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Volumn 97, Issue , 2017, Pages 282-292

Donor's support tool: Enabling informed secondary use of patient's biomaterial and personal data

Author keywords

Biobank; Dynamic consent; Electronic consent; Secondary use of biomaterial and personal data

Indexed keywords

APPLICATION OF INFORMATION TECHNOLOGIES; BIOBANK; BIOMEDICAL RESEARCH; DYNAMIC CONSENTS; ELECTRONIC CONSENT; EUROPEAN LEGISLATION; INDIVIDUAL DECISION MAKING; NOCV2; SECONDARY USE;

EID: 84994910713     PISSN: 13865056     EISSN: 18728243     Source Type: Journal    
DOI: 10.1016/j.ijmedinf.2016.10.019     Document Type: Article
Times cited : (27)

References (63)
  • 1
    • 84994887128 scopus 로고    scopus 로고
    • eHealth Task Force: Redesigning health in Europe for 2020, Available online:. Visited October 2016.
    • [1] eHealth Task Force: Redesigning health in Europe for 2020, Available online: http://goo.gl/wyIZhO. Visited October 2016.
  • 2
    • 84911493416 scopus 로고    scopus 로고
    • An index of barriers for the implementation of personalised medicine and pharmacogenomics in Europe
    • [2] Horgan, D., Jansen, M., Leyens, L., et al. An index of barriers for the implementation of personalised medicine and pharmacogenomics in Europe. Public Health Genom. 17:5–6 (2014), 287–298.
    • (2014) Public Health Genom. , vol.17 , Issue.5-6 , pp. 287-298
    • Horgan, D.1    Jansen, M.2    Leyens, L.3
  • 4
    • 84994843042 scopus 로고    scopus 로고
    • The European Parliament and the Council of the European Union, Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. Available online:. Visited October 2016.
    • [4] The European Parliament and the Council of the European Union, Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. Available online: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31995L0046:en:HTML. Visited October 2016.
  • 5
    • 84994843041 scopus 로고    scopus 로고
    • The European Parliament and the Council of the European Union, Regulation (EU) 2016/679 of the European Parliament and of the Council of 27. April 2016. Available online:. Visited October 2016.
    • [5] The European Parliament and the Council of the European Union, Regulation (EU) 2016/679 of the European Parliament and of the Council of 27. April 2016. Available online: http://data.europa.eu/eli/reg/2016/679/oj. Visited October 2016.
  • 6
    • 84872841266 scopus 로고    scopus 로고
    • Ethical and Legal Requirements for Transnational Genetic Research
    • Hart Publishing Oxford
    • [6] Forgo, N., Kollek, P., Arning, M., Kruegel, T., Kruegel, I., Ethical and Legal Requirements for Transnational Genetic Research. 2010, Hart Publishing, Oxford.
    • (2010)
    • Forgo, N.1    Kollek, P.2    Arning, M.3    Kruegel, T.4    Kruegel, I.5
  • 7
    • 84994834325 scopus 로고    scopus 로고
    • Deutscher Ethikrat (German Ethics Council): Human biobanks for research, Available online:. Visited October 2016.
    • [7] Deutscher Ethikrat (German Ethics Council): Human biobanks for research, Available online: http://www.ethikrat.org/files/der_opinion_human-biobanks.pdf. Visited October 2016.
  • 8
    • 84994815194 scopus 로고    scopus 로고
    • The CONTRACT Informed Consent Helpdesk, Available Online:. Visited October 2016.
    • [8] The CONTRACT Informed Consent Helpdesk, Available Online: https://cdp.custodix.com/index.php/contract/317-the-contract-informed-consent-helpdesk. Visited October 2016.
  • 9
    • 9644254793 scopus 로고    scopus 로고
    • Case studies of existing human tissue repositories best practice for a biospecimen resource for the genomic and proteomic era
    • (ISBN: 0-8330-3527-4)
    • [9] Eiseman, E., Bloom, G., Brower, J., Clancy, N., Olmstedt, S., Case studies of existing human tissue repositories best practice for a biospecimen resource for the genomic and proteomic era. RAND, 2003 (ISBN: 0-8330-3527-4).
