Did you know that much of the data generated in clinical trials is never published or made available to other researchers? Sharing secondary data could advance scientific discovery and improve clinical care by maximizing the knowledge gained from data collected in trials, stimulating new ideas for research, and avoiding unnecessarily duplicative trials. The practice of sharing clinical trial data is already frequently mandated in conditions for obtaining federal grants and publications in some scholarly journals. As the practice of data sharing gains increasing acceptance across the research enterprise, do you find yourself wondering how to implement this at your institution? Or how to protect research subjects whose data are shared? (Presented on June 23, 2015)
The Institute of Medicine (IOM) assembled the Committee on Strategies for Responsible Sharing of Clinical Trial Data to develop a set of guiding principles and a practical framework to implement data sharing across the research enterprise. In 2015, this committee produced a report titled Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk that contained recommendations for developing a culture and policies to foster responsible data sharing.
During this webinar Bernard Lo, MD, president of The Greenwall Foundation and chair of the IOM committee that produced the report, discussed IOM recommendations as they apply to those who review research with human subjects, and Stacey Donnelly, MPA, senior director of strategic operations and chief compliance officer at the Broad Institute, addressed data sharing in a research environment and the culture of data sharing at academic institutions.
Topics for discussion included:
- Balancing different interests of stakeholders to achieve a common goal
- Suggestion for institutional review board (IRB) involvement in data sharing plans during review of original study proposals, particularly to protect research subjects
- Challenges of incorporating this practice amid limited staff resources
- The role of medical journalism in promoting data sharing
What will I learn?
After attending this webinar, attendees were able to:
- Understand the benefits and risks of data sharing
- Articulate why data sharing helps research subjects
- Implement recommendations outlined in the IOM report at your place of work
- Identify best practices for data sharing at your institution, including steps to protect research subjects whose data are shared
Who should attend?
This intermediate-level webinar was of interest to IRB members, chairs, and staff as well as human research protections program staff and researchers.
Webinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.0 continuing education credits towards CIP recertification. Learn More »
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