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?
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:
What will I learn?
After attending this webinar, attendees were able to:
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.
Stacey Donnelly, MPA, currently serves as senior director of strategic operations and chief compliance officer at the Broad Institute of MIT and Harvard. She has been with the Broad Institute since they were part of the Whitehead Center for Genome Research at the time that Center completed the sequencing of the human genome. Stacey designed the Broad’s office of research subject protection and created the regulatory structure for the Broad’s use of laboratory animals in research, designing the first institutional animal care and use committee and served as the first institutional officer.
Ms. Donnelly also serves on the board of managers as an officer (clerk) to the Broad’s clinical research sequencing platform (CRSP) which operates as a limited liability corporation of the Broad Institute. CRSP is the Broad’s clinical lab (CLIA certified) that performs testing for hospitals, physicians, and other companies.
Ms. Donnelly holds a Bachelor of Science degree in psychology from the State University of New York at Albany and a Master’s degree in Public Administration from The Maxwell School of Citizenship and Public Policy, Syracuse University.
Bernard Lo, MD, is president of the Greenwall Foundation, whose mission is supporting bioethics research and young researchers in bioethics. He is professor emeritus of medicine and director emeritus of the program in medical ethics at the University of California San Francisco (UCSF). A member of the Institute of Medicine (IOM), Dr. Lo served on the IOM Council and chaired the Board on Health Sciences Policy. He chaired an IOM committees on conflicts of interest in medicine and on responsible sharing of clinical trials data.
Dr. Lo serves on the Board of Directors of Association for the Accreditation of Human Research Protection Programs (AAHRPP) and on the Medical Advisory Panel of Blue Cross/Blue Shield. Formerly he was a member of the National Bioethics Advisory Commission, the National Institutes of Health Recombinant DNA Advisory Committee, and Ethics Subcommittee of the Centers for Disease Control and Prevention.
Dr. Lo and his colleagues have published close to 200 peer-reviewed articles on ethical issues concerning decision-making near the end of life, oversight of research, the doctor-patient relationship, and conflicts of interest. He is the author of Resolving Ethical Dilemmas: A Guide for Clinicians (5th edition, 2013) and of Ethical Issues in Clinical Research (2010). He continues to care for a panel of primary care internal medicine patients at UCSF.
Certificates of attendance will be made available at the conclusion of the webinar. To access the certificate, you must first complete the online evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.
If you would like to receive a certificate of attendance for a previous PRIM&R educational program, please email firstname.lastname@example.org or call 617.423.4112, ext. 0.
CE Credit for Certified IRB Professional (CIP®) RecertificationWebinar participants holding the CIP®credential who wish to apply credits from this webinar toward CIP®recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation. Participation in this 60-minute webinar counts as 1 CE credit hour.
For recertification by CE, CIPs must complete 30 documented hours of continuing education. At least 15 of the 30 hours must either carry credits issued by a recognized accrediting body or have received advanced recognition from the Council for Certification of IRB Professionals (CCIP). Credits from PRIM&R webinars have received such advance recognition, and may be counted towards these 15 hours.
Additional information about CIP® recertification can be found here.
All of our webinars are recorded and available for purchase and/or access.
If you have additional questions about webinar archives, please contact us by phone (617.423.4112, ext. 1876) or via email.
As a Webinar Blog Squad member, you receive a complimentary registration for the webinar of your choice. Learn more and apply.