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Home Publications Advice 2004 Genetic Research and PrivacyAdvisory Memorandum, PDF format, 46 KB February 2004 Advisory MemorandumThe unlocking of the human genome has given us the potential to revolutionize medicine and therefore what it means to be "healthy." Gaining this knowledge requires researchers to have access to large amounts of genetic information obtained from many thousands of individuals collected in "population biobanks." Unlike other information used for health purposes, Canadians feel there is something special about genetic information that it is not just information about us but, because of its uniqueness, it is us. While Canadians recognize the potential benefits that could arise from biobank research, we also want to know that, by sharing our genetic information, our privacy and human rights will not be infringed. Now before such population biobanks have been established in Canada is the time to determine how this balance is to be achieved. The Canadian Biotechnology Advisory Committee issues advisory memoranda to achieve the following objectives:
ContextFor Canadian medical and health researchers to be able to take maximum advantage of the information generated by the Human Genome Project, they must be able to conduct research using the genetic information of large numbers of Canadians. This task requires obtaining samples of DNA (usually from a blood or saliva sample) from individuals, which can then be analyzed to obtain the genetic information. Research collections of physical samples and databases of the information derived from them are often generally called "biobanks" or "genetic databanks." Until recently, most biobanks have been relatively small, consisting of perhaps several hundred or a few thousand samples or data entries, usually from a patient population with a common illness or condition. Research using these collections or databases derived from them is generally focussed on a specific disease. Population biobanks consist of a minimum of several thousand samples from the population at large. Research using population databases can identify the genetic patterns that are prevalent in a country or geographic area. Such research may hold the key to a new era of medical knowledge and health care. If each person's individual genome could be understood, a personalized plan could be developed to support a healthier and longer life. Prevention and treatment could be tailored to the individual. Drugs and dosages could be chosen to maximize healing benefits without side-effects. Population biobanks have already been established or are in the planning stages in Iceland, Estonia, Tonga, United Kingdom and a number of other countries. Analysis of the differences in the approaches taken to setting up and operating them are instructive for anyone considering undertaking such a large-scale initiative. Proposals are under consideration in Canada to establish similar research databanks.
While Canadians tend to be very supportive of medical research, they also worry that their genetic information could somehow be used to their disadvantage. If researchers are to be able to build the databases of genetic information that will be needed for this kind of research, Canadians must be assured of protection of their rights to privacy, autonomy and non-discrimination. The key question is, how can a society benefit from the medical knowledge that biobank research may make available while at the same time ensuring protection of the privacy and confidentiality interests of its citizens? CBAC and Genetic Research and PrivacyIn 2002, CBAC commissioned four papers to identify and examine social, ethical and legal issues associated with the establishment and use of population biobanks. The focus on biobanks was chosen to complement policy research being carried out on other privacy issues raised in relation to genetic information by the interdepartmental Canadian Biotechnology Strategy Working Group on Genetic Information and Privacy. Early versions of these four papers (survey of existing biobanks, Canadian legal framework, privacy issues, and analyses of public and professional opinion) were presented at Genome Canada's first GE3LS (Genome ethical, environmental, economic, legal and social issues) Symposium, held in February 2003. A fifth paper was commissioned in 2003 to synthesize and summarize the earlier work. The Recommendations section of this Advisory Memorandum is drawn from the concluding section of that paper. The Role of the Federal GovernmentThe federal government plays a number of roles related to genetic research and the privacy and other rights of research subjects. As a legislator, the federal government is responsible for the Privacy Act, the Canadian Human Rights Act and the Canada Health Act. The federal government also has a significant role as a funder of health and health-related research through the Canadian Institutes of Health Research (CIHR) and the National Research Council's Genomics and Health Initiative as well as other programs. It supports the Interagency Advisory Panel on Research Ethics (PRE). Finally, the federal government contributes to the health of Canadians, both through its direct responsibility for the provision of health care to certain Canadians and its financial contributions to the provinces and territories for medicare services. Since both privacy and health care also fall largely within the domain of the provinces and territories, the federal government cannot resolve all the issues on its own. The federal government and most of the provinces and territories have both privacy and human rights legislation. The federal laws generally apply only to federal employees and those industries that are federally regulated such as airlines and banking. Consequently, the privacy and human rights legislation affecting most Canadians lies within the jurisdictions of the provinces and territories. While generally similar, the specific privacy and human rights protections available to Canadians vary from one province or territory to another. The federal government may be best placed to facilitate the development of a consistent approach to resolving the privacy and confidentiality issues that will enable all Canadians, no matter where they live, to benefit equally from new advances. RecommendationsThe following recommendations are CBAC's view of what will be required to achieve the balance between access to genetic information for research to improve the health of Canadians and respect of the right of Canadians to dignity, privacy and confidentiality. Although many of the recommendations are not within the direct fiat of the federal government, the Government of Canada can play a significant leadership role in encouraging their achievement. Public Education and Consultation
Privacy and Confidentiality
Recruitment and Informed Consent
This model strikes a reasonable balance that is supportive of individual autonomy and of genetic research and is supported by the Tri-Council Policy Statement (Article 8.6) and accords with public opinion. Commercialization
Governance
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Created: 2005-07-13 Updated: 2006-06-22 |
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