Charles Weijer

weijer

Professor, Canada Research Chair in Bioethics

Department of Philosophy, Medicine (joint), Epidemiology and Biostatistics (cross); CRC in Bioethics

Research Area:
Bioethics
Research Ethics

Western University
Stevenson Hall 2150c
London, Ontario, Canada N6A 5B8

Tel: (519) 661-2111 x 80090

Fax: 519-661-3261

Charles Weijer is a philosopher and physician. His academic interests center on the ethics of medical research. Charles has written about using placebos in clinical trials, weighing the benefits and harms of medical research, and protecting communities in research. One recent project talks about a special kind of clinical trial in which groups of people— rather than individual patients—are randomized to one treatment or another. He is also currently collaborating with Adrian Owen on the ethics of functional neuroimaging after serious brain injury. Charles is one of the co-founders of the Rotman Institute and he has worked with a number of organizations around the world, including the World Health Organization, the United Nations, and the U.S. National Academies Institute of Medicine. He is motivated by the belief that medical research raises profound philosophical questions about the nature of our obligations to one another, particularly in relationships of inequality, such as that between researcher and research subject.

One broad area of inquiry, in collaboration with Jeremy Grimshaw and Monica Taljaard at the Ottawa Health Research Institute, addresses ethical and policy challenges posed by cluster randomized trials, a key technology in knowledge translation research. Since cluster trials randomize socially intact groups such as hospitals or primary care practices—rather than individuals—it is unclear whether current ethical concepts in research ethics apply to such studies. The project explored a set of six questions on the ethics of cluster randomized trials and developed international guidelines for cluster trials. Further work will examine the application of the guidelines to specific research contexts (such as global health, public health, and knowledge translation research) and differing national regulatory frameworks. More information about this project can be found here.

A second area of inquiry involves novel collaboration with Adrian Owen’s team on the ethical dimensions of research to detect awareness in disorders of consciousness. Owen has developed a technique to reliably detect unrecognized awareness in patients diagnosed as being in a persistent vegetative state. Patients are placed in a fMRI scanner and are given various mental imagery tasks. Activation of distinct areas of the brain can be visualized with fMRI and this activation is used as a proxy for the patient’s inability to behaviorally respond to commands. We are currently exploring a number of ethical issues. What obligations do researchers have to share individual research results with the families of these patients? How can decision making capacity be assessed in patients who can only communicate through a brain-computer interface? To what research risks may such patients be legitimately exposed? Further information about this project may be found here.

Books:

Corrigan O, Liddell K, McMillan J, Richards M, Weijer C (eds.). Limits of Consent: A Socio-ethical Approach to Human Subjects Research in Medicine. Oxford: Oxford University Press, 2009.

Weijer C, Skelton A, Brennan S. Bioethics in Canada. Toronto: Oxford University Press Canada, 2013.

 

Articles:

Peterson A, Naci L, Weijer C, Owen AM. A principled argument, but not a practical one. AJOB Neuroscience 2013; 4(1): 52–3.

Hey SP, Weijer C. Assay sensitivity and the epistemic contexts of clinical trials. Perspectives in Biology and Medicine 2013; 56(1): 1-17.

McRae AD, Bennett C, Brown JB, Weijer C, Boruch R, Brehaut J, Chaudhry S, Donner A, Eccles M, Grimshaw J, Zwarenstein M, Taljaard M. Researchers’ perceptions of ethical challenges in cluster randomized trials: A qualitative analysis. Trials 2013; 14: 1.

McRae AD, Taljaard M, Weijer C, Bennett C, Skea Z, Boruch R, Brehaut J, Eccles MP, Grimshaw JM, Donner A. Reporting of patient consent in healthcare cluster randomized trials is associated with the type of study interventions and publication characteristics. Journal of Medical Ethics 2013; 39(2): 119–24.

Chaudhry SH, Brehaut JC, Grimshaw JM, Weijer C, Boruch R, Donner A, Eccles MP, McRae AD, Saginur R, Skea ZC, Zwarenstein M, Taljaard M. Challenges in the research ethics review of cluster randomized trials: International survey of investigators. Clinical Trials 2013; 10(2): 257–68.

