eIRB Transition Plan - CRITICAL NEED TO KNOW!
As you are probably aware, an electronic submission system for IRB protocols has been in development for several months. This will streamline operations and strengthen compliance with Federal regulations and Institutional policy for human subject research. Colleagues from all areas of the University have taken part in this project, and we are now approximately three months from our implementation date of October 1, 2012.
We have developed a strategic plan to transition from paper to electronic submissions that will allow the IRB to review and approve submissions to the office during the transition phase and insure that no ongoing research approvals lapse. We are sharing this plan with you now in order to provide time for you to prepare.
Paper submissions of the following types will NOT be accepted by the IRB after Wednesday, August 29th, 2012:
- Applications for Initial Review
- Modifications to Approved Human Research
- Continuing Review Progress Reports
Please note: Continuing Review Progress Reports for studies with a current expiration date of November 30, 2012, or prior must be submitted by August 29th, 2012.
These submissions will be processed and scheduled for IRB Meetings during the month of September. We have added an additional IRB meeting in the month of September in order to address the expected large number of submissions.
Reportable New Information submissions have no deadline and are the only submissions that will continue to be accepted after August 29th. Submissions of all other types will resume with implementation of the electronic system on October 1.
For Continuing Review Progress Reports, reminder notices will be sent in the coming weeks if your research approval is set to expire on or before November 30, 2012. (Depending on when the IRB conducts the Continuing Review of a given study, the expiration date may change.)
Any exceptions to the above transition plan must be discussed with Michael Centola, IRB Manager, and will be evaluated on a case-by-case basis.
Training opportunities for users are being scheduled for September 2012 to prepare you to use the system when we “go-live” on October 1, 2012. Additional information regarding training and support will be announced in the near future.
If you have questions or concerns regarding this information please contact the IRB Office at 508-856-4261.