Legal Issues of Institutional Review Boards (IRBs) in an Era of Investigational New Drugs/Devices (INDs)
Program Code: 312-A
Monday, October 25, 2004
10:30 AM to 12:00 PM (ET)

SPEAKERS
Roger Dodd, PhD, American Red Cross Blood Services
Barbara L. Starklauf, MAS, CIP, The Johns Hopkins University School of Medicine

DESCRIPTION
This session will examine the legal issues of institutional review boards and how they have been utilized in recent national INDs in transfusion medicine. The first speaker will present both the scientific and clinical aspects of this topic and give practical examples on how the IRB functions.
The second speaker will discuss the interaction between federal and state laws with regard to IRB functions and discuss commercial versus academic IRBs. A question and answer period will follow the presentations.

OBJECTIVES

• Explain how IRBs have been utilized in recent transfusion medicine IND protocols
• Discuss how an IRB is composed and how it functions
• State the differences between FDA and DHHS regulations that govern IRBs

AUDIENCE
Physicians, Scientists, Technologists, Managers/Supervisors

PROGRAM LEVEL
Intermediate