There are separate trainings for UI researchers who submit to the biomedical research board (IRB-01) and for those that submit to the social/behavioral research board (IRB-02). For UI researchers, human subjects protection training is a one-time requisite. The UI IRB does not require completion of a refresher course. However, the National Institutes of Health (NIH) and some sponsors, may require refresher training every 3 years. If you have questions regarding the UI IRB requirements for human subjects protection training, please contact an HSO CITI Program administrator or call 319-335-6564.

The UI generally does not accept human subject protections training completed at another institution, even if it was completed through the CITI Program unless indicated as acceptable via an IRB Reliance Agreement. Each institution selects the CITI Program modules for their training requirements.  The modules required by the UI IRB may be different than those required by other institutions. 

If you previously completed human subject protections training through the CITI Program at another institution, you may receive credit for the completion of modules that are required by the UI and your previous institution. To ensure that you receive this credit, you must log in to the same profile you used at your previous institution and add an affiliation with the UI. See the ‘UI Learner Completed Training on the CITI Program at Another Institution’ section of the UI CITI Program Users Guide for complete instructions.

The VAHCS has training requirements for researchers who submit to the VAHCS board (IRB-03). VAHCS researchers must renew this training every 3 years by taking a refresher course. If a research team member fails to adhere to the training renewal requirements, the VAHCS Research Office could issue restrictions to conduct VAHCS related research activities. If you have questions about the VA human subjects protection training, contact the VA Research Office at 319-339-7151.

In addition to the human subjects protection training required by the UI IRB, there may be additional training requirements for researchers who submit to the UI Department of Defense board (IRB-04). 

• Department of Defense Requirements (DoD) – Human subjects research training requirements may vary depending on the sponsor (e.g., Army, Air Force).  Check with your DoD representative to determine DoD research-related training you will need. If you have taken DoD-related training in the past, check with your DoD representative to see if it needs to be renewed.
• Department of Navy (DoN) – The Navy requires that you take additional certification modules, check with your DoN representatives to determine requirements.

The CITI Program website notes that the average learner spends about 4 ½ hours completing a basic course and about 2 hours completing a refresher course. You do not have to complete the entire course in one sitting. If you leave and come back, the training will resume where you previously left off.

Researchers complete human subjects protection training through an online education program called the Collaborative Institutional Training Initiative program (CITI Program).  This training provides education about the ethical conduct of human subjects research.

Follow the step-by-step instructions in the UI CITI Program Users Guide to ensure completion of the correct course. There are several institutional training courses available to UI learners on the CITI Program platform. Only one of them satisfies the UI human subjects protection training requirement. If a research team member completes the wrong course, there will be delays in New Project and Modification forms adding them to the research team.

The UI IRB maintains a Certified Investigator Database within the HawkIRB platform documenting who has completed UI and\or VAHCS required human subjects protection training. CITI Program notifies the HSO automatically of the completion of all human subjects protection courses (with the exception of courses required by the DoD) within 24 hours. Completion records are verified and entered in the Certified Investigators Database within one to two business days. HSO staff will notify you via email if there are any issues with your completion record. To check if someone has completed the human subjects protection training, search for their name in the Certified Investigator Database. If you are not able to find a researcher’s name listed in the Certified Investigators Database, please contact an HSO CITI Program administrator or call 319-335-6564.

Prior to using the CITI Program, the UI IRB accepted completion of the NIH course on Protecting Human Research Participants (PHRP) as meeting the requirements for human subjects protection training. Researchers that completed this NIH course for human subjects protection prior to the UI transitioning to the CITI Program are still compliant with the UI IRB training requirement. However, the NIH no longer offers the PHRP course. Therefore, if a UI researcher completed the NIH course several years ago, and a current sponsor requires that their human subjects protection training be renewed, the researcher must complete the CITI Program training instead. See the ‘Creating a New Profile for First Time Completion of Human Subjects Protection Training’ section in the UI CITI Program Users Guide.

If you completed the Protection of Human Subjects in Research workshop presented by the UI IRB and no longer have proof of completion of this workshop, you will need to complete the CITI program training. See the ‘Creating a New Profile for First Time Completion of Human Subjects Protection Training’ section in the UI CITI Program Users Guide.

In addition to the UI required training, here are several institutional training courses available to UI learners on the CITI Program platform. Not all of these courses apply to human subjects research. 

