PhD Student University of British Columbia Vancouver, British Columbia
Abstract: The pragmatic clinical trial (PCT) model has grown increasingly popular as a tool for evaluating healthcare interventions in real-world contexts, yet standards of consent for PCTs remain inconsistent. Regulatory and ethical bodies may provide conflicting guidance on when and how consent should be obtained, leading to unclear consent standards and, in many cases, the absence of meaningful informed consent. This lack of consistency raises critical concerns about transparency, patient autonomy, and public trust in research.
This presentation examines the fragmented landscape of consent in PCTs, highlighting major points of divergence, such as varying thresholds for waiving consent, differing interpretations of minimal risk, and the inconsistent use of learning healthcare models. These gaps create uncertainty for researchers and ethics boards alike, resulting in a lack of clear standards surrounding patient consent.
Rather than treating these inconsistencies as an unavoidable challenge of PCTs, we argue that clearer, more standardized consent frameworks are both feasible and necessary as components of ethical research. This presentation will be of interest to researchers, ethicists, and policymakers interested in improving ethical standards in clinical research.
Keywords: Informed consent, Pragmatic clinical trials, Research ethics
Learning Objectives:
After participating in this conference, attendees should be able to:
Recognize the implications of inconsistencies in current consent guidelines for research ethics, patient autonomy, and public trust.
Understand research ethics implications of conducting PCTs with and without meaningful informed consent.
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