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Evaluation

2025 PRIM&R Annual Conference

Emerging Challenges and Innovations in Research

IRB Operations and Management

Regulatory Frameworks and Compliance

Navigating Ethical Challenges

N19 - Round Table Discussion: Should We Still Be Using Unconsented Biospecimens for Research in 2025?

Saturday, November 8, 2025
12:30 PM - 1:30 PM ET
Location: Room 349-350
Crossover Networking Series Call for Session Proposal - CSP
Feel free to bring your lunch to this session!


Research using biological samples is vital but ethically complex. The Common Rule requires informed consent for identifiable samples, yet allows secondary use without consent under certain conditions, including use of de-identified or excess clinical specimens. Despite these allowances, unresolved ethical questions persist—particularly around autonomy, public trust, and best practices when consent is not mandated. High-profile cases, like that of Henrietta Lacks, underscore these tensions. This session presents findings from interviews and surveys with IRB and HRPP leaders at major U.S. academic medical centers revealing limited adoption of broad consent and continued reliance on unconsented samples. We will explore the ethical, regulatory, and institutional challenges of secondary biospecimen use and offer recommendations for more ethically sound practices.

Learning Objectives:

  • Learn current practices and policies concerning informed consent for secondary research use of biospecimens at academic medical centers
  • Understand the ethical challenges posed by the continued use of unconsented samples in research in 2025
  • Identify best practices and sound ethical approaches concerning consent for secondary sample use