If the currently approved IRB application or protocol does not specifically state that data, specimens, and/or images (collectively “materials”) will be shared with a site or personnel external to the UW, a change of protocol must be submitted to the IRB prior to the sharing. Additionally, reconsent or a waiver of consent and authorization may be needed to address the sharing.

The change of protocol should include:

• Where the materials are going and the reason for sharing;
• Whether the individuals receiving the materials are collaborators on the study, are using the materials for their own purpose, or providing a professional service for the study;
• What information (particularly identifying information) is associated with the materials;
• How the materials will be transmitted securely and what confidentiality protections will be in place;
• Whether materials will be returned to the UW and if not, why not (e.g., samples will be exhausted).

Transfer of research data, specimens and/or images requires a data transfer and use agreement (DTUA) and/or material transfer agreement (MTA). See Guidance on External Sharing of Human Subjects Research Data.