Joffe Laboratory for the Ethics of Biomedical Research

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Researchers in the Joffe Lab 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 Lab are helping to shape guidelines for the integration of genetic testing into the care of young adults with cancer. We are testing whether a universal approach (offering a broad panel of germline cancer risk tests to all young adults with cancer) identifies significantly more patients with cancer risks than the current guideline-based approach.

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-subject research in diverse settings, and the integration of genomic technologies into cancer research and care.

Research Highlights

  • Development and validation of one of the most widely used instruments for measuring participants’ knowledge of their clinical trials, which is one of the most important outcomes of the clinical trials process
  • Developing an approach to seeking the assent of children considering participation in cancer clinical trials
  • Conducting one of the first systematic studies of the financial relationships between patient advocacy organizations and the biopharmaceutical industry
  • Developing a conceptual model of the investigator-participant relationship grounded in the ethics of scientific experimentation rather than in the ethics of clinical medicine