Taljaard M, Weijer C, Grimshaw JM, Eccles MP and the Ottawa Ethics of Cluster Randomized Trials Consensus Group. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomised Trials: A précis for researchers and research ethics committees. British Medical Journal 2013; 346: f2838.

Holbrook A, Lexchin J, Pullenayegum E, Campbell C, Marlow B, Troyan S, Weijer C, Blackmer J, Brazil K, Willison D. What do Canadians think about physician-pharmaceutical industry interactions? Health Policy 2013: 112: 255–263.

Hey SP, Heilig CM, Weijer C. Accumulating evidence and research organization (AERO) model: A new tool for representing, analyzing, and planning a translational research program. Trials 2013; 14: 159.

Peterson A, Naci L, Weijer C, Cruse D, Fernández-Espejo D, Graham M, Owen AM. Assessing decision making capacity in the behaviorally non-responsive patient with residual covert awareness. AJOB Neuroscience 2013; 4(4): 3–14.

Sheehan M, Timlin C, Peach K, Binik A, Puthenparampil W, Lodge M, Kehoe S, Brada M, Burnet N, Clarke S, Crellin A, Dunn M, Fossati P, Harris S, Hocken M, Hope T, Ives J, Kamada T, London AJ, Miller R, Parker M, Pijls-Johannesma M, Savulescu J, Short S, Skene L, Tsujii H, Tuan J, Weijer C. Position statement on ethics, equipoise and research on charged particle therapy. Journal of Medical Ethics 2013: Sep 28. doi: 10.1136/medethics-2012-101290. [Epub ahead of print].

Weijer C. Is clinical research and ethics a zero sum game? Critical Care Medicine 2005; 33(4): 912–3.

Heilig CM, Weijer C. A critical history of individual and collective ethics in the lineage of Lellouch and Schwartz. Clinical Trials 2005; 2(3): 244–53.

Weijer C. Clinical trials. Encyclopedia of Science, Technology, and Ethics. New York: Macmillan Reference Library, 2005.

Fernandez CV, Taweel S, Kodish ED, Weijer C. Disclosure of research results to research participants: Needs and attitudes of adolescents and parents. Pediatrics and Child Health 2005; 10(6): 332–4.

Weijer C. Meaningful work as due inducement. Theoretical Medicine and Bioethics 2005; 26(5): 431–5.

McRae AD, Ackroyd-Stolarz S, Weijer C. Risk in emergency research using a waiver of/exception from consent: implications of a structured approach for IRB review. Academic Emergency Medicine 2005; 12(11): 1104–12.

Miller PB, Weijer C. Fiduciary obligation in clinical research. Journal of Law, Medicine & Ethics 2006; 34(2): 424–40.

Miller PB, Weijer C. The trust-based obligations of the state and physician-researchers to patient-subjects. Journal of Medical Ethics 2006; 32(9): 542–7.

Weijer C, LeBlanc GJ. The balm of Gilead: is the provision of treatment to those who seroconvert in HIV prevention trials a matter of moral obligation or moral negotiation? Journal of Law, Medicine & Ethics 2006; 34(4): 793–808.

Fernandez CV, Weijer C. Obligations in offering to disclose genetic research results. American Journal of Bioethics 2006: 6(6): 44–6.

Fernandez CV, Santor D, Weijer C, Strahlendorf C, Moghrabi A, Pentz R, Gao J, Kodish E. The return of research results to participants: pilot questionnaire of adolescents and parents of children with cancer. Pediatric Blood & Cancer 2007; 48(4): 441–6.

Miller PB, Weijer C. Equipoise and the duty of care in clinical research: a philosophical response to our critics. Journal of Medicine and Philosophy 2007; 32(2): 117–33.

Weijer C, Miller PB. Refuting the net-risks test: a response to Wendler and Miller’s “Assessing research risks systematically”. Journal of Medical Ethics 2007; 33(8): 487–90.

