jonathan.kimmelman [at] mcgill.ca
Tel: (514) 398-3306
Fax: (514) 398-8349
Address: Biomedical Ethics Unit
3647 Peel St.
Montreal, QC H3A 1X1
Jonathan Kimmelman is Associate Professor in the Biomedical Ethics Unit / Social Studies of Medicine. He has cross appointments in Experimental Medicine, Epidemiology, Biostatistics and Occupational Health, and Human Genetics. Kimmelman holds a PhD in Molecular Biophysics and Biochemistry from Yale University, and joined McGill in 2005. His research revolves around the ethical, social and policy dimensions of translational research. He received the Institute of Genetics Maud Menten New Investigator Prize, a CIHR New Investigator Award (2008) and a Friedrich Bessel- Humboldt Award (2014). Kimmelman chaired the ethics committee of the American Society of Gene and Cell Therapy, 2008-2010, and chairs the ethics committee of the International Society of Stem Cell Research. He also served on the CIHR Stem Cell Oversight Committee, is a current member of the Gene and Cell Therapy DSMB of U.S. National Heart, Lung, and Blood Institute, and has been a member of two U.S. Institute of Medicine committee reports. His book, Gene Transfer and the Ethics of First-in-Human Trials: Lost in Translation, was published by Cambridge University Press.
For the most up-to-date information about Kimmelman, including recent publications, lab members and press clips, please visit translationalethics.com
Kimmelman's research centers on the ethical, social, and policy challenges in testing novel medical technologies in human beings ("translational clinical research"). Current projects are investigating risk, prediction, validity and knowledge value across the trajectory of drug development. Another set of projects is pursuing alternative frameworks and understandings concerning the role and content of clinical research ethics. Kimmelman directs the Group for Studies of Translation, Ehtics, and Medicine (Stream). Click here to learn more about specific research projects.
Our research group welcomes inquiries from talented students interested in graduate study and research personnel.
Kimmelman is principal investigator and co-investigator on several operating grants. He is Principal Investigator on several CIHR-funded operating grants including Signals, Safety, and_Success: An Analysis of Risk, Benefit, and Translation after Detection of Clinical Activity in Drug Development.pdf, - and Can Researchers Accurately Predict Trial Outcomes?
Kimmelman teaches a master's level course on the ethics of human experimentation PHIL 543B: Medical Ethics: The Ethics of Human Experimentation [.pdf]; he also supervises Master's, Doctoral, and Postdoctoral students, and teaches in the Medical School. Kimmelman has also taught at the National Institute of Neurological Disorders and Stroke-funded Clinical Trials Methods Course in Neurology.
Articles and Chapters
Hey S, Kimmelman J*. Can Researchers and Reviewers Estimate Risk/Benefit Accurately? Bioethics (in press).
London AJ, Kimmelman J*. Why Clinical Translation Cannot Succeed Without Failure. eLife (2015); 4: e12844.
Henderson V, Demko N, Hakala A, Fergusson D, Kimmelman J*. A Meta-analysis of Sunitinib Preclinical Studies. eLife 2015; 4 doi: 10.7554.
Kimmelman J,* Henderson V. Assessing Risk/Benefit for Trials Using Preclinical Evidence. J Med Ethics 2015; Oct 13 (Epub ahead of print)
Hakala A, Kimmelman J,* Carlisle B, Fergusson D. Accessibility of Trial Reports for Drugs Stalling in Clinical Development. BMJ 2015; 350: h1116.
Hey SH, Kimmelman J*. Are Outcome Adaptive Allocation Clinical Trials Ethical? Clin Trials 2015; 12: 102-6
Federico C, Kimmelman J*, Carlisle B, Fergusson DA. Late, Never or Nonexistent: The Inaccessibility of Preclinical Evidence for New Drugs. Br J Pharmacol 2014; 171: 4247-54.
Kimmelman J,* Mogil J, Dirnagl U. Distinguishing Between Exploratory and Confirmatory Preclinical Research will Improve Translation. PLoS Biology 2014; 12: e1001863.
Hey SH, Kimmelman J*. The Risk Escalation Model: A Principled Design Strategy for Early Phase Trials. Kennedy Inst. Ethics J. 2014; 24: 121-39.
Hey SH, Kimmelman J*. The Questionable Use of Unequal Randomization in Confirmatory Trials. Neurology 2014; 82: 77-9.
Freeman GA, Kimmelman J*, Dancey J, Monzon JG. Reporting Practices of Pharmacodynamic Studies Involving Invasive Research Procedures in Cancer Trials. Br J Cancer 2013; 109: 897-908.
Henderson VH, Kimmelman J*, Fergusson D, Grimshaw JM, Hackam DG. Threats to Validity in the Design and Conduct of Preclinical Efficacy Studies: A Systematic Review of Guidelines for In Vivo Animal Experiments. PLoS Med 2013; e1001489†
Hey SH, Kimmelman J*. Ethics, Error, and Initial Trials of Efficacy. Sci Trans Med 2013; 5: 184-6.
Freeman GA, Kimmelman J.* Publication and Reporting Conduct for Pharmacodynamic Analyses of Tumor Tissue in Early Phase Oncology Trials. Canc Clin Res 2012; 18(23): 1478-84.
Kimmelman J,* Anderson JA. Should Preclinical Studies be Registered? Nat Biotechnol 2012; 30: 488-9.
