메뉴 건너뛰기




Volumn 21, Issue 3, 2014, Pages 271-296

The promotion of data sharing in pharmacoepidemiology

Author keywords

data protection; data reuse; data sharing; health research; pharmacoepidemiology; secondary uses

Indexed keywords

ARTICLE; DRUG SURVEILLANCE PROGRAM; EUROPEAN UNION; HUMAN; INFORMATION DISSEMINATION; INFORMATION PROCESSING; LEGAL ASPECT; PATIENT SAFETY; PHARMACOEPIDEMIOLOGY;

EID: 84902506551     PISSN: 09290273     EISSN: 15718093     Source Type: Journal    
DOI: 10.1163/15718093-12341323     Document Type: Article
Times cited : (9)

References (119)
  • 1
    • 0037826936 scopus 로고    scopus 로고
    • Learning from experience: Privacy and the secondary use of data in health research
    • W. Lowrance, "Learning from experience: privacy and the secondary use of data in health research", Journal of Health Services Research & Policy 8(2) (2003) 2-7.
    • (2003) Journal of Health Services Research & Policy , vol.8 , Issue.2 , pp. 2-7
    • Lowrance, W.1
  • 4
    • 84902472447 scopus 로고    scopus 로고
    • Medicines and Healthcare products Regulatory Agency, Retrieved 7 January 2014
    • Medicines and Healthcare products Regulatory Agency. 2013. "Information for healthcare professionals: Adverse drug reactions". Retrieved 7 January 2014, www.mhra.gov.uk.
    • (2013) Information for Healthcare Professionals: Adverse Drug Reactions
  • 5
    • 45849119038 scopus 로고    scopus 로고
    • Pharmacovigilance: Methods, recent developments and future perspectives
    • at 745
    • L. Härmark, A. C. van Grootheest, "Pharmacovigilance: methods, recent developments and future perspectives", European Journal of Clinical Pharmacology 64 (2008) 743-752, at 745.
    • (2008) European Journal of Clinical Pharmacology , vol.64 , pp. 743-752
    • Härmark, L.1    Van Grootheest, A.C.2
  • 6
    • 47349113508 scopus 로고
    • Thalidomide and congenital malformations
    • Thalidomide was used to treat morning sickness in pregnant mothers and resulted in thousands of babies being born with congenital deformities. W. McBride, "Thalidomide and congenital malformations", Lancet 2 (1961) 1358.
    • (1961) Lancet , vol.2 , pp. 1358
    • McBride, W.1
  • 7
    • 84867606887 scopus 로고    scopus 로고
    • Reform, regulation and pharmaceuticals - The Kefauver-Harris amendments at 50
    • These amendments were made to the Food, Drug and Cosmetic Act in 1962. To ensure greater drug safety, drug manufacturers had to prove the efficacy of drugs prior to marketing. J. Greene and S. Podolsky, "Reform, Regulation and Pharmaceuticals - The Kefauver-Harris Amendments at 50", New England Journal of Medicine 367 (2012) 1481-1483.
    • (2012) New England Journal of Medicine , vol.367 , pp. 1481-1483
    • Greene, J.1    Podolsky, S.2
  • 8
    • 84880184814 scopus 로고    scopus 로고
    • Drug regulation: History, present and future
    • C. van Boxtel, B. Santoso and I. Edwards (eds.), revised 2nd edition( IOS Press and Uppsala Monitoring Centre)
    • L. Rägo and B. Santoso, "Drug Regulation: History, Present and Future" in: C. van Boxtel, B. Santoso and I. Edwards (eds.), Drug Benefits and Risks: International Textbook of Clinical Pharmacology, revised 2nd edition( IOS Press and Uppsala Monitoring Centre, 2008) 66.
    • (2008) Drug Benefits and Risks: International Textbook of Clinical Pharmacology , vol.66
    • Rägo, L.1    Santoso, B.2
  • 9
    • 0009122692 scopus 로고    scopus 로고
    • Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products
    • (As amended by Directives 66/454/EEC, 75/319/EEC, 83/570/EEC, 87/21/EEC, 89/341/EEC 89/342/EEC 89/343/EEC, 92/27/EEC, 92/73/EEC et 93/39/EEC)
    • Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ L No 22 of 9. 2. 1965, p. 369). (As amended by Directives 66/454/EEC, 75/319/EEC, 83/570/EEC, 87/21/EEC, 89/341/EEC 89/342/EEC 89/343/EEC, 92/27/EEC, 92/73/EEC et 93/39/EEC).
