The term “discrimination” can be interpreted in different ways. The following are examples of various understandings:

• Distinction, exclusion, or preference for a reason that is prohibited by the 1982 Canadian Charter of Rights and Freedoms (such as race, gender etc.);
• Any distinction, exclusion, or preference, regardless of the reason;
• Selecting a person for employment based on presumed genetic risk.

Genetic discrimination, in particular, is discrimination based on an individual’s genetic status.

In Canada, there are no existing legal documents specifically prohibiting genetic discrimination.

• Article 15 of the Canadian Charter of Rights and Freedoms (1982) guarantees equality and grants each person the right to not be subjected to discrimination. However, this Charter does not apply to the disputes between individuals. It applies only to state actors.
• The Canadian Human Rights Act (1985) protects individuals against discrimination based on disability (Art. 3) and could therefore protect individuals whose genetic information reveals the risk of disease.
• The Tri-Council Policy Statement (1998, 2000, 2005) recognizes that the risks of discrimination are a part of the risks related to participation in genetic research. Researchers who are carrying out genetic research should reveal possible risks to research ethics boards and participants.

In Canada, there are no existing legal documents specifically prohibiting genetic discrimination. However, genetic information could be contained in the notion of personal information, so it would be protected by legal instruments relating to privacy and discrimination.

• The Canadian Charter of Rights and Freedoms (1982) protects individual privacy against State intrusion, unless access is reasonable and justifiable. The Charter does not apply between individual citizens or non-governmental enterprises; it applies only to state actors.
• The Privacy Act (1983) imposes obligations on ministers and federal organizations to respect individual privacy rights in regulating the collection, use, and communication of personal information.
• The Personal Information Protection and Electronic Documents Act (2000) outlines basic rules relating to the way that private sector organizations can collect, use and communicate personal information in the context of commercial activities.

In Canada, there is no existing legal framework specifically prohibiting insurance providers from asking for the results of an insurance candidate’s genetic tests.

Genetic information, insofar as it is a form of personal information, is protected by legal instruments related to privacy and discrimination.

• The Privacy Act (1983) imposes obligations on ministers and federal organizations to respect privacy rights by limiting the collection, use, and communication of personal information.
• The Personal Information Protection and Electronic Documents Act (2000) creates basic rules about the manner in which private sector organizations may collect, use, and communicate personal information in the framework of commercial activities.

The Personal Information Protection and Electronic Document Act and the Privacy Act are two Canadian federal acts pertaining to the secondary use of information concerning living and dead individuals.

Under these acts, a researcher may, in the scope of a study or research, use personal information contained within federal organizations, if he demonstrates that:
1) The study or research cannot be achieved without the use of the data;
2) The information is used in a manner that ensures its confidential nature; and
3) Consent is practically impossible to obtain.

Furthermore, the researcher or organization must commit (in writing and to the person in charge of the institution) to abstain from all subsequent disclosure of the information as long as its format seemingly allows for identification of the individual concerned.

In addition, the first edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) (1998, 2000 and 2005) and the CIHR Best Practices for Protecting Privacy in Health Research both mention that ethics review committees can approve a consent procedure that renounces or modifies, in part or fully, the obligation of obtaining informed consent when:
1) The identifying data is essential to the study;
2) Measures are put in place in order to protect confidentiality of participants and to reduce the inconveniences of research; and
3) Individuals to whom the data refers to are not opposed to the re-use of their data.

These criteria seemingly apply to data from deceased individuals, as long as these individuals did not manifest, before their deaths, any objection to the use of their data.

Ethical and legal norms recognize certain conditions under which it is justifiable to have an exception to the requirement of obtaining consent. These conditions often vary from one norm to the other and from one law to another.

Here are some frequently encountered conditions:
•    The research project is important;
•    The research project is epidemiological;
•    It is impossible to contact potential participants;
•    The data or biological material has already been collected;
•    The anticipated risk is minimal;
•    The rights of the participant will be protected.

Often, more than one of these conditions will be required at the same time.

