Ethics and research in emergency medicine

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Despite the difficulties facing researchers in the area of emergency medicine, there is recent thoughtful and constructive discussion on how to conduct this research¹. The need is as great in this specialty as in others and, as elsewhere, tends to be generated by new technology and new pharmacology.

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Emergency medicine can be defined as a medical specialty involving care for undifferentiated, unscheduled patients with potentially serious acute illnesses or injuries that require immediate medical attention.
While not usually providing long-term or continuing care, emergency physicians undertake the necessary investigations and interventions to diagnose patients in the acute phase, to liaise with physicians from other specialities, and to resuscitate and stabilise those who are seriously ill or injured. Emergency physicians generally practice in hospital emergency departments, pre-hospital settings via emergency medical services, and intensive care units, but may also work in primary care settings such as urgent care clinics.
As with other medical specialties, there is a recognised need for practice in emergency medicine to be based on evidence of efficacy and safety. For this to be the case, continuing research is necessary.
Over the last six decades, a well-established consensus has emerged of the ethical values and principles that are essential for the conduct of research involving humans and, in particular, of medical research. In Australia, these principles and values are expressed, in the National Statement on Ethical Conduct in Human Research, 2007 (as amended 2015) NHMRC, ARC, UA (National Statement) as:
‘Research merit and integrity – that is, only when proposed research has merit: scientific validity and social value, and the researchers who are to conduct it have integrity, is the involvement of human participants in the research ethically justifiable.’
The elements in the above definition of emergency medicine reveal clearly the ethical difficulties of research in emergency medicine. Although devising a scientifically valid project is unlikely to be particularly difficult, demonstrating the value of establishing that a trial treatment is superior to the conventional methods, in the face of the urgent need of participants, is likely to be challenging to ethical reviewers.
The fact that patients are experiencing serious, acute illnesses or injuries and that emergency clinicians do not normally provide continuing care, are likely to make it more difficult than in other specialties to clearly distinguish the risks of the emergency situation from the risks involved in conducting a research study.
The fact that emergency patients are undifferentiated, unscheduled and require immediate medical attention vastly complicates conformity with the principle of respect. Not only will the capacity of many (or even most) potential participants be impaired or even lacking, the time available to provide information, generate understanding and achieve consent will usually be severely limited.
Lastly, because patients are characteristically undifferentiated and unscheduled it may appear difficult to ensure justice in their recruitment and in the burdens that they bear as participants compared with the benefits that may flow to others.
The primary focus of the current conversation appears to be on consent: specifically the practical difficulties presented by potential participants who either lack or have a severely impaired capacity. In other medical specialties, there are well-established means of addressing these shortcomings by relying on ethical and legal authorisation of substitute decision-makers to provide consent on behalf of impaired or unconscious participants. These remain available in emergency medicine but there may not be time available to locate, contact and gain consent from an authorised representative.
In the face of these difficulties, some modifications of conventional means of seeking and gaining consent to research participation have been explored. These include providing a limited or simplified amount of information, staging participation from initial intervention and providing options to continue or revert to standard care thereafter, or reliance on ‘ethics committee approval’ of either a deferred consent or a waiver of the requirement for consent.
The National Statement provides sets of criteria to be considered by an ethics committee in reaching a decision to either defer (National Statement, paragraphs 4.4.13 to 4.4.14) or to waive the requirement for consent (National Statement paragraphs 2.3.9 to 2.3.10). Both of these sets of ethical criteria make it clear that they are subject to proposed research procedures being lawful within the relevant jurisdiction. It is notable here that guardianship laws in Queensland, New South Wales and Victoria have made some provision for the recruitment of participants lacking decisional capacity to certain kinds of human research.
When considering a research project in emergency medicine, seeking advice from an experienced human research ethics staff member, committee chair or member will always be a prudent first step. Carefully assessing how a proposed project can be shown to meet each of the four National Statement principles is a task to be confronted at the commencement of the project, and not after the project has been designed. Use of and reliance on the relevant parts of the National statement in order to demonstrate how a proposed unique study in emergency medicine will conform is an appropriate strategy.

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‘Research merit and integrity – that is, only when proposed research has merit: scientific validity and social value, and the researchers who are to conduct it have integrity, is the involvement of human participants in the research ethically justifiable.’
National Statement on Ethical Conduct in Human Research, 2007

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The National Statement makes clear, at page 6, that: These ethical guidelines are not simply a set of rules. Their application should not be mechanical. It always requires, from each individual, deliberation on the values and principles, exercise of judgement, and an appreciation of context.
Colin Thomson
BA, LLB, LLM (Sydney)
www.ehealthinfo.gov.au
Colin Thomson, BA, LLM (Sydney) is Professor of Law at the University of Wollongong and Academic Leader for Health Law and Ethics in the Graduate School of Medicine. He also works as a consultant.
He was a member of the Medical Research Ethics Committee (1988-91) of the National Health and Medical Research Council and, from 1998-2002 a member, and from 2006-2009, chair of the Australian Health Ethics Committee. As a consultant, he has advised NHMRC, FaHCSIA, Health Departments of NSW, Qld and Vic and several universities. He is a Senior Consultant with Australasian Human Research Ethics Consultancy Services (www.ahrecs.com).
Colin has provided training to human research ethics committees, chairs the CSIRO Social Science HREC and is a member of HRECs at Department of Health and Ageing and University of Wollongong/ Illawarra Shoalhaven LHD.
He is a joint author of Good Medical Practice: professionalism, ethics and law, 2010, Cambridge University Press.

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Beneficence – that is, all risks to participants, must be justified by the potential benefits of the research.
Respect – that is, giving due scope to the capacity of participants to make their own decisions and having due regard for their privacy, beliefs, customs and culture.
Justice – that is that the selection, exclusion and inclusion of participants is fair and that the distribution of the burdens and benefits of participation and research is also fair.

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References
1. Dickert, N.W at al Confronting Ethical and Regulatory Challenges of Emergency Care Research with Conscious Patients, (2015) http://dx.doi.org/10.1016/j.annemergmed.2015.10.026