Creation and Governance of Human Genetic Research Databases by Organization for Economic Cooperation &

By Organization for Economic Cooperation &

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By Organization for Economic Cooperation &

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Php (accessed 9 August 2006). 58. php (accessed 7 September 2006). 59. php (accessed 7 September 2006). 60. php (accessed 9 August 2006) and UK Biobank Ethics and Governance Council, Annual Report 2004-2005. 61. pdf (accessed 7 September 2006). 62. htm; (accessed 7 September 2006). K. Erickson (2003), “Ethnicity Puts Clinical Trials to the Test”, Nature Medicine Vol. 9, No. 8, p. 983; M. htm (accessed 16 May 2006); M. htm (accessed 16 May 2006). 63. htm. CREATION AND GOVERNANCE OF HUMAN GENETIC RESEARCH DATABASES – ISBN-92-64-02852-8 © OECD 2006 51 52 – CHAPTER 2.

Another key issue is the purpose for which access should be granted. With respect to commercialisation, one consideration is whether or not it is desirable to commercialise the database and/or whether commercialisation is in line with the participants’ expectations. If commercial exploitation of the database is undertaken, consideration should also be given to the manner in which it should be carried out. Should the database be commercialised on an exclusive or non-exclusive basis? If commercial exploitation is to be undertaken on an exclusive basis, how can fair access to the database and how can compliance with competition law be ensured?

Therefore, the issue becomes what constitutes informed consent within the context of an HGRD given that the purposes for which the data, information and biological samples are collected and the uses for which they may be employed, usually, may be described only in a general manner. Many have queried whether the traditional model of informed CREATION AND GOVERNANCE OF HUMAN GENETIC RESEARCH DATABASES – ISBN-92-64-02852-8 © OECD 2006 31 32 – CHAPTER 1. INTRODUCTION consent is applicable in the context of HGRDs or whether a new model/paradigm should be developed.

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