Good Clinical Practice (GCP) Training

Unlike human subjects protection training, not everyone needs to complete GCP training at the University of Iowa even though they may have contact or interactions with research subjects or with their private, identifiable information and/or biospecimens. The requirement to complete this training is usually determined by your funding source. GCP training is required for all investigators and staff who are involved in the conduct, oversight or management of NIH-funded clinical trials. This training is consistent with  Food and Drug Administration (FDA) Good Clinical Practice regulations and must be renewed every 3 years. Additional information about this training requirement can be found here. This policy applies to all active NIH grants and contracts. In addition to the NIH, other clinical trial sponsors may require that researchers complete GCP training as well. You will need to check with your sponsor to see if they have this requirement.   

See the ‘Registering for Additional Courses’ section in the UI CITI Program Users Guide for more information about how to register for GCP training.

GCP training is not the same as human subjects protection training. It is a separate course and the content is not covered in the human subjects protection training. GCP training is not required by the UI IRB; however, the HSO does keep track of UI researchers’ completion of this training in the Certified Investigator Database as a courtesy. All researchers are expected to retain their own documentation of completion of this training.

You will receive automated reminder emails from the CITI Program at 90 days, 30 days and 7 days prior to the expiration date of your GCP certification. If your certification expires, you will not receive any additional notification from either the CITI Program or the HSO. Some sponsors may not require renewal of this training every 3 years like the NIH. Even if your sponsor does not require renewal, you may still receive the automated reminder emails from the CITI Program. Due to programming constraints, the CITI Program cannot distinguish learners who are completing GCP training for an NIH funded study from those that are completing GCP training for a different sponsor that may not require that GCP training be renewed. It is the responsibility of the individual to ensure that they are compliant with their sponsor’s requirements.

If you have questions about the Good Clinical Practice (GCP) curriculum, please contact an HSO CITI Program administrator or call 319-335-6564.

Refresher Course

The UI offers a refresher course for human subjects protection training for both biomedical researchers and social/behavioral researchers on the CITI Program. This is a courtesy to those researchers who may need to renew their human subjects protection training for NIH or a study sponsor.

You should only complete a refresher course if you have previously taken the UI basic course for either ‘Group 1 – Biomedical - IRB-01’ or ‘Group 2 – Social/Behavioral – IRB-02’ through the CITI Program. 

Do not complete a refresher course if:

• You completed the NIH tutorial "Protecting Human Research Participants" to satisfy the UI IRB requirements for human subjects protection training.
• You completed an HSO Workshop to satisfy the UI IRB requirements for human subjects protection training. 
• You completed human subjects protection training in the CITI Program at a previous institution.

If any of these situations apply to you, you must complete the UI basic course for either ‘Group 1 – Biomedical - IRB-01’ or ‘Group 2 – Social/Behavioral – IRB-02’ through the CITI Program as your ‘refresher’ course. Subsequent renewals can then be satisfied by completing the refresher course. 

See the ‘Registering for Additional Courses’ section of the UI CITI Program Users Guide for more information about how to register for human subjects protection refresher training.

Responsible Conduct of Research (RCR) Training

This training is a federal requirement for faculty, staff, and/or students conducting research that is funded by the National Science Foundation (NSF), NIH and U.S. Department of Agriculture (USDA) National Institute of Food and Agriculture (NIFA). A University of Iowa Responsible Conduct of Research (RCR) Plan has been created under the joint sponsorship and responsibility of the Graduate College and the Office of the Vice President for Research to ensure funded investigators are formally trained in RCR. The UI provides this training via the CITI Program to ensure these compliance guidelines are met.

RCR training is not the same as human subjects protection training. It is a separate course and the content is not covered in the human subjects protection training. Your department will determine if you need to complete this training. 

For contact information, FAQs, a list of training requirements, and to view the UI Responsible Conduct of Research Plan, please click on the RCR link above.

The UI provides access to additional research compliance courses and webinars for the institution. These offerings are optional but may be beneficial for continued learning. Research compliance training courses include topics such as conflict of interest, information privacy and undue foreign influence. Research compliance webinar options include topics such as clinical research and Good Clinical Practice, grants and blockchain/higher education. Follow the step-by-step instructions in the UI CITI Program Users Guide to register and review these courses or webinars.