The Online Edge: Your E-IRB News Resource: March 2021

Exempt Applications: Early Closure Requests [HTML]

The researcher and ORI have the ability to close an exempt (XX) application prior to the six year certification end date. This may be necessary for reasons like if a PI is leaving UK (or has left), or the research activities have been completed and the PI does not want the application open until the end of the six year certification date.

To start an XX closure request, select “Request Study Closure” located in the menu on the left of the approved application’s landing page.

Upon selecting “Request Study Closure”, the user is prompted to confirm the closure request (or cancel if accidentally selected).

If the user confirms the XX closure request, ORI will receive the request like they would for an administrative study closure (as an Other Review). The user cannot create more than one study closure request; a message will appear on the Study Closure Request pop-up window to block the user from doing so. If “cancel” is selected, nothing happens to the application -- the closure request pop-up window just closes.

If ORI should require additional information prior to processing the closure request, the researcher will be prompted with a “Modify Reportable” task on their Dashboard (under the Other Reviews tab of their Inbox). When the researcher clicks “Modify Reportable” the Review Notes can be read to identify what additional information is required, and a response can be inserted on the page:

When the XX closure request has been completed by ORI:

• an automated E-IRB email is disseminated to the researcher as notification of completion of the closure; 
• the application is located under the researcher’s Inactive folder; and
• an official closure letter goes on the application’s record (see application’s Protocol History).

Questions about the exemption closure process can be directed to the ORI Staff who have been managing your application (for Medical Exempt reviews, it will be either Joe Brown, Jenny Smith, or Kasandra Lambert; for Nonmedical Exempt reviews, Lori Miller, Daniel Ehrlich or Craig Vaughn).