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Last Updated: 03/13/16

References for Best Practices

  1. NCI Best Practices for Biospecimen Resources. http://biospecimens.cancer.gov/practices/.
  2. College of American Pathologists. http://www.cap.org/.
  3. NCI Biospecimen Research Network. http://biospecimens.cancer.gov/researchnetwork/.
  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. http://biospecimens.cancer.gov/resources/sops/default.asp.
  14. NCI BBRB Biospecimen Research Database. https://brd.nci.nih.gov/brd/ (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. http://biospecimens.cancer.gov/resources/bemt.asp.
  17. Matharoo-Ball B, Thomson BJ. Nottingham Health Science Biobank: a sustainable bioresource. Biopreserv Biobank 2014;12(5):312-6.
  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.
  22. Baird P, Frome RJ. Large scale repository design. Cell Pres Technology 2005;3:256-266.
  23. ISBER. Self Assessment Tool. http://www.isber.org/?page=SAT.
  24. Institute NC. Specimen Resource Locator. https://specimens.cancer.gov/tissue/default.htm.
  25. International Society for Biological and Environmental Repositories. http://www.isber.org.
  26. Bioresource Research Impact Factor. http://www.gen2phen.org/groups/brif-bio-resource-impact-factor.
  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.
  28. Portier BP, Wang Z, Downs-Kelly E, et al. Delay to formalin fixation 'cold ischemia time': effect on ERBB2 detection by in-situ hybridization and immunohistochemistry. Mod Pathol 2013;26(1):1-9.
  29. Standardisation and improvement of generic pre-analytical tools and procedures for in-vitro diagnostics (SPIDIA). http://www.spidia.eu/.
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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. http://www.nature.com/authors/policies/reporting.pdf.
  43. Biorepository Accreditation Program. In: College of American Pathologists, (ed): CAP; 2014.
  44. National Cancer Institute. NCI Biospecimen Evidence-Based Practices. http://biospecimens.cancer.gov/resources/bebp.asp.
  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. http://www.cap.org/apps/docs/laboratory_accreditation/lap_info/
    biorepository_accreditation_program_checklist_sample.pdf
    .
  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. http://www.iata.org/training/courses/Pages/infectious-substances-tcgp43.aspx.
  54. US Occupational Safety and Health Agency (OSHA). CFR 1910 Subpart Z, Toxic and Hazardous Substances. https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10147.
  55. Master Control Suite. http://www.mastercontrol.com/.
  56. National Institute of Standards and Technology (NIST). NIST Guide for conducting risk assessments for information security. http://csrc.nist.gov/publications/nistpubs/800-30-rev1/sp800_30_r1.pdf.
  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. http://osp.od.nih.gov/office-biotechnology-activities/biosafety/biosafety-guidance.
  59. Centers for Disease Control & Prevention (CDC). CDC and NIH (National Institutes of Health). Biosafety in Microbiological and Biomedical Laboratories. http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf.
  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. http://oig.hhs.gov/authorities/docs/05/032905FRselectagents.pdf.
  62. US Occupational Safety and Health Agency (OSHA). General Industry Standards 1910. https://www.osha.gov/pls/oshaweb/owastand.display_standard_group?p_toc_level=1&p_part_number=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. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11.
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  66. National Institute of Standards and Technology (NIST). Federal Information Security Management Act (FISMA) Implementation Project. http://csrc.nist.gov/groups/SMA/fisma.
  67. National Cancer Institute. NCI Specimen Resource Locator. https://specimens.cancer.gov/tissue/default.htm.
  68. NIH. NIH Sharing Policy. http://grants.nih.gov/grants/sharing.htm.
  69. National Human Genome Research Institute. NIH Genomic Data Sharing Policy. https://gds.nih.gov/03policy2.html.
  70. US Department of Health and Human Services. Human Subjects Research (45 CFR 46). http://www.hhs.gov/ohrp/humansubjects/guidance/.
  71. US Department of Health and Human Services. 42 CFR Part 50 Subpart F http://www.gpo.gov/fdsys/pkg/CFR-2006-title42-vol1/pdf/CFR-2006-title42-vol1-part50-subpartF.pdf.
  72. US Department of Health and Human Services. HHS Policy for Protection of Human Research Subjects, 45 CFR Part 46 Subpart A http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#subparta.
