World of Irish Nursing & Midwifery May 2019


Informed consent Research is seen as a core value by the Nursing and Midwifery Board of Ireland (NMBI). Principle 3 of the Code of Profes- sional Conduct and Ethics states: “Nurses and midwives value research. Research is central to the nursing and midwifery pro- fessions. Research informs standards of care and ensures that both professions provide the highest quality and most cost-effective services to society.” 1 and assessing the information…to refuse participation in, or to be withdrawn from, the clinical trial at any time is considered by the investigator.” 4 There is no universal agreement on what age you should start to seek a child’s assent. 7 Each information sheet and assent form, given to a child, must be suitable for their stage of development. Study informa- tion sheets and their accompanying assent forms are usually broken up into different age groups, eg. four to six years, seven to 12 years and 13 to 17 years. Hazel A Smith discusses the process of obtaining informed consent and assent in children’s clinical research

Informed consent and assent is an ongoing process and is much more than a paper exercise. It starts as early as recruit- ment and continues throughout the child’s participation in the research study. The process of informed consent and assent must adhere to the study protocol that was approved by the ethics committee and be fully documented in the child’s medi- cal records. Nurses and midwives can take consent for observational (non-interven- tional) studies once it has been approved by the ethics committee. In Ireland, children under 18 years of age require the consent of their parent(s) to participate in observational studies. 5 Parents who are under 18 years of age themselves may still consent for their child. Currently, only one parent is required to sign the consent form but it is preferable to have the signatures of all parents. When approaching parents and their children to participate in research stud- ies it is important that the environment is appropriate. Waiting rooms are usually not suitable as it is a busy environment, par- ents and children can be distracted waiting to hear their name being called and other parents and children can hear the conver- sation. Parents and children must be given information sheets about the study, have the opportunity to ask questions and time (where possible) to think about participat- ing in the study. The language used, both oral and writ- ten, should be as non-technical as possible so that both the parent and, where pos- sible, the child can understand what is involved with taking part in the study. The language used cannot be coercive or influ- ential (eg. ‘we need you to take part’). It is also important to remember that Ireland’s adult literacy levels are below the Euro- pean average 6 and that some parents and children may have learning disabilities or difficulties with sight and/or hearing.

It is important to note that if the child changes age group during the course of the study then you will need to seek their assent again based on their new age group- ing. For example, if you recruit a child when they are five years old to participate in a longitudinal study and they are still partic- ipating in the study when they turn seven years old you will need to gain their assent again. This is important because as children grow their understanding of the research and what it involves develops and it is important that they are re-approached to participate based on their greater under- standing of the study. For observational studies, when a child turns 18 they can consent for themselves. Hazel A Smith is a research co-ordinator for haematology/ oncology at Our Lady’s Children’s Hospital, Crumlin References: 1.Nursing &Midwifery Board of Ireland (2014).Code of Professional Conduct and Ethics for Registered Nurses and Registered Midwives.Dublin:NMBI 2.Nursing &Midwifery Board of Ireland (2015).Ethical Conduct In Research Professional guidance.Dublin:NMBI. 3.Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws,regulations and administrative provisions of the Member States relating to the application of good clinical practice in the conduct of clinical trials withmedicinal products for human use.Off.J.2001;(34) EC No L 121 4.Irish Statute Book (2004) SI No.190/2004 - European Communities (ClinicalTrials on Medicinal Products For Human Use) Regulations,2004 Retrieved fromhttp:// accessed in March 2019 5.Health Service Executive (2017).National Consent Policy 2017 Retrieved from qid/other-quality-improvement-programmes/consent/ national-consent-policy-august-2017.pdf in March 2019 6.Organisation for Economic Co-operation and Development (2016).Compare your County:Adult Skills Retrieved from adult-skills?cr=oecd&lg=en&page=0&charts=c14652932 39548+c1465293241698+c1466427128067&template=6 accessed in March 2019 7.Lepola P et al (2016).Informed consent for paediatric clinical trials in Europe Archives of Disease in Childhood 101:1017-1025

Patients, family members and staff deserve the opportunity to benefit from and participate in research. Children, regardless of age, are no exception to this standard of care. As children are a unique and vulnerable population there are additional ethical and legal steps that must be adhered to when undertaking paediatric research. 2 Informed consent and assent are one of the most important elements of research. The aim of this article is to discuss, in brief, informed consent and assent for nurses and midwives undertaking their own research in child health. In this article a child’s legal guardian(s) will be referred to as parent(s). Legal definitions of informed consent and assent in research come from legisla- tion involving clinical trials. The European Union Clinical Trials Directive (2001/20/ EC) defines informed consent as a: “deci- sion, which must be written, dated and signed, to take part in a clinical trial, taken freely after being duly informed of its nature, significance, implications and risks and appropriately documented, by any person capable of giving consent or, where the person is not capable of giving consent, by his or her legal representative.” 3 This definition is transposed into Irish law (SI No190/2004 – European Commu- nities [Clinical Trials on Medicinal Products For Human Use] Regulations, 2004). Under part four of SI No 190/2004 child assent is defined as providing “information according to his or her [child’s] capacity of understanding, from staff with experi- ence with minors, regarding the trial, its risks and its benefits. The explicit wish of a minor who is capable of forming an opinion

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