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Volumn 20, Issue 4, 2012, Pages 516-539

Medical research data-sharing: The 'public good' and vulnerable groups

Author keywords

Aging; Data sharing; Elderly; Medical research; Open science; Regulation

Indexed keywords

ACCESS TO INFORMATION; AGED; ARTICLE; FRAIL ELDERLY; GOVERNMENT REGULATION; HUMAN; INFORMATION DISSEMINATION; LEGAL ASPECT; MEDICAL RESEARCH; PUBLIC HEALTH; VULNERABLE POPULATION;

EID: 84870027164     PISSN: 09670742     EISSN: 14643790     Source Type: Journal    
DOI: 10.1093/medlaw/fws006     Document Type: Article
Times cited : (4)

References (140)
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    • Representations at the International Data Sharing Conference, hosted by HeLEX, in Oxford, on 20-22 September 2010, and those directed at the Oxford Call to Action, which is emerging therefrom.
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    • Primary biobanks generate new data collections for defined purposes. An example includes the UK Biobank, a repository of biological samples, and health data from some 500,000 volunteers between the ages of 40-69 aimed at helping scientists develop better methods of prevention, diagnosis, and treatment for combating the conditions of old age, and to thereby improve the health of future generations: Secondary biobanks aggregate and manage samples and data originated by others for specific purposes but which now may be valuable for other research purposes. An example is the UK DNA Banking Network which aims to provide data to genome-wide association studies which seek to identify multiple loci which contribute to genetic risk for given diseases
    • Primary biobanks generate new data collections for defined purposes. An example includes the UK Biobank, a repository of biological samples, and health data from some 500,000 volunteers between the ages of 40-69 aimed at helping scientists develop better methods of prevention, diagnosis, and treatment for combating the conditions of old age, and to thereby improve the health of future generations: ,http://www.ukbiobank.ac.uk/. Secondary biobanks aggregate and manage samples and data originated by others for specific purposes but which now may be valuable for other research purposes. An example is the UK DNA Banking Network which aims to provide data to genome-wide association studies which seek to identify multiple loci which contribute to genetic risk for given diseases: ,http://www.dna-network.ac.uk/.
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    • So claimed by M Yuille in comments posted, relation to the International Data Sharing Conference, hosted by HeLEX, in Oxford, on 20-22 September 2010, and so noted in Academy of Medical Sciences, A New Pathway for the Regulation and Governance of Health Research (AMS, London 2011).
    • So claimed by M Yuille in comments posted at ,http://helexoxford.com/content/oxford-statement-data-sharing. in relation to the International Data Sharing Conference, hosted by HeLEX, in Oxford, on 20-22 September 2010, and so noted in Academy of Medical Sciences, A New Pathway for the Regulation and Governance of Health Research (AMS, London 2011).
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    • Note
    • House of Lords Science and Technology Committee, above, n 5, at para 6.15.
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    • AMS, above, n 22, at 2 and 3. A position confirmed by the HFEA, HTA, and MHRAwhen they conceded the need for their Interim UK Regulatory Route Map for Stem Cell Research & Manufacture
    • AMS, above, n 22, at 2 and 3. A position confirmed by the HFEA, HTA, and MHRAwhen they conceded the need for their Interim UK Regulatory Route Map for Stem Cell Research & Manufacture ,http://www.keele.ac.uk/research/istm/HTA/Governance/Interim%20UKSC%20routemap.pdf..
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    • The HapMap Project (2002-2007) was a multi-country collaboration among scientists and agencies from Canada, China, Japan, Nigeria, the UK, and the USA aimed at identifying and cataloguing human genetic similarities and differences and thereby discovering genes that affect health, disease, and individual responses to medicines and environmental factors.
    • The HapMap Project (2002-2007) was a multi-country collaboration among scientists and agencies from Canada, China, Japan, Nigeria, the UK, and the USA aimed at identifying and cataloguing human genetic similarities and differences and thereby discovering genes that affect health, disease, and individual responses to medicines and environmental factors.
  • 32
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    • See ,http://hapmap.ncbi.nlm.nih.gov/thehapmap.html.en..
  • 33
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    • The 1000 Genome Project (2007-) is a human genome reference project aimed at finding the most genetic variants that have frequencies of at least 1% in the populations studied