Kimmelman J. A Theoretical Framework for Early Human Studies: Uncertainty, Intervention Ensembles, and Boundaries. Trials 2012; 13:173.
Kimmelman J, Lemmens T, Kim SYH. Analysis of Consent Validity for Invasive, Nondiagnostic Research Procesures. IRB 2012; 34:1-7.
Kimmelman J. Biologics, Ethics and the Human Brain. In: Neuroethics in Practice. Farah M, Chatterjee A, eds. New York: Oxford University Press. (2012)
Kimmelman J. Ethics in Clinical Trials Involving the Central Nervous System: Risk, Benefit, Justice, and Integrity. In: Clinical Trials in Neurology: Design, Conduct, and Analysis. Ravina B, Cummings J, McDermott M, and Poole RM, eds. New York: Cambridge University Press. Pp 173-86. (2012).
Kimmelman J, Duckworth K, Ramsay T, Voss T, Ravina B, Emborg ME. Risk of Surgical Delivery to the Basal Ganglia: A Meta-analysis. Mov Disord 2011; 26: 1415-21.
Kimmelman J, London AJ. Predicting Harms and Benefits in Translational Trials: Ethics, Evidence, and Uncertainty. PLoS Medicine 2011; 3: e1001010
Kimmelman J. Ethics, Ambiguity Aversion, and Review of Complex Clinical Trials. Bioethics (in press).
Braude H, Kimmelman J.* The Ethics of Managing Affective and Emotional States to Improve Informed Consent: Autonomy, Comprehension, and Voluntariness. Bioethics (in press)
London AJ, Kimmelman J.* Emborg ME. Beyond Access vs. Protection in Trials of Innovative Therapies. Science 2010; 328: 829-30
Anderson JA, Kimmelman J.* Extending Clinical Equipoise to Phase 1 Trials Involving Patients: Unresolved Problems. Kennedy Inst Ethics J. 2010; 20(1):75-98.
Brehaut JC, Fergusson DA, Kimmelman J, Shojania KG, Saginur R, Elwyn G Contemp Clin Trials. 2010; 31: 218-20
Kimmelman J. Tomorrow, interrupted? Risk, ethics, and medical advance in gene transfer. Mol Ther. 2009; 17: 1838-9.
Kimmelman J, London AJ, Ravina B, Ramsay T, Bernstein M, Stahnnisch FW, Emborg ME. Launching Invasive, First-in-Human Trials Against Parkinson's Disease: Ethical Considerations. Movement Disorders 2009; 24: 1893-901. Preprint [.pdf]
Kimmelman J, Weijer C, Meslin EM. Helsinki Discords: FDA, Ethics, and International Drug Trials. Lancet 2009; 373: 13-4.
London AJ, Kimmelman J. Justice in Translation: From Bench to Bedside in the Developing World. Lancet 2008; 372: 82-5. Preprint [.pdf]
Kimmelman J. The Ethics of Human Gene Transfer. Nature Reviews—Genetics 2008; 9: 239-44.
Kimmelman J. Staunch protections: the ethics of haemophilia gene transfer research. Haemophilia. 2008; 14: 5-14
Kimmelman J. Ethics at Phase 0: Clarifying the Issues. Journal of Law, Medicine, and Ethics 2007; 35(4): 727-33 Abstract [.pdf]
Kimmelman J. The Therapeutic Misconception at 25: Treatment, Research, and Confusion. Hastings Centre Report 2007; 6: 36-42. Abstract plus supplementary materials Abstract plus supplementary materials [.pdf]
Kimmelman J. Staunch protections: the ethics of haemophilia gene transfer research. Haemophilia 2007 14: 5-14.
Kimmelman, J. Missing the Forest: Further Thoughts on Bystander Risk in Medical Research. Cambridge Quarterly Healthcare Ethics 2007; 16: 483-90. Abstract [.pdf]
Kimmelman J. Stable Ethics: Enrolling Non-Treatment Refractory Volunteers in Novel Gene Transfer Trials. Molecular Therapy 2007; 15: 1904-6. Abstract [.pdf]
Kimmelman, J. Clinical Trials and SCID Row: The Ethics of Phase 1 Trials in the Developing World. Developing World Bioethics 2007; 7(3): 483-90.
Kimmelman J, Nalbantoglu J. Faithful Companions: A Proposal for Neurooncology in Pet Dogs. Cancer Research 2007; 67: 4451-4. Abstract [.pdf]
Kimmelman, J. Investigators as Inventors: Patents, Clinical Research, and Conflict of Interest. Academic Medicine 2007; 82: 24-31.
Kimmelman J, Baylis F, and Glass, KC. Stem Cell Trials: Lessons from Gene Transfer Research. Hastings Center Report 2006; 36(1): 23-6.
Kimmelman J. Medical Research, Risk and Bystanders. IRB 2005; 27(4): 1-6. Abstract [.pdf]
Kimmelman J and Levenstadt A. Elements of Style: Consent Form Language and the Therapeutic Misconception in Trials of Gene Therapy. Human Gene Therapy 2005; 16(4): 502-8.
Kimmelman J. Recent developments in gene transfer: risk and ethics. BMJ 2005 330: 79-82.
Kimmelman J. Valuing Risk: The Ethical Review of Clinical Trial Safety. Kennedy Institute of Ethics Journal 2004; 14(4): 369-393.