Data storage and DNA banking for biomedical research: Informed consent, confidentiality, quality issues, ownership, return of benefits. A professional perspective

European Journal of Human Genetics

Volumn 11, Issue SUPPL. 2, 2003, Pages

  Godard, Béatrice ^a,d   Schmidtke, Jörg ^b   Cassiman, Jean Jacques ^c   Aymé, Ségolène ^a  

^a HÔPITAL BROUSSAIS   (France)

^b HANNOVER MEDICAL SCHOOL   (Germany)

^c Center for Human Genetics   (Belgium)

^d UNIVERSITÉ DE MONTRÉAL   (Canada)

Author keywords

Benefits; Data protection; DNA banking; Europe; Ownership; Research; Security

Indexed keywords

DNA;

CONFIDENTIALITY; DNA DETERMINATION; EUROPE; GENETIC DATABASE; HEALTH CARE POLICY; HUMAN; INFORMATION PROCESSING; INFORMED CONSENT; LEGAL ASPECT; MEDICAL ETHICS; MEDICAL EXPERT; MEDICAL RESEARCH; ORGANIZATION AND MANAGEMENT; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROFESSIONAL STANDARD; QUALITY CONTROL; REVIEW; SOCIAL ASPECT; WORKSHOP;

BIOMEDICAL AND BEHAVIORAL RESEARCH; GENETICS AND REPRODUCTION;

BIOMEDICAL RESEARCH; CONFIDENTIALITY; DNA; EUROPE; HUMANS; INFORMATION STORAGE AND RETRIEVAL; INFORMED CONSENT; OWNERSHIP; QUALITY ASSURANCE, HEALTH CARE;

EID: 1342282436     PISSN: 10184813     EISSN: None     Source Type: Journal    
DOI: 10.1038/sj.ejhg.5201114     Document Type: Review

References (77)