  73. National Human Genome Research Institute. NHGRI Informed Consent for Genomic Research. http://www.genome.gov/27026588.
  74. US Department of Health and Human Services. OHRP - Guidance on Research Involving Coded Private Information or Biological Specimens. http://www.hhs.gov/ohrp/policy/cdebiol.html.
  75. US Department of Health and Human Services. Exemption for Research and Demonstration Projects on Public Benefit and Service Programs. http://www.hhs.gov/ohrp/policy/exmpt-pb.html.
  76. US Department of Health and Human Services. General requirements for informed consent. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116.
  77. US Department of Health and Human Services. OHRP Policy and Guidance for Informed Consent. http://www.hhs.gov/ohrp/policy/consent/index.html.
  78. US Department of Health and Human Services. OHRP Regulations. http://www.hhs.gov/ohrp/humansubjects/index.html.
  79. National Human Genome Research Institute NHGR. Informed Consent Web Resource for Genomics Research. http://www.genome.gov/27531909.
  80. US Food and Drug Administration (FDA). CFR - Code of Federal Regulations Title 21. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=812.
  81. US Food and Drug Administration (FDA). CFR - Code of Federal Regulations Title 21, Part 50 Protection of Human Subjects. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=50.
  82. US Food and Drug Administration (FDA). CFR - Code of Federal Regulations Title 21, Part 56 IRB. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=56.
  83. NIH Office of Science Policy. Genomic Data Standards Consent Guideance. https://gds.nih.gov/pdf/NIH_Guidance_on_Elements_of_Consent_under_the_GDS_Policy_07-13-2015.pdf.
  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. http://www.genome.gov/27559023.
  91. US Library of Congress. Genetic Information Non-Discrimination Act. http://thomas.loc.gov/cgi-bin/bdquery/z?d110:HR493: .
  92. Office of Human Research Protections (OHRP). Guidance on GINA. http://www.hhs.gov/ohrp/policy/gina.html.
  93. National Human Genome Research Institute (NHGRI). Genetic Discrimination. http://www.genome.gov/10002077#al-2.
  94. US Department of Health and Human Services. Health Insurance Portability and Accountability Act (HIPAA). http://www.hhs.gov/ocr/privacy/.
  95. Center for Medicare and Medicade Services. Clinical Laboratory Improvement Amendments. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/.
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  98. US Government Printing Office. Title 45: Public Welfare PART 164 — SECURITY AND PRIVACY http://www.ecfr.gov/cgi-bin/text-idx?SID=da26a96be9a4467f323a64d682f87bc4&node=sp45.1.164.a&rgn=div6.
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  102. US Department of Health and Human Services.. 45 CFR Parts 160 and 164 http://www.gpo.gov/fdsys/pkg/FR-2013-01-25/pdf/2013-01073.pdf.
  103. NIH Office of Science Policy NOoS. GDS Institutional Certifications. https://gds.nih.gov/Institutional_Certifications.html.
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  107. National Institutes of Health.Grants and Funding. http://grants.nih.gov/grants/policy/coc/index.htm.
  108. National Institutes of Health. dbGAP Code of Conduct. https://dbgap.ncbi.nlm.nih.gov/aa/Code_of_Conduct.html.
  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.
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  113. NIH Office of Science Policy. GDS Data Security Best Practices. http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/GetPdf.cgi?document_name=dbgap_2b_security_procedures.pdf.
  114. US Department of Health and Human Services.. NIH Research Tools Policy. http://grants.nih.gov/grants/intell-property_64FR72090.pdf.
  115. Office of Human ResearchProtections. Exempt Research and Research That May Undergo Expedited Review. http://www.hhs.gov/ohrp/policy/hsdc95-02.html.
  116. National Institutes of Health. Enhanced Access to Archived Publications. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html.
  117. NIH U. Public Access Policy Details. http://publicaccess.nih.gov/policy.htm.
  118. National Institutes of Health. Changes to Public Access Policy. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-042.html.
  119. Association of University Technology Managers. Uniform Biological Material Transfer Agreement. http://www.autm.net/resources-surveys/material-transfer-agreements/uniform-biological-material-transfer-agreement/.
  120. National Institutes of Health. Grants and Funding Conflict of Interest Policy. http://grants.nih.gov/grants/policy/coi/.
  121. National Institutes of Health. NIH Ethics Web Site. https://ethics.od.nih.gov/.