Countries around the world have adopted different approaches to the regulation of stem cell research. These approaches reflect their legal traditions and cultural and religious beliefs. A list of laws, policies, regulations or guidelines by country or region in relation to stem cells is available on the HumGen module StemGen at the following address: http://www.stemgen.org/mapworld.cfm

• The World Medical Association Statement on Genetics and Medicine (WMA, 2005) states that the results of genetic testing must be kept confidential and that physicians should support laws offering protection from genetic discrimination.
• Resolution 2004/9: Genetic Privacy and Non-Discrimination (UNESCO, 2004) and Resolution 2001/39: Genetic Privacy and Non-Discrimination (UNESCO, 2001) affirm that information obtained from genetic tests should be held confidential and urges States to protect the privacy of those who undergo genetic testing.
• The International Declaration on Human Genetic Data (IBC UNESCO, 2003) provides that States should protect the privacy of individuals and the confidentiality of human genetic data.
• The Universal Declaration on the Human Genome and Human Rights (IBC UNESCO, 1997) also holds that genetic information must be kept confidential.
• The International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS, 2002) requires researchers to establish secure safeguards for the confidentiality of subject’s research data.
• The Statement of WHO Expert Advisory Group on Ethical Issues in Medical Genetics (WHO, 1997) states that genetic data should be treated as highly confidential at all times.
• The Proposed International Guidelines on Ethical Issues in Medical Genetics and Genetic Services (WHO, 1997) proposes guidelines concerning disclosure and confidentiality.
• The Convention on Human Rights and Biomedicine (Council of Europe, 1997) states that everyone has the right to respect for private life in relation to information about his or her health.
• The Statement on the Principled Conduct of Genetics Research (HUGO, 1996) states that recognition of privacy and protection against unauthorized access be ensured by the confidentiality of genetic information.

• The Canadian Institutes of Health Research Act (2000) specifies that research must “take into consideration ethical issues”. The law delegates to the Canadian Institutes of Health Research (CIHR) the role of ensuring that international norms are respected in research, and encouraging the discussion of ethical questions within the scientific community.
• The Tri-Council Policy Statement (1998, 2000, 2005) applies to all research projects financed or carried out in an institution that is receiving funding from one of the following federal funding agencies: Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC) or the Social Sciences and Humanities Research Council of Canada (SSHRC). The Statement includes provisions on REB membership, conflicts of interest and confidentiality, amongst others. It also provides guidance for the evaluation of research, including: respect for human dignity, and vulnerable people, consent, confidentiality and the need to balance the advantages and disadvantages of research.

• The Fonds de recherche en santé du Québec’s (FRSQ) Guide d'éthique de la recherche et d'intégrité scientifique (2003) address REB membership and require REBs to be independent of all financial or material advantages and to maintain administrative independence. The Guidelines also provide requirements relative to confidentiality, consent and risks of research.
• It is important to underline that individual institutions, such as hospitals, may have internal governance frameworks for research evaluation and REBs. Such frameworks must respect provincial and national law.

• The federal Privacy Act (1983) provides rules for the collection, retention and disposal of personal information; it applies solely to federal government institutions.
• The federal Personal Information Protection and Electronic Documents Act (2000) sets rules for the collection, use and disclosure of personal information in the course of commercial activities.
• The Tri-Council Policy Statement (CIHR, SSHRC, NSERC, 1998, 2000, 2005) provides guidelines for the protection of privacy and confidentiality of genetic data in a research setting.
• The CIHR Best Practices for Protecting Privacy in Health Research (CIHR, 2005) provides guidance in the interpretation of the Tri-Council Policy Statement.
• Genetic Testing and Privacy (Privacy Commissioner of Canada, 1995) recommends protecting the confidentiality of genetic data.

• At the federal level, there are no laws that specifically explore questions related to human genetic research. Nonetheless, certain articles in the Food and Drugs Act and its various regulations govern the use and sale of medications resulting from research involving humans. This Act could apply in the context of research with the goal of evaluating a genetic test before allowing its use in the clinic.
• Also, certain articles in the Assisted Human Reproduction Act deal with genetic research in humans.
• The Tri-Council Policy Statement (CIHR, SSHRC, NSERC, 1998, 2000, 2005) devotes an entire chapter (chapter 8) to genetic research involving humans.

