The Online Reliance System allows submitters to add new sites to a reliance request after a reliance arrangement has been determined for the original request.
This article covers the following:
- Overview of the amendment process
- How to submit an amendment
- Information needed to submit amendment
- Which sites can be added through an amendment
Overview of the amendment process
Once a request has resulted in a reliance arrangement, the submitter (e.g., the overall PI or other study team member) of the original request may request to add additional sites to the reliance arrangement via an amendment process. Amendments are reviewed on a site-by-site basis. Site amendments can now process independently and concurrently, allowing each site to work at their own pace.
After the submitter completes and submits the site amendment form, the system notifies the Reliance Point of Contact (POC) and any Reliance POC Backup(s) for the new site, who are provided access to the request. The POC(s) for the new site are asked to review the amendment form, the original reliance request, and related supporting documentation, and to discuss any issues with the Reviewing IRB POC(s). The new site’s POC(s) will then indicate their site’s willingness to rely upon the Reviewing IRB for oversight of the research.
The Reviewing IRB POC will review the information for the new site and, if the site has indicated it would like to rely upon the Reviewing IRB, decide whether the Reviewing IRB will take on oversight of the research for this site. The Reviewing IRB POC will then issue a determination specific to the new site.
All parties involved in the amendment process will be notified at the appropriate points in time in the amendment process and provided with instructions for any actions that may be required.
How to submit amendment
The submitter (e.g., the overall PI or other study team member) of the original request may request to add additional sites to the reliance arrangement via an amendment process.
As the submitter of the request, you should navigate to the appropriate request. Click the “Add a Site” link directly above the Sites Involved visulizaion to begin:
Information needed to submit an amendment
You will be prompted to provide the following information about the new site:
- The Site Investigator’s name and contact information (required)
- Research activities and targeted subject populations at the new site (required)
- Research protocol for the new site (optional)
Which sites can be added through an amendment
The amendment process may be used to:
- Request to add a new site to an existing reliance arrangement
- Submit a new request for a non-relying site from the original request.
The submitter will be able to add any Participating Institution to the request through the amendment process, with the following exceptions:
- A site that was included in the original request and is already listed as a Relying Institution for that request.
- A site that is an independent IRB organization and therefore cannot be a site engaged in research.
- A site that is not yet listed in the Online Reliance System.