Revised Requirements for Human Subjects Training
February 1st, 2017
The IRB’s training policy for Human Subject Research training and Good Clinical Practice (GCP) training has been revised as follows:
- All biomedical investigators and staff must complete both (a) Human Subject Research training and (b) GCP training. This is regardless of funding sources or federal regulatory oversight. Both of these trainings must be re-certified every three (3) years.
- All social/behavioral investigators and staff must re-certify Human Subject Research Training every three (3) years.
Prior to this change, the IRB required all investigators and staff to complete and
re-certify a Human Subject Research course every 5 years. This is incongruous with
the NIH’s GCP training requirement, which requires recertification every 3 years.
Thus, the IRB has chosen to align the recertification periods for both trainings.
In addition, while the NIH policy only requires GCP training for NIH-funded investigators and staff, it is beneficial for all biomedical researchers and staff to complete GCP training, especially those conducting FDA-regulated research, which may or may not be NIH-funded.
Training Options and ERICA Information
The CITI Program (www.citiprogram.org) continues to be the most convenient method for securing Human Subject Research training.
A GCP course is also available through the CITI program to all University of Utah
employees and students. Within the next 30 days, the CITI Program will list the GCP
course among the required courses for biomedical investigators and staff at the University
of Utah, which will make the course easier to locate and complete.
Investigators and staff may continue to complete GCP training via other offerings, such as the RATS program, and the IRB will accept these completion certificates to meet the requirement.
The ERICA system will be updated this spring to display each individual’s training completion dates for BOTH Human Subject Research training and GCP training. If you would like to access your training certificates that the IRB has on file, follow the instructions at the bottom of this webpage: http://irb.utah.edu/training/index.php. You cannot access the training certificates for others on your study team.
- The requirement for initial Human Subject Research training and GCP training is being enforced now on new studies and continuing reviews, as well as for individuals being added to approved studies via an amendment.
- The requirement for 3-year recertification of GCP training is being enforced now, in the case that you have provided a GCP certificate that is older than 3 years. This is being enforced on new studies and continuing reviews, as well as for individuals being added to approved studies via an amendment.
- The requirement for 3-year recertificationof Human Subject Research training will not be enforced until July 1, 2017. This will be enforced on new studies and continuing reviews, as well as for individuals being added to approved studies via an amendment.
Please contact the IRB with questions 801-581-3655 or firstname.lastname@example.org.
Effective January 1, 2017, the University of Utah IRB requires clinical investigators and staff listed on an IRB application funded by the NIH to have both human subjects training and GCP training before an IRB application will be approved.
The IRB office is currently undergoing construction. Several of our staff members have moved to temporary accommodations away from their desks and usual telephones while the remodel is under way.
Please join us in welcoming our new Panel 4 Coordinator.
Due to new staff onboarding and training currently happening at the IRB, as well as a greater than usual amount of applications submitted in recent weeks, we are running several days behind schedule on pre-reviews for all applications.
We are excited to welcome a new Administrator to the IRB.
We are happy to welcome a new IRB Coordinator. We are also pleased to announce that Jessica Loayza has joined the Administrator team.
We have added two new positions to the IRB.
We are pleased to welcome a new Coordinator to the IRB.
We are happy to welcome a new IRB Administrator to the New Study pre-review team.
Due to F&A increase to 36.5%, the IRB fee schedule is changing for industry-sponsored new studies, continuing reviews, and amendments. The new IRB fee schedule will be effective on July 1, 2016.
Please join us in welcoming our new IRB Clerk.
Effective 5/1/2016, the RDRC-HUS will now review all amendments related to radiation use within the ERICA system.
Please join us in welcoming our newest IRB Administrator.
All studies conducted at Shriners Hospitals for Children in Salt Lake City are now required to obtain approval from Shriners Hospital leadership before the IRB will issue final approval of the study.
Beginning January 15, 2016, the conflict of interest review process for all New Study applications will include a review for Institutional Conflicts of Interest (ICoI).