Steven Joffe, MD, MPH

Department	Hematology/Oncology
Hospital Title	Associate in Medicine
Academic Title	Associate Professor of Pediatrics
Phone	617-632-5295
Fax	617-632-2270
Email	Steven Joffe
Location	450 Brookline Ave. Boston, MA 02215

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, as well as children's participation in decisions about research. 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. Additional research focuses on ethical issues in genetic and genomic research, such as how researchers should handle genetic information about individual research participants that may be relevant to their current or future health, as well as how whole-genome technologies can be integrated into clinical care. 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 underlie ethical research with human subjects.
• Address ethical challenges in the application of whole-genome technologies to research and patient care.

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 Boston Children's Hospital and Dana-Farber Cancer Institute.

Dr. Joffe received an Award For Excellence In Human Research Protection-- Innovation from the Health Improvement Institute in 2002. He chairs the Bioethics Committee of the Children’s Oncology Group, the National Cancer Institute-supported cooperative group for clinical trials in pediatric oncology. He is also a member of the U.S. Food and Drug Adminstration’s Pediatric Ethics Subcommittee, and of the U.S. Department of Health and Human Services Secretary’s Advisory Committee for Human Research Protections (SACHRP).

Key Publications

• Miller FG, Joffe S. Equipoise and the dilemma of randomized clinical trials. New Engl J Med 2011;364:476-80.

• Joffe S, Miller FG. Bench to bedside: mapping the moral terrain of clinical research. Hastings Cent Rep 2008; 32: 30-42.

• Joffe S, Fernandez CV, Pentz RD, et al. Involving children with cancer in decision-making about research participation. J Pediatr. 2006;149(6):862-868.

• 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.