To: UNC-Chapel Hill Research Community,
As of June 1, 2020, UNC-Chapel Hill Office of Human Research Ethics (OHRE) will require Human Subjects Protection (HSP) training through the Collaborative Institutional Training Initiative (CITI Program) be renewed every three years. This requirement aligns with many of UNC’s federal and industry sponsors requirements as well as best practices.
All individuals who completed their human subject training more than three years ago will have their previous training time out and new refresher modules on the CITI site will be available as of March 1, 2020. Instructions can be found at: https://research.unc.edu/human-research-ethics/getting-started/training/
The OHRE will also be checking for completion of Good Clinical Practice (GCP) starting June 1, 2020 and transitioning this from the Office of Clinical Trials to the OHRE. The OHRE will be checking the status of GCP both at initial submissions, renewals, and modifications to add personnel as appropriate. This transition will hopefully assist the research community by consolidating effort, additional information can be found at: https://research.unc.edu/clinical-trials/training/gcp/
- Who does this apply to?
This requirement applies to all UNC personnel who are conducting human subject research activities.
2. My entire study team took this training more than three years ago, does this mean we are all out of compliance on June 1, 2020 and my existing study will expire?
No, the OHRE will use the month of the year that the last human subject training was completed for renewal so as to prevent study expiration. For example, if a principal investigator completed their training in November 2015 and the study coordinator completed their training in June of 2015, and the project renewal came due in August of 2020, the coordinator would be required to complete the training before the renewal (as June is before August), and the PI would not have to have completed at time of renewal but expected to complete prior to November 1, 2020.
3. I have personnel who have left the study or no longer at UNC, what should I do?
To avoid issues with annual renewals please remove personnel who have left the study or no longer at UNC prior to the 45-day COI period (45 days before expiration) as this will both help facilitate the COI process as well as the education requirement.
4. Does this effect new projects/study submissions?
The OHRE until June 1, 2020 will only be checking that training had previously been completed. New study submissions started after 5/31/2020 will require all individuals to have completed human subjects training within three years and GCP if applicable.
5. Why do I show up expired, I thought the requirement was not until June 2020?
In order for individuals to be able to take the training before the June 2020 implementation and utilize the completion month, to limit the impact to study teams, we need to “turn the requirement on” and requires us to set the expiration for those more than three years out in the CITI system. IRBIS however will not show the individuals as expired prior to June 2020. If you feel that you are being advised differently please reach out to the OHRE.
The OHRE will be presenting a session at NCTraCS on February 20, 2020 regarding Chart Reviews: Exempt 4 vs Expedited 5 and will also be briefly discussing this update along with others, additional information can be found at: https://tracs.unc.edu/index.php/calendar/3398.
If you have additional questions, please reach out to one of the individuals below:
Mike Matamoros, Associate Director, Operations & Education
919-966-2738 | firstname.lastname@example.org
Cassandra (Cassie) Myers, OHRE Director
919-966-6893 | email@example.com