Research involving children is important because children are not merely small adults; they are both physiologically and psychologically different. Disease expression and reaction to treatments are influenced by children’s developmental stages, such that research performed on adults may lead to little or no known health benefit for children. Moreover, many diseases only affect children. With these diseases, children’s involvement in research is an absolute necessity for understanding disease pathophysiology and for the development of new treatments.

However, because children are unable to consent to participate in research, specific conditions must apply to genetic research involving children. The four conditions that must be met are the following: 

• The research could not be carried out in an adult population;
• The research has a direct benefit for the child or for the health of other children belonging to the same group (i.e. with the same medical condition or in the same age group). In cases where the research does not directly benefit the child, it must not expose the child to undue risk or harm;
• The child’s legal representative(s) have given free and informed consent to the child’s participation in the research;
• To the extent that a child is able to understand the nature and consequences of the research, his/her views on participating (also called "assent") must be taken into consideration according to his/her age, degree of comprehension and level of maturity.

• The Universal Declaration on Bioethics and Human Rights (UNESCO, 2005) provides specific guidelines for the involvement of ‘persons without the capacity to consent’, such as children. It addresses issues of consent, assent and the assessment of risks and benefits.
• The 25 Recommendations on the Ethical, Legal and Social Implications of Genetic Testing (European Commission, 2004) requires that children’s interests be considered prior to participation in research and outlines some specific considerations.
• The Declaration of Helsinki (WMA, 2008) also contains provisions to protect ‘legally incompetent’ persons such as children, and addresses issues of consent, assent and the assessment of risks and benefits.
• The International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS, 2002) provides specific guidelines for the involvement of children in research. These guidelines provide criteria that must be met for child inclusion in research and address the issues of consent, assent and the assessment of risks and benefits.
• The Universal Declaration on the Human Genome and Human Rights (IBC UNESCO, 1997) sets conditions for the participation of minors in genetic research.
• The Convention on Human Rights and Biomedicine (Council of Europe, 1997) addresses the ‘protection of persons not able to consent’ with regards to consent, assent and the assessment of risks and benefits.
• In its Ethical Issues with Genetic Testing in Pediatrics, the American Academy of Pediatrics mentions predisposition genetic testing in research involving children and states that such research requires informed consent and recommends pre- and post-test counseling.

• 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.

• The Civil Code of Quebec (Art. 21) states that “A minor who is incapable of giving consent may not be submitted to an experiment if the experiment involves serious risk to his health or, if he objects upon understanding the nature and consequences of the experiment.” It adds that a minor may only be submitted to an experiment if it has the potential to benefit his or her health or that of the group to which he or she belongs. Finally, the Civil Code states that consent must be sought from the person having parental authority or a legal representative.

When recruiting children to participate in genetic research, researchers must ensure that the potential benefits and risks of the research are reasonably balanced. When direct benefits for the child participant may be expected from research, the risks must be justified in relation to these expected benefits for the individual participant. However, there is a limit to the risks that children can be subjected to in research: children may not be subjected to research that involves a serious risk to health.

Research that does not hold the prospect of direct benefit for child research participants must hold prospect of benefits to persons in the same age category or having the same disease or handicap as participants. The risk to which the child may be exposed should be minimal or similar to the risk associated with his/her medical or psychological condition.