Human biospecimens have played a crucial role in scientific and medical advances. Although the ethical and policy issues associated with biospecimen research have long been the subject of scholarly debate, the story of Henrietta Lacks, her family, and the creation of HeLa cells captured the attention of a much broader audience. The story has been a catalyst for policy change, including major regulatory changes proposed in the United States surrounding informed consent. These proposals are premised in part on public opinion data, necessitating a closer look at what such data tell us. The development of biospecimen policy should be informed by many considerations—one of which is public input, robustly gathered, on acceptable approaches that optimize shared interests, including access for all to the benefits of research. There is a need for consent approaches that are guided by realistic aspirations and a balanced view of autonomy within an expanded ethical framework.


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Literature Cited

  1. Albala I, Doyle M, Appelbaum PS. 1.  2010. The evolution of consent forms for research: a quarter century of changes. IRB 32:7–11 [Google Scholar]
  2. Ball MP, Bobe JR, Chou MF, Clegg T, Estep PW. 2.  et al. 2014. Harvard Personal Genome Project: lessons from participatory public research. Genome Med. 6:10 [Google Scholar]
  3. Bathe OF, McGuire AL. 3.  2009. The ethical use of existing samples for genome research. Genet. Med. 11:712–15 [Google Scholar]
  4. Beardsley E, Jefford M, Mileshkin L. 4.  2007. Longer consent forms for clinical trials compromise patient understanding: So why are they lengthening?. J. Clin. Oncol. 25:e13–14 [Google Scholar]
  5. Bergenmar M, Johansson H, Wilking N. 5.  2011. Levels of knowledge and perceived understanding among participants in cancer clinical trials—factors related to the informed consent procedure. Clin. Trials 8:77–84 [Google Scholar]
  6. Bergenmar M, Molin C, Wilking N, Brandberg Y. 6.  2008. Knowledge and understanding among cancer patients consenting to participate in clinical trials. Eur. J. Cancer 44:2627–33 [Google Scholar]
  7. Beskow LM, Burke W, Fullerton SM, Sharp RR. 7.  2012. Offering aggregate results to participants in genomic research: opportunities and challenges. Genet. Med. 14:490–96 [Google Scholar]
  8. Beskow LM, Dean E. 8.  2008. Informed consent for biorepositories: assessing prospective participants’ understanding and opinions. Cancer Epidemiol. Biomark. Prev. 17:1440–51 [Google Scholar]
  9. Beskow LM, Dombeck CB, Thompson CP, Watson-Ormond JK, Weinfurt KP. 9.  2015. Informed consent for biobanking: consensus-based guidelines for adequate comprehension. Genet. Med. 17:226–33 [Google Scholar]
  10. Beskow LM, Friedman JY, Hardy NC, Lin L, Weinfurt KP. 10.  2010. Developing a simplified consent form for biobanking. PLOS ONE 5:e13302 [Google Scholar]
  11. Beskow LM, Friedman JY, Hardy NC, Lin L, Weinfurt KP. 11.  2010. Simplifying informed consent for biorepositories: stakeholder perspectives. Genet. Med. 12:567–72 [Google Scholar]
  12. Beskow LM, Smolek SJ. 12.  2009. Prospective biorepository participants’ perspectives on access to research results. J. Empir. Res. Hum. Res. Ethics 4:99–111 [Google Scholar]
  13. Bledsoe MJ, Grizzle WE. 13.  2013. Use of human specimens in research: the evolving United States regulatory, policy, and scientific landscape. Diagn. Histopathol. 19:322–30 [Google Scholar]
  14. Bloss CS. 14.  2013. Does family always matter? Public genomes and their effect on relatives. Genome Med. 5:107 [Google Scholar]
  15. Blumberg BS, Millman I, London WT. 15.  1985. Ted Slavin's blood and the development of HBV vaccine. N. Engl. J. Med. 312:189 [Google Scholar]
