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 the following training initiative before the IRB will approve a project(s):
Complete VA modules or University of Utah modules, as applicable.
In addition, an accepted GCP training module may also be required (as applicable, see the GCP Training tab for more information).
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".
ERICA users can also access training reports in ERICA for any individual with an ERICA
account. The training reports will confirm the last training completion date that
the IRB has on file for all the training options required and accepted by the IRB.
The ERICA system does not provide access to training completion certificates as part
of this report.
To access these reports, log into ERICA and follow these instructions:
- Click on the IRB tab.
- Click on Training Reports in the sub-menu.
- Search for any individual by first or last name.
All investigators and staff conducting a clinical trial 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 NIH training options, so long as the training program covers all of ICG E6. The IRB will accept these completion certificates to meet the requirement.
The ERICA system displays 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)".
- Many GCP training options are offered beyond the CITI GCP module. 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.
- 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 research education to view the class page.
- Click the “ENROLL” button
- Click on “Sign in here” at the middle of the page after “Already have an account?” (IMPORTANT)
- Log in by using your Unid and password
- Click the “Enroll in Course”
- Click “Go To My Dashboard” and you should be able to see the course and access it
- After finishing all the requirements of this course, you should be able to view and download the Class Completion under “Completed” tab of your dashboard
- Please send the Class Completion certificate to email@example.com
- The University of Utah IRB will also schedule group-specific training sessions upon request. Please contact firstname.lastname@example.org 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 email@example.com.
To retrieve your certificate from Canvas:
- Please CLICK HERE to return to the Research Education page
- Click on “Login” at the top right corner of the page
- Log in using your CIS uNID and password
- Click on your name at the top right corner of the page
- Click on “Completed” at the top of the page
- View/download your Class Completion certificate
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.
There are several extra-curricular courses available through REd 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 REd website for more information. Members of the IRB staff teach several of these courses, including:
IRB Instructional Video Library
Several instructional videos relating to various IRB topics are available. We encourage you to review our video library and reference them as needed.
What is a "Community Partner"?
Community partners are non-academic personnel (e.g. business associates, local government representatives, school system representatives) who may or may not be engaged in research requiring IRB approval.
Will the IRB accept community partner trainings in place of CITI?
Yes, for anyone who is a community partner. These trainings do not replace human subjects research training required for University of Utah personnel engaged in research requiring IRB approval.
CIRTification is a training program in human research protections that is tailored to the unique roles of community research partners. It is interactive and relevant to the roles and responsibilities that community partners have in research projects. The program considers community partners’ limited experience with research, discusses key concepts in research ethics and responsible conduct of research in plain language, and focuses on applying knowledge to real-life scenarios. Ideally, CIRTification Online will not only teach community partners about the importance of protecting research participants, it will also empower them to be active contributors to their respective research teams.
The online version of CIRTification introduces learners to the basics of the research – the terminology, people, and methods. It also reviews the history of research abuses that has informed current ethical principles, rules, and regulations.
The training program also:
- Covers standards and best practices for:
- Recruitment and informed consent
- Collecting and protecting data
- Handling challenges that may arise during participant interactions
- Reviews the role of the institutional review board in protecting the right and safety of research participants
Learners complete a knowledge quiz at the end of the program and receive a date- stamped certificate of completion. The program takes about 4 hours and can be completed in multiple sessions.