Human Research Protections Training
Northwestern University requires all individuals involved in the conduct of human research to complete Human Research Protections Training and refresh their training every 3 years. IRB approval will be withheld if these training requirements are not met. These requirements apply to all persons engaged in human research and listed on the eIRB+ study application. Those individuals include, but are not limited to:
- Principal Investigator and Co-investigators
- Individuals named on a study grant or contract proposal
- Individuals listed on an FDA form 1572 for the conduct of the research at Northwestern University or an affiliate institution
- Individuals who are responsible for the informed consent process or recruitment of research participants
- Individuals who obtain individually identifiable health information under a Northwestern Business Associate Agreement or Northwestern Individual Investigator Agreement.
All Principal Investigators (PIs) are required to maintain documentation (CITI Program-issued certificate) of Human Research Protections Training outside of the eIRB+ system for each study personnel engaged in the research. Please see Study Support Resources and Templates for required documentation the PI must maintain on file.
Quick Links, Tips, and Best Practices:
- Collaborative Institutional Training Initiative (CITI) Program website
- eIRB+ webpage
- Human Research Protections Training Guidance (PDF)
- Northwestern University IRB Office requires and accepts only Human Research Protections Training; it does not require or accept Good Clinical Practice (GCP), Responsible Conduct of Research (RCR), Information Privacy and Security (IPS) or any training other than that specifically covering human research protections
- Training records will appear in eIRB+ after 24 hours; Please be patient as training records will not appear in eIRB+ immediately following training completion in CITI due to systems integration cycles
- Contact the Department of Information Technology to reactivate an expired Northwestern NetID; temporary/returning researchers should avoid creating a new eIRB+ account with a new NetID as doing so often interrupts an important automated process and delays training and research timelines; see Troubleshooting below for more information
- Jump to training requirements for Northwestern University and Northwestern University-affiliated Researchers
- Jump to How to Transfer CITI Training
- Jump to Troubleshooting
Human Research Protections Training Pathways
Human Research Protections Training Level Requirements
Human Research Protections Training Cycle
Human Research Protections Training Requirements by Group
Northwestern University and Northwestern University-Affiliated Researchers
On September 1, 2023, training requirements moved from a dual-track (social behavioral and biomedical) to a single-track course for all Northwestern University and Northwestern University-affiliated human researchers. No action is needed and current training records will maintain validity until expiration. At the time of basic or refresher training, “Human Research Protections (IRB)” will be the only course enrollment option in CITI. Northwestern University-affiliated researchers include those at Shirley Ryan AbilityLab and those covered by the Northwestern University Memorandum of Understanding (MOU) with Northwestern Memorial HealthCare (NMHC) (i.e., NMHC clinician-researchers who also serve as Northwestern University faculty members). NMHC clinician-researchers who have no professional appointment or affiliation with Northwestern University are not covered under this MOU.
Training Requirements
- Register with eIRB+
- Register with or affiliate existing CITI Program account using Northwestern University single sign-on (SSO) (see screenshots below)
- Add Human Research Protections (IRB) course to Northwestern University CITI account by responding to Question 1, Human Subjects Research
- Complete course requirements/modules (see table below); retain completion report and certificate for independent record-keeping
Important:
- CITI training records integrate with eIRB+ twice daily. It is important to wait 24 hours for records to appear in eIRB+.If records do not appear after that time, see Troubleshooting below.
- Training status must be verified (as valid or expired) in eIRB+ by researchers under My Profile or by study coordinators under the application’s Study Team Training tab.
- Automated systems processes no longer require training records be manually updated or supplied via email.
How to Transfer CITI Training
Northwestern University researchers who have completed another institution’s Human Research Protections Training in the CITI Program may initiate the credit transfer process by following the below steps. Credit is given for (a) modules meeting Northwestern Human Research Protections Training requirements (i.e., those with matching module ID numbers; see table under Training Requirements section above) and (b) completed within two years of the date of CITI account affiliation with Northwestern University.
- Register with eIRB+
- Affiliate existing CITI Program account using Northwestern University (SSO)
- Add Human Research Protections (IRB) course to Northwestern University CITI curriculum by responding to Question 1, Human Subjects Research
- Complete outstanding course requirements/modules; retain completion report and certificate for independent record-keeping.
Important:
- CITI training records integrate with eIRB+ twice daily. It is important to wait 24 hours for records to appear in eIRB+. If records do not appear after that time, see Troubleshooting below.
- See table under Training Requirements section (above) for Northwestern University Human Research Protections Training course requirements/modules
- Only after completing all required modules and receiving a completion certificate is Human Research Protections Training complete
- Because Northwestern training requirements include a custom module, researchers will always be responsible for one outstanding module; far more often, however, researchers must complete several outstanding modules
Northwestern Memorial HealthCare Researchers (Affiliated with Northwestern University)
Researchers who (a) are covered by the Northwestern University Memorandum of Understanding (MOU) with Northwestern Memorial HealthCare (NMHC) (i.e., NMHC clinician-researchers who also serve as Northwestern University faculty members), (b) have completed NMHC’s Human Research Protections Training requirements, but (c) have yet to complete the Northwestern University Human Research Protections Training requirements may submit their training records to Northwestern University IRB Training for a one-time courtesy credit for this training.
MOU-covered researchers must affiliate their CITI account following the process outlined on the page and meet Northwestern University’s Human Research Protections Training requirements before but no later than the time of the next training refresher.
To receive the one-time training credit, please include the following in an email to irbtraining@northwestern.edu:
- Subject line: “NMHC MOU transition exception”
- Message body: “This MOU-covered researcher (state first and last name, and their Northwestern University NetID) would like to use their one-time exception for a manual eIRB+ records update.”
- Attach: The CITI Program training certificate that indicates that the researcher completed Human Research Protections Training under the requirements of NMHC
Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern Memorial HealthCare Researchers (Unaffiliated with Northwestern University)
Unaffiliated, Community-Based, and External Collaborators
Government-Sponsored Research
Individuals conducting research sponsored by the U.S. Department of Defense or U.S. Department of the Navy must complete Human Research Protections Training requirements and confirm if/what additional CITI training is required by the study sponsor. If the study sponsor requires additional training, email a copy of the completed training certificate to irbtraining@northwestern.edu for manual eIRB+ record entry.
Veterans Affairs researchers who have or will obtain a Northwestern NetID must register with eIRB+ and email their Human Research Protections Training certificate to irbtraining@northwestern.edu. Northwestern University IRB accepts only Human Research Protections Training.
Troubleshooting
STEP 1: For Northwestern University and Northwestern University-affiliated researchers, ensure the following four steps are met:- Register with eIRB+
- Register with or affiliate existing CITI Program account using Northwestern University single sign-on (SSO)
- Add Human Research Protections (IRB)course to Northwestern University CITI curriculum by responding to Question 1, Human Subjects Research
- Complete all Northwestern IRB training requirements/modules (see table under Northwestern University and Northwestern University- Affiliated Researchers > Training Requirements)
- Wait 24 hours for CITI training record to integrate with eIRB+ system
STEP 2: If the eIRB+ account does not reflect CITI training records after 24 hours, update CITI profile credentials using the SSO feature. This will resolve 95% of issues.
- "Log in through My Organization" > select the hyperlink "See our full list of SSO-enabled organizations" > search "Northwestern University" > select “Continue to SSO Login/Instructions” > enter organizational credentials (NetID), if prompted > when asked about existing CITI account, select “yes” to update CITI profile.
Please check the eIRB+ account for the training record after 24 hours following this process.
STEP 3: If the above steps do not resolve issues, the researcher likely has more than one CITI account, more than one eIRB+ account, or both.
To proceed, please include the following in an email to irbtraining@northwestern.edu:
- Subject line: “Request to check for multiple accounts”
- Message body: “The following researcher (state researcher's first and last name, and their current/active Northwestern University NetID) has taken all steps to complete training requirements and has logged into their CITI account using the Northwestern University SSO feature. Per Troubleshooting Step 3, please check for multiple eIRB+ and/or CITI accounts.”
NOTES: To avoid issues with competing accounts, it is best to reactivate “expired” Northwestern NetID (do not obtain a new one) by contacting the Northwestern University Department of Information Technology.
The CITI Program Support website offers robust information on affiliating institutions, adding/enrolling in courses, and other actions required to integrate your CITI account with Northwestern records.
Submit an eIRB+ Support Form for further assistance.