Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement (TCPS): Ethical Conduct for Research Involving Humans, December 2022. Chapter 1 - Ethics Framework: 9-page chapter (pages 4-12)

• Summary: Chapter 1 introduces the importance of research and research ethics, core principles (i.e., respect for persons, concern for welfare, justice), and guidance on how to apply the Tri-Council Policy Statement (TCPS) regarding: proportionate approach to research ethics board review, research ethics and law, the perspective of the participant, and appropriate expertise for review. (Note: A review of this entire policy statement will be relevant for those who have not completed the TCPS 2: CORE-2022 training as a requirement of their research institution. CORE-2022 is a self-paced online course that consists of nine modules, each followed by a quiz.)

HRB Trials Methodology Research Network (UCC & HRB-TMRN Event: Deliberating Ethics in Trials: Scope and necessity of ethical oversight) - A framework for the ethical design and conduct of pragmatic trials in health and social care (May 2, 2024): 20-min webinar.

• Summary: Dr. Cory Goldstein overviews the explanatory-pragmatic continuum for randomized trials. Potential ethical issues related to pragmatic design features and the nature of the interventions tested in pragmatic trials are also discussed. Further, four ethical principles are introduced (1. Respect for persons, 2. Justice, 3. Beneficence, and 4. Respect for communities) along with corresponding ethical obligations and considerations for pragmatic trials.

Nicholls SG, et al. The ethical challenges raised in the design and conduct of pragmatic trials: an interview study with key stakeholders. Trials. 2019 Dec 23;20(1):765. (16-page paper)

• Summary: Pragmatic trials may increase the relevance of research findings to practice, but they may also raise new ethical considerations. This article describes interviews with 45 individuals between April and September 2018 (i.e., clinical investigators, methodologists, patient partners, ethicists, and other knowledge users) with the aim of identifying potential ethical challenges in the design and conduct of pragmatic trials with a view to developing future guidance on these issues.

Kass NE, et al. Making the Ethical Oversight of All Clinical Trials Fit for Purpose. JAMA. 2025 Jan 7;333(1):75-80. (6-page special communication) * As this is an optional resource, an institutional login (e.g., university or research institute e-mail address) is required to access this material.

• Summary: This special communication argues that as more comparative effectiveness and other research on widely used clinical interventions is conducted, ethical oversight should be fit for purpose. It is stated that the degree of ethical oversight should be based on two morally relevant features of a trial: (1) The degree to which risks and burdens increase or change when research is integrated into clinical care (compared with what patient-participants would have experienced in care absent the research), and (2) Whether the activity restricts meaningful patient decision-making about care in morally important ways.