Biobanking Basics: An Overview of Current Legal and Compliance Issues

Related to Human Specimens Collected in Research

Tuesday, April 5, 2011
1:00 - 2:30 p.m. EST

Biobanking is increasingly in the news and on the radar of elected officials, scientists, public and private sponsors, and regulators. The potential gains in scientific knowledge and funding support are balanced by significant regulatory, legal and ethical challenges. As part of conducting human research, institutions and sponsors have responded to some of these concerns through established processes, while lawmakers and regulators have enacted a patchwork of laws, rules and regulations in an attempt to address these issues. To ensure continued legal and regulatory compliance associated with the collection, storage and use of biological specimens, investigators and institutions must steer their way through increasingly complex requirements. Additionally, as social and ethical concerns continue to evolve, so do the procedures, laws and regulations to address those concerns.

Learning Objectives:

1. Identify the differences between HHS and FDA Informed Consent requirements and their applicability to different scenarios such as clinical trials and material transfer arrangements with industry sponsors.
2. Describe the application of HIPAA to the use of protected health information.
3. Describe and discuss the applicability of case law, as well as trends and developments in state and federal legislation (including GINA and ARRA), with regard to "ownership" of biological specimens, with a view toward understanding current industry sponsor and academic medical center concerns in clinical research and development.

Webinar Instructors:

Shana Fried, Reed Smith, LLP
Celeste Letourneau, Reed Smith, LLP

All attendees with receive 1.5 RCR contact hours.  RSVP to Elizabeth.  Email: Elizabeth or Phone: 852-1637