  16. Botkin JR. 16.  2015. Crushing consent under the weight of expectations. Am. J. Bioeth. 15:47–49 [Google Scholar]
  17. Botkin JR. 17.  2015. Waving goodbye to waivers of consent. Hastings Cent. Rep. 45 inside back cover [Google Scholar]
  18. Botkin JR, Rothwell E, Anderson R, Stark L, Goldenberg A. 18.  et al. 2012. Public attitudes regarding the use of residual newborn screening specimens for research. Pediatrics 129:231–38 [Google Scholar]
  19. Breese P, Burman W, Rietmeijer C, Lezotte D. 19.  2004. The Health Insurance Portability and Accountability Act and the informed consent process. Ann. Intern. Med. 141:897–98 [Google Scholar]
  20. Callier S, Husain R, Simpson R. 20.  2014. Genomic data-sharing: What will be our legacy?. Front. Genet. 5:34 [Google Scholar]
  21. Caulfield T. 21.  2007. Biobanks and blanket consent: the proper place of the public good and public perception rationales. King's Law J. 18:209–26 [Google Scholar]
  22. Caulfield T, McGuire AL. 22.  2013. Policy uncertainty, sequencing, and cell lines. G3 3:1205–7 [Google Scholar]
  23. Chadwick R, Berg K. 23.  2001. Solidarity and equity: new ethical frameworks for genetic databases. Nat. Rev. Genet. 2:318–21 [Google Scholar]
  24. Chan TW, Mackey S, Hegney DG. 24.  2012. Patients’ experiences on donation of their residual biological samples and the impact of these experiences on the type of consent given for the future research use of the tissue: a systematic review. Int. J. Evid. Based Healthc. 10:9–26 [Google Scholar]
  25. Cohn E, Larson E. 25.  2007. Improving participant comprehension in the informed consent process. J. Nurs. Sch. 39:273–80 [Google Scholar]
  26. Collins FS, Varmus H. 26.  2015. A new initiative on precision medicine. N. Engl. J. Med. 372:793–95 [Google Scholar]
  27. Corrigan O. 27.  2003. Empty ethics: the problem with informed consent. Sociol. Health Illn. 25:768–92 [Google Scholar]
  28. Couzin-Frankel J. 28.  2010. Researchers to return blood samples to the Yanomamö. Science 328:1218 [Google Scholar]
  29. Cressey D. 29.  2012. Informed consent on trial. Nature 482:16 [Google Scholar]
  30. Cunningham S, O'Doherty KC, Senecal K, Secko D, Avard D. 30.  2015. Public concerns regarding the storage and secondary uses of residual newborn bloodspots: an analysis of print media, legal cases, and public engagement activities. J. Community Genet. 6:117–28 [Google Scholar]
  31. D'Abramo F, Schildmann J, Vollmann J. 31.  2015. Research participants’ perceptions and views on consent for biobank research: a review of empirical data and ethical analysis. BMC Med. Ethics 16:60 [Google Scholar]
  32. De Vries ROB, Gordijn B. 32.  2009. Empirical ethics and its alleged meta-ethical fallacies. Bioethics 23:193–201 [Google Scholar]
  33. 33. Editorial 2013. Privacy and protection in the genomic era. Nat. Med. 19:1073 [Google Scholar]
  34. Emanuel EJ. 34.  2015. Reform of clinical research regulations, finally. N. Engl. J. Med. 373:2296–99 [Google Scholar]
  35. Emanuel EJ, Grady C. 35.  2008. Case study. Is longer always better?. Commentary. Hastings Cent. Rep. 38:10–11 [Google Scholar]
  36. Ewing AT, Erby LA, Bollinger J, Tetteyfio E, Ricks-Santi LJ, Kaufman D. 36.  2015. Demographic differences in willingness to provide broad and narrow consent for biobank research. Biopreserv. Biobank. 13:98–106 [Google Scholar]
  37. Faden R, Powers M. 37.  2011. A social justice framework for health and science policy. Camb. Q. Healthc. Ethics 20:596–604 [Google Scholar]
  38. Feldman R. 38.  2011. Whose body is it anyway? Human cells and the strange effects of property and intellectual property law. Stanford Law Rev. 63:1377–402 [Google Scholar]
