Charles Weijer

weijer

Professor
Joint Appointment with Department of Medicine
Cross Appointment with Department of Epidemiology and Biostatistics
Member, Rotman Institute of Philosophy

Bioethics, Research Ethics
BMdSc, MD Alberta; BA (Hons) MSc, PhD McGill

Phone: 519-661-2111 ext. 80090
Office: Western Interdisciplinary Research Building (WIRB), Room 7160
Email: cweijer@uwo.ca
Website: charlesweijer.com/

Charles Weijer is the leading expert on the ethics of randomized controlled trials. Publications on the duty of care in clinical research, the ethical analysis of study benefits and harms, and empowering communities in research have been broadly influential.

From 2008 to 2013 Charles co-led a collaboration that produced the first international ethics guidelines for cluster randomized trials. From 2014 to 2018 he collaborated with Dr. Adrian M. Owen on a project exploring the ethics of functional neuroimaging after severe brain injury. Charles’ current work explores ethical issues in pragmatic randomized controlled trials that evaluate health interventions in real-world conditions to better inform patients, health providers and health systems managers. This project, funded by the Canadian Institutes of Health Research (2017–2021), brings together a research team comprising philosophers, biostatisticians and trialists from five countries. Charles led the writing team for the World Health Organization guidance on “Ethical Considerations for Health Policy and Systems Research,” published in 2019. In 2020, he served on the WHO Working Group for Guidance on Human Challenge Studies in COVID-19. 

Charles held the Canada Research Chair in Bioethics from 2005 to 2019. In 2008, Charles worked with philanthropist Dr. Joseph Rotman to found the Rotman Institute of Philosophy, which is dedicated to fostering collaboration between the humanities and the sciences and served as the Institute’s first director. In 2014, he received Western’s Hellmuth Prize for Achievement in Research, and, in 2016, he was elected to the Royal Society of Canada.

Recent Publications

Reports/ Books

World Health Organization. Key criteria for the ethical acceptability of COVID-19 human challenge studies. Geneva: WHO, 2020. [Member of the Working Group for Guidance on Human Challenge Studies for COVID-19]

World Health Organization. Ethical considerations for health policy and systems research. Geneva: WHO, 2019. [Lead writer] 

Bioethics in Canada, second edition (with A. Skelton eds). Don Mills: Oxford University Press, 2019. 

Articles

Reporting of key methodological and ethical aspects of cluster trials in hemodialysis require improvement: a systematic review,” (with A.A. Al-Jaishi, K. Carroll, C.E. Goldstein, S.N. Dixon, A.X. Garg, S.G. Nicholls, J.M. Grimshaw, J. Brehaut, L. Thabane, P.J. Devereaux & M. Taljaard). In Trials 21, 2020: 752.

“Cluster over individual randomization: are study design choices appropriately justified? Review of a random sample of trials,” (with M. Taljaard, C.E. Goldstein, B. Giraudeau, S.G. Nicholls, K. Carroll, S.P. Hey, J.C. Brehaut, V. Jairath, A.J. London, S.M. Eldridge, J.M. Grimshaw & D.A. Fergusson). In Clinical Trials 17 (3), 2020: 253-263.

“Rules of the road for patient-driven consent processes,” (with H.P. Nix). In American Journal of Bioethics 20 (5), 2020: 36–37.

Ethical issues in cluster randomized trials conducted in low- and middle-income countries: an analysis of two case studies,” (with A.T. Choko, G. Roshandel, D.F. Conserve, E.L. Corbett, K. Fielding, K. Hemming & R. Malekzadeh). In Trials 21 (Suppl 1), 2020: 314. 

“Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines),” (with D.J. Beard, M.K. Campbell, J.M. Blazeby, A.J. Carr, B.H. Cuthbertson, R. Buchbinder, T. Pinkney, F.L. Bishop, J. Pugh, S. Cousins, I.A. Harris, L.S. Lohmander, N. Blencowe, K. Gillies, P. Probst, C. Brennan, A. Cook, D. Farrar-Hockley, J. Savulescu, R. Huxtable, A. Rangan, I. Tracey, P. Brocklehurst, M.L. Ferreira, J. Nicholl, B.C. Reeves, F. Hamdy, S.C. Rowley & J.A. Cook). In The Lancet 395 (10226), 2020: 828–838.

