Common Risk Issues Associated with Medical Research and IRB's
Track
:
Legal and Regulatory
Program Code:
FR-04
Date:
Friday, October 23, 2009
Time:
9:15 AM to 10:15 AM
EST
Location:
203
CO-PRESENTER
:
Kari Zangerle, Partner at Law Firm of Campbell Yost and Norell, Campbell, Yost, Clare & Norell, P.C.
Ms. Zangerle is a partner at the firm. Ms. Zangerle emphasizes medical malpractice defense and health law in her practice. She has substantial trial experience and represents physician and hospital systems throughout the country in medical research matters and has extensive experience in advising medical research programs. She presently chairs the Institutional Review Board at Phoenix Children's Hospital which oversees clinical research trials at the hospital. She is a member of the American Health Lawyers Association, Health Law Section of the American Bar Association, Arizona Association of Health Care Lawyers, and the Sandra Day O'Connor American Inns of Court.
PRESENTER
:
Annette Vince, Director of Risk Management, Northwest Medical Center
Annette Vince is a resident of Tucson, Arizona and been in healthcare for 34 years and healthcare risk management for 9 years. She received her Bachelor of Science in Nursing and Master in Business Administration from the University of Phoenix.Annette is currently employed as the Director of Risk Management for Northwest Medical Center in Tucson, Arizona and has additional responsibility for the coordination of The Joint Commission and Regulatory compliance. She is a member of ASHRM at both the state and national level. She has held various offices in the Tucson Chapter including Board Member, Secretary, Vice President, and President
Description
This session looks at common risk issues associated with institutional review boards (IRB) and consent issues, the use of unapproved drugs/devices and how to coordinate IRB activities among hospital departments to minimize risk. The session also deals with education for IRB members and hospital staff, the financial risks associated with research and IRB activities and how to prepare for an FDA audit. Reporting requirements of research activities are covered, too.
LEARNER OUTCOMES:
be able to identify common risk issues associated with Institutional IRB's and Research
HAve knowlege of how to prepare for an FDA audit
identify how to coordinate a hosptial IRB with ohter hospital departments to reduce risk