By Rebecca Doyle.

Robust, research evidence informs best practice and facilitates medical care that is both current and of the highest quality. In an effort to protect children and families who may be exposed to sources of vulnerability in the paediatric critical care environment, is the Australian National Statement jeopardising advancements to critical care research by failing to provide clear guidelines on the use of deferred consent? Will a lack of research evidence in the paediatric critical care population result in the most vulnerable and severely ill patients receiving unreliable and untested medical procedures and medications?  In our efforts to protect the research rights of sick children we may be presenting an alternative which carries a very real risk of exposure to harm caused by treatment and medicines that are not proven safe.

Research in the critical care environment often requires rapid recruitment, especially if the intervention is lifesaving. Children as research participants in the critical care setting add another layer of complexity to the consenting process. The process of obtaining prospective, informed consent from a parent or legal guardian in paediatric research is a fundamental principle aimed at protecting the rights of children as participants. Informed consent supports the principles of autonomy, justice, beneficence and non-maleficence. But what about the rights of participants if prospective consent can’t be obtained before the intervention takes place? The same principles of justice, beneficence and non-maleficence are potentially jeopardised by excluding patients from research because they don’t meet current consent guidelines. Beneficence and non-maleficence are supported through providing the best evidence-based care.

The vulnerability of this patient group is highlighted by the commonly cited challenges to prospective informed consent. Paediatric intensive care patients are critically unwell, sometimes unaccompanied by a parent or guardian, and require emergent care. Families of critically ill children are also vulnerable as they are usually very distressed and may have diminished capacity to make informed decisions. The requirement of prospective informed consent in this complex population may be asking too much of potential participants and their parents, and alternative consenting processes need to be considered to progress medical research.

Without deferred consent, research in this population may be unfeasible, ungeneralisable, and suffer selection bias impacting research outcomes. Good quality research and well-designed clinical trials in children are essential for advancements in paediatric critical care medicine. Results from studies performed in adults and animals cannot be routinely applied to the paediatric population for a range of reasons. In the absence of paediatric specific research, the management of critically ill infants and children may often be based on anecdotal experience and theoretical treatment.

The National Health and Medical Research Council of Australia (NHMRC) is currently seeking public consultation regarding the revision of Sections 4 and 5 of the National Statement on Ethical Conduct in Human Research. Section 4 refers to ethical considerations related to potentially vulnerable research participants, including patients in emergency and intensive care. The draft provides improved definitions of vulnerability which it describes as existing on a scale and being dependent on circumstances, as opposed to labelling specific groups as vulnerable. This is more in keeping with the notion that anyone can be vulnerable depending on the situation they are faced with.

The proposed draft also recommends researchers conduct research with participants who accurately represent the target population. It advocates for participants to be included in research who may previously have been excluded because they were thought to be too sick, too young, too distressed, or too disadvantaged. This way, the results will be generalisable to that specific population and will likely benefit a wider population.

While these changes to the National Statement are welcomed, there are elements of the draft that remain ambiguous and contradictory. Statements relating to the use of deferred consent in participants of emergency and intensive care research are particularly confusing and equivocal. Human Research Ethics Committees in Australia use the guidance of the National Statement as a basis to approve studies wanting to use deferred consent. Without clear direction and concise criteria, the use of deferred consent will continue to be inconsistent and open to interpretation.

Author: Rebecca Doyle

Affiliations: Griffith University, Queensland, Australia; Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee, Queensland Australia

Competing Interests:

Rebecca Doyle is a member of the Children’s Health Queensland Human Research Ethics Committee, and is undertaking a Master of Medical Research and this submission forms part of her thesis.

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Rebecca Doyle on Twitter: @rns75_doyle