    • (2003) RAND
    • Eiseman, E.1    Bloom, G.2    Brower, J.3    Clancy, N.4    Olmstedt, S.5
  • 10
    • 84884255195 scopus 로고    scopus 로고
    • A tiered-layered-staged model for informed consent in personal genome testing
    • [10] Bunnik, E., Janssens, A., Schermer, M., A tiered-layered-staged model for informed consent in personal genome testing. Eur. J. Hum. Genet. 21:6 (2013), 596–601.
    • (2013) Eur. J. Hum. Genet. , vol.21 , Issue.6 , pp. 596-601
    • Bunnik, E.1    Janssens, A.2    Schermer, M.3
  • 11
    • 77950863513 scopus 로고    scopus 로고
    • Changing defaults in biobank research could save lives too
    • [11] Forsberg, J.S., Eriksson, S., Hansson, M.G., Changing defaults in biobank research could save lives too. Eur. J. Epidemiol. 25:2 (2010), 65–68.
    • (2010) Eur. J. Epidemiol. , vol.25 , Issue.2 , pp. 65-68
    • Forsberg, J.S.1    Eriksson, S.2    Hansson, M.G.3
  • 12
    • 84862895096 scopus 로고    scopus 로고
    • The necessity of broad consent and complementary regulations for the protection of personal data in Biobanks: what can we learn from the German case?
    • [12] Taupitz, J., Weigel, J., The necessity of broad consent and complementary regulations for the protection of personal data in Biobanks: what can we learn from the German case?. Public Health Genom. 15:5 (2012), 263–271.
    • (2012) Public Health Genom. , vol.15 , Issue.5 , pp. 263-271
    • Taupitz, J.1    Weigel, J.2
  • 13
    • 84921382128 scopus 로고    scopus 로고
    • Dynamic consent: a patient interface for twenty-first century research networks
    • [13] Kaye, J., Whitley, E.A., Lund, D., Morrison, M., Teare, H., Melham, K., Dynamic consent: a patient interface for twenty-first century research networks. Eur. J. Hum. Genet. 23 (2015), 141–146.
    • (2015) Eur. J. Hum. Genet. , vol.23 , pp. 141-146
    • Kaye, J.1    Whitley, E.A.2    Lund, D.3    Morrison, M.4    Teare, H.5    Melham, K.6
  • 15
    • 84882449721 scopus 로고    scopus 로고
    • Broad consent versus dynamic consent in biobank research: is passive participation an ethical problem?
    • [15] Steinsbekk, K.S., Myskja, B.K., Solberg, B., Broad consent versus dynamic consent in biobank research: is passive participation an ethical problem?. Eur. J. Hum. Genet. 21 (2013), 897–902.
    • (2013) Eur. J. Hum. Genet. , vol.21 , pp. 897-902
    • Steinsbekk, K.S.1    Myskja, B.K.2    Solberg, B.3
  • 16
    • 77955678476 scopus 로고    scopus 로고
    • Building the EnCoRr dictionary collaboratively: strategy and practice
    • [16] Krief, A., Colaux-Castillo, K., Henry, J., Juilliard, C., Peraldi, S., Building the EnCoRr dictionary collaboratively: strategy and practice. IJKL 4:2/3 (2008), 203–216.
    • (2008) IJKL , vol.4 , Issue.2/3 , pp. 203-216
    • Krief, A.1    Colaux-Castillo, K.2    Henry, J.3    Juilliard, C.4    Peraldi, S.5
  • 17
    • 84994892223 scopus 로고    scopus 로고
    • BioShaRE EU project. Available Online:. Visited October 2016.
    • [17] BioShaRE EU project. Available Online: https://www.bioshare.eu/. Visited October 2016.
