Ethical and Regulatory Concerns in Pragmatic Clinical Trial Monitoring and Oversight

Ethics Hum Res. 2020 Sep;42(5):29-37. doi: 10.1002/eahr.500066.


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.

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

Publication types

  • Pragmatic Clinical Trial

MeSH terms

  • Biomedical Research / ethics*
  • Documentation
  • Ethics Committees, Research / organization & administration*
  • Ethics Committees, Research / standards
  • Ethics, Research*
  • Government Regulation*
  • Health Insurance Portability and Accountability Act
  • Humans
  • Informed Consent / ethics*
  • United States