Two documents dominate references to “biorepository best practices” in the research-data-management and biobanking literature: the ISBER Best Practices for Repositories, published by the International Society for Biological and Environmental Repositories, and the NCI Best Practices for Biospecimen Resources, published by the National Cancer Institute’s Biorepositories and Biospecimen Research Branch (BBRB). They are frequently cited together, and institutional biobank SOPs often map to both, but they are distinct documents with different publishers, different scope, and different relationships to funding compliance. This guide explains what each one is, how they differ, and how institutions typically use them together.
ISBER Best Practices for Repositories
ISBER (the International Society for Biological and Environmental Repositories) is an international professional membership society for people who operate biorepositories and biobanks. Its Best Practices for Repositories: Collection, Storage, Retrieval, and Distribution of Biological Materials for Research, generally referred to simply as the ISBER Best Practices, is a voluntary, consensus-based reference document developed by working groups of repository professionals and periodically revised. The current edition is the Fifth Edition, published in 2023.
The ISBER Best Practices are broad in scope: they apply across repository types and sample sources, not just human specimens, covering collections of animal, plant, microbial, and environmental materials as well. Topics addressed include repository governance and management, ethical, legal, and informed-consent considerations, specimen collection, processing, storage, and retrieval procedures, quality management systems, biosafety and shipping (including compliance with dangerous-goods transport regulations), and procedures for repository closure or discontinuation. Because ISBER is a professional society rather than a funding or regulatory body, adherence to its Best Practices is not a legal or grant-funding requirement in itself, but the document functions as the field’s general operational reference and is widely used internationally as the baseline standard repositories audit themselves against.
NCI Best Practices for Biospecimen Resources
The NCI Best Practices for Biospecimen Resources is developed and maintained by the Biorepositories and Biospecimen Research Branch (BBRB) within the National Cancer Institute (part of NIH). It was first published in 2007, with the U.S. Federal Register recording a formal notice of availability for a revised edition in 2010, and further revisions issued in 2016. NCI’s Division of Cancer Treatment and Diagnosis (DCTD) has continued to maintain and update the document since.
Unlike the ISBER document, the NCI Best Practices are scoped specifically to human biospecimen resources supporting NCI-funded and NIH-funded cancer and biomedical research. They address biospecimen-resource governance and custodianship, informed consent and human-subjects protections specific to the collection and future use of biospecimens, quality control and quality assurance for specimens intended for molecular and genomic analysis, and reporting expectations for NCI grantees operating a biospecimen resource. Because NCI expects grantees who operate NCI-funded biospecimen resources to align their practices with this document, it carries a degree of funder-specific compliance weight that the ISBER document, as a general voluntary professional standard, does not have on its own.
How the two documents differ
| Dimension | ISBER Best Practices for Repositories | NCI Best Practices for Biospecimen Resources |
|---|---|---|
| Publisher / steward | International Society for Biological and Environmental Repositories (ISBER), an international professional society | NCI Biorepositories and Biospecimen Research Branch (BBRB), part of NIH’s National Cancer Institute |
| First published / current edition | Multiple editions since the 2000s; current edition is the Fifth Edition (2023) | First published 2007; revised 2010/2011 and 2016, with further updates maintained by NCI DCTD |
| Sample scope | Broad: human, animal, plant, microbial, and environmental biological materials | Human biospecimens specifically, in the context of cancer and biomedical research |
| Legal / funding status | Voluntary professional-society guidance; not tied to a specific funder | Not itself a federal regulation, but NCI expects NCI-funded biospecimen resources to align with it, giving it de facto grant-compliance relevance |
| Primary audience | Repository and biobank operators worldwide, across research domains | NCI/NIH grantees and institutions operating human biospecimen resources for cancer research |
| Depth on general repository operations | Extensive: SOPs for collection, processing, storage, retrieval, shipping, quality management, closure | Focused on biospecimen-specific governance, human-subjects considerations, and quality control for downstream molecular analysis |
How institutions typically use them together
The two documents are complementary rather than competing. A U.S. academic biobank operating with NCI funding will generally treat the NCI Best Practices as the governing reference for the human-subjects, consent, and NCI-reporting obligations attached to its grant, while drawing on the ISBER Best Practices for the more granular, day-to-day operational detail, such as specimen-processing SOPs, cold-chain and shipping procedures, and quality-management-system design, that the NCI document does not cover in the same depth. Many institutional biobank SOP manuals cross-reference both documents explicitly for this reason, and biorepository accreditation and self-assessment checklists commonly draw on ISBER’s Best Practices as the general operational baseline regardless of which specific funder’s requirements also apply.
Neither document is a data standard in the same sense as a data management plan template or a metadata schema; both are practice-and-procedure guidance. Consent language and human-subjects handling addressed in the NCI Best Practices should also be read alongside an institution’s informed consent processes and IRB requirements, which govern the underlying human-subjects research regardless of which best-practices document a specific biorepository also follows.
Frequently asked questions
Is the ISBER Best Practices document mandatory?
No. It is voluntary, consensus-based guidance from a professional society, not a regulation. It is, however, widely treated as the de facto operational standard for repositories internationally, and many institutions require compliance with it as a matter of internal policy or accreditation.
Is the NCI Best Practices document mandatory?
It is not a standalone federal regulation, but NCI expects biospecimen resources it funds to align their practices with it, which makes it effectively a compliance expectation for NCI grantees operating a biospecimen resource, distinct from a purely voluntary standard.
Do I need to follow both documents?
It depends on your repository’s funding and sample scope. A non-human or non-NCI-funded repository would typically look to the ISBER Best Practices alone. A biospecimen resource funded by NCI, or another NIH institute that references the NCI document, typically needs to satisfy the NCI Best Practices for its human-subjects and reporting obligations, and often follows the ISBER Best Practices as well for general operational procedure.
What is the difference between a “biorepository” and a “biospecimen resource”?
The terms are largely overlapping in practice. “Biospecimen resource” is the term NCI’s document uses specifically for human-biospecimen-holding facilities in the cancer-research context, while “biorepository” (and “biobank”) are used more broadly across the field, including by ISBER, to cover repositories of any biological material type. See the biorepository and biobank dictionary entries for how these terms are used across the wider field.
Where can I get the current edition of each document?
ISBER publishes its Best Practices through its own website, isber.org. NCI publishes its Best Practices for Biospecimen Resources through the National Cancer Institute’s Division of Cancer Treatment and Diagnosis (DCTD) site, cancer.gov. Both organizations periodically revise the documents, so institutions should confirm they are working from the current edition rather than an archived one.
References
- ISBER, “Best Practices for Repositories: Collection, Storage, Retrieval, and Distribution of Biological Materials for Research,” Fifth Edition (2023), isber.org.
- National Cancer Institute, Biorepositories and Biospecimen Research Branch, “NCI Best Practices for Biospecimen Resources,” cancer.gov / dctd.cancer.gov.
- Federal Register, “National Cancer Institute’s Best Practices for Biospecimen Resources” (notice of availability, 2010).