    • OJ L No 22 of 9. 2. 1965 , pp. 369
  • 11
    • 84902530321 scopus 로고    scopus 로고
    • The University of Manchester, Retrieved 26 March
    • See for example: The University of Manchester, "Centre for Pharmacoepidemiology and Drug Safety". Retrieved 26 March 2014, www.pharmacy.manchester.ac.uk/cpds
    • (2014) Centre for Pharmacoepidemiology and Drug Safety
  • 14
    • 84958953876 scopus 로고    scopus 로고
    • Retrieved 21 January 2014
    • At a European level, the European Medicines Agency has established ENCePP (the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance) 'to further strengthen the post-authorisation monitoring of medicinal products in Europe' European Network of Centres for Pharmacoepidemiology and Pharmacivigilance, "What is ENCePP?" 2014. Retrieved 21 January 2014, www.encepp.eu/structure/index.shtml.
    • (2014) European Network of Centres for Pharmacoepidemiology and Pharmacivigilance, "What Is ENCePP?"
  • 16
    • 84902530323 scopus 로고    scopus 로고
    • Retrieved 25 March
    • See also MHRA Yellow Card Scheme website. Retrieved 25 March 2014, yellowcard.mhra.gov.uk.
    • (2014) MHRA Yellow Card Scheme Website
  • 17
    • 84902530324 scopus 로고    scopus 로고
    • Unplanned medication discontinuation as a potential pharmacovigilance signal: A nested young person cohort study
    • A. Sun et al., "Unplanned medication discontinuation as a potential pharmacovigilance signal: a nested young person cohort study", BMC Pharmacology and Toxicology 15(11) (2014).
    • (2014) BMC Pharmacology and Toxicology , vol.15 , Issue.11
    • Sun, A.1
  • 19
    • 84887166744 scopus 로고    scopus 로고
    • Exclusion of pregnant women from industry-sponsored clinicaltrials
    • K. Shields and A. Lyerly, "Exclusion of pregnant women from industry-sponsored clinicaltrials", Obstet Gynecol 122(5) (2013) 1077-1081.
    • (2013) Obstet Gynecol , vol.122 , Issue.5 , pp. 1077-1081
    • Shields, K.1    Lyerly, A.2
  • 20
    • 84864497515 scopus 로고    scopus 로고
    • Pediatric versus adult drug trials for conditions with high pediatric disease burden
    • F. Bourgeois et al., "Pediatric versus adult drug trials for conditions with high pediatric disease burden", Pediatrics 130(2) (2012) 285-292.
    • (2012) Pediatrics , vol.130 , Issue.2 , pp. 285-292
    • Bourgeois, F.1
  • 21
    • 80054910011 scopus 로고    scopus 로고
    • Improving recruitment of older people to research through good practice
    • M. Murdo et al., "Improving recruitment of older people to research through good practice", Age and Ageing 40(6) (2011) 659-665.
    • (2011) Age and Ageing , vol.40 , Issue.6 , pp. 659-665
    • Murdo, M.1
  • 22
    • 33947498821 scopus 로고    scopus 로고
    • Eligibility criteria of randomized control trials published in high-impact general medical journals
    • H. Van Spall et al., "Eligibility Criteria of Randomized Control Trials Published in High-Impact General Medical Journals", Journal of the American Medical Association 297(11) (2007) 1233-1240.
    • (2007) Journal of the American Medical Association , vol.297 , Issue.11 , pp. 1233-1240
    • Van Spall, H.1
  • 23
    • 0037067884 scopus 로고    scopus 로고
    • Representation of the elderly, women, and minorities in heart failure clinical trials
    • A. Heiat, C. Gross and H. Krumholz. "Representation of the Elderly, Women, and Minorities in Heart Failure Clinical Trials", Archives of Internal Medicine 162(15) (2002) 1682-1688.