“It does not matter whether research interventions are usual care,” (with C.E. Goldstein). In American Journal of Bioethics 20 (1), 2020: 47–48.

Cultivating Innovative Pragmatic Cluster-Randomized Registry Trials Embedded in Hemodialysis Care: Workshop Proceedings from 2018,” (with E.J. Lee, A. Patel, R.R. Acedillo, J.C. Bachynski, I. Barrett, E. Basile, M. Battistella, D. Benjamin, D. Berry, P.G. Blake, P. Chan, C.J. Bohm, K.K. Clemens, C. Cook, L. Dember, J.S. Dirk, S. Dixon, E. Fowler, L. Getchell, N. Gholami, C. Goldstein, E. Hahn, B. Hogeterp, S. Huang, M. Hughes, M.J. Jardine, S. Kalatharan, S. Kilburn, E. Lacson Jr, S. Leonard, C. Liberty, C. Lindsay, J.M. MacRae, B.J. Manns, J. McCallum, C.W. McIntyre, A.O. Molnar, R.A. Mustafa, G.E. Nesrallah, M.J. Oliver, M. Pandes, S. Pandeya, M.S. Parmar, E.Z. Rabin, J. Riley, S.A. Silver, J.M. Sontrop, M.M. Sood, R.S. Suri, N. Tangri, T.J. Tascona, A. Thomas, R. Wald, M. Walsh, M.A. Weir, H. Vorster, D. Zimmerman, A.X. Garg & Gardener’s Grove Participants). In Canadian Journal of Kidney Health and Disease 6, 2019: 6:2054358119894394.

The ethical challenges raised in the design and conduct of pragmatic trials. An interview study with key stakeholders,” (with S.G. Nicholls, K. Carroll, M. Zwarenstein, J.C. Brehaut, S.P. Hey, C.E. Goldstein, I.D. Graham, J. McKenzie, J.M. Grimshaw, D.A. Fergusson, M. Taljaard on behalf of the CIHR Ethics of Pragmatic Trials project). Trials 20, 2019: 765.

Ethical issues in the design and conduct of stepped-wedge cluster randomized trials in low-resource settings,” (with K. Joag, G. Ambrosio, E. Kestler, K. Hemming & R. Van der Graaf. In Trials 20 (Suppl 2), 2019: 703.

“Towards the assessment of quality of life in in patients with disorders of consciousness,” (with J. Tung, K.N. Speechley, T. Gofton, L. Gonzalez-Lara, M. Graham, L. Naci, A.H. Peterson & A.M. Owen. In Quality of Life Research 29 (5), 2020: 1217-1227. 

“Stepped-wedge trials should be classified as research for the purpose of ethical review,” (with K. Hemming, M. Taljaard, T. Marshall, & C.E. Goldstein). In Clinical Trials 16 (6), 2019: 580-588. 

Ottawa Statement does not impede randomised evaluation of government health programmes,” (with M. Taljaard). In Journal of Medical Ethics 46 (1), 2019, 31-33. 

The ethics of psychedelic research in disorders of consciousness,” (with A. Peterson & E. Tagliazucchi). In Neuroscience of Consciousness 5 (1), 2019: niz013.

“A stepwise approach to ethically assess pragmatic cluster randomized trials: implications for informed consent for suicide prevention implementation research,” (with C.E. Goldstein). In American Journal of Bioethics 19 (10), 2019: 101–103. 

“Emergence of human immunoprofiling in health and disease,” (with B. Singh, K.L. Summers, G. Barker, E. Desjardins & J. Madrenas). In Current Trends in Immunology 19, 2019: 11–19.

“The ethics of cluster randomized trials: Response to a proposal for revision of the Ottawa Statement,” (with M. Taljaard). In Journal of Clinical Epidemiology 116, 2019: 140-145. 

“Working for the weekend is not meaningful work,” (with M.S. Graham). In American Journal of Bioethics 19(9), 2019: 48-50. 

