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Protocol Templates

1. 1. 1. 1. Biomedical Investigator Initiated Protocol Template
            NIH e-Protocol Writing Tool supports the Behavioral and Social Sciences Research Involving Humans Clinical Trials Template in addition to Phase 2 and 3 IND/IDE Clinical Trials Template.
         2. Social Behavioral Protocol Template
         3. Secondary Data Analysis Protocol Template 

Consent Templates and Instructions

1. 1. 1. 1. 1. 1. Informed Consent Form Instructions for Industry Sponsored, Cooperative Group, or External IRB Studies
                  The IRB accepts all industry sponsored consent forms with minimal change in content.  Consent forms provided by an industry sponsor, cooperative group, or external IRB need to be modified only to include the addition of USC specific requirements, such as local contact information, cost/injury, payment language and removal of HIPAA. The iStar submission must include an electronic version of the study’s consent template and the consent version that includes all USC specific modifications for review.
               2. Informed Consent Form Template
                  This document must be utilized for projects with Expedited or Full Committee review when there is no consent form from an industry sponsor or cooperative group.
                  Includes the essential elements of consent, instructions for use, the California Subjects Bill of Rights, conflict of interest requirements, considerations for long term specimen use and other institutional requirements. Read more about Informed Consent.
               3. Information Sheet for Exempt Studies
                  This document should be used for exempt research only.
               4. Assent Form Template – Child/Youth (7-13 Years)
            GDPR Addendum

            • GDPR Addendum to Consent | for USC studies complying with GDPR. Learn more about the GDPR regulations governing data obtained from Europe/European Economic Area (EEA) or on behalf of organizations based in the EEA.
            National Cancer Institute (NCI) / Central Institutional Review Board (CIRB) USC Required Informed Consent Language and Spanish Translation

            • USC IRB SOP for NCI CIRB Consent
            • USC Required Language for NCI CIRB Consent
            • Certificate of Spanish Translation for USC Required Language for NCI CIRB Consent
            • USC IRB Boilerplate Language (English) 
            • USC IRB Boilerplate Language (Spanish) | Spanish CoT 
            Translation Services

            It is the responsibility of the investigator or study sponsor to provide translation of an IRB approved Informed Consent Form (ICF). For studies that are greater than minimal risk (Full Board), one of the following is required a) A Certificate of Translation (CoT) by a professional certified translator/translation company, or b) documentation that the translation has undergone quality review by an entity such as an NIH Regulatory Support Center or the NIH Translation Unit. The translated ICF and appropriate documentation must be sent to the IRB via “Send Message to IRB.” The translated consent form with IRB stamp will be uploaded into the iStar application. Investigators will receive email notification that the translated consent form is ready for use. A letter of IRB approval will not be issued for the translated consent document.
            Minimal risk studies (Exempt or Expedited) do not require a CoT to be submitted.

            USC has approved suppliers/vendors (translation services) listed in eMarket at https://kuali.usc.edu/usc-emarket-login-and-information/
            For assistance call: (213) 740-5857

   Drafting a Consent Form

   • Lay Terms for Use in Consent
   • Description and Risks of Common Medical Procedures
   Short Form Consent Templates

   • Consent and Short Forms: Who Must Sign?
   • Short Form Certificate of Translation (CoT)
   • Bill of Rights Certificate of Translation (CoT)

   Amharic CA Bill of Rights – Amharic	Arabic CA Bill of Rights- Arabic
   Armenian CA Bill of Rights- Armenian	Bengali CA Bill of Rights- Bengali Bengali CoT
   Cambodian CA Bill of Rights- Cambodian	Chinese CA Bill of Rights- Chinese
   Dari CA Bill of Rights- Dari	English CA Bill of Rights- English
   Farsi CA Bill of Rights- Farsi	French CA Bill of Rights- French
   Greek CA Bill of Rights- Greek	Hebrew CA Bill of Rights- Hebrew
   Hindi CA Bill of Rights- Hindi	Indonesian CA Bill of Rights- Indonesian
   Japanese CA Bill of Rights- Japanese	Korean CA Bill of Rights- Korean
   Romanian CA Bill of Rights- Romanian	Russian CA Bill of Rights- Russian
   Spanish CA Bill of Rights- Spanish Spanish CoT	Tagalog CA Bill of Rights- Tagalog
   Thai CA Bill of Rights- Thai	Vietnamese CA Bill of Rights- Vietnamese

HIPAA Research Authorization

The following can be found on the Office of Ethics and Compliance website:

HIPAA Privacy Rule: Forms and Other Resources

• HIPAA Research Authorization Forms (English and translations)
• Instructions for completing HIPAA Research Authorization
• Data Use Agreement for receipt of a limited data set
• Request form for Decedents Protected Health Information
• Authorization to Use Protected Health Information for Education and Instruction
• Request for Protected Health Information for Preparatory Research Activities – Certification
• FWA & IRB Registration Numbers
• USC HIPAA Policy

Other IRB Forms and Templates

• • Biomedical IRB Authorization Agreement
  • Social Behavioral IRB Authorization Agreement
  • NIH Budget Form
  • Required Documents for Research with Other Sites
  • Research Advisory Panel of California
  • Research Site Permission Template
  • Waiver of Full-Time Faculty Status to Serve as Advisor for Research Proposal
  • Right to Try Informed Consent Template
  • Right to Try Checklist

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.

Ancillary Committees

Clinical Trials Unit at USC
Ancillary Research Committees

LAC+USC Healthcare Network Forms

Lab Utilization Worksheet

Investigator Initiated Studies (Drug or Device)

Sponsor Investigator Agreement