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What is the purpose of this manual?

This document, “INVESTIGATOR MANUAL (HRP-103),” is designed to guide you through policies and procedures related to the conduct of Human Research that are specific to this institution.

General information regarding Human Research protections and relevant federal regulations and guidance is incorporated into the required human protections training. For additional information, see below: “What training do my staff and I need to conduct Human Research?”

This document references guidance, policies, standard operating procedures (SOP), forms, worksheets, checklists, templates, and other documents. The IRB Office continuously updates these tools and posts them to the IRB Office website for use by the research community. Please contact the IRB Office with questions or if you identify any broken links.

Scope

Throughout this document, “institution” refers to Northwestern University.

Definitions

Although some terms are defined in this document, a comprehensive set of definitions relevant
to Human Research can be found in “SOP: Definitions (HRP-001).” Please refer to the SOP definitions of terms employed throughout this document (linked on first use).