Lurie Children's Research Education Requirements
Human Subject Research (HSR) Protection education is required for anyone engaged in human subject research at Lurie Children's prior to the start of study activity. Consistent with the NIH policy, this requirement applies to all human subjects' research, regardless of the risk level of the study, the institutional affiliation of the personnel, and/or the source of funding.
Good Clinical Practice (GCP) training is required for all research personnel involved in the conduct, management and oversight of a clinical trial at Lurie Children's, additionally it may be required by sponsors or funding agencies. Consistent with the NIH policy, this requirement applies to all studies meeting the NIH definition of a clinical trial, "a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on biomedical or behavioral outcomes."
Please Note: IRB approval will not be issued unless all research personnel follow the Human Subject Research Protection and Good Clinical Practice education requirements as applicable.
For more information, refer to the IRB Policy and Procedure Manual Section 6: Required Education or contact the Office of Research Integrity and Compliance (ORIC) at IRB@luriechildrens.org
To obtain access to Cayuse, refer to the Cayuse page.
All required education training modules must be completed through CITI. The courses will populate once a CITI account is created and affiliated to Lurie Children’s Hospital or when an existing account is affiliated with Lurie Children’s Hospital. More information on the two options below:
- For those creating a CITI account for the first time, please click here for instructions on how to create a CITI account and complete initial training required at Lurie Children's listed below.
- For individuals that have created and/or completed CITI course under another institution, you will need to ensure the completed courses match Lurie Children’s required courses. Please click here for instructions on how to affiliate an existing CITI account to Lurie Children’s.
- Biomedical or Social Behavioral Human Subjects Research (HSR) Basics course (depending upon the type of research one conducts)
- Biomedical Researchers Refresher Course Social Behavioral Researchers Refresher Course (to renew education requirements only)
- Good Clinical Practice
Once courses are completed, it is the responsibility of the individual to maintain certificate copies of completed course and expiration dates. Individuals will need to complete the refresher course(s) every 3 years. CITI will send expiration reminders individually but it is the study team’s responsibility to keep track and maintain a list of all individuals listed on the studies with each expiration date. It is recommended that each division/study team create a tracking form for ALL staff engaged in research studies within your area. Here is a template tracking form (CITI Training Tracker) that study teams can utilize to keep track of expiration dates.
To complete a Refresher course through CITI:
- You will receive an email reminder from CITI 90 days before your certification is due to expire. Follow the directions in the email to complete the appropriate refresher course(s).
For further guidance, please refer to the CITI support center.
Questions may also be directed to IRB@luriechildrens.org.
Prior to our CITI integration in November 2018, some researchers completed education requirements outside of Lurie Children’s CITI Program and were given an expiration date of January 1st, 2021.
Moving forward, all continuing education must be completed in CITI.
In addition, you can also check your CITI training expiration dates.
Need to check your CITI training expiration date? Follow these steps:
Via CITI Program:
- Log into your CITI account, and click on your Ann & Robert H. Lurie affiliation.
- Click on "records". Here you will see the date of completion and the date of expiration for your certifications/completed modules.
To view a person’s CITI courses and expiration dates, click "View" under Trainings in Section 1, item B within the study application. A box will appear with the name, status, completion date, and expiration date of the courses in that person’s CITI profile.
If the trainings are not populating:
- CITI courses have not yet been completed. Follow the instructions on how to create a CITI account and complete the initial education.
- The existing CITI profile is not affiliated with Lurie Children’s, completed courses will not populate until the profile is affiliated with Lurie Children’s. Please follow the instructions on how to affiliate the CITI profile.
- If you have completed the required CITI courses and affiliated your account but the records aren’t populating, you will need to contact CITI support and request to have your completed courses be merged.