IRB FAQs

1. Submit a ceded study application in iStar
2. Upload any reliance agreements, IRB approval letters, approved protocol, approved consent forms, and/or consent templates to section D1.2 of the iStar application.
3. 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.

1. Submit a ceded study application in iStar
2. Upload any reliance agreements, IRB approval letters, approved protocol, approved consent forms, and/or consent templates to section D1.2 of the iStar application.
3. 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.

No.

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”

Yes.

No, USC IRB does not serve as the reviewing IRB for multi-site DoD funded studies.

You should submit the iStar application first. The USC IRB will review information in the iStar application with the information included in the SMART IRB reliance request to ensure that the information is consistent.

The community organization needs to have IRB approval for their study activities. They will need to rely on the USC IRB for IRB review due to the federal funding. Please refer to the “USC IRB Serving as the Single IRB (sIRB)” for more information.

You 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.

If the study has federal funding and USC is the prime awardee, the USC IRB is willing to be the IRB of record. Please refer to the “USC IRB Serving as the Single IRB (sIRB)” for more information.

If the study does not have federal funding, each researcher should obtain IRB approval from their own institution.

You will need to submit the study to the USC IRB for review and after initial approval, add the other site via an amendment. Please refer to the “USC IRB Serving as the Single IRB (sIRB)” for more information.

You 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.

USC prefers to use SMART IRB reliance agreement as the basis of reliance for all studies where we serve as the sIRB. Any exceptions to using SMART IRB for the reliance agreement must be discussed with and approved by the USC IRB Reliance Team. Please contact the IRB Reliance Team at reliance@usc.edu.