Clinical research without consent in adults in the emergency setting: a review of patient and public views

Abstract

BackgroundIn emergency research, obtaining informed consent can be problematic. Research to develop and improve treatments for patients admitted to hospital with life-threatening and debilitating conditions is much needed yet the issue of research without consent (RWC) raises concerns about unethical practices and the loss of individual autonomy. Consistent with the policy and practice turn towards greater patient and public involvement in health care decisions, in the US, Canada and EU, guidelines and legislation implemented to protect patients and facilitate acute research with adults who are unable to give consent have been developed with little involvement of the lay public. This paper reviews research examining public opinion regarding RWC for research in emergency situations, and whether the rules and regulations permitting research of this kind are in accordance with the views of those who ultimately may be the most affected.MethodsSeven electronic databases were searched: Medline, Embase, CINAHL, Cochrane Database of Systematic Reviews, Philosopher's Index, Age Info, PsychInfo, Sociological Abstracts and Web of Science. Only those articles pertaining to the views of the public in the US, Canada and EU member states were included. Opinion pieces and those not published in English were excluded.ResultsConsidering the wealth of literature on the perspectives of professionals, there was relatively little information about public attitudes. Twelve studies employing a range of research methods were identified. In five of the six questionnaire surveys around half the sample did not agree generally with RWC, though paradoxically, a higher percentage would personally take part in such a study. Unfortunately most of the studies were not designed to investigate individuals' views in any depth. There also appears to be a level of mistrust of medical research and some patients were more likely to accept an experimental treatment 'outside' of a research protocol.ConclusionThere are too few data to evaluate whether the rules and regulations permitting RWC protects – or is acceptable to – the public. However, any attempts to engage the public should take place in the context of findings from further basic research to attend to the apparently paradoxical findings of some of the current surveys.

Is Emergency Research Without Initial Consent Justified?

“…8,9 Yet, a 2001 European Union directive seems to prohibit emergency research. 4,6,10,11 Moreover, no ethical justification for conducting emergency research without informed consent has been widely accepted. 12,13 Critics of the practice characterize the waiver of informed consent requirements as "a triumph of the interests of the pharmaceutical industry, medical device companies and the research community .…”

“…Regulations permit waiver of informed consent requirements under certain conditions in the United States, Canada, and Australia. [4][5][6][7] The Declaration of Helsinki and the International Ethical Guidelines for Biomedical Research Involving Human Subjects explicitly allow emergency research without consent. 8,9 Yet, a 2001 European Union directive seems to prohibit emergency research.…”

Research in Emergency and Critical Care Settings: Debates, Obstacles and Solutions

“…These are the guidelines for conducting emergency research under a waiver of informed consent to safeguard against unethical research conduct. Currently, in various countries such as the US, EU member states, Canada, and Australia, there are provisions for the research without informed consent in emergency situations (Lecouturier et al 2008). In addition, European nations such as Austria, Belgium, France, Netherlands, Germany, and Spain have their own national legislation for emergency research (Lemaire et al 2005).…”

Views of emergency research (VERA): A qualitative study of women and their partners' views of recruitment to trials in severe postpartum haemorrhage

“…This mismatch is compounded by the fact that the research literature currently offers little insight into this situation. Studies describing views of the general public about emergency research without prior consent have not as yet yielded a coherent body of opinion, and authors of a review of these studies concluded that they provided insufficient evidence of whether or not there is public support for such research (Lecouturier et al, 2008). Much of the research considering patients' views of the management of trial enrolment without prior consent has been carried out with populations which are demographically different from labouring women, and while studies of participants' views of emergency trials offer insights into research in stressful, life-threatening circumstances, they are tangential to labour and the particular circumstances of obstetric emergencies.…”