1. Deschênes M, Cardunal G, Knoppers BM, Glass KC: Human genetic research, DNA banking and consent: a question of "form"? Clin Genet 2001; 59: 221-239.
2. McEwen JE, Reilly PR: Setting standards for DNA banks: toward a model code of conduct, Microb. Comp. Genomics 1996; 1: 165-177.
3. Moutel G, de Montgolfier S, Meningaud JP, Herve C: Bio-libraries and DNA storage: assessment of patient perception of information. Med Law 2001; 20: 193-204.
4. Medical Research Council: Human Tissue and Biological Samples for Use in Research, Operational and Ethical Guidelines, 2001.
5. National Bioethica Advisory Commission (NBAC): Research involving human biological materials: ethical issues and policy guidance. Rockville, MD; August 1999.
6. Clinical Genetics Society Yates JRW, Malcom S, Read AP: Guidelines for DNA Banking. Med Genet 1989; 26: 245.
7. Danish Council of Ethics: Ethics and mapping of the human genome. Copenhagen: Danish Council of Ethics; 1993.
8. Health Council of the Netherlands: Proper Use of Human Tissue. The Hague: Health Council of the Netherlands; 1994.
9. Human Genetics Commission: Inside information: balancing interests in the use of personal genetic data, 2002.
10. Wertz D: Archived specimens: a platform for discussion. Community Genet 1999; 2: 51-60.
11. American society of human genetics, statement on informed consent for genetic research: Am J Hum Genet 1996; 59: 471-474.
12. American Society of Human Genetics: Response to the NBAC on ethical issues surrounding research using human biological samples, January 15, 1999.
13. Human Genome Organization (HUGO): Statement on the Principled Conduct of Genetic Research. Genome Digest 1996; 32: 2.
14. World Health Organization (WHO): Proposed international guidelines on ethical issues in medical genetics and genetic services. Geneva: WHO; 1997.
15. Medical Research Council: Human Tissue and Biological Samples for Use in Research. Report of the Medical Research Council Working Group to develop Operational and Ethical Guidelines, 1999.
16. American Society of Human Genetics, Ad Hoc Committee on DNA Technology: DNA banking and DNA analysis: points to consider. Am J Hum Genet 1988; 42: 781-783.
17. Danish Council of Ethics: Health science information banks - Biobanks. Copenhagen: Danish Council of Ethics; 1996.
18. American College of Medical Genetics, Laboratory practice committee quality assurance subcommittee: Standards and guidelines: clinical genetics laboratories. Bethesda; 1994.
19. Knoppers BM, Hirtle M, Lormeau S, Laberge C, Laflamme M: Control of DNA samples and information. Genomics 1998; 50: 385-401.
20. Hirtle M: International policy positions on the banking of human genetic material. in Knoppers BM, Caulfield T, Kinsella TD (Eds): Legal rights and human genetic material. Toronto: Emond Montgomery Publications Limited; 1996.
21. France Ministry of Higher Education and Research. Report of the Study Group on the Intellectual Protection of the Results of Research on the Human Genome, Cell Collection, and DNA Sequence Data, Paris, June 10, 1994.
22. Eiseman E: Stored tissue samples: an inventory of sources in the United States. Washington DC: RAND Critical Technologies Institute; 1999.
23. Marshall E: Clinical research Company plans to bank human DNA profiles. Science 2001; 26: 575.
24. Service RF: Can data banks tally profits? Science 2001; 16: 1203.
25. Martin P, Kaye J: The use of biological sample collections and personal medical information in human genetics research. London: The Wellcome Trust; 1999.
26. American College of Medical Genetics, Storage of Genetic Materials Committee: ACMG Statement, Statement on storage and use of genetics materials. Am J Hum Genet 1995; 1499-1500.
27. Medical Research Council: Human tissue and biological samples for use in research. Report of the Medical Research Council Working Group to develop operational and ethical guidelines. London: Medical Research Council; 1999.
28. Royal College of Physicians Committee on Ethical Issues in Medicine: Research based on archived information and samples. J Roy College Phys London 1999; 33: 264-266.
29. Reilly PR: Efforts to regulate the collection and use of genetic information. Arch Pathol Lab Med 1999; 123: 1066-1070.
30. Council of Europe. Recommendation No. R (97)5 of the Committee of Ministers to Member States on the Protection of Medical Data; 1997.
31. HUGO Ethics Committee. Statement on DNA sampling control and access: 1998.
32. The Swiss Academy of Medical Sciences: Medical-ethical guidelines for genetic investigations in human, Approved by the Senate of the Swiss Academy of Medical Sciences; June 1993.
33. Clayton EW, Steinberg KK, Khoury MJ, Thomson E, Andrews L, Kahn MJE, Kopelman ML, Weiss JO: Informed consent for genetic research on stored tissue samples. JAMA 1995; 274: 1786-1792.
34. French Ordinance: Laying down various measures of a health-related, social, and statutory nature. Ordinance No. 96-452; 28 May 1996.
35. Nuffield Council on Bioethics: Human tissue: ethical and legal issues. London: Nuffield Council on Bioethics; April 1995.
36. Swibel LH: Tissue banking: genetic donations and informed consent. Princet J Bioeth 1999; 2: 6-17.
37. Nelkin D, Andrews L: Do the dead have interests? policy issues for research after life. Am J Law Med 1998; 24: 261-291.