    • (2002) Archives of Internal Medicine , vol.162 , Issue.15 , pp. 1682-1688
    • Heiat, A.1    Gross, C.2    Krumholz, H.3
  • 24
    • 0036020411 scopus 로고    scopus 로고
    • Admissions caused by adverse drug events to internal medicine and emergency departments in hospitals: A longitudinal population-based study
    • See for example: S. Schneeweiss et al., "Admissions caused by adverse drug events to internal medicine and emergency departments in hospitals: a longitudinal population-based study", European Journal of Clinical Pharmacology 58 (2002) 285-291
    • (2002) European Journal of Clinical Pharmacology , vol.58 , pp. 285-291
    • Schneeweiss, S.1
  • 25
    • 72849116877 scopus 로고    scopus 로고
    • Modern methods of pharmacovigilance: Detecting adverse effects of drugs
    • G. Niklas Noren and R. Edwards, "Modern methods of pharmacovigilance: detecting adverse effects of drugs", Clinical Medicine 9(5) (2009) 486-489.
    • (2009) Clinical Medicine , vol.9 , Issue.5 , pp. 486-489
    • Niklas Noren, G.1    Edwards, R.2
  • 26
    • 84555187267 scopus 로고    scopus 로고
    • Consideration of multiple chronic diseases in randomized control trials
    • A. Jadad and T. Matthew, "Consideration of Multiple Chronic Diseases in Randomized Control Trials", Journal of the American Medical Association 306(24) (2011).
    • (2011) Journal of the American Medical Association , vol.306 , Issue.24
    • Jadad, A.1    Matthew, T.2
  • 27
    • 33750576990 scopus 로고    scopus 로고
    • The role of serendipity in drug discovery
    • T. Ban, "The Role of Serendipity in Drug Discovery", Dialogues Clinical Neuroscience 8(3) (2006) 335-344.
    • (2006) Dialogues Clinical Neuroscience , vol.8 , Issue.3 , pp. 335-344
    • Ban, T.1
  • 28
    • 4344668661 scopus 로고    scopus 로고
    • Drug repositioning: Identifying and developing new uses for existing drugs
    • T. Ashburn and K. Thor, "Drug repositioning: identifying and developing new uses for existing drugs", National Review of Drug Discovery 3 (2004) 673-683
    • (2004) National Review of Drug Discovery , vol.3 , pp. 673-683
    • Ashburn, T.1    Thor, K.2
  • 29
    • 0032516296 scopus 로고    scopus 로고
    • Oral sildenafil in the treatment of erectile dysfunction
    • I. Goldstein et al., "Oral Sildenafil in the Treatment of Erectile Dysfunction", New England Journal of Medicine 338 (1998) 1397-1404.
    • (1998) New England Journal of Medicine , vol.338 , pp. 1397-1404
    • Goldstein, I.1
  • 30
    • 84904118648 scopus 로고    scopus 로고
    • A human rights approach to an international code of conduct for genomic and clinical data sharing
    • (epub ahead of print). Retrieved 31 March 2014
    • B. Knoppers et al., "A human rights approach to an international code of conduct for genomic and clinical data sharing", Human Genet (2014) (epub ahead of print). Retrieved 31 March 2014, www.ncbi.nlm.nih.gov/pubmed/ 24573176.
    • (2014) Human Genet
    • Knoppers, B.1
  • 32
    • 84881560892 scopus 로고    scopus 로고
    • General Medical Council, 31 January 2013. Retrieved 8 April 2014
    • General Medical Council. 2013. "Good practice in prescribing and managing medicines and devices" 31 January 2013. Retrieved 8 April 2014, www.gmc uk.org/guidance/ethical-guidance/14316.asp.
    • (2013) Good Practice in Prescribing and Managing Medicines and Devices
  • 33
    • 84902530316 scopus 로고    scopus 로고
    • The Medicines and Healthcare Products Regulatory Agency Yellow Card Scheme
    • The Medicines and Healthcare Products Regulatory Agency Yellow Card Scheme.
  • 36
    • 33646744337 scopus 로고    scopus 로고
    • A systematic review
    • A Systematic Review", Drug Safety 29(5) (2006) 385-396.
    • (2006) Drug Safety , vol.29 , Issue.5 , pp. 385-396
  • 37
    • 0032876624 scopus 로고    scopus 로고
    • Attitudinal survey of voluntary reporting of adverse drug reactions
    • I. Eland, et al., "Attitudinal survey of voluntary reporting of adverse drug reactions", Journal of Clinical Pharmacology 48(4) (1999) 623-627.
