TY - JOUR
T1 - Ethics and Collateral Findings in Pragmatic Clinical Trials
AU - Morain, Stephanie R.
AU - Weinfurt, Kevin
AU - Bollinger, Juli
AU - Geller, Gail
AU - Mathews, Debra J.H.
AU - Sugarman, Jeremy
N1 - Funding Information:
This work is supported within the National Institutes of Health (NIH) Health Care Systems Research Collaboratory by the NIH Common Fund through cooperative agreement U24AT009676 from the Office of Strategic Coordination within the Office of the NIH Director. The views presented here are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health. Alan Regenberg and Elizabeth May assisted with the literature review.
Publisher Copyright:
© 2020, © 2020 Taylor & Francis Group, LLC.
PY - 2020/1/2
Y1 - 2020/1/2
N2 - 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.
AB - 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.
KW - incidental findings
KW - learning health systems
KW - pragmatic clinical trial
KW - research ethics
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U2 - 10.1080/15265161.2020.1689031
DO - 10.1080/15265161.2020.1689031
M3 - Article
C2 - 31896322
AN - SCOPUS:85077265109
SN - 1526-5161
VL - 20
SP - 6
EP - 18
JO - American Journal of Bioethics
JF - American Journal of Bioethics
IS - 1
ER -