Scope, Applicability, and Implementation

Scope

This document identifies technical; operational; and ethical, legal, and policy best practices in order to ensure a level of consistency and standardization across biospecimen resources. A biospecimen resource is defined as a collection of human specimens and associated data for research purposes, the physical structure where the collection is stored, and all associated processes and policies. Biospecimen resources vary considerably, ranging from formal organizations in a warehouse to informal collections of materials in an individual researcher’s freezer. The NCI chose to use the term biospecimen resource to encompass both the physical structure and the policies and procedures which are associated with such resources.

Applicability and Implementation

The NCI Best Practices are intended to be applicable to all biospecimen resources. The implementation of the NCI Best Practices is voluntary, and much of the information in the NCI Best Practices can be broadly or narrowly applied depending on the mission of the biospecimen resource and/or the study design. Biospecimen resource managers are encouraged to implement the NCI Best Practices in their biospecimen management plans as appropriate.