Abstract 969: Revising and updating NCI's best practices for biospecimen resources

In 2007 the NCI Office of Biorepositories and Biospecimen Research (OBBR) published the NCI Best Practices for Biospecimen Resources (http://biospecimens.cancer.gov/practices/). The Best Practices were originally published following a public comment period on the Federal Register and internal review by several National Institutes of Health offices. The Best Practices do not comprise detailed laboratory procedures and are intended to be adapted, as appropriate, based on the mission and scientific needs of individual biospecimen resources. The Best Practices were developed to address the heterogeneity and the generally unknown or uneven quality of biospecimens used for research, which can lead to unreliable and irreproducible results. In addition to these technical and operational issues, many ethical, legal and policy guidelines and concerns must be addressed when conducting research involving the use of biospecimens from patients and other research participants. The revised version of the Best Practices is intended to respond to comments received from the biospecimen resource community over the past 2 years, and provide more current and detailed recommendations related to biospecimen and data quality. Major revisions include the addition of new sections on biospecimen resource management and operations and conflicts of interest, and expansion of recommendations related to custodianship and informed consent based on the consensus findings of the 2007 NCI-hosted Workshop on Custodianship and Ownership Issues in Biospecimen Research, addition of current references throughout the document, and harmonization with current Federal guidance documents and recommendations from international biospecimen organizations. The revised Best Practices will be launched using an interactive Web format, to provide a mechanism for more frequent updates and encourage feedback from the community. The Best Practices will continue to evolve as the field of biospecimen biology advances; novel scientific, technological, and clinical practices develop; and new ethical and legal policies and regulations emerge. Results from biospecimen research initiatives will inform future versions of the Best Practices as the community moves toward the development of evidence-based standard operating procedures that are both specimen 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. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 101st Annual Meeting of the American Association for Cancer Research; 2010 Apr 17-21; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2010;70(8 Suppl):Abstract nr 969.