Patients generously donate their biospecimens, such as tumor tissue and blood, for research with the hope that the biospecimens will be useful, and utilized, in research. These biospecimens are a critical resource for basic and translational cancer research because they tell the molecular story of an individual’s disease – they are a key element of the research that drives precision medicine. Biospecimens from many different individuals may be analyzed in research to identify targets for cancer therapy, detection, and prevention. The reliability of molecular data derived from human biospecimens depends on the quality and consistency of the biospecimens being analyzed, as well as the quality and breadth of the associated clinical data. It is increasingly important that the procedures guiding biospecimen collection, processing and storage are standardized and/or harmonized to the greatest extent possible.
To improve the quality and availability of biospecimens and associated data for cancer research, the National Cancer Institute (NCI) over the course of many years undertook an intensive due diligence process to understand the state of its funded biospecimen resources and the quality of biospecimens used in cancer research. In response to the findings, the NCI developed the NCI Best Practices for Biospecimen Resources (NCI Best Practices). The NCI Best Practices identifies guiding principles that define state-of-the-science biospecimen resource practices, promotes biospecimen and data quality, and supports adherence to ethical and regulatory requirements.
The NCI Best Practices were first released in June 2007 and revised versions were published in 2011, 2016, and 2026 (Appendices). The NCI Best Practices are based on extensive research and community input, and each new edition provides new and updated information that reflects developments in the field. Revisions in the 2011 edition included, among other updates, the expansion of information related to custodianship and informed consent based on various workshops and published literature. The 2016 revisions provided more current information related to biospecimen and data quality as well as updated information about informed consent for genomics research, return of research results, incidental findings, and community engagement.
The 2026 revision includes the following updates:
- A new, overarching Governance section which replaces and expands upon the previous Ethical, Legal, and Policy Best Practices section.
- Discussion of regulatory changes imposed by implementation of the 2018 Common Rule “Final Rule” requirements (45 CFR part 46).
- New information addressing evolving norms and consensus regarding the management of risks associated with genomic and other molecular-based technologies.
- Ethical and operational considerations regarding the sharing of study findings and clinically actionable individual results.
- The importance of community engagement.
- Expansion of the section on legacy planning
- Extensive updates on biospecimen collection, processing, storage, retrieval, and distribution.
- Updated content on biospecimen science and biospecimen evidence-based best practices, with supporting references.
- Courtesy of the College of American Pathologists (CAP), an updated CAP Biorepository Accreditation Program (BAP) checklist.
- Updated references, web resources, and additional appendices.
Biobanking best practices have continued to evolve internationally as the field of biospecimen science advances and the research community moves toward the development and utilization of evidence-based practices. Additional best practices efforts include the comprehensive best practices published by the International Society for Biological and Environmental Repositories (ISBER). Many of the principles outlined in the NCI and ISBER Best Practices have been adopted, in whole or in part, by accreditation programs for biorepositories, such as the CAP BAP, the American National Standards Institute (ANSI) National Accreditation Board (ANAB) Biobanking Accreditation Program, and the International Standards Organization. Organizations contemplating an application for accreditation by CAP or other entities will find careful review of the NCI Best Practices a helpful starting point in evaluating biospecimen resource practices and administrative oversight.
The information contained within this document is 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, biospecimen resources are encouraged to align with the principles outlined in this document and take a leading role in optimizing biospecimens for cancer research and improving research reproducibility.