A new document from the Ethics and Regulatory Core is available that provides considerations around determining which individuals or groups are engaged in research in pragmatic clinical trials (PCTs). Developed for investigators designing and conducting PCTs as well as institutional review boards overseeing them, the document introduces these questions in relation to research subjects, study team members, and service providers:
- Which individuals/groups are included in the research?
- Are these individuals/groups research subjects, study team members, or service providers?
- Why does it matter how the individuals/groups are categorized for the research?