Nurses, and indeed any professional wishing to be involved in research with children, must have a basic understanding of the fundamental differences between adults and children. Children are not small adults, so having an appreciation of what children really are will increase the likelihood of a successful outcome. Rates of physical and psychological change throughout childhood are so great that simply discussing ‘the child’ as one would ‘the adult’ is not sufficient. Further subgroups are necessary to describe childhood fully. Common divisions of childhood include infant, child and teenager. These can be divided more finely and have been discussed in other chapters (see Chapter 11).

The legal definition of a child in England, Wales and Northern Ireland is simply anyone under the age of 18 years (Department of Health (DoH) 2001a); in Scotland it is under 16 years (Age of Legal Capacity (Scotland) Act 1991). But the characteristics and diversity of childhood creates a far more complex picture. Children’s unique qualities will impact upon every aspect of the research project and ultimately determine its success or failure. Most importantly, infants, children and teenagers are distinctive individuals and the nurse involved in research with children must continually assess and meet the needs of these young volunteers.

Children participating in research have the same rights to protection offered all research volunteers by the declaration of Helsinki (World Medical Association (WMA) 2000). These issues will be discussed later in this chapter. In addition there is further protection from the Children Act (DoH 1989) and the NSF for Children (DoH 2003a), which stipulate requirements regarding the specific needs of children. This includes a Draft Standard on Child Protection stating:

Families have a right to expect separate facilities, properly staffed by paediatricians, sick children’s nurses and play therapists. Television, well-equipped playrooms and age-appropriate food are just some of the requirements. Collaboration between agencies is necessary, with multidisciplinary development of child protection guidelines, policies and involvement in Serious Case Reviews. All staff must have child protection training and those who have direct contact with children require pre-employment police checks (DoH 2003a). For further information on child protection, see Chapter 19.

The lack of autonomy allowed children by society increases the vulnerability of young research volunteers. The amount of independence afforded to children is a matter of choice for society. It has been argued that children are unable to exercise choice due to cultural constraints rather than biological necessity. When children are not given the opportunity or permission to exercise their autonomy, it is often mistakenly assumed that they do not have the capacity to do so (Alderson & Montgomery 1996).

The United Nations (UN) Convention on the Rights of the Child, Article 12 (UN General Assembly 1989) sets no minimum age for involvement in decisions and refers to children’s ‘evolving capacity’, with adult members of society expected to foster participation.

Under UK law, children lack complete autonomy and are unable to make some decisions independently. Although they always have the right to assent or agree to participate, their parents usually make legal decisions and consent on their behalf (DoH 2001a). Issues of Gillick competency, consent and assent will be discussed later, as will involving children actively in the research process. The NSF for Children mandates the delivery of child-centred care and staff to support children ‘to be active partners in decision making’ (DoH 2003a). The child must come first and his or her needs are paramount within any research project.

At the basis of the research process is the trusting relationship between volunteer and researcher. It is critical that the research nurse prepares the child properly, taking into account the unique needs of each child with respect to age, development and social/family considerations. Research professionals must also put the needs and best interests of their volunteers first, ahead of research aspirations (DoH 2005). Using age- and developmentally appropriate interactions and information, research nurses can be strong, dependable advocates for their young patients. Theories of growth and development, combined with an understanding of physical differences and needs of children, provide guidelines for researchers working with children and young people. However, assessing each child as a unique individual will increase the likelihood of successful interactions and research. Alderson & Montgomery (1996) warn there is a risk of holding on to outdated misconceptions that can result in the infantalisation of highly capable children and young people. Balancing the amount and types of support given to children can be difficult to judge and adults are often overcautious in assessing children’s capabilities. Research nurses must ensure young volunteers are looked after in an appropriate and safe manner. Investing time to build a relationship will allow informed dialogue so that children are given the protection they need and the choices they deserve.

Consent is a legal contract entered into by an adult or individual with parental responsibility; assent is the voluntary permission of an individual without legal status (Lamprill 2002).

