NIH is a Participating Site Relying on an External IRB

A Reliance Agreement confirms that the NIH is using an external IRB to oversee NIH's research activities for a specific study. 

• To request a reliance agreement, you must first submit the Reliance Request Form found at the the Request a Reliance Agreement page. 
• After the reliance arrangement is documented, the Reliance Specialist will notify the NIH study team. 

Requirement: 

If you plan to use an external IRB for your NIH study, you must first go through an NIH Institutional Pre-Review by the NIH IRBO.

Purpose: 

The NIH will let an external IRB handle the review and approval of its research activities, but it still must make sure the research follows all relevant NIH policies. 

• This pre-review checks that all documents you will submit to the external IRB (like the protocol, consent forms, recruitment flyers, etc.) are accurate and meet NIH requirements. 
• This review is not the same as an IRB review. It doesn't try to question or redo the work of the reviewing IRB. 

The Institutional Review is a Two-Stage Clearance Process: 

1. Pre-Review: This happens before you submit your study to the external IRB. It gives you the go-ahead to submit to the external IRB for the first time and makes sure all your documents and requirements are in order. 
2. Post-Review: This happens after the external IRB has approved NIH as a study site. It confirms the external IRB approval of the NIH study site and allows your study to start at NIH. 

Submitting to IRBO:

The NIH Study Team needs to create and submit an External IRB Study in PROTECT to match what is sent to the external IRB. This helps track your research activities. 

You can find the PROTECT External IRB Guide in the Help Center tab of PROTECT. It will show you how to create and submit a study reviewed by an external IRB. 

Timing: 

You can submit the study at the same time as, or after, documenting the reliance arrangement in an agreement. Usually, you can't submit until the external IRB has approved the protocol and any model consents as you will use these documents to develop an NIH site protocol addendum and NIH site consent/assents. 

Ancillary Review: 

Make sure you complete all necessary ancillary reviews or IRBO will not be able to clear your submission. 

• Scientific Review
• DEC (Conflicts of Interest) if a covered protocol
• Radiation Safety Committee
• Institutional Biosafety Committee
• PRIA

Required Documents:  

• Sponsor/Core/Main protocol
• NIH Protocol Addendum
• Model/Master Consent(s) and Assent(s)
• NIH site specific Consent(s) and Assent(s)
• Recruitment Materials
• Investigator Brochure/package insert

Completion of the NIH IRBO Pre-Review:

IRBO reviews your submission and sends you a Clarification Request along with an NIH Institutional Review Memo. This memo is your clearance document to submit to the external IRB. 

Submission:  

The NIH Study Team needs to submit the Institutional Review Memo and NIH documents to the external IRB, asking to be added as a site to the multi-site protocol. 

Timing:  

Be sure to submit after the Reliance Agreement is in place with the external IRB and the pre-review is completed. 

Additional Information: 

Sometimes, the external IRB will ask for a Local Context Form or Conflicts of Interest disclosures. Try to complete the form and email it to the Reliance and sIRB team when you submit the NIH Institutional Review in PROTECT. The IRBO reviewer will help you complete the form and provide the necessary institutional information to the external IRB.

Approval:  

The external IRB will review and approve NIH as a site. 

The NIH Study Team needs to submit the approved documents and corresponding IRB approvals back into PROTECT so that NIH IRBO can conduct a post-review.

The submission usually includes: 

• External IRB’s approval letter(s) for all documents uploaded in PROTECT 
• External IRB’s risk determination for the protocol (except WCG IRB). If not included in the IRB approval letter, please provide other documentation. 
• Sponsor/ Core/ Main Protocol
• Model/ Master/ Consent(s)/ Assent(s) if NIH is the lead site
• NIH Protocol Addendum
• NIH site-specific Consent(s)/ Assent(s)
• Recruitment Materials
• Investigator Brochure/package insert if updated

When completed, IRBO issues an Acknowledgment Letter to mark the conclusion of the post review, and this activates the NIH as a site.

The NIH site is activated once it has the external IRB's approval and the NIH IRBO's acknowledgment. However, you usually need to complete some Clinical Center requirements before the study can open at the NIH site.

Requirement:  

The NIH Study Team needs to maintain the external IRB Study in PROTECT for as long as their study team's research is overseen by an external IRB. 

Purpose:  

This helps both the NIH study team and the IRBO office comply with regulatory and institutional requirements.  

• It allows NIH IRBO to: 
  • Confirm ongoing external IRB approval of NIH's research activities 
  • Conduct administrative reviews of study actions, such as modifications and continuing reviews 
  • Review NIH study team changes 
• It helps the NIH team: 
  • Inform IRBO about any NIH Study Team changes 
  • Report any changes to the research that might impact the terms of the Reliance Agreement 
  • Notify IRBO when the study has closed (either the overall study or at the NIH site) 
  • Maintain the currently approved versions of key study documents (e.g., protocol, NIH consents) and all corresponding external IRB approvals in PROTECT 

Required Submissions:  

All Modifications, Continuing Reviews, and Closures must be submitted through PROTECT to IRBO for an administrative review. 

Process:  

Submit to IRBO after the external IRB has approved an action. Each submission must include an external IRB Letter (except for non-PI personnel changes) so that NIH IRBO can confirm that the changes are approved. You can find the instructions for submitting these actions for a study reviewed by an external IRB in the PROTECT External IRB Guide, located in the Help Center tab of PROTECT.