Academic clinical research in the new regulatory environment.
As a result of European legislation passed in 2001 (Directive 2001/20/EC), all clinical trials, whether sponsored by industry, a major national body or charity, or done by a single academic investigator, must get approval from the Medicines and Healthcare products Regulatory Agency (MHRA) as well as obtaining ethical approval. This requires all studies to be carried out to the standards of 'Good Clinical Practice' and places burdens on investigators in terms of reporting adverse events and archiving. A new directive has been published in draft form that will finally define what is meant by Good Clinical Practice in Europe.
Gennery
Brian
B
Faculty of Pharmaceutical Medicine, London. bagqual@aol.com
D000046:Academic Medical Centers / Q000941:ethics / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence*; D032984:Ethics, Research; D005062:European Union; D006801:Humans; D006113:United Kingdom