Continuous monitoring of clinical research: the REB's unfulfilled obligation

Abstract

The lack of specificity about the role of Research Ethics Boards concerning monitoring of clinical research in this new context of private sponsorship, and centrally depending on researchers to monitor clinical research is worrying—given the level of research misconduct and the recurrence of preventable scandals and unethical practices. This thesis is about the ethical necessity of ongoing REB monitoring, while clinical research is being conducted. An initial review, nominal annual reporting, and ad hoc notifications of problems after they occur are likely only to detect problems after harms have occurred. While acknowledging the recommendations of the various policy documents like Canada's TCPS2, US Common Rule, and ICH-GCP have been inadequate, I argue that adequate REB post-initial-review monitoring requires greater REB involvement, rather than trust and researchers’ assurances. The REBs’ monitoring should include continual onsite monitoring and paternalistic continuous review, to protect subjects who are contributing to scientific knowledge. Subject safety and overall research integrity are imperative to good science.