Phase 1 Progress Update & Preparing for Phase 3

Phases 1 and 2 of the HRPP Alignment have launched successfully, marking progress toward a unified Human Research Protection Program across Brown University, Brown University Health, and Care New England.

Phase 1 established a shared HRPP structure and introduced a unified IRB review model, including the first full-committee reviews of the combined research portfolio.

Phase 2 introduced revised Huron SmartForms, implementation of the Huron registration process, and the transition of Care New England to the Brown Huron Toolkit.

The HRPP Support Hub for Information and Planning (SHIP) is now live, providing centralized guidance, consultation, and planning support for IRB processes and human subjects research.

Both IRBNet and Huron remain active during this transition. One IRB panel is now reviewing in Huron, while three continue in IRBNet, with HRPP triaging submissions between systems.

This dual-system period will end with Phase 3, when all IRB panels transition fully into Huron IRB following data migration in May 2026.

Phase 1 – Live (January 2026)

• Unified HRPP structure implemented
• Four-panel IRB system launched
• Centralized review, training, and support established

Phase 2 – Live (March 2026)

• Revised SmartForms launched in Huron
• Huron user registration implemented
• CNE transition to Brown Huron Toolkit
• Training and onboarding expanded

Phase 3 – Upcoming (May 2026)

• New studies begin in Huron IRB
• IRBNet closes to new submissions in early May
• Active studies migrate into Huron IRB
• All research managed in a single system

Single IRB (sIRB) Updates

Since January 6, 2026, new studies involving reliance between Brown University, Brown University Health, and/or Care New England have been using a single IRB submission for all BIRCH sites. Reliance agreements are executed administratively through the reviewing site using their standard processes, and no separate submission to the relying site(s) is required.

Example:

A Brown University investigator submits a new study in Huron that will involve reliance with Brown University Health. The study is reviewed and approved in a single submission. After approval, the investigator submits a modification in Huron and uploads the typically required documents and the HRP-899 Reliance Cover Page to request enactment of the reliance agreement. HRPP executes the reliance agreement administratively, and no separate submission to Brown University Health IRBNet is required.

Beginning April 1, 2026, we will be taking steps to streamline oversight of studies with existing reliance agreements between our affiliated sites by administratively closing the study submissions of the relying sites. This will allow existing reliance agreements to operate using the single submission procedures already adopted for new reliance admissions. Additionally, by having one study record for our affiliated reliance agreements, we eliminate duplicate record migration.

The reliance agreement will remain active and the research will remain open and under the oversight of the Reviewing Site. All subsequent reviews relative to each study including site-specific submissions (i.e. modifications to research procedures, updates to key study personnel, required reporting) will be submitted through the reviewing site using standard procedures for that system.

Example:

A study being reviewed at Brown University as the reviewing IRB with a collaborating PI at Butler Hospital and Women and Infants Hospital will remain active and under the oversight of Brown University in Huron. The study records at both Butler Hospital and Women and Infants Hospital will be closed in IRBNet with documentation that the research remains active at the Reviewing Site. 

This approach:

• Reduces duplicative submissions and administrative burden
• Improves consistency in review and communication
• Supports efficient study start up for collaborative research
• Clarifies roles and responsibilities across institutions

Beginning April 8, 2026, all registered users may submit new reliance (sIRB) submissions directly in Huron.

This change helps avoid duplication of effort for studies not yet approved through migration and supports a smoother transition to the unified system.

Guidance is available on Brown University’s Submit Your Research Study webpage under How to Manage Submissions in Huron.

Questions about sIRB review may be directed to reliance@brown.edu.

Revised SmartForms in Huron IRB

Revised SmartForms have been released in Huron IRB to support the aligned HRPP structure and review processes. These forms are available only in Huron and only to current Huron users. The updates are designed to streamline submissions and ensure consistency across all three institutions.

To understand what has changed in the SmartForms, please review the training on the Training page:  What’s New in Huron IRB for Returning Users

Impact: Revising the forms was necessary to support alignment within a single submission system. Launching them ahead of full data migration allows new projects to be directed into Huron IRB before go-live, avoiding any blackout period for new submissions.

Early Huron Registration

Early registration for Huron opened during Phase 2, allowing individuals who do not currently have access—but will need it—to register in advance.

