Ethics briefings
Proxy consent for the involvement of incapacitated adults in drug trials was discussed in a previous ethics briefing on the implementation of the EU Clinical Trials Directive.1 In 2003, the BMA expressed concern about the piecemeal introduction of proxy decision making, prior to the introduction of...
| Authors: | ; ; ; |
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| Format: | Electronic Article |
| Language: | English |
| Check availability: | HBZ Gateway |
| Journals Online & Print: | Drawer...
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| Fernleihe: | Fernleihe für die Fachinformationsdienste |
| Published: |
BMJ Publ.
2004
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| In: |
Journal of medical ethics
Year: 2004, Volume: 30, Issue: 4, Pages: 421-422 |
| Online Access: |
Volltext (JSTOR) Volltext (kostenfrei) |
| Summary: | Proxy consent for the involvement of incapacitated adults in drug trials was discussed in a previous ethics briefing on the implementation of the EU Clinical Trials Directive.1 In 2003, the BMA expressed concern about the piecemeal introduction of proxy decision making, prior to the introduction of more wide ranging mental incapacity legislation. In May 2004, this was echoed by the House of Lords in ongoing debate about the Medicines for Human Use (Clinical Trials) Regulations.2 It also became clear that the forthcoming Mental Capacity Act (formerly the Mental Incapacity Bill) would provide a proxy consent mechanism for strictly controlled research on incapacitated adults. In late 2003, a joint lords and commons committee scrutinising the draft incapacity bill recommended that “a clause be included to explore the causes and consequences of mental incapacity and to develop effective treatment for such conditions”.3 The government accepted this proposal and consulted stakeholders about its potential scope and appropriate safeguards. The act is expected to permit a range of research including studies on health and social care, subject to approval by research ethics committees. It may also amend the Human Tissue Bill to permit research on residual tissue taken from incapacitated people for diagnosis or therapy. Research must, however, relate to conditions affecting only incapacitated people in circumstances where there is no possibility of involving competent adults. Not only research expected to benefit the incapacitated individual, will be permitted: the act is also likely to allow research primarily intended to benefit others with the same condition, as long as it presents only minimal risk. It remains to be seen, however, how the medicinal trials regulations and the capacity act create joined up rules in this first attempt to introduce legally recognised proxy decision making in England and Wales. It is … |
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| ISSN: | 1473-4257 |
| Contains: | Enthalten in: Journal of medical ethics
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