sIRB Alliance at NYU School of Medicine | NYU Langone Health

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sIRB Alliance at NYU School of Medicine

Through consensus building, the sIRB Alliance has standardized the sIRB review process for NIH-funded multisite studies.

In response to a National Institutes of Health (NIH) policy that proposed the use of a single institutional review board, or sIRB, for multisite research, NYU Langone’s Institutional Review Board (IRB) Operations and Clinical and Translational Science Institute developed the sIRB Alliance at NYU School of Medicine.

Launched in 2018, our alliance aims to establish consensus on standardization of relevant policies, procedures, and information technology to support broad adoption of the NIH sIRB model.

Our members include more than 100 research institutions, some funded by the NIH Clinical and Translational Science Award (CTSA) Program, and Huron Consulting Group.

Through structured surveys, working group teleconferences, and consensus meetings, the sIRB Alliance at NYU School of Medicine has been working on standardized sIRB best practices intended to guide administrative processes for sIRB review of NIH-funded multisite clinical studies. Having a standard approach for review also facilitates efficient and effective communication between institutions participating in the sIRB model.

Implementation of these best practices and information technology solutions will reduce variations in sIRB review and enable institutions across the country to carry out the NIH’s vision for a streamlined sIRB model.

sIRB Alliance Background

In January 2018, the NIH implemented a policy on the use of a single institutional review board for multisite research. The policy proposes an sIRB model for NIH-funded multisite clinical studies to improve efficiency of the ethical and regulatory review process and enhance protection for human subjects research.

The NIH’s sIRB policy aims to eliminate duplicative IRB review processes for multisite research. However, standardizing the review of study documents, addressing oversight of local context issues, and exchanging data across electronic study submission platforms pose challenges.

The solution proposed by the sIRB Alliance at NYU School of Medicine is intended to unify the sIRB process so institutions can more efficiently fulfill the NIH’s policy. By implementing an easy-to-use, standardized process, investigators can follow the same process regardless of the participating site, saving them time and eliminating the hassle of relearning the process.

Our work is supported in part by the NIH National Center for Advancing Translational Sciences, which provided an administrative supplement to the CTSA grant (UL1 TR 001445) held by the Clinical and Translational Science Institute at NYU School of Medicine.

Objectives and Approaches of the CTSA Supplemental Grant

The following objectives were established to overcome challenges to standardization:

  • establish a consensus for best practices for standardized administrative oversight of local context issues during initial and continuing review in the sIRB model—in both sIRB and participating site contexts
  • test whether a cloud-based messaging and data management system (sIRB cloud exchange) can implement best practices for the initial and continuing review of local context issues in the sIRB model
  • test whether an open-source platform based on the sIRB cloud exchange technology’s application programming interface (API) can implement best practices for participating sites in a network of non-CTSA research institutions

To reach a consensus on a unified sIRB model, the sIRB Alliance at NYU School of Medicine engaged CTSA and non-CTSA stakeholders through a structured survey, working groups, and consensus meetings.

Survey Results

We distributed a survey based on existing published information on evaluation of local context issues to stakeholders at research network partners, CTSA institutions, Huron Consulting Group clients, and other non-CTSA institutions.

The survey was designed to collect data on characteristics of the institution, IRB staffing and review volume, current local IRB data management practices, existing resources for the sIRB model, willingness to adapt current institutional policies and procedures to the sIRB model, and prioritization of the local context issues.

View the survey results with summarized responses and statistics.

System Solution

The sIRB Alliance is committed to finding an agnostic system solution that allows discrete electronic IRB systems to effectively communicate and exchange information within the sIRB review model. We are working with technology leaders Huron Consulting Group and the IRB Reliance Exchange (IREx) to find a solution.

Huron IRB Exchange

Huron IRB Exchange is a cloud-based service designed to facilitate the sharing of information between sIRBs and participating sites. This highly reliable service offers monitoring 24 hours a day, 7 days a week to minimize the impact on institutional information technology resources. Using the Huron IRB Exchange allows institutions to avoid the troublesome task of provisioning user accounts for each of the participating sites.

Huron IRB Exchange software also includes several layers of APIs, including a web services API and a software development kit, enabling organizations not on Huron’s upgradeable software solution to access the sIRB cloud exchange.

To see a video with more details about Huron’s information technology infrastructure, see the Huron IRB Exchange website.

IRB Reliance Exchange

Supported by the Trial Innovation Center created by Duke Clinical Research Institute and Vanderbilt University Medical Center, IREx is available to help IRBs and institutions, coordinating centers, and study teams in the United States implement sIRB review for their multisite studies.

The IREx web-based portal is a tool that can be used to support the reliance process and exchange of information throughout the life of a study from initial IRB approval to study close.

After identifying a reviewing IRB, IREx can help investigators with the following:

  • document and track reliance arrangements between Federalwide Assurance holders and component sites
  • track participating site progress toward initial IRB approval
  • streamline and centralize the capture of participating sites’ local considerations on a study-by-study basis
  • centrally manage participating site approval documents from initial approval through study close
  • facilitate communications to participating sites when actions are required
  • automate notifications to participating sites of new approvals and upcoming continuing reviews