Training

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):

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 Report

From the CITI website:

1. Log onto CITI Program (www.citiprogram.org).
2. Click on “University of Utah Courses” in the Main Menu.
3. 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 completion report by clicking on “View-Print-Share” under “Completion Record”. 

From ERICA:

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.  

1. Log onto ERICA.
2. Click on your name (top right corner of the page).
3. In the “Select View” drop-down menu, select “Certifications”.
4. 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:

1. Click on the IRB tab.
2. Click on Training Reports in the sub-menu.
3. Search for any individual by first or last name.

GCP Training 

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 available here: 

    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.

• 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 irb@hsc.utah.edu 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.

We have an optional training module available to help the research community learn more about SIRB research. SIRB training does not replace the standard human subject research or GCP trainings required by the IRB.

The Research Education (REd) office 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.

1. The online version of the Single IRB (SIRB) training module is now available via the REd 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
   • If you would like your certificate logged into your ERICA profile, please send the Class Completion certificate to irb@hsc.utah.edu.

To retrieve your certificate from Canvas:

1. Please CLICK HERE to return to the Research Education page
2. Click on “Login” at the top right corner of the page
3. Log in using your CIS uNID and password
4. Click on your name at the top right corner of the page and select "Student Dashboard"
5. Click on “Completed” at the top of the page
6. 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.  

Research Education 

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:

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 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

 

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.

IRB Instructional Video Library

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. 

Who is Responsible to ensure community partners receive this training?  
The Principal Investigator (PI) listed in the IRB application is responsible to ensure that their community partners receive this training. IRB applications will not be approved by the IRB if the application lists community partners that have not taken this training. The PI or the staff member assisting the PI with their IRB application can forward this webpage to their community partners and direct them to the heading below: Online Training Instructions.

icon  CIRTification Online

CIRTification is a training program in human research protections created by the University of Illinois Chicago CCTS 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.

CIRTification Online is also available in Spanish. Simply access the training portal, enroll in CIRTification or login, and select the option to launch the course in Spanish (empezar in Español).

iconOnline Training Instructions

To enroll in CIRTification, please follow the instructions below. Please select the University of Utah only from the list. If you do not select the University of Utah, you will not be able to access the user information/progress reports.

1. Go to https://training.ccts.uic.edu/
2. Click "Register" (top right hand corner. Select "I am not from UIC".
3. Complete the registration form. When asked to select a site, select "University of Utah".
4. Click "Register" to finish.
5. Visit the Course Catalog. Scroll until you find information about CIRTification. Click "Learn More" and "Enroll" to enroll in CIRTification.

 

icon  Frequently-Asked Questions (FAQ)

 

CIRTification is funded through the University of Illinois at Chicago Center for Clinical and Translational Science and supported by the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant UL1TR002003. We encourage mention and citation of CIRTification Online in grant proposals, conference presentations, published manuscripts, and other reporting. Suggested citation: CIRTification Online: Community Involvement in Research Training. University of Illinois at Chicago, Center for Clinical and Translational Science.