  • 18
    • 84994816776 scopus 로고    scopus 로고
    • Reg4All. Available online:, Visited 2016.
    • [18] Reg4All. Available online: https://www.reg4all.org/, Visited 2016.
  • 19
    • 84994831891 scopus 로고    scopus 로고
    • The p-medicine Project, Available Online:. Visited October 2016.
    • [19] The p-medicine Project, Available Online: http://www.p-medicine.eu/. Visited October 2016.
  • 20
    • 84994859046 scopus 로고    scopus 로고
    • Enabling big data through Europe's new data protection regulation
    • [20] Mayer-Schönberger, V., Padova, Y., Enabling big data through Europe's new data protection regulation. Columbia Sci Technol. Law Rev. vol. XVII (2016), 315–335.
    • (2016) Columbia Sci Technol. Law Rev. , vol.XVII , pp. 315-335
    • Mayer-Schönberger, V.1    Padova, Y.2
  • 21
    • 84994858167 scopus 로고    scopus 로고
    • Swedish Biobanks in Medical Care Act; Norwegian Act on Medical and Health Research (Health Research Act) 2008-06-20 no. 44, Spanish Biomedical Research Act (BRA) 2007.
    • [21] Swedish Biobanks in Medical Care Act; Norwegian Act on Medical and Health Research (Health Research Act) 2008-06-20 no. 44, Spanish Biomedical Research Act (BRA) 2007.
  • 22
    • 84994815202 scopus 로고    scopus 로고
    • T. Weichert T, in: Däubler W, Klebe T, Wedde P, Weichert T (eds.) Kommentar zum Bundesdatenschutzgesetz, Frankfurt/M: Bund-Verlag 2014, section 3 margin note 16; M. Eßer, in: M. Eßer, P. Kramer and K. v. Lewinski (eds.), Kommentar zum Bundesdatenschutzgesetz, Köln: Carl Heymans Verlag, 2014, section 3 margin note 9; J. Simon, R., Paslack, J., Robienski, J.W. Goebel and M. Krawczak, Biomaterialbanken −Rechtliche Rahmenbedingungen, Berlin : Medizinisch Wissenschaftliche Verlagsgesellschaft 2006, p. 48.
    • [22] T. Weichert T, in: Däubler W, Klebe T, Wedde P, Weichert T (eds.) Kommentar zum Bundesdatenschutzgesetz, Frankfurt/M: Bund-Verlag 2014, section 3 margin note 16; M. Eßer, in: M. Eßer, P. Kramer and K. v. Lewinski (eds.), Kommentar zum Bundesdatenschutzgesetz, Köln: Carl Heymans Verlag, 2014, section 3 margin note 9; J. Simon, R., Paslack, J., Robienski, J.W. Goebel and M. Krawczak, Biomaterialbanken −Rechtliche Rahmenbedingungen, Berlin : Medizinisch Wissenschaftliche Verlagsgesellschaft 2006, p. 48.
  • 23
    • 84994877856 scopus 로고    scopus 로고
    • Der Schutz genetischer Daten unter besonderer Berücksichtigung des Gendiagnostikgesetzes, Heidelberg, Dordrecht, London, New York: Springer 2013, p. 5, 10.1007/978-3-642-35192-1; Art. 29 Working Party Opinion 4/2007 on the concept of personal data, WP 136, p. 9. Central Ethics Commission (Zentrale Ethikkommission), Opinion ‘Die (Weiter-)Verwendung von menschlichem Körpermaterial für Zwecke der medizinischen Forschung’, 2003, p. 4; German Ethics Council (Deutscher Ethikrat), Human biobanks for research, 2010, p.16.
    • [23] C. Vossenkuhl, Der Schutz genetischer Daten unter besonderer Berücksichtigung des Gendiagnostikgesetzes, Heidelberg, Dordrecht, London, New York: Springer 2013, p. 5, 10.1007/978-3-642-35192-1; Art. 29 Working Party Opinion 4/2007 on the concept of personal data, WP 136, p. 9. Central Ethics Commission (Zentrale Ethikkommission), Opinion ‘Die (Weiter-)Verwendung von menschlichem Körpermaterial für Zwecke der medizinischen Forschung’, 2003, p. 4; German Ethics Council (Deutscher Ethikrat), Human biobanks for research, 2010, p.16.