    • The 1000 Genome Project (2007-) is a human genome reference project aimed at finding the most genetic variants that have frequencies of at least 1% in the populations studied. ,http://www.1000genomes.org/about..
  • 34
    • 84878021150 scopus 로고    scopus 로고
    • The dbGaP is a repository for archiving and distributing the study documents, phenotypic data, genetic data, and statistical results of studies that have investigated the interaction of genotype and phenotype. Such studies include genome-wide association (GWA) studies, medical sequencing, molecular diagnostic assays, as well as association between genotype and nonclinical traits
    • The dbGaP is a repository for archiving and distributing the study documents, phenotypic data, genetic data, and statistical results of studies that have investigated the interaction of genotype and phenotype. Such studies include genome-wide association (GWA) studies, medical sequencing, molecular diagnostic assays, as well as association between genotype and nonclinical traits. ,http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/about.html..
  • 35
    • 84878021561 scopus 로고    scopus 로고
    • GAIN is a public-private partnership which invites data from investigators of existing case-control or trio (parent-offspring) studies, and it supports GWA studies designed to identify the relation between specific DNAvariation and particular common diseases. Data are held in a database at the National Library of Medicine at the NIH for further use by other researchers. GAIN gives data producers a six-month publishing lead over competitors. Requests for access are considered by an NIH Data Access Committee
    • GAIN is a public-private partnership which invites data from investigators of existing case-control or trio (parent-offspring) studies, and it supports GWA studies designed to identify the relation between specific DNAvariation and particular common diseases. Data are held in a database at the National Library of Medicine at the NIH for further use by other researchers. GAIN gives data producers a six-month publishing lead over competitors. Requests for access are considered by an NIH Data Access Committee. ,http://www.genome.gov/19518664..
  • 36
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    • The WTCCC is a collaboration of UK-based geneticists analysing thousands of DNA samples from a range of specific GWA studies aimed at identifying common genetic variations for different diseases. While some data are available on the internet, genotypic and phenotypic data are obtained by application to the Consortium Data Access Committee
    • The WTCCC is a collaboration of UK-based geneticists analysing thousands of DNA samples from a range of specific GWA studies aimed at identifying common genetic variations for different diseases. While some data are available on the internet, genotypic and phenotypic data are obtained by application to the Consortium Data Access Committee. ,http://www.wtccc.org.uk/..
  • 37
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    • NASC offers a transcriptomics service to process samples and RNA with Affymetrix gene chips. It makes all donated data publicly available after a confidentiality period of 3, 6, or 12 months, depending on what donors/customers choose; the length of the confidentiality period is linked to the priority that donors demand for analysis service (ie a request for quick processing results in the provision of a shorter confidentiality period)
    • NASC offers a transcriptomics service to process samples and RNA with Affymetrix gene chips. It makes all donated data publicly available after a confidentiality period of 3, 6, or 12 months, depending on what donors/customers choose; the length of the confidentiality period is linked to the priority that donors demand for analysis service (ie a request for quick processing results in the provision of a shorter confidentiality period). ,http://affymetrix.arabidopsis.info/..
  • 38
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    • Should Health Care be Rationed by Age?
    • An avalanche of policy documents on this exists, but see T Nilstrum and R Ohlsson, 'Should Health Care be Rationed by Age?' (1995) 23 Scan J Social Med 81.
    • (1995) Scan J Social Med , vol.23 , pp. 81
    • Nilstrum, T.1    Ohlsson, R.2
  • 39
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    • Note
    • We are generally trying to forge a society shaped by positive rights supported by legal protections and processes that are available to all, including scientists, the elderly, and others. However, as a result of individual and collective practices, that society remains, in many ways, aspirational.
  • 40
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    • UN General Assembly Res. 217A (III), UN GAOR, 3d Sess., UN Doc A/810, 1948, Art 25.
