As studies continue to leverage digital solutions to virtually interact with participants to deliver treatment intervention or session content, collect patient reported outcomes (survey/questionnaire data, sensor data, etc.), collect eSignature (eConsent) it’s important to navigate through the necessary WashU approvals and resources to successfully launch your research study.
Below we describe some pathways for WashU approval when using digital solutions to interact with participants and/or to capture participant data (including eSignature).
Pathway for leveraging third party digital solutions that are NOT WashU Enterprise-Level solutions:
Please note this pathway is not relevant to WashU Enterprise-Level solutions (like WashU Box, WashU HIPAA Compliant Zoom, Qualtrics for Sensitive Data, etc., as these digital solutions can go straight to Step 3 listed below).
Step 1: Complete an IT Procurement Vendor Intake Form through the WashU Resource Management web page.
- If you have questions when attempting to complete the IT Procurement Vendor Intake Form, you can contact Lisa Owens with Resource Management at owenslisa@wustl.edu and The Office of Information Security (OIS) at infosec@wustl.edu.
- Please note, when Resource Management reviews your IT Procurement Vendor Intake Form, they will review your project to make sure the proper contracts and agreements are in place. In addition, they will let you know if you also must complete an IRB Security Review Form. The Resource Management IT Procurement Team will provide you with access to complete this form via the OneTrust portal.
Step 2: Finalize and gain approval for all items determined necessary in Step 1
- Please note contracts and agreements can take up to a few months to complete. Review and approval of your IT Procurement Vendor Intake Form and/or your IRB Security Review Form may take up to a few weeks to complete.
Step 3: Move forward with finalizing your IRB/HRPO submission with description the digital solutions you’re using.
- Resource Management and OIS should automatically share your completed IRB Security Review Form with the IRB/HRPO.
For studies (e.g., IND or IDE studies) that must adhere to more complex regulatory requirements (e.g., The FDA’s 21 CFR Part 11) there will be additional steps involved for approval. Please reach out to the mHRC for a joint consultation with the mHRC and Trial-CARE.