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Steven Joffe, MD, MPH Children's logo Harvard logo
Steven Joffe, MD, MPH
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   Department  Hematology/Oncology
   Hospital Title  Assistant in Medicine
   Academic Title  Assistant Professor of Pediatrics
   Phone  617-632-5295
   Fax  617-632-2270
   Email  Steven Joffe
   Location  44 Binney Street
Boston
MA 02115
Research Overview
Steven Joffe's work aims to improve our understanding of the nature of clinical research and to apply that improved understanding to the design of research and to interactions with research participants. The major focus of Dr. Joffe's current work is the ethics of research involving human subjects. He conducts observational and intervention studies of informed consent to clinical trials. He also studies how methodological and ethical considerations intersect in clinical trial design. Dr. Joffe is interested in the implications of human subjects regulations for clinical research and drug development, and in how clinicians and investigators navigate their complex roles. Finally, he studies how the human subjects' protection system works to protect research participants and what impact that system has on the research process.

The specific goals of his research are to:
  • Understand and improve the informed consent process for clinical research.
  • Understand and enhance the human subjects protection system
  • Clarify the conceptual models that lie behind ethical research with human subjects.
About Steven Joffe

Steven Joffe received his MD from University of California San Francisco and his MPH from University of California Berkeley. He completed an internship and residency at University of California San Francisco and a fellowship in pediatric oncology at Children's Hospital Boston and Dana-Farber Cancer Institute.

Dr. Joffe received an Award For Excellence In Human Research Protection-- Innovation from the Health Improvement Institute in 2002.

Key Publications
  • Joffe S, Fernandez CV, Pentz RD, Ungar DR, Mathew NA, Turner CW, Alessandri AJ, Woodman CL, Singer DA, Kodish E. Involving Children In Decision-Making About Research Participation. J Pediatr 2006 (in press).

  • Joffe S, Miller FG. Rethinking risk-benefit assessment for phase I cancer trials. J Clin Oncol. 2006;24(19):2987-90.

  • Joffe S, Harrington DP, George SL, Emanuel EJ, Budzinski LA, Weeks JC. Satisfaction of the uncertainty principle in cancer clinical trials: retrospective cohort analysis. British Medical Journal 2004; 328: 1463.

  • Peppercorn JM, Weeks JC, Cook EF, Joffe S. Comparison of outcomes in cancer patients treated within and outside clinical trials: conceptual framework and structured review. Lancet 2004; 363: 263-270.

  • Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet 2001; 358: 1772-1777.
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