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    • Available at ,http://apps.who.int/gb/bd/PDF/bd47/EN/constitution-en.pdf..
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    • Note
    • 993 UNTS 3, Arts 9 and 12 and General Comment 3.
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    • Note
    • 660 UNTS 195.
  • 44
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    • WHO
    • WHO ,http://www.who.int/hpr/NPH/docs/declaration_almaata.pdf..
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    • WHO
    • WHO ,http://www.who.int/healthpromotion/conferences/previous/ottawa/en/..
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    • Note
    • 1577 UNTS 44.
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    • WHO
    • WHO ,http://www.who.int/healthpromotion/conferences/6gchp/hpr_050829_%20BCHP.pdf..
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    • Uganda Ministry of Health, Review of the HSSPII in Relation to Human Rights and Gender as Part of the Third-Term Review for the Health Sector, Second Draft (Ministry of Health, Kampala).
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    • (2008)
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    • Note
    • Tutela Decision, T-760/2008, 31 July 2008, Colombian Constitutional Court.
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    • Is Access to Essential Medicines as Part of the Fulfilment of the Right to Health Enforceable Through the Courts?
    • H Hogerzeil and others, 'Is Access to Essential Medicines as Part of the Fulfilment of the Right to Health Enforceable Through the Courts?' (2006) 368 Lancet 305.
    • (2006) Lancet , vol.368 , pp. 305
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    • See for example, Art 9 of the ICESCR (1966), which states that every person should be granted access to social security, and Art 3 of the European Convention on Biomedicine (1998) and Art 34 of the EU Charter of Fundamental Rights (2000), which emphasise the right to equitable access to healthcare of appropriate quality without discrimination.
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    • Part I, Art E
    • See Part I, Art E ,http://conventions.coe.int/treaty/en/treaties/html/163.htm..
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    • Art 14
    • See Art 14 ,http://www.echr.coe.int/NR/rdonlyres/D5CC24A7-DC13-4318-B457-5C9014916D7A/0/ENG_CONV.pdf..
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    • Art 21
    • See Art 21 ,http://www.europarl.europa.eu/charter/pdf/text_en.pdf.
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    • Note the UN International Year of Older Persons 1999.
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    • (1999) Global Health Promo , vol.6 , pp. 20
    • Kalache, A.1    Keller, I.2
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    • Arts 9 and 17 of the Additional Protocol to the American Convention on Human Rights in the Area of Economic, Social and Cultural Rights, OASTS 69
    • Arts 9 and 17 of the Additional Protocol to the American Convention on Human Rights in the Area of Economic, Social and Cultural Rights (1989), OASTS 69 ,http://www.oas.org/juridico/english/treaties/a-52.html.
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    • Art 18 of the African Charter on Human and Peoples' Rights 21 ILM 58.
    • Art 18 of the African Charter on Human and Peoples' Rights (1981) 21 ILM 58.
    • (1981)
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    • Art 25 of the EU Charter of Fundamental Rights
    • Art 25 of the EU Charter of Fundamental Rights (2000).
    • (2000)
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    • Arts 12 and 23 of the Revised European Social Charter
    • Arts 12 and 23 of the Revised European Social Charter (1996).
    • (1996)
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    • UN Principles for Older Persons, General Assembly Res 46/91, UN GAOR, 46th Sess, 74th Plen. Meeting, Annex 1, UN Doc A/RES/46/91
    • UN Principles for Older Persons, General Assembly Res 46/91, UN GAOR, 46th Sess, 74th Plen. Meeting, Annex 1, UN Doc A/RES/46/91 (1991).
    • (1991)
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    • UN Human Rights Committee, General Comment 7: Torture or Cruel, Inhuman or Degrading Treatment or Punishment, UN Doc HRI/GEN/1/ Rev. 1
    • UN Human Rights Committee, General Comment 7: Torture or Cruel, Inhuman or Degrading Treatment or Punishment, UN Doc HRI/GEN/1/ Rev. 1 (1994).
    • (1994)
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    • Note
    • Including strong mobility rights, increasing levels of education, widely available information about technological capabilities and geographic inequalities, and rising desires for varied, self-actualising leisure opportunities.
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    • The Ageing Populations of Europe: Implications for Health Systems and Patients' Rights
