Involving adults who lack capacity in research: ethical and legal challenges for the pre-hospital and emergency medicine context

The free and informed consent of a potential research participant is regarded as the fundamental basis of ethical research (Declaration of Helsinki, 2013). The now well known horrible history of abuse and exploitation of vulnerable persons in research has served to emphasise the point (Beecher, 1963; Pappworth, 1967; Annas et al, 1992). However, this genuine concern for the vulnerability of those who lack the capacity to consent has created an ethical dilemma. Involving adults in research in circumstances when they lack or lose the capacity to consent has been legally problematic and remains ethically troubling. An absolute ban on the involvement of people who cannot consent may be the only effective measure to protect the vulnerable but it would have the negative consequence that important, often life-saving research for the direct benefit of those individuals could not be conducted. The effect of a ban is that those very people who would most benefit from research are unable to benefit (Chalmers, 2007). An equal and related concern has been consistently raised by researchers, namely that an overly stringent insistence upon what Roberts et al (2011) call the ‘rituals of consent’ may also be detrimental. In the recent past, researchers and Research Ethics Committees (REC) were forced to employ an ethical ‘fudge’ with regard to research involving adults who lacked capacity. In such cases either the research was justified on the basis of the ‘doctrine of necessity’ or else a ‘proxy’ consent for the incapacitated person was given by the next of kin or closest relative. However, such practices had no basis in law and left the participant, an already vulnerable person, open to further exploitation as there were no legal safeguards. These actions also left the researcher and REC open to legal challenge, since the actions violated the principles of common law and left them open to a charge of unethical practice.