  39. Flory J, Emanuel E. 39.  2004. Interventions to improve research participants’ understanding in informed consent for research: a systematic review. JAMA 292:1593–601 [Google Scholar]
  40. Forsberg JS, Hansson MG, Evers K. 40.  2013. International guidelines on biobank research leave researchers in ambiguity: Why is this so?. Eur. J. Epidemiol. 28:449–51 [Google Scholar]
  41. Fullerton SM, Anderson NR, Guzauskas G, Freeman D, Fryer-Edwards K. 41.  2010. Meeting the governance challenges of next-generation biorepository research. Sci. Transl. Med. 2: 15cm3 [Google Scholar]
  42. Gamble VN. 42.  2014. The Immortal Life of Henrietta Lacks reconsidered. Hastings Cent. Rep 44inside back cover [Google Scholar]
  43. Garrison NA, Sathe NA, Antommaria AHM, Holm IA, Sanderson SC. 43.  et al. 2016. A systematic literature review of individuals’ perspectives on broad consent and data sharing in the United States. Genet. Med. 18663–71 [Google Scholar]
  44. Giesbertz NA, Bredenoord AL, van Delden JJ. 44.  2012. Inclusion of residual tissue in biobanks: opt-in or opt-out?. PLOS Biol. 10:e1001373 [Google Scholar]
  45. Gottweis H, Chen H, Starkbaum J. 45.  2011. Biobanks and the phantom public. Hum. Genet. 130:433–40 [Google Scholar]
  46. Grady C. 46.  2015. Enduring and emerging challenges of informed consent. N. Engl. J. Med. 372:2172 [Google Scholar]
  47. Grady C, Eckstein L, Berkman B, Brock D, Cook-Deegan R. 47.  et al. 2015. Broad consent for research with biological samples: workshop conclusions. Am. J. Bioeth. 15:34–42 [Google Scholar]
  48. Greely HT. 48.  2007. The uneasy ethical and legal underpinnings of large-scale genomic biobanks. Annu. Rev. Genom. Hum. Genet. 8:343–64 [Google Scholar]
  49. Greely HT, Cho MK. 49.  2013. The Henrietta Lacks legacy grows. EMBO Rep. 14:849 [Google Scholar]
  50. Grizzle WE. 50.  2015. Missed opportunities and lost lives: consequences of some proposed changes to regulations on research with human tissues—letter. Clin. Cancer Res. 21:5404–5 [Google Scholar]
  51. Gymrek M, McGuire AL, Golan D, Halperin E, Erlich Y. 51.  2013. Identifying personal genomes by surname inference. Science 339:321–24 [Google Scholar]
  52. Hansson MG, Dillner J, Bartram CR, Carlson JA, Helgesson G. 52.  2006. Should donors be allowed to give broad consent to future biobank research?. Lancet Oncol. 7:266–69 [Google Scholar]
  53. Hayden EC. 53.  2012. Informed consent: a broken contract. Nature 486:312–14 [Google Scholar]
  54. Helgesson G. 54.  2012. In defense of broad consent. Camb. Q. Healthc. Ethics 21:40–50 [Google Scholar]
  55. Henderson GE. 55.  2011. Is informed consent broken?. Am. J. Med. Sci. 342:267–72 [Google Scholar]
  56. Henderson GE, Cadigan RJ, Edwards TP, Conlon I, Nelson AG. 56.  et al. 2013. Characterizing biobank organizations in the U.S.: results from a national survey.. Genome Med. 5:3 [Google Scholar]
  57. Henderson GE, Edwards TP, Cadigan RJ, Davis AM, Zimmer C. 57.  et al. 2013. Stewardship practices of U.S. biobanks. Sci. Transl. Med. 5:215cm7 [Google Scholar]
  58. Hewitt R, Watson P. 58.  2013. Defining biobank. Biopreserv. Biobank. 11:309–15 [Google Scholar]
  59. Hirschberg I, Kahrass H, Strech D. 59.  2014. International requirements for consent in biobank research: qualitative review of research guidelines. J. Med. Genet. 51:773–81 [Google Scholar]
  60. Hoeyer K. 60.  2010. Donors perceptions of consent to and feedback from biobank research: time to acknowledge diversity?. Public Health Genom. 13:345–52 [Google Scholar]
  61. Hofmann B. 61.  2009. Broadening consent—and diluting ethics?. J. Med. Ethics 35:125–29 [Google Scholar]
  62. Homer N, Szelinger S, Redman M, Duggan D, Tembe W. 62.  et al. 2008. Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping microarrays. PLOS Genet. 4:e1000167 [Google Scholar]
