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Cincinnati, OH and Durham, NC – Schulman IRB announced today that its commercial institutional biosafety committee (IBC) service will launch in May 2017. The IBC service represents Schulman’s response to requests from research sponsors, CROs and institutions seeking an independent option for establishing IBCs when required by federal guidelines.
Led by Dr. Daniel Eisenman, Ph.D., RBP, SM(NRCM), CBSP, the IBC service provides comprehensive support for research sponsors and sites conducting research involving recombinant DNA (genetic engineering). Schulman’s commercial IBC service will support clinical, pre-clinical and non-clinical research, providing all components to complement an existing IBC or build and administer an entirely new IBC.
“Clinical trials involving recombinant DNA are becoming more common, especially in oncology,” said Michael Woods, President and CEO of Schulman IRB. “The IBC service will compliment and coordinate with Schulman’s existing IRB services, providing the expertise and efficiencies necessary to help clients conduct this research safely and expediently.”
NIH Guidelines require both IRB and IBC review for gene therapy (human gene transfer) research that receives NIH funding or takes place at NIH funded sites. The IBC reviews safety aspects of research involving recombinant DNA (genetic engineering), including risks associated with genetic modifications and experimental procedures as well as occupational and environmental safety.
About Schulman IRB
Schulman IRB has been a leader in the protection of human research participants in the U.S., Puerto Rico and Canada since 1983. Schulman offers thorough, timely IRB review services – including dedicated review capabilities for all phases of research across all therapeutic areas – to clinical trial sponsors, CROs, investigators and institutions. Schulman also provides global consulting services in clinical quality assurance (CQA) and human research protections (HRP), and its commercial institutional biosafety committee (IBC) service will launch in May 2017. Fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), Schulman has an unparalleled clean audit history with the Food and Drug Administration (FDA).
For more information, please visit http://www.sairb.com or follow @SchulmanIRB on Twitter or on LinkedIn.