Grant: Catalyst Grant: Ethics

Randomized controlled trials (RCTs) are essential to acquiring new medical knowledge. However, an RCT is not required to answer every clinical question, nor is every RCT ethical. Therefore, there must be certain conditions that, when satisfied, render RCTs scientifically and ethically justifiable. This study explores the interplay between ethical (value-based) and epistemic (knowledge based) issues in medical research. The central questions of this research project are: 1.Under what epistemic conditions are RCTs ethically justified? 2.Do current regulatory processes adequately assess whether RCTs have fulfilled these conditions? We will seek to answer these questions by performing two phases of data gathering: 1. A Systematic Qualitative Review of the philosophical, bioethical and research literature on the epistemic conditions that justify RCTs 2.A series of Semi-Structured Interviews with decision-makers at national regulators (HealthCanada, FDA, etc.) and research ethics boards (REBs) about the processes by which they perform the epistemic evaluation of RCTs The main hypothesis of this research program is that the epistemic conditions that justify RCTs are difficult to establish without specialized knowledge in the area of the research question. Moreover, we hypothesize that such expertise is generally lacking from the process by which RCTs receive regulatory approval. This work has implications for the way RCTs are evaluated by national regulators and by local REBs. It represents one piece of an ongoing research program intended to explore and rationalize ethical-epistemic issues surrounding RCTs.