An interprofessional approach to the ethics of

children and families

An interprofessional approach to the ethics of undertaking research with children

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Research involving children requires careful consideration of key ethical issues, says Alison Twycross children ethics research guidelines

Introduction Ethics has been defined as moral principles that in the context of research pertain to treating participants fairly and responsibly throughout the research process (Williamson 1981). No researcher would deny that this is important. Research with or on children (defined as people younger than 18 years old) is important (Royal College of Paediatrics and Child Health 2000, Medical Research Council 2004) but children taking part in research projects are particularly vulnerable. In light of this, several organisations in the UK have published ethical guidelines relating to research with or on children. In this paper, I will identify a number of ethical guidelines and identify common themes, including: informed consent, payments to participants, limiting the guarantees of confidentiality and protecting participants. I will look at the areas where the guidelines are in agreement, and the issues that require further debate before there can be an interprofessional approach to the ethics of research with or on children. Methods I first identified the ethical guidelines relating to undertaking research with or on children by putting the search terms ‘ethics’, ‘research’ and ‘children’ into Google and limiting the search to the UK. This revealed three sets of guidelines. NURSERESEARCHER 2009, 16, 3

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Other guidelines were identified by searching the websites of organisations whose members were considered likely to undertake research with children. The following guidelines relating specifically to children were identified: n Royal College of Paediatrics and Child Health’s Guidelines for the Ethical Conduct of Medical Research Involving Children (2000). n National Children’s Bureau’s Guidelines for Research (2003). n Medical Research Council Ethics Guide; Medical Research Involving Children (2004). n Barnardo’s Statement of Ethical Research Practice (2002). The British Psychological Society, the British Sociological Association and the Royal College of Nursing do not have guidelines relating specifically to research with or on children. However, this paper considers the general ethical guidelines produced by these organisations as psychologists, sociologists and nurses often carry out research with or on children. In the following section the key points from each set of guidelines will be identified. Guidelines relating to research with or on children Guidelines from the Royal College of Paediatrics and Child Health The Royal College of Paediatrics and Child Health (RCPCH) acknowledges in its guidelines (RCPCH 2000) that research involving children is important. Children are not small adults and the trajectory of many diseases in childhood is different from that in adults. It is therefore important to carry out research with or on children. However, research should only be done on children if comparable research on adults could not answer the same question and, when possible, older children should be included in preference to younger children. A research procedure not intended to benefit the child directly is not necessarily illegal or unethical; the potential harm needs weighing carefully against the potential benefits. Legally valid consent should be obtained from the child, parent or guardian as appropriate. When parental consent is obtained, the agreement of schoolaged children should also be obtained. Further consent should be seen as an ongoing process. The RCPCH clearly states that no financial inducements should be offered to children or their parents but that expenses should be paid. 8 NURSERESEARCHER 2009, 16, 3


The guidelines also require researchers to respect participants’ confidentiality. There is no mention of the limits of confidentiality if harm or potential harm is disclosed during the course of the study. All proposals involving children should be reviewed by a research ethics committee, which should include someone with close, practical knowledge of babies and children, such as a children’s nurse. Members of research ethics committees should also have a breadth of expertise in relation to qualitative and quantitative research methodologies. Guidelines from the Medical Research Council The Medical Research Council (MRC) (2004) guidelines are similar to those of the RCPCH. These state that research should only include children where the relevant knowledge cannot be obtained by research on adults. The purpose of such research should be to obtain knowledge relevant to the health, wellbeing or healthcare needs of children. Researchers must take account of the cumulative medical, emotional, social and psychological consequences of the child being involved in research. Informed consent should be obtained prior to data collection with competent children, the guidelines acknowledging that many children are competent to consent if information is presented in an appropriate way and are supported through the decision-making process. They also draw on guidance from the Department of Health (DH) (2001) about informed consent, stating that for someone to have the capacity to make a decision they must be able to: n Comprehend and retain information material to the decision, especially the consequences of having or not having any intervention. n Use and weigh this information in a decision-making process. n Reach and communicate a decision. A child’s refusal to participate or continue in a research study should be respected, and if a child becomes upset by a procedure, researchers must accept this as a valid refusal. Parents or guardians should be involved in the decision to participate wherever possible and in all cases where the child is not yet competent. In obtaining consent, researchers should avoid any pressures that may lead the child or parent to volunteer for research expecting direct benefit (whether therapeutic or financial). The MRC sees consent as an ongoing process. NURSERESEARCHER 2009, 16, 3

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Confidentiality should be respected and disclosure can only be justified if there is reasonable cause to suspect that the child is suffering or is likely to suffer significant harm as a result of non-disclosure. Any decision to disclose confidential information must be discussed with the child beforehand. The MRC guidelines also state that all researchers should undergo security screening including a criminal records review to ensure the safety of children involved in research. Guidelines from the National Children’s Bureau The National Children