|By PR Newswire||
|August 26, 2014 08:01 AM EDT||
PRINCETON, N.J., Aug. 26, 2014 /PRNewswire/ -- WIRB-Copernicus Group (WCG), the world's largest provider of regulatory and ethical review services for clinical research, announced today that it has appointed David Borasky as vice president of quality management for the Copernicus Group Independent Review Board.
"David brings a wealth of international experience to the WCG team," said WCG Chairman & Chief Executive Officer Donald A. Deieso, Ph.D. "David has extensive experience ensuring that clinical studies adhere to global regulations and policies governing human research. He has also consulted for a broad range of institutions, including the U.S. Office for Human Research Protections, World Health Organization, and U.S. Agency for International Development."
In his new role, Borasky will be responsible for creating and implementing programs, policies and procedures that establish compliance and ethical conduct standards for human research. He will also ensure that the Copernicus Group Independent Review Board complies with all applicable federal and state laws, regulations, and accreditation standards.
Borasky has more than 15 years' experience developing and managing institutional review boards (IRBs) and human research protection programs. Prior to joining WCG, Borasky served as deputy director in the Office of Human Research Ethics at the University of North Carolina at Chapel Hill. Before that, he was an IRB manager in the Office for Research Protections at RTI International, advising the director on issues relating to institutional policy and regulatory compliance.
He also has more than a decade of international oversight and research ethics experience having held increasingly senior positions at FHI360 in Durham, NC, culminating in him holding both the director of Regulatory Affairs and Quality Assurance, and director of the Office of International Research Ethics positions simultaneously.
In addition, Borasky serves as co-chair of the Subpart A (Common Rule) Subcommittee of the Secretary's Advisory Committee on Human Research Protections for the U.S. Department of Health and Human Services (DHHS). He is also an expert consultant to the Office for Human Research Protections at DHHS. Furthermore, he is a member of the HIV Prevention Trials Network Ethics Working Group, and a Public Responsibility in Medicine and Research (PRIM&R) board member.
Borasky has previous experience working with the Copernicus Group Independent Review Board, having served as an IRB member from 2002-2005.
He has a master's degree in public health leadership from the University of North Carolina at Chapel Hill and a BA in English from Le Moyne College in Syracuse, NY.
About the WIRB-Copernicus Group
WIRB-Copernicus Group (WCG) is the world's largest provider of regulatory and ethical solutions for clinical research, including Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) review. The pioneer of independent ethical oversight, WCG continues to drive progress in the clinical research space. Today, WCG's solutions are built upon the foundation of ethical review, but have grown to include a suite of complementary services and technologies. These offerings include electronic informed-consent solutions, interactive Part 11-compliant online learning management solutions for clinical research professionals, and software compliance and research oversight solutions for institutions. WCG leverages its industry insight to stimulate growth, foster compliance, and maximize efficiency for those who perform clinical trials.
For more information, please visit www.wcgclinical.com or follow us on Twitter @WCGClinical.
SOURCE WIRB-Copernicus Group
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