Aug 26, 2014, 00:00
by
Michael Croft
PRINCETON, NJ - Aug 26, 2014 - WIRB-Copernicus Group (WCG), the worlds 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
PRINCETON, NJ - Aug 26, 2014 - WIRB-Copernicus Group (WCG), the
worlds 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 Secretarys 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 masters 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, WCGs 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.