Focus will be on new information that needs to be included in informed consent materials for clinical trials
Princeton, NJ – May 20, 2019 – The WIRB-Copernicus Group® (WCG™) announced today that David Borasky, MPH, CIP, its vice president, IRB Compliance will be leading an educational session on the revised Common Rule at the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) 2019 Annual Conference. This meeting will be held from May 21-23 at The Ritz Carlton New Orleans.
“WCG is delighted to continue to partner with AAHRPP on our shared mission of helping to ensure the highest standards of human subject protections in clinical trials,” said Mr. Borasky. “This conference will provide an excellent opportunity to share our experiences and best practices from implementing the revised Common Rule with our industry colleagues.”
Mr. Borasky will co-present “Institutional Policies, Process and Best Practices for Implementing the Key Information Requirement in the Revised Common Rule” during the inaugural Collaborative AAHRPP Network (CAN) pre-conference workshop. His fellow presenter will be Megan Kasamatis Singleton, JD, MBE, CIP, assistant dean, Human Research Protections and Director of the Human Research Protections Program at Johns Hopkins University School of Medicine.
Their session will provide an overview of the “key information” that now needs to be included in the consent materials for all research that is subject to the Common Rule. Mr. Borasky will outline The Secretary’s Advisory Committee on Human Research Protections (SACHRP) recommendations concerning this new regulatory requirement and also describe approaches taken by different organizations to address it. Mr. Borasky and Ms. Singleton will also facilitate an attendee discussion about how they are implementing this aspect of the rule, any issues they have experienced with it, and how AAHRPP can best address it through the organization’s tip sheets and processes.
Continuing WCG’s efforts to impart practical information to conference attendees, the company is also providing complimentary copies of its human research protection program standard operating procedures (SOPs) for AAHRPP Sections C and D at its booth. These documents were prepared by Jeffrey A. Cooper, MD, MMM, vice president, Process & Strategic Improvement at WCG and a co-founder of AAHRPP.
Also featured at the WCG booth will be the company’s “synchronous negotiation” solution that reduces or eliminates delays typically encountered when drafting the IRB-approved informed consent form during sponsor negotiations.
Further information about the AAHRPP Annual Conference is available at http://www.aahrpp.org/grow/aahrpp-learning-opportunities/annual-conference.
WCG is the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research. Comprised of two divisions, the industry’s first central IRB – WCG IRB – and first clinical services organization, WCG enables biopharmaceutical companies, CROs, and institutions to advance the delivery of new treatments and therapies to patients, while maintaining the highest standards of human participant protection. For more information, please visit www.wcgirb.com, www.wcgclinical.com or follow us on Twitter @WCGClinical or LinkedIn.