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.