All personnel engaged in human subjects research must have a Huron account to be added to the Personnel List in the Basic Information Form. Inclusion on this list is required to access a project in Huron. This differs from IRBNet, where personnel were granted access through application sharing.

To support a smooth transition, personnel on active IRBNet studies will be pre-loaded into Huron. Individuals will appear in the system; however, registration may still be required to activate access.  If you do not need Huron access, no action is required.

Access guidance:

• Brown credentials only: No registration needed; you already have access to Huron IRB.
• Brown + health system credentials: Register using your health system credentials to link them to your Brown account. You may then use either login going forward.
• Health system credentials only: Register using these credentials to activate your account and link to your pre-loaded profile. After migration, your active projects will be visible in Huron.
• Guest users (no credentials): Additional registration steps will be required.
• Note: If you have multiple health system credentials and would like them linked, each credential must be registered individually.

Use the Huron Access and Registration page to register or request access.

CNE Only: If you receive a 403 error when logging in with your CNE credentials, contact the CNE Helpdesk or submit a support ticket to CNE and request that the Cirrus Proxy application be approved for your profile.

Impact: All users without Brown credentials who require access to Huron must register. Launching registration now provides ample time to complete this process and prepare to work in Huron IRB.

CNE Toolkit Transition - In Progress

The transition of the Care New England research community to the Brown University Human Research Protection Program (HRPP) Toolkit is now underway. This milestone brings HRPP administrators, IRB members, and researchers under a shared set of materials, supporting a more efficient, consistent, and aligned review process across the research community.

All Toolkit materials are available on the Brown HRPP website within the HRPP Toolkit. Training to support this transition can be found in the Education Center, including a dedicated course on transitioning to the Toolkit and a crosswalk mapping former CNE IRB materials to the Brown Huron Toolkit. HRPP has also created a living Frequently Asked Questions (FAQ) located in the Education Center to support researchers in this transition. 

Transition Timeline

• March 30 – Transition Begins
  • Huron forms and templates should be used for all new submissions in IRBNet.
  • This marks the start of a five-week transition period.
  • Former CNE forms and templates will remain in the IRBNet library for reference only.
  • These documents will be labeled “Do Not Use” beginning March 30 to avoid confusion.
• During the Transition Period (March 30 – May 4)
  • HRPP will accept former CNE submission forms only for studies that were already in progress prior to March 30.
• May 4 – Compliance Date
  • Only Huron forms and templates will be accepted.
  • Submissions using former CNE forms on or after this date will be returned for correction.
  • Former CNE forms and templates will be removed from the IRBNet library.
  • Toolkit materials become the standard for all submissions.

What This Means for CNE Researchers

While the Toolkit replaces all IRB materials (SOPs, checklists etc), the impact of the transition is primarily limited to submission forms and templates.

• New research submissions created on or after March 30 must use the Toolkit forms and templates.
• Active studies will generally only be affected when new submission forms are required (such as for modifications or continuing review). Active research does not need to convert to any Toolkit documents post-March 30.

The Toolkit is designed to streamline submissions, resulting in fewer forms and clearer guidance for researchers.

Phase 3 is the final step in the HRPP alignment, marking the move to one centralized system for managing all active human subjects research. During this phase, all active exempt, expedited, and full committee studies from BUH and CNE currently in IRBNet are migrated into Huron IRB.

This phase has the largest impact on the research community and requires careful preparation. Brown has been working to correctly map IRBNet project data to comparable fields in Huron IRB. Because mappings are not always one-to-one, sequential testing ensures accuracy. The result is that project-level data from IRBNet—including project title, PI name, initial approval date, personnel lists, and other key fields—is pre-populated in Huron IRB, reducing manual entry for HRPP and research staff.

Deadlines

• April 20, 2026: No new project submissions in IRBNet.
• May 4, 2026: IRBNet enters transition blackout period; historical data still viewable.
• Around May 13, 2026: Final data pull from IRBNet—any edits after this will not appear in Huron IRB.
• May 21, 2026 - Go live

Studies Approaching Expiration – Full Committee Review

This section is applicable to studies expiring on or before July 31, 2026 that are expected to require Full Committee continuing review. 

