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The lack of standardized, high-quality biospecimens has been widely recognized as one of the most significant roadblocks to the progress of cancer research. Over the past several years, the National Cancer Institute (NCI) has undertaken an intensive due diligence process to understand the state of its funded biospecimen resources and the quality of biospecimens used in cancer research. This process, which began in 2002 with NCI surveys and community forums, resulted in 2004 and 2005 in the establishment of a trans-divisional Biorepository Coordinating Committee (BCC), followed by the creation of the Biorepositories and Biospecimen Research Branch (BBRB) to lead and coordinate a strategic plan to confront and resolve the issues in a stepwise fashion. These efforts culminated in 2005 with the development of the First-Generation Guidelines for NCI-Supported Biorepositories ("Guidelines"). This first-iteration document was published in the Federal Register on April 28, 2006 (71 FR 25184), and on the BBRB website. The NCI requested public comments on the Guidelines both through the Federal Register and the BBRB Web site (click here to view the summary of public comments (PDF Document: 41 KB)).

The Guidelines were subsequently revised, based on public comment and input from content experts, and renamed the NCI Best Practices for Biospecimen Resources ("NCI Best Practices"). Through this process, the NCI has identified salient guiding principles that define state-of-the-science biospecimen resource practices, promote biospecimen and data quality, and support adherence to ethical and legal requirements. The current NCI Best Practices do not comprise detailed laboratory procedures; rather they consist of principles by which such procedures should be developed by biospecimen resources. The recommendations contained within this document are intended to be adapted, as appropriate, based on the mission and scientific needs of individual biospecimen resources. While adoption of the NCI Best Practices is voluntary, the Institute believes that the principles outlined in this document support the goal of optimizing biospecimens for cancer research.

The final version of the NCI Best Practices for Biospecimen Resources was accepted by the National Cancer Advisory Board and is now available. This document outlines the operational, technical, ethical, legal, and policy best practices for NCI-supported biospecimen resources. The document was updated through expert and public consultation in 2011.

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