IRB Education & Training
IRB Education & Training
Required Training
The following describe training requirements that must be completed by researchers and research personnel involved in the conduct of human research prior to participation in any aspect of research. For detailed information about training requirements, see HRP-103: Investigator Manual (download), (“What training is required to conduct Human Research?” section) and HRP-066-SOP: Human Research Education and Training.
Researchers and research personnel may also be required to complete additional training as noted by their organization, department, and/or unit.
- Required for social-behavioral researchers and study personnel: The Collaborative Institutional Training Initiative (CITI) course, “Social/Behavioral or Humanist Research Investigators and Key Personnel—Basic Course”. See the CITI Training Instructions below. This training is required by the IRB. See below for optional CIRTification training option community members serving as study personnel.
- Required for biomedical principal investigators, researchers, and study personnel: The Collaborative Institutional Training Initiative (CITI) course, “Good Clinical Practice and Human Research Protections for Biomedical Study Teams—Basic Course”. See the CITI Training Instructions below. This training is required by the IRB.
- Research Ethics for All may be allowed as an alternative, with approval by the HRPP.
Research Ethics For All
Research Ethics For All (RE4All) provides disability-accessible education on ethical issues in social and behavioral research focused on the roles and responsibilities of community research partners. The HRPP offers RE4All as an alternative training to the standard IRB training requirements, upon request.
RE4All should not be considered a substitute for the standard IRB training courses, except in cases where it is clear that the content of the standard CITI modules would not be accessible to those who need research ethics training (e.g., in the case of a person with an intellectual or developmental disability).
The HRPP will consider the following, when determining if the training can be allowed:
- The RE4All curriculum is suitable based on the proposed study.
- A senior member of the research team will conduct comprehension assessments with researchers who use the RE4All modules, and provide a written confirmation to the HRPP that assessments were completed.
- RE4All is suitable given the individual(s) role and responsibilities for the specific study.
RE4All is not allowed when:
- The study is subject to Good Clinical Practice requirements
Email the completed Alternative Training Request form to [email protected] to request approval for this alternative course.
Optional Training for Community Members serving as External Study Personnel
In some cases, external personnel may complete the community-focused ethics training course, CIRTification (CIRT), in lieu of the standard CITI training courses. CIRT training is administered by the University of Illinois at Chicago available online training.
Who is eligible to take this training?
All following criteria must be met to be eligible to complete CIRTification training in lieu of CITI training
- The study is minimal risk;
- The study is social/behavioral (biomedical research personnel are not eligible for this training);
- The external personnel is not employed by an institution with an FWA;
- The external personnel is considered a “community member”
- The study is not subject to Good Clinical Practice requirements as a result of funding.
If you are unsure if the external team member is eligible to complete this course, please email [email protected].
Instructions for Learners
The CIRTification class is free learners. The instructions below describe how to register for and complete the course.
- Go to training.ccts.uic.edu
- Click “register (top right hand corner). Select “I am not from UIC.”
- Complete the registration form. When asked to select a site, select “University of Minnesota”.
- Click “Register” to finish.
- Visit the Course Catalog. Information about CIRTification (make sure users select CIRTification: Community Involvement in Research Training and not the Refresher version) will appear. Click “Learn More” and “Enroll” to enroll in CIRTification.
After completion, the learner must download the certificate of completion. This certificate must be uploaded in ETHOS to confirm compliance with the training requirement.
Citi Training Instructions & Resources
Log in to Collaborative Institutional Training Initiative (CITI).
University of Minnesota Employees
CITI uses a single sign-in application, so UMN employees can use their UMN internet IDs when logging into CITI.
To enroll in a course for the first time:
- Click “I don't have a CITI Program account and I need to create one.”
- Expand the tab “University of Minnesota Courses.”
- Click “Add a Course.”
- Select the training required by or most appropriate to your research activities.
- Click “Submit.”
Use your U of M email address ([username]@umn.edu) for the institutional email in the CITI Program Profile. You can verify this by going to "My Profiles" in CITI.
To merge your U of M internet ID with a previously created CITI account, email [email protected] with the following information:
- Your first and last name
- The name of your institution
- The username or Member ID for the account to keep
- The username or Member ID for the account to merge
Non-University of Minnesota Employees
Non-University of Minnesota personnel participating in UMN research can complete CITI training at no cost.
- Go to the CITI program site and click “Register.”
- Enter "University of Minnesota" in the “Select Your Organization Affiliation” search field.
- Provide the requested information in steps 2–6. For required questions that do not apply to you (e.g. your employee number), enter "N/A."
- In step 7, select the training that is required and/or is most appropriate to your research activities.
- Click “Submit.”
Additional CITI Resources
If you have completed your CITI training but it does not appear in the ETHOS training tab of your study, you may need to update your CITI profile. Please find those instructions here: Updating your CITI Profile.
Educational Opportunities
Assessing Capacity to Consent to Research
As noted above, the Assessing Capacity to Consent to Research course is required for study personnel participating in the consent process for studies enrolling adults with absent, diminished, or fluctuating capacity. However, it is encouraged for everyone who participates in the consent process for studies enrolling adult participants, whether or not the participants have absent, diminished, or fluctuating capacity to consent.
The course is accredited by the University of Minnesota Office of Continuing Professional Development. Additional information regarding continuing education credits is described in the course. Access the course through the Training Hub.
IRB Lunch and Learns
IRB staff lead regularly scheduled lunch meetings covering topics related to IRB preparation, review, and post-approval requirements. Sign up to receive calendar invitations for the series.
This recording list provides recordings of past IRB Lunch and Learn sessions. The content covered in the recordings is subject to change over time due to procedural or policy changes. For the most current information, please review the guidance in the HRPP Toolkit [e.g. Investigator Manual (HRP-103)].
ETHOS Learning Labs
The IRB offers monthly ETHOS learning labs via Zoom. Intended for both new and experienced ETHOS users, each session will include an overview of ETHOS followed by opportunities to ask questions, learn navigation tips, and apply new skills.
Learning labs are held the first Thursday of every month from 12:00-12:45 p.m. Registration is not required, just click here to join.
Tools & Resources
Informed Consent Resources
The following resources are available to assist in the development of the informed consent document and enhancing the informed consent process.
Electronic Consent
Using REDCap for eConsent Job Aid: Instructions on how to design an eConsent form in REDCap and how to set up eConsent for studies requiring a signature.
Use Simple Words & Phrases
- Plain Language Thesaurus for Health Communications
- Clear Language and Design
- Minnesota Health Literacy
- Medical terms, procedures, and conditions for younger children and teenagers
- Best Practices and New Models of Health Literacy for Informed Consent (Institute of Medicine, 2015)
- Health Literacy Plain Language eToolkit
- Health Literacy in Clinical Research
Improve Readability of Consent Forms
Use the Teach-Back Method
- Agency for Healthcare Research and Quality
- "Always Use Teach-Back!" training toolkit
- Informed Consent Authorization Toolkit for Minimal Risk Research, Agency for Healthcare Research and Quality
IRB/HRPP Training Calendar
Check this calendar for upcoming training opportunities for the research community, including Lunch and Learns, ETHOS Learning Labs, and others.