This is the fourth in a series of five papers on the role, remit and function of research ethics committees which are intended to provide for REC members a broad understanding of the most important issues in research ethics and governance. This paper explores the role of ethics committees in reviewing proposed conditions for recruiting human subjects and in checking the intended procedures for gaining consent. In so doing the paper will reiterate the conditions which are traditionally thought to make consent valid, identify a number of limitations to meeting these conditions, and show when consent, however broadly construed or indeterminately focused, may be unnecessary.
References
1.
GrubbA. Principles of medical law (2nd edn). Oxford: OUP2004.
2.
MansonNO'NeillO. Rethinking informed consent in bioethics. Cambridge: CUP2007.
CaleGS. Continuing the debate over risk-related standards of competenceBioethics1999; 13(2): 131–148.
12.
RobinsonEJKerrCStevensALilfordRBraunholtzDEdwardsS. Lay public's understanding of equipoise and randomisation in randomised controlled trials. Hlth Tech Assess2005; 9(8).
13.
AppelbaumPSRothLHLidzC. The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiat1982; 5: 319–329.
14.
RobinsonEJKerrCStevensALilfordRBraunholtzDEdwardsS. Lay conceptions of the ethical and scientific justifications for random allocation in clinical trials. Soc Sci Med2004; 58(4): 811–824.
15.
WilkinsonMMooreA. Inducement in research. Bioethics1997; 11: 373–89.
16.
DonovanJMillsNSmithMBrindleLJacobyAPetersTFrankelSNealDHamdyFLittleP. Quality improvement report. Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: presenting unbiased information to patients can be difficult. BMJ2002; 325: 766.
17.
EdwardsSJ. Restricted treatments, inducements, and research participation. Bioethics. 2006; 20(2): 77–91.
18.
EdwardsSJL. Assessing the remedy: the case for contracts in clinical trials. Am J Bioethics: forthcoming.
19.
HareJPrattCNelsonC. Agreement between patients and their self-selected surrogates on difficult medical decisions. Arch Intern Med.1992; 152: 1049–1054.
20.
ZelenM. Randomised consent designs for clinical trials: an update. Stat Med1990; 9: 645–6.
21.
SnowdonCGarciaJElbourneD. Making sense of randomization: responses of parents of critically ill babies to random allocation of treatment in a clinical trial. Soc Sci Med1997; 45(9): 1337–1355.
