Four main ethical topics emerged from the data. These were: 1) respondents’ assessments of harms and benefits of participating in the observational study and the proposed trial; 2) the process of gaining informed consent; 3) views about models of advanced consent; and 4) what should happen when residents lose capacity during a trial. Data extracts, including the respondent identification number, are used to illustrate the themes.
Respondents’ assessments of the harms and benefits of participation in research studies
Respondents generally had few concerns about low-risk observational studies. Residents reported that they wanted to participate in the PAAD study as it was an interesting topic, and they wanted to participate altruistically on the basis of helping science and reducing diarrhoea in their care home. A few residents who had consented to the PAAD stage 1 study subsequently withdrew, and care home staff suggested that these residents might not have fully understood the study when consent was given. “I think that’s why they’ve withdrawn, because they didn’t fully understand at the beginning, or, they may have forgotten, just because of, you know, slight memory problems”. (Focus Group, senior staff).
Similarly relatives felt that the PAAD study was “relatively harmless” and could see the potential benefits to medicine and society “well, any advance in science is worthwhile” (Interview, Relative 2), as well as the potential benefits to their family member in the care home “it’s for her benefit at the end, the long term isn’t it?” (Interview, Relative 8). However, a few relatives did have some general concerns, for example whether the proposed intervention had been tested on healthy populations. While most relatives expressed full support for research conducted in care homes, a few stated they had concerns that residents were too elderly or frail and their participation in research was inappropriate (despite the residents sometimes themselves being mentally capable and having consented to take part).
Care home staff reported that one of their main reasons for participating in research generally was that older people, and care homes settings more specifically, had traditionally been neglected in medical research “because there isn’t a lot of research in elderly care, we just felt that it’d be nice to do something that would be research based” (Focus Group, junior staff). They also felt that there were professional benefits of being involved in university based research, supported by training, that would motivate the staff “you need something to bring you up, bring you out, make sure that you’re still doing something with your career, if you like, and we did, we sat down at one of our meetings, for the qualified and we talked about it, and felt it would be good for us, stimulate us.” (Focus Group, senior staff). Care home staff also felt that the PAAD study topic (antibiotics and diarrhoea) was an important issue for them. “I think from our point of view, we see lots of antibiotics prescribed regularly, and all too often, not perhaps the correct antibiotic being prescribed, which does have the effect of diarrhoea” (Focus group, senior staff).
Some GPs were concerned about how they, or their GP colleagues, would be financially reimbursed for their role in the PAAD Stage 2 study, but others reflected that the PAAD study would be clinically useful and would benefit GPs educationally, perhaps through increased awareness of antibiotic associated diarrhoea within care homes. “Rates of C.diff or harm that comes from it […]I think you have to see it as something clinically useful, as something that is going to make a clinical difference in the end’ (Interview, GP 8).
The process of obtaining consent
Residents were generally supportive that relatives should be asked to act in the capacity of a personal consultee or a personal legal representative. Most felt that the relative would have a good idea of their wishes and that it would be better to ask a relative than a professional legal representative as the former would know the resident well. “Oh yes, a relative, yes, because I think they know you better, and you understand them better” (Interview, Resident 10). However, one resident doubted whether all relatives could be trusted to act in the best interests of residents “you don’t know see, whether they’re [the family] all that trustworthy” (Interview, Resident 9). Other residents felt that some relatives may not want to be bothered and may be too busy to help. Other potential problems included difficulties with relatives who live a long way from the care home, and some relatives themselves being mentally incapable.
Many relatives reported that they had wanted more details about the PAAD study in the information sheet (4 pages long), while others reported that they were overwhelmed with the paperwork, and wanted the information in a simple and short format. The relatives included in the sample for the qualitative sub-study were typically regular visitors at the homes. Many reported that they found their close relationship with the resident and with care home helpful when being asked to be a personal consultee. They felt they knew the residents’ wishes well: “I think they [residents] trust their relative to act on their behalf. I think a stranger coming in and trying to talk them into doing something, they would be on their guard” (Interview, Relative 12). It was felt that relatives who visit irregularly, or who have little contact with the home, would feel more anxious about being asked to take on the role of personal consultee or personal legal representative, partly because they would not be able to personally monitor the resident’s condition and partly because trust would be less well established between care home staff and relatives “I would probably say no [to acting as a personal legal representative] if I was here only once a month to be honest with you” (Interview, Relative 8).
