CINCINNATI and DURHAM, N.C., May 1, 2017 /PRNewswire/ -- Schulman IRB, the industry-leading central IRB in customer service and technology, announced today that its commercial institutional biosafety committee (IBC) service is now open for business.
The commercial IBC service provides comprehensive support for research sponsors and sites conducting research involving recombinant DNA (genetic engineering), offering research sponsors, CROs and institutions an independent option for establishing IBCs when required by federal guidelines.
Led by Dr. Daniel Eisenman, Ph.D., RBP, SM(NRCM), CBSP, Schulman's IBC service supports clinical, pre-clinical and non-clinical research, providing all components to complement an existing IBC or build and administer an entirely new IBC.
"We are thrilled to now offer IBC services as a part of Schulman's extensive suite of research compliance services," said Michael Woods, President and CEO of Schulman IRB. "By coordinating IBC review with the IRB review, we will provide clients with the expertise and efficiencies necessary to conduct genetic engineering research safely and with minimal regulatory delay."
NIH Guidelines require both IRB and IBC review for gene therapy (human gene transfer) research funded by NIH or taking place at sites that receive NIH funding. The IBC reviews safety aspects of research involving recombinant DNA, including risks associated with genetic modifications and experimental procedures as well as occupational and environmental safety.
Clients seeking IBC support are encouraged to visit schulmanirb.com/IBC to learn more.
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 it also offers a commercial institutional biosafety committee (IBC) service. 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).
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SOURCE Schulman IRB