    • (1999) Journal of Clinical Pharmacology , vol.48 , Issue.4 , pp. 623-627
    • Eland, I.1
  • 38
    • 0033381445 scopus 로고    scopus 로고
    • Underreporting of adverse drug reactions: Attitudes of Irish doctors
    • D. Williams and J. Feely, "Underreporting of adverse drug reactions: attitudes of Irish doctors", Ir J Med Sci 168(1999) 257-261
    • (1999) Ir J Med Sci , vol.168 , pp. 257-261
    • Williams, D.1    Feely, J.2
  • 39
    • 0034469051 scopus 로고    scopus 로고
    • Attitudes to reporting adverse drug reactions in northern Sweden
    • M. Backstrom et al., "Attitudes to reporting adverse drug reactions in northern Sweden", European Journal of Clinical Pharmacology 56 (2000) 729-732.
    • (2000) European Journal of Clinical Pharmacology , vol.56 , pp. 729-732
    • Backstrom, M.1
  • 40
    • 26444531116 scopus 로고    scopus 로고
    • Physicians' attitudes and adverse drug reaction reporting
    • M. Herdeiro, "Physicians' Attitudes and Adverse Drug Reaction Reporting", Drug Safety 28 (9) (2006) 825-833.
    • (2006) Drug Safety , vol.28 , Issue.9 , pp. 825-833
    • Herdeiro, M.1
  • 43
    • 80055001722 scopus 로고    scopus 로고
    • New approaches to strengthen pharmacovigilance
    • P. Arlett and X. Kurz, "New approaches to strengthen pharmacovigilance", Drug Discovery Today: Technologies 8(1) (2011), e15-e19.
    • (2011) Drug Discovery Today: Technologies , vol.8 , Issue.1
    • Arlett, P.1    Kurz, X.2
  • 45
    • 83655214959 scopus 로고    scopus 로고
    • Bearing the risks of prescription drugs
    • D. Light (ed.), (Columbia University Press), at 7
    • D. Light, "Bearing the Risks of Prescription Drugs" in: D. Light (ed.), The Risks of Prescription Drugs (Columbia University Press, 2010), pp. 1-39, at 7.
    • (2010) The Risks of Prescription Drugs , pp. 1-39
    • Light, D.1
  • 46
    • 40449103107 scopus 로고    scopus 로고
    • Public good though data linkage: Measuring research outputs from the Western Australian Data Linkage System
    • E. Brook, D. Rosman and C. Holman, "Public good though data linkage: measuring research outputs from the Western Australian Data Linkage System", Australian and New Zealand Journal of Public Health 32(1) (2008) 19-23.
    • (2008) Australian and New Zealand Journal of Public Health , vol.32 , Issue.1 , pp. 19-23
    • Brook, E.1    Rosman, D.2    Holman, C.3
  • 47
    • 84902530317 scopus 로고    scopus 로고
    • Linköping University Medical Dissertations No. 1030, Linköping. Retrieved 23 January 2014
    • I.e. recall bias or interview bias, drop outs and completeness of response may be reduced'. A. Jönsson, "Drug-related morbidity and mortality: Pharmacoepidemiological aspects", Linköping University Medical Dissertations No. 1030, Linköping (2007). Retrieved 23 January 2014, www.diva-portal.org/smash/get/diva2:17207/FULLTEXT01.
    • (2007) Drug-related Morbidity and Mortality: Pharmacoepidemiological Aspects
    • Jönsson, A.1
  • 49
    • 84887401594 scopus 로고    scopus 로고
    • Electronic health records: New opportunities for clinical research
    • P. Coorevits et al., "Electronic health records: new opportunities for clinical research", Journal of Internal Medicine 274 (2013) 547-560.
    • (2013) Journal of Internal Medicine , vol.274 , pp. 547-560
    • Coorevits, P.1
  • 50
    • 84902530318 scopus 로고    scopus 로고
    • Retrieved 28 March
    • A UK example is the Clinical Practice Research Datalink (CPRD) in the UK This was previously known as the General Practice Research Database. For more information see CPRD website. Retrieved 28 March 2014, www.cprd.com/intro.asp.
    • (2014) CPRD Website
  • 51
    • 84902530319 scopus 로고    scopus 로고
    • Retrieved 28 March
    • Pharmo Record Linkage system as developed in the Netherlands. See Pharmo Institute for Outcomes Research. Retrieved 28 March 2014, www.pharmo.nl.