    • Vossenkuhl, C.1
  • 24
    • 84994854605 scopus 로고    scopus 로고
    • Die juristische Analogie
    • [24] Luther, C., Die juristische Analogie. Juristische Ausbildung, 2013, 449–453.
    • (2013) Juristische Ausbildung , pp. 449-453
    • Luther, C.1
  • 25
    • 84994856456 scopus 로고    scopus 로고
    • Human Tissue Research—A European Perspective on the Ethical and Legal Challenges, 2010, p. XX (preface).
    • [25] C. Lenk, N. Hoppe, K. Beier and C. Wiesemann, Human Tissue Research—A European Perspective on the Ethical and Legal Challenges, 2010, p. XX (preface).
    • Lenk, C.1    Hoppe, N.2    Beier, K.3    Wiesemann, C.4
  • 26
    • 84994877851 scopus 로고    scopus 로고
    • Art. 29 (1) Regulation 536/2014 or Art. 3 Directive 2001/20/EC.
    • [26] Art. 29 (1) Regulation 536/2014 or Art. 3 Directive 2001/20/EC.
  • 27
    • 84994815197 scopus 로고    scopus 로고
    • Art. 3 Directive 2001/20/EC or Art. 28 and 29 Regulation 536/2014.
    • [27] Art. 3 Directive 2001/20/EC or Art. 28 and 29 Regulation 536/2014.
  • 28
    • 84994847918 scopus 로고    scopus 로고
    • The p-medicine consortium: D5.4 Report on legal and ethical issues regarding patient empowerment, 2012.
    • [28] The p-medicine consortium: D5.4 Report on legal and ethical issues regarding patient empowerment, 2012.
  • 29
    • 84994836202 scopus 로고    scopus 로고
    • Medical Research Council, Human Tissue and Biological Samples for Use in Research, 2014,. Visited October 2016.
    • [29] Medical Research Council, Human Tissue and Biological Samples for Use in Research, 2014, http://www.mrc.ac.uk/publications/browse/human-tissue-and-biological-samples-for-use-in-research/. Visited October 2016.
  • 30
    • 84994857426 scopus 로고    scopus 로고
    • The CONTRACT Consortium, Deliverable D3.1 Initial Report and Guidelines on Identified Good Practice Cases, 2011.
    • [30] The CONTRACT Consortium, Deliverable D3.1 Initial Report and Guidelines on Identified Good Practice Cases, 2011.
  • 32
    • 84994835662 scopus 로고    scopus 로고
    • Arbeitskreis medizinischer Ethikkommissionen in der Bundesrepublik Deutschland e.V. Available Online:. Visited October 2016.
    • [32] Arbeitskreis medizinischer Ethikkommissionen in der Bundesrepublik Deutschland e.V. Available Online: http://www.ak-med-ethik-komm.de/formulare.html. Visited October 2016.
  • 33
    • 84994874331 scopus 로고    scopus 로고
    • The p-medicine consortium: D5.4 Report on legal and ethical issues regarding patient empowerment, Appendix B: Listing of a choice of European Member States’ legal statements on the scope and form of informed consent referring processing of personal data and biosamples.
    • [33] The p-medicine consortium: D5.4 Report on legal and ethical issues regarding patient empowerment, Appendix B: Listing of a choice of European Member States’ legal statements on the scope and form of informed consent referring processing of personal data and biosamples.
  • 34
    • 84994886466 scopus 로고    scopus 로고
    • Federal Data Protection Act (Bundesdatenschutzgesetz), English version:. Visited October 2016.
    • [34] Federal Data Protection Act (Bundesdatenschutzgesetz), English version: http://www.gesetze-im-internet.de/englisch_bdsg/. Visited October 2016.
