Learning Health Systems (LHS) take patient and healthcare systems data collected from routine clinical care, apply research and quality improvement methods to derive new insight and generate new evidence, which can then be returned to clinicians to improve care.  Digital clinical trials methods are one method of knowledge generation within a LHS, but also have a larger role in making standard clinical trials more efficient and pragmatic.  Both are underpinned by the development of a 'learning culture' within a health system and bring unique ethical challenges, often exploring areas where the lines between research and quality improvement become blurred. 
 
This project will explore the role of organisational culture in LHSs, highlighting strategies associated with success and key evidence gaps to guide future research.  It will also investigate the feasibility and acceptability of using proportionate consent methods to recruit participants to low or minimal risk comparative effectiveness trials within LHS settings. 
 
These aims will be addressed through:

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• A scoping review exploring the existing literature base for organisational culture within LHS.

• A modified delphi study seeking to define consensus amongst research ethics committee members for the appropriate use of proportionate consent methods for different clinical trial designs meeting low and minimal risk criteria.

• A feasibility study examining the technical delivery and acceptability of an opt out consent platform for a perioperative LHS recruiting elective surgical patients.