Weijer C, Miller PB. Evaluating benefits and harms in intensive care research. Intensive Care Medicine 2007; 33(10): 1819–22.

Ramsey K, Weijer C. Ethics of surgical training in developing countries. World Journal of Surgery 2007; 31(11): 2067–9.

Miller PB, Weijer C. Revisiting equipoise: a response to Gifford. Kennedy Institute of Ethics Journal 2007; 17(3): 227–46.

McRae AD, Weijer C. US federal regulations for emergency research: a practical guide and commentary. Academic Emergency Medicine 2008; 15(1): 88–97.

Ross S, Robert M, Harvey MA, Farrell S, Schultz J, Wilkie D, Lovatsis D, Epp A, Easton B, McMillan B, Schachter J, Gupta C, Weijer C. Ethical issues associated with the introduction of new surgical devices, or just because we can, doesn’t mean we should. Journal of Obstetrics and Gynecology of Canada 2008; 30(6): 508–13.

Rowan-Legg R, Weijer C, Gao J, Fernandez C. A comparison of journal instructions regarding institutional review board approval and conflict-of-interest disclosure between 1995 and 2005. Journal of Medical Ethics 2009; 35(1): 74–8.

Kimmelman J, Weijer C, Meslin EM. Helsinki discords: FDA, ethics, and international drug trials. Lancet 2009; 373(9657): 13–4.

Fernandez CV, Gao J, Strahlendorf C, Moghrabi A, Pentz RD, Barfield RC, Baker JN, Santor D, Weijer C, Kodish E. The return of research results to participants: attitudes and needs of adolescents and parents of children with cancer. Journal of Clinical Oncology 2009; 27(6): 878–83.

Sampson H, Weijer C, Pullman D. Research governance lessons from the National Placebo Initiative. Health Law Review 2009; 17(2,3 [special issue]): 26–32.

Caulfield T, Weijer C. Minimal risk and large-scale biobanks and cohort studies. Health Law Review 2009; 17(2,3 [special issue]): 53–8.

Taljaard M, Weijer C, Grimshaw JM, Belle Brown J, Binik A, Boruch R, Brehaut JC, Chaudhry SH, Eccles MP, McRae A, Saginur R, Zwarenstein M, Donner A. Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study. Trials 2009; 10: 61.

Read K, Fernandez CV, Gao J, Strahlendorf C, Moghrabi A, Pentz RD, Barfield RC, Baker JN, Santor D, Weijer C, Kodish E. Decision-making by adolescents and parents of children with cancer regarding health research participation. Pediatrics 2009; 124(3): 959–65.

Ross S, Weijer C, Gafni A, Ducey A, Thompson C, Lafreniere R. Ethics, economics and the regulation and adoption of new medical devices: case studies in pelvic floor surgery. BMC Medical Ethics 2010; 11:14.

Weijer C, Grimshaw JM, Taljaard M, Binik A, Boruch R, Brehaut JC, Donner A, Eccles MP, Gallo A, McRae AD, Saginur R, Zwarenstein M. Ethical issues posed by cluster randomized trials in health research. Trials 2011; 12: 100.

Taljaard M, McRae A, Weijer C, Bennett C, Dixon S, Taleban J, Skea Z, Brehaut J, Eccles MP, Donner A, Saginur R, Boruch RF, Grimshaw JM. Inadequate reporting of research ethics review and informed consent in cluster randomized trials: review of a representative sample of published trials. British Medical Journal 2011; 342: d2496.

Binik A, Weijer C, McRae AD, Grimshaw JM, Baruch R, Brehaut JC, Donner A, Eccles MP, Saginur R, Taljaard M, Zwarenstein M. Does clinical equipoise apply to cluster randomized trials in health research? Trials 2011: 12: 118.

Binik A, Weijer C, Sheehan M. Minimal risk remains an open question. American Journal of Bioethics 2011; 11(6): 25–7.

