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1
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0345134216
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Monitoring ethical, legal and social issues in developing population genetic databases
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Austin M.A., Harding S.E., and McElroy C.E. Monitoring ethical, legal and social issues in developing population genetic databases. Genet Med 5 (2003) 451-457
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(2003)
Genet Med
, vol.5
, pp. 451-457
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Austin, M.A.1
Harding, S.E.2
McElroy, C.E.3
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2
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40049109301
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Godard B, Schmidtke J, Cassiman JJ, Aymé S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issue, ownership, return of benefits. A Professional Perspective. EUROGAPP PROJECT 1999-2000. ESHG 1; November 2002.
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Godard B, Schmidtke J, Cassiman JJ, Aymé S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issue, ownership, return of benefits. A Professional Perspective. EUROGAPP PROJECT 1999-2000. ESHG 1; November 2002.
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3
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3543141747
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Informed consent and biobanks: a population-based study of attitudes towards tissue donation for genetic research
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Hoeyer K., Olofsson B., Mjörndal T., and Lynöe N. Informed consent and biobanks: a population-based study of attitudes towards tissue donation for genetic research. Scand J Public Health 32 (2004) 224-229
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(2004)
Scand J Public Health
, vol.32
, pp. 224-229
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Hoeyer, K.1
Olofsson, B.2
Mjörndal, T.3
Lynöe, N.4
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4
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11844269810
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The ethics of research using biobanks. Reason to question the importance attributed to informed consent
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Hoeyer K., Olofsson B., Mjörndal T., and Lynöe N. The ethics of research using biobanks. Reason to question the importance attributed to informed consent. Arch Intern Med 165 (2005) 97-100
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(2005)
Arch Intern Med
, vol.165
, pp. 97-100
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Hoeyer, K.1
Olofsson, B.2
Mjörndal, T.3
Lynöe, N.4
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5
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0842287305
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Science is really needed-that's all I know: informed consent and the non-verbal practices of collecting blood for genetic research in Northen Sweden
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Hoeyer K. Science is really needed-that's all I know: informed consent and the non-verbal practices of collecting blood for genetic research in Northen Sweden. New Genet Soc 22 (2003) 229-244
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(2003)
New Genet Soc
, vol.22
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Hoeyer, K.1
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6
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40049101362
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note
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Nuremberg Code (1946), The Belmont Report (1978), The Declaration of Helsinki (WMA, 1964-2000), International Ethical Guidelines for Biomedical Research involving Human Subjects (CIOMS, 1993-2002), Good Clinical Practice (GCP) consolidate guidelines (1996) and Directive 2001/20/EC of the European Parliament and of the Council relating to the implementation of GCP in the conduct of clinical trials, 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 (Council of Europe, 1997) and additional protocol concerning biomedical research (2005); for the specific field of biological and genetic research: Universal Declaration on the human genome and human rights (UNESCO, 1997), International Declaration on human genetic data (UNESCO, 2003); Recommendation Rec (2006) 4 of the Committee of Ministers to the member states on research on biological materials of human origin (Council of Europe, 2006)
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7
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27244459748
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Potential harms, anonymization, and the right to withdraw consent to biobank research
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Eriksson S., and Helgesson G. Potential harms, anonymization, and the right to withdraw consent to biobank research. Eur J Hum Genet 13 (2005) 1071-1076
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(2005)
Eur J Hum Genet
, vol.13
, pp. 1071-1076
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Eriksson, S.1
Helgesson, G.2
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8
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40049089173
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UNESCO. International Declaration on human genetic data; October 16, 2003 [art. 4].
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UNESCO. International Declaration on human genetic data; October 16, 2003 [art. 4].
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9
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40049086612
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European Agency for the Evaluation of medical products. Position paper on terminology in pharmacogenetics. London; November 21, 2002. http://www.emea.europa.eu/pdfs/human/press/pp/307001en.pdf.
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European Agency for the Evaluation of medical products. Position paper on terminology in pharmacogenetics. London; November 21, 2002. http://www.emea.europa.eu/pdfs/human/press/pp/307001en.pdf.
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10
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33645326005
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Rhetoric of anonymity and property rights in human biological materials (HBMs)
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Tallacchini M.C. Rhetoric of anonymity and property rights in human biological materials (HBMs). Law Hum Genome Rev 22 (2005) 153-175
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(2005)
Law Hum Genome Rev
, vol.22
, pp. 153-175
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Tallacchini, M.C.1
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11
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1342303602
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Data storage and DNA banking for biomedical research: technical, social and ethical issues. Recommendations of the European Society of Human Genetics. Eur J Hum Genet 2003;11 (Suppl. 2): S8-S10.
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Data storage and DNA banking for biomedical research: technical, social and ethical issues. Recommendations of the European Society of Human Genetics. Eur J Hum Genet 2003;11 (Suppl. 2): S8-S10.
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12
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40049106755
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As to the Italian situation refer to: Comitato Nazionale per la Bioetica, Biobanche e ricerca sul materiale biologico umano. Rome; June 9, 2006; Comitato Nazionale per la Biosicurezza e le Biotecnologie. Linee guida per l'istituzione e l'accreditamento delle biobanche. Rome; April 19, 2006; Società italiana di genetica umana, Fondazione Telethon. Le biobanche genetiche. Linee guida. Proposta. Genoa; July 4, 2003.
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As to the Italian situation refer to: Comitato Nazionale per la Bioetica, Biobanche e ricerca sul materiale biologico umano. Rome; June 9, 2006; Comitato Nazionale per la Biosicurezza e le Biotecnologie. Linee guida per l'istituzione e l'accreditamento delle biobanche. Rome; April 19, 2006; Società italiana di genetica umana, Fondazione Telethon. Le biobanche genetiche. Linee guida. Proposta. Genoa; July 4, 2003.
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13
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40049099496
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Comitato Nazionale per la Bioetica. Biobanche e ricerca sul materiale biologico umano. Rome; June 9, 2006.
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Comitato Nazionale per la Bioetica. Biobanche e ricerca sul materiale biologico umano. Rome; June 9, 2006.
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14
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0037701973
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On behalf of the EUROGENEBANK consortium. An empirical survey on biobanking of human genetic material and data in six EU countries
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Hirtzlin I., Dubreuil C., Préaubert N., Duchier J., Jansen B., Simon J., Lobato de Faria P., Perez-Lezaun A., Visser B., Williams G., and Cambon-Thomsen A. On behalf of the EUROGENEBANK consortium. An empirical survey on biobanking of human genetic material and data in six EU countries. Eur J Hum Genet 11 (2003) 475-488
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(2003)
Eur J Hum Genet
, vol.11
, pp. 475-488
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Hirtzlin, I.1
Dubreuil, C.2
Préaubert, N.3
Duchier, J.4
Jansen, B.5
Simon, J.6
Lobato de Faria, P.7
Perez-Lezaun, A.8
Visser, B.9
Williams, G.10
Cambon-Thomsen A11
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15
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40049101520
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Good Clinical Practice, ICH Guidelines. Section 4, Investigator - Informed consent of the trial subject; 1996 [art. 4.8].
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Good Clinical Practice, ICH Guidelines. Section 4, Investigator - Informed consent of the trial subject; 1996 [art. 4.8].
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16
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40049103687
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Council of Europe. Recommendation Rec (2006) 4 of the Committee of Ministers to the member states on research on biological materials of human origin. Chapter 1, Object, scope and definitions, Identifiability of biological materials; 2006 [art. 3].
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Council of Europe. Recommendation Rec (2006) 4 of the Committee of Ministers to the member states on research on biological materials of human origin. Chapter 1, Object, scope and definitions, Identifiability of biological materials; 2006 [art. 3].
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17
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40049090609
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Council of Europe. Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research. Chapter 8, Confidentiality and right to information, Confidentiality; 2005 [art. 25].
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Council of Europe. Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research. Chapter 8, Confidentiality and right to information, Confidentiality; 2005 [art. 25].
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18
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40049095776
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The European Group on Ethics in Science and New Technologies to the European Commission. Opinion on the ethical aspects of genetic testing in the workplace. Opinion no.18. Bruxelles; July 28, 2003.
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The European Group on Ethics in Science and New Technologies to the European Commission. Opinion on the ethical aspects of genetic testing in the workplace. Opinion no.18. Bruxelles; July 28, 2003.
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19
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40049108236
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World Health Organization. Proposed international guidelines on ethical issues in medical genetics and genetics services. Section 11, Banked DNA; 1998.
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World Health Organization. Proposed international guidelines on ethical issues in medical genetics and genetics services. Section 11, Banked DNA; 1998.
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20
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40049107219
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Council of Europe. Recommendation Rec (2006) 4 of the Committee of Ministers to the member states on research on biological materials of human origin. Chapter 2, General provision, Prohibition of financial gain; 2006 [art. 7].
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Council of Europe. Recommendation Rec (2006) 4 of the Committee of Ministers to the member states on research on biological materials of human origin. Chapter 2, General provision, Prohibition of financial gain; 2006 [art. 7].
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21
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40049112658
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Council of Europe. Convention on human right and biomedicine. Chapter VII, Prohibition of financial gain and disposal of a Part of the Human Body, Prohibition of financial gain; and Convention Explanatory report; 1997 [art. 21].
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Council of Europe. Convention on human right and biomedicine. Chapter VII, Prohibition of financial gain and disposal of a Part of the Human Body, Prohibition of financial gain; and Convention Explanatory report; 1997 [art. 21].
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22
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40049102242
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Steering Committee on Bioethics. Draft explanatory memorandum to the draft recommendation on research on biological materials of human origin. Strasbourg; March 15, 2006.
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Steering Committee on Bioethics. Draft explanatory memorandum to the draft recommendation on research on biological materials of human origin. Strasbourg; March 15, 2006.
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23
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40049110350
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Ethics Committee of the Catholic Hospital Institutions of Brescia. Ethical Code for the use of biological material for research or experimental purposes. Brescia; March 21, 2002. http://www.fatebenefratelli.it/s.giovanni and https://oss-sper-clin.agenziafarmaco.it/dati.htm.
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Ethics Committee of the Catholic Hospital Institutions of Brescia. Ethical Code for the use of biological material for research or experimental purposes. Brescia; March 21, 2002. http://www.fatebenefratelli.it/s.giovanni and https://oss-sper-clin.agenziafarmaco.it/dati.htm.
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