• The Declaration of Helsinki (WMA, 2008) states that research subjects must be informed of the aims, methods, sources of funding, conflicts of interest, and potential risks and benefits of the research. It also states that consent must be obtained from research participants in writing.
• The International Declaration on Human Genetic Data (IBC UNESCO, 2003) provides that prior, free and informed consent is necessary for the collection, use and storage of human genetic and proteomic data, as well as other biological samples. It also outlines the information that must be provided to the person whose consent is sought, including: the purpose for which the data is collected, the risks and consequences associated with that collection and the right to withdraw consent.
• The Universal Declaration on the Human Genome and Human Rights (IBC UNESCO, 1997) states that prior, free and informed consent to research must be obtained.
• The International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS, 2002) requires researchers to obtain the voluntary informed consent of prospective subjects for all biomedical research.
• Resolution 2001/39: Genetic Privacy and Non-Discrimination (United Nations Economic and Social Council, 2001) urges States to ensure that genetic testing is done with the prior, free, informed and express consent of the individual or to ensure that authorization is obtained in the manner prescribed by law.
• The Statement on the Principled Conduct of Genetics Research (HUGO, 1996) states that informed decisions to consent to participate in genetic research can be individual, familial, or at the level of communities and populations.

Most countries have provisions within their national laws or constitution that would prohibit the patenting of a transgenic human. The situation is different when it comes to transgenic plants or animals. Canada’s position, however, runs contrary to the international tendency. This position arose from a controversial Canadian legal decision, which prevents a definite answer to the question pertaining to transgenic plants and animals, at the federal level. In the majority of jurisdictions (e.g., United States, France, Japan, and the United Kingdom), patents on inventions relating to transgenic plants and animals are allowed.

The Quebec Charter of Human Rights and Freedoms prohibits discrimination against disabled employees. If an employer deems that a person is unable to hold a job due to a health problem, in the eyes of the law, a disability has been attributed to him/her and he/she will be protected by the Charter, which prohibits discrimination based on disability. This includes those whose disability is caused by a genetic condition.

An individual could face discrimination in the hiring process or in the allocation of tasks, which could affect the possibility of advancement. An employee with a genetic disease such as cystic fibrosis who experiences discrimination in the workplace is also protected under the Charter.

The term “disability” could also apply to those who are in good health, but considered unfit for a certain position because of a susceptibility to developing a genetic disease at some time in the future. An employer might hesitate to hire employees who run the risk of developing debilitating disease.

• The Civil Code of Quebec devotes several articles to human experimentation. Article 20 states that “an adult, capable of consenting, may take part in an experiment as long as the risk involved is proportionate with the benefits that can be reasonably expected.” The situation is different for minors or incompetent adults and is dealt with in Article 21. In addition, Article 22 states that consent must be obtained for research that requires the use of a person’s body part (such as tissue or blood), collected during care. Finally, Article 24 requires that consent to participate in research must be given in writing.
• Certain Quebec laws, having as a goal the protection of the confidentiality of personal and medical information, also deal with research in general and genetic data (Act Respecting the Protection of Personal Information in the Private Sector, Act Respecting Access to Documents held by Public Bodies and the Protection of Personal Information).
• The ‘Plan d’action ministériel en éthique de la recherche et en intégrité scientifique’ (1998) by the Minister of Health and Social Services proposes measures that apply to all establishments of the health and social services network that are taking part in research activities.
• The Guide d'éthique de la recherche et d'intégrité scientifique (2003) by the ‘Fonds de recherche en santé du Québec’ (FRSQ) pertains to research carried out in institutions or by researchers who are funded by this organisation.
• The Quebec 'Réseau de Médecine Génétique Appliquée' (RMGA) has developed two position statements specifically addressing issues surrounding human genetic research (Statement of Principles: Human Genome Research (2000) and Statement of Principles for Genetic Research Involving Children (2007)). These statements constitute non-binding guidelines, but often serve as a reference for ethics committees.

In law, informed consent requires the ability to fully understand the nature of a research project as well as the consequences of participating in research. Because children’s decision-making capacity is less developed, they are considered legally incompetent to understand all the relevant aspects of participation in research required in order to provide their informed consent. Therefore, a child’s parent or legal guardian must provide consent for the child’s participation in research.

• The Quebec Charter of Human Rights and Freedoms (Art. 5) states that every person has a right to respect for his private life.
• The Civil Code of Quebec (Art. 3) provides that every person has a right to privacy.
• An Act Respecting Access to Documents Held by Public Bodies and the Protection of Personal Information applies to the collection, use, release and keeping of personal information by public bodies.
• An Act Respecting the Protection of Personal Information in the Private Sector applies to personal information collected, held, used or communicated in the course of carrying on an enterprise in the private sector, such as a private medical clinic.
• The Final Report of the Advisory Group on a Governance Framework for Data Banks and Biobanks Used for Health Research (FRSQ, 2006) recommends appropriate legislation be established to ensure that participation in health research is confidential and prohibits requests for information regarding that participation by employers or insurers.
• The Énoncé de principes sur la conduite éthique de la recherche en génétique humaine concernant des populations (RMGA, 2003) recognizes the confidentiality of genetic data.
• Les enjeux éthiques des banques d'information génétique : pour un encadrement démocratique responsable (Commission de l’éthique de la science et de la technologie, 2003) discusses the confidentiality of data. It recommends that only anonymized data be permitted to leave Quebec.
• Health and Welfare in the Age of Genetic Information: Managing the Individual and Social Issues at Stake (Conseil de la santé et du bien-être, 2003) recommends the regulation of access by insurers and employers to medical information.
• The Énoncé de principes : Recherche en génomique humaine (RMGA, 2000) requires the confidentiality of genetic data. It impedes the divulgation of genetic data to insurers and employers except in cases where the person has given consent or where authorized by law.

Quebec law protects the confidentiality of all personal information, such that health care information obtained by insurance providers may not be disclosed to a third party without first obtaining consent from the individual concerned.

Such consent is typically obtained in a specific provision of the application form. It allows insurance providers to communicate the candidate’s personal information to the Medical Information Bureau (MIB). The MIB is a non-profit organization of 750 insurance companies that compiles information regarding candidates with a medical condition that may have a significant impact on their life expectancy, in order to make the information accessible to insurance companies. The goal of this organization is to prevent fraud. By signing an insurance contract, applicants consent to the disclosure of their personal information to MIB.

If an employer believes that an employee is unable to hold a job due to a health problem, the law considers that a disability has been attributed to him/her. The employee becomes protected by the Charter, which prohibits discrimination for this reason. The term “disability” could also apply to people who are in good health, but are considered unfit because they are susceptible to developing a disease in the future.

The Quebec Charter of Human Rights and Freedoms prohibits the discrimination of employees due to disability. The Charter would therefore protect employees against discrimination, but not against all uses of genetic tests. In addition, the Charter foresees that distinct practices based on the required competences of a job are not discriminatory. Certain decisions on the part of an employer with regard to the use of genetic information may therefore not be considered discriminatory in the sense of the Charter.

The Office of the Privacy Commissioner of Canada supports a prohibition on the collection of personal genetic information of employees through compulsory screening and surveillance, except if an employee voluntarily offers to undergo the testing and he/she has absolute control over the genetic samples that are obtained.

In Quebec, no law prohibits an employer from requiring that employees undergo genetic testing and genetic screening is not systematically practiced in the workplace. Many considerations come into play with the possibility of imposing such testing. On the employee’s side, the consequences of the disclosure of confidential health information (right to privacy), of the manner in which the biological collection will be carried out (right to integrity), and of the use of results (right to be protected against discrimination) must be taken into account. On the employer’s side, the right to manage the business and the duty to protect the health and security of the employees must be balanced. Finally, public security must also be considered.

Due to the variety of employment situations and genetic diseases, it is difficult to determine if there are situations where an employer would be justified in imposing genetic testing on employees. For example, airline companies could be interested in imposing genetic testing on airplane pilots to predict the development of diseases that typically involve a loss of control or loss of consciousness. Although passenger and public security is in play, other factors must also be considered, such as: the reliability of the genetic test, the existence of other methods of surveillance (i.e. routine exams), the real risk that the pilot could lose control of the airplane, etc.

In Quebec, there are no legal rules specifically addressing genetic testing. However, general legal provisions can apply to genetic testing.

• For example, the Civil Code of Quebec contains articles dealing with personal integrity that can apply to genetic testing.
• Various organizations have created recommendations concerning genetic testing. For example, the ‘Comité d’éthique de santé publique’ released an opinion in 2007 on genetic testing for recessive hereditary diseases (Avis sur le Projet-pilote d’offre de tests de porteur pour quatre maladies héréditaires récessives au Saguenay-Lac-St-Jean). It states that the identification of carriers, by way of genetic testing, for recessive diseases must have a diagnostic objective. When testing is discussed, as well as when results are communicated, those tested must be well informed about the diseases being tested for. It is important to ensure complete comprehension of the information received.

In Quebec, there are no legal rules specifically addressing genetic screening. However, general legal rules can apply to genetic screening.

