Overview of the CIRB Pilot Initiative

For the past 4 years, the ALS Association funded an initiative to pilot the establishment of a central IRB (cIRB) process for NEALS research studies. It used the NIH funded NeuroNEXT Network (www.neuronext.org) as a model.   The goal of the pilot was to determine whether a streamlined IRB and contracting process could successfully be implemented within NEALS Network.  Site selection for this pilot project occurred in 2014.  Currently there are two studies utilizing the cIRB program – the Cross-Sectional ALS Biofluid Biomarker (CABB) Study and the Evaluation of the Safety, Tolerability, Efficacy and Activity of AMX0035, a Fixed Combination of Phenylbutyrate (PB) and Tauroursodeoxycholic Acid (TUDCA), for Treatment of Amyotrophic Lateral Sclerosis (ALS) (CENTAUR) Study.

Overview of the Central IRB

The central Institutional Review Board (cIRB) for selected NEALS clinical trials is the Partners Human Research Committee (PHRC), comprised of the IRBs of the Massachusetts General Hospital (MGH) and the Brigham and Women’s Hospital (BWH) both located in Boston, MA.  It is the same cIRB that oversees all studies conducted by the NeuroNEXT Network.  Sites that participate in studies that utilize the NEALS cIRB must have an executed cIRB Authorization Agreement also called a Reliance Agreement (RA) to rely on the PHRC.  Signing the NEALS RA does not preclude a site from participating in any other IRB authorization agreements that it may have or entered with other entities.  For each study that utilizes the NEALS cIRB, sites are asked to confirm that their institution agrees to rely on the cIRB (via the terms of the agreed upon RA), with an option to opt out of participation in any study if their institution does not agree

If your site is interested in executing a Reliance Agreement with the PHRC, please contact Catherine Gladden, the cIRB Liaison Regulatory Manager, at cgladden@mgh.harvard.edu.

List of Participating NEALS Sites with an Executed Reliance Agreement

Current as of February 2019 – list is updated approximately every 2 months

  • ALS Center at the Swedish Neuroscience Institute
  • Barrow Neurological Institute
  • Beth Israel Deaconess Medical Center
  • Brigham and Women’s Hospital
  • California Pacific Medical Center
  • Cleveland Clinic
  • Drexel University
  • Duke University Medical Center
  • Emory University
  • Henry Ford Hospital
  • Johns Hopkins University
  • Lahey Clinic
  • Loma Linda University
  • Massachusetts General Hospital
  • Mayo Clinic (includes Jacksonville, Phoenix, and Rochester)
  • Medical University of South Carolina
  • Methodist Neurological Institute
  • Minneapolis Medical Research Foundation
  • Mount Sinai Beth Israel
  • Neurology Associates
  • Northwestern University
  • Ochsner Neuroscience Institute
  • Ohio State University
  • Oregon Health & Science University
  • Penn State University School of Medicine
  • Temple University
  • Texas Neurology, P.A.
  • Twin Cities ALS
  • University of California, Irvine
  • University of Florida, Gainesville
  • University of Iowa
  • University of Kansas Medical Center
  • University of Kentucky
  • University of Massachusetts Medical School
  • University of Miami
  • University of Michigan
  • University of Missouri
  • University of Pennsylvania
  • University of South Florida
  • University of Texas Health Science Center, San Antonio
  • University of Washington
  • Vanderbilt University Medical Center
  • Wake Forest University Health Sciences
  • Washington University in St. Louis

Additional Details:

Central IRB: Partners Human Research Committee/IRB (Massachusetts General Hospital and Brigham and Women’s Hospital)

FWA information: https://www.partners.org/Medical-Research/Support-Offices/Human-Research-Committee-IRB/Federal-Assurances.aspx

Resources for Sites:

Webinars:

NEALS Central IRB (cIRB) Model Webinar
September 12, 2016
This webinar was presented by the NEALS Central IRB. Covered in this webinar were general comments on central IRBs, a brief overview of the NEALS cIRB model, and a discussion on the NEALS Reliance Agreement.

Watch Here

NEALS cIRB and CENTAUR Study Webinar
November 1, 2016
This webinar was presented by the NEALS Central IRB and the CENTAUR Study Principal Investigator. Covered in this webinar were general NEALS cIRB processes, an overview of the NEALS CENTAUR Study, and a discussion on potential protocol issues.

Watch Here

The pilot initiative was made possible by the generous support of ALSA.