Symposium on the ethics of an innovative approach to healthcare trial design (360G-Wellcome-201424_Z_16_Z)

Usual care or new treatment, which is best? In an ideal world, healthcare systems would integrate research and healthcare and provide the answers to this question. Historically however, research and healthcare have been seen as conceptually distinct, and in practice have distinct oversight regimes, and different approaches to informed consent. Recently, the innovative 'cohort multiple randomised controlled trial (cmRCT) design (Relton et al, 2010) attempts to bridge these differences by encouraging a 'tailored' approach to informed consent for the patient in health research, rather than 'full disclosure' of information to the research participant. To date 18+ funded and ethics committee approved studies in the UK, Canada and Netherlands are using the cmRCT design with it's 'tailored' approach to informed consent (and reporting high recruitment and consent rates). This symposium will address key questions relating to the 'tailored' approach to informed consent used in the cmRCT design; namely, what information is conveyed, to whom, and when. Researchers using/ interested in the design together with leaders in bioethics, informed consent research and comparative effectiveness trial design will discuss the acceptability of the 'tailored' approach to informed consent for trials designed to inform routine healthcare decisions by patients and their healthcarers.