Research participants' perceptions and views on consent for biobank research: a review of empirical data and ethical analysis

BMC Medical Ethics

Volumn 16, Issue 1, 2015, Pages

  D'Abramo, Flavio ^a,b   Schildmann, Jan ^a   Vollmann, Jochen ^a  

^a RUHR UNIVERSITY BOCHUM   (Germany)

^b CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

Author keywords

Biobank; Consent; Genomic research; Research ethics

Indexed keywords

BIOBANK; COMPREHENSION; ETHICS; GENOMICS; HUMAN; INFORMED CONSENT; MEDICAL RESEARCH; MORALITY; PERCEPTION; PRIVACY; PSYCHOLOGY; RECALL; RESEARCH ETHICS; RESEARCH SUBJECT; STANDARDS; STATISTICS AND NUMERICAL DATA; THERAPEUTIC MISCONCEPTION;

BIOLOGICAL SPECIMEN BANKS; BIOMEDICAL RESEARCH; COMPREHENSION; ETHICAL ANALYSIS; ETHICS, RESEARCH; GENOMICS; HUMANS; INFORMED CONSENT; MENTAL RECALL; MORAL OBLIGATIONS; PRIVACY; RESEARCH SUBJECTS; SOCIAL PERCEPTION; THERAPEUTIC MISCONCEPTION;

EID: 84941331033     PISSN: None     EISSN: 14726939     Source Type: Journal    
DOI: 10.1186/s12910-015-0053-5     Document Type: Article

References (69)

