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Last Updated: 11/04/14

Overview Statement

Since its inception in 2005, the National Institutes of Health (NIH) National Cancer Institute (NCI) Office of Biorepositories and Biospecimen Research (OBBR) has been assessing the need for standardization in biobanking and biospecimen quality standards for postgenomic medical research and technology development. To further this end, OBBR launched the Cancer Human Biobank (caHUB) in 2009. Through the development of publicly available tools and resources, such as standard operating procedures (SOPs), quality measures, and ethical and regulatory guidelines, the caHUB will provide a national infrastructure to support the advancement of molecular medicine. In 2009, OBBR commissioned a large-scale survey and several focus-group research projects through the NCI’s Office of Communication and Education in order to gain insight into the types and quantities of biospecimens and data most needed by the research community as well as to better anticipate the challenges and opportunities OBBR would face in launching caHUB. Also in 2009 OBBR established expert working groups (the Administrative Working Group and eight subgroups) through a Federally Funded Research and Development Center (SAIC-Frederick, Inc.) to provide input in several critical areas, including strategic planning; ethical, legal, and social issues (ELSI); partnerships development; informatics; cost modeling and cost recovery; and biospecimen collection and processing SOPs. The market research, the working group deliverables, and other reports and white papers developed by OBBR staff and expert consultants through early 2011 represent the due diligence performed by OBBR in planning for the establishment of caHUB. In January of 2011, the caHUB budget was significantly reduced, and the scope modified to preclude prospective collection of biospecimens (referred to as the "benchmark collection"). The focus of the pilot phase of caHUB was altered to accommodate the new scope and resource limitations. During the pilot phase, caHUB is focusing on the conduct of biospecimen research to create biospecimen-quality standards and evidence-based protocols. It will continue to provide an array of biospecimen-collection and -processing services in support of strategic, funded NCI and NIH projects. caHUB also continues to develop strategic partnerships with stakeholder groups with the aim of leveraging resources and expertise in the area of biospecimen research and standards development. While the objectives of caHUB have changed since the Working Groups were charged with their mission, the recommendations provided by this team of experts are relevant to any group attempting to improve the reach and impact of its biospecimen sample collection, and continue to inform and guide the implementation of caHUB's biospecimen-research focused mission.