  • 35
    • 84994855595 scopus 로고    scopus 로고
    • The German Telemedia Act allows electronic consent under restricted circumstances, but it is questionable whether e-consent tools such as the Donor's Support Tool would benefit from this regulatory relief as the processing of the data must relate to the provisioning of telemedia for this to apply. It is also under debate whether content data – which health and biosample data qualify – are covered by the Telemedia Act.
    • [35] The German Telemedia Act allows electronic consent under restricted circumstances, but it is questionable whether e-consent tools such as the Donor's Support Tool would benefit from this regulatory relief as the processing of the data must relate to the provisioning of telemedia for this to apply. It is also under debate whether content data – which health and biosample data qualify – are covered by the Telemedia Act.
  • 36
    • 84994858097 scopus 로고    scopus 로고
    • Art. 27 (2) (1) Polish Data Protection Act.
    • [36] Art. 27 (2) (1) Polish Data Protection Act.
  • 37
    • 80855138689 scopus 로고    scopus 로고
    • The New Belgian Law on Biobanks: Some Comments from an Ethical Perspective
    • [37] Sterckx, S., Van Assche, K., The New Belgian Law on Biobanks: Some Comments from an Ethical Perspective. Health Care Anal. 19:3 (2011), 252–253.
    • (2011) Health Care Anal. , vol.19 , Issue.3 , pp. 252-253
    • Sterckx, S.1    Van Assche, K.2
  • 38
    • 84857170357 scopus 로고    scopus 로고
    • Consent an instrument for patient empowerment
    • [38] Verhenneman, G., Consent an instrument for patient empowerment. FITCE, 2010, 4.
    • (2010) FITCE , pp. 4
    • Verhenneman, G.1
  • 39
    • 84994834295 scopus 로고    scopus 로고
    • Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC.
    • [39] Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC.
  • 40
    • 84994837277 scopus 로고    scopus 로고
    • Bundesdatenschutzgesetz, English version including amendments of the Act of 14.08.2009:, Visited October 2016.
    • [40] Bundesdatenschutzgesetz, http://www.gesetze-im-Internet.de/bdsg_1990/; English version including amendments of the Act of 14.08.2009: http://www.gesetze-im-Internet.de/englisch_bdsg/, Visited October 2016.
  • 41
    • 84994830512 scopus 로고    scopus 로고
    • Simitis −Kommentar zum Bundesdatenschutzgesetz (Commentary on Federal Data Protection Law) edited by Spiros Simitis, pp. 387–389; Gola P and Schomerus R, Kommentar zum Bundesdatenschutzgesetz (Commentary on Federal Data Protection Law), 2005, pp. 166–167.
    • [41] Simitis S, Simitis −Kommentar zum Bundesdatenschutzgesetz (Commentary on Federal Data Protection Law) edited by Spiros Simitis, pp. 387–389; Gola P and Schomerus R, Kommentar zum Bundesdatenschutzgesetz (Commentary on Federal Data Protection Law), 2005, pp. 166–167.
    • Simitis, S.1
  • 42
    • 84994880524 scopus 로고    scopus 로고
    • Stellungnahme: Biobanken für die Forschung, 2004, pp. 58-62, Visited October 2016.
    • [42] Stellungnahme: Biobanken für die Forschung, 2004, http://www.ethikrat.org/dateien/pdf/biobanken-fuer-die-forschung.pdf, pp. 58-62, Visited October 2016.
  • 43
    • 84994856426 scopus 로고    scopus 로고
    • Nationaler Ethikrat, Stellungnahme Biobanken für die Forschung, op cit., pp. 58–62.
    • [43] Nationaler Ethikrat, Stellungnahme Biobanken für die Forschung, op cit., pp. 58–62.
  • 44
    • 84994843023 scopus 로고    scopus 로고
    • Arbeitskreis medizinischer Ethikkommissionen, op. cit.