The issue of competency can be complicated but the DoH (2001a) has given some guidelines. Someone is deemed competent if they:

Children’s competency is not an issue when they agree to treatment – it is when they refuse that questions of competency are raised (Alderson 1995). Until the youngster is 16 in Scotland, or 18 in the rest of the UK, parents have the legal authority to reverse the wishes of their child and give consent for treatment even if the youngster withholds consent (Age of Legal Capacity (Scotland) Act 1991, DoH 2001a). This creates a double standard for consent, with young people under the age of 18 free to agree and give consent but not able to disagree and withhold consent (Alderson 1995). The ‘NSF for Children’ (DoH 2003a) states that:

Therefore it is advisable to check local policies regarding consent. In extreme cases of disagreement, the courts can decide whether or not treatment is given (DoH 2001a).

The ‘DoH Research Governance Framework’ (2005) states that ‘informed consent is at the heart of ethical research’. That is to say that information must be given so that consent is based on sufficient knowledge of what is planned and any possible risks involved. Extensive patient information sheets are required for each study and are ethically approved as part of formal research protocols. When children are involved in studies, special age-appropriate information sheets are needed (Robinson 2001). As stated in part 22 of The Declaration of Helsinki (WMA 2000), there is clear stipulation as to the type of information researchers are mandated to provide. This includes information regarding:

The DoH (2001a) clearly states that children should be involved in decision making and suggests the use of toys, pictures and play and to ensure that written information is given in age-appropriate language. Prospective volunteers should be given this information in advance of their participation, ideally at least 24 hours prior to the signing of consent forms. This enables them to consult with their family, GP or any person with whom they choose to discuss the study and possible concerns. It also allows time to formulate questions for the researcher prior to participation (Alderson 1995). The person obtaining consent must also ‘check the child’s understanding’ (DoH 2001a). This can be achieved by including a simple quiz, which can be kept as a record of comprehension with other study forms (Lamprill 2002).

Participation in research is not mandatory. Participants in research studies are called ‘volunteers’. That word describes an individual who freely takes part in the research process. Protection and care of the research subject is enshrined in internationally accepted guidelines.

The first international standard was written in 1947 as a reaction to the atrocities of the Second World War, and later became known as the Nuremberg Code. The ten principles have become the basis for ethical research practice involving humans. These principles include freely given consent, capacity to consent, freedom from coercion, comprehension of the risks and benefits, minimisation of risk and harm with a favourable risk/benefit ratio, the presence of qualified investigators using appropriate research designs and freedom for the subject to withdraw at any time. Children were excluded from participating in research by the stipulation of informed, voluntary consent free of coercion (Burns 2003).

The WMA Declaration of Helsinki, adopted in 1964 and then regularly amended (WMA 2000), has since allowed the participation of children in research as long as there is consent from a parent or ‘legally authorised individual in accordance with applicable law’. It also states that when the subject is a ‘minor child’ and ‘able to give assent to decisions about participation in research, the investigator must obtain that assent in addition to the consent from a legally authorised representative’. This document distinguishes between therapeutic research, described as ‘research combined with medical care’, and non-therapeutic research involving ‘healthy volunteers’.

The principles of the Declaration of Helsinki (WMA 2000) led to the creation of an international standard for clinical trials involving human subjects. The International Conference on Harmonisation guideline for good clinical practice (ICH GCP) came into effect in 1997 with the objective of providing a ‘unified standard for the European Union, Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions’. The principles established in ICH GCP guidelines ‘may also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects’, not just clinical trials (ICH 2002).

In the UK, the DoH has developed the Research Governance Framework for Health and Social Care (DoH 2005) to set standards and improve research quality by promoting good practice. In section 1.1, it recognises the need for health and social research while ensuring public confidence through ‘high scientific, ethical and financial standards, transparent decision-making processes, clear allocation of responsibilities and robust monitoring arrangements’ (DoH 2005).

The DoH (2001a) states that children may participate in therapeutic research based on new treatment that may be as effective or more effective than standard treatment. Participation in non-therapeutic research is possible if doing so is ‘not against the interests of the child and imposes only a minimal burden’. In both cases it is stipulated that sufficient information must be given prior to participation. Minimal burden is not clearly defined and it is left to the researcher to assess each child and gives the examples of bone marrow donations and more simple injections. The bone marrow would require a therapeutic benefit to the child but an injection would not. However, as there is considerable variation in response to injections researchers must bear in mind the individual reaction of young volunteers. Some children might not consider an injection a ‘minimal burden’.