• For example, the Civil Code of Quebec contains general provisions dealing with personal integrity that can apply to genetic screening.
• Various organizations have created recommendations that address genetic screening. For example, the 'agence d’évaluation des technologies et des modes d’interventions en santé’ (Aetmis) created a report entitled Tandem Mass Spectrometry and Neonatal Blood Screening in Quebec. This report recommends, among other things, that a clear policy concerning the information communicated to parents be created and that consent be established. It also states that sample conservation policies (duration, justification, and conditions for conservation) and policies addressing the permitted uses of secondary information be revised.
• The ‘Institut national de santé publique du Québec’ created a 'Rapport d’évaluation du programme québécois de dépistage sanguin des maladies génétiques chez le nouveau-né' (2005) in which it recommends the establishment of a clear policy concerning consent and the information to be transmitted to the parents.

A governance framework for a biobank guides its management. The way a biobank is governed will depend on the following elements :

1. Scientific evaluation;
2. Ethical evaluation;
3. Laws on the protection of information, data registry, statistics, and research on human beings;
4. Restrictions from funding organizations;
5. Guidelines for biobanks and/or for research using tissues/elements of the body;
6. Mechanisms to evaluate access to the biobank or project resources by third parties.

At the federal level in Canada, there is a lack of guidance for research ethics boards reviewing prospective biobanks.

In Quebec, the FRSQ proposal for a Governance Framework for Data Banks and Biobanks Used for Health Research, outlines twelve elements for biobank governance frameworks:

1. The role of bank as trustee (as opposed to ‘owner’);
2. Clearly defined accountability for information and samples;
3. Continuing staff training on pertinent issues in biobanking;
4. Mandatory approval of the biobank and research projects by a competent research ethics committee;
5. Clearly determined research objectives;
6. Determining the need for free and informed consent;
7. Free and informed consent obtained, as needed;
8. Appropriate storage of data and biological material and confidentiality protection;
9. Access to personal information by participants;
10. Transparent management practices;
11. An appointed grievance officer;
12. Confidentiality protection for shared samples and information.

In Quebec, few laws authorize the use of personal information for research purposes, without necessarily obtaining the consent of the individuals concerned:
•    An Act respecting access to documents held by public bodies and the protection of personal information;
•    An Act respecting the protection of personal information in the private sector;
•    An Act respecting health services and social services.

The conditions provided in these acts are: that the use of the information will not be frivolous, that research cannot be done with anonymous data and that confidentiality will be protected.

This use must be authorized, either by the Commission d’accès à l’information or by the Director of professional services of a Quebec health care establishment.

The Canadian Oxford Dictionary defines the term “eugenics” as “the science of improving (esp. human) populations by controlled breeding for desirable inherited characteristics.”

The use of cloning for eugenic purposes is the most common concern about this technology. The majority of laws, guidelines, and formal agreements forbid the use of cloning for eugenic purposes.

According to the Declaration of Helsinki (2008), research participants must be informed that they have the option to not participate in a study and a right to withdraw from research at any time, without fear of prejudice or any effect on their medical care.

In Quebec, the law indicates that a person can withdraw from a research project at any time: he can do this verbally or in writing (Civil Code of Quebec, Art. 24).

There is divergence between authors on property rights in this context. No clear consensus has emerged:

• In Canada, the CIHR Guidelines on Ethics in Health Research Involving Aboriginal People (2007) states that researchers should recognize the property rights of individual participants and of the community in the data and biological samples produced or collected during the course of research.
• In Australia, the Australian Law Reform Commission dedicated an entire chapter to this question in its document entitled, Essentially Yours: The Protection of Human Genetic Information in Australia (2003). The chapter explores arguments for and against the adoption of a property regime in this context. The debate continues as to whether property rights in genetic data collected in research should be recognized.
• In civil law jurisdictions such as Quebec, there are no property rights in the body or its elements. The issue is one of the right of control what happens to one’s biological sample. Biobanks are seen as stewards or guardians of samples.

In Canada, newborn screening laboratories are responsible for bloodspots and authorize the release of bloodspots. Storage timelines are variable across the country and are regulated by laboratory directors.

Quebec newborn screening laboratories store newborn screening samples to 1) confirm results and 2) check quality. Quebec law and policy does not directly address storage duration for newborn screening samples. This issue is left to the discretion of laboratory directors. In practice in Quebec, samples are conserved approximately one year.