McRae AD, Weijer C, Binik A, White A, Grimshaw JM, Baruch R, Brehaut JC, Donner A, Eccles M, Saginur R, Zwarenstein, M Taljaard M. Who is the research subject in cluster randomized trials in health research? Trials 2011; 12: 183.

Ivers N, Taljaard M, Dixon S, Bennett C, McRae A, Taleban J, Skea Z, Brehaut J, Boruch RF, Eccles M, Grimshaw JM, Weijer C, Zwarenstein M, Donner A. Impact of the CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of a random sample of 300 trials from 2000 to 2008. British Medical Journal 2011;343: d5886.

McRae AD, Weijer C, Binik A, Grimshaw JM, Baruch R, Brehaut JC, Donner A, Eccles MP, Saginur R, White A, Taljaard M. When is informed consent required in cluster randomized trials in health research? Trials 2011;12: 202.

Angelski C, Fernandez CV, Weijer C, Gao J. The publication of ethically uncertain research:  attitudes and practices of journal editors. BMC Medical Ethics 2012; 13: 4.

Gallo A, Weijer C, White A, Grimshaw JM, Baruch R, Brehaut JC, Donner A, Eccles MP, McRae AD, Saginur R, Zwarenstein M, Taljaard M. What is the role and authority of gatekeepers in cluster randomized trials in health research? Trials 2012; 13: 116.

Weijer C, Grimshaw JM, Eccles MP, McRae AD, White A, Brehaut JC, Taljaard M, and the Ottawa Ethics of Cluster Randomized Trials Consensus Group. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials. PLoS Medicine 2012; 9(11): e1001346.

Chaudhry SH, Brehaut JC, Grimshaw JM, Weijer C, Boruch R, Donner A, Eccles MP, McRae AD, Saginur R, Skea ZC, Zwarenstein M, Taljaard M. Challenges in the research ethics review of cluster randomized trials: International survey of investigators. Clinical Trials 2012.

Binik A, Weijer C. Why the debate over minimal risk needs to be reconsidered. Journal of Medicine and Philosophy 2012.

Hey SP, Weijer C. Assay sensitivity and the epistemic contexts of clinical trials. Perspectives in Biology and Medicine 2012.

McRae AD, Taljaard M, Weijer C, Bennett C, Skea Z, Boruch R, Brehaut J, Eccles MP, Grimshaw JM, Donner A. Reporting of patient consent in healthcare cluster randomized trials is associated with the type of study interventions and publication characteristics. Journal of Medical Ethics 2012.

Peterson A, Naci L, Weijer C, Owen AM. A principled argument, but not a practical one. AJOB Neuroscience 2013.

Book Chapters:

Miller PB, Weijer C. Evaluating risks of non-therapeutic research in children. In: Kodish E (ed.). Ethics and Research with Children: A Case-based Approach. New York: Oxford University Press, 2005: 29–45.

Emanuel EJ, Weijer C. Protecting communities in research: from a new principle to rational protections. In: Childress JF, Meslin EM, Shapiro HT (eds.). Belmont Revisited: Ethical Principles for Research with Human Subjects. Washington: Georgetown University Press, 2005: 165–83.

Brunger F, Weijer C. Politics, risk, and community in the Maya ICBG case. In: Lavery JV, Wahl E, Grady C, Emanuel EJ (eds.). Ethical Issues in International Biomedical Research: A Case Book. New York: Oxford University Press, 2007: 35–42.

Miller PB, Weijer C. Evaluating benefits and harms in clinical research. In: Ashcroft R, Dawson A, Draper H, McMillan J (eds.). Principles of Health Care Ethics (2nd ed.). London: John Wiley & Sons, 2007: 711–17.

Rudnick A, Weijer C. Ethics and schizophrenia. In: Mueser KT, Jeste DV (eds.). Clinical Handbook of Schizophrenia. New York: Guilford Press, Inc., 2008: 624–30.

Corrigan O, McMillan J, Weijer C. Introduction. In: Corrigan O, et al. (eds.). Limits of Consent: A Socio-ethical Approach to Human Subjects Research in Medicine. Oxford: Oxford University Press, 2009: 1–9.

