Huron Webinar: Regulatory and Management Considerations for Biorepositories

With their central role in genetic, molecular, and translational research, biorepositories are an essential tool and a frequent sight in the research landscape. At the same time, biorepositories continue to face significant regulatory, operational, and management challenges including patient privacy / HIPAA considerations, a patchwork of state laws and regulations, and the operational realities of managing samples, clinical data, and staff. Additionally, as more multi-organizational models are implemented and as biorepositories seek to characterize a large cohort of specimens with more extensive clinical data, the level of complexity and need to improve management, compliance, and oversight has increased.

Event details

When

Aug 24, 2011
from 01:00 PM to 02:30 PM

Where

Brinkhous-Bullitt, Room 219

Contact Name

Add event to calendar

In this session, topics addressed will include:

  • Examples of different repository models
  • Repository management considerations (use of an honest broker, staffing)
  • Legal, ethical and regulatory considerations (HIPAA requirements, informed consent)
  • Potential implications from the Advance Notice of Proposed Rulemaking "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators"

Presented by:

Madeleine Williams
Director, Huron Life Sciences
P: 202-585-6872
mwilliams@huronconsultinggroup.com

Dr. Scott Jewell
Deputy Director for Research Resources
Professor and Director, Program for Biospecimen Science
Van Andel Research Institute



More information about this event…

Filed under: