In response to the U.S. National Alzheimer's Project Act and the recent NIH mandate for single IRB review in multisite clinical trials, the National Biomedical Research Ethics Council (NBREC) and Schulman IRB have developed an alliance to improve the quality and efficiency of Alzheimer's disease clinical research.
This alliance enhances the regulatory ethics review requirement with the addition of an expert scientific review committee (SRC). The addition of the SRC will provide early identification of potential areas of improvement in study design that will minimize study delays and the need for costly protocol amendments.
"The alliance will provide a combination of experience, expertise, and quality of review unmatched among central IRB service providers," Ara Khachaturian, Chair and President of NBREC said. "The enterprise integrates the ethics review platform, organization and resources of Schulman IRB—one of the oldest and most reputable centralized research ethics review boards—with the international network of neurodegenerative disease experts and support from global patient advocacy groups that support NBREC."
The alliance aims to improve research volunteer participation in Alzheimer's disease trials, and increase efficiencies in the conduct of large-scale multi-site trials. The partnership will also serve as an international model for trans-national interventional studies of Alzheimer's, dementia and other neurodegenerative disease.
"The Schulman team is honored to partner with NBREC in this unique venture," Eli Alford, COO at Schulman IRB said. "By combining Schulman's unmatched efficiency and IRB expertise with NBREC's network of neurodegenerative disease key opinion leaders and educational outreach programs, we hope to make a significant contribution to science's understanding of Alzheimer's disease, and the diagnosis, prevention, and eventual cure of this and other neurological disorders."
Schulman and NBREC are currently developing the systems and processes to support the SRC-IRB integration and expect to make these services available in summer 2017.