Analysis center studies apply to situations where the UW’s role is limited to analysis of data, samples, or images on behalf of a multi-site study. These are studies that do not qualify for an exempt or not human research determination. Analysis centers do not cover establishment of tissue banks or databases at the UW.

For FDA-regulated analysis center studies, IRB approval will likely be required. If there is federal funding, our analysis center work will be subject to Single IRB requirements. If there is no federal funding, UW’s analysis center work can be covered via reliance on the central IRB reviewing the main study OR via the local submission of an analysis center application in ARROW. Analysis center applications are submitted via the non-Protocol-Based Application in ARROW even if the study has a standalone protocol.

For non-FDA regulated SDACs, it may be the case that SDAC work at UW Madison will not require local IRB coverage. Please reach out to RELIANT to discuss your SDAC study.