Research without prior consent in paediatric emergency and critical care medicine

Strategies to enhance recruitment and consent to intensive care studies: a qualitative study with researchers and patient–public involvement contributors

“…Such an approach has been useful in addressing methodological challenges in organ donation research, 35 while research evidence on stakeholders' perspectives has been pivotal in informing guidance on bereavement in the context of the critical care studies involving children. [36][37][38] Evidence on the perspectives of patients, relatives and staff regarding consent processes in adult critical care studies has been collected as part of the wider perspectives study and could be similarly informative on this and other issues.…”

Insisting on prospective consent in paediatric critical care research may be throwing the baby out with the bathwater

“…Child victims of trauma may be unaccompanied as their parent/guardian may have been injured, or even killed, in the same traumatic event. 7 IniƟal database search of Griffith Library catalogue, PubMed, CINAHL and Google Scholar using basic search terms.…”

“…The concept of prospective informed consent from a parent or legal guardian as a principle of ethical paediatric research is a fundamental of good clinical practice intended to protect the safety and rights of all potential research participants. 3,7 Prospective informed consent in research requires adequate and accurate disclosure of the study; capacity of the participant or proxy for decision-making; and a completely voluntary willingness to participate not subject to coercion or time pressures. 6,10 Identified challenges in paediatric critical care research are widely published and include: the absence of a parent/guardian; time constraints when the intervention needs to occur in a narrow therapeutic window; and overwhelmed parents/guardians suffering intense emotional distress which may affect the capacity to provide consent.…”

“…There exists a well-established need for high-quality clinical research in the paediatric intensive care population. [5][6][7][8][9][10] Rigorous research evidence informs clinical decision-making and advances medical knowledge while ultimately saving lives and decreasing the morbidity of critically ill infants and children. The best available care needs to be underpinned by well-conducted studies unique to this clinical area.…”

“…Child victims of trauma may be unaccompanied as their parent/guardian may have been injured, or even killed, in the same traumatic event. 7 IniƟal database search of Griffith Library catalogue, PubMed, CINAHL and Google Scholar using basic search terms. A study of traumatic brain injuries found children arrived within 1-2 h of injury, but parents did not arrive until 2-3 h or more later.…”