The risk/benefit ratio first mentioned in the Nuremberg Code remains a source of debate. Alderson (1995) argues that ‘risk’ is vague and refers to both possible and definite harms, whereas ‘benefits’ implies there will be definite good. She states that ‘risk and hoped-for benefits’ is a more balanced phrase. These terms can be misleading depending on their context, with clarity needed regarding who is at risk and who will benefit. There is potential for great benefit to society at the great expense of a few volunteers. However, the Declaration of Helsinki (WMA 2000) states ‘the considerations related to the well-being of the human subject should take precedence over the interests of society’. This ethical stance is reaffirmed in the DoH Research Governance Framework, which mandates ‘The dignity, rights, safety and well being of participants must be the primary consideration in any research study’ (DoH 2005).

The International Conference on Harmonisation (ICH) Document E11 (ICH 2000) gives clear guidelines regarding the need to balance the protection of young, potentially very vulnerable research volunteers with the benefits to be gained from participation in research. Research nurses must be the advocates for their young volunteers and empower them to make decisions free of any coercion. Recruitment must be free from inappropriate inducements to the parent or child and while reimbursement for expenses is allowed, it must be included in the protocol and approved by the ethics committee (ICH 2000).

The UN Convention on the Rights of The Child, Article 12 (United Nations General Assembly 1989) states that children have a right to participate in the decision-making process that may be relevant to their lives. Adults are also expected to promote and empower children so that they may express their views and influence decisions. Standards for healthcare professionals in the NSF for Children (DoH 2003a) include the need to provide a child-centred service, with the needs of the child put first. Choices should be offered to all children and young people regarding aspects of treatment. Young people must ‘never feel that decisions are being made over their heads’ (DoH 2001a). This should be the ethos of the multidisciplinary research team. In ‘Advocating for children’, the Royal College of Paediatrics and Child Health (RCPCH 2000) has adopted as an overall aim ‘To advocate the rights of children and young people in society and to promote their health needs and services’. It refers to the concept of ‘best interest’ enshrined in the UN Convention on the Rights of The Child, and expects ‘all members to act within the framework’. This clear guidance for all professionals working with children, combined with the mandate of the NMC (2008b), requires the research nurse to advocate for the best interests of young volunteers. This includes working with the research team and family to facilitate the child’s participation as a partner in the research process. Providing information, choices and support for young volunteers will allow the continued development of safe, accurate and successful research.

Involving children in research requires the same child-centred approach as caring for sick children in a ward setting (DoH 2003a). Successful completion of any research project involving children demands careful planning, organisation, implementation and evaluation.

Researchers have to find ways of engaging children using negotiation rather than imposition (Barker & Weller 2003). To be successful, researchers need to think about how children will perceive them (Balen et al 2001). Children like to meet a person they can trust and someone who is fun to be around, therefore researchers need to make an effort to ensure they are creative (Curtin 2000) and provide an age-appropriate approach. Instead of employing existing adult methodologies, child-led methodologies have been developed to enable children to communicate using qualitative methods, e.g. drawing, dairies and photography (Avery 2003, Balen et al 2001). Such methods aim to build a rapport, trust and confidence, allowing children to clearly articulate their views and opinions. Hence by giving information in a child-centred way the researcher can empower young people, gain their trust and cooperation and obtain their assent to be active participants in research.

When designing information sheets, consent forms and constructing quantitative research tools such as questionnaires, child-centred researchers should be aware of the significance children and young people place on language. It is also important to consult with children about the development of appropriate research methods. Researchers should not impose their own interpretations, made up of adult feelings and presumptions, which can suppress or misrepresent the voices of children (Barker & Weller 2003).

Research methods can be divided into two main approaches, quantitative and qualitative:

Before deciding on which method to use the researcher needs to be satisfied that they have chosen the most appropriate design, which provides suitable answers to the following questions (Edwards & Talbot 1994):

By combining a range of research methods within one study, known as triangulation, a picture can be built up of the phenomenon under investigation from a range of perspectives (Morrow 2001). For example, in their pilot study, Avery et al (2003) used a ‘quality of life’ questionnaire and the children took photographs of how their lives were affected by their illness and then wrote about their feelings when they took their photographs.

A pilot study can be described as a ‘dummy-run’ and enables the researcher to see whether the methods chosen do indeed collect the data needed to answer the chosen research question. This also provides an opportunity to get feedback from children themselves on the chosen methodology and their experience of participation (Balen et al 2001).

Research with children is carried out for many different reasons, and therefore different child-centred methods are required to elicit information.