Introduction

Unprecedented advances in biomolecular technology have greatly increased the power and precision of analytical tools used in cancer research and have accelerated the drive toward personalized medicine. Human specimens that are analyzed using these new and developing technology platforms have emerged as a critical resource for basic and translational research in cancer because they are a direct source of molecular data from which targets for therapy, detection, and prevention are identified and molecular taxonomies of cancer are derived. The reliability of molecular data derived from these new analysis platforms is dependent on the quality and consistency of the biospecimens being analyzed. As a result of the increased requirement for biospecimen quality, standardization of biospecimen resources using state-of-the-science approaches has become a pressing need across the research enterprise. The lack of standardized, high-quality biospecimens is widely recognized as a significant roadblock to 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. During 2004 and 2005, the NCI first established a transdivisional Biorepository Coordinating Committee and then created the Office of Biorepositories and Biospecimen Research (OBBR) to lead and coordinate a strategic plan to confront and resolve the issues in a stepwise fashion. These efforts culminated with the development of the First-Generation Guidelines for NCI-Supported Biorepositories, a first-iteration document published in the Federal Register on April 28, 2006 (71 FR 25184) . The Guidelines were subsequently revised based on public comment and input from content experts, renamed the NCI Best Practices for Biospecimen Resources (NCI Best Practices) , and released on the OBBR Web site in June 2007

This revised version of the NCI Best Practices is intended to both respond to comments received from the biospecimen resource community and to provide more current and detailed recommendations related to biospecimen and data quality. Major revisions include the addition of new sections on biospecimen resource management and operations and conflicts of interest (COIs) , expansion of recommendations related to custodianship and informed consent based on the consensus findings of the 2007 NCI-hosted Symposium-Workshop on Custodianship and Ownership Issues in Biospecimen Research, addition of current references throughout the document, and harmonization with current Federal guidance documents and recommendations from international biospecimen organizations. Like the 2007 release, this version of the NCI Best Practices underwent scrutiny by experts within NCI and throughout the National Institutes of Health. It also was posted online for public comment, and the input received was considered as the document was finalized.

The NCI Best Practices identifies 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 does not comprise detailed laboratory procedures; rather, the document consists 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. Although adoption of the NCI Best Practices is voluntary, the NCI believes that the principles outlined in this document support the goal of optimizing biospecimens for cancer research.

The NCI Best Practices will continue to evolve as the field of biospecimen biology advances; novel scientific, technological, and clinical practices develop; and new ethical and legal policies and regulations emerge. Results from biospecimen research initiatives will inform future versions of the NCI Best Practices as the community moves toward the development of evidence-based standard operating procedures (SOPs) that are both biospecimen-type specific and analysis-platform specific. The NCI is committed to maintaining current and scientifically accurate best practices for biospecimen resources and will continue to solicit input from stakeholders in the cancer research community.