1. Hilgartner S. Making maps and making social order. Governing American genome centers, 1988-93. In: Gaudilliere JP, Rheinberger HJ, editors. From molecular genetics to genomics. The mapping cultures of twenty-century genetics. London and New York: Routledge; 2004. p. 113-28.
2. Mauron A. Biobanks, genomic and research. A nighmare for public policy makers? In: Elger B, Biller-Andorno N, Mauron A, Capron AM, editors. Ethical issues in governing biobanks. Global perspectives. Hampshire, UK: Ashgate; 2008. p. 1-9.
3. Scott CT, Caulfield T, Borgelt E, Illes J. Personal medicine - the new banking crisis. Nat Biotechnol. 2012;30(2):141-7. doi: 10.1038/nbt.2116.
4. Browman GP, Vollmann J, Virani A, Schildmann J. Improving the quality of 'personalized medicine' research and practice: through an ethical lens. Pers Med. 2014;11(4):413-23. doi: 10.2217/pme.14.17.
5. Dawson A. Informed consent: should we really insist upon it? New review of bioethics. 2003;1(1):59-71. doi: 10.1080/1740028032000131422.
6. Vollmann J, Winau R. Informed consent in human experimentation before the Nuremberg code. BMJ (Clinical research ed). 1996;313(7070):1445-9.
7. Sass HM. Reichsrundschreiben 1931: pre-Nuremberg German regulations concerning new therapy and human experimentation. J Med Philos. 1983;8(2):99-111.
8. Jonsen A. The Birth of Bioethics. USA: Oxford University Press; 1998.
9. Caulfield T, Upshur RE, Daar A. DNA databanks and consent: a suggested policy option involving an authorization model. BMC Med Ethics. 2003;4:E1.
10. Hofmann B, Solbakk JH, Holm S. Consent to Biobank Research: One Size Fits All? In: Solbakk JH, Holm S, Hofmann B, editors. The Ethics of Research Biobanking. New York: Springer US; 2009. p. 3-23.
11. Kaye J, Whitley EA, Lund D, Morrison M, Teare H, Melham K. Dynamic consent: a patient interface for twenty-first century research networks. Eur J Hum Genet. 2014. doi: 10.1038/ejhg.2014.71.
12. Stein DT, Terry SF. Reforming biobank consent policy: a necessary move away from broad consent toward dynamic consent. Genet Test Mol Biomarkers. 2013;17(12):855-6. doi: 10.1089/gtmb.2013.1550.
13. Casali PG. Risks of the new EU Data Protection Regulation: an ESMO position paper endorsed by the European oncology community. Ann Oncol. 2014;25(8):1458-61. doi: 10.1093/annonc/mdu218.
14. European Commission. Background document: Public Consultation 'Science 2.0': Science in Transition. Directorates-General for Research and Innovation (RTD) and Communications Networks, content and Technology (CONNECT). 2014. http://ec.europa.eu/research/consultations/science-2.0/background.pdf.Accessed 05/09/2015.
15. Simeon-Dubach D, Henderson MK. Sustainability in biobanking. Biopreserv Biobank. 2014;12(5):287-91. doi: 10.1089/bio.2014.1251.
16. Gaskell G, Gottweis H, Starkbaum J, Gerber MM, Broerse J, Gottweis U, et al. Publics and biobanks: Pan-European diversity and the challenge of responsible innovation. Eur J Hum Genet. 2013;21(1):14-20. doi: 10.1038/ejhg.2012.104.
17. Greely HT. Breaking the stalemate: a prospective regulatory framework for unforseen research uses of human tissue samples and health information. Wake Forest Law Review. 1999;34(3):737-66.
18. Hansson MG, Dillner J, Bartram CR, Carlson JA, Helgesson G. Should donors be allowed to give broad consent to future biobank research? Lancet Oncol. 2006;7(3):266-9. doi: 10.1016/s1470-2045(06)70618-0.
19. Helgesson G, Dillner J, Carlson J, Bartram CR, Hansson MG. Ethical framework for previously collected biobank samples. Nat Biotechnol. 2007;25(9):973-6. doi: 10.1038/nbt0907-973b.
20. Hansson MG, Levin M. Biobanks as resources for health. Uppsala: Research Program Ethics in Biomedicine; 2003.
21. Chadwick R, Berg K. Solidarity and equity: new ethical frameworks for genetic databases. Nat Rev Genet. 2001;2(4):318-21. doi: 10.1038/35066094.
22. Hoedemaekers R, Gordijn B, Pijnenburg M. Solidarity and justice as guiding principles in genomic research. Bioethics. 2007;21(6):342-50. doi: 10.1111/j.1467-8519.2007.00562.x.
23. Knoppers BM, Chadwick R. Human genetic research: emerging trends in ethics. Nat Rev Genet. 2005;6(1):75-9. doi: 10.1038/nrg1505.
24. Petrini C. "Broad" consent, exceptions to consent and the question of using biological samples for research purposes different from the initial collection purpose. Soc Sci Med. 2010;70(2):217-20. doi: 10.1016/j.socscimed.2009.10.004.
