Exploring the Experiences of the Consent Process for Aboriginal and Torres Strait Islander People Having Cardiac Surgery and Participating in Medical Research: A Study Protocol

Background: Gaining informed consent is a critical step before any medical procedure, and before taking part in medical research. Cultural differences in concepts of health and healing, communication, language, and racism, can play a part in forming barriers to gaining informed consent for Aboriginal and Torres Strait Islander people. For Aboriginal and Torres Strait Islander people, a lack of informed consent can worsen distrust and contribute to continuing health disparities. This protocol describes a study aimed at providing a better understanding of informed consent experiences of Aboriginal and Torres Strait Islander people undergoing heart surgery and participating in research. This will be complemented by comparing those experiences to the ones of the clinicians and researchers who obtain informed consent from Aboriginal and Torres Strait Islander people. Methods: The study will be conducted at the Fiona Stanley Hospital in Western Australia and Townsville University Hospital in Queensland. Participants will include Aboriginal and Torres Strait Islander patients undergoing cardiac surgery, clinicians of the cardiothoracic surgery team and medical researchers at both hospitals. Yarning will be used as an Indigenous research method to collect meaningful data from Aboriginal and Torres Strait Islander people undergoing cardiac surgery whilst semi-structured interviews will be conducted to explore Clinician’s and researchers’ experiences. Data from Aboriginal and Torres Strait Islander participant will be analysed following a cyclical approach to ensure Aboriginal and Torres Strait Islander voices are not lost during data interpretation. Inductive thematic analysis of data will be conducted to yield practical recommendations. Conclusions: We present the protocol of a study that will inform the development of strategies to ensure that informed consent processes are culturally appropriate and guarantee Aboriginal and Torres Strait Islander people’s right to self-determination. This will contribute to the provision of culturally safe healthcare services and promote the conduct of medical research that is ethical, safe and benefits Aboriginal and Torres Strait Islander people.