Ethical Issues in Pragmatic Cluster-Randomized Trials in Dialysis Facilities,” (with C.E. Goldstein, M. Taljaard, A.A. Al-Jaishi, E. Basile, J. Brehaut, C.L. Cook, J.M. Grimshaw, E. Lacson Jr, C. Lindsay, M. Jardine, L.M. Dember & A.X. Garg). In American Journal of Kidney Diseases 74 (5), 2019: 659-666. 

Ethical issues raised by cluster randomised trials conducted in low-resource settings: identifying gaps in the Ottawa Statement through an analysis of the PURE Malawi trial,” (with T.K. Mtande, M.C. Hosseinipour, M. Taljaard, M. Matoga, C.E. Goldstein, B. Nyambalo & N.E. Rosenberg). In Journal of Medical Ethics 45 (6), 2019: 388–393.

Informed consent for functional MRI research on comatose patients following severe brain injury: balancing the social benefits of research against patient autonomy,” (with T. Bruni, M. Graham, L. Norton, T. Gofton & A.M. Owen). In Journal of Medical Ethics 45 (5), 2019: 299-303. 

Stakeholder views regarding ethical issues in the design and conduct of pragmatic trials: Study Protocol,” (with S.G. Nicholls, K. Carroll, J.C. Brehaut, S.P. Hey, C.E. Goldstein, M. Zwarenstein, I. Graham, J.E. McKenzie, L. McIntyre, V. Jairath, M.K. Campbell, J.M. Grimshaw, D.A. Fergusson & M. Taljaard). In BMC Medical Ethics 19, 2018: 90.

Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration,” (with K. Hemming, M. Taljaard, J.E. McKenzie, R. Hooper, A. Copas, J.A. Thompson, M. Dixon-Woods, A. Aldcroft, A. Doussau, M. Grayling, C. Kristunas, C.E. Goldstein, M.K. Campbell, A. Girling, S. Eldridge, M.J. Campbell, R.J. Lilford, A.B. Forbes & J.M. Grimshaw). In British Medical Journal 363, 2018: k1614.

Developing a framework for the ethical design and conduct of pragmatic trials to improve patient health and health system outcomes: Study protocol for a mixed methods study,” (with M. Taljaard, J.M. Grimshaw, A. Ali, J.C. Brehaut, M.K. Campbell, K. Carroll, S. Edwards, S. Eldridge, C.B. Forrest, B. Giraudeau, C.E. Goldstein, I. Graham, K. Hemming, S.P. Hey, A.R. Horn, V. Jairath, T.P. Klassen, A.J. London, S. Marlin, J.C. Marshall, L. McIntyre, J.E. McKenzie, S.G. Nicholls, P.A. Paprica, M. Zwarenstein & D.A. Fergusson). In Trials 19, 2018: 525. 

FLUID trial: a protocol for a hospital-wide open-label cluster crossover pragmatic comparative effectiveness randomised pilot trial,” (with L. McIntyre, M. Taljaard, T. McArdle, A. Fox-Robichaud, S.W. English, C. Martin, J. Marshall, K. Menon, J. Muscedere, D.J. Cook, R. Saginur, A. Maybee, A. Iyengar, A. Forster, I.D. Graham, S. Hawken, C. McCartney, A.J. Seely, I.G. Stiell, K. Thavorn & D.A. Fergusson DA). In BMJ Open 8 (8), 2018: e022780. 

Accommodating quality and service improvement research within existing ethical regulations,” (with C.E. Goldstein, J. Brehaut, M. Campbell, D. Fergusson, J.G. Grimshaw, K. Hemming, A.R. Horn & M. Taljaard). In Trials 9 (1), 2018: 334.

Using neuroimaging to uncover awareness in brain-injured and anesthetized patients,” (with M. Graham, A.M. Owen, L. Naci). In Frontiers in Bioscience 10, 2018: 337–349.

When and how should we cluster and cross over: methodological and ethical issues,” (with C.E. Goldstein, B. Giraudeau & M. Taljaard). In Canadian Journal of Anesthesia 65 (7), 2018: 760–765. 

“Thinking Clearly About the FIRST Trial: Addressing ethical challenges in cluster randomized trials of policy interventions involving health providers,” (with A.R. Horn, S.P. Hey, J. Brehaut, D. Fergusson, C.E. Goldstein, J.G. Grimshaw & M. Taljaard). In Journal of Medical Ethics 44 (9), 2018: 593-598. 

