NIH is the Lead Study Team and the NIH IRB is the Reviewing IRB (sIRB)

Confirm NIH IRB Use: If NIH is the lead institution, the NIH IRB will usually be the Reviewing IRB.

Consult with the NIH IRB Office if: 

• The new study includes 6 or more Participating Sites (pSites). 
• A proposed pSite is linked to the Department of Defense (DoD), another Federal agency, or is international. 
• An existing multi-site study plans to add 5 or more enrolling sites. 

Establish Safeguards:

To keep studies on track: 

• Secure regulatory support, like a Protocol Navigator or Study Coordinator. 
• Learn about the NIH IRB's submission requirements. 
• Decide if NIH will be the coordinating center. 

Develop a Communication Plan: Establish a plan for the setting up the study and for its duration, including site initiation meetings, conference calls, newsletters, email blasts, and training materials. 

Select pSites: Early in the planning, identify all external sites that will participate and rely on the NIH IRB. 

Engage with pSites: Confirm their willingness to rely on the NIH IRB and ensure they understand participation expectations. 

• Confirm the research locations. 
• Learn how they will implement the protocol. 
• Determine if the pSite team must get clearance from their IRB office before submitting to the NIH IRB. 

pSite Team: Identify a Site PI and a regulatory contact. 

• Educate them about the NIH IRB submission process. 
• Gauge their experience with HSR as well as their ability to handle IRB submissions and protocol implementation. 

Develop Protocol and Templates: As the lead team, create the protocol, NIH site documents, and templates that pSites will adapt, like consent forms and recruitment materials. 

Be clear about the intended use and purpose of documents: 

• Study-wide documents are used across all sites. 
• Templates are for each pSite to adapt. 
• Distinguish between documents used exclusively at the NIH site or a specific pSite. 

Protocol: Ensure it includes all information needed for NIH IRB review and approval. 

• Address NIH-specific procedures in an NIH Protocol Addendum or within the protocol. 
• Avoid specifics for pSites; include general descriptions instead. 

Model Documents: Scale content across sites and over the protocol's lifespan. 

• Harmonize content across sites to limit customizations. 
• Allow necessary customizations based on law or policy. 
• Be flexible where it makes sense. 
• Use the IRBO template to develop the Model Consent. 

Prepare the IRB application in PROTECT:

• Indicate the study is multi-site, with the NIH IRB as the Reviewing IRB.
• Upload model templates and NIH site-specific documents.
• Refer to the PROTECT NIH as the Single IRB of Record Guide for additional instructions.

pSite Onboarding:

• Add pSites after the protocol is complete and the Reliance Agreement is in place.

The NIH IRB reviews and approves the protocol and documents. Respond to requests for more information or revisions.

• Communicate with pSites: Keep pSites informed throughout the review process. Provide approved template documents and the pSite Protocol Addendum template so that the pSite can customize these documents.
• Request pSite PROTECT Account: Request PROTECT accounts for pSite PI and Study Coordinator so they can submit to the NIH IRB after the reliance is in place.

Submit the Reliance Request Form after the protocol is approved. Refer to the "Request a Reliance Agreement" page.

Overview:  

• When you go through the Initial Review, you need to get approval for the research protocol and the NIH Site. This review assumes that the pSite will follow the protocol exactly as described and will use the same methods as the NIH. 
• When the pSite is added, make sure to give the NIH IRB all the details they need to oversee the pSite properly. Important things to highlight include if the pSite will:
  • Not implement the research in the way described 
  • Implement it in a different way 
  • Do something in addition to what is approved in the protocol 

Process: 

• The pSite can be added to the NIH protocol after the study is approved and the reliance agreement is in place. 
• By this time, the pSite Principal Investigator (PI) must have a PROTECT account. If they don’t, refer to step 3 above for instructions. 
• The pSite dashboard must be in the "Awaiting Study Materials" state. This dashboard is set up by the Reliance Specialist after the reliance agreement is finalized and the pSite PI has an external PROTECT account. 

The pSite submission must provide Basic Site Information in PROTECT and supporting documents in the Local Site Documents section. These documents should include: 

• pSite Protocol Addendum (using the IRBO template) 
• pSite Recruitment materials (if applicable) 
• pSite Consents/Assents (if applicable) 
• pSite HRPP Clearance (via letter or email) 
  • pSite HRPP Clearance confirms that the pSite's institutional requirements are met and that the local context information is approved by the Relying Institution. This can be documented through a letter, email, memo, etc. A simple email from an appropriate person at the pSite to the NIH study team saying: "pSite confirms that the submission to the NIH IRB by our site meets pSite institutional requirements and that local context information provided is accurate," will suffice.  

The NIH study team should collaborate closely with the pSite study team to prepare the submission. Once ready, the NIH study team submits it in PROTECT. This step is only needed for the first submission; after that, the pSite can handle any modifications. 

• After submission, the NIH IRB will review and approve the pSite. The pSite will receive an approval letter once this is complete. 

You need to submit all modifications through PROTECT. The NIH study team must ensure that pSites know about and follow these changes.

Responsibilities of the NIH Study Team

1. Act as the main contact between the NIH IRB and pSites.
2. Submit all study-wide modifications, continuing reviews (CR), event reports (study-wide, NIH site, or pSite), and closures to the NIH IRB.
3. Communicate and plan with pSites ahead of time when study-wide changes need them to update their documents.
4. Consider the time needed to approve a study-wide amendment and the subsequent pSite amendments, including the time required for reconsenting (e.g., changes in consent forms)

Responsibilities of pSites

1. Submit site-specific modifications, provide CR information, site-specific event reports, and site-specific closures.
2. Ensure protocol compliance and safety monitoring.

Continuing Review

Coordinate CR submissions to the NIH IRB and gather necessary information from pSites. PROTECT lets pSites report their CR data, and the NIH team then submits a study-wide CR that includes all pSite data.

Reportable Events

• The NIH PI is responsible for making sure all reportable events are communicated to the NIH IRB. This includes overseeing reports from pSites.
• As a pSite PI, ensure that events at your site are reported to the NIH IRB. You may also need to report to your home institution.
• Any PROTECT user can submit RNI forms.

Closures

Only close a pSite when all closure criteria are met, including the analysis of identifiable data at the site. The overall study cannot close until all pSites are officially closed in PROTECT.

Monitoring and Reporting

Ensure that pSites follow the approved protocol and quickly report any deviations, adverse events, or unexpected problems to the NIH IRB.

Provide Training

Ensure that all pSite study teams are well-trained in human subject research (HSR), the study protocol, and their specific roles and responsibilities.

Support and Resources

Offer ongoing support to pSites, including guidance on regulatory requirements, protocol adherence, and reporting obligations.