    • [44] Arbeitskreis medizinischer Ethikkommissionen, op. cit.
  • 45
    • 84994859028 scopus 로고    scopus 로고
    • Visited October 2016.
    • [45] http://www.landesrecht-hamburg.de/jportal/portal/page/bshaprod.psml?nid=l&showdoccase=1&doc.id=jlr-KHGHAV1P12a&st=lr, Visited October 2016.
  • 46
    • 84994877831 scopus 로고    scopus 로고
    • Österreich Budeskanzleramt Bioethikkommission, Biobanks for Medical Research, Opinion of the Bioethics Commission at the Federal Chancellery, 2007, p.33 (It is also stated in this document that the consent for data processing should be in writing).
    • [46] Österreich Budeskanzleramt Bioethikkommission, Biobanks for Medical Research, Opinion of the Bioethics Commission at the Federal Chancellery, 2007, p.33 (It is also stated in this document that the consent for data processing should be in writing).
  • 47
    • 84994859027 scopus 로고    scopus 로고
    • [47] https://www.privacycommission.be/sites/privacycommission/files/documents/protection-of-personal-data-in-belgium.pdf. Visited October 2016.
  • 48
    • 80855138689 scopus 로고    scopus 로고
    • Van Assche K. The New Belgian Law on Biobanks: Some Comments from an Ethical Perspective, Health Care Analysis 2011, 19 (3):247-258; Wagstaff A, International Biobanking Regulations: the Promise and the Pitfalls, Cancer World 2011: 22–29; Biobanks and Tissue Research: The Public, the Patient and the Regulation, 2011, p. 103.
    • [48] Sterckx S and Van Assche K. The New Belgian Law on Biobanks: Some Comments from an Ethical Perspective, Health Care Analysis 2011, 19 (3):247-258; Wagstaff A, International Biobanking Regulations: the Promise and the Pitfalls, Cancer World 2011: 22–29; Biobanks and Tissue Research: The Public, the Patient and the Regulation, 2011, p. 103.
    • Sterckx, S.1
  • 49
    • 84994877826 scopus 로고    scopus 로고
    • Medical Research Council, Study Policy on Sharing Research Data, Visited October 2016.
    • [49] Medical Research Council, Study Policy on Sharing Research Data, http://www.mrc.ac.uk/Ourresearch/Ethicsresearchguidance/datasharing/Policy/PHSPolicy/studypolicy/index.htm, Visited October 2016.
  • 50
    • 84994825095 scopus 로고    scopus 로고
    • Art. 7.3. Organic Law 15/1999 of 13 December on the Protection of Personal Data; Casabona R, and Nicolás P: The Implementation of Directive 95/46/EC in Spain, in Beyleveld et.al., Implementation of the Data Protection Directive in Relation to Medical Research in Europe, 2004, p. 377.
    • [50] Art. 7.3. Organic Law 15/1999 of 13 December on the Protection of Personal Data; Casabona R, and Nicolás P: The Implementation of Directive 95/46/EC in Spain, in Beyleveld et.al., Implementation of the Data Protection Directive in Relation to Medical Research in Europe, 2004, p. 377.
  • 52
    • 84994856425 scopus 로고    scopus 로고
    • Usign-A security enhanced electronic consent model, engineering in medicine and biology society (EMBC), 2014
    • [52] Li, Y., Bian, J., Usign-A security enhanced electronic consent model, engineering in medicine and biology society (EMBC), 2014. 36th Annual International Conference of the IEEE, Issue Date: 26-30.08, 2014, 4487.
    • (2014) 36th Annual International Conference of the IEEE, Issue Date: 26-30.08 , pp. 4487
    • Li, Y.1    Bian, J.2
  • 53
    • 84994877836 scopus 로고    scopus 로고
    • ObTiMA Clinical Trial Management System:. Visited May 2016.
    • [53] ObTiMA Clinical Trial Management System: http://obtima.org/. Visited May 2016.
  • 55
    • 84924851143 scopus 로고    scopus 로고
    • Evaluation of personal health record systems through the lenses of EC research projects
    • [55] Genitsaridi, I., Kondylakis, H., Koumakis, L., Marias, K., Tsiknakis, M., Evaluation of personal health record systems through the lenses of EC research projects. CBM J. 59 (2015), 175–185.
    • (2015) CBM J. , vol.59 , pp. 175-185
    • Genitsaridi, I.1    Kondylakis, H.2    Koumakis, L.3    Marias, K.4    Tsiknakis, M.5
  • 56
    • 84896913796 scopus 로고    scopus 로고
    • Towards intelligent personal health record systems: review, criteria and extensions
    • [56] Genitsaridi, I., Kondylakis, H., Koumakis, L., Marias, K., Tsiknakis, M., Towards intelligent personal health record systems: review, criteria and extensions. Proc. Comput. Sci. 21 (2013), 327–334.
    • (2013) Proc. Comput. Sci. , vol.21 , pp. 327-334
    • Genitsaridi, I.1    Kondylakis, H.2    Koumakis, L.3    Marias, K.4    Tsiknakis, M.5
  • 57
    • 84994892203 scopus 로고    scopus 로고
    • Center for Data Protection. Available online:. Visited May 2016
    • [57] Center for Data Protection. Available online: https://cdp.custodix.com/. Visited May 2016.
  • 58
    • 84994843027 scopus 로고    scopus 로고
    • Consentir: an electronic patient consent management system
    • University of Waterloo
    • [58] Khan, A., Nadi, S., Cheriton, D., Consentir: an electronic patient consent management system. Cheriton School of Computer Science, 2013, University of Waterloo.
    • (2013) Cheriton School of Computer Science
    • Khan, A.1    Nadi, S.2    Cheriton, D.3
  • 59
    • 84994843032 scopus 로고    scopus 로고
    • The CONTRACT consortium, D4.2 Final Guidelines for Informed Consent and Data Security, 2012.
    • [59] The CONTRACT consortium, D4.2 Final Guidelines for Informed Consent and Data Security, 2012.
  • 60
    • 15044361400 scopus 로고    scopus 로고
    • Patient consent principles and guidelines for e-consent: a New Zealand perspective
    • [60] Galpottage, P.A.B., Norris, A.C., Patient consent principles and guidelines for e-consent: a New Zealand perspective. Health Inform. J. 11:1 (2005), 5–18.
    • (2005) Health Inform. J. , vol.11 , Issue.1 , pp. 5-18
    • Galpottage, P.A.B.1    Norris, A.C.2
  • 61
    • 42549096829 scopus 로고    scopus 로고
    • Audio-visual presentation of information for informed consent for participation in clinical trials
    • [61] Ryan, R.E., Prictor, M.J., McLaughlin, K.J., Hill, S.J., Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database Syst. Rev., 2008, D003717.
    • (2008) Cochrane Database Syst. Rev. , pp. D003717
    • Ryan, R.E.1    Prictor, M.J.2    McLaughlin, K.J.3    Hill, S.J.4
  • 62
    • 84994882770 scopus 로고    scopus 로고
    • ISO 9241-1:1997: Available online:? csnumber=21922 (Accessed 10.10.2016)
    • [62] ISO 9241-1:1997: Available online: http://www.iso.org/iso/home/store/catalogue_ics/catalogue_detail_ics.htm?csnumber=21922 (Accessed 10.10.2016).
  • 63
    • 84994856431 scopus 로고    scopus 로고
    • The p-Medicine Consortium, D15.1 Evaluation Criteria and Verification procedures, Available online: (Accessed 10.10.2016).
    • [63] The p-Medicine Consortium, D15.1 Evaluation Criteria and Verification procedures, Available online: http://p-medicine.eu/fileadmin/p-medicine/public_website/downloads/p-medicine_270089_D15-1_evaluation_criteria_and_verificationprocedures_v2-0.pdf (Accessed 10.10.2016).


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.