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Please be aware that the IRB has adopted uniform consent template language consistent with VUMC's policy on subject injury. We now only offer injury language that states insurance “may be billed” for injuries, which is most often the case. Any deviation from that language would be rare instances only with institutional approval. This is NOT applied retroactively, but for all studies not yet IRB Approved. Please see the updated MEMO from Dr. Wesley Self, Senior Vice President for Clinical Research.

Check out the NEW Children in Research page of the HRPP website if you are involved in the conduct of pediatric research. This page includes improved assent templates for children as well as a helpful FAQ section. This page is listed under the "Forms and Tools" drop down on the HRPP website titled "Children in Research".

Reminder Regarding Electronic Systems and Signatures: VUMC researchers participating in FDA-regulated studies that involve electronic records must maintain compliance with 21 CFR Part 11 (Part 11). The FDA requires Part 11 compliance for FDA-regulated clinical research to ensure that electronic records and signatures are as reliable as paper records and handwritten signatures. Study activities requiring Part 11 validation include eConsent transactions, electronic document management, and study data collection, management, and archival.

 If you are using REDCap, Part 11 compliance applies to both the REDCap system and the individual project setup.  Investigators requiring Part 11 should review their project configurations for compliance.

In the last year, VUMC REDCap has released REDCap Central, a cloud-based, fully compliant Part 11 environment.   As of March 1, 2025, VUMC is requiring that all newly submitted FDA-regulated studies that plan to use REDCap for electronic records to use REDCap Central. REDCap Central is designed to provide a comprehensive compliance framework, ensuring that all regulatory requirements are met. There is a cost associated with REDCap Central. If you have any questions about whether your project setup aligns with Part 11 requirements or about the costs associated with REDCap Central, please contact REDCapCentral@vumc.org.