Recent laws, and their interpretation, have made clinical research more difficult to do, and sometimes impossible. Furthermore the results of that research which can be done may even be unreliable. This is certainly against the public interest, and indeed the individual patient interest as well. But ethics committees have to abide by the law and so even though it is surely unethical to work against the public and individual interest that is exactly what ethics committees now have to endorse. The unintended consequences of the new regulations must be reduced by amending the law.
References
1.
Confidentiality: Protecting and providing information. General Medical Council, 2000.
2.
Confidentiality: Protecting and providing information. General Medical Council, 2004.
WadeD. Ethics, audit, and research: all shades of grey. BMJ2005330468–473.
6.
Human Tissue Act2004.
7.
The Inquiry into the management of care of children receiving complex heart surgery at Bristol Royal Infirmary, 2001.
8.
The Royal Liverpool Children's Inquiry Report. London: The Stationary Office, London. 2001.
9.
Scottish Study of Intracranial Vascular Malformation Study (SIVMS). http://www.sivms.com/ (Accessed 4 May 2005).
10.
SudlowC. Lessons from a pregnancy and childbirth. BMJ2005330973.
11.
Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use implemented in the UK as the Medicines for Human Use (Clinical Trials) Regulation 2004.
