tive and efficient health research. Its recommendations included improving data and privacy security and the proper application of privacy protections.

Conducting Biosocial Surveys: Collecting, Storing, Accessing, and Protecting Biospecimens and Biodata (NRC, 2010) evaluated the best approaches to the collection, storage, use, and sharing of biospecimens gathered in social-science surveys and studies. The committee recommended that potentially sensitive data or data that could be used to identify a particular research subject should be shared only under very restricted circumstances and only if the data have been encrypted. The report also recommended that the National Institutes of Health develop procedural standards that would maintain the privacy of data held in repositories, including the use of informed consents.

Establishing Precompetitive Collaborations to Stimulate GenomicsDriven Drug Development (IOM, 2011) summarized the results of a July 2010 workshop convened to elucidate a conceptual framework for the sharing of stored biospecimens and associated data by academe, industry, government, and other stakeholders. Speakers emphasized that high-quality data can be derived only from high-quality biospecimens. Workshop participant Carolyn Compton, a member of the present committee, noted that the salient question was not “Can I get access to existing samples?” but “Do I want them?” Highly variable specimen quality and lack of consent for research use were among the other identified barriers to effective research.

ORGANIZATION OF THIS REPORT

The remainder of this report is divided into three chapters and supporting appendixes. Chapter 2 addresses the determinants of the research value of biospecimens held in repositories, concentrating on scientific and technical considerations. It begins with a summary of the means by which specimens are preserved and an explication of the education, clinical care, and research uses to which they are put. The text then describes the technologies used to manage specimen and data acquisition and to maintain and analyze specimens and data. It concludes with a discussion of the scientific and technical limitations on using in research samples that were originally obtained for pathology purposes.

Legal, ethical, and regulatory considerations regarding the use of repository specimens in clinical care, education, and research activities are taken up in Chapter 3. It begins with a general discussion of these considerations and previous scholarly work concerning them. The text then addresses considerations regarding the source of specimens, before finishing with an examination of the federal laws and regulations, DoD rules, and



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