69. Gill D. Ethical principles and operational guidelines for good clinical practice in paediatric research. Recommendations of the ethics working group of the confederation of european specialists in paediatrics (CESP). Eur J Pediatr 2004;163(2):53-7.
Download Abstract at: http://www.ncbi.nlm.nih.gov/pubmed/14716559
To protect the best interests of the child one must balance the ethical demand to do clinical studies with the necessity to avoid doing harm. To justify any research project one must balance the benefit/risk ratio, provide experienced, competent personnel and infracture, obtain adequate informed consent/assent, and have the study evaluated and approved by an ethics committee containing expertise on the rights and needs of children.
70. McLean SAM. What and who are clinical ethics committees for? Br Med J. 2007;33(9):497.
Download Abstract at: http://jme.bmj.com/content/33/9/497.extract
71. Edwards SJL, Lilford RJ, Hewison J. The ethics of randomised controlled trials from the perspectives of patients, the public, and healthcare professionals. Br Med J. 1998;317(7167):1209-12.
Download Full text at: http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=9794861
Doctors do not seem to take informed consent from competent patients as seriously as they should; ways in which practice might be improved need to be tested empirically Most doctors expressed willingness to enter their patients in trials even when the treatments offered were widely available but were not an equal bet prospectively; the fact that members of the public suspect this might undermine their confidence in trials.
Willingness to undergo randomisation drops as prospective participants are given more preliminary data and as they are made aware of any accumulating evidence of effectiveness A large number of participants, even in phase III trials, emerge from consultations expecting to benefit personally; self interest, rather than altruism, seems to be their motive for participating.
72. Knox S. Health economic decision making in Europe–a new priority for breast cancer advocacy. The Breast. 2009;18(2):71-2.
73. EFGCP. Impact on clinical research of european legislation. EFGCP; 2009 February 2009. Report No.1
Download report at: http://www.efgcp.be/downloads/icrel_docs/Final_report_ICREL.pdf
74. INVOLVE UK. Survey of lay members of research ethics commitees.INVOLVE UK; 2009 February 2009. 3
Download survey at: http://invo.org.uk/pdfs/CompleteRECreport070409.pdf