Impact of the demand for ‘proxy assent’ on recruitment to a randomised controlled trial of vaccination testing in care homes

Abstract

Legal frameworks are in place to protect those who lack the capacity to consent to research, such as the Mental Capacity Act in the UK. Assent is sought instead from a proxy, usually a relative. However, the same legislation may, perversely, affect the welfare of those who lack capacity and of others by hindering the process of recruitment into otherwise potentially beneficial research. In addition, the onus of responsibility is moved from those who know most about the study (ie, the scientific community) to those who know less (the proxies). In this paper, we describe the characteristics of a sample at different stages of the recruitment process of an influenza vaccine-based randomised control trial in elderly care home residents (the FEVER study). 62% (602/968) of potential subjects lacked capacity but only 29% (80/277) of those actually randomised. Older age, being female and living in an Elderly Mentally Ill care home were the only variables associated with lacking capacity. Considering this was a study based in a care home setting where the prevalence of dementia approximates 80%, the trial, like many others, was thus significantly biased. We believe that difficulties seeking proxy assent contributed significantly to this problem. Further thought should be given to how assent to enter research for those who lack capacity should be provided, and we suggest avenues for further discussion such as independent risk/benefit expert panels.

Challenges of conducting research in long-term care facilities: a systematic review

“…There were 24 studies which reported challenges that fall under this theme [ 27 – 29 , 31 – 33 , 35 – 37 , 39 – 42 , 44 , 50 – 55 , 57 , 59 , 61 , 62 ]. Some major issues included in this theme were: recruitment, consent, residents prefer treatment over placebo, and attrition.…”

“…Obtaining informed consent from LTC residents, including cognitively impaired and emotionally unstable candidates, was described as difficult and time consuming [ 28 , 40 , 50 , 54 , 59 ]. Residents’ ability to consent could change during the research period, and some were excluded unnecessarily due to incorrect evaluations of their ability to consent [ 40 , 51 , 62 ].…”

Research involving adults lacking capacity to consent: the impact of research regulation on ‘evidence biased’ medicine

“…However, there are significant differences under these two separate regulatory regimes in the provisions for those lacking capacity to participate in medical research (Table 1). These differences increase the burden on researchers and clinicians responsible for recruiting eligible participants which presents additional barriers to conducting research with vulnerable groups [25]. …”

Healthcare professionals’ understanding of the legislation governing research involving adults lacking mental capacity in England and Wales: a national survey

“…The complexity of the current legal framework, its legislative differences and uncertainty surrounding their interpretation has resulted in confusion both for researchers and Research Ethics Committees,5 6 as well as clinicians, relatives and carers involved in decisions about adults lacking capacity participating in research 7. These differences increase the burden on those involved in making decisions about research participation and present barriers to conducting research with individuals with cognitive impairments 8 9. As a result, the exclusion of these groups from research is widespread, and concerns about their exclusion have been reported 10 11.…”