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Safeguarding decentralized research from insincere participants: Case series and review of literature

Published online by Cambridge University Press:  07 August 2026

Sarah Sutter*
Affiliation:
North Carolina Translational and Clinical Sciences Institute, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
Summer Choudhury
Affiliation:
North Carolina Translational and Clinical Sciences Institute, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
Blair Wendlandt
Affiliation:
School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
Tessa Englund
Affiliation:
School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
Saira Sheikh
Affiliation:
School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
Victoria Scott
Affiliation:
North Carolina Translational and Clinical Sciences Institute, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
Ashley Brown
Affiliation:
North Carolina Translational and Clinical Sciences Institute, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
Michael Kappelman
Affiliation:
School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
*
Corresponding author: S. Sutter; Email: sarah_sutter@med.unc.edu
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Abstract

Decentralized clinical trials (DCTs) and direct-to-participant recruitment have expanded opportunities for research participation, broadening the reach and accessibility. Traditional site-based research often requires in-person visits, limiting participation for individuals who live far from trial sites or have competing responsibilities. Without in-person verification, decentralized research may attract insincere participants, or individuals or bots who misrepresent themselves to gain study access, often motivated by compensation. This literature review explores the growing concern of insincere participation in decentralized research, drawing on real-world case studies from a large academic research institution and published literature. We examine how insincere participation threatens study integrity, increases burden for research teams, and poses ethical challenges, particularly in studies leveraging online and social media recruitment. Through analysis of patterns and behaviors, we discuss various mitigation strategies and propose a risk-based framework to help researchers align mitigation efforts with their study’s needs and tolerance for data quality risk. As decentralized research expands, adaptable safeguards are important to preserve data integrity. These findings highlight a central challenge: determining how much verification is necessary without excluding genuine participants.

Information

Type
Review Article
Creative Commons
Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution and reproduction, provided the original article is properly cited.
Copyright
© The Author(s), 2026. Published by Cambridge University Press on behalf of Association for Clinical and Translational Science
Figure 0

Table 1. Comparison of insincere participant mitigation strategiesTable 1 long description.

Figure 1

Figure 1. Figure 1 long description.Risk analysis mitigation framework along a risk tolerance continuum.

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