This generally includes studies that are:

• Greater than minimal risk
• Open to enrollment, or
• Closed to enrollment but with ongoing participant involvement

Submission Guidance

Due to the upcoming Huron IRB migration (May 2026), continuing reviews should be submitted in IRBNet as soon as possible and no later than April 24, 2026 to ensure review prior to migration. Submissions will be prioritized and may be scheduled for a special meeting.

Please submit continuing reviews separately from modifications.

Submitting New Projects in Huron IRB

New projects take the longest to move from submission to approval. To streamline this, new projects are accepted in Huron IRB immediately. During this transition, the highest priority is:

• New research requiring Full Committee review, and
• New research relying on a Single IRB (sIRB).

Full Committee review generally applies to studies with greater than minimal risk, or research involving vulnerable populations or sensitive data. Single IRB studies involve multi-site coordination and additional reliance processes, which require extra time to establish.

New project submissions in IRBNet are not permitted on or after April 20, allowing sufficient time for these studies to complete review before migration. Any new research still in progress at the time of migration must be manually re-entered into Huron IRB.

Access to Huron IRB requires Brown credentials or registration using health system credentials. Only team members who need access must register. [Link to registration guidance]

Which Studies Will Be Migrated

Only active projects will be migrated. “Active” refers to studies that have received a final outcome of Approved (or Site Activation for single IRB studies). Any projects that have not reached this status when data is pulled from IRBNet will not be migrated and must be manually entered into Huron after go-live.

What Will Be Migrated

Studies will be imported into Huron IRB as project shells with limited project-level data, examples including:

• Study title
• Principal Investigator (PI)
• Protocol number
• Initial approval date
• Expiration date (if applicable)
• Level of review/risk category
• Basic study identifiers

A list of project information that will be imported in Huron is available in the HRPP Alignment Education Center. 

What Will Not Be Migrated

Due to system limitations, the following cannot be migrated:

• Project history (e.g., modifications, continuing reviews, reportable information)
• Reviewer comments or determinations
• Study documents (e.g., protocols, consent forms, recruitment materials)

Modifications and RNI submissions may continue to be submitted in IRBNet until May 6, when the system transition blackout period is anticipated to begin. All historical records will remain in IRBNet, which will continue to be available for reference and audit purposes.

PI Proxy Designation for Huron IRB

As part of preparation for the transition to Huron IRB, Principal Investigators with active studies in IRBNet at Brown University Health (BUH) and Care New England (CNE) are asked to identify one or more PI Proxies for their projects.

Why This Matters

Huron IRB manages submissions differently from IRBNet. While any study team member listed on a project may create and edit submissions, only the Principal Investigator (PI) or a designated PI Proxy can formally submit items to the IRB.

Designating a PI Proxy allows trusted members of the study team to assist with submissions and helps ensure continuity if the PI is unavailable.

Supporting the Migration to Huron

As part of the Phase 3 data migration, study personnel from IRBNet will be preloaded into Huron IRB. To support a smooth transition, the Brown Data Conversion team can also pre-load designated PI Proxies into projects during migration, allowing them to assist with the initial Population modification and future submissions once the system goes live.

How to Designate a Proxy

Complete the PI Proxy Designation Form for each project by May 1, 2026.

Huron IRB: PI Proxy Designation Form (Qualtrics Form)

For investigators with a large number of active studies, proxy designations may also be submitted via spreadsheet by emailing irb@brown.edu. Please include the PI name, project title, and designated proxy(ies) for each study.

Key Points

• The designated proxy must already be listed as an active study team member in IRBNet.
• Anyone on the study team may complete the form on behalf of the PI.
• Individuals who need access to Huron IRB must have a registered Huron account.
• Additional proxies can be added or updated after migration by the PI or any assigned proxy within Huron IRB.

Identifying proxies in advance will help ensure a smooth transition and minimize delays when submitting updates or new materials in Huron IRB.

Research Team Actions After Go-Live

After migration to Huron IRB, research teams play a critical role in ensuring that project information and documents are accurate and complete. The following steps outline the key actions required to finalize project records, maintain compliance, and prepare studies for ongoing management in the new system. Completing these steps correctly ensures a smooth transition and prevents delays in approvals or project closure.