  63. Horn EJ, Edwards K, Terry SF. 63.  2011. Engaging research participants and building trust. Genet. Test Mol. Biomark. 15:839–40 [Google Scholar]
  64. Hudson KL, Collins FS. 64.  2013. Biospecimen policy: family matters. Nature 500:141–42 [Google Scholar]
  65. Hudson KL, Collins FS. 65.  2015. Bringing the Common Rule into the 21st century. N. Engl. J. Med. 373:2293–96 [Google Scholar]
  66. Hughes R. 66.  1998. Considering the vignette technique and its application to a study of drug injecting and HIV risk and safer behaviour. Sociol. Health Illn. 20:381–400 [Google Scholar]
  67. Hughes SE, Barnes RO, Watson PH. 67.  2010. Biospecimen use in cancer research over two decades. Biopreserv. Biobank. 8:89–97 [Google Scholar]
  68. Im HK, Gamazon ER, Nicolae DL, Cox NJ. 68.  2012. On sharing quantitative trait GWAS results in an era of multiple-omics data and the limits of genomic privacy. Am. J. Hum. Genet. 90:591–98 [Google Scholar]
  69. Javitt GH. 69.  2013. Take another little piece of my heart: regulating the research use of human biospecimens. J. Law Med. Ethics 41:424–39 [Google Scholar]
  70. Jefford M, Mileshkin L, Matthews J, Raunow H, O'Kane C. 70.  et al. 2011. Satisfaction with the decision to participate in cancer clinical trials is high, but understanding is a problem. Support. Care Cancer 19:371–79 [Google Scholar]
  71. Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. 71.  2001. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet 358:1772–77 [Google Scholar]
  72. Joffe S, Miller FG. 72.  2008. Bench to bedside: mapping the moral terrain of clinical research. Hastings Cent. Rep. 38:30–42 [Google Scholar]
  73. Johnsson L, Helgesson G, Rafnar T, Halldorsdottir I, Chia KS. 73.  et al. 2010. Hypothetical and factual willingness to participate in biobank research. Eur. J. Hum. Genet. 18:1261–64 [Google Scholar]
  74. Jones HW Jr, McKusick VA, Harper PS, Wuu KD. 74.  1971. George Otto Gey (1899–1970): the HeLa cell and a reappraisal of its origin. Obstet. Gynecol. 38:945–49 [Google Scholar]
  75. Karlsen JR, Solbakk JH, Holm S. 75.  2011. Ethical endgames: broad consent for narrow interests; open consent for closed minds. Camb. Q. Healthc. Ethics 20:572–83 [Google Scholar]
  76. Kass NE, Chaisson L, Taylor HA, Lohse J. 76.  2011. Length and complexity of US and international HIV consent forms from federal HIV network trials. J. Gen. Intern. Med. 26:1324–28 [Google Scholar]
  77. Kaufman DJ, Murphy-Bollinger J, Scott J, Hudson KL. 77.  2009. Public opinion about the importance of privacy in biobank research. Am. J. Hum. Genet. 85:643–54 [Google Scholar]
  78. Kaye J, Whitley EA, Lund D, Morrison M, Teare H, Melham K. 78.  2015. Dynamic consent: a patient interface for twenty-first century research networks. Eur. J. Hum. Genet. 23:141–46 [Google Scholar]
  79. Knoppers BM. 79.  2013. From tissues to genomes. G3 3:1203–4 [Google Scholar]
  80. Knoppers BM, Chadwick R. 80.  2005. Human genetic research: emerging trends in ethics. Nat. Rev. Genet. 6:75–79 [Google Scholar]
  81. Koenig BA. 81.  2013. Fixing research subjects protection in the United States: moving beyond consent. Mayo Clin. Proc. 88:428–30 [Google Scholar]
  82. Koenig BA. 82.  2014. Have we asked too much of consent?. Hastings Cent. Rep. 44:33–34 [Google Scholar]
  83. Koh J, Goh E, Yu KS, Cho B, Yang JH. 83.  2012. Discrepancy between participants’ understanding and desire to know in informed consent: Are they informed about what they really want to know?. J. Med. Ethics 38:102–6 [Google Scholar]
  84. Koyfman SA, Agre P, Carlisle R, Classen L, Cheatham C. 84.  et al. 2013. Consent form heterogeneity in cancer trials: the cooperative group and institutional review board gap. J. Natl. Cancer Inst. 105:947–53 [Google Scholar]
