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Consent Templates

1. 1. Informed Consent Form Template – Biomedical Research/Industry Sponsor, Cooperative Group, or External IRB
      The IRB accepts all industry sponsored consent forms with minimal change in formatting. Industry consent forms need to only be modified to include the addition of USC specific requirements, such as local contact information, cost/injury payment language and removal of HIPAA. To facilitate review, submit an electronic version of the industry consent form and the version containing all USC specific modifications with all industry sponsored iStar submissions.
   2. Informed Consent Form Template
      Used 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
   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

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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 researchers to provide the IRB with translated versions of Spanish ICFs for all other studies.

The IRB will require a Certificate of Translation (CoT) to be submitted with all translated consent documents for studies that are determined to be greater than minimal risk (Full Board). The CoT must be uploaded into section 40.1. The IRB will not require a CoT, or a back translated consent, for minimal risk (expedited) studies.   However, funding agencies or study sponsors may require a CoT or back translation.

USC has approved suppliers/vendors listed in eMarket at https://kuali.usc.edu/usc-emarket-login-and-information/

Amharic CA Bill of Rights – Amharic	Arabic CA Bill of Rights- Arabic
Armenian CA Bill of Rights- Armenian	Bengali CA Bill of Rights- Bengali
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	Tagalog CA Bill of Rights- Tagalog
Thai CA Bill of Rights- Thai	Vietnamese CA Bill of Rights- Vietnamese

 

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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

See also

• FWA & IRB Registration Numbers
• USC HIPAA Policy

Other IRB Forms and Templates

• • IRB Authorization Agreement
  • NIH Budget Form
  • Protocol Template for an Investigator Initiated Study
  • Required Documents for Research with Other Sites
  • Research Advisory Panel of California
  • Research Site Permission Template

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