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

Source: Journal of Medical Ethics Area: Evidence > Medicines Management > References 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 (i.e. the scientific community) to those who know less (the proxies). This paper describes 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 ...
Source: NeLM - Care of Older People - Category: Geriatrics Source Type: news