Brief report on the experience of using proxy consent for incapacitated adults

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.

Informed Consent in Emergency Research: A Contradiction in Terms

“…The need for consent also affected the number of patients recruited; with an average of 1.5 per month when consent was necessary compared to 2 per month when it was not. This appears to substantiate the concerns raised by Mason et al [15].…”

“…Mason et al reported their experiences of recruiting incapacitated adults to the PRESSURE trial, which was investigating the best pressure relieving mattress for preventing pressure sores [15]. Incapacitated, and therefore immobile, patients are vulnerable to pressure sores, so were a group to whom the results would particularly apply.…”

ICU research: the impact of invasiveness on informed consent

“…Nonetheless, this was an increase on our pilot study. Such participation rates are not rare in ICU research [20,23,24,36,37], especially for complex questionnaires on vignettes. This is undoubtedly due to patients' considerable residual fatigue and other impairments after recent ICU stays (Fig.…”

The ethics of consent in delirium studies

“…Mason et al [14] investigated the effectiveness of pressure-relieving mattresses for use with older, frail patients, a study involving minimal risk to patients. They found that only 18% of those patients who possessed capacity refused consent compared to a 45% refusal rate from proxies for those patients who required proxy consent.…”