Genetic Research and Privacy

Advisory Memorandum, PDF format, 46 KB

February 2004

Advisory Memorandum

The 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:

• to alert the Government of Canada on issues of immediate importance and provide recommendations to assist decision makers in developing an effective course of action
• to inform government of the "state of the debate" on topics that will likely require government attention in the short to medium term
• to report on the impact that government policy is having on biotechnological developments in Canada.

Context

For 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.

• The Canadian Institutes of Health Research (CIHR) are developing the Canadian Lifelong Health Initiative, designed to follow an as yet undetermined number of newborns (Canadian National Birth Cohort) and 50 000 Canadians aged 45 years and older (Canadian Longitudinal Study on Aging) to understand gene-environment interactions.
  
  The Canadian Lifelong Health Initiative (CLHI) is intended to facilitate the establishment of a research program to conduct large multi-centred longitudinal cohort studies of Canadians. These studies will analyse the role and interaction of different genetic and environmental exposures involved in the human development and aging processes over the life course, the multifactorial causes and evolution of common diseases, and the utilization of health care services
  
  The resulting infrastructure will help create a common research platform that will give Canadian scientists a unique advantage in allowing the conduct of original population studies, over decades, that will place Canada at the forefront of modern health research and help attract and retain the best investigators and trainees.
• CARTaGENE is a proposal for a biobank for the population of Quebec. Once funding is secured and following public consultation, samples will be randomly collected from 60 000 individuals aged 25-74 within a period of four years. This information will allow large-scale medical, pharmacogenomic and public health studies, including association studies of common diseases or "protective" phenotypes and lead to the discovery of new susceptibility genes. Globally, the aim of CARTaGENE is to provide information for the best use of genetic knowledge and technology in the public health system.

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 Privacy

In 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 Government

The 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.

Recommendations

The 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

1. A public education and consultation strategy must precede the establishment of any large-scale population genetic research initiative. Applicants for federal funds should be required to include detailed descriptions of their proposed strategy. The federal government should encourage other funders (provincial/territorial or private) to apply the same criteria.

Privacy and Confidentiality

2. How to increase understanding of the interactions among all federal and provincial/territorial privacy statutes that may affect biobanking should be further examined. Based on this examination, consideration should be given to the need for developing uniform legislation specific to biobanking. The federal government should request the Law Reform Commission of Canada or the Uniform Law Conference of Canada to undertake this review.
3. Biobanks must be planned from the earliest stages to ensure that they embody optimal strategies for data collection and storage with appropriate mechanisms for encryption, anonymization and sharing of data.

Recruitment and Informed Consent

4. Methods of recruiting participants must be supported on scientific, legal and ethical grounds.
5. For biobank research to be most beneficial, the current norms of informed consent must be reviewed. Consideration should be given to establishing an "authorization model" of informed consent specifically for prospective population genetic research.

Authorization model:


• Informed consent must be required for the initial collection of the biological sample.
• Authorization of subsequent research must be given (or denied) by the research participant at the time of the initial sample collection.
• Individuals must be able to specify which uses of their biological material and associated data are permitted or excluded as well as the degree of subsequent decision-making authority they want to retain.
• Individuals must have the option to give general or "blanket consent" to any and all future uses, although this form of consent may not be recognized in all jurisdictions.

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

6. As part of the informed consent process, research participants must be informed of the potential for future commercialization of any research based on examination of their biological materials and genetic information.
7. Benefit sharing arrangements should be incorporated into the overall design of biobank initiatives and specific research projects. CBAC has previously recommended that all research involving human subjects address the question of benefit sharing (see CBAC's report on Patenting of Higher Life Forms, Recommendation 7):
   
   CBAC recommends that the federal government, in consultation with other levels of government and other stakeholders, develop policies and practices that encourage the sharing of the benefits of research involving genetic material. In particular, we recommend that the benefits of medical and pharmaceutical research based on human genetic material (including its commercial exploitation) be shared with the groups or communities who provided the material. All bodies (public, private and corporate) involved in funding research and/or establishing guidelines or codes of conduct for the ethical conduct of research should ensure that benefit sharing is addressed in both policy and practice. Health Canada should lead an initiative to engage all stakeholders in developing best practices for research involving human subjects.

Governance

8. Persons responsible for current governance mechanisms at every level — law, policy, best practices, ethical norms — should review those mechanisms to ensure they adequately address the concerns raised by biobanking issues. Consideration should also be given to whether a specific regulatory regime is required for biobanks.
9. Professional bodies should also review their codes of professional responsibility to ensure that specific guidance related to biobanking is provided. This may require a novel multidisciplinary conception of professional responsibility.