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Cancer Epidemiol Biomarkers Prev. 2010 Apr;19(4):1012-5. doi: 10.1158/1055-9965.EPI-10-0029. Epub 2010 Mar 23.

Custodianship as an ethical framework for biospecimen-based research.

Author information

1
Division of Cancer Biology, National Cancer Institute, 6130 Executive Boulevard, Suite 5000, Bethesda, MD 20892, USA. ry38k@NIH.gov

Abstract

Human biological specimens (biospecimens) are increasingly important for research that aims to advance human health. Yet, despite significant proliferation in specimen-based research and discoveries during the past decade, research remains challenged by the inequitable access to high-quality biospecimens that are collected under rigorous ethical standards. This is primarily caused by the complex level of control and ownership exerted by the myriad of stakeholders involved in the biospecimen research process. This article discusses the ethical model of custodianship as a framework for biospecimen-based research to promote fair research access and resolve issues of control and potential conflicts between biobanks, investigators, human research participants (human subjects), and sponsors. Custodianship is the caretaking obligation for biospecimens from initial collection to final dissemination of research findings. It endorses key practices and operating principles for responsible oversight of biospecimens collected for research. Embracing the custodial model would ensure transparency in research, fairness to human research participants, and shared accountability among all stakeholders involved in biospecimen-based research.

PMID:
20332272
PMCID:
PMC2858050
DOI:
10.1158/1055-9965.EPI-10-0029
[Indexed for MEDLINE]
Free PMC Article
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