Steven Joffe Research Program

Led by Steven Joffe MD, MPH, researchers in the Joffe Research Program are addressing the ethical challenges that arise during the design and conduct of biomedical research, including clinical trials and genomic research in both adult and pediatric settings. The long-term goal of the research is to provide guidance and create an ethical framework for clinicians and researchers seeking to conduct human subjects research in accordance with the highest ethical standards.

Ongoing studies in the Joffe Research Program are helping to shape guidelines for the integration of whole-exome and tumor sequencing technologies into the clinical care of cancer patients. Results from recent studies showed that while a majority of oncology patients want cancer-related sequencing results, patients’ low level of genetic knowledge coupled with oncologists’ inexperience with large-scale sequencing may hinder easy integration of these technologies into existing cancer. Additional studies are underway to address some of these challenges.

Other studies focus on the roles and responsibilities of oncology researchers in multicenter randomized clinical trials, accountability of various actors in the clinical research enterprise, oversight of learning activities (including both research and quality improvement) within learning healthcare systems, children’s capacity to engage in research decisions and the return of individual genetic results to participants in epidemiological and clinical studies.

Future studies will continue to focus on ethical challenges in clinical trial design, informed consent, the scientific and ethical oversight of human subjects research in diverse settings, and the integration of genomic technologies into cancer research and care.