Abstract
Background: Clinical treatments for pregnant women and premature infants often lack quality evidence supporting efficacy and safety. Perceptions of risk and potential for harm in these complex populations often exclude them from the very research required to overcome the problem. Furthermore, the urgent nature of many treatments often makes prospective approaches for consent ethically inappropriate or impossible. Researchers have increasingly advocated for alternative modes of consent or consent waivers to address these challenges, but their appropriate use remains controversial. Maintaining research integrity and public trust in research is essential. A novel consent matrix was developed to support different consent methodologies for perinatal clinical trials, while upholding ethical principles and fostering trust with research participants.
Methods: A co-design process was used to develop the consent matrix, utilising expert opinion from clinical researchers, bioethicists, and persons with lived experience across Australia and New Zealand, informed by best evidence from a systematic review of the literature.
Results: The consent matrix's “stop/go” system indicates ethical considerations for and against a consent mode in relation to each of the four ethical principles underpinning ethical research, and provides real examples and practical considerations for use.
Conclusions: This novel consent matrix provides ethical considerations for consent modes according to risk, providing guidance to researchers undertaking clinical research in complex populations. It also provides evidence to assist ethics review boards with their consideration of a trial. It will provide a framework for perinatal clinical trials running within the PLatform for Adaptive Trials In Perinatal UnitS (PLATIPUS).
Poster presentation.