent could only be included in research if they had an advance research directive in place.
‘My underlying catastrophizing around some of these things is that if we set up an advanced research plan or advance research directive, as a requirement for participation, we are going to filter out anyone but the very, very most informed who will undoubtedly be the tertiary educated white, well-paid, well-represented people in research. It’s going to become naturally exclusive through its attempts to include’ [ID 03, clinician]
Ensuring accessibility of ARP
A number of strategies were suggested by participants to enhance the opportunities for historically under-served populations to be able to engage with ARP. These included ensuring that the format of ARP is accessible. It was also thought important that all communication aimed at raising awareness about ARP uses accessible language to avoid the risk of these groups not understanding the purpose of ARP (and thus make an uninformed decision) or not be able to engage with it.
‘I think a booklet’s a good idea. I think that’s an accessible resource to all. You could make it in different languages, different print for those visually impaired. I think a website, also. I think it needs to be very clear about the different types of research that they might be involved in …. to explain all those terms, the kind of layman’s terms, so they can understand what they may be involved in, and then for them to make an informed decision of what they do and don’t want to do going forward’ [ID 04, HCP]
Participants also stressed the need to ensure that information is accessible for all the groups and individuals likely to be involved in ARP, including those in clinical roles who may themselves be less familiar with research.
‘You don’t want to assume that much research literacy in clinicians, and you don’t know the level of understanding of the consultee either. You can’t assume it’s better or worse than anybody else, so I think focusing on less being the key and accessibility is the best way to go’ [ID 11, researcher]