Ethics and Collateral Findings in Pragmatic Clinical Trials

Am J Bioeth. 2020 Jan;20(1):6-18. doi: 10.1080/15265161.2020.1689031.


Pragmatic clinical trials (PCTs) offer important benefits, such as generating evidence that is suited to inform real-world health care decisions and increasing research efficiency. However, PCTs also present ethical challenges. One such challenge involves the management of information that emerges in a PCT that is unrelated to the primary research question(s), yet may have implications for the individual patients, clinicians, or health care systems from whom or within which research data were collected. We term these findings as ?pragmatic clinical trial collateral findings,? or ?PCT-CFs?. In this article, we explore the ethical considerations associated with the identification, assessment, and management of PCT-CFs, and how these considerations may vary based upon the attributes of a specific PCT. Our purpose is to map the terrain of PCT-CFs to serve as a foundation for future scholarship as well as policy-making and to facilitate careful deliberation about actual cases as they occur in practice.

Keywords: incidental findings; learning health systems; pragmatic clinical trial; research ethics.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Decision Making*
  • Disclosure / ethics*
  • Ethical Analysis*
  • Humans
  • Incidental Findings*
  • Pragmatic Clinical Trials as Topic / ethics*
  • Quality Improvement / ethics*
  • Research Design / standards
  • Researcher-Subject Relations