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2019 AER Conference
Jason Gerson, PhD
Senior Program Officer, Patient-Centered Outcomes Research Institute
This interactive session will be led by a representative from PCORI, a funder of clinical comparative effectiveness research (CER). Critical human subjects protections challenges arise in the conduct of the “real-world” studies funded by PCORI, such as big data studies requiring data linkages between two or more data sets (e.g., claims data, electronic health record data, and registry data) that are held by different entities, which raises privacy and informed consent issues for the data owners, funders, researchers, and IRBs. For cluster randomized clinical trials where individual informed consent is not usually feasible, alternative ways of involving and informing patient communities that a study is underway would be extremely valuable. PCORI staff will discuss some of these challenges. Attendees are encouraged to come with questions of interest to all. During this session, speakers and attendees will: