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 cancer research 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. The NCI Best Practices for Biospecimen Resources (NCI Best Practices) were first published and released in June 2007. The Best Practices were again revised in 2011 and posted on the NCI Biorepositories and Biospecimen Research Branch (BBRB) web site [1]. Major revisions in 2011 included: 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; updating and addition of more current references; and harmonization with current Federal guidance documents and recommendations from international biospecimen organizations.

This revised 2016 version of the NCI Best Practices is intended to provide more current and detailed recommendations related to biospecimen and data quality. This version includes updates and revisions as follows;

• Section B, Technical and Operational Best Practices, has updated internet references, updated recommendations based on more recent research, guidance and standards for collecting, processing and storing specimens; updated (Sections B.5, B.6) informatics practices in recognition of the phasing out of the caBIG and caGRID programs; and updated literature references.
• Section C, Ethical, Legal and Policy Practices, has been updated based on more recent guidance concerning informed consent for genomics research; return of research results, and incidental findings; community engagement; and corrections and updates to internet references.

The NCI Best Practices identifies salient guiding principles that define state-of-the-science biospecimen resource practices, promotes biospecimen and data quality, and supports 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. Many of the principles have been adopted, in whole or in part, by accrediting programs for biorepositories, such as the Biorepository Accreditation Program of the College of American Pathologists (College of American Pathologists, or CAP [2]). Organizations contemplating an application for accreditation by CAP or other entities will find careful review of the Best Practices a helpful starting point in evaluating biospecimen resource practices and administrative oversight. 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 science advances; novel scientific, technological, and clinical practices develop; and new ethical and legal policies and regulations emerge. Results from biospecimen research initiatives such as those from the NCI Biospecimen Research Network (BRN) [3-11] will continue to inform future versions of the NCI Best Practices as the community moves toward the development of biospecimen evidence-based practices [12] and 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.