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

Journal of Medical Ethics 39 (1):36-40 (2013)
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
Keywords No keywords specified (fix it)
Categories (categorize this paper)
Options
 Save to my reading list
Follow the author(s)
My bibliography
Export citation
Find it on Scholar
Edit this record
Mark as duplicate
Revision history Request removal from index
 
Download options
PhilPapers Archive


Upload a copy of this paper     Check publisher's policy on self-archival     Papers currently archived: 9,360
External links
  •   Try with proxy.
  •   Try with proxy.
  •   Try with proxy.
  •   Try with proxy.
  •   Try with proxy.
  • Through your library Configure
    References found in this work BETA

    No references found.

    Citations of this work BETA

    No citations found.

    Similar books and articles
    Analytics

    Monthly downloads

    Sorry, there are not enough data points to plot this chart.

    Added to index

    2012-09-02

    Total downloads

    1 ( #306,343 of 1,089,155 )

    Recent downloads (6 months)

    1 ( #69,735 of 1,089,155 )

    How can I increase my downloads?

    My notes
    Sign in to use this feature


    Discussion
    Start a new thread
    Order:
    There  are no threads in this forum
    Nothing in this forum yet.