38. De Renzo EG, Biesecker LG, Meltzer N: Genetics and the dead: implications for genetics research with samples from deceased persons. Am J Med Genet 1997; 69: 332-334.
39. American Society for Investigative Pathology. Use of human tissues for molevular research: 1996.
40. Association of American Medical Colleges: Health data security, patient privacy, and the use of archival patient materials in research, United States, 27 February 1997.
41. Greely HT: Informed consent and other ethical issues in human population genetics. Ann Rev Genet 2001; 35: 785-800.
42. Tri-Council of Canada, Medical Research Council, Natural Sciences and Engineering Research Council: Social Sciences and Humanities Research Council, Code of Conduct for Research Involving Humans. Ministry of Supply and Services Canada, Ottawa; 1997.
43. North American Regional Committee: Human Genome Diversity Project. Houston Law Rev 33: 1431-1473.
44. Lähteenmaki R: Estonian parliament considers genome law. Nature Biotech 2000; 18: 1135.
45. McQueen MJ: Ethical and legal issues in the procurement, storage and use of DNA. Clin Chem Lab Med 1998; 36: 545-549.
46. Ashcroft R: The ethics of reusing archived tissue for research. Neuropathol Appl Neurobiol 2000; 26: 408-411.
47. National Bioethics Advisory Commission: Research involving persons with mental disorders that may affect decisionmaking capacity, 2 Vols. Washington DC: U.S. Government Printing Office; 1998.
48. Council of Europe: Recommendation No. R (89)4 of the Committee of Ministers to Member States on Collection of Epidemiological data on Primary Health Care. Int Dig Health Leg 1990; 41: 148.
49. UNESCO - International Bioethics Committee: Universal declaration on the human genome and human rights. Paris; 11 November 1997.
50. Knoppers BM: Ethical aspects of genome research and banking. Biotechnology 2001; 5b: 418-427.
51. Health Council of the Netherlands: Heredity: science and society - on the possibilities and limits of genetic testing and gene therapy. The Hague: Health Council of the Netherlands; 1989.
52. Ministry of Health and Social Affairs of Norway. Biotechnology Related to Human Beings (Report No. 25) Norway, 1992-1993.
53. Nuffield Trust Genetics Scenario Project: Genetics and Health: Policy issues for genetic science and their Implications for health and health services. London: Nuffield Trust; 30 May 2000.
54. Annas GJ, Glantz LH, Roche PA: Drafting the Genetic Privacy Act: science, policy, and practical considerations. Law Med Ethics 1995; 23: 360-366.
55. Veatch RM: A theory of medical ethics. New York: Basic Books; 1981.
56. Skene L: Ownership of human tissue and the law. Nat Rev Genet 2002; 3: 145-148.
57. Human Genome Organization: Position statement on cDNAs: Patients. London, 6 January 1992.
58. Human Genome Organization: Statement on patenting of DNA sequences. Genome Digest 1995; 6: 2.
59. Greely HT: The control of genetic research: involving the "groups in between". Houston Law Rev 1997; 33: 1397.
60. Human Genome Organization: Statement on Benefit-Sharing. Vancouver, 9 April 2000.
61. World Health Organization: Control of hereditary diseases - report of a WHO scientific group. Geneva: WHO; 1 January 1996.
62. Knoppers BM: Status, sale and patenting of human genetic material: an international survey. Nature Genet 1999; 22: 23-26.
63. North American Regional Committee-Human Genome Diversity Project: Model Ethical Protocol For Collecting DNA Samples. Houston Law Review 1997; 1431-1473.
64. Jones RW, Ring S, Tyfield L et al.: A new human genetic resource: a DNA bank established as part of the Avon longitudinal study of pregnancy and childhood. ALSPAC 2000; 8: 653-660.
65. Pembrey M, Golding J: The Avon Longitudinal Study of Pregnancy and Childhood. VIIth CEPH Annual Conference on Human Genetics. Paris; 1999; 65.
66. Haraldsdottir R: Fire and fury in Iceland. Will Iceland's privately-financed central health database compromise patient confidentiality? Science Public Affairs, British Association for the Advancement of Science. The United Kingdom, February: 2000.
67. Duncan N: World Medical Association opposes Icelandic gene database. BMJ 1999; 318: 1096.
68. Council of Europe. Recommendation R(81) 1 on Regulations for Automated Medical Data Banks: 1981.
69. Council of Europe: Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: convention on human rights and biomedicine. Int Dig Health Leg 1997; 48: 99.
70. Council of Europe, Recommendation 152. Protection of the Human Genome: 2001.
71. Andersen B, Arnason E: Iceland's database is ethically questionable. BMJ 1999; 318: 1565.
72. Berger A: Private company wins rights to Icelandic gene database. BMJ 1999; 318: 11.
73. Chadwick R: The Icelandic database-do modern times need modern sagas? BMJ 1999; 319: 441-444.
74. Haraldsdottir R: A tool for the future. BMJ 1999; 318: 11.
75. McEwen JE, Reilly PR: Stored guthrie cards as DNA banks. Am J Hum Genet 1994; 55: 196-200.
76. Therrell BL, Hannon WH, Pass KA et al.: Guidelines for the retention, storage, and use of residual dried blood spot samples after newborn screening analysis: statement of the Council of Regional Networks for Genetic Services. Biochem Mol Med 1996; 57: 116-124.
77. Norgaard-Pedersen B, Simonsen H: Biological specimen banks in neonatal screening. Acta Paediatr Suppl 1999; 88: 106-109.