Advancing Policy on RISK in Embedded Pragmatic Trials: Community PERSPECTIVES on a Trial to Reduce Kidney injury in Children (RISK PERSECTIVES) (HIKO STEC Risk Perspectives (formerly Bioethics))

Whether or not risks in pragmatic trials comparing standard treatments for serious illness are considered clinical risks or research risks remains an unresolved bioethics policy issue after a decade of discussion. RISK PERSECTIVES will engage caregivers and expert clinicians, about their perspectives and experiences during an ongoing embedded pragmatic clinical trial (HIKO STEC) that compares inpatient hyperhydration to observation to reduce kidney injury following infection with Shiga toxin-producing Escherichia coli (STEC). HIKO-STEC, endorsed by PECARN, considered the risks of STEC treatment to be clinical risks, in contrast to 2014 draft regulatory guidance that suggests these should be considered research risks. RISK PERSECTIVES will convene an interdisciplinary working group to consider the policy implications of categorizing risk for seeking parental permission for future pragmatic trials, grounded in the community perspectives expressed during this project. The outcome of this project will be recommendations to guide regulators and investigators