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Brief report on the experience of using proxy consent for incapacitated adults
  1. S Mason1,
  2. H Barrow2,
  3. A Phillips1,
  4. G Eddison1,
  5. A Nelson3,
  6. N Cullum3,
  7. J Nixon1
  1. 1Clinical Trials Research Unit, University of Leeds, Leeds, UK
  2. 2Leeds Teaching Hospitals NHS Trust, Leeds, UK
  3. 3Department of Health Sciences, University of York, York, UK
  1. Correspondence to:
 Su Mason PhD
 Clinical Trials Research Unit, University of Leeds, 17 Springfield Mount, Leeds, LS2 9NG, UK; medsam{at}leeds.ac.uk

Abstract

The Medicines for Human Use (Clinical Trials) Regulations 2004, which came into force in the UK in May 2004, cover the conduct of clinical trials on medicinal products. They allow a legal representative (a person not connected with the conduct of the trial) to consent to the participation of incompetent adults in medical research. Currently, very little is known about how such representatives will make their decisions.

We have experience with proxy consent for older adults in a large, national trial. From 2445 potentially eligible but incapacitated patients, proxy, relative assent resulted in trial participation of only 87 (3.6%) patients. The reasons for this were that a large number of incapacitated patients had no relative available for assent (2286), but also a high proportion of relatives approached refused to provide assent (72/159, 45.3%). In comparison, 17.7% of patients declined participation in the trial.

Proxy consent allowed only a small increase in trial recruitment of incapacitated patients. The fact that a greater proportion of relatives than patients refused to provide assent implies that they were more cautious than the patients themselves, or perhaps used different criteria, when making their decision.

In future research involving incapacitated older patients there is likely to be heavy reliance on proxy consent provision by legal representatives. Our findings imply that consent decisions of legal representatives will not necessarily reflect those of patients themselves.

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Footnotes

  • All authors declare no competing interests.

  • There has been substantial contribution by all authors to the: 1) conception and design, or acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content, and 3) final approval of the version to be published.

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