Ethical and Regulatory Concerns in Pragmatic Clinical Trial Monitoring and Oversight

Michelle K. Roberts, Dylan M. Fisher, Lea E. Parker, Doyanne Darnell, Jeremy Sugarman, Judith Carrithers, Kevin Weinfurt, Gregory Jurkovich, Douglas Zatzick

Research output: Contribution to journalArticlepeer-review

1 Scopus citations


The implementation of pragmatic clinical trials (PCTs) can be accompanied by unique regulatory challenges. In this paper, we describe the experience and management of regulatory noncompliance during a 25-site acute care PCT. During the trial, the study team conducted a comprehensive audit of all enrollment forms (informed consent and Health Insurance Portability and Accountability Act authorization forms) and related study documentation. A review of 997 participants’ enrollment forms identified 138 (13.8%) that required reporting to the institutional review board due to noncompliance. To prevent subsequent noncompliance, the study team developed and introduced a revised participant tracking system, reviewed all enrollment documentation, and retrained sites regarding study procedures. Based on these experiences, we developed a set of recommendations for future PCTs to ensure both operational success and regulatory compliance.

Original languageEnglish (US)
Pages (from-to)29-37
Number of pages9
JournalEthics & human research
Issue number5
StatePublished - Sep 1 2020


  • Good Clinical Practice (GCP)
  • Health Insurance Portability and Accountability Act (HIPAA)
  • informed consent documentation
  • institutional review board (IRB)
  • noncompliance
  • pragmatic clinical trials

ASJC Scopus subject areas

  • Health(social science)
  • Medicine(all)


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