2026-09-28 release notes (comprehensive editing; document and site investigator updates for life of study)

This latest patch marks the most significant update to the Reliance System since its launch in 2025. The changes focus on editing capabilities and directly respond to community feedback collected through our 2026 survey, help desk requests, and public programming.

The changes will benefit all system users by reducing duplicative work, making it easier to correct errors, and allowing key updates throughout the life of a study. This new functionality is now available for all new and existing reliance requests.

What’s New

• Expanded editing options: Edit site details at any point up until the site-specific reliance determination; relying institution personnel can edit their own site details.
• Update site personnel as needed: Site investigators and research personnel can be changed at any time, with automatically updated documentation and no need for countersignature.
• Ensure accurate study documents: Add/update study documents throughout the life of the study.

Editing Site Details: Longer Window and Expanded Edit-Access for Relying Institutions

Who this affects: Study teams, relying institution site admins, and research personnel

Site details can now be edited up until a reliance determination is reached between the institution and the reviewing IRB, allowing the correction of records before an arrangement is finalized.

In addition, once an institution is added to a request, that institution’s site admins can directly edit their site’s details, as can any listed research personnel (site investigator, regulatory coordinator, study coordinator, etc.,). For site admins, this means that if you find something is incorrect, you can simply revise and save, and cede review (confirm your institution’s reliance) once the request is ready.

Previously: Only the study team could edit site details, and the editing function was limited to early request states (“Draft” through “Under Review”). Because states apply to the whole request, rather than to individual sites, there was no option to edit site details for institutions added at a  later date.

Updating Site Investigator(s) and Research Personnel (Updated PDFs; No Signature Required)

Who this affects: Study teams, relying institution site admins, and reviewing IRB staff

Study teams (and site admins) can edit, add, or remove the site investigators and research personnel on a reliance request at any time, so study teams can keep their records accurate. The one exception is the Overall PI field, which remains locked for now, but stay tuned for future improvements that will enable changes to the Overall PI! (Note that, per the SMART IRB Agreement, every site must still have a designated site investigator.)

The SMART IRB Agreement does not require that institutions re-execute reliance arrangements when a site investigator changes. If your institution’s policy calls for an arrangement that names the current site investigator, you can simply download the updated determination PDF from the reliance request. It automatically reflects the new site investigator, and the other party does not need to countersign. We hope this significantly reduces duplicative work.

Previously: Once research personnel were added, they could not be changed in later request states, causing problems when typos or personnel changes occurred.

Document Updates for the Life of the Study

Who this affects: Reviewing IRB staff and research personnel at the Overall PI’s home institution

You are no longer limited to the original consent form or protocol narrative uploaded with your initial reliance request. Reviewing IRB staff and research personnel at the Overall PI’s home institution can now update documents as needed throughout the study. In a future system update, we plan to add email notifications to inform relevant parties of any document updates.

Previously: Documents were locked once a request reached the “Eligible” state, so materials like the protocol narrative or consent form could be outdated by the time additional institutions were added.

Note on protocol narratives: The system currently allows up to two protocol narratives per request, though more consent forms and other documents can be uploaded. Would it help to have the option to upload more than two protocol narratives? We want to hear from you! Let us know at help@smartirb.org.

What’s Next

We’re always working on ways to improve the Reliance System and better meet the needs of the research community. Here is a preview of what we are working on:

• More Detailed Request History Log: Will record changes made in the system with greater granularity.
• Improved Site Removals and Request Withdrawals: Will allow removal of a site from a request at any point before a reliance determination is reached between the reviewing IRB and that institution; will allow complete withdrawal of a request at any time before reliance is reached between any two institutions.
• Overall PI Changes: Will allow changes to the Overall PI on a reliance request, the one role that remains locked in this patch.
• Document Update Notifications: Email notifications will be sent when a study document(s) is updated (e.g., consent form, protocol narrative, or other study document).
• And more!

Questions about any of the updates described above? Contact help@smartirb.org.

With thanks to the National Center for Advancing Translational Sciences (NCATS) Information Technology Resources Branch (ITRB) for its work continuing to improve the SMART IRB Reliance System.