Successful Strategies for Adjusting to the New Rule
In light of extensions of the effective date for the revised Common Rule or New Rule, organizations are facing a moving target for adherence. At the time of this writing, it is unclear whether July 19 will become the next effective date, however some burden-reducing provisions may be permitted…or not. This webinar will discuss strategies and guidance tools that can help organizations structure degrees of readiness in order to be as prepared as possible for the unknown. Register here.
Meet the Speakers:
Dave Borasky, MPH, CIP, Vice President, IRB Compliance, WIRB-Copernicus Group, is responsible for leading quality and compliance activities for the WCG IRBs. Borasky has 20 years’ experience in managing IRBs. He has facilitated training activities in basic research ethics and IRB operations and management for IRB staff and has provided hands-on technical assistance to IRBs throughout North America, Africa, and Asia. He has served as a consultant for the OHRP, the U.S. Department of Energy, the WHO, and numerous other institutions. He currently serves as co-chair of SACHRP’s Subpart A Subcommittee. Borasky hold the CIP credential and is a former member of the board of directors of PRIM&R.
Monika Markowitz, PhD, MA, MSN, RN, Director, Office of Research Integrity and Ethics, Virginia Commonwealth University, directs the Research Conflict of Interests Program, chairs the Individual and Institutional Conflict of Interests committees, and serves as VCU’s research integrity officer. Dr. Markowitz is a research ethics consultant and co-investigator for NIH grants on research subjects compensation and responsible conduct of research mentoring. Her clinical background lies in pediatric critical care nursing, and she holds a PhD in biomedical/religious ethics from the University of Virginia. As adjunct faculty in the VCU School of Nursing, Dr. Markowitz has taught courses in nursing and health care ethics, and she frequently presents on topics in research ethics at VCU. She serves as a faculty member for PRIM&R, AAHRPP, the American Association of Medical Colleges Forum on Conflict of Interests in Academe (FOCI-A), and the Virginia IRB Consortium. She sits on the FOCI-A Steering Committee and serves as an AAHRPP accreditation Step 1 reviewer, site visitor, and team leader.