Welcome to the Ethical Issues in Cluster Randomized Trials Wiki!

Since 2007, our international research team has been working on a Canadian Institutes of Health Research funded project to study the ethical challenges in cluster randomized trials (CRTs). The ultimate goal of our project was to produce international consensus guidelines for the ethical conduct and ethics review of CRTs. The project comprised three components: an in-depth ethical analysis leading to a series of normative articles discussing the ethical issues in CRTs; review of the reporting of ethical issues in published CRTs; and surveys of CRT trialists and ethics review committee chairs. We have created this Wiki webpage to facilitate an open discussion about the ideas expressed in the series of articles and the proposed ethics guidelines. For further information about our project, please see our published study protocol.

UPDATE: We are please to announce that the consensus guidelines have now been published in Plos Medicine!
Link to article:

Pdf file of final consensus statement:

Series of normative articles:
1. Ethical Issues posed by cluster randomized trials in health research
2. Who is the research subject in cluster randomized trials in health research?
3. When, and from whom, is informed consent required in cluster randomized trials?
4. Does clinical equipoise apply to cluster randomized trials in health research?
5. Assessing benefits and harms in cluster randomized trials (In preparation)
6. What is the role and authority of gatekeepers in cluster randomized trials?
7. Cluster randomized trials in vunerable populations (In preparation)

International consensus conference:
To develop ethics guidelines from this process, we held an international consensus conference in Ottawa, Ontario from 28-30 November, 2011. The first day of the conference was an open session on the ethics of CRTs (with simultaneous webcast), attended by invited representatives from funding agencies, regulators, research ethics committees, ethicists, journal editors and investigators. The results of the empirical studies and analyses of the six issues were presented and commented on by expert discussants and the audience. Attendees of the meeting included members of a multi-disciplinary Expert Panel, who subsequently met together in closed session for one and a half days to discuss identified issues and to develop guidelines. The Expert Panel is composed of external members — ethicists, researchers (cluster trialists, statisticians), policy makers and journal editors and four of the members of the research team.

The draft guidance produced as a result of this process is now available and public comments are being invited. There are two ways to provide comments: (1) clicking on the link below will take you to the discussion page within this wiki where you may post your comments as publicly visibly discussion points (you will need to "sign in" first, by providing your e-mail address and a password); (2) you may e-mail your comments, without registering, to crtethics@ohri.ca. Comments are accepted until 2 April 2012.

Link to draft consensus statement

Pdf file of draft consensus statement:

Video from open session at the consensus conference:
Session1 Part1: Introduction, Overview and Objectives: Professor Martin Eccles
Session1 Part2: Introduction to Cluster Randomized Trials: Dr. Allan Donner
Session1 Part3: Ethical issues posed by Cluster Randomized Trials: Dr. Jeremy Grimshaw
Session1 Part4: Overview of our Research Project: Dr. Monica Taljaard
Session1 Part5: Discussion

Session2 Part1: Consent issues in Cluster Randomized Trials: Dr. Andrew McRae
Session2 Part2: Discussant: Dr. Kathleen Lohr
Session2 Part3: Discussion

Session3 Part1: Justification of Cluster Randomized Trials: Dr. Charles Weijer
Session3 Part2: Discussant: Dr. Catarina Kiefe
Session3 Part3: Discussion

Session4 Part1: Vulnerable populations in Cluster Randomized Trials: Dr. Angela White
Session4 Part2: Discussant: Dr. Jonathan Kimmelman
Session4 Part3: Discussion

Discussion and next steps

Slides and audio from consensus conference:

Slides and audio from consensus meeting

Transcripts from Public discussion at consensus conference:

Discussion Session 1: Introduction to Ethical issues in CRTs

Discussion Session 2: Who is the research subject and Informed Consent
Discussion Session 3: Clinical Equipoise and Benefits/Harms
Discussion Session 4: Vulnerable populations and Gatekeepers

Further comment and discussion on these pages are welcomed.

Thank you for your participation!

Members of the research team:
Dr. Jeremy Grimshaw (Ottawa Hospital Research Institute, Canada)Dr. Charles Weijer (University of Western Ontario, Canada)Dr. Monica Taljaard (Ottawa Hospital Research Institute, Canada)Ms. Ariella Binik (University of Western Ontario, Canada)
Dr. Robert Boruch (University of Pennsylvania, U.S.A)
Dr. Jamie Brehaut (Ottawa Hospital Research Institute, Canada)Dr. Allan Donner (University of Western Ontario, Canada)
Dr. Martin Eccles (University of Newcastle upon Tyne, U.K.)
Mr. Antonio Gallo (University of Western Ontario, Canada)Dr. Raphael Saginur (Ottawa Hospital Research Institute, Canada)Dr. Andrew McRae (University of Calgary, Canada)Dr. Angela White (University of Western Ontario, Canada)Dr. Merrick Zwarenstein (University of Toronto, Canada)