Over 85 universities and research-performing organisations, including the Aurora Universities Network (and of its member universities, University of Duisburg-Essen, University Federico II Napoli, University of Iceland, and Vrije Universiteit Amsterdam) signed a joint statement coordinated by KU Leuven on the updated NIH Policy Guidance for Subaward/Consortium that will become active for grants starting as of 1 October 2023.
According to the new policy guidance, such awardees must provide copies of all lab notebooks, all data, and all documentation supporting the research outcomes described in the progress report at least every six months. For EU awardees, this implies legal obstacles (Personal Data Protection Regulations, Clinical Trial Regulations), IPR constraints, issues with using the transferred data by the Pass-Through Entity, increased costs and administrative burden, and a hampered continuation of ongoing grants.
In this statement, the signatories ask the NIH to reconsider implementing these requirements.
For more information, please read this statement.
