Single IRB

Investigators from Multiple U.S. Organizations Collaborate on First Embedded Pragmatic Clinical Trial Using National Health Plans’ Data

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CTTI Project: Electronic Healthcare Data

Today, at the ESC Congress 2020 – The Digital Experience, a group of U.S. investigators from several organizations announced their collaborative findings from the Implementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AFib), the first trial to use the U.S. Food and Drug Administration’s (FDA) FDA-Catalyst System network of electronic health data from a diverse group of national health plan data partners.

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CTTI to Support NIH Workgroup in Developing Evaluation Plan for Single IRB Policy

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CTTI Project: Single IRB

The National Institutes of Health (NIH) has selected the Clinical Trials Transformation Initiative (CTTI) to support a workgroup that will develop a comprehensive plan for assessing the NIH’s new single institutional review board (sIRB) policy. The policy, which became effective in January, requires U.S. sites participating in nonexempt multicenter human subjects research funded by the NIH to use a sIRB for ethical review, with the goal of improving the quality and efficiency of clinical research.

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Use of Central IRBs for Multi-center Clinical Trials

APRIL 25, 2012 TO APRIL 26, 2012

CTTI Project: Single IRB

Meeting Background:

The willingness of institutions to defer full local institutional review board (IRB) review and approval to a central IRB in multi-center trials continues to vary, despite a 2006 U.S. Food and Drug Administration (FDA) guidance and a more recent endorsement by the U.S. Office for Human Research Protections recommending this approach. The goal of the CTTI project is to identify potential solutions to address barriers to the adoption of central IRBs for multi-center clinical trials.

Meeting Objectives:

  • Present research findings from the CTTI project entitled, Use of Central IRBs for Multi-center Clinical Trials
  • Discuss research findings among experts present at the meeting
  • Solicit additional feedback to refine proposed solutions

Meeting Location:

Hilton Washington DC/Rockville Executive Meeting Center, Rockville, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

*The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Are You Ready for Mandated Single IRB Review for Multicenter Clinical Trials?

NOVEMBER 14, 2017

CTTI Project: Single IRB

Meeting Objectives:

  • Review upcoming NIH policy and Common Rule changes regarding single IRB review as well as existing FDA Guidance on Centralized IRB Review Process in Multicenter Clinical Trials.
  • Discuss the remaining gaps in knowledge, guidance and tools for implementing a single IRB review model.
  • Propose solutions regarding implementation of single IRB model for federally funded (e.g., NIH-sponsored), and for FDA-regulated drug and device, multicenter clinical studies.

Meeting Location:

DoubleTree by Hilton Hotel Silver Spring, 8727 Colesville Rd., Silver Spring, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

  1. Introduction to CTTI and the Single IRB Project by Sara Calvert
  2. NIH Single IRB Policy by Petrice Brown-Longenecker
  3. Changes to the Common Rule for Single IRB by Lyn Lau
  4. FDA Guidance on Centralized IRB Review Process in Multicenter Clinical Trials by Bridget Foltz
  5. Resources from the CTTI Single IRB Projects by Cynthia Hahn
  6. SMART IRB Platform Overview by Petra Kaufmann
  7. SMART IRB Exchange NIH Trial Innovation Network by Emily Serdoz
  8. AAHRPP Proposed Single IRB Review Standard by Robert Hood

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Advancing the Use of Central IRBs for Multi-center Clinical Trials in the United States

JUNE 12, 2014 TO JUNE 13, 2014

CTTI Project: Single IRB

Meeting Objectives:

  • Discuss practices, implementation strategies, and solicit additional suggestions for increasing the use of central IRBs for multi-center clinical trials
  • Present findings from the CTTI Central IRB Advancement project’s collection of IRB authorization agreements and standard operating procedures
  • Obtain additional feedback to refine proposed IAA template and tools

Meeting Location:

Hilton Washington DC/Rockville Executive Meeting Center, Rockville, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

DAY 1 – JUNE 12 , 2014

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Research Institution Perspectives on Advancing the Use of Central IRBs for Multi-center Clinical Trials in the United States

CTTI Project: Single IRB

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Webinar Presenters

  • Daniel Nelson, Director, Office of Human Research Ethics, University of North Carolina at Chapel Hill
  • Cynthia Hahn, VP, Clinical Research and Regulatory Affairs, North Shore-LIJ Health System

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Objective

To share experiences from two research institutions about implementation of a central IRB model for multi-center clinical trials

Webinar Agenda

  1. Results from a randomized, controlled trial of central versus local IRB review
  2. The institutional policy resulting from study results and a summary of conclusions that can be applied more broadly
  3. The continuing role of the institution in research compliance
  4. Examples from a research institution that serves as a central IRB and relies on commercial, academic, and federal external IRBs for multi-center clinical trials
  5. Questions and Discussion

CTTI Publication Explores Stakeholder Reflections on Implementing the National Institutes of Health’s Policy on Single Institutional Review Boards

Posted on by Hannah Faulkner

A new CTTI publication, published in the Journal of Ethics and Human Research, explores stakeholder reflections on implementing the National Institutes of Health’s policy on single Institutional Review Boards (sIRB). CTTI interviewed 34 stakeholders with various roles in the single IRB process to gather perspectives about their experiences implementing the sIRB model, focusing specifically on the six goals of the NIH sIRB policy. Some stakeholders suggested that using the sIRB model has streamlined and reduced inefficiencies associated with local IRB model. However, new inefficiencies were created due to unclear roles, lack of systems and processes, and increased workloads for some stakeholders. 

These stakeholder responses suggest that standardizing the sIRB process and implementing new systems that support the NIH’s goal for enhancing and streamlining the IRB process are needed. For example, standardizing the roles and responsibilities of reviewing IRBs and relying institutions, improving the compatibility of IRB software, and having a central repository for institutional information may improve the efficiency of the sIRB process. CTTI utilized the findings of these interviews to inform an sIRB evaluation framework.