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Case Studies of Existing Human Tissue Repositories

Case Studies of Existing Human Tissue Repositories: "Best Practices" for a Biospecimen Resource for the Genomic and Proteomic Era

Elisa Eiseman
Gabrielle Bloom
Jennifer Brower
Noreen Clancy
Stuart S. Olmsted
Copyright Date: 2003
Edition: 1
Published by: RAND Corporation
Pages: 246
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  • Book Info
    Case Studies of Existing Human Tissue Repositories
    Book Description:

    Case studies of twelve existing human biospecimen repositories performed to evaluate their utility for genomics- and proteomics-based cancer research and to identify "best practices" in collection, processing, annotation, storage, privacy, ethical concerns, informed consent, business plans, operations, intellectual property rights, public relations, marketing, and education that would be useful in designing a national biospecimen network.

    eISBN: 978-0-8330-3593-6
    Subjects: Health Sciences, Technology

Table of Contents

  1. Front Matter
    (pp. i-ii)
  2. Preface
    (pp. iii-iv)
  3. The RAND Corporation Quality Assurance Process
    (pp. v-vi)
  4. Table of Contents
    (pp. vii-xii)
  5. Figure and Tables
    (pp. xiii-xiv)
  6. Summary
    (pp. xv-xxx)
  7. Acknowledgments
    (pp. xxxi-xxxiv)
  8. Abbreviations
    (pp. xxxv-xxxviii)
  9. CHAPTER ONE Introduction
    (pp. 1-6)

    Human tissue has been stored for more than 100 years in the United States. An earlier RAND study conservatively estimated that there were more than 307 million tissue specimens from more than 178 million cases stored in the United States, accumulating at a rate of more than 20 million specimens per year (Eiseman and Haga, 1999). These tissue specimens are stored at military facilities, the National Institutes of Health (NIH) and its sponsored facilities, other federal agencies, state collection agencies (e.g., state forensic DNA banks and newborn screening laboratories), diagnostic pathology and cytology laboratories, university- and hospital-based research laboratories, commercial...

  10. CHAPTER TWO Methodology
    (pp. 7-26)

    RAND evaluated existing human tissue resources at several tissue repositories in the United States chosen to represent a broad spectrum of repository types and allow the description of a wide array of best practices that might be used by the National Biospecimen Network (NBN). RAND identified these repositories in conjunction with the sponsor to meet the criteria described below.

    The repositories were selected to represent resources funded primarily by the federal government or the private sector and are located at federal agencies, academic institutions, and private companies.

    They also represent a range of operating models:

    Banking versus prospective collection and...

  11. CHAPTER THREE Biospecimen Collection, Processing, Annotation, Storage, and Distribution
    (pp. 27-83)

    Each biospecimen repository evaluated for this study was established to fulfill a specific set of objectives, and the design of each repository is integrally linked to those objectives. Techniques for tissue collection, processing, annotation, and storage—the core functions of a biospecimen repository—vary depending on the purpose for which the repository was established. Likewise, the quality and extent of information collected with the specimens vary depending on the purpose for which the tissue was originally collected. Details about biospecimen collection, processing, annotation, storage, and distribution at each repository evaluated and the best practices identified are described in this chapter....

  12. CHAPTER FOUR Bioinformatics and Data Management
    (pp. 84-95)

    A critical part of the design of a tissue repository is the bioinformatics and data management system. Bioinformatics is an evolving discipline that has been defined in several ways, but all definitions emphasize the use of computer and statistical methods to understand biological data.¹ Bioinformatics often refers to research involving genomics, the study of the genes and their function in a genome, and proteomics, the study of proteins and their function in the genome.²

    The RAND interview instrument addressed questions regarding the use of bioinformatics systems at the sites, including standardization of data reporting, data searching and mining capabilities, accessibility...

  13. CHAPTER FIVE Consumer/User Needs
    (pp. 96-107)

    Ensuring that a repository meets its user needs involves continual self-assessment and re-evaluation. Repository users in the academic, government, and industry sectors may have different needs or impose different kinds of demands on their repositories. It is important, therefore, to analyze each repository in terms of its initial design and intent as well as its actual customer profile and demonstrated effectiveness.

    The consumers of biospecimen repositories include academia, government, and industry. In general, the commercial repositories—Ardais and GCI—sent a higher percentage of their biospecimens to industry than did the academic centers (see Table 5.1). GCI’s mission is to...

  14. CHAPTER SIX Business Plan and Operations
    (pp. 108-120)

    RAND evaluated twelve repositories, which were grouped into three general sectors: government, academia, and industry (see Chapter Two, Table 2.1). The first category, government, includes two repositories funded by and operated by federal agencies, one repository contracted by a federal agency, and three repositories funded through cooperative agreements with a federal agency. The second category, academia, includes repositories at three major academic medical centers that are funded through Specialized Center Grants (P50s) from NCI, and one repository at a major academic medical center that houses both NCI-funded resources and institute-funded programs. The third category, industry, includes two private companies that...

  15. CHAPTER SEVEN Privacy, Ethical Concerns, and Consent Issues
    (pp. 121-137)

    A major concern with the storage and distribution of biospecimens is protecting the privacy of individuals who contribute specimens to the repository and maintaining the confidentiality of the associated data. Another issue is ensuring that these individuals are treated ethically. There are several layers of oversight of research involving human participants, including federal regulations governing research with human participants (the Federal Policy for the Protection of Human Subjects (45 C.F.R. §46; the Common Rule); and the FDA Protection of Human Subjects Regulations (Title 21 C.F.R. Part 50 and Part 56)), state legislation governing the privacy of and research use of...

  16. CHAPTER EIGHT Intellectual Property and Legal Issues
    (pp. 138-145)

    The repositories’ practices and procedures are generally based on the presence of developed standards and policies associated with research involving human participants, and it seems that few problems have been encountered regarding intellectual property or liability. In this chapter, we describe some of the specific mechanisms the institutions have in place to ensure that these policies and procedures are clear and consistent.

    The majority of repositories do not retain any intellectual property rights to the samples they distribute, unless they are performing the research in collaboration with other researchers, in which case the intellectual property rights are shared. Similarly, institutions...

  17. CHAPTER NINE Public Relations, Marketing, and Education
    (pp. 146-148)

    Public relations, marketing, and education are critical to the success of large tissue repositories and repositories for rare conditions. The repositories evaluated use a combination of approaches to increase the visibility of their resource and mission.

    The repositories use a variety of means to market themselves to researchers, including advertisements in major journals (e.g.,ScienceandNature), exhibits at appropriate professional conferences, direct mailings, word of mouth, and Web sites for the repositories and associated clinical trials and research projects. Some of the smaller repositories do not market themselves at all. CHTN uses exhibits at scientific meetings and mailings to...

  18. CHAPTER TEN Findings and Summary of Best Practices
    (pp. 149-192)

    Each of the repositories evaluated for this study was established to fulfill specific needs, and its procedures and operations were designed to enable it to do so. Thus, each repository’s design is integrally linked to the needs it was established to fulfill. Table 10.1 summarizes the findings presented in Chapters Three through Nine for each of the repositories evaluated for this study. The design and operation of each repository and other relevant findings are detailed in the first half of this chapter.

    CHTN is an NCI-funded repository that prospectively collects and distributes over 60,000 tissue samples per year to academic,...

  19. APPENDIX: Interview Instrument for RAND Evaluation of Existing Tissue Resources
    (pp. 193-202)
  20. Glossary
    (pp. 203-206)
  21. References
    (pp. 207-208)