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:

1. 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.
2. All social/behavioral investigators and staff must re-certify Human Subject Research Training every three (3) years.

Justification

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 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 the Training web page. You cannot access the training certificates for others on your study team. 

Enforcement Timelines

1. 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.  
2. 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.  
3. 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 irb@hsc.utah.edu.