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Volumn 71, Issue 1, 2008, Pages 136-142

A proposal for a model of informed consent for the collection, storage and use of biological materials for research purposes

Author keywords

Biobank; Bioethics; Biological materials; Informed consent

Indexed keywords

BIOMATERIAL;

EID: 40049095337     PISSN: 07383991     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.pec.2007.12.003     Document Type: Article
Times cited : (37)

References (23)
  • 1
    • 0345134216 scopus 로고    scopus 로고
    • Monitoring ethical, legal and social issues in developing population genetic databases
    • 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
    • (2003) Genet Med , vol.5 , pp. 451-457
    • Austin, M.A.1    Harding, S.E.2    McElroy, C.E.3
  • 2
    • 40049109301 scopus 로고    scopus 로고
    • 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.
    • 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.
  • 3
    • 3543141747 scopus 로고    scopus 로고
    • Informed consent and biobanks: a population-based study of attitudes towards tissue donation for genetic research
    • 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
    • (2004) Scand J Public Health , vol.32 , pp. 224-229
    • Hoeyer, K.1    Olofsson, B.2    Mjörndal, T.3    Lynöe, N.4
  • 4
    • 11844269810 scopus 로고    scopus 로고
    • The ethics of research using biobanks. Reason to question the importance attributed to informed consent
    • 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
    • (2005) Arch Intern Med , vol.165 , pp. 97-100
    • Hoeyer, K.1    Olofsson, B.2    Mjörndal, T.3    Lynöe, N.4
  • 5
    • 0842287305 scopus 로고    scopus 로고
    • 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
    • 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
    • (2003) New Genet Soc , vol.22 , pp. 229-244
    • Hoeyer, K.1
  • 6
    • 40049101362 scopus 로고    scopus 로고
    • note
    • 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)
  • 7
    • 27244459748 scopus 로고    scopus 로고
    • Potential harms, anonymization, and the right to withdraw consent to biobank research
    • 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
    • (2005) Eur J Hum Genet , vol.13 , pp. 1071-1076
    • Eriksson, S.1    Helgesson, G.2
  • 8
    • 40049089173 scopus 로고    scopus 로고
    • UNESCO. International Declaration on human genetic data; October 16, 2003 [art. 4].
    • UNESCO. International Declaration on human genetic data; October 16, 2003 [art. 4].
  • 9
    • 40049086612 scopus 로고    scopus 로고
    • 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.
    • 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.
  • 10
    • 33645326005 scopus 로고    scopus 로고
    • Rhetoric of anonymity and property rights in human biological materials (HBMs)
    • Tallacchini M.C. Rhetoric of anonymity and property rights in human biological materials (HBMs). Law Hum Genome Rev 22 (2005) 153-175
    • (2005) Law Hum Genome Rev , vol.22 , pp. 153-175
    • Tallacchini, M.C.1
  • 11
    • 1342303602 scopus 로고    scopus 로고
    • 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.
    • 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.
  • 12
    • 40049106755 scopus 로고    scopus 로고
    • 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.
    • 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.
  • 13
    • 40049099496 scopus 로고    scopus 로고
    • Comitato Nazionale per la Bioetica. Biobanche e ricerca sul materiale biologico umano. Rome; June 9, 2006.
    • Comitato Nazionale per la Bioetica. Biobanche e ricerca sul materiale biologico umano. Rome; June 9, 2006.
  • 15
    • 40049101520 scopus 로고    scopus 로고
    • Good Clinical Practice, ICH Guidelines. Section 4, Investigator - Informed consent of the trial subject; 1996 [art. 4.8].
    • Good Clinical Practice, ICH Guidelines. Section 4, Investigator - Informed consent of the trial subject; 1996 [art. 4.8].
  • 16
    • 40049103687 scopus 로고    scopus 로고
    • 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].
    • 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].
  • 17
    • 40049090609 scopus 로고    scopus 로고
    • 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].
    • 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].
  • 18
    • 40049095776 scopus 로고    scopus 로고
    • 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.
    • 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.
  • 19
    • 40049108236 scopus 로고    scopus 로고
    • World Health Organization. Proposed international guidelines on ethical issues in medical genetics and genetics services. Section 11, Banked DNA; 1998.
    • World Health Organization. Proposed international guidelines on ethical issues in medical genetics and genetics services. Section 11, Banked DNA; 1998.
  • 20
    • 40049107219 scopus 로고    scopus 로고
    • 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].
    • 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].
  • 21
    • 40049112658 scopus 로고    scopus 로고
    • 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].
    • 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].
  • 22
    • 40049102242 scopus 로고    scopus 로고
    • Steering Committee on Bioethics. Draft explanatory memorandum to the draft recommendation on research on biological materials of human origin. Strasbourg; March 15, 2006.
    • Steering Committee on Bioethics. Draft explanatory memorandum to the draft recommendation on research on biological materials of human origin. Strasbourg; March 15, 2006.
  • 23
    • 40049110350 scopus 로고    scopus 로고
    • 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.
    • 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.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.