  85. Larson E, Foe G, Lally R. 85.  2015. Reading level and length of written research consent forms. Clin. Transl. Sci. 8:355–56 [Google Scholar]
  86. Levitt M. 86.  2003. Public consultation in bioethics. What's the point of asking the public when they have neither scientific nor ethical expertise?. Health Care Anal. 11:15–25 [Google Scholar]
  87. Lipton LR, Santoro N, Taylor H, Kidwai N, Isaac B. 87.  et al. 2011. Assessing comprehension of clinical research. Contemp. Clin. Trials 32:608–13 [Google Scholar]
  88. Lipworth W, Forsyth R, Kerridge I. 88.  2011. Tissue donation to biobanks: a review of sociological studies. Sociol. Health Illn. 33:792–811 [Google Scholar]
  89. Loe J, Robertson CT, Winkelman DA. 89.  2015. Cascading consent for research on biobank specimens. Am. J. Bioeth. 15:68–70 [Google Scholar]
  90. Lunshof JE, Gurwitz D. 90.  2013. Parental consent: guarding children's genetic privacy. Nature 494:430 [Google Scholar]
  91. Maschke KJ. 91.  2006. Alternative consent approaches for biobank research. Lancet Oncol. 7:193–94 [Google Scholar]
  92. Master Z, Nelson E, Murdoch B, Caulfield T. 92.  2012. Biobanks, consent and claims of consensus. Nat. Methods 9:885–88 [Google Scholar]
  93. McCarty CA, Nair A, Austin DM, Giampietro PF. 93.  2007. Informed consent and subject motivation to participate in a large, population-based genomics study: the Marshfield Clinic Personalized Medicine Research Project. Community Genet. 10:2–9 [Google Scholar]
  94. McGuire AL, Beskow LM. 94.  2010. Informed consent in genomics and genetic research. Annu. Rev. Genom. Hum. Genet. 11:361–81 [Google Scholar]
  95. Mello MM, Wolf LE. 95.  2010. The Havasupai Indian tribe case—lessons for research involving stored biologic samples. N. Engl. J. Med. 363:204–7 [Google Scholar]
  96. Minari J, Teare H, Mitchell C, Kaye J, Kato K. 96.  2014. The emerging need for family-centric initiatives for obtaining consent in personal genome research. Genome Med. 6:118 [Google Scholar]
  97. Montalvo W, Larson E. 97.  2014. Participant comprehension of research for which they volunteer: a systematic review. J. Nurs. Sch. 46:423–31 [Google Scholar]
  98. Natl Comm. 98.  Prot. Hum. Subj. Biomed. Behav. Res.; 1979. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: US Gov. Print. Off. [Google Scholar]
  99. Nisbet MC, Fahy D. 99.  2013. Bioethics in popular science: evaluating the media impact of The Immortal Life of Henrietta Lacks on the biobank debate. BMC Med. Ethics 14:10 [Google Scholar]
  100. Nishimura A, Carey J, Erwin PJ, Tilburt JC, Murad MH, McCormick JB. 100.  2013. Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. BMC Med. Ethics 14:28 [Google Scholar]
  101. Nobile H, Vermeulen E, Thys K, Bergmann MM, Borry P. 101.  2013. Why do participants enroll in population biobank studies? A systematic literature review. Expert Rev. Mol. Diagn. 13:35–47 [Google Scholar]
  102. 102. Not. Propos. Rulemaking 2015. Federal policy for the protection of human subjects 80 Fed. Reg. 53931 (Sep. 8). https://federalregister.gov/a/2015-21756 [Google Scholar]
  103. O'Doherty KC, Hawkins A. 103.  2010. Structuring public engagement for effective input in policy development on human tissue biobanking. Public Health Genom. 13:197–206 [Google Scholar]
  104. Ormond KE, Cirino AL, Helenowski IB, Chisholm RL, Wolf WA. 104.  2009. Assessing the understanding of biobank participants. Am. J. Med. Genet. A 149A:188–98 [Google Scholar]
  105. Paasche-Orlow MK, Brancati FL, Taylor HA, Jain S, Pandit A, Wolf MS. 105.  2013. Readability of consent form templates: a second look. IRB 35:12–19 [Google Scholar]
