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.
The Fall 2012 IRB Newsletter is now available online.
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.
Continuing review reminders will only be sent out 60 and 30 days before expiration.
You are no longer required to attach study documents, including any informed consent documents or the protocol document with your Continuing Review submissions. The IRB office maintains copies of all approved study documents in eRA and will reference those documents during the review.
The Panel 2 Meeting submission deadline is March 1, 2012. The Panel 2 meeting will convene on March 15, 2012.