Impact of the demand for 'proxy assent' on recruitment to a randomised controlled trial of vaccination testing in care homes
David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
Learn more about PhilPapers
Journal of Medical Ethics 39 (1):36-40 (2013)
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)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
No references found.
Citations of this work BETA
No citations found.
Similar books and articles
H. Mann (2005). Controversial Choice of a Control Intervention in a Trial of Ventilator Therapy in ARDS: Standard of Care Arguments in a Randomised Controlled Trial. Journal of Medical Ethics 31 (9):548-553.
L. Trevena (2006). Impact of Privacy Legislation on the Number and Characteristics of People Who Are Recruited for Research: A Randomised Controlled Trial. Journal of Medical Ethics 32 (8):473-477.
Gordon C. S. Smith & Jill P. Pell (2003). Parachute Use to Prevent Death and Major Trauma Related to Gravitational Challenge: Systematic Review of Randomised Controlled Trials. Bmj 327 (7429):1459--61.
P. Allmark (2006). Should Desperate Volunteers Be Included in Randomised Controlled Trials? Journal of Medical Ethics 32 (9):548-553.
P. Allmark (2001). Is It in a Neonate's Best Interest to Enter a Randomised Controlled Trial? Journal of Medical Ethics 27 (2):110-113.
Valerie Shilling & Bridget Young (2009). How Do Parents Experience Being Asked to Enter a Child in a Randomised Controlled Trial? BMC Medical Ethics 10 (1):1-.
Charles Weijer, Stanley H. Shapiro & Kathleen Cranley Glass, Clinical Equipoise and Not the Uncertainty Principle Is the Moral Underpinning of the Randomised Controlled Trial.
B. Arda, A. Aciduman & J. C. Johnston (2012). A Randomised Controlled Trial of Ribavirin in Crimean Congo Haemorrhagic Fever: Ethical Considerations. Journal of Medical Ethics 38 (2):117-120.
David J. Torgerson & Carole J. Torgerson (2003). Avoiding Bias in Randomised Controlled Trials in Educational Research. British Journal of Educational Studies 51 (1):36 - 45.
J. B. Grant, A. J. Mackinnon, H. Christensen & J. Walker (2009). Participants' Perceptions of Motivation, Randomisation and Withdrawal in a Randomised Controlled Trial of Interventions for Prevention of Depression. Journal of Medical Ethics 35 (12):768-773.
Y.-Y. Chen & Y.-C. Chen (2008). Evaluating Ethics Consultation: Randomised Controlled Trial is Not the Right Tool. Journal of Medical Ethics 34 (8):594-597.
M. I. Zia, R. Heslegrave & G. E. Newton (2011). Post-Trial Period Surveillance for Randomised Controlled Cardiovascular Studies: Submitted Protocols, Consent Forms and the Role of the Ethics Board. Journal of Medical Ethics 37 (12):762-765.
P. S. Myles, K. Leslie, J. McNeil, A. Forbes & M. T. V. Chan (2004). Bispectral Index Monitoring to Prevent Awareness During Anaesthesia: The B-Aware Randomised Controlled Trial. Lancet 363 (9423).
J. G. Berry, P. Ryan, M. S. Gold, A. J. Braunack-Mayer & K. M. Duszynski (2012). A Randomised Controlled Trial to Compare Opt-in and Opt-Out Parental Consent for Childhood Vaccine Safety Surveillance Using Data Linkage. Journal of Medical Ethics 38 (10):619-625.
Carole J. Torgerson & David J. Torgerson (2001). The Need for Randomised Controlled Trials in Educational Research. British Journal of Educational Studies 49 (3):316 - 328.
Sorry, there are not enough data points to plot this chart.
Added to index2012-09-02
Total downloads1 ( #431,671 of 1,098,129 )
Recent downloads (6 months)1 ( #283,807 of 1,098,129 )
How can I increase my downloads?