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Ethical and Regulatory Concerns in Pragmatic Clinical Trial Monitoring and Oversight
Author(s) -
Roberts Michelle K.,
Fisher Dylan M.,
Parker Lea E.,
Darnell Doyanne,
Sugarman Jeremy,
Carrithers Judith,
Weinfurt Kevin,
Jurkovich Gregory,
Zatzick Douglas
Publication year - 2020
Publication title -
ethics and human research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.353
H-Index - 32
eISSN - 2578-2363
pISSN - 2578-2355
DOI - 10.1002/eahr.500066
Subject(s) - health insurance portability and accountability act , documentation , audit , authorization , accountability , business , informed consent , clinical trial , compliance (psychology) , health care , medicine , medical education , process management , psychology , accounting , political science , alternative medicine , computer science , computer security , social psychology , pathology , law , programming language
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.