New EU rules might hinder researchBMJ 2001; 322 doi: https://doi.org/10.1136/bmj.322.7283.385/a (Published 17 February 2001) Cite this as: BMJ 2001;322:385
- Rory Watson
Legislators for the European Union are trying to reassure medical researchers that recently agreed rules on clinical trials will not hinder their efforts to develop new drugs to help adult patients incapacitated with diseases such as Alzheimer's disease.
The new legislation was adopted by the 15 EU governments and the European parliament shortly before Christmas (13 January, p 68). It stipulates that medicinal products for trial may be administered to individuals incapable of giving their consent only when foreseeable risks and inconveniences have been weighed against the anticipated benefit for the individual trial subject and society. Consent to the subject's participation must be given by …