Although the care home staff were motivated to participate in PAAD, most staff were surprised at the scale and intensity of the workload involved with implementing research and with the time required for consenting patients “it’s also finding the time to do the consenting, and spend that extra bit of time to talk through, ‘cos we’re getting them interested in it, you know, um, well we did find that a bit hard, just getting the time and really sit down, ‘cos with 54 residents, and getting the relatives in, a lot of them would come in after tea-time, which is a really busy time, you know around tea-time, after tea-time, a really busy time, only two qualified on, quite hard then” (Focus group, senior staff). Focus group participants reported that senior staff were better able to seek consent from relatives than junior staff. Specific difficulties included: i) communicating with relatives who visited infrequently, ii) locating a nominated consultee when no relative could be found, and iii) explaining the study to residents considered to have capacity, only for the resident to forget the purpose of the study afterwards. Some staff reported that relatives wanted simple explanations and were slightly put off by the length of the information sheet: “I think the way it will be written down will make a lot of difference as to whether people consent or not because, you know, a lot of words can sometimes put people off, if it’s a lot of terminology” (Focus group, junior staff). Simplified information sheets, which had been designed for residents, were consequently sometimes used with relatives.
Some GPs reflected on the difficulties in obtaining consent from older people with cognitive impairments. They had concerns that residents would forget important details about the study, even during the time they were given to reflect on their participation. In view of this, some queried whether truly informed consent could ever be obtained. The majority of GPs felt that most relatives would be happy to be a personal consultee or a personal legal representative and relatives would consent to the PAAD study since it was a “benign study” (Interview, GP 08). However one GP felt uncomfortable including patients without capacity in a trial on the basis of another’s advice “I don’t feel comfortable about it at all because it, partly because I, I do feel that the patient should be able to give informed consent if they are receiving something that is out of the ordinary from their usual treatment” (Interview, GP 5). Another GP stated that relatives may not always act in the resident’s best interests, “I’m not always convinced that relatives act in the patient’s best interests” (Interview, GP 4). Moreover, a few GPs felt that some relatives would not want to take on this responsibility and some may also be unable to retain or understand the information, “it’s possible that the relative might be very elderly as well, and maybe losing their memory too” (Interview, GP 2).
Views about models of advanced consent
All but two of the residents stated that they would be happy to be consented just once to a 12 month study and it was not necessary to keep checking throughout the year to see if they still wanted to be involved “once in the beginning, I think that would be sufficient” (Interview, Resident 9). However, residents wanted to ensure that they could withdraw during the study “I think um, there should be um, an escape route if you like” (Interview, Resident 12). Other respondents suggested that their doctor should check every few months to ensure that they were well enough to participate in the study. In this respect, they wanted to be checked for eligibility rather than for consent.
None of the 14 relatives we interviewed expressed any major concerns about obtaining advanced consent for a study lasting 12 months. Generally they understood why obtaining advanced consent was required, although two relatives commented that 12 months can be an important time span, with residents’ health deteriorating considerably in this time. Relatives’ opinions on whether the research team needed to re-consent during the 12 months were divided. Three relatives felt that consent needed to be checked at regular intervals (typically every 3–6 months), although none of these relatives felt that this re-consent needed to be established in writing. Four relatives felt that it was not necessary to re-consent but that the care home staff should continue to remind relatives informally that the resident was still enrolled in the study “well, if you’ve given consent, it might be nice to be reminded of it, you know” (Interview, Relative 13). Seven relatives stated that re-consenting during a 12-month study was not required, as long as it was made clear that residents and relatives had the right to withdraw from the study.
