Transferring Human Biological Material

Research & Collaboration Agreement

The UW School of Medicine has a strict policy regarding the transfer of human biological material to third parties. “Human biological material” means any material that comes from a person (e.g., blood, urine, cells, DNA, etc.). Human biological material is removed from patients during the process of clinical care and is available after all clinical procedures have been completed. It may also include use of material originally collected for research purposes.

In order to transfer human biological material samples collected at UW to a third party, a bona fide collaboration must first be in place between UW and the third party. The transfer requires both a Research and Collaboration Agreement (negotiated by the UW Center for Commercialization) and Institutional Review Board (IRB) approval from the UW Human Subjects Review Committees. For IRB approval, the IRB application must include the collaborator as a named researcher. The IRB must also check to see if the original consent is consistent with the planned research/use of the sample. If this collaboration is with any entity other than a not-for-profit research entity (e.g., a company), it must be approved by the School of Medicine’s Office of Research and Graduate Education.

For IRB approval, please contact the appropriate individual at Human Subjects Division who is familiar with your particular IRB application. If you are still unsure, contact the Human Subjects Division.

For a Research and Collaboration Agreement, please contact the Agreements Group.

Grant Applications Directed Toward Collection of Human Biological Material Specimens or for Creation of Human Biological Material Banks

If human biological material is collected under grant applications for specific projects in which a partial aim of the grant is to disseminate the collected specimens to other researchers or other sub-contractors, an MTA is required if the original grant application did not address the transfer of materials between the parties or sub-contractors. The MTA ensures that the specimens will be used only within the approved consent, that they will not be transferred to third parties, and that the receiving institution has appropriate IRB approval to work with the samples.

If you require an MTA for the transfer of human biological material samples under a grant application, please contact the Agreements Group. Please be prepared to provide us with your IRB application number and the specifics of the proposed transfer. For example, please include:

  • Name of party receiving materials
  • Names of materials and quantities
  • Contact name and e-mail address of recipient

Before the transfer is approved by the UW Center for Commercialization, confirmation is needed from the Human Subjects Division.

Prospective Human Biological Material

All requests to transfer prospective Human Biological Material are handled by the Office of Sponsored Programs and the Human Subjects Division.

For any questions, please contact the Agreements Group.