Clinical Research Data Sharing Principles
Modern biomedical research often requires access to clinical data generated in the context of routine clinical care, and the availability of the electronic medical record (EMR) and other digital clinical data greatly simplifies and enhances the ability to conduct such research. The BSD has created the Center for Research Informatics (CRI), which amongst other services, collates clinical data for research use in a Clinical Research Data Warehouse (CRDW). An increasing number of faculty have used this clinical data to conduct highly innovative and impactful research. Nevertheless, accessing and sharing such data raises significant issues about our obligation to be careful stewards of patient’s private information, even if all legal and regulatory mandates are met.
To this end, we have created the Clinical Research Data Stewardship Committee, which is chaired by Walter Stadler, Dean for Clinical Research, and is composed of faculty, administrative leaders, and regulatory and legal representatives from the University and UCMC. A major role for this committee is to consider the circumstances under which clinical data should be accessed, shared, and transferred. Rather than creating a set of firm rules, which may have unintended consequences for research activities, the committee has elected to create a set of principles that will be used to review any specific research project.
We anticipate that acceptability for most projects will be self-evident, but the committee will provide review and guidance on projects for which the relative research value in the context of patient privacy and institutional reputation is less clear. Projects may be forwarded to the committee for review by the CRI, IRB, UCMC Quality Improvement, or other entities that desire further input on their own review of the project. The data sharing principles will guide these discussions, and the Committee welcomes any feedback on this topic.