What is the regulatory framework governing the participation of children in genetic research in Canada?
• The Tri-Council Policy Statement (CIHR, SSHRC, NSERC, 1998) outlines three conditions to be met for children to be involved in research. It also states that those who are not competent to consent shall not be excluded from research that could be beneficial to them or to the group they represent. The statement addresses the general issues of consent, assent and the assessment of risks and benefits. • The Guidance for Industry: Clinical Investigation for Medicinal Products in the Pediatric Population (Health Canada, 2003) establishes guidelines for recruitment, consent and assent, risk and distress. • In Guidelines for Genetic Testing of Healthy Children (addendum), the Canadian Paediatric Society and the Canadian College of Medical Geneticists released a joint statement that includes a recommendation for genetic research testing with children.
• The Tri-Council Policy Statement (CIHR, SSHRC, NSERC, 1998, 2000, 2005) outlines three conditions to be met for children to be involved in research. It also states that those who are not competent to consent shall not be excluded from research that could be beneficial to them or to the group they represent. The statement addresses the general issues of consent, assent and the assessment of risks and benefits. • The Guidance for Industry: Clinical Investigation for Medicinal Products in the Pediatric Population (Health Canada, 2003) establishes guidelines for recruitment, consent and assent, risk and distress. • In Guidelines for Genetic Testing of Healthy Children (addendum) (2009), the Canadian Paediatric Society and the Canadian College of Medical Geneticists released a joint statement that includes a recommendation for genetic research testing with children.
