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Boundaries and Balances Track
Breakout Session Series D
Mark Barnes, JD, LLM
Partner
Ropes & Gray Law Firm
Harvard University and Brigham and Women’s Hospital
Julie Kaneshiro, MA
Deputy Director
Office for Human Research Protections
Susan Stayn, JD
Senior University Counsel
Stanford University
The revised Common Rule introduces the option of broad consent and limited IRB review for secondary research, as well as two new exemptions (exemptions seven and eight) for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens when broad consent is used. These options, and the revised definitions of "human subject," offer new opportunities and challenges for the research enterprise and IRB professionals, but also raise questions about how and whether they can be effectively utilized to facilitate research. During this session, speakers and attendees will: