Cover -- Preface -- The RAND Corporation Quality Assurance Process -- Contents -- Figure and Tables -- Summary -- Acknowledgments -- Abbreviations -- CHAPTER ONE -- Introduction -- Background -- National Dialogue on Cancer -- RAND Study -- Purpose -- Description of Study -- Organization of This Report -- CHAPTER TWO -- Methodology -- Selection of Repositories -- Interviews -- Repositories Evaluated -- Government -- Academia -- Industry -- Repositories Not Included in the Evaluation -- SPOREs -- IMPATH Inc. -- National Surgical Adjuvant Breast and Bowel Project (NSABP) -- Program for Critical Technologies in Molecular Medicine -- Determining "Best Practices" -- Types of Information Not Shared -- CHAPTER THREE -- Biospecimen Collection, Processing, Annotation, Storage, and Distribution -- Biospecimen Collection -- Tissue Sources -- Minority Populations, Children, and Foreign Tissue Sources -- Collection Locations -- Biospecimen Collection -- Centralized Versus Decentralized Collection and Storage -- Quality Assurance, Auditing, and Standardization for Biospecimen Collection -- Biospecimen Processing and Annotation -- Biospecimen Processing -- Tissue Characterization and Quality Control Testing of Biospecimens -- Data Collection and Specimen Annotation -- Longitudinal Data -- Quality Assurance, Auditing, and Standardization for Processing of Biospecimens -- Quality Assurance, Auditing, and Standardization for Annotation of Biospecimens -- Biospecimen Storage -- Number and Types of Tissue in Storage -- Storage Techniques -- Freezer Maintenance and Backup -- Quality Control, Auditing, and Standardization for Biospecimen Storage -- Specimen Distribution -- Shipment of Samples to Researchers -- Quality Assurance and Standardization of Biospecimen Collection, Processing, Annotation, Storage, and Distribution -- Best Practices -- Biospecimen Collection.

Biospecimen Processing and Annotation -- Biospecimen Storage and Distribution -- Quality Assurance and Standardization of Biospecimen Collection, Storage, Processing, Annotation, and Distribution -- CHAPTER FOUR -- Bioinformatics and Data Management -- Use of Bioinformatics Systems -- Types of Data Contained in Bioinformatics Systems -- Data Accessibility -- Bioinformatics System Security -- Quality Control, Auditing, and Standardization for Bioinformatics Systems -- Best Practices -- CHAPTER FIVE -- Consumer/User Needs -- Customer Profile -- Academic, Government, and Industry Users -- Distribution of Samples Outside the Institution -- Meeting Researcher Needs -- Review and Prioritization of Requests for Tissue -- Unmet User Needs -- Tracking the Use of Biospecimens -- Types of Research/Use of Samples -- Metrics and Feedback on Repository Use -- Best Practices -- CHAPTER SIX -- Business Plan and Operations -- Government Repositories -- Academic Repositories -- Industry Repositories -- Repository/Collection Site Relationships -- Repository Operations -- Lessons Learned -- Repository Model -- Banking Versus Prospective Collection -- Centralized Versus Decentralized -- Costs -- Repository Costs -- Costs to Researchers -- Developing and Adopting New Technologies -- Tracking of Sample Use -- Acknowledgments in Publications -- Best Practices -- CHAPTER SEVEN -- Privacy, Ethical Concerns, and Consent Issues -- Identifiability of Tissue -- Institutional Review Boards -- Protection of Privacy and Confidentiality -- Impact of Federal and State Privacy Laws -- Consent Issues -- Best Practices -- CHAPTER EIGHT -- Intellectual Property and Legal Issues -- Policies Regarding Intellectual Property Rights -- Rights of Tissue Source and Contributing Institutions to Tissue -- Compensation -- Agreements Used in Tissue Distribution -- Liability Issues.

Ensuring Responsible Use of Resources -- Best Practices -- CHAPTER NINE -- Public Relations, Marketing, and Education -- Marketing -- Outreach, Patient Education, and Post-Research Communications -- Best Practices -- CHAPTER TEN -- Findings and Summary of Best Practices -- Findings -- Cooperative Human Tissue Network -- Tissue Array Research Program -- Early Detection Research Network -- Philadelphia Familial Breast Cancer Registry -- National Heart, Blood, and Lung Institute -- Armed Forces Institute of Pathology National Pathology Repository -- Duke University Breast SPORE -- Mayo Clinic Prostate SPORE -- University of Alabama at Birmingham Breast and Ovarian SPOREs -- University of Pittsburgh Health Sciences Tissue Bank -- Ardais -- Genomics Collaborative Inc. -- Best Practices -- Best Practices for Biospecimen Collection, Processing, Annotation, Storage, and Distribution -- Best Practices for Bioinformatics -- Best Practices for Consumer/User Needs -- Best Practices for Business Plan and Operations -- Best Practices for Privacy, Ethical Concerns, and Consent Issues -- Best Practices for Intellectual Property and Legal Issues -- Best Practices for Public Relations, Marketing, and Education -- Conclusions -- APPENDIX Interview Instrument for RAND Evaluation of Existing Tissue Resources -- Glossary -- References.