PLoS Medicine
(Accessed 22 November 2009)
http://medicine.plosjournals.org/perlserv/?request=browse&issn=1549-1676&method=pubdate&search_fulltext=1&order=online_date&row_start=1&limit=10&document_count=1533&ct=1&SESSID=aac96924d41874935d8e1c2a2501181c#results

Published 17 Nov 2009
The Unintended Consequences of Clinical Trials Regulations
Alex D. McMahon, David I. Conway, Tom M. MacDonald, Gordon T. McInnes

Summary Points
– Trial regulations are damaging noncommercial research and patients.
– The International Conference on Harmonisation (ICH) version of Good Clinical Practice (GCP) is inapplicable to most noncommercial research.
– ICH GCP is not usually legally binding (as conceded by the regulatory authorities in the UK).
– Other parts of the world should learn a lesson from the misguided trial regulations that have been created in Europe.