IRB

On November 16 the IRB website will be undergoing Phase 2 revisions which will affect the navigation of the website. The changes will be completed by December 1, 2012 .

The HRP-502: TEMPLATE - Informed Consent, Parental Permission form, and Informed Consent Guidance have been updated and are downloadable from the Forms & Templates page.

In the coming weeks the IRB website will be undergoing revisions that will affect the navigation of the website. The changes will be completed by November 15, 2012 .

Reportable events and deviations should now be submitted as a New Information submission in eRA.

The IRB has modified the Initial Application eForm. The form name has been changed to HRP-211: FORM - Initial Application. It is only accessible within an Initial Application submission in eRA.. If you have any questions please contact the IRB Office .

Due to the changes to the informed consent approval process and template , the eRA Versions folder for each study file will no longer contain the “Consent Form – Word Vers.” folder. All documents including the Word version of the informed consent document, assent, or parental permissions form are now located in the “Approved Documents” folder.

A new informed consent template has been released. Informed consent forms will no longer be stamped with an expiration date. The documents will still have an IRB approved date which will be located in the header of the document.

Amendment submission eForms have been replaced with the HRP-213: FORM - Amendment.

Study Closures are now called Final Reviews. Additionally, the associated eForm has been replaced with the HRP-212: FORM - Continuing/Final Review Progress Report.

Continuing Review submissions eForms have been replaced with the HRP-212: FORM - Continuing/Final Review Progress Report.