When UCSF Can Serve as IRB of Record

Federally funded studies at grant stage

As part of the revised Common Rule and the NIH Single IRB (sIRB) policy, all domestic multi-site research studies are generally required to use a single IRB. Before submitting your proposal, consult with the UCSF IRB to determine which institution should serve as the IRB of Record.
 
  • Please complete the Single IRB consultation form as soon as possible and email it to [email protected]. The UCSF IRB will contact you to schedule a consultation. 
  • During the consultation, you will discuss your study and determine the appropriate IRB of Record. After the call, you will receive the information needed for your grant application or instructions on how to proceed if another IRB will serve as the reviewing IRB.

Examples of common federal funding agencies that require a single IRB include the NIH (all institutes), DoD, DoJ, AHRQ, CDC, and others.

All other studies

If you would like UCSF to serve as the IRB of Record for a site participating in your study, please complete this Reliance request form.

To help avoid delays and streamline the IRB review process, we ask that you submit this form, whenever possible, before submitting your initial review application or modification to the UCSF IRB.

After the UCSF IRB receives your Reliance request form, you will receive further instructions.

Considerations for serving as the IRB of record

When agreeing to serve as the IRB record, UCSF will review the study for all sites that are engaged in research. UCSF generally does not provide IRB review for sites that do not meet the federal engagement criteria, even when the site’s local policies are more restrictive than federal requirements.

The UCSF IRB uses IREx to coordinate with external sites. Relying sites will be asked to obtain an IREx account.

All relying sites must obtain any and all applicable local ancillary committee approvals (for example, Radiation Safety Committee). The UCSF IRB will not conduct the IRB review for sites that cannot secure ancillary committee reviews. The UCSF HRPP is unable to facilitate any such reviews

Resources

  • Reliance request form - This form is used when a study team would like to request that a collaborating site(s) use the UCSF IRB as its IRB of Record. 
  • Single IRB consultation form - This form is used for federally funded studies at grant stage. 

 

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