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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. Chart Review Protocol Template
         3. Social Behavioral Protocol Template

Consent Templates and Instructions

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
         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?
         • Certificate of Translation

         Currently the IRB Office pays for and facilitates the translation of Informed Consent Forms (ICF) into Spanish for specific types of research studies. In order to be consistent with the memo distributed by Randolph (Randy) Hall, Vice President of Research on May 22, 2018, the IRB Office will no longer provide this service as of January 1, 2020. Exceptions may be made for non-funded, non-industry sponsored, investigator initiated clinical trials that have undergone Scientific Review (USC or external).

         If the principal investigator believes the study meets the above criterion and Spanish translation of ICF is required, the application must include this information. The IRB will then determine whether it will provide the translation and communicate that information to the principal investigator (PI). If the IRB determines that the study does not qualify, it will be incumbent upon the PI to ensure the ICF is translated into Spanish and provide the IRB with a translated version.

         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

         Certificate of Translation (CoT) for Short Forms can be found here.

         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

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