  106. Paasche-Orlow MK, Taylor HA, Brancati FL. 106.  2003. Readability standards for informed-consent forms as compared with actual readability. N. Engl. J. Med. 348:721–26 [Google Scholar]
  107. Paltoo DN, Rodriguez LL, Feolo M, Gillanders E, Ramos EM. 107.  et al. 2014. Data use under the NIH GWAS data sharing policy and future directions. Nat. Genet. 46:934–38 [Google Scholar]
  108. Persky S, Kaphingst KA, Condit CM, McBride CM. 108.  2007. Assessing hypothetical scenario methodology in genetic susceptibility testing analog studies: a quantitative review. Genet. Med. 9:727–38 [Google Scholar]
  109. Petrini C. 109.  2010. “Broad” consent, exceptions to consent and the question of using biological samples for research purposes different from the initial collection purpose. Soc. Sci. Med. 70:217–20 [Google Scholar]
  110. Platt J, Bollinger J, Dvoskin R, Kardia SL, Kaufman D. 110.  2014. Public preferences regarding informed consent models for participation in population-based genomic research. Genet. Med. 16:11–18 [Google Scholar]
  111. Ploug T, Holm S. 111.  2015. Meta consent: a flexible and autonomous way of obtaining informed consent for secondary research. BMJ 350:h2146 [Google Scholar]
  112. 112. Precis. Med. Initiat. Work. Group. 2015. The Precision Medicine Initiative Cohort Program—building a research foundation for 21st century medicine. Rep., Precis. Med. Initiat. Work. Group, Natl. Inst. Health, Bethesda, MD. http://acd.od.nih.gov/reports/DRAFT-PMI-WG-Report-9-11-2015-508.pdf [Google Scholar]
  113. Rachul C, McGuire A, Caulfield T. 113.  2012. Public perceptions and biobanking: What does the research really say?. Stud. Ethics Law Technol. 6:3 [Google Scholar]
  114. Rahm AK, Wrenn M, Carroll NM, Feigelson HS. 114.  2013. Biobanking for research: a survey of patient population attitudes and understanding. J. Community Genet. 4:445–50 [Google Scholar]
  115. Ram N. 115.  2008. Tiered consent and the tyranny of choice. Jurimetrics 48:253–84 [Google Scholar]
  116. Rhodes R. 116.  2015. Love thy neighbor: replacing paternalistic protection as the grounds for research ethics. Am. J. Bioeth. 15:49–51 [Google Scholar]
  117. Rodriguez LL, Brooks LD, Greenberg JH, Green ED. 117.  2013. The complexities of genomic identifiability. Science 339:275–76 [Google Scholar]
  118. Rothstein MA. 118.  2005. Expanding the ethical analysis of biobanks. J. Law Med. Ethics 33:89–101 [Google Scholar]
  119. Royston I. 119.  1985. Cell lines from human patients: Who owns them? A case report. Clin. Res. 33:442–43 [Google Scholar]
  120. Salloch S, Vollmann J, Schildmann J. 120.  2014. Ethics by opinion poll? The functions of attitudes research for normative deliberations in medical ethics. J. Med. Ethics 40:597–602 [Google Scholar]
  121. Schadt EE. 121.  2012. The changing privacy landscape in the era of big data. Mol. Syst. Biol. 8:612 [Google Scholar]
  122. Schadt EE, Woo S, Hao K. 122.  2012. Bayesian method to predict individual SNP genotypes from gene expression data. Nat. Genet. 44:603–8 [Google Scholar]
  123. Schulman AN. 123.  2012. What is the body worth?. New Atlantis 35:99–115 [Google Scholar]
  124. Scott CT, Caulfield T, Borgelt E, Illes J. 124.  2012. Personal medicine—the new banking crisis. Nat. Biotechnol. 30:141–47 [Google Scholar]
  125. Sharp SM. 125.  2004. Consent documents for oncology trials: Does anybody read these things?. Am. J. Clin. Oncol. 27:570–75 [Google Scholar]
  126. Shaw DM, Elger BS, Colledge F. 126.  2014. What is a biobank? Differing definitions among biobank stakeholders. Clin. Genet. 85:223–27 [Google Scholar]
  127. Shelton RH. 127.  2011. Electronic consent channels: preserving patient privacy without handcuffing researchers. Sci. Transl. Med. 3:69cm4 [Google Scholar]
