Hood Trials

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See entire library of World music Good Deals. In our study recently published in Trials , in which we conducted a content analysis of Participant Information Sheets provided to consultees and legal representatives of adults who lack capacity, we noted the small number of trials designed to include participants who lack capacity [ 29 ]. What was missing from this account was an understanding of not just how many trials are designed to include adults who lack capacity to consent, but how many participants who lack capacity are subsequently enrolled in these trials.

Knowing how many of the participants enrolled in trials who lacked capacity to consent will aid understanding of the generalisability of the findings to these populations; help identify under-represented or underserved groups; and ensure transparency around the recruitment of under-represented groups. The inadequate recruitment of traditionally under-represented populations prevents researchers from creating tailored interventions [ 30 ]; therefore, understanding the populations included in research is an important first step towards eliminating the existing health disparities that in part arise from these research inequalities [ 31 ].

We explored this through a further analysis of participant data from trials completed within the preceding three years, which we now describe in this commentary. In England and Wales, the legal frameworks govern the inclusion of adults who lack capacity in clinical trials of medicinal products under the Medicines for Human Use Clinical Trials Regulations [ 32 ], with other types of research governed by the Mental Capacity Act [ 3 ]. Under this legal framework, someone who knows the person who lacks capacity is approached by the researcher to act as their legal representative or consultee.

here In circumstances where no-one is available or willing to act in a personal capacity, then a professional who cares for the person can act as a professional legal representative usually the doctor primarily responsible for their medical treatment or nominated consultee on their behalf [ 3 , 32 ]. This legal basis is regardless of how well the professional legal representative or nominated consultee knows the person who lacks capacity to consent, and so in turn the extent to which they can determine the wishes and feelings of the person.

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Our previous study identified particular issues with the information provided to professionals acting as a proxy decision-maker legal representative or consultee. We were therefore interested in examining the data reporting on the use of personal versus professional legal representatives and consultees in order to consider for the first time the extent of the use of professionals as proxy decision-makers in the UK. Our previous analysis of Participant Information Sheets and this additional study form part of a larger project exploring research involving adults who lack capacity to consent, and the involvement of consultees and legal representatives.

The study reported in this commentary aimed to identify 1 the number of trials completed in the UK within the last three years that included adults who lack decision-making capacity; 2 the number of participants enrolled in the trials and the percentage who lacked decision-making capacity; and 3 who acted as their proxy decision maker. A search of clinical trials was conducted using the ISRCTN registry [ 34 ] to identify trials that included adults who lacked capacity to consent that were registered in the UK.

We amended the search strategy that was reported in our Trials paper to identify only trials that had been completed in the previous three years. As in our previous study, eligible studies were those that 1 included or did not exclude adults who lacked capacity to consent and therefore required proxy consultee or legal representative involvement, and 2 had recruited participants in the UK.

As the focus of the larger project is on the involvement of consultees and legal representatives we excluded trials that used a deferred consent model or consent waiver in emergency research settings, such as post cardiac arrest, where obtaining consent from a legal representative or consulting others is not reasonably practicable [ 35 ].

As described in our previous study, trial registries such as ISRCTN are not necessarily intended for searches of this nature [ 29 ]. However, they are the only available source for identifying studies across multiple sites, funders, settings, and conditions or populations under investigation. This necessitated a pragmatic search strategy which identified condition or population-specific search terms that would capture trials likely to include adults who lack capacity to consent. The process for trial registry searches, eligibility screening of trials, and data extraction is shown in Fig.

The sampling methods used in the published study and in this analysis are derived from similar studies assessing the inclusion of older people [ 19 , 36 ] and people with intellectual disabilities [ 21 ] in medical research. Searches were conducted in July Searches were only limited by relevant fields: trial status completed only , countries of recruitment United Kingdom , and either condition e.

Trial records were then screened for eligibility by reviewing the participant inclusion and exclusion criteria detailed in the registry record and, where available, the protocol or other study publication. The published participant data were extracted from study publications and reviewed, and the total number of participants, the number of participants who lacked capacity, and details of consultee or legal representative involvement were extracted. Where these data were not available e.

As many data were unpublished, trial teams or Chief Investigators were advised when we requested the data that the trials would not be identifiable in our study. Descriptive statistics were used to report the number of studies, total number of participants, and number of participants who lacked capacity. Where known, the number of participants who had a personal consultee or legal representative, versus a nominated consultee or professional legal representative, were reported.

No data were obtained for three trials as there were no publications associated with the trial, and there was no response to our request from the trial team or Chief Investigator. Trials that used a combination were conducted across a range of settings, including long-term care settings such as care homes Study ID 07 , primary care Study ID 09 , as well as acute critical care settings Study ID Only a small proportion of clinical trials include adults who lack capacity to consent, even in populations with conditions which can be characterised by impaired decision-making capacity.

Despite the size of the population of people who lack capacity in England and Wales being roughly equivalent to the number of people living with cancer in the UK [ 37 ], the number of clinical trials that include participants who lack capacity appears to be considerably lower than the number of cancer trials. The number of cancer patients in the UK participating in clinical studies has risen dramatically in the past decade from one in 26, to around one in six patients diagnosed [ 38 ]. Our findings suggest that this under-representation is seen in a range of different populations experiencing impaired capacity.

The data suggest that professionals acting as a nominated consultee or professional legal representative for an adult who lacks capacity to consent is not a rare occurrence and, in some trials, they alone take on this role. There may be a number of factors affecting who is involved in decisions about research participation.

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It may be linked to the timeframes within which the participant needs to be recruited in an acute setting and the subsequent availability of a family member within that timeframe. It was also reported by one trial that family members of care home residents sometimes felt unable to make a decision on behalf of their relative, and therefore consider the care home staff better placed to do so, whilst others failed to respond to contact by the research team.

There are concerns about whether those acting as nominated consultees and professional legal representatives are sufficiently informed and prepared for their role.

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Our previous research has shown that there is a lack of knowledge amongst health and social care professionals about the legislation governing research involving adults who lack capacity [ 33 ], leading to concerns about the confidence and competence of care professionals when including those who lack capacity in their care in medical research. As a result, guidance for professionals is urgently needed beyond that briefly included in the Mental Capacity Act Code of Practice [ 2 ]. There is also a need for further research to examine the informational needs of health and social care professionals acting as nominated consultees and professional legal representatives and explore how they approach decision-making in such ethically complex roles.

As reported in our previous study [ 29 ] there are a number of limitations to note. Whilst capacity is considered to be time and decision-specific rather than global [ 3 ], the circumstances under which a consultee or legal representative is required, and whether their relationship with the adult who lacks capacity to consent is a personal or professional relationship, are relevant factors in this context.