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Last Updated: 03/13/16

References for Best Practices

  1. NCI Best Practices for Biospecimen Resources.
  2. College of American Pathologists.
  3. NCI Biospecimen Research Network.
  4. Aktas B, Sun H, Yao H, et al. Global gene expression changes induced by prolonged cold ischemic stress and preservation method of breast cancer tissue. Mol Oncol 2014;8(3):717-27.
  5. David KA, Unger FT, Uhlig P, et al. Surgical procedures and postsurgical tissue processing significantly affect expression of genes and EGFR-pathway proteins in colorectal cancer tissue. Oncotarget 2014;5(22):11017-28.
  6. Neumeister VM, Anagnostou V, Siddiqui S, et al. Quantitative assessment of effect of preanalytic cold ischemic time on protein expression in breast cancer tissues. J Natl Cancer Inst 2012;104(23):1815-24.
  7. Neumeister VM, Parisi F, England AM, et al. A tissue quality index: an intrinsic control for measurement of effects of preanalytical variables on FFPE tissue. Lab Invest 2014;94(4):467-74.
  8. Hatzis C, Sun H, Yao H, et al. Effects of tissue handling on RNA integrity and microarray measurements from resected breast cancers. J Natl Cancer Inst 2011;103(24):1871-83.
  9. Hassis ME, Niles RK, Braten MN, et al. Evaluating the effects of preanalytical variables on the stability of the human plasma proteome. Anal Biochem 2015;478:14-22.
  10. Vassilakopoulou M, Parisi F, Siddiqui S, et al. Preanalytical variables and phosphoepitope expression in FFPE tissue: quantitative epitope assessment after variable cold ischemic time. Lab Invest 2015;95(3):334-41.
  11. Zhao H, Shen J, Hu Q, et al. Effects of preanalytic variables on circulating microRNAs in whole blood. Cancer Epidemiol Biomarkers Prev 2014;23(12):2643-8.
  12. Engel KB, Vaught J, Moore HM. National Cancer Institute Biospecimen Evidence-Based Practices: a novel approach to pre-analytical standardization. Biopreserv Biobank 2014;12(2):148-50.
  13. NCI BBRB Standard Operating Procedures Library.
  14. NCI BBRB Biospecimen Research Database. (4 November 2015; date last accessed).
  15. 2012 best practices for repositories collection, storage, retrieval, and distribution of biological materials for research international society for biological and environmental repositories. Biopreserv Biobank 2012;10(2):79-161.
  16. NCI Biospecimen Economic Modeling Tool.
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  18. Bromley RL. Financial stability in biobanking: unique challenges for disease-focused foundations and patient advocacy organizations. Biopreserv Biobank 2014;12(5):294-9.
  19. Barnes RO, Schacter B, Kodeeswaran S, et al. Funding sources for Canadian biorepositories: the role of user fees and strategies to help fill the gap. Biopreserv Biobank 2014;12(5):300-5.
  20. Albert M, Bartlett J, Johnston RN, et al. Biobank bootstrapping: is biobank sustainability possible through cost recovery? Biopreserv Biobank 2014;12(6):374-80.
  21. Vaught J, Rogers J, Carolin T, et al. Biobankonomics: developing a sustainable business model approach for the formation of a human tissue biobank. J Natl Cancer Inst Monogr 2011;2011(42):24-31.
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  23. ISBER. Self Assessment Tool.
  24. Institute NC. Specimen Resource Locator.
  25. International Society for Biological and Environmental Repositories.
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  27. Poste G, Carbone DP, Parkinson DR, et al. Leveling the playing field: bringing development of biomarkers and molecular diagnostics up to the standards for drug development. Clin Cancer Res 2012;18(6):1515-23.
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  29. Standardisation and improvement of generic pre-analytical tools and procedures for in-vitro diagnostics (SPIDIA).
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  31. Malentacchi F, Ciniselli CM, Pazzagli M, et al. Influence of pre-analytical procedures on genomic DNA integrity in blood samples: the SPIDIA experience. Clin Chim Acta 2015;440:205-10.
  32. Malentacchi F, Pizzamiglio S, Verderio P, et al. Influence of storage conditions and extraction methods on the quantity and quality of circulating cell-free DNA (ccfDNA): the SPIDIA-DNAplas External Quality Assessment experience. Clin Chem Lab Med 2015; 10.1515/cclm-2014-1161.
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  35. Spruessel A, Steimann G, Jung M, et al. Tissue ischemia time affects gene and protein expression patterns within minutes following surgical tumor excision. Biotechniques 2004;36(6):1030-7.
  36. Lin DW, Coleman IM, Hawley S, et al. Influence of surgical manipulation on prostate gene expression: implications for molecular correlates of treatment effects and disease prognosis. J Clin Oncol 2006;24(23):3763-70.
  37. Ma Y, Dai H, Kong X. Impact of warm ischemia on gene expression analysis in surgically removed biosamples. Anal Biochem 2012;423(2):229-35.
  38. Groelz D, Sobin L, Branton P, et al. Non-formalin fixative versus formalin-fixed tissue: a comparison of histology and RNA quality. Exp Mol Pathol 2013;94(1):188-94.
  39. Moore HM, Kelly AB, Jewell SD, et al. Biospecimen reporting for improved study quality (BRISQ). J Proteome Res 2011;10(8):3429-38.
  40. Moore HM, Kelly A, McShane LM, et al. Biospecimen reporting for improved study quality (BRISQ). Clin Chim Acta 2012;413(15-16):1305.
  41. Moore HM, Kelly AB, Jewell SD, et al. Biospecimen reporting for improved study quality (BRISQ). Cancer Cytopathol 2011;119(2):92-101.
  42. Nature Publishing Group. Nature Policy Guide for Authors.
  43. Biorepository Accreditation Program. In: College of American Pathologists, (ed): CAP; 2014.
  44. National Cancer Institute. NCI Biospecimen Evidence-Based Practices.
  45. Vaught JB, Hsing AW. Methodologic data: important foundation for molecular and biomarker studies. Cancer Epidemiol Biomarkers Prev 2010;19(4):901-2.
  46. Clement O, Whitney S, Muller-Cohn J, et al. Following nature's lead: generating compounds for stabilizing biomolecules. Biopreserv Biobank 2012;10(4):395-402.
  47. CAP Biorepository Accreditation Program Checklist.
  48. Hubel A, Spindler R, Skubitz AP. Storage of human biospecimens: selection of the optimal storage temperature. Biopreserv Biobank 2014;12(3):165-75.
  49. Xie R, Chung JY, Ylaya K, et al. Factors influencing the degradation of archival formalin-fixed paraffin-embedded tissue sections. J Histochem Cytochem 2011;59(4):356-65.
  50. Hayes RB, Smith CO, Huang WY, et al. Whole blood cryopreservation in epidemiological studies. Cancer Epidemiol Biomarkers Prev 2002;11(11):1496-8.
  51. Bell WC, Sexton KC, Grizzle WE. Organizational issues in providing high-quality human tissues and clinical information for the support of biomedical research. Methods Mol Biol 2010;576:1-30.
  52. Engel KB, Moore HM. Effects of preanalytical variables on the detection of proteins by immunohistochemistry in formalin-fixed, paraffin-embedded tissue. Arch Pathol Lab Med 2011;135(5):537-43.
  53. International Air Transport Association (IATA). Shipping Guidelines for Infectious Substances.
  54. US Occupational Safety and Health Agency (OSHA). CFR 1910 Subpart Z, Toxic and Hazardous Substances.
  55. Master Control Suite.
  56. National Institute of Standards and Technology (NIST). NIST Guide for conducting risk assessments for information security.
  57. Grizzle WE, Fredenburgh J. Avoiding biohazards in medical, veterinary and research laboratories. Biotech Histochem 2001;76(4):183-206.
  58. NIH Office of Science Policy. Biosafety Guidance.
  59. Centers for Disease Control & Prevention (CDC). CDC and NIH (National Institutes of Health). Biosafety in Microbiological and Biomedical Laboratories.
  60. Schmid I, Lambert C, Ambrozak D, et al. International Society for Analytical Cytology biosafety standard for sorting of unfixed cells. Cytometry A 2007;71(6):414-37.
  61. US Code of Federal Regulations. 42 CFR Parts 72 and 73: Possession, Use, and Transfer of Select Agents and Toxins; Final Rule.
  62. US Occupational Safety and Health Agency (OSHA). General Industry Standards 1910.
  63. Riegman PH, Morente MM, Betsou F, et al. Biobanking for better healthcare. Mol Oncol 2008;2(3):213-22.
  64. US Food and Drug Administration.
  65. Sandhu R, Ferruiolo, D, Kuhn, R. The NIST Model for Role-Based Access Control: Toward a Unified Standard. National Inst for Standards and Technology document 2000,
  66. National Institute of Standards and Technology (NIST). Federal Information Security Management Act (FISMA) Implementation Project.
  67. National Cancer Institute. NCI Specimen Resource Locator.
  68. NIH. NIH Sharing Policy.
  69. National Human Genome Research Institute. NIH Genomic Data Sharing Policy.
  70. US Department of Health and Human Services. Human Subjects Research (45 CFR 46).
  71. US Department of Health and Human Services. 42 CFR Part 50 Subpart F
  72. US Department of Health and Human Services. HHS Policy for Protection of Human Research Subjects, 45 CFR Part 46 Subpart A
  73. National Human Genome Research Institute. NHGRI Informed Consent for Genomic Research.
  74. US Department of Health and Human Services. OHRP - Guidance on Research Involving Coded Private Information or Biological Specimens.
  75. US Department of Health and Human Services. Exemption for Research and Demonstration Projects on Public Benefit and Service Programs.
