Publication

Contemporary Issues for Protecting Patients in Cancer Research - Workshop Summary


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Note: Proceedings contain the opinion of the presenters, but do NOT reflect the conclusions of the Health and Medicine Division or the National Academies. Learn more about the differences between Reports and Proceedings.

In the nearly 40 years since implementation of federal regulations governing the protection of human participants in research, the number of clinical studies has grown exponentially and the studies themselves have become much more complex. In addition, growing emphasis on targeted cancer therapies requires greater collaboration and sharing of research data—including use of electronic records—and thus has also increased concerns about the potential for inappropriate or unauthorized use of data. These changes and challenges raise new ethical and practical questions for the oversight of clinical studies, and for protecting patients and their health information in an efficient manner that does not compromise the progress of biomedical research.

On February 24 and 25, 2014, the National Cancer Policy Forum of the Institute of Medicine convened a workshop to frame and discuss contemporary issues in human subjects protections as they pertain to cancer research, with the goal of identifying potential relevant policy actions. This document summarizes the workshop.