Pre-2019 Exempt Study Transition Request Form

 

In preparation for the launch of the new Penn eIRB system to replace HSERA, plans for study record migration are underway.

Study records for human research reviewed at the exempt level in 2018 or earlier with a “No Continuing Review Required” status are not planned to be migrated to eIRB from HSERA. These records will remain view only in HSERA for one year post eIRB launch. After one year, study data for these protocols will be archived and only accessible to IRB staff.

 

Rationale: these studies are more than 6 years old, and this approval status indicates that the IRB has not received any modifications or updates about these studies in the past 6 years. It is assumed many of these studies are inactive and completed, despite no study closure. 

 

If researchers wish these studies reviewed at the exempt level with a “No Continuing Review Required” status to be migrated to the new eIRB system, they should complete this Qualtrics Form for the IRB to update the IRB study status to “Exempted” prior to system launch. This will ensure that modifications can be submitted to these studies in the future, if needed. The IRB strongly recommends that any such studies working with the Penn Medicine Data Analytics Center (DAC) migrate to the new system. 

 

If you are unsure whether any of your active studies have this IRB determination status, you can search by protocol number, PI name, or full study title here: https://upenn.box.com/s/uw60zidtmdzwjljljm9u7hzpmrpntgxw. This file is password protected. The password was shared in the March 2025 IRB Bulletin. If you require the password, please contact Asher Dubas at adubas@upenn.edu.

 

FAQs

My study status in HSERA is “Exempted”; Do I have to do anything?
No. Existing active studies with an “Exempted” status will be migrated to the new system. 

 

My study status is “Approved” or “Approved No CR”; Do I have to do anything?
No. These are studies reviewed at the expedited or convened level. Existing active studies with this status will be migrated to the new system.

 

What is the difference between “No Continuing Review Required” and “Approved No CR.”

Studies with a “No Continuing Review Required” status are studies reviewed at the exempt level prior to the implementation of the 2018 Common Rule, which happened in January 2019. 

 

Studies with an “Approved No CR” status have been reviewed at the expedited level under the 2018 Common Rule. As noted above, these studies will migrate if they are still open with the IRB at eIRB launch.

 

My study is not on the No Continuing Review Required report in Penn Box. What do I have to do? 

If your study is not in the report, it does not have a No Continuing Review Required status. You do not have to submit anything. 

 

If I do not migrate my “No Continuing Review Required” exempt studies, will I be able to modify them if needed?
No. HSERA will no longer allow new submissions of any kind with the launch of eIRB.

 

If I do not migrate my “No Continuing Review Required” exempt studies are they still consider approved?
Yes, they would still be considered approved by the IRB.