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.

When Aug 24, 2011
from 01:00 PM to 02:30 PM
Where Brinkhous-Bullitt, Room 219
Contact Name
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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

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

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