Guidance

This page provides essential resources for USC researchers, staff, and board members to ensure their work adheres to ethical standards, legal requirements, and institutional policies designed to protect human research participants.

TOPIC	GUIDANCE
Belmont Principles	Incorporating the Belmont Principles into Exempt Studies: A Guidance Tool for Investigators and IRB Staff
Children	Additional DHHS Protections for Children Involved as Subjects in Research
Compliance Flowcharts	Compliance Process Charts
Decisional Impaired Guidance Checklist	Guidance for Adult Participants with Decisional Impairment
DOD Processes	Department of Defense (DoD) Guidance website
FDA List	University of Southern California FDA Guidance List for study review
IRB Management	Reference Guide
IRB Member Regulatory Guide	Regulatory Guide
IRB Review & Approval Guidance Checklist	Requirements for IRB Review and Approval
Medicare	Medicare Coverage Analysis at The University of Southern California
Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research	Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research (Subpart B)
Reportable Events	Reportable Events Document Reportable Events Reporting Timelines
Right to Try	Right to Try Checklist for Submission and Review
Suicide Prevention	Suicidal Ideations in Research Recommendations Suicidal Thought Ideation SOP Keck Norris and Verdugo