General FAQs
No. USC is not supervising your research and you do not need to submit to USC IRB. You may need site permission from the specific department on campus if you are targeting specific students. Please reach out to that department.
For any exempt and expedited studies the study team can translate any document for the study.
For full board studies (Greater than Minimal Risk) the consent must be translated by a certified translator. Please also submit the ‘official’ certificate of translation.
If the investigator determines that study team member is able to translate recruitment documents/questionnaires/surveys etc that is allowable, even for full board studies.
In all cases all study documents must be reviewed by the IRB.
You do not need USC IRB approval to conduct the research since no faculty/students at USC are involved in conducting the research.
All investigators must use the approved ICF(s) posted in iStar. If you need help finding the approved ICF please reach out to the iStar team at istar@usc.edu. There is a specific button that says “Approved Documents.”
Multi-site Study FAQs
- Submit a ceded study application in iStar
- Upload any reliance agreements, IRB approval letters, approved protocol, approved consent forms, and/or consent templates to section D1.2 of the iStar application.
- If you will consent participants at USC, you will also need to create the USC consent by using the consent template from the other IRB, and adding USC required information using tracked changes within MS word. You will find the “Informed Consent Form Instructions for Industry Sponsored, Cooperative Group, or External IRB Studies” on the USC HRPP website.
- Submit a ceded study application in iStar
- Upload any reliance agreements, IRB approval letters, approved protocol, approved consent forms, and/or consent templates to section D1.2 of the iStar application.
- If you will consent participants at USC, you will also need to create the USC consent by using the consent template from the other IRB, and adding USC required information using tracked changes within MS word. You will find the “Informed Consent Form Instructions for Industry Sponsored, Cooperative Group, or External IRB Studies” on the USC HRPP website.
If there are no USC faculty, students or employees involved in conducting the research you do not need USC IRB approval.
No. If you are using equipment as a commercial service you do not need to go through the USC IRB and you do not need a reliance agreement between USC and your university.
Yes. If the study is funded by a subcontract from a grant, a USC faculty member will need to be designated as the USC PI, a ceded study application must be filled out in the USC iStar system and a reliance agreement will need to be made between the institutions.
If they are reliance documents, you may submit to the USC IRB via the Ceded application. The analyst will review the information you submit, and then return the application with feedback and ask for the the missing documents.
No, you have to obtain a CPHS IRB reliance agreement for USC to sign.
Yes. The USC faculty member will need to submit a ceded application via the iStar system. They will need the following documents from you: any reliance agreements from your IRB, IRB approval letters, approved protocol, approved consent forms, and/or consent templates to section D1.2 of the iStar application. If participants will be consented, you will also need to create the USC consent by using the consent template from the other IRB, and adding USC required information using tracked changes within MS word. You will find the “Informed Consent Form Instructions for Industry Sponsored, Cooperative Group, or External IRB Studies” on the USC HRPP website.
The USC IRB does not require a continuing review submission for ceded studies. You will need to submit a continuing review submission to the reviewing IRB.
There are no reliance agreements for exempt studies. However USC would like you to submit an exempt study application and please clearly state your role and activities in the application.
No, if USC is relying on another IRB the iStar application is the same. There is only a single choice within iStar.
For ceded studies please submit these documents (IRB approval, approved protocol, and informed consent). The USC IRB may not do the local context review without them. The reliance documents (IAA/reliance agreement and/or local context form) may be missing at initial review, but will be requested in the future.
Use the approved ICF and insert USC required language/information in track changes. You can find this under “forms and templates”, and chose: “Informed Consent Form Instructions for Industry Sponsored, Cooperative Group, or External IRB Studies”
Repository FAQs
Yes. In this case the IRB would like the investigator to consent the patients and let them know that a biorepository is going to be created. The patients (now research participants) would go through the informed consent process and it should be clarified what will be done with the tissue, how the tissue will be stored, any identifiers, and these samples/data will be shared in the future.
Maybe: If the specimens will be used to test a medical device you will need to submit an IRB application.
If the study’s collection of information and discarded specimens doesn’t affect the care of the patients and that the collection was going to be done regardless, and there are no identifiers, this is considered Not Human Subject Research and you do not need to go through the IRB. If you do, however, need IRB determination, you may submit to the iStar system and receive an official determination.
