iStar Update on Protocol Use
As a part of our ongoing effort to increase efficiency, the quality of study protocol submissions, and to reduce review wait times, on December 4th the iStar platform removed prompts in sections 10, 11 and 12 from the application. Study teams are now be required to submit a fully developed protocol into iStar section 5.2.
For industry or multicenter studies, the sponsor’s protocol will suffice. For all other studies, researchers will be required to submit a protocol based on one of USC’s template protocols, available on the IRB/OPRS website under the “Most Used Documents” banner on the right hand side of the home page, underneath the “Current Wait Time” banner. The appropriate template must be used. For Biomedical IRB submissions, use the Biomedical Investigator Initiated Protocol Template. For Social Behavioral IRB submissions, use the Social Behavioral Protocol Template. For Chart Review applications, please utilize the Chart Review Template Protocol. If you are not sure which IRB you should be submitting to, please review the OPRS/IRB website (biomedical or social behavioral) or contact us at irb@usc.edu. If you are also submitting to the USC Cancer Center, please use the CISO template available through their website (https://uscnorris.com/core/ciso/CIR.aspx). Grant applications and protocols from grant submissions will no longer be accepted in lieu of a fully developed protocol using the appropriate IRB template.
Any study already in queue will be grandfathered in and reviewed as is. A grace period (December 5 – December 31st) will be observed for new submissions. As of January 1, 2021, all applications submitted without a fully developed protocol using the appropriate IRB template will be returned without review with a request to submit a fully developed protocol into section 5.2.