Health Insurance Portability and Accountability Act (HIPAA)-compliant authorization addendum. In California, study subjects are required to sign a separate HIPAA-compliant authorization addendum unless a HIPAA waiver is requested and granted. The most recent version can be obtained from the IRB website (http://www.usc.edu/admin/oprs/hsirb/forms/).
Budget Detail. A budget page must be submitted for all funded proposals. However, individual salary information does not have to be included in the study budget. Budgets must be reviewed and approved by either the Health Research Association business office or USC Contracts and Grants. Proposals requesting funds from Health Research Association must also complete the Health Research Association research support information form.
IRB reviewer checklist/guidelines (Optional). This form lists all items required by the IRB for initial IRB review. It also lists other institutional committees who may need to review the study in addition to the IRB.
Recruitment materials (including brochures, flyers, advertisements, audio tapes, video tapes, or letters to potential subjects) that will be used to inform people about the study.
Questionnaires, survey instruments, stimuli, etc., that will be used in the study.
Investigational Drug or Device Brochure. If the study involves an investigational drug or device, a copy of the investigator's brochure must be provided. If the study involves an investigational drug, include documentation of the Investigational New Drug (IND) number from the sponsor (if not indicated on the investigator's brochure or protocol), or, in the case of investigator-held INDs, a copy of the FDA letter that informed the PI of the IND number.
Other Items. Phone and verbal scripts for situations that involve providing information to potential subjects via telephone or in person, as well as texts of emails or website postings.
13.2 Application Processing Screening IRB Applications and Investigator Responses All IRB applications and investigator responses are screened by IRB staff. If the application is incomplete it is returned to the investigator, and/or additional information is requested via iStar, phone or e-mail. Investigator responses are again reviewed by staff and if complete forwarded for full board review or expedited review. Once the complete application is submitted, it is assigned an IRB number. The IRB number remains with the
Chapter 13: The IRB Application and Forms USC HSPP Policies and Procedures
Page 179 of 369