Care home staff did not see a problem with using a model of advanced consent as they regularly used this method to gain consent for activities such as taking photographs within the care home or taking residents on outings. Care home staff thought that residents, or their legal representatives, should be reminded of their participation at the point of randomisation.
The majority of GPs felt that re-consenting during the course of the year would be unnecessary paperwork. One GP also raised the issue of how this could be managed if trial participants were to lose capacity during the study period “I suppose the issue would be for someone who went from having capacity to losing capacity, and if you’re going to do, re-consent, you’re going to have to re-consent everybody, because it ought to be consistent.” (Interview, GP1) However, some GPs did comment that it would be appropriate, and a matter of courtesy, to verbally remind residents (or relatives in cases where residents do not have capacity) at 3–4 month intervals that they are still part of the study, and are free to withdraw at any time.
What should happen if a resident loses mental capacity during the trial?
Mental capacity relates to the ability of a person to make a specific decision at a particular time. For the PAAD study, senior care home staff were tasked with assessing whether residents had capacity to give consent for themselves or whether a personal consultee would need to be approached for their advice. PAAD stage 2 is planned as a 12 month study. Consequently, residents may consent in month 1, but could be randomised to either probiotic or placebo at any time between month 1 and month 12 depending on when they are next prescribed an antibiotic. It is possible that, if they were assessed for mental capacity at the point of randomisation, they would no longer be deemed as having mental capacity for the decision of whether or not to participate in the PAAD study. Residents were divided on whether they should continue to participate in the study without further consent from a relative if they lost mental capacity during the study. Some felt that if they lost mental capacity during that time they would want to continue regardless, “I would say exceptionally, I would want to proceed with the survey [research study], because it’s so important” (Interview, Resident 12). However, some felt that the resident would need reassessment by a health professional, “I’d want you to check with my doctor to make certain it wasn’t doing any harm, because if my mental facility was going, I might be, it might be caused through that [the study drug]” (Interview, Resident 3). Opinions were divided on whether to give this decision to the relative, “the people doing the, er, research, I think they should really ask whoever is acting on their behalf” (Interview, Resident 13), or the GP “I think it must depend on the doctor, the GP who is in touch with the resident” (Interview, Resident 12).
Relatives also differed in their opinions of this issue. Five relatives felt that a relative should be consulted about the resident’s continued participation “you’re going to want somebody to act on his behalf” (Interview, Relative 1), while four others felt that a relative should just be informed, as a matter of courtesy, that the resident had given their consent to participate in the study “you know maybe it would just be like an act of common courtesy” (Interview, Relative 14). However, five relatives felt that the resident should continue in the study regardless of whether a relative is informed or has given their consent. Many of the relatives acknowledged that this was a difficult issue. Some argued that relatives might have very strong views about this, but none speculated what might happen should a relative disagree with a resident’s continued participation.
With the exception of only a couple of individuals, all members of staff felt that if a resident loses capacity during a trial, then a legal representative would need to be approached and consent taken. When it was explained that, legally, this was not the case, some care home staff still insisted that they would still want to do this to “cover themselves”. At an absolute minimum, they felt that they should inform the relatives. “Well, I think you’d have to re-consent with somebody that could give, well I feel I’d have to ask the next of kin, if we could carry on, I really do feel I’d have to do that.” (Focus Group, senior staff).
With the exception of one GP, who said that he felt relatives should be approached for consent should a resident lose capacity, all felt that a resident should be allowed to continue in the trial. Most GPs said that it would be appropriate to inform the next of kin that the resident had consented in the study, but (with the exception of the one GP previously mentioned) no GP suggested that the relative could over-ride the resident’s wishes. The fact that residents could lose (and regain) capacity during the study supported their arguments that residents did not need to be re-consented during a trial lasting 12 months, as it would be impossible to re-consent those who had originally given consent for themselves and then lost capacity. They argued that if residents were to re-consent, we would need to do this consistently across the study population regardless of whether or not they had lost (or gained) capacity.