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Engagement in Research for Pragmatic Clinical Trials

April 16, 2020

Authors: Pearl O’Rourke, MD; Judith Carrithers, JD; and Jeremy Sugarman, MD, MPH, MA
Publication: NIH Health Care Systems Research Collaboratory

Judith Carrithers, JD, Director of Regulatory Services contributed to the article Engagement in Research for Pragmatic Clinical Trials for the NIH Health Care Systems Research Collaboratory.

Determining which individuals or groups are engaged in research can be particularly complex in pragmatic clinical trials (PCTs). Nevertheless, doing so is essential to protecting those engaged according to their particular role (i.e., research subject, study team member, or service provider) and in ensuring compliance with federal research regulations. This document provides considerations for investigators designing and conducting PCTs as well as institutional review boards (IRBs) overseeing them. The Office for Human Research Protections (OHRP), the overarching federal oversight body for research with human subjects, issued guidance on the general topic of engagement in 2008, but it was not directed at PCTs in particular. Given the complexities in this context, more specific guidance from OHRP would be welcome.

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