The Investigator Manual (IM) is designed to guide you through policies and procedures related to the conduct of Human Research that are specific to this institution. The manual is comprehensive and covers everything from who can serve as PI and the IRB review process, to investigator responsibilities post-approval.

Investigator Manual

The Investigator Manual has 10 parts. Click a link to review a particular part, or download the IM from the References & Resources section below.

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Part 1: Introduction – Describes the scope & purpose of the IM, defines human participant research, and an overview of the Toolkit Library and the Human Research Protection Program (HRPP).

Part 2: Researcher Requirements – Describes who can serve as PI, PI responsibilities, study team member responsibilities, student research, course instructor & advisor responsibilities, and training requirements.

Part 3: IRB Review Requirements and Application Types – Describes when IRB review is required, protocol guidelines, application types, and institutional requirements.

Part 4: Preparing Supporting Documents – Describes writing a consent document, writing a HIPAA authorization form, preparing recruitment materials, and which subject facing materials that require IRB review.

Part 5: Submitting IRB Applications – Describes scientific review requirements, how to submit a new application, change, continuing review, updating personnel, and study closure.

Part 6: IRB Review Process – Describes non-committee review, committee review, exemption changes, and IRB review decisions.

Part 7: Conducting Human Participant Research – Describes guidelines for recruitment, initial contact, participant remuneration and compensation, informed consent & assent, enrolling vulnerable populations, participant protections, research involving biospecimens & data, registries & repositories, and the application of HIPAA, FERPA, and FDA regulations.

Part 8: Post-Approval Responsibilities – Describes researcher responsibilities after IRB approval, ClinicalTrials.gov, requirements for changes, continuing reviews, and reportable events, addressing study complaints or concerns, and reporting clinically relevant information to participants

Part 9: Other Issues – Describes conducting VA research, fetal tissue research, and the General Data Privacy Regulation (GDPR).

Part 10: Appendices – Includes additional requirements for federal research, Single IRB studies, EU GDPR, PI request form, Self-Certification Tool, Exemption Category Tool, Exemption Change Table, consent form wizard, and a IDB and package insert log.


References & Resources

Last Updated: October 2021