Table 6.

Rationale for waived patient consent in EPOCH

1	Consent for routine documentation practice is implied with hospital admission + this is also true for other practices including staffing, ICU consultation, physician review
	+ Documentation is an inherent and routine part of hospital care
	+ In intervention hospitals the BedsidePEWS becomes the accepted standard for documentation
	+ In control hospitals and before implementation in hospitals randomized to implement BedsidePEWS, consenting to routine care in a situation where that there is no alternative is counter-intuitive
2	Patient-level data are retrospectively obtained and + does not require patient contact
	+ does not require additional clinical investigation
	+ precedent exists for waived consent for this type of data collection
3	Preemptive consent for events (including in-hospital cardiac arrest, death) that have not occurred - and that may not occur
	+ Is potentially distressing to families
	+ Is inefficient use of research resources
4	Obtaining consent is not feasible for 100,000 patients anticipated in the study sample
	+ retrospective consent from families of deceased children may add burden and is potentially distressing to families
5	Incomplete enrollment would undermine and bias the scientific validity of the study
6	Data will be presented in aggregate.
	No identifying information will leave the study office in the participating hospital