Skip to main content

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

From: Accommodating quality and service improvement research within existing ethical principles

Approach Key features Implications for the Surgical Checklist Trial Problems identified
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