Ethical implications of excessive cluster sizes in cluster randomized trials,” (with K. Hemming, M. Taljaard, G. Forbes & S. Eldridge). In BMJ Quality & Safety 27 (8), 2018: 664-670. 

“An ethical analysis of the SUPPORT trial: addressing challenges posed by pragmatic comparative effectiveness randomized controlled trials with usual care interventions,” (with A.R. Horn, J.M. Grimshaw, J. Brehaut, D. Fergusson, C.E. Goldstein & M. Taljaard). In Kennedy Institute of Ethics Journal 28 (1), 2018: 85–117.

Minimizing the harm of accidental awareness under general anesthesia: new perspectives from patients misdiagnosed as being in a vegetative state,” (with M. Graham, A.M. Owen, K. Çipi K & Naci L). In Anesthesia & Analgesia 126 (3), 2018; 1073–1076.

Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation,” (with C.E. Goldstein, J.C. Brehaut, D. Fergusson, J.M. Grimshaw, A.R. Horn & M. Taljaard). In BMC Medical Ethics 19 (1), 2018: 14. 

“Research ethics for emerging trial designs: does equipoise need to adapt?,” (with S.P. Hey, M. Taljaard & A.S. Kesselheim), In British Medical Journal 360, 2018: k226.

TwiC or treat? Are Trials within Cohorts ethically defensible?,” (with C.E. Goldstein & M. Taljaard). In Clinical Trials 15 (1), 2018: 21-24. 

“Is the concept of clinical equipoise still relevant to research?,” (with S.P. Hey, A.J. London, A. Rid & F. Miller). In British Medical Journal 359: 2017: j5787. 

“Does consent form follow function?,” (with C.E. Goldstein & J. Brehaut J). In American Journal of Bioethics 17 (12), 2017: 29–31. 

When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework,” (with J. Jull, M. Whitehead, M. Petticrew, E. Kristjansson, J. Petkovic, J. Volmink, M. Taljaard, S. Edwards, L. Mbuagbaw, R. Cookson, J. McGowan, A. Lydiatt, Y. Boyer, L.G. Cuervo, R. Armstrong, H. White, M. Yoganathan, T. Pantoja, B. Shea, K. Pottie, O. Norheim, S. Baird, B. Robberstadt, H. Sommerfelt, Y. Asada, G. Wells, P. Tugwell & V. Welch). In BMJ Open 7, 2017: e015815.

How to design efficient cluster randomised trials,” (with K. Hemming, S. Eldridge, G. Forbes & M. Taljaard). In British Medical Journal 358, 2017: j3064.

“Do doctors have a duty to take part in pragmatic randomised trials?,” (with M.K. Campbell, C.E. Goldstein & S.J.L. Edwards SJL). In British Medical Journal 357, 2017: j2817. 

“Inadequacy of ethical conduct and reporting of stepped wedge cluster randomized trials: Results from a systematic review,” (with M. Taljaard, K. Hemming, L. Shah, B. Giraudeau & J.M. Grimshaw). In Clinical Trials14 (4), 2017: 333–341.

Covert narrative capacity: Mental life in patients thought to lack consciousness,” (with L. Naci, M. Graham M & A.M. Owen). In Annals of Clinical and Translational Neurology 4 (1), 2016: 61–70.

“Assessing decision-making capacity in patients with communication impairments: a case study,” (with M. Cairncross, A. Peterson & A. Lazosky). In Cambridge Quarterly of Healthcare Ethics 25, 2016: 691–699. 

“What questions can a placebo help answer?,” (with S.P. Hey). In Monash Bioethics Review 34 (1), 2016: 23-36.

The ethics of future trials: qualitative analysis of physicians' decision making,” (with F. Webster, L. Todd, J.M. Grimshaw, A.P. Marshall, D. Cook, G. MacLennan, B.H. Cuthbertson, J.J. Francis for the SuDDICU International Group). In Trials 17 (1), 2016: 12.

Clinical equipoise,” (with A.R. Horn). In Encyclopedia of Global Bioethics 2016: 1–11.

“Cluster randomized trials: a closer look,” (with A.M. McRae & M. Taljaard). In Clinical Trials 13 (3), 2016: 294–300.