New Study Submission and Continuing Review
All proposals (Exempt, Expedited, Full Board Review, and Continuing Review) must be submitted through iStar: http://istar-chla.usc.edu

Required Forms and Instructions for IRB Applications

• Template of a Protocol for Investigator Initiated Study
• NIH Budget Form
• HRA Budget Form (for password call: 323-223-4091)
• Experimental Subject's Bill of Rights
• HIPAA Authorization Form
• USC Institutional Biosafety Committee
• USC Institutional Biosafety Committee Protocol Forms
• Radiation Safety Committee Application Forms
• USC Department of Contracts and Grants

Forms for studies conducted at LAC+USC Healthcare Network:

• Laboratory Agreement Template (March 2007)
• Drug Inventory Form for LAC + USC Healthcare Network
• Research Oversight Committee Form

Informed Consent Templates and Guidance

• HSIRB Informed Consent Template Revised (NEW)
• Template and Instructions for Adult Informed Consent
• Template (subtitles only) for Adult Informed Consent
• Assent Template
• Short Form Informed Consent for Use with Non-English Speaking Subjects (English; Spanish; Korean; Chinese; Thai; Vietnamese; Russian; Farsi; Armenian; French)
• Significant New Information/Findings Policy (NEW)
• Significant New Information/Findings Template (NEW)
• Guidance for Use of Short Form Informed Consent and Translation of Informed Consent
• Lay Term List for Use in Informed Consent

Experimental Subject's Bill of Rights Templates
Experimental Subject's Bill of Rights Template (English; Spanish; Korean; Traditional Chinese; Thai; Vietnamese; Russian; Farsi; Armenian; French)

HIPAA Template and Instructions
NOTE: The new HIPAA Authorization forms (dated 9/2007) are for New Studies only. It is not necessary to replace/amend prior HIPAA forms in ongoing studies. For any questions regarding this matter please contact the HSIRB at (323) 223-2340.

• USC HIPAA Authorization Form (English; Spanish)
• HIPAA Authorization Form Instructions
• Preparatory Research Activities

Reportable Events Instructions
All reportable events (internal or external adverse events, DSM reports, protocol deviaitons/errors) must be submitted via iStar: http://istar-chla.usc.edu

IRB Reviewer Guidelines
The IRB Reviewer Guidelines are used by IRB members and staff to aid in the review of applications. The guidelines provide guidance on issues/questions that the IRB considers when reviewing a study.

• USC Investigator/Sponsor Agreement Form (For IDE or IND investigator initiated studies)
• IRB Authorization Agreement
• Research Consultant Non-Engagement Agreement
• Unaffiliated Investigator Agreement
• Lab Utilization Worksheet
• The Research Advisory Panel of California (California requires proposed research projects involving certain opioid, stimulant, and hallucinogenic drugs classified as Schedule I and Schedule II controlled substances to be pre-reviewed and authorized by the Research Advisory Panel of California in the Attorney General's Office.)