    • (2014) Pharmo Institute for Outcomes Research
  • 52
    • 84902530309 scopus 로고    scopus 로고
    • Retrieved 7 April
    • Electronic Health Records for Clinical Research (EHR4CR) See EHR4CR website Retrieved 7 April 2014, www.ehr4cr.eu.
    • (2014) EHR4CR Website
  • 53
    • 84902457145 scopus 로고    scopus 로고
    • Medical Research Council, Retrieved 29 August 2012
    • Medical Research Council. 2012. "E-Health Informatics Research Centres Call." Retrieved 29 August 2012, www.mrc.ac.uk/ Fundingopportunities/Calls/E-healthCentresCall/index.htm.
    • (2012) E-health Informatics Research Centres Call
  • 54
    • 84902530310 scopus 로고    scopus 로고
    • Retrieved 9 January 2014
    • For more information, see The Farr Institute, 2014. Retrieved 9 January 2014, www.farrinstitute.org.
    • (2014) The Farr Institute
  • 60
    • 78650345071 scopus 로고    scopus 로고
    • 'Review of the European data protection directive' technical report sponsored by the information commissioner's office
    • ICO
    • N. Robinson et al., 'Review of the European Data Protection Directive' Technical Report Sponsored by the Information Commissioner's Office, RAND Europe, (2009) ICO
    • (2009) RAND Europe
    • Robinson, N.1
  • 62
    • 84902530312 scopus 로고    scopus 로고
    • Construction of a linked health and social care database resource -lessons on process, content and culture
    • (Epub ahead of print). Retrieved 5 April 2014
    • M. Witham et al., "Construction of a linked health and social care database resource -lessons on process, content and culture", Informatics for Health and Social Care (2014) (Epub ahead of print). Retrieved 5 April 2014, www.ncbi.nlm.nih.gov/pubmed/24650248.
    • (2014) Informatics for Health and Social Care
    • Witham, M.1
  • 65
    • 77953213147 scopus 로고    scopus 로고
    • Myths and fallacies of "Personally Identifiable Information"
    • A. Narayanan and V. Schmatikov, 'Myths and fallacies of "Personally Identifiable Information" ', Communications of the ACM 53(6) (2010) 24-26.
    • (2010) Communications of the ACM , vol.53 , Issue.6 , pp. 24-26
    • Narayanan, A.1    Schmatikov, V.2
  • 66
    • 77957594024 scopus 로고    scopus 로고
    • Broken promises of privacy: Responding to the surprising failure of anonymization
    • P. Ohm, "Broken Promises of Privacy: Responding to the Surprising Failure of Anonymization", UCLA Law Review, 57 (2010) 1701.
    • (2010) UCLA Law Review , vol.57 , pp. 1701
    • Ohm, P.1
  • 68
    • 77952294318 scopus 로고    scopus 로고
    • Meeting the governance challenges of next-generation biorepository research
    • S. Fullerton et al., "Meeting the governance challenges of next-generation biorepository research", Science Translational Medicine 2(15) (2010).
    • (2010) Science Translational Medicine , vol.2 , Issue.15
    • Fullerton, S.1
  • 69
    • 84866868429 scopus 로고    scopus 로고
    • The Royal Society', The Royal Society Science Policy Centre report 02/12
    • The Royal Society 2012. 'Science as an Open Enterprise', The Royal Society Science Policy Centre report 02/12.
    • (2012) Science As An Open Enterprise
  • 72
    • 34548557737 scopus 로고    scopus 로고
    • Multi-centric universal pseudonymisation for secondary use of the HER
    • at p. 239
    • L. Lo Iacono, "Multi-centric Universal Pseudonymisation for Secondary Use of the HER", Studies in Health Technology and Informatics 126 (2007) 239-247, at p. 239.
    • (2007) Studies in Health Technology and Informatics , vol.126 , pp. 239-247
    • Lo Iacono, L.1
  • 73
    • 77950330795 scopus 로고    scopus 로고
    • Anonymisation vs. Pseudonymisation: Which one is most Useful for both Privacy Protection and Usefulness of E-healthcare Data?
    • Retrieved 21 January 2014
    • R. Tinabo et al., "Anonymisation vs. Pseudonymisation: Which one is most Useful for both Privacy Protection and Usefulness of E-healthcare Data?" In Proc. IEEE 4th International Conference for Internet Technology and Secured Transactions (ICITST). (2009) Retrieved 21 January 2014, ieeexplore.ieee.org/xpls/abs-all.jsp?arnumber=5402501&tag=1.
