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Research involving Data and Biospecimens Track
2019 AER Conference
Julie Ozier, MHL, CHRC, CIP
Director, HRPP, Vanderbilt University and Medical Center
Nicholas A. Wallace, JD
Attorney, Ropes & Gray LLP
Carol Juliet Weil, JD
Program Director, Ethical and Regulatory Affairs, Division of Cancer Treatment and Diagnosis, National Cancer Institute
The revised Common Rule introduced the option of broad consent 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 and limited IRB review occurs. 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. With almost a year of implementation underway, this session will review whether institutions have implemented these options and, if so, what the benefits and challenges have been. Have any institutions adopted broad consent and, if so, in what circumstances? What has limited IRB review looked like in practice? Attendee participation and sharing of best practices developed since the revised Common Rule went into effect will be encouraged. During this session, speakers and attendees will: