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 NU or at 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.
Quick Links, Tips, and Best Practices:
- Collaborative Institutional Training Initiative (CITI) Program website
- eIRB+ webpage
- Human Research Protections Training Guidance (PDF)
- Northwestern 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
- Principal Investigators are required to maintain documentation evidencing valid Human Research Protections Training for all individuals engaged in Human Research; the eIRB+ and study applications are the IRB’s records and do not serve as study document repositories. Utilize the IRB's Study Support Resources to maintain research records
- Jump to training requirements for Northwestern and Northwestern-affiliated Researchers
- Jump to Troubleshooting
Human Research Protections Training Pathways
Accessible version of Human Research Protections Training Pathways
Human Research Protections Training Level Requirements
Human Research Protections Training Cycle
Human Research Protections Training Requirements by Group
Northwestern and Northwestern-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 and Northwestern- 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-affiliated researchers include those at Shirley Ryan AbilityLab, those at Central DuPage Hospital, and those covered by the MOU with Northwestern Memorial HealthCare.
Lurie Children's Hospital and Northwestern Memorial HealthCare Researchers
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 Northwestern human research protections training requirements and confirm if/what additional CITI training is required by the study sponsor. If additional training is required by the study sponsor, 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
- For Northwestern and Northwestern-affiliated researchers, ensure the following four steps are complete:
- eIRB+ registration
- CITI account affiliation with Northwestern University (SSO)
- “Human Research Protections (IRB)” course enrollment
- All Northwestern IRB training requirements/modules (see above)
- If the eIRB+ account does not reflect CITI training records after 24 hours, update CITI profile credentials: "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.
- If the above steps do not resolve issues, the researcher like has more than one CITI account, more than one eIRB+ account, or both. NOTE: To avoid issues with competing eIRB+ accounts, it is best to reactivate “expired” Northwestern NetIDs and not to obtain a new one.
- To merge CITI accounts, contact CITI Support and cite the account numbers to be merged.
- eIRB accounts may not be merged; submit an eIRB+ Support Form ticket and cite the NetID associated with the eIRB+ account to be deleted. Note the standing eIRB+ account must be associated with researcher’s active NetID.
- Log into CITI using Northwestern Single Sign-On to ensure systems integration between CITI and eIRB+.
- Wait 24 hours for the CITI training record to integrate into eIRB+.
- 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.