The University of Utah Human Research Protections Program (HRPP) offers several resources for investigators, staff, and board members who want to learn more about the ethical conduct of research and associated requirements at our institution. The HRPP conducts many training activities throughout the year. If you are interested in attending one of these sessions or would like to address a specific topic please contact us via email or telephone (801) 581-3655.
Human Subject Research Training
University of Utah investigators and study staff who conduct human subject research must complete one of the following training initiatives before the IRB will approve a project(s):
- Collaborative IRB Training Initiative (CITI), including GCP modules. Complete VA modules or University of Utah modules, as applicable; or
- National Institutes of Health (NIH) Protecting Human Research Participants (PHRP) Training; or
- IRB & Human Subject Research Online Module
- Criteria for Approval of IRB Research Module + 3 Electives
For all researchers and study staff, the University of Utah will honor a valid training certificate for three (3) years from the date of completion. After three years, training will need to be repeated.
Please Note: The IRB will not waive the training requirements for those who have viewed the NIH training video or NIH web training.
Online CITI Training
The University of Miami Collaborative IRB Training Initiative is an interactive set of modules designed to improve knowledge of the Common Rule, HIPAA Privacy Rule, and Good Clinical Practices for individuals involved in human subjects research.
Completing the Training
Please go to www.citiprogram.org to register. Please Note: Registering for the CITI Training does not create your account with the ERICA System - you must do this separately. For instructions on how to register with the ERICA System, please read the log in instructions on ERICA's login page.
Select your institution or organization as follows:
- If you plan to conduct research at the University of Utah, Primary Children's Hospital, or Shriners please indicate "University of Utah" under the "All Others" section.
- If you plan to conduct research at the VA, please select "Salt Lake City, UT 660." This option will meet VA requirements for annual training. Any researcher can complete the VA training for a review or introduction to Good Clinical Practices.
The self-registration page will ask you which course you plan to take. Please choose the course most appropriate for the type of research you conduct. IRB members and IRB staff must complete the Social & Behavioral and Biomedical courses.
- Group 1 Biomedical. This is for everyone inside the covered entity that will work with medical studies, and/or that will use protected health information (PHI); or
- Group 2 Social/Behavioral. This is for Main Campus personnel who are not working with protected health information (PHI).
Accessing your CITI Training Completion Certificate
From the CITI website:
- Log onto CITI Program (www.citiprogram.org).
- Click on “University of Utah Courses” in the Main Menu.
- Click on “View Previously Completed Coursework”.
You will see the list of all the courses you completed at least in the last 5 years. You can print or save any certificate by clicking on “View” under “Completion Report”.
This option is only available if you have previously sent the IRB a copy of your certificate. The IRB saves all copies of your certificates in ERICA, which can be accessed as follows.
- Log onto ERICA.
- Click on your name (top right corner of the page).
- In the “Select View” drop-down menu, select“Certifications”.
- You should be able to see the date you completed your training. You may download your certificates under ”Attachments".
Effective February 1, 2017, 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.
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. The accepted GCP Training course is titled "Good Clinical Practice (US FDA Focus)".
Investigators and staff may continue to complete GCP training via other offerings, such as the RATS program and NIH training options, and the IRB will accept these completion certificates to meet the requirement.
The ERICA system will be updated in Spring 2017 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.
GCP training does not replace the standard human subject research training required by the IRB.
To assist University of Utah clinical investigators and staff members in meeting this requirement, the following resources are available:
- An online GCP training module is available through the CITI Program for University of Utah investigators and staff. The accepted GCP Training course is titled "Good Clinical Practice (US FDA Focus)".
- The Research Administration Training Series (RATS) offers an in-person and online
course titled, "Basics of Good Clinical Practice", which is available to University of Utah investigators and staff.
- To register for the in-person course, visit https://education.research.utah.edu/class_details.jsp?offeringId=38.
- To register for the online course, visit https://education.research.utah.edu/online_classes.jsp?content=Online%20Classes.
- Many GCP training options are offered beyond the CITI GCP module and the RATS program.
Such training options will be accepted by the IRB, so long as the training program
covers all of ICH E6 and issues a training completion certificate.
- Social & Behavioral GCP eTraining: There is a social & behavioral GCP training course that was created by the CTSA Program
http://www.sbm.org/training/good-clinical-practice-for-social-and-behavioral-research-elearning-course. This course meets the requirements for GCP training, and the IRB will accept this training course from Main Campus personnel and social-behavioral researchers at the UUHSC.
- Social & Behavioral GCP eTraining: There is a social & behavioral GCP training course that was created by the CTSA Program available here:
- ERICA now has the capacity to track GCP training. For those who complete the training, ERICA will display a ‘G’ next to the names of investigators and staff listed on the Contacts and Title page of an IRB application. GCP training completion certificates must be sent to firstname.lastname@example.org to be tracked in ERICA.
Single IRB (SIRB) Training
Use of a SIRB for multi-center research requires additional components to ensure that an agreement for institutional reliance on a SIRB is established, that the requirements of all participating institutions and human research protection programs (HRPPs) are being met, and that all investigators and study team members are aware of their roles and responsibilities to the SIRB as well as to their local institution.
Effective February 1, 2017, the University of Utah Human Research Protection Program requires investigators and staff performing research under a SIRB model to complete SIRB training before the research can be activated at the University of Utah.
This is a one-time training requirement and does not require recertification. SIRB training does not replace the standard human subject research or GCP trainings required by the IRB.
The Research Administration Training Series (RATS) offers an in-person and online course titled, Multi-Center Research Using a Single Institutional Review Board (SIRB), which is available to University of Utah investigators and staff.
- Multiple in-person sessions are available. To register for an in-person session, visit https://education.research.utah.edu/class_details.jsp?offeringId=281
- The online version of the Single IRB (SIRB) training module is now available via the
RATS Program. To complete the SIRB training online, log in to your account at https://education.research.utah.edu/ and follow these instructions:
- Go to RATS Online Classes using the Main menu.
- Click the Access Your Online Classes button.
- Click on the Single IRB Model link in the RATS/Institutional Review Board (IRB) Online Classes section.
- Click the Enroll Me button.
- The University of Utah IRB will also schedule group-specific training sessions upon request. Please contact email@example.com to schedule a group training session.
Upon completion of all units in the SIRB training module, please provide a copy of
your completion certificate to firstname.lastname@example.org.
The UU IRB also has videos available that may be helpful to those who would like to learn more about the SIRB review process. You can view them on the SIRB Training Resources page. Watching the videos on this page DOES NOT fulfill the SIRB training requirement for the University of Utah.
Research Administration Training Series (RATS)
There are several extra-curricular courses available through the RATS program that have content specific to IRB processes. These courses do not fulfill the IRB requirement for human subject research training, but offer content that will improve your understanding of a wide variety of topics. Please visit the RATS website for more information. Members of the IRB staff teach several of these courses, including:
- Advanced Consideration of Reportable Events in Human Subject Research
- Data & Safety Monitoring: Plans, Boards & Committees
- Expanded Access to Investigational Drugs & Devices
- Informed Consent: Models & Requirements
- Institutional Review Board (IRB) and Human Subject Research
- Introduction to the IRB, the IACUC, and the IBC
- Managing the Return of Incidental Findings in Research
- Multi-Center Research Using a Single Institutional Review Board (SIRB)
- Preparation for Investigator-Initiated Drug and Device Studies
- Tissue Banking in Research
- Understanding IRB Applications in ERICA: New Studies, Amendments, and Continuing Reviews
- Understanding IRB Report Form Submissions in ERICA