Director of Biomedical Ethics Unit
jonathan.kimmelman [at] mcgill.ca
Tel: (514) 398-3306
Address: Biomedical Ethics Unit
3647 Peel St.
Montreal, QC H3A 1X1
Jonathan Kimmelman is a James McGill 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. In 2018, he was named as a Hastings Center Fellow.
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.
Selected Articles and Chapters from Last 5 Years
Carlisle B, Federico C, Kimmelman J*. Trials That Say “Maybe:” The Disconnect Between Exploratory and Confirmatory Testing after Drug Approval. BMJ 2018; 360: k959
Yarborough M, Bredenoord A, D'Abramo F, Joyce NC, Kimmelman J, Ogbogu U, Sena E, Strech D, Dirnagl U. The bench is closer to the bedside than we think. PLoS Biol. 2018 Jun 6;16(6):e2006343
Shah S, Kimmelman J, Lyerly AD, Lynch HF, Miller FG, Palacios R, Pardo CA, Zorilla C. Bystander Risk, Social Value, and the Ethics of Human Research. Science 2018; 360: 158-9.
Wiechowski S, Chin W, Sievers S, Federico C, Kimmelman J, Strech DJ. Preclinical Efficacy Studies in Investigator Brochures: Do They Enable Risk-Benefit Assessment? PLoS Biol 2018; 16: e20044879.
London AJ, Kimmelman J.* Clinical Trials in Medical Center Advertising. JAMA-Onc 2018; Apr5.
Waligora M, Bala MM, Koperny M, Jaeschke RR, Wozniak A, Piasecki J, Sliwka A, Mitus JW, Wasylewski MT, Strzebonska K, Polak M, Nowis D, Fergusson D, Kimmelman J*. Risk and
Surrogate Benefit for Pediatric Phase 1 Trials in Oncology: A Systematic Review with Meta-analysis. PLoS Medicine 2018; 15(2): e1002505.
Kimmelman J*. Better to Be in the Placebo Arm for Trials of Neurological Therapies? Cell Transplantation (in press).
Kimmelman J,* Carlisle B, Gönen M. Drug Development at the Portfolio Level Is Important for Policy, Care Decisions, and Human Protections. JAMA 2017 doi: 10.1001/jama.2017.11502.
Benjamin D, Mandel DR, Kimmelman J*. Can Cancer Researchers Accurately Judge Whether Preclinical Reports will Reproduce? PLoS Biology 2017; 15: e2002212.
Hakala A, Fergusson D, Kimmelman J*. Nonpublication of Trial Results for New Neurological Drugs: A Systematic Review. Annals of Neurol 2017; 81: 782-89.
Benjamin D, Kimmelman J*. Does the Unrealistic Optimist in Research Have a Defense? Perspect Biol Med 2017; 59: 491-506.
Neumann K, Grittner U, Piper SK, Rex A, Florez-Vargas O, Karystianis G, Schneider A, Wellwood I, Siegerink B, Ioannidis JP, Kimmelman J, Dirnagl U. Increasing efficiency of preclinical research by group sequential designs. PLoS Biol. 2017 Mar 10;15(3):e2001307.
Federico C, Kimmelman J*. First in Human Drug Testing: Higher Standards Required. Nature 2017; 542: 25-7.
Mattina J, Carlisle B, Hachem Y, Fergusson D, Kimmelman J*. Inefficiencies and Patient Burdens in the Development of the Targeted Cancer Drug Sorafenib: A Systematic Review. PLoS Biology 2017; 15: e2000487.
Kimmelman J*, Resnik DB, Peppercorn J, Ratain MJ. Burdensome Research Procedures in Trials: Why Less is More. JNCI 2017; 109: djw315.†
Kimmelman J*, Kesselheim AS. Translational Research and the U.S. Federal Elections. Sci Trans Med 2016; 8: 361ed13.
Kimmelman J.* Are Phase 1 Cancer Trials Really Therapeutic? J Clin Oncol 2017; 35: 135-8.†
London AJ, Kimmelman J.* Accelerated Approval and Health Inequality. JAMA Intern Med 2016; 176: 883-4.
Barsanti-Innes B, Hey SP, Kimmelman J.* “The Challenges of Validating in Precision Medicine: The Case of ERCC1 Diagnostic Testing.” The Oncologist 2017: 22: 89-96.
Mattina J, MacKinnon N, Henderson VC, Fergusson D, Kimmelman J.* Design and Reporting of Targeted Anti-Cancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumour Efficacy. Canc Res 2016. Pii: canres.3455.2016.
Kimmelman J,* Hyun I, Benvenisty N, Caulfield T, Heslop HE, Murry CE, Sipp D, Studer L, Sugarman J, Daley GQ. Global Standards for Stem Cell Research. Nature. 2016; 533(7603): 311-3.
Kimmelman J,* Heslop HE, Sugarman J, Studer L, Benvenisty N, Caulfield T, Hyun I, Murry CE, Sipp D Daley GQ. The New ISSCR Guidelines: Clinical Translation of Stem Cell Research. Lancet 2016; 387(10032): 1979-81.
Caulfield T, Sipp D, Murry CE, Daley GQ, Kimmelman J. Confronting Stem Cell Hype. Science 2016; 352(6287): 776-7.
Daley GQ, Hyun I, Apperly JF, … Kimmelman J,*. Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines. Stem Cell Reports 2016; S2213-6711.
Grankvist H, Kimmelman J.* How do Researchers Decide Early Clinical Trials? Med Health Care Philos 2016; 19: 191-8.
Franck C, Filion KB, Kimmelman J, Grad R, Eisenberg MJ. Ethical considerations of e-cigarette use for tobacco harm reduction. Respir Res 2016; 17: 53.
Hey S, Kimmelman J*. Do We Know Whether Researchers and Reviewers Are Estimating Risk and Benefit Accurately? Bioethics 2016; 30: 609-17.
Holman C, Piper SK, Grittner U, Diamantaras AA, Kimmelman J, Siegerink B, Dirnagl U. Where Have All the Rodents Gone? The Effects of Attrition in Experimental Research on Cancer and Stroke. PLoS Biology 2016; 14: e1002331.
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.