Forms and Templates


Consent Templates

    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

Drafting a Consent Form


Short Form Consent Templates

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/

 


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

Other IRB Forms and Templates

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