Introduction

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 personalized medicine. Very often, biospecimens from many different individuals are analyzed in research to identify targets for cancer therapy, detection, and prevention and to derive molecular taxonomies of cancer. It is increasingly important that the procedures guiding biospecimen collection, processing and storage are standardized and/or harmonized to the extent possible, because the reliability of molecular data derived from human biospecimens is dependent on the quality and consistency of the biospecimens being analyzed, as well as the quality and breadth of the associated clinical data.

The lack of standardized, high-quality biospecimens is widely recognized as a significant roadblock to 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, and in response to the findings, developed The NCI Best Practices for Biospecimen Resources (NCI Best Practices). The NCI Best Practices were first published and released in June 2007 and revised in 2011 and 2016. The revisions to the NCI Best Practices provide new and updated information that reflect developments in the field. For example, the 2011 revisions included, among other updates, the expansion of information related to custodianship and informed consent based on various workshops and publications; 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 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. 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 (CAP). 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.