• When to use this form?

Use this form to add a relying site to an IRB study. This is the only change that can be made via the Add Relying Site form.

• What is a “relying site”?

Relying sites are non-UCSF and non-UCSF-affiliated study sites that are seeking to rely on the UCSF IRB to serve as their “IRB of Record” in lieu of their own IRB or another non-UCSF IRB.

• Why was the Add Relying Site Form created?

This standalone form will help the IRB more efficiently triage this type of request to the correct review team.

• What information does the Add Relying Site Form require?

The form asks for the name(s) of the site(s) that are seeking to rely on the UCSF IRB, then prompts you to attach a revised IRB application and other relevant documentation as applicable.

• Can I still use the Modification Form to add relying sites?

No. Relying sites can only be added via the Add Relying Site Form.

• I need to add a relying site, and I also want to make other changes to my study (not related to the relying site). What should I do?

Use the Add Relying Site form to request the addition of the relying site, and use the Modification Form for the other changes.

CAUTION: Do not submit the two forms concurrently. You must choose which form to submit first, then wait for approval before submitting the next form. If you have any time-sensitive changes not related to adding a relying site that you plan to submit via Modification Form, you can ask your IRB analyst which to submit first.

• Are there prerequisites to submitting the Add Relying Site Form?

Yes. You must consult with the UCSF IRB and receive advance agreement before adding relying sites to a study. The UCSF IRB makes decisions about whether sites can rely on us on a case-by-case basis, depending on a number of factors.

• What changes have been made to the Modification Form?

New questions have been added about funding, study sites, Investigator Brochures & drug package inserts. Note: These questions only appear if applicable to your study.

Additionally, the form will no longer allow the addition of relying sites. That must be done via the Add Relying Site form.

• I don’t see the new questions. Where are they?

You will only see the new questions if you are starting a new Modification Form on/after today.

• I started a Modification Form prior to today and have not submitted it yet. Do I need to switch to the new form?

No. You do not need to update your draft Modification Form. The IRB will still accept Modification Forms that were created prior to today.

• What changes have been made to the IRB application?

The only section that has been updated is the “Outside Site Information” section. It now includes several new questions about non-UCSF and non-UCSF-affiliated sites. Note: This section will only appear if applicable to your study.

• I don’t see the new questions. Where are they?

You will only see the new questions if you are starting a new IRB application or if you update your application to add new outside sites. Otherwise, you will not see these questions in your application.

• Do I need to update my application because of this?

No. You do not need to take any action in response to this form update.