    • E Rynning, 'The Ageing Populations of Europe: Implications for Health Systems and Patients' Rights' (2008) 15 Euro J Health Law 297.
    • (2008) Euro J Health Law , vol.15 , pp. 297
    • Rynning, E.1
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    • Note
    • We recognise that desires, even those indirectly fuelled by rights, do not automatically entitle, much less grant, individuals the right to have those desires satisfied, but, we contend, a welfare-based rights society would and should endeavour, as far as possible, to deliver on the desires that our rights instruments feed.
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    • Demography: Broken Limits to Life Expectancy
    • With respect to long life, some argue that there is no evidence that humans have reached the limit of life expectancy
    • With respect to long life, some argue that there is no evidence that humans have reached the limit of life expectancy: J Oeppen and J Vaupel, 'Demography: Broken Limits to Life Expectancy' (2002) 296 Science 1029.
    • (2002) Science , vol.296 , pp. 1029
    • Oeppen, J.1    Vaupel, J.2
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    • For evidence of the hope being placed in new technologies, see European Commission, Together for Health: A Strategic Approach for the EU 2008-2013 (EU Publications Office, Luxembourg).
    • For evidence of the hope being placed in new technologies, see European Commission, Together for Health: A Strategic Approach for the EU 2008-2013 (EU Publications Office, Luxembourg 2007).
    • (2007)
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    • Health Systems and the Right to Health: An Assessment of 194 Countries
    • Increased sharing of research and health data is also important for measuring how countries are performing with respect to health; current data practice hinders investigations into whether adequate and appropriate health research is being conducted in conformity with international right-to-health demands
    • Increased sharing of research and health data is also important for measuring how countries are performing with respect to health; current data practice hinders investigations into whether adequate and appropriate health research is being conducted in conformity with international right-to-health demands: G Backman and others, 'Health Systems and the Right to Health: An Assessment of 194 Countries' (2008) 372 Lancet 2047.
    • (2008) Lancet , vol.372 , pp. 2047
    • Backman, G.1
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    • The Greying World: A Challenge for the Twenty-First Century
    • A Kalache and I Keller, 'The Greying World: A Challenge for the Twenty-First Century' (2000) 83 Science Progress 33.
    • (2000) Science Progress , vol.83 , pp. 33
    • Kalache, A.1    Keller, I.2
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    • European Observatory on the Social Situation, Demographic Trends, Socio-Economic Impacts and Policy Implications in the European Union - 2007 (EU Publications Office, Luxembourg).
    • European Observatory on the Social Situation, Demographic Trends, Socio-Economic Impacts and Policy Implications in the European Union - 2007 (EU Publications Office, Luxembourg 2008).
    • (2008)
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    • Note
    • UN, World Population Prospects: The 2010 Revision (Department of Economic & Social Affairs, Population Division, NY 2011). Although we note that the global population has just topped seven billion, having grown by a billion people in just 12 years.
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    • WHO, Active Aging: A Policy Framework (WHO, Geneva).
    • WHO, Active Aging: A Policy Framework (WHO, Geneva 2002).
    • (2002)
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    • WHO, Active Aging: A Policy Framework (GWHO, Geneva), at 17.
    • WHO, Active Aging: A Policy Framework (GWHO, Geneva 2002), at 17.
    • (2002)
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    • From a programmes perspective, one can already find discussions about retirement ages and the management and funding of pension schemes into the future: see Editorial, '70 of Bust', 9-15 April, Economist
    • From a programmes perspective, one can already find discussions about retirement ages and the management and funding of pension schemes into the future: see Editorial, '70 of Bust', 9-15 April 2011, Economist, p 13.
    • (2011) , pp. 13
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    • 9-11 April, Economist, Special Report. From a systemic perspective, there are concerns about how to accommodate the growing number of geriatric patients.
    • P Coggan and others, 'Pensions - Falling Shorts', 9-11 April 2011, Economist, Special Report. From a systemic perspective, there are concerns about how to accommodate the growing number of geriatric patients.
    • (2011) Pensions - Falling Shorts
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