Human Research Protections Training

1. Register with eIRB+
2. Users who do not have a CITI Program system account:
   1. Register with the CITI Program system using the LOG IN THROUGH MY ORGANIZATION option shown in the screenshot below and select Northwestern University. Do not use the REGISTER pathway.
3. Users who already have a CITI Program account: 
   1. Affiliate your existing CITI Program account with Northwestern University using Northwestern University single sign-on (SSO)
4. New and existing CITI Program system users then add Northwestern University’s Human Research Protections (IRB) course by responding to Question 1, Human Subjects Research
5. Complete course requirements/modules (see table below); retain completion report and certificate for independent record-keeping

 Important:

• Only after completing all of Northwestern’s required modules and receiving a completion certificate is Human Research Protections Training complete
• It is important to wait 24 hours after affiliating your account with Northwestern AND completing Northwestern's training requirements for records to appear in eIRB+.
• 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 have eliminated manual entry of training records for Northwestern University and affiliated researchers.

Northwestern University and affiliate researchers who have completed another institution’s Human Research Protections Training course in the CITI Program may initiate the credit transfer process by following the below steps. Northwestern gives credit 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) modules completed within two years of the date that users add Northwestern University’s Human Research Protections (IRB) course to their account.

1. Register with eIRB+
2. Affiliate your existing CITI Program account using the Northwestern University (SSO)
3. Add the Human Research Protections (IRB) course by responding to Question 1, Human Subjects Research
4. Complete outstanding course requirements/modules; retain completion report and certificate for independent record-keeping.

Important: 

• See the table above for Northwestern University's Human Research Protections Training course requirements/modules.
• Only after completing all of Northwestern's 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.
• Individuals can view their training status by navigating to My Profile in the drop-down menu by clicking on their name in the top right corner of their screen after logging into eIRB+. Study coordinators may verify study personnel training statuses within the eIRB+ study application’s “Study Team Training” tab/page. If the training record appears there and is current (with a three-year validation window), the researcher is approved to conduct Human Research with Northwestern University and its affiliates.

Northwestern University’s IRB accepts Lurie Children’s Human Research Protections Training completed by Lurie Children’s researchers.

1. Register with eIRB+
2. Verify training status (as valid or expired) in eIRB+;
   • Individuals can view their training status by navigating to My Profile in the drop-down menu by clicking on their name in the top right corner of their screen after logging into eIRB+. Study coordinators may verify study personnel training statuses within the eIRB+ study application’s “Study Team Training” tab/page.
3. If the training record appears there and is current (with a three-year validation window), the researcher is approved to conduct Human Research with Northwestern University and its affiliates.
4. Please include the following in an email to irbtraining@northwestern.edu for manual eIRB+ record entry:

• Subject line: Lurie Children’s researcher manual entry
  • Message body:
    • Include “This Lurie Children’s researcher would like to request a manual eIRB+ records update:”
    • Researcher’s first and last name, and their Northwestern University NetID
  • Attach: The CITI Program training certificate indicating that the researcher completed Human Research Protections Training under Lurie Children’s requirements.

Researchers external to Northwestern University and its affiliates who are primarily affiliated with another institution must fulfill their institutions’ training requirements.

Those external researchers who are not affiliated with another institution may satisfy Human Research Protections Training requirements by completing one course from the following training options: 

• Protecting Human Research Participants (PHRP) Online Training (Fees Applicable)
• CIRTification: Community Involvement in Research Training (Free)
• Office for Human Research Protections (OHRP): Human Research Protection Training (Free)

Upon completion, upload the training certificate to the Supporting Documents section of the eIRB+ study application.

Northwestern University requires that Unaffiliated, Community-Based, and External Collaborators complete Human Research Protections Training and refresh their training every 3 years in alignment with the training requirements of Northwestern University-Affiliated Researchers. These individuals may fulfill renewal requirements by re-taking their initial course or another valid course listed in this section.

NOTE: Obtaining a Northwestern University NetID for someone who is not an agent of Northwestern University or its affiliates does not automatically confer any right to engage in Human Research at Northwestern University or its affiliates or act as an agent of these institutions, including accessing or using Northwestern University resources, which includes IRB services and access to the University’s subscription to the Collaborative Institutional Training Initiative (CITI) resources.

Before engaging in Human Research associated with Northwestern or its affiliates, the Northwestern IRB must first determine whether external researchers or others will act as agents of another institution, such as through a primary affiliation with another institution. In this case, they must either obtain IRB or ethics committee approval from the institution they are primarily affiliated with, or a Northwestern University or affiliated PI or designee may submit a modification request to add their primary institution as a site relying on the Northwestern IRB for oversight to the existing study, following the steps outlined on the Northwestern University IRB’s webpage, Northwestern Serving as the IRB of Record.

Principal Investigators are responsible for supporting external researchers covered under an Individual Investigator Agreement (IIA). They must upload the external researcher's Human Research Protections Training certificate to the Supporting Documents section of the eIRB+ study application.

• For more information regarding IIAs, please see the Northwestern Serving as the IRB of Record webpage.