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Research

Human Subjects Protection Training

As federally mandated and required by the UM IRB, all key study personnel must complete a self-study course in human subject protection. 

Key study personnel include the Principal Investigator and any other investigators and research personnel who are directly involved in conducting research with study participants or who are directly involved in using study participants’ identifiable private information during the course of the research. Key personnel also include faculty supervisors/advisors who provide direct oversight to undergraduate and graduate students, as well as postdoctoral fellows. Members of the research team who have not completed human subject research protection training, or whose training is expired, may not take part in aspects of the research that involve human subjects or their private identifiable data.

The course requirement may be satisfied by taking the appropriate CITI course within the last three years. Keep a copy of the completion certificate in a safe place, such as wherever you store your resume or transcripts. The certificate is good for three years. Investigators and staff must renew their training certification before it expires by taking either a refresher course or retaking the full course. Certificates must be current throughout the duration of the research conducted under IRB oversight.

The time to complete any training course will vary depending on your subject knowledge and how many breaks you take. 

Collaborative Institutional Training Initiative (CITI) Training Course

Collaborative Institutional Training Initiative (CITI) training is recognized world-wide as the gold standard of human subjects protection training.

Federal IRB training requirements mandate that investigators take either the Social/Behavioral-Basic course, or the Biomedical-Basic course. You should take the module that is most relevant to your specific research project. 

Training completion certificates are valid for three years. Completion time for a CITI course is usually several hours, so plan accordingly.

Researchers needing to renew their human subjects protection training should take a Refresher course. In CITI, you will see this offiered as either the Social/Behavioral-Refresher course or the Biomedical-Refresher course. You should take the module that is most relevant to your specific research project. Refresher courses are only valid for researchers who have previously taken a Basic course. A Refresher course is not a substitute for the Basic human subjects protection courses. 

UM also has additional CITI modules that researchers may be required to take, depending on the research project, including Conflict of Interest and FERPA. Please note that Good Clinical Practice and Responsible Conduct of Research courses DO NOT fulfill federal IRB training requirements. The IRB office will require you to retake the appropriate course if you try to submit these trainings to fulfill IRB training requirements. 

 

Setting Up a CITI Account 

You must set up an account to use the CITI program – click here  or go to https://about.citiprogram.org/. If you already have an account, you can login by choosing the "My Courses" button in the top right hand corner of the Home screen. From there, choose the "Login Through My Organization" tab, and enter in the University of Montana. You will be redirected to an SSO login screen. 

For new users - once you are logged in, on the CITI homepage, click on the “Register” box in the upper right corner. Under “Select Your Organization Affiliation,” type in and select “University of Montana.” Follow the instructions to continue with your account set-up (username and password).

 

CITI Course Enrollment

You can add the courses that you need to take from the "My Courses" tab. For Human Subjects Protection Training, navigate to Question 4 and select either Biomedical Research or Social/Behavioral Research. These are the Basic courses that you need to fulfill the federal IRB training requirement. Please note that Good Clinical Practice and Responsible Conduct of Research courses DO NOT fulfill federal IRB training requirements. To view past courses and course completion records, choose the "My Records" tab. 

Questions? Contact the IRB office at irb@umontana.edu.

 

Transferring CITI Training from Another Institution

The UM IRB will generally accept CITI training from other institutions. UM investigators who already have CITI Human Subjects Protection Training certificates from other institutions need to affiliate themselves with the University of Montana within CITI by choosing our university as their institutional affiliation. This will transfer completed courses and individuals will then only be required to complete any additional courses exclusive for the University of Montana. 

 CITI training from Montana State University will automatically be accepted; there is no need to transfer institutional affiliation in this case. 

 

CITI Certification Renewal/Refresher Courses

CITI offers streamlined refresher courses in each track (Social/Behavioral and Biomedical). The estimated time to complete the renewal course is 1-2 hours. Refresher courses are only valid for researchers who have previously taken a Basic course. A Refresher course is not a substitute for the Basic human subjects protection courses. 

 

New! CITI Webinar Series

UM faculty, staff, and students now have FREE access to over 100 of CITI's professional development webinars. Webinar topics span dozens of research focuses, including:

  • Artificial Intelligence (AI) and Human Subject Protections
  • Best Practices for Global Research Partnerships
  • Data Management and Security for Student Researchers: An Overview
  • Improving the Clinical Trial Participant’s Experience: From Recruitment through Study Closure
  • Getting Started in Grant Writing: An Introduction for Graduate Students, Postdocs, and New Faculty
  • Healthcare Robot Ethics: Human-Robot Interaction & Human Well-Being
  • Medical Marijuana: A Budding Field of Research
  • Remote Informed Consent
  • Research with Native American Communities: Important Considerations When Applying Federal Regulation
  • Open Access Publishing: An Introduction
  • Social Media and Research Recruiting

To access CITI's webinars, log in to your CITI account. Select the "My Courses" tab, then click on View Courses. Scroll down to the bottom of the page and click on Add a Course. Select the Webinars option, then select the webinar categories that you are interested in. Review the webinar options provided and select all the webinars you would like to review. Select Next until you are sent to your My Courses page to complete your enrollment in the webinar(s). Your selected webinars will now appear on your My Courses page. Click Start Now next to begin a webinar.

University of Montana Online Research Ethics Course (Discontinued) 

As of July 2024, the UM IRB will no longer offer the Online Research Ethics course and is moving its human subjects protection training exclusively to the CITI platform. CITI is recognized world-wide as the gold standard of human subjects protection training and provides the most updated and relevant information concerning human subjects' involvement in research.

Researchers may still submit valid (within three years) course completion records from this training with their IRB application; however, once your training certificates expire, you will be required to renew them through CITI. 

Please note that this course is only recognized by the University of Montana and its affiliated campuses.

Additional Trainings

Please note that researchers pursuing sponsored (funded) projects may need to complete additional training or other compliance requirements, such as a Responsible Conduct of Research (RCR) course. RCR courses are overseen by the Office of Sponsored Programs and are typically required by them for any sponsored projects. RCR courses do not fulfill the IRB human subjects protection training course requirement. 

Investigators and staff funded by the National Institutes of Health (NIH) may be required to complete a Good Clinical Practice (GCP) course. GCP training demonstrates that individuals have attained the fundamental knowledge of clinical trial quality standards for designing, conducting, recording, and reporting trials that involve human research participants. GCP courses do not fulfill the IRB human subjects protection training course requirement.

UM also has additional CITI modules that researchers may be required to take, depending on the research project, including Conflict of Interest and FERPA. UM IRB members are also required to complete their own specific training modules. 

Questions?  Contact the IRB office at irb@umontana.edu.