Upload Active Study Documents

• Only current, active documents—no historical or superseded files.
• See [Population Modification Guidance] for what to upload.

Make Administrative Edits Only

• Change personnel, IRB contact info, or other administrative fields.
• All other research-related edits must wait until the Population Modification is approved.

Review Project Data

• Confirm all project information in Huron is accurate.
• No submissions accepted until Population Modification is submitted and acknowledged.

Timing for Less Active Projects

• Wait 30–60 days before populating records if research is less active.
• HRPP will notify if earlier submissions are possible.

Closing Projects Without Edits

• If no edits are needed, document upload is not required.
• Complete blank questions in the Basic Information form to close the project.

Submission Authority

• Only PIs and designated PI proxies can submit.
• Both are preloaded to support initial project setup.

Institutional Review Board (IRB) Structure and Meeting Schedule

A single, flexible IRB roster will support four dedicated panels. These panels will meet once per month, on the first, second, third, and fourth weeks.  All meetings are set for Wednesdays or Thursdays between 12:00 PM and 2:00 PM.

The panels will feature a generalist composition, ensuring the combined roster reflects the full range of research in our current portfolio.

Specifically, each panel will include the necessary mix of scientists and non-scientists, affiliated and unaffiliated members as mandated by federal regulations. To maximize review capability, panels will also combine diverse experience, including:

• Biomedical and social-behavioral expertise
• Reviewers experienced in pediatric and pregnancy research
• Experience in oncology and other specialties
• A variety of academic degrees (MD, PhD, Pharm D, BS, BA, etc.)
• Mixed representation from all institutions affiliated with this project.

This comprehensive approach guarantees that any new research can be competently reviewed by any of the four panels, creating the most flexible and optimal model for our organizations.

Each panel will be led by a Chair and Vice Chair, consistent with common practice. Additionally, an Executive Chair will focus on administrative oversight, process coordination, and strategic planning across all panels.

These nine individuals will form the leadership team, working collaboratively as equal members fully engaged in policy discussions, planning, and decision-making.

2026 Meeting Schedule

Important Note on Data Transfer Agreements

While HRPP operations are aligning across the three institutions, data transfer agreements and related policies remain institution specific and unchanged. Researchers should continue to follow their home institution’s established processes for data sharing and transfer. Aligning data related processes remains a longer term goal to support streamlined research collaboration.

A comprehensive, institution specific training and support plan is in place to prepare researchers, study teams, and IRB members for the Huron IRB transition.

Support includes:

• HRPP Toolkit orientation materials
• Role based Huron training
• Live sessions, office hours, and one on one assistance

Links to training materials can be accessed here:

Access training materials

Throughout this process, the Brown HRPP is committed to providing comprehensive support:

• Dedicated Transition Help Desk
• Live Chat and Email Support
• 1-on-1 Assistance by Appointment

Links to support resources will be published as soon as they are available. Please don’t hesitate to reach out to the HRPP with any questions or concerns at irb@brown.edu.

Stay Informed

The Brown HRPP will continue to share updates via email, this webpage, the HRPP Insider newsletter, and through department administrators. Please check back regularly for new information, FAQs, and additional resources.

Register for CREW: Collaborative Research Engagement Workgroup

The Collaborative Research Engagement Workgroup (CREW) is a monthly virtual meeting hosted by the HRPP to foster engagement and collaboration with the research community. CREW provides a forum for researchers, staff, and stakeholders to share updates, discuss best practices, and address questions or challenges related to human research protections. These sessions are open to all members of the research community and are designed to encourage dialogue, provide timely updates, and strengthen connections across institutions.

CREW meets monthly on the second Thursday of the month from 2-3 p.m. (new time). Register via Zoom meeting link.

REGISTER TO RECEIVE CALENDAR INVITES

Thank You for Attending the HRPP Town Halls

Thank you to everyone who joined the December HRPP Town Halls. We appreciate your engagement and thoughtful questions as we shared updates on ongoing progress and the planned HRPP alignment in January 2026.

For those who were unable to attend or would like a refresher, the final Town Hall was recorded and is available here: 

HRPP Town Hall Zoom Recording

Thank you for your cooperation and engagement during this transition. This move will enhance our ability to support ethical, efficient, and collaborative research across all institutions.