    • (2009) Proc. IEEE 4th International Conference for Internet Technology and Secured Transactions (ICITST)
    • Tinabo, R.1
  • 75
    • 84902463716 scopus 로고    scopus 로고
    • The complexities of privacy and anonymity XRDS: Crossroads
    • Information Commissioner's Office (ICO), Fall, ACM New York, NY, USA
    • Iain Bourne, Information Commissioner's Office (ICO) 'The Complexities of Privacy and Anonymity XRDS: Crossroads', The ACM Magazine for Students, Volume 20 Issue 1, Fall 2013 Pages 27-31, ACM New York, NY, USA.
    • (2013) The ACM Magazine for Students , vol.20 , Issue.1 , pp. 27-31
    • Bourne, I.1
  • 78
    • 85016024869 scopus 로고    scopus 로고
    • Towards principles-based approaches to governance of health-related research using personal data
    • See G. Laurie and N. Sethi, "Towards Principles-Based Approaches to Governance of Health-related Research using Personal Data", European Journal of Risk Regulation 1 (2013) 43-57
    • (2013) European Journal of Risk Regulation , vol.1 , pp. 43-57
    • Laurie, G.1    Sethi, N.2
  • 79
    • 84900838941 scopus 로고    scopus 로고
    • Delivering proportionate governance in the era of eHealth: Making linkage and privacy work together
    • N. Sethi and G. Laurie, "Delivering proportionate governance in the era of eHealth: Making linkage and privacy work together", Medical Law International 13(2-3) (2013) 168-204.
    • (2013) Medical Law International , vol.13 , Issue.2-3 , pp. 168-204
    • Sethi, N.1    Laurie, G.2
  • 81
    • 84902496384 scopus 로고    scopus 로고
    • European Parliament', 4 March, Retrieved 29 March 2014
    • European Parliament, 'Q&A on EU data protection reform', 4 March 2014. Retrieved 29 March 2014,www.europarl.europa.eu/pdfs/news/expert/ background/20130502BKG07917/20130502BKG07917-en.pdf.
    • (2014) Q&A on EU Data Protection Reform
  • 82
    • 84979809728 scopus 로고    scopus 로고
    • The EU Data Protection Directive: An engine of a global regime
    • For discussion see: M. Birnhack, "The EU Data Protection Directive: An engine of a global regime", Computer Law & Security Review 24(6) (2008) 508-520
    • (2008) Computer Law & Security Review , vol.24 , Issue.6 , pp. 508-520
    • Birnhack, M.1
  • 83
    • 21844508835 scopus 로고
    • European data protection law and restrictions on international data flow 80
    • P. Schwartz, "European Data Protection Law and Restrictions on International Data Flow", 80 Iowa Law Review 80 (1995) 471.
    • (1995) Iowa Law Review , vol.80 , pp. 471
    • Schwartz, P.1
  • 84
    • 84902476015 scopus 로고    scopus 로고
    • The shape of things to come: Swedish developments on the protection of privacy
    • R. Wong, 'The Shape of Things to Come: Swedish Developments on the Protection of Privacy', SCRIPTed 2(1) (2005) 98-113.
    • (2005) SCRIPTed , vol.2 , Issue.1 , pp. 98-113
    • Wong, R.1
  • 85
    • 84902496384 scopus 로고    scopus 로고
    • European Parliament News, 4 March 2014. Retrieved 17 March 2014
    • European Parliament News. 2014. QA on Data Protection Reform, 4 March 2014. Retrieved 17 March 2014, www.europarl.europa.eu/news/en/news-room/content/ 20130502BKG07917/html/QA-on-EU-data-protection-reform.
    • (2014) QA on Data Protection Reform
  • 87
    • 84902530303 scopus 로고    scopus 로고
    • International Pharmaceutical Privacy Consortium. March 2012.' Retrieved 7 April 2014
    • Directive 2010/84/EU and Regulation (EU) No 1235/2010 impose obligations on pharmaceutical companies to report adverse events however it has not always been clear how those legislation interact with the EU Data Protection Directive. The Draft Data Protection Regulation specifies that health data may be processed for 'ensuring high standards of quality and safety for medicinal products and product safety' thus potentially providing a clearer legislative base for the use of personal data and the retention of data for research. See: International Pharmaceutical Privacy Consortium. March 2012. 'Comments in response to the call for evidence on EU Data Protection Proposals.' Retrieved 7 April 2014, www.pharmaprivacy.org/download/ IPPC%20Comments%20UK%20Consultation%20on%20Proposed%20Data%20Protection%20Regul ation.pdf.
