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Updated: Jun 14, 2026
08:01
Biobank for Translational Medicine: Standard Operating Procedures for Optimal Sample Management
Published on: November 30, 2022
Custodianship as an ethical framework for biospecimen-based research.
Rihab Yassin1, Nicole Lockhart, Mariana González del Riego
1Division of Cancer Biology, National Cancer Institute, 6130 Executive Boulevard, Suite 5000, Bethesda, MD 20892, USA. ry38k@NIH.gov
Summary
The custodianship model offers a framework for equitable access to human biological specimens (biospecimens) in research. This ethical approach ensures transparency and fairness for all stakeholders involved in biospecimen research.
Area of Science:
- Biomedical Research Ethics
- Biobanking
- Human Subject Protection
Background:
- Human biological specimens (biospecimens) are critical for advancing human health research.
- Current research faces challenges due to inequitable access to high-quality, ethically collected biospecimens.
- Complex stakeholder control and ownership issues hinder biospecimen research progress.
Purpose of the Study:
- To introduce the ethical model of custodianship for biospecimen research.
- To promote fair research access and resolve control issues among stakeholders.
- To establish a framework for responsible oversight of biospecimens.
Main Methods:
- Discussion of the ethical model of custodianship.
- Analysis of stakeholder roles (biobanks, investigators, participants, sponsors).
- Endorsement of key practices for responsible biospecimen oversight.
Main Results:
- The custodianship model provides a framework for managing biospecimens from collection to dissemination.
- It addresses issues of control and potential conflicts among diverse stakeholders.
- It promotes transparency, fairness, and shared accountability in biospecimen research.
Conclusions:
- Adopting the custodianship model enhances transparency in biospecimen research.
- It ensures fairness and ethical treatment for human research participants.
- Shared accountability among all stakeholders is fostered through this model.
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