IRB Related Responsibilities
If a study team member (including the PI) is leaving UW-Madison, the IRB application needs to be updated to reflect this. If the PI leaves UW-Madison while the study is ongoing and does not intend to find another PI to assume PI responsibilities, they should contact the IRB office to discuss transfer or closure of the study prior to departure. We strongly recommend allowing extra time prior to your departure to allow for any processes associated with transfer or study closure to be completed before UW-Madison credentials are terminated.
If a study team member involved in the project (not the PI) leaves UW-Madison, they may (with approval of the PI) take (only) copies of research data they have generated or which they have made substantial contributions to with them. If the study is going to remain open at UW after the study team member leaves, but that study team member will continue to collaborate on the study at UW, you encouraged to consult with the HRPP Reliance and Navigation Team (RELIANT) on campus (email@example.com).
However, regardless of who is taking research data with them, there are additional non-IRB processes that will also need to be addressed. Please see sections below.
When the PI leaves and wants to take the original research data or specimens, or when a study team member leaves and wants to take copies of the research data or specimens, there are contractual agreements that may be needed in order to share individual level human subjects research data/specimens. These agreements include but are not limited to: Data Transfer and Use Agreements (DTUA), Clinical Trials Agreements (CTA), Material Transfer Agreements (MTA), Consortium Agreements, or Sponsored Research Agreements. These agreements establish terms and conditions to protect the interests of researchers and the institution, and importantly – to protect the confidentiality of the human subjects involved. Such agreements cover a variety of important issues, including restrictions on permitted uses and further disclosures of data, authorship, attribution, warranties, confidentiality, liability, and intellectual property. The specific type of agreement needed varies based on the nature of the data/specimens and research study.
For more information on sharing data outside UW-Madison or transferring data to UW-Madison from another institution, please see the HRPP’s guidance on External Sharing and Receiving of human subjects research data.
Additionally, per UW-Madison campus policy, research data must be retained using campus resources for at least 7 years following the conclusion of the study, and as noted above, the original data must be retained at UW–Madison by the PI. It is considered the PI’s responsibility to either retain or make provisions for retaining the research data from the study or studies they are overseeing. Records will normally be retained in the unit where they are produced, but other campus resources are also available (see Data Storage Finder Tool for more options). For questions about campus data retention policies, please contact Associate Vice Chancellor for Research Policy and Integrity, Brian Fox at firstname.lastname@example.org or (608) 262-1044.