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Evaluation On-Demand Video

2024 PRIM&R Annual Conference

Research Involving Data and New Technologies

Legal Considerations in Research Oversight

IRB Review

Pharma/Biotech Perspectives

H06 - What Are You Going To Do With My Specimens and Data? When Research Specimens and Data are Used for Commercial Profit

Wednesday, November 20, 2024
10:30 AM – 11:45 AM PT
Location: Signature Room
Human Subject Research - HSR Live Streamed Session Live Session Recorded Deep Dive Series Call for Session Proposal - CSP CIP Accredited
CLICK HERE to view captioning for this session! 

When applicable, HHS regulations require informed consent forms to include a statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit. However, it may not be clear to many subjects/participants why commercial uses of biospecimens are essential for scientific and medical advancement, how they are used for commercial research, and why it may not be possible to share commercial profits with them. This session will discuss scenarios when research biospecimens and data may be used for commercial profit and best practices for explaining these issues to potential research subjects.

Learning Objectives:

  • Identify when it is appropriate to include the additional element of consent regarding use of biospecimens for commercial profit in consent forms
  • Discuss different scenarios where biospecimens may be used for commercial profit
  • Examine best practices for communicating with potential research subjects on why commercial uses of biospecimens are important, how biospecimens may be used commercially and when such research could result in commercial profit, and why the sharing of any profits might not be possible