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AAMC Submits Comments to PCORI on Data Sharing Policy

January 6, 2017—The AAMC Dec. 14 submitted comments to the Patient-Centered Outcomes Research Institute (PCORI) regarding a proposed Policy for Data Access and Data Sharing. The draft policy would facilitate the reproduction of original analyses and stimulate additional analyses using data from PCORI-funded studies.

The AAMC commented on the policy requirements for awardee data package management and retention, appropriate documentation of patient consent, and third party requests for data access.

In the comment letter, the AAMC “agrees awardees should construct a data management and data sharing plan” that accounts for applicable privacy, security, and legal requirements. Additionally, the AAMC recommended that PCORI “require all data packages to be deposited into an established repository” in order to limit institutional and researcher burden associated with archiving and sharing data.

The AAMC also noted that informed consent documents require language giving explicit permission for the future use of data, and encouraged “PCORI to consider the inclusion of requirements for third party requests,” including research hypothesis and questions to be address, verification of IRB approval, and other items.


Emily Cahill
Lead Specialist, Implementation Research & Policy
Telephone: 202-741-6460



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