Coming Soon! This page will include access to the eIRB+ Compliance Workspace, training materials and guidance for navigating post-approval monitoring in eIRB+.
eIRB+ Compliance WorkspaceCompliance & Education
The goals of the Compliance Team within the Northwestern University IRB Office are to enhance the caliber of research performed by investigators at Northwestern University and external institutions relying on the Northwestern University IRB for review. We strive to increase the effectiveness of the University’s Human Research Protection Program (HRPP) through program oversight, education and training, and outreach. We accomplish this by collaborating with researchers to ensure compliance with federal regulations, state laws, and institutional policies that govern human research. Protecting research participants at Northwestern University is a shared responsibility with HRPP Offices, the IRB Office, and researchers working together toward this common goal.
The Compliance Team executes the IRB Office's compliance and education program aims of ensuring that educational resources and guidance materials are available to the research community and that researchers and their teams have Study Support Resources to perform compliant research.
Education drives our Compliance Team’s activities and we use observations made across the IRB Office's various teams to inform and enhance human participants’ involvement in research at Northwestern and its affiliates.
Discover more about post-approval monitoring activities, training and education, and more in the following sub-pages:
Post-approval monitoring (PAM) is an education-focused routine compliance review of the conduct of IRB-approved studies to help improve research practices.
Post-Approval Monitoring
IRB Compliance performs various directed review (for-cause audit) activities to ensure the rights and welfare of research participants are protected.
Directed Reviews
Guidance on responding to incidents, including taking immediate corrective action, conducting a root cause analysis, and implementing a CAPA plan.
Corrective and Preventive Action Plans
Federal Agency site inspections are performed on clinical investigators, study sponsors, or IRBs. Access guidance to support clinical investigators undergoing FDA site inspection.
FDA Site Inspections
Instructions on fulfilling Northwestern's Human Research Protections Training requirements requirements; applicable to all individuals engaged in Human Research at Northwestern and its affiliates.
Human Research Protections Training
Information on the IRB's education program, including the monthly Brown Bag series and the Navigating Human Research myHR Learn course.
Education