Ethics Relating to Children in Research in FP7 Introduction

Basic Ethical Principles for Conducting Research on Human Subjects 1. Respect for Persons - includes: respect for autonomy and self-determination protection of the vulnerable, particularly those with impaired or diminished autonomy 2. Beneficence: maximise benefit and minimise harm deliberately inflicting harm is not permitted 3. Justice: fairness in relation to risks and benefits protection of vulnerable individuals, groups or populations against exploitation “In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society” (Helsinki Declaration - Clause 5)

Key Ethical Guidelines World Medical Association Declaration of Helsinki 2000 World Health Organization,  Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products (1995) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidelines for Good Clinical Practice (1996) “Oviedo Convention” - Council of Europe Convention on Human Rights and Biomedicine and it's additional protocols, particularly the Additional Protocol concerning Biomedical Research (January 2005) CIOMS (Council for International Organizations of Medical Sciences) International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002) Universal Declaration of Human Rights (1948) UN Convention on the Rights of the Child (1989) EU Clinical Trials Directive (2001/20/EC)

What is a Child? Article 1 of the UN Convention on the Rights of the Child states that: “For the purposes of the present Convention, a child means every human being below the age of eighteen years unless under the law applicable to the child, majority is attained earlier.”

Children’s Rights (From the UN Convention on the Rights of the Child) States Parties shall take all appropriate measures to ensure that the child is protected…….. In all actions concerning children,….. the best interests of the child shall be a primary consideration (Art.3.1) Every child has the inherent right to life (Art.6.1) It is the right of the child to preserve his or her identity (Art.8.1) The child who is capable of forming his or her own views has the right to express those views freely in all matters affecting the child, the views of the child being given due weight in accordance with the age and maturity of the child (Art.12.1) The freedom to seek, receive and impart information (Art.13.1)

Why carry out research on children? Children are not small adults They differ from adults in development, physiology, psychology and behaviour Vital for clinical trials of drugs tested in adults but also used to treat children Many drugs used to treat children have never been tested on them as a group Essential for research into diseases of childhood and conditions to which children are particularly susceptible

Why can Research on Children be Problematic? All research involving human subjects requires the individual to provide an informed consent Children are considered a vulnerable group because of their incapacity to protect their own interests. This incapacity includes the inability to provide a legally valid consent International law provides additional protections for children with the State having a particular duty to protect The age at which a child becomes legally competent to give consent can differ substantially from one jurisdiction to another

Resolving the Difficulties Researchers must obtain informed consent from a legally authorised representative Research should only be undertaken on children if similar results cannot be obtain using legally competent individuals Children should only be included if the research is likely to promote the health of the individual or the population they represent. If the latter the burden on participants must be minimal. The assent of the child should be sought through provision of age-appropriate information Assent alone is insufficient without the consent of the child’s legal representative Deliberate objection by a child should always be respected

Additional sensitivities (1) “Therapeutic” vs “non-therapeutic” research There are particular sensitivities about submitting children to research which can have no benefit to them as an individual. In those cases it is important that the level of risk and the level of burden should be minimal* Level of Burden The research entails only minimal risk and minimal burden for the individual concerned. For example, taking a single blood sample from a child would generally only present a minimal risk, and therefore be regarded as acceptable** * Article15 of the Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Biomedical Research. Council of Europe January 2005 ** Article 17 - Explanatory report to the Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Biomedical Research. Council of Europe January 2005

Additional Sensitivities (2) Inducements Children could be vulnerable to exploitation for financial gain by parents or guardians. Therefore no recompense should be offered other than travel and related expenses Cultural issues Where research is to be carried out on children from different cultural backgrounds both informed consent and assent should be obtained using independent mediators who understand the language, traditions, religion and other aspects of the social and cultural context