Building together: A scoping review to inform better consenting practices for the most vulnerable in healthcare research
Kristen Gibbons1,2, Helen Liley2,3, Mary Boyde1,2, Ross Pinkerton4, Kerina Denny2,5, Alan Isles6, David Milne7, Marta Cucchi8, Melissa Bloomer9, 10, Debbie Long8, 11, Sainath Raman2, 8, Metro South Health Woolloongabba2, South Brisbane Q3, 56 Children’s Health Queensland1Metro South Health, Woolloongabba, Q, Australia2The University of Queensland, South Brisbane, Q, Australia3Mater Mothers’ Hospitals 4Mater Health 5Gold Coast University Hospital 6Children’s Health Queensland
Abstract
Background
In a life-threatening situation when urgent life-saving care in an intensive care unit (ICU) is required, any delay to receiving treatment may increase the likelihood of a poor clinical outcome. In such instances, obtaining prospective informed consent for research from substitute decision makers for adult patients, and the families/carers of a paediatric patient, is challenging. This can lead to a lack of evidence-based guidelines and new treatments for acutely ill patients, due to suboptimal research participation.
Discussion
The importance of conducting high-quality research in ICUs has been recognised internationally. Across many jurisdictions, legislation has been amended to include consent approaches that, where the treatment is time-critical, permits researchers to administer experimental treatments prior to gaining consent. This approach seeks to gain consent from the participant or caregiver after the treatment has been administered, and the emergency nature of the clinical situation has passed. Although not labelled in the National Statement, this process is variably known as deferred consent, delayed consent, research without prior consent, or consent-to-continue. However, adoption of this approach is relatively recent, with 1) uncertainty about the acceptability to patients, families, clinicians, researchers and the general public, 2) inconsistency in nomenclature causing confusion and misinterpretation, and 3) discrepancies amongst human research ethics committee (HREC) interpretation of the guidance. A scoping review of published literature, current policies and guidelines has therefore been undertaken to inform consent practices in ICUs and understand the perceptions of a broad range of stakeholders involved in consenting practices.
Conclusion
The results of this scoping review will inform the development of future processes and materials to enhance understanding and implementation of delayed consent.
Biography
Kristen Gibbons is Associate Professor, Senior Epidemiologist and Program Lead, Child Health Research Centre, The University of Queensland, and Deputy Chair, Metro South Human Research Ethics Committee, Brisbane, Australia. Kristen’s collaborations have resulted in more than 150 peer-reviewed publications; she is currently a CI on >$13m in research funding, including CIA on a NHMRC Clinical Trials and Cohort Studies Grant for an international paediatric sepsis trial. Kristen enjoys working at the intersection of research ethics, clinical research and data science, and has particularly interests in enhancing clinical trial methodologies and conduct, particularly for investigator-initiated studies. Kristen is the Vice-Chair of the Australian and New Zealand Intensive Care Society Paediatric Study Group (ANZICS PSG)—the first non-clinician to be elected to the Executive Committee—and Chair, Data Science Working Group, ANZICS PSG.