HRPP Newsletter December 2022
NIH Data Management and Sharing Policy
Effective for applications starting January 25, 2023 and after, all NIH-supported researchers producing scientific data will be expected to submit a data management & sharing plan as part of their proposals. See the policy. Research Data Services will serve as the primary office for data management help, writing and review of data management plans, and data sharing/archiving. IRB protocol and consent templates will be updated to prompt study teams to include details relevant to the sharing of human subjects data.
VA Access to Toolkit Documents
IRB Toolkit documents are housed on UW Box, which is not accessible through VA computers or when logged in through the VA network. If you are a VA researcher and are having trouble accessing Toolkit documents, these will soon be available through IRBNet, the VA research portal. In the meantime, Toolkit should be accessible by logging in through the UW network. Please contact the VA R&D Office, VHAMADRDCoordinator@va.gov, Kal Watson (email@example.com), or Karen Hoffman (firstname.lastname@example.org) with questions.
Good Manufacturing Practices (GMP) Course Added to CITI
CITI’s GMP course has been added to UW-Madison’s subscription and is available to anyone interested in learning more about GMP and to groups involved in manufacturing on campus looking to expand their current training program. It might also be helpful for anyone putting together Chemistry, Manufacturing, and Control (CMC) information for an IND. To add the course, log into CITI, select “View Courses” next to “University of Wisconsin-Madison,” click “Add a Course” under “Learner Tools,” and select the GMP course in Question 4. If you have questions about GMP training, contact Jake Rome. For CITI questions, contact email@example.com.
With our last newsletter of the year, we would like to take a moment to thank our entire research community for your contributions to such a successful Human Research Protection Program. The end of 2022 marks a major milestone in that the bulk of the IRB Efficiency Project work has been completed and we were reaccredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Over the past two years, we have implemented many major changes, from reorganization of the IRB offices and boards, to a complete overhaul of our applications, guidance documents, and websites. This was no small feat and IRB staff, members, and the entire research community have been a critical part in making these changes a success. Key improvements were use of the toolkit to guide systematic review, the development of the protocol-based application, which significantly reduced duplicative information in the application and the streamlined non-protocol-based application with even more templated language. Our changes are paying dividends: median time to first comments for full board studies in 2022 is 10 days compared to historical median of 22 days and median time from submission to approval is now 45 days compared to historical averages of 72 days!