Miller PB, Weijer C. Trust and exploitation in clinical research. In: Corrigan O, et al. (eds.). Limits of Consent: A Socio-ethical Approach to Human Subjects Research in Medicine. Oxford: Oxford University Press, 2009: 25–37.

Weijer C. Private religious schools and public reasons. In: Herzberg A (ed.). Statistics, Science and Public Policy XIII. Kingston: Queen’s University Press, 2009.

Weijer C, Lanata CF, Plowe CV. Ethical considerations in the conduct of vaccine trials in developing countries. In: Levine MM, Dougan G, Good MF, Liu MA, Nabel GJ, Nataro JP, Rappuoli R (eds.). New Generation Vaccines (4th edition). New York: Informa Health Care, Inc., 2010: 59–65.

Taljaard M, Weijer C, Grimshaw J. Ethical issues in cluster randomized trials in knowledge translation. In: Strauss SE, Tetroe J, Graham ID (eds.). Knowledge Translation in Health Care. Second edition. Oxford: BMJ Books, Wiley Blackwell, 2013.

Project Title: Ethics of Neuroimaging After Serious Brain Injury
Role: Co-Principal Investigator
Project Members: Adrian Owen (Co-Principal Investigator, Western), Tenielle Gofton (Western), Andrea Lazosky (Western), Kathy Speechley (Western), Fiona Webster (Toronto), Bryan Young (Western)
Brief Description: With 50,000 new cases occurring each year in Canada, serious brain injuries place an enormous burden on patients, families, and the healthcare system. Patient outcome after serious brain injury is highly variable. Following a period of coma (unconsciousness) lasting days or weeks, some patients make a good recovery, while others progress into a vegetative or minimally conscious state. As it is difficult to predict who will make a good recovery after serious brain injury, families and physicians are forced to make treatment decisions in the face of uncertainty. Further the diagnosis of vegetative and minimally conscious states is itself difficult, with error rates as high as 43%. Recent advances in neuroimaging allow for the detection of intact brain functions that cannot be found by routine bedside examination. Neuroimaging offers the prospect of improved prediction of patient outcome and increased diagnostic accuracy. Remarkably, in 3 cases, neuroimaging has been used to communicate with patients thought to be vegetative or minimally conscious. Neuroimaging after serious brain injury raises difficult ethical issues that must be addressed before it can be responsibly adopted in practice. Our research team brings together philosophers, neurologists, and neuroscientists to provide answers to these difficult problems.

Project Title: Ethical and Policy Issues in Cluster Randomized Trials
Role: Co-Principal Investigator
Project Members: Monica Taljaard (Ottawa Health Research Institute (OHRI)), Jeremy Grimshaw (OHRI), Judith Belle Brown (Western), Robert Boruch (University of Pennsylvania), Jamie Brehaut (OHRI), Allan Donner (Western), Martin Eccles (Newcastle University), Raphael Saginur (OHRI), Merrick Zwarenstein (University of Toronto).
Brief Description: The project addresses ethical and policy challenges posed by cluster randomized trials, a key technology in knowledge translation research. Since cluster trials randomize socially intact groups such as hospitals or physicians practices, it is unclear whether current ethical concepts in research ethics apply to such studies. The project will explore a set of six questions on the ethics of cluster randomized trials and will seek to develop international guidelines for cluster trials.

Philosophy Undergraduate Courses

Advanced Topics in Ethics (2005–6)
Advanced Topics in Philosophy of Science (2007–8)
Health Care Ethics (2005–6, 2007–8, 2008–9, 2009–10, 2014–15)

Philosophy Graduate Courses

Research Ethics (2005–6)
Topics in Bioethics (2008–9)
Ethics and Epistemology of Clinical Trials (2009–10)

Medicine Post-graduate                

Clinical Teaching Unit Ethics Rounds (2005–12)
Academic Half Days in Bioethics (2005–12; 2014–15)