  76. US Department of Health and Human Services. General requirements for informed consent.
  77. US Department of Health and Human Services. OHRP Policy and Guidance for Informed Consent.
  78. US Department of Health and Human Services. OHRP Regulations.
  79. National Human Genome Research Institute NHGR. Informed Consent Web Resource for Genomics Research.
  80. US Food and Drug Administration (FDA). CFR - Code of Federal Regulations Title 21.
  81. US Food and Drug Administration (FDA). CFR - Code of Federal Regulations Title 21, Part 50 Protection of Human Subjects.
  82. US Food and Drug Administration (FDA). CFR - Code of Federal Regulations Title 21, Part 56 IRB.
  83. NIH Office of Science Policy. Genomic Data Standards Consent Guideance.
  84. Andrews LB. Harnessing the benefits of biobanks. J Law Med Ethics 2005;33(1):22-30.
  85. Burhansstipanov L, Bemis L, Kaur JS, et al. Sample genetic policy language for research conducted with native communities. J Cancer Educ 2005;20(1 Suppl):52-7.
  86. Hewitt R, Watson PH, Dhir R, et al. Timing of consent for the research use of surgically removed tissue: is postoperative consenting acceptable? Cancer 2009;115(1):4-9.
  87. Kiviniemi MT, Saad-Harfouche FG, Ciupak GL, et al. Pilot intervention outcomes of an educational program for biospecimen research participation. J Cancer Educ 2013;28(1):52-9.
  88. Lemke AA, Wu JT, Waudby C, et al. Community engagement in biobanking: Experiences from the eMERGE Network. Genomics Soc Policy 2010;6(3):35-52.
  89. Hiratsuka V, Brown J, Dillard D. Views of biobanking research among Alaska native people: the role of community context. Prog Community Health Partnersh 2012;6(2):131-9.
  90. National Human Genome Research Institute (NHGRI). Informed Consent Sample Documents.
  91. US Library of Congress. Genetic Information Non-Discrimination Act. .
  92. Office of Human Research Protections (OHRP). Guidance on GINA.
  93. National Human Genome Research Institute (NHGRI). Genetic Discrimination.
  94. US Department of Health and Human Services. Health Insurance Portability and Accountability Act (HIPAA).
  95. Center for Medicare and Medicade Services. Clinical Laboratory Improvement Amendments.
  96. Wendler D. Consent for research with biological samples: one-time general consent versus a gift model. Ann Intern Med 2012;156(8):596-8.
  97. Eiseman E BG, Brower J, et al. Case Studies of Existing Human Tissue Repositories: “Best Practices” for a Biospecimen Resource for the Genomic and Proteomic Era. . Santa Monica, CA: RAND Corporation; 2003.
  98. US Government Printing Office. Title 45: Public Welfare PART 164 — SECURITY AND PRIVACY
  99. US Government Printing Office. Title 45: Public Welfare PART 160 — GENERAL ADMINISTRATIVE REQUIREMENTS
  100. National Institutes of Health. Research Repositories, Databases, and the HIPAA Privacy Rule.
  101. US Department of Health and Human Services. Summary of HIPAA Security Rule.
  102. US Department of Health and Human Services.. 45 CFR Parts 160 and 164
  103. NIH Office of Science Policy NOoS. GDS Institutional Certifications.
  104. Merz JF, Sankar P, Taube SE, et al. Use of human tissues in research: clarifying clinician and researcher roles and information flows. J Investig Med 1997;45(5):252-7.
  105. Sankar P, Mora S, Merz JF, et al. Patient perspectives of medical confidentiality: a review of the literature. J Gen Intern Med 2003;18(8):659-69.
  106. Cornell University Law Institute. 42 U.S. Code § 241 — Research and investigations generally.
  107. National Institutes of Health.Grants and Funding.
  108. National Institutes of Health. dbGAP Code of Conduct.
  109. Homer N, Szelinger S, Redman M, et al. Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping microarrays. PLoS Genet 2008;4(8):e1000167.
  110. Schadt EE, Woo S, Hao K. Bayesian method to predict individual SNP genotypes from gene expression data. Nat Genet 2012;44(5):603-8.
  111. Gymrek M, McGuire AL, Golan D, et al. Identifying personal genomes by surname inference. Science 2013;339(6117):321-4.
  112. NIH Office of Science Policy. GDS Data Use Certification.
  113. NIH Office of Science Policy. GDS Data Security Best Practices.
  114. US Department of Health and Human Services.. NIH Research Tools Policy.
  115. Office of Human ResearchProtections. Exempt Research and Research That May Undergo Expedited Review.
  116. National Institutes of Health. Enhanced Access to Archived Publications.
  117. NIH U. Public Access Policy Details.
  118. National Institutes of Health. Changes to Public Access Policy.
  119. Association of University Technology Managers. Uniform Biological Material Transfer Agreement.
  120. National Institutes of Health. Grants and Funding Conflict of Interest Policy.
  121. National Institutes of Health. NIH Ethics Web Site.