Jul 20, 2017 2:45 PM

7.20.17 - On the evening of July 24, 2017 HSERA is scheduled for a system wide update. All department heads, investigators, and research support staff will be affected by these changes. Please see below to review detailed information related to each component of the update:

1. Addition of a new HSERA initial application type for submitting reliance agreements

Complete information about this new application is attached here for reference

2. Revisions to the IRB determination letters

In alignment with the release of the new Reliance Agreement application, the IRB has a new letter template for when the Penn IRB agrees to rely on an external IRB. This letter will not include an IRB administrator signature and does not require one. The new template is currently being rolled out for reliance agreements only but eventually all official IRB correspondence will follow this template and will no longer include IRB administrator signatures. The IRB SOP section GA 107 describes the written communications which will still require IRB Director, Chair or Executive chair signature. Those situations that require signature are unrelated to routine determination letters which have historically required administrator level signature.

An example of the new letter template is attached here for reference

 3. New attachment display and download function

As part of an HSERA upgrade to assist in the review process, HSERA users will see a change to the content displayed when using the eyeglasses view in HSERA. The eyeglasses view is available in manage drafts, items to be resubmitted, submission history, and when PIs and department heads go in to approve submissions.

Complete information about the changes is attached here for reference

 4. HSERA Confirmation Page Update

As part of an HSERA upgrade to assist in the submission process, documents previously submitted will no longer appear as archived on the confirmation page when creating new submissions for approved research protocols.

Complete information about the update is attached here for reference