Informed Consent
Abadie R, Kimmelman J, Lafleur J, Lemmens T. Consent for Nondiagnostic Research Biopsies: A Pilot Study of Participant Recall and Therapeutic Orientation. IRB, 2014.
Braude H and Kimmelman J. The Ethics of Managing Affective and Emotional States to Improve Informed Consent: Autonomy, Comprehension, and Voluntariness. Bioethics, 2012.
Kimmelman J, Lemmens T, Kim SY. Analysis of Consent Validity for Invasive,
Nondiagnostic Research Procedures. IRB, 2012.
Kimmelman J. The Therapeutic Misconception at 25: Treatment, Research, and Confusion. Hastings Center Report, 2007.
Risk & Uncertainty
London AJ, Kane PB, Kimmelman J. Varieties of community uncertainty and clinical equipoise. Kennedy Institute of Ethics Journal. 2023;33(1):1-9
Kim SY, Kimmelman J. Practical steps to identifying the research risk of pragmatic trials. Clinical Trials. 2022 Mar 29.
Hutchinson N, Carlisle B, Doussau A, Bosan R, Gumnit E, MacPherson A, Fergusson DA, Kimmelman J. Patient Participation in Clinical Trials of Oncology Drugs and Biologics Preceding Approval by the US Food and Drug Administration. JAMA network open. 2021.
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.
Hey SP. Ethics and Epistemology of Accurate Prediction in Clinical Research. Journal of Medical Ethics, 2015.
Hey SP, Kimmelman J. The Risk-Escalation Model: A Principled Design Strategy for Early-Phase Trials. Kennedy Institute of Ethics Journal, 2014.
Kimmelman J. A Theoretical Framework for Early Human Studies: Uncertainty, Intervention Ensembles, and Boundaries. Trials, 2012.
Kimmelman J, London AJ. Predicting Harms and Benefits in Translational Trials: Ethics, Evidence, and Uncertainty. PLOS Medicine, 2011.
Anderson JA, Kimmelman J. Extending Clinical Equipoise to Phase 1 Trials Involving Patients: Unresolved Problems. Kennedy Institute of Ethics Journal, 2010.
Kimmelman J. Stable Ethics: Enrolling Non-Treatment Refractory Volunteers in Novel Gene Transfer Trials. Molecular Therapy, 2007.
Kimmelman J. Medical Research, Risk and Bystanders. IRB: Ethics and Human Research 2005; 27(4): 1-6. Abstract
Kimmelman J. Valuing Risk: The Ethical Review of Clinical Trial Safety. Kennedy Institute of Ethics Journal, 2004.
Kimmelman J. Ethics, Ambiguity Aversion, and Review of Complex Clinical Trials. Bioethics, 2012.
Foundations of Research Ethics
London AJ, Kimmelman J, Carlisle B. Rethinking Research Ethics: The Case of Postmarketing Trials. Science, 2012.
London AJ, Kimmelman J, Emborg ME. Beyond Access vs. Protection in Trials of Innovative Therapies. Science, 2010.