Informed Consent and Tissue Ownership
- August 22, 2025
- Matt Deutsch , Husch Blackwell LLP
- Peter Enko , Husch Blackwell LLP
- Stephen Gardner , Husch Blackwell LLP
- Trevor Foster , Husch Blackwell LLP
The informed consent document is critical to the acquisition and use of human tissues for research and commercial purposes and ensures that study subjects are fully apprised of the consequences of their donation. To prevent disputes over the control, use, or transfer of biological samples, it is essential that research consent forms state expressly that tissue donations are gifts from the participants and that all ownership rights are transferred to the research institution. Additionally, the informed consent document should indicate that, upon donation, the study subject relinquishes all rights to the sample, including any products, treatments, or profits generated from those tissues. Underpinning these legal requirements are fundamental ethical principles of autonomy and respect for study participants, which demand that donors understand and agree to the uses of their tissues.
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