    • Comments in Response to the Call for Evidence on EU Data Protection Proposals
  • 88
    • 84902583614 scopus 로고    scopus 로고
    • Committee on Civil Liberties, Justice and Home Affairs, Draft Report on the proposal for a regulation of the European Parliament and of the Council on the protection of individual with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation)
    • 0011 - C7-0025/2012 - 2012/0011(COD)
    • Rapporteur Jan Philipp Albrecht, Committee on Civil Liberties, Justice and Home Affairs, Draft Report on the proposal for a regulation of the European Parliament and of the Council on the protection of individual with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation) COM (2012) 0011 - C7-0025/2012 - 2012/0011(COD)).
    • (2012) COM
    • Albrecht, R.J.P.1
  • 89
    • 84880940838 scopus 로고    scopus 로고
    • Proposed EU data protection regulation is a threat to medical research
    • (Editorial)
    • M. Ploem and K. Stronks, "Proposed EU data protection regulation is a threat to medical research" (Editorial), British Medical Journal 346 (2013)f3534
    • (2013) British Medical Journal , vol.346
    • Ploem, M.1    Stronks, K.2
  • 90
    • 84902490644 scopus 로고    scopus 로고
    • Data protection regulation and the promotion of health research: Getting the balance right
    • R. Fears et al., "Data protection regulation and the promotion of health research: getting the balance right", Quarterly Journal of Medicine 107 (2014) 3-5.
    • (2014) Quarterly Journal of Medicine , vol.107 , pp. 3-5
    • Fears, R.1
  • 92
    • 4143098103 scopus 로고    scopus 로고
    • The use of personal data from medical records and biological materials: Ethical perspectives and the basis for legal restrictions in health research
    • p. 1976
    • E. Regidor, "The use of personal data from medical records and biological materials: ethical perspectives and the basis for legal restrictions in health research", Social Science and Medicine (54) (2004) 1975-1894, at p. 1976
    • (2004) Social Science and Medicine , vol.54 , pp. 1975-1894
    • Regidor, E.1
  • 93
    • 11144302577 scopus 로고    scopus 로고
    • Obtaining explicit consent for the use of archival tissue samples: Practical issues
    • P. Furness and L. Nicholson, "Obtaining Explicit Consent for the Use of Archival Tissue Samples: Practical Issues", Journal of Medical Ethics 20 (2004) 561.
    • (2004) Journal of Medical Ethics , vol.20 , pp. 561
    • Furness, P.1    Nicholson, L.2
  • 94
    • 48349127513 scopus 로고    scopus 로고
    • Evidence of support for biobanking practices
    • G. Laurie, "Evidence of support for biobanking practices", British Medical Journal 337 (2008) 337
    • (2008) British Medical Journal , vol.337 , pp. 337
    • Laurie, G.1
  • 95
    • 84883183581 scopus 로고    scopus 로고
    • Rhetoric or Reality: What is the legal status of the consent form in health-related research?
    • G. Laurie and E. Postan, "Rhetoric or Reality: What is the legal status of the consent form in health-related research?", Medical Law Review 21(3) (2013) 371-414.
    • (2013) Medical Law Review , vol.21 , Issue.3 , pp. 371-414
    • Laurie, G.1    Postan, E.2
  • 96
    • 84929842173 scopus 로고    scopus 로고
    • Cancer registration, public health and the reform of the European data protection framework: Abandoning or improving European public health research?
    • (Epub ahead of print)
    • M. Andersen and H. Storm, "Cancer registration, public health and the reform of the European data protection framework: Abandoning or improving European public health research?", European Journal of Cancer (2013) (Epub ahead of print).
    • (2013) European Journal of Cancer
    • Andersen, M.1    Storm, H.2
  • 97
    • 84902530304 scopus 로고    scopus 로고
    • Article 29 Data Protection Working Party, 0829/14/EN WP216, adopted 10 April 2014
    • Article 29 Data Protection Working Party, Opinion 05/2014 on Anonymisation Techniques, 0829/14/EN WP216, adopted 10 April 2014.
