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Dear SOM Clinical Research Community,

We are writing to update you on the status of the SOP for Informed Consent of Adult Participants that has been in development for some time. We received thoughtful, valuable feedback from the SOM community that enabled finalization of a comprehensive and concise SOP that has since been approved by the SOM Research Leadership Committee. Unfortunately, we have encountered an unexpected barrier to disseminating the SOP via the SOM Personnel Profile and Training System (PaTS) as planned. We are now focusing on developing a new platform for PaTS that will support effective, streamlined dissemination of SOPs and other resources. We aim to finalize and launch the new PaTS in early 2022.

In the meantime, while the SOP is not officially issued or in effect (marked as “DRAFT”), we are sharing the finalized document for your reference. Please feel free to refer to this document to support and inform your team’s processes. Once we are able to issue the SOP via the updated PaTS, we will host training and discussion sessions to address any questions and promote compliance with the standardized procedure. We are also working to develop accompanying tip sheets and informational documents to provide more specific best practices associated with the standardized procedure (to be released soon).

Click here to review or download the “DRAFT” SOP
(Onyen login required)

We are continuing to develop additional SOPs and other resources to promote efficiency and compliance across the SOM. If you have suggestions or thoughts to share, please contact us anytime. We look forward to your continued involvement and collaboration in supporting the SOM clinical research community!