IRB Education

IRB approval will not be issued unless all research personnel are in compliance with the Human Subject Research Protection and Good Clinical Practice education requirements as applicable. Training for each should be completed through Collaborative Institutional Training Initiative (CITI). Please refer to the instructions below.

Announcement 

Human Subject Research Protection 

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.

Education completed outside of Lurie Children's CITI:

Good Clinical Practice

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 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 behavorial outcomes."

CITI Human Subjects Research Education and Good Clinical Practice Training

To create a CITI account and complete initial training required at Lurie Children's:

1. To create an account, follow the steps found on the CITI website.

2. When completing your CITI profile ensure that the institutional email address listed in your Lurie Children's CITI profile matches the email address in your Cayuse profile. To change your institutional email address listed in CITI, go to "My Profile" and scroll down to select the "Ann & Robert H. Lurie Children's Hospital of Chicago Profile", update the institutional email address as necessary. Click "Update Profile" to save.

3. Once your profile is complete, select the appropriate role and course(s) in Question 1. Please note, it is a requirement to complete either the Biomedical or Social Behavioral Human Subjects Research (HSR) Basics course. Therefore in Question 1, please select either the Biomedical or Social Behavioral option, do not select “Not at this time”.  For Question 2, please select “Not at this time” for the refresher courses. Finalize your registration.

4. The HSR and Good Clinical Practice courses will populate on your homepage.

5. To begin, click on the applicable course name(s) and complete the required modules.

6. You will need to complete and pass all required modules to earn your completion certificate(s).

7. Please keep a copy of your certificate(s) in your study records. 

To affiliate an existing CITI account with Lurie Children's:

1. Go to the CITI website

2. Click "Log In" located in the top right corner of the page and enter your existing username and password.

3. To affiliate your existing account with Lurie Children's, and transfer your completed courses, follow the steps found on the CITI website.

4. Ensure that the institutional email address listed in your Lurie Children's CITI profile matches the email address in your Cayuse profile. To change your institutional email address listed in CITI, go to "My Profiles" and scroll down to select the "Ann & Robert H. Lurie Children's Hospital of Chicago Profile", update the institutional email address as necessary. Click "Update Profile" to save.

5. Once affiliated with Lurie Children's, click "Add a Course" under your "Ann & Robert H. Lurie Children's Hospital of Chicago Profile". 

6. In Question 1, select either the Biomedical or Social-Behavioral group for the Human Subjects Research (HSR) and/or Good Clinical Practice (GCP) Basics course(s) that you have completed. If you have also completed a refresher training, and need to transfer this coursework, please indicate this in Question 2. If your basics training has not expired, and you do not need to transfer coursework for a refresher training, please select “Not at this time” in Question 2. 

7. Enroll in the courses that are applicable to you: HSR and/or GCP. The courses will populate on your homepage, and any modules shared between the institutions will have the credit transferred automatically.

8. If the course states incomplete, or your certification has expired, click the course name to complete the necessary modules. You will need to complete and pass all required modules to earn your completion certificate(s).

9. Please keep a copy of your certificate(s) in your study records. 

To complete a Refresher course through CITI:

  1. Refresher courses are required every 3 years. 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).

To find more information on CITI:

For further guidance, please refer to the CITI support center.
Questions may also be directed to IRB@luriechildrens.org

Cayuse IRB Access 

Cayuse IRB is the web-based electronic submission system for all human subjects research protocols and projects. To obtain access to Cayuse IRB please submit the Cayuse Access Form to IRB@luriechildrens.org

Once completed in CITI, HSR and GCP status will populate in the Cayuse IRB system. IRB approval will not be issued until educational requirements have been met for all study personnel.

Cayuse IRB Access Form

For more information, please 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