25. Kohnen T, Schildmann J, Vollmann J. Patients' self-determination in "personalised medicine": The case of whole genome sequencing and tissue banking in oncology. In: Braun M, Dabrock P, editors. Individualised Medicine "between hype und hope". Münster: LIT; 2013. p. 97-110.
26. Beauchamp TL. Informed consent: its history, meaning, and present challenges. Camb Q Healthc Ethics. 2011;20(4):515-23. doi: 10.1017/s0963180111000259.
27. Schildmann E, Schildmann J. Palliative sedation therapy: a systematic literature review and critical appraisal of available guidance on indication and decision making. J Palliat Med. 2014;17(5):601-11. doi: 10.1089/jpm.2013.0511.
28. Schildmann J. Decisions about limiting treatment in cancer patients. A systematic review and clinical-ethical analysis of reported variables. J Palliat Med. 2015. doi: 10.1089/jpm.2014.0441.
29. Schildmann J, Vollmann J. Evaluation of clinical ethics consultation: a systematic review and critical appraisal of research methods and outcome criteria. In: Gordon PDJS, Vollmann PJ, Schildmann J, editors. Clinical Ethics Consultation: Theories and Methods. Implementation: Evaluation. Ashgate Publishing Limited; 2013. p. 203-15.
30. Boniolo G, Di Fiore PP, Pece S. Trusted consent and research biobanks: towards a 'new alliance' between researchers and donors. Bioethics. 2012;26(2):93-100. doi: 10.1111/j.1467-8519.2010.01823.x.
31. Cambon-Thomsen A, Rial-Sebbag E, Knoppers BM. Trends in ethical and legal frameworks for the use of human biobanks. Eur Respir J. 2007;30(2):373-82. doi: 10.1183/09031936.00165006.
32. Hofmann B. Broadening consent - and diluting ethics? J Med Ethics. 2009;35(2):125-9. doi: 10.1136/jme.2008.024851.
33. Mascalzoni D, Hicks A, Pramstaller P, Wjst M. Informed consent in the genomics era. PLoS Med. 2008;5(9):e192. doi: 10.1371/journal.pmed.0050192.
34. Sheehan M. Can broad consent be informed consent? Public Health Ethics. 2011;4(3):226-35. doi: 10.1093/phe/phr020.
35. Philipp M. Qualitative inhaltsanalyse. Forum Qualitative Sozialforschung/Forum: Qualitative Social Research. 2000;1(2):Art. 20.
36. Cervo S, Rovina J, Talamini R, Perin T, Canzonieri V, De Paoli P, et al. An effective multisource informed consent procedure for research and clinical practice: an observational study of patient understanding and awareness of their roles as research stakeholders in a cancer biobank. BMC Med Ethics. 2013;14:30. doi: 10.1186/1472-6939-14-30.
37. Hoeyer K, Olofsson BO, Mjorndal T, Lynoe N. The ethics of research using biobanks - reason to question the importance attributed to informed consent. Arch Intern Med. 2005;165(1):97-100. doi: 10.1001/archinte.165.1.97.
38. Lipworth W, Morrell B, Irvine R, Kerridge I. An empirical reappraisal of public trust in biobanking research: rethinking restrictive consent requirements. J Law Med. 2009;17(1):119-32.
39. McGuire AL, Hamilton JA, Lunstroth R, McCullough LB, Goldman A. DNA data sharing: research participants' perspectives. Genet Med. 2008;10(1):46-53. doi: 10.1097/GIM.0b013e31815f1e00.
40. McGuire AL, Oliver JM, Slashinski MJ, Graves JL, Wang T, Kelly PA, et al. To share or not to share: a randomized trial of consent for data sharing in genome research. Genet Med. 2011;13(11):948-55. doi: 10.1097/GIM.0b013e3182227589.
41. Oliver JM, Slashinski MJ, Wang T, Kelly PA, Hilsenbeck SG, McGuire AL. Balancing the risks and benefits of genomic data sharing: genome research participants' perspectives. Public Health Genomics. 2012;15(2):106-14. doi: 10.1159/000334718.
42. Ormond KE, Cirino AL, Helenowski IB, Chisholm RL, Wolf WA. Assessing the understanding of biobank participants. Am J Med Genet A. 2009;149A(2):188-98. doi: 10.1002/ajmg.a.32635.
43. Robinson JO, Slashinski MJ, Wang T, Hilsenbeck SG, McGuire AL. Participants' recall and understanding of genomic research and large-scale data sharing. J Empir Res Hum Res Ethics. 2013;8(4):42-52. doi: 10.1525/jer.2013.8.4.42.
44. Valle-Mansilla JI, Ruiz-Canela M, Sulmasy DP. Patients' attitudes to informed consent for genomic research with donated samples. Cancer Invest. 2010;28(7):726-34. doi: 10.3109/07357907.2010.494320.
45. Watanabe M, Inoue Y, Chang C, Hong H, Kobayashi I, Suzuki S, et al. For what am I participating? The need for communication after receiving consent from biobanking project participants: experience in Japan. J Hum Genet. 2011;56(5):358-63. doi: 10.1038/jhg.2011.19.
46. Hobbs A, Starkbaum J, Gottweis U, Wichmann HE, Gottweis H. The privacy-reciprocity connection in biobanking: comparing German with UK strategies. Public Health Genomics. 2012;15(5):272-84. doi: 10.1159/000336671.
