Table 1 Current approaches to accommodating QSI research within existing research regulations

QSI research is not research for regulatory purposes

For regulatory purposes, QSI research is distinct from other types of research

QSI research is designed to bring about improvement in a local setting

The Surgical Checklist Trial  is not research, as traditionally conceived

The Surgical Checklist Trial does not require formal research ethics committee review

It is unclear how QSI research is distinct from other types of research

QSI research meets the formal definition of research

QSI is research, but is exempt from REC review

QSI research often poses only minimal risk and uses routinely collected data

As such, QSI research should be exempt from review

Risks of participation are minimal and the study only makes use of routinely collected and anonymized patient data

The Surgical Checklist Trial is exempt from REC review

QSI research often involves study interventions such as educational programs that target human participants

As such, QSI research is not exempt from REC review

QSI research is part of the learning healthcare system and requires a new ethics framework

Rejects the research-practice distinction

Articulates “learning” as a novel ethical obligation

QSI research that poses only minimal risk and does not infringe on patient values should be integrated into clinical care

The study poses only minimal risk and does not infringe on the rights of participants

Surgeons and patients have an obligation to participate in the trial

The Surgical Checklist Trial should be integrated into the learning healthcare system

Research and practice are distinct

There is no compelling justification for making research participation (“learning”) an obligation