In this paper, the author shows how research ethics committees must deal with illegality in the research protocol. He defines their legal duty by reference to the 2001 Clinical Trials Directive, and especially in the key areas of insurance, indemnity and no-fault compensation. The author is critical of the current GAfREC and recent guidelines issued by the Royal College of Physicians. He concludes that new rules are needed to replace the 2001 edition of GAfREC.
References
1.
Guidelines on the practice of ethics committees in medical research with human participants (4th edn). London: The Royal College of Physicians, 2007.
2.
Governance arrangements for NHS research ethics committees. Dept of Health: July 2001.
3.
SaundersJ. Invited editorial: Meeting the needs of the investigator and the REC member. Res Ethics Rev2007; 3(4): 111–112.
4.
SI 2006 No. 2984 The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations2006.
Directive 2001/20/EC; Directive 2005/28/EC; SI 2004 No. 1031; SI 2006 No. 1928: SI 2006 No. 2984.
8.
Source: Int J Pharm Med/EFGCP2007; 21(1): 1–113.
9.
PRIVIREAL: a European Commission framework 5 funded project examining the implementation of the Data Protection Directive 95/46/EC in relation to medical research and the role of ethics committees.
10.
LaurenceDR. Guide, guide thyself: law and order in clinical research. Res Ethics Rev2008; 4(2): 69–72.
