To: UNC Research Community,
On April 9, 2019, IRBIS will undergo a system update. This system update is part of the changes discussed during the communication and education provided for the Final Revision to the “Common Rule” that went into effect on January 21, 2019. These changes are primarily focused in two areas; 1) automatic creation of COI in relation to the expiration date of a study and 2) New Safety Information (NSI) navigation revisions and stipulation process.
Annual COI disclosures will be automatically created 45 days prior to expiration date for expedited and full board research. This automation of the COI disclosure creation is being implemented to reduce stipulations for COI submissions only, that was previously contributing to expiration and delay for studies.
A few key points regarding this update include:
- When you create the renewal submission, the Annual COI submission and reference ID will automatically converted into the Renewal Submission.
- Notices will be sent independently of a renewal submission at the 45 day mark. If a renewal submission has been submitted prior to the 45 day mark, a second COI disclosure will not be triggered at the 45 day mark.
- Modification-only submissions cannot be created within 45 days prior to the expiration date, however the system will allow a renewal which may include a modification.
Questions regarding the IRB process or the IRBIS system please contact Laura Cowan, OHRE Data and Information Manager at IRBIS@unc.edu or call (919) 966-3685 or Mike Matamoros, OHRE Quality Manager (919) 966-2738 , If you have any questions regarding a COI that has been submitted please contact the COI Program at coi@unc.edu or call 919-843-9953
The New Safety Information (NSI) submission process has been revised to improve navigation and functionality. NSI submissions will now be submitted and processed similarly to other submissions in IRBIS. To improve user experience, researchers will be able to respond to stipulations within the NSI submission and update the initial NSI submission with new information. As a new feature IRBIS will also send automated reminders for outstanding NSI stipulations. You may receive an additional NSI letter for NSIs in progress to enable the transition to the updated system. We anticipate a smooth transition, but please contact Jeanne Lovmo, OHRE Compliance Manager at (919) 843-8806 if you have any concerns or questions.
Thank you,
Cassie
Cassandra Myers, CIP
Director, Office of Human Research Ethics
University of North Carolina at Chapel Hill
720 Martin Luther King Jr. Boulevard
Chapel Hill, NC 27599-7097
919.966.6893 (Office Line)| 919.966.3113 (Main Line)
cassandra.myers@unc.edu