    • Opinion 05/2014 on Anonymisation Techniques
  • 98
    • 84902530305 scopus 로고    scopus 로고
    • Proposal for a regulation Article 81 - paragraph 2 a (new)
    • Albrecht Report, Amendment 328, Proposal for a regulation Article 81 - paragraph 2 a (new).
    • Albrecht Report Amendment , vol.328
  • 101
    • 84872459720 scopus 로고    scopus 로고
    • Identifying personal genomes by surname inference
    • M. Gymrek et al., "Identifying personal genomes by surname inference", Science 339 (2013) 321-324.
    • (2013) Science , vol.339 , pp. 321-324
    • Gymrek, M.1
  • 102
    • 84902530308 scopus 로고    scopus 로고
    • European Commission, Retrieved 29 March
    • European Commission, Article 29 Working Party. Retrieved 29 March 2014, ec.europa.eu/justice/data-protection/article-29/index-en.htm.
    • (2014) Article 29 Working Party
  • 103
    • 84865463343 scopus 로고    scopus 로고
    • Article 29 Data Protection Working Party, Adopted 13 July
    • Article 29 Data Protection Working Party, Opinion 15/2011 on the definition of consent, Adopted 13 July 2011.
    • (2011) Opinion 15/2011 on the Definition of Consent
  • 107
    • 84902530299 scopus 로고    scopus 로고
    • Retrieved 31 March 2014
    • For more see SHIP website. Retrieved 31 March 2014, www.scot-ship.ac.uk.
    • SHIP Website
  • 109
    • 79960288854 scopus 로고    scopus 로고
    • Towards a data sharing Code of Conduct for international genomic research
    • B. Knoppers et al., 'Towards a data sharing Code of Conduct for international genomic research', Genome Medicine 46(3) (2011) 4.
    • (2011) Genome Medicine , vol.46 , Issue.3 , pp. 4
    • Knoppers, B.1
  • 110
    • 21644458498 scopus 로고    scopus 로고
    • Reconciling rules and principles: An ethics-based approach to corporate governance
    • L. Sama and V. Shoaf, "Reconciling Rules and Principles: An Ethics-Based Approach to Corporate Governance", Journal of Business Ethics 58 (2005), p. 1
    • (2005) Journal of Business Ethics , vol.58 , pp. 1
    • Sama, L.1    Shoaf, V.2
  • 111
    • 0142029113 scopus 로고    scopus 로고
    • In praise of unprincipled ethics
    • See for example, J. Harris, 'In praise of unprincipled ethics', Journal of Medical Ethics 29 (5) (2003) 303-306.
    • (2003) Journal of Medical Ethics , vol.29 , Issue.5 , pp. 303-306
    • Harris, J.1
  • 113
    • 84860529598 scopus 로고    scopus 로고
    • When four principles are too many: Bloodgate, integrity and an action-guiding model of ethical decision making in clinical practice
    • W. Muirhead, 'When four principles are too many: bloodgate, integrity and an action-guiding model of ethical decision making in clinical practice', Journal of Medical Ethics 38 (2012) 195-196.
    • (2012) Journal of Medical Ethics , vol.38 , pp. 195-196
    • Muirhead, W.1
  • 114
    • 84902471464 scopus 로고    scopus 로고
    • Cheltenham: Edward Elgar Publishing
    • For discussion on rule-based and principle-based regulation, see: A. Kern and N. Moloney, Law Reform and Financial Markets (Cheltenham: Edward Elgar Publishing: 2011) at p. 8
    • (2011) Law Reform and Financial Markets , pp. 8
    • Kern, A.1    Moloney, N.2
  • 117
    • 33750332996 scopus 로고    scopus 로고
    • Striking a balance between rules and principles-based approaches for effective governance: A risk-based approach
    • et seq., at p. 65
    • S. Arjoon, "Striking a Balance Between Rules and Principles-based Approaches for Effective Governance: A Risk-based Approach", Journal of Business Ethics 68 (2006) 53 et seq., at p. 65.
    • (2006) Journal of Business Ethics , vol.68 , pp. 53
    • Arjoon, S.1
  • 118
    • 84902530292 scopus 로고    scopus 로고
    • Regulation (EU) No . . . /2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
    • Regulation (EU) No . . . /2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.