Grant: CIHR Fellowship

Conventional clinical trials, known as explanatory trials, test whether a novel medical treatment works in optimal, tightly controlled conditions. But the real world is messy and unpredictable. How can patients, doctors, and policymakers know whether medical treatments work in the context of routine clinical practice? The answer is through pragmatic clinical trials. Pragmatic trials are embedded into routine care settings and ideally include patients similar to those who require treatment in clinical practice. But these trials raise complex ethical issues that have not been adequately addressed. Research ethics guidelines and regulations were created for explanatory trials, and so their application to pragmatic trials is not straightforward. A lack of dedicated ethics guidance for pragmatic trials may, on the one hand, lead to inadequate protections for research participants and, on the other hand, lead to unnecessary obstacles to socially valuable research. The goal of my project is to use a combination of conceptual work (e.g., ethical analysis) and empirical work (e.g., surveys, interviews, case studies) to study the most pressing ethical issues raised by pragmatic trials. Ethical issues include: What approach to obtaining informed consent from patients is ethically permissible and practically feasible in pragmatic trials? What reasons justify the use of novel research designs over standard patient randomized designs in pragmatic trials? What does it mean for a patient to be vulnerable in research? How should vulnerable patients be protected consistent with the aims of a pragmatic trial to minimally disturb clinical practice and use streamlined recruitment procedures? Providing answers to these questions will lay the foundations for developing ethical guidelines for pragmatic trials that ensure adequate protections for research participants while promoting socially valuable research.