WCG Thought Leaders to Help Debunk Regulatory Myths and Discuss Proposed Changes to Human Subject Protections at MAGI Clinical Research Conference East
PRINCETON, N.J., Apr. 18, 2016 – WIRB-Copernicus Group® (WCG™), one of the world’s leading providers of solutions that measurably improve the quality and efficiency of clinical research, today announced that two of its thought leaders will be presenting at MAGI’s Clinical Research Conference – 2016 East, which is being held at the Westin Copley Place in Boston, MA from May 1-4.
R. Bert Wilkins, JD, MHA, CIP, IRB chair at Western Institutional Review Board (WIRB), will address common myths relating to research and IRB review during panel discussion C293 starting at 8:30 a.m. on May 3. His fellow panelists will be Association for Accreditation of Human Research Participant Protection Programs (AAHRPP) Executive Vice President Michelle Feige; University of Pennsylvania Associate Director, IRB Megan Kasimatis Singleton; and IntegReview IRB President Lynn Meyer.
“Human subjects make clinical research possible. Protecting them is at the heart of everything we do,” commented Mr. Wilkins. “It is vitally important that IRBs not only know all the regulations but understand how to apply them correctly. We are proud to share our knowledge and experience with other clinical research professionals.”
This MAGI East session will focus on myths concerning what is not considered human subjects research, i.e. exemptions, FDA-regulated research, and IRB review. Attendees can look forward to an active, participatory session. Panelists will present a belief to the audience and ask them if it is true. Then they will discuss whether or not it is in fact a myth.
“We decided to take a fun approach to this serious subject because people tend to learn better when they feel at ease,” added Mr. Wilkins. “That is especially important as we may be challenging some of their previously-held beliefs.”
Mr. Wilkins chairs one of seven WIRB review boards that evaluate human subjects research.
David Borasky, Jr., MPH, CIP, vice president of quality management at Copernicus Group IRB, will co-present session C525 about emerging issues in human subject protections starting at 11:30 a.m. on Monday, May 2. His fellow presenter will be Emily Fogler, JD, counsel at Verrill Dana LLP.
Their session will focus on recommended changes to informed consent and biospecimen regulations described in the Notice of Proposed Rulemaking (NPRM) to the Federal Policy for the Protection of Human Subjects, known as the Common Rule.
“The NPRM will make the consent form shorter and more focused on information that is important to the study participant. Less important information will be placed in appendices,” said Mr. Borasky. “Also, broad consent will be required for all biospecimen research, reflecting the public’s desire to control the use of its specimens and the increasing likelihood that in the future biospecimens will be identifiable based on genetic analysis.”
Mr. Borasky has more than 17 years of experience managing IRBs, and he has consulted for the Office for Human Research Protections and the World Health Organization. He currently serves as co-chair of the Subpart A Subcommittee to the Secretary’s Advisory Committee on Human Research Protections.
For more information about this conference, please visit https://magiworld.org/events/2016E.
About WIRB-Copernicus Group
WIRB-Copernicus Group (WCG) is one of the world’s leading providers of solutions that measurably improve the quality and efficiency of clinical research. The industry’s first Clinical Services Organization (CSO), WCG enables biopharmaceutical companies, contract research organizations and institutions to accelerate the delivery of new treatments and therapies to patients, while maintaining the highest standards of human subject protections.
WCG solutions include contract and budget negotiation, study start-up acceleration, regulatory and ethical review services, oversight of research involving gene therapy, and lab safety consulting. Powered by a suite of proprietary technologies, WCG solutions help clients to increase regulatory compliance and support the digital management of clinical trials. For more information, please visit www.wcgclinical.com or follow us on Twitter @WCGClinical.