  128. Simon CM, L'Heureux J, Murray JC, Winokur P, Weiner G. 128.  et al. 2011. Active choice but not too active: public perspectives on biobank consent models. Genet. Med. 13:821–31 [Google Scholar]
  129. Skloot R. 129.  2001. Cells that save lives are a mother's legacy. New York Times Nov. 17. http://www.nytimes.com/2001/11/17/arts/cells-that-save-lives-are-a-mother-s-legacy.html [Google Scholar]
  130. Skloot R. 130.  2010. The Immortal Life of Henrietta Lacks New York: Crown [Google Scholar]
  131. Skloot R. 131.  2013. The immortal life of Henrietta Lacks, the sequel. New York Times Mar. 23. http://www.nytimes.com/2013/03/24/opinion/sunday/the-immortal-life-of-henrietta-lacks-the-sequel.html [Google Scholar]
  132. Stein DT, Terry SF. 132.  2013. Reforming biobank consent policy: a necessary move away from broad consent toward dynamic consent. Genet. Test Mol. Biomark. 17:855–56 [Google Scholar]
  133. Steinsbekk KS, Kare Myskja B, Solberg B. 133.  2013. Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem?. Eur. J. Hum. Genet. 21:897–902 [Google Scholar]
  134. Stone J. 134.  1988. Cells for sale. Discover 9:33–39 [Google Scholar]
  135. Szego MJ, Buchanan JA, Scherer SW. 135.  2013. Building trust in 21st century genomics. G3 3:1209–11 [Google Scholar]
  136. Tamariz L, Palacio A, Robert M, Marcus EN. 136.  2013. Improving the informed consent process for research subjects with low literacy: a systematic review. J. Gen. Intern. Med. 28:121–26 [Google Scholar]
  137. Taylor P. 137.  2008. Personal genomes: when consent gets in the way. Nature 456:32–33 [Google Scholar]
  138. Thorne A. 138.  2015. Common reading programs: trends, traps, tips. Acad. Quest. 28:135–46 [Google Scholar]
  139. Trinidad SB, Fullerton SM, Bares JM, Jarvik GP, Larson EB, Burke W. 139.  2010. Genomic research and wide data sharing: views of prospective participants. Genet. Med. 12:486–95 [Google Scholar]
  140. Trinidad SB, Fullerton SM, Ludman EJ, Jarvik GP, Larson EB, Burke W. 140.  2011. Research practice and participant preferences: the growing gulf. Science 331:287–88 [Google Scholar]
  141. Truog RD, Kesselheim AS, Joffe S. 141.  2012. Paying patients for their tissue: the legacy of Henrietta Lacks. Science 337:37–38 [Google Scholar]
  142. Ulrich CM, Ratcliffe SJ. 142.  2007. Hypothetical vignettes in empirical bioethics research. Empirical Methods for Bioethics: A Primer L Jacoby, LA Siminoff 161–81 Adv. Bioeth 11 Amsterdam: Elsevier [Google Scholar]
  143. 143. US Dep. Health Hum. Serv 2008. Guidance on research using coded private information or specimens Guid. Doc., Off. Hum. Res. Prot., US Dep. Health Hum. Serv., Washington, DC. http://www.hhs.gov/ohrp/regulations-and-policy/guidance/research-involving-coded-private-information [Google Scholar]
  144. Vermeulen E, Schmidt MK, Aaronson NK, Kuenen M, Baas-Vrancken Peeters MJ. 144.  et al. 2009. A trial of consent procedures for future research with clinically derived biological samples. Br. J. Cancer 101:1505–12 [Google Scholar]
  145. Wadman M. 145.  2013. Medical research: cell division. Nature 498:422–26 [Google Scholar]
  146. Watson PH. 146.  2014. Biobank classification: communicating biorepository diversity. Biopreserv. Biobank. 12:163–64 [Google Scholar]
  147. Wilson D. 147.  2016. A troubled past? Reassessing ethics in the history of tissue culture. Health Care Anal. In press. doi: 10.1007/s10728-015-0304-0 [Google Scholar]
  148. Yassin R, Lockhart N, Gonzalez del Riego M, Pitt K, Thomas JW. 148.  et al. 2010. Custodianship as an ethical framework for biospecimen-based research. Cancer Epidemiol. Biomark. Prev. 19:1012–15 [Google Scholar]

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