47. Ridgeway JL, Han LC, Olson JE, Lackore KA, Koenig BA, Beebe TJ, et al. Potential bias in the bank: what distinguishes refusers, nonresponders and participants in a clinic-based biobank? Public Health Genomics. 2013;16(3):118-26. doi: 10.1159/000349924.
48. Steinsbekk KS, Ursin LO, Skolbekken JA, Solberg B. We're not in it for the money-lay people's moral intuitions on commercial use of 'their' biobank. Med Health Care Philos. 2013;16(2):151-62. doi: 10.1007/s11019-011-9353-9.
49. Williams PH, Nemeth LS, Sanner JE, Frazier LQ. Thematic analysis of cardiac care patients' explanations for declining contribution to a genomic research-based biobank. Am J Crit Care. 2013;22(4):320-7. doi: 10.4037/ajcc2013838.
50. Rahm AK, Wrenn M, Carroll NM, Feigelson HS. Biobanking for research: a survey of patient population attitudes and understanding. J Community Genet. 2013;4(4):445-50. doi: 10.1007/s12687-013-0146-0.
51. Tindana P, Bull S, Amenga-Etego L, de Vries J, Aborigo R, Koram K, et al. Seeking consent to genetic and genomic research in a rural Ghanaian setting: a qualitative study of the MalariaGEN experience. BMC Med Ethics. 2012;13:15. doi: 10.1186/1472-6939-13-15.
52. Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent: a new measure of understanding among research subjects. J Natl Cancer Inst. 2001;93(2):139-47.
53. Khan A, Capps BJ, Sum MY, Kuswanto CN, Sim K. Informed consent for human genetic and genomic studies: a systematic review. Clin Genet. 2014;86(3):199-206. doi: 10.1111/cge.12384.
54. Salloch S, Vollmann J, Schildmann J. Ethics by opinion poll? The functions of attitudes research for normative deliberations in medical ethics. J Med Ethics. 2014;40(9):597-602. doi: 10.1136/medethics-2012-101253.
55. Salloch S, Schildmann J, Vollmann J. Empirical research in medical ethics: how conceptual accounts on normative-empirical collaboration may improve research practice. BMC Med Ethics. 2012;13:5. doi: 10.1186/1472-6939-13-5.
56. Bergler JH, Pennington AC, Metcalfe M, Freis ED. Informed consent: how much does the patient understand? Clin Pharmacol Ther. 1980;27(4):435-40.
57. Cassileth BR, Zupkis RV, Sutton-Smith K, March V. Informed consent - why are its goals imperfectly realized? N Engl J Med. 1980;302(16):896-900. doi: 10.1056/nejm198004173021605.
58. Estey A, Wilkin G, Dossetor J. Are research subjects able to retain the information they are given during the consent process? Health Law Review. 1994;3(2):37-41.
59. Hassar M, Weintraub M. "Uniformed" consent and the wealthy volunteer: an analysis of patient volunteers in a clinical trial of a new anti-inflammatory drug. Clin Pharmacol Ther. 1976;20(4):379-86.
60. Ethikrat N. Human biobanks for research. Berlin: The German National Ethics Council; 2010.
61. Henderson GE, Churchill LR, Davis AM, Easter MM, Grady C, Joffe S, et al. Clinical trials and medical care: defining the therapeutic misconception. PLoS Med. 2007;4(11):e324. doi: 10.1371/journal.pmed.0040324.
62. Hoeyer K. Ambiguous gifts. Public anxiety, informed consent and biobanks. In: Tutton R, Corrigan O, editors. Genetic databases. Socio-ethical issues in the collection and use of DNA. London: Taylor & Francis; 2004. p. 97-116.
63. Terry SF, Shelton R, Biggers G, Baker D, Edwards K. The haystack is made of needles. Genet Test Mol Biomarkers. 2013;17(3):175-7. doi: 10.1089/gtmb.2012.1542.
64. Li AM, Terry SF. Linking personal health data to genomic research. Genet Test Mol Biomarkers. 2015;19(1):1-2. doi: 10.1089/gtmb.2015.1562.
65. Barr M, Souan L, MacGabhann P, Muller J, Al Ashhab M, Jasser M, et al. The establishment of an ISO compliant cancer biobank for Jordan and its neighboring countries through knowledge transfer and training. Biopreserv Biobank. 2014;12(1):3-12. doi: 10.1089/bio.2013.0072.
66. Onvomaha Tindana P, Kass N, Akweongo P. The informed consent process in a rural African setting: a case study of the Kassena-Nankana district of Northern Ghana. IRB. 2006;28(3):1-6.
67. Ahram M, Othman A, Shahrouri M. Public support and consent preference for biomedical research and biobanking in Jordan. Eur J Hum Genet. 2012. doi: 10.1038/ejhg.2012.213.
68. Rotimi C, Leppert M, Matsuda I, Zeng C, Zhang H, Adebamowo C, et al. Community engagement and informed consent in the International HapMap project. Community Genet. 2007;10(3):186-98. doi: 10.1159/000101761.
69. D'Abramo F. Biobank research, informed consent and society. Towards a new alliance? J Epidemiol Community Health. 2015. doi: 10.1136/jech-2014-205215.