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Human Research Policies, Guidance, & Oversight

Human Research Protection Program Compliance

The University’s policy on Human Research Protection Program Compliance (HRPP)sets forth Northwestern’s commitment to protecting the rights and welfare of human research participants and establishes the framework for the University’s Human Research Protection Program (HRPP).

Human Research Protection Program Plan

The Human Research Protection Program Plan (HRP-101) describes how the University complies with the ethical and legal requirements in the conduct of research with human participants.

Investigator Manual

The Investigator Manual (HRP-103) is designed to guide investigators through the policies and procedures relating to research with human participants.

HIPAA Guidance

The Health Insurance Portability and Accountability Act (HIPAA) and Research addresses the role of the University and the University’s IRB with respect to HIPAA  obligations.

Post-Approval Monitoring And For-Cause Audits

Post-approval monitoring and/or for-cause audits provide internal oversight on compliance issues relating to the conduct of human subject research on behalf of the Northwestern University Institutional Review Board (IRB). All active human subject research studies under the purview of the Northwestern University IRB can be chosen for review. Information about the IRB Office’s Post-Approval Monitoring and For-Cause Auditing program.