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

Bediako, Ramseyer Apau (2020) Continuous monitoring of clinical research: the REB's unfulfilled obligation. Masters thesis, Memorial University of Newfoundland.

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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.

Item Type: Thesis (Masters)
Item ID: 14358
Additional Information: Includes bibliographical references (pages 67-87).
Keywords: Continuous monitoring, Research integrity, Research Ethics Boards, Trust mechanism, Subject safety
Department(s): Medicine, Faculty of > Community Health
Date: May 2020
Date Type: Submission
Digital Object Identifier (DOI):
Library of Congress Subject Heading: Research--Evaluation; Research--Moral and ethical aspects.

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