Informed Consent: Is it Sacrosanct?

Abstract

Following Alder Hey and the earlier and much more extreme practices at Nuremberg, legislation has been developed governing the practice of medical ethics and research involving human participants more generally. In the medical context, relevant legislation includes GMC guidance, which states that disclosure of identifiable patient information without consent, for research purposes, is not acceptable unless it is justified in the public interest. There is a presumption, in other words, in favour of the view that patient consent ought to be obtained before any piece of research is conducted. The Data Protection Act, furthermore, requires informed consent to be given before any use of identifiable personal data is made for any purpose. Moreover, ensuring that the informed consent of participants is gained is common practice on most research ethics committees. I argue, in this paper, that applying the principle of ‘informed consent’ too mechanistically in the research ethics context risks undermining the very principle it is designed to support – the principle of autonomy. This issue has been much discussed in medical ethics but not so much, so far, in the research ethics context. It will be argued that a more discerning and a less rigid and mechanistic approach, applied by research ethics committees, may help ensure that ethical issues are properly considered.