Empirical research related to the ethics of pragmatic clinical trials: A scoping review

There has been progress in understanding many ethical issues encountered in PCTs, including appropriately navigating alternatives to obtaining written informed consent, trust-building, and the operational role of stakeholder engagement. However, critical gaps remain, with research concentrated in Western contexts and reliant on surveys and hypothetical scenarios, limiting generalizability and real-world insights. Addressing these gaps with geographically inclusive studies, innovative methods, and nested empirical work will be important for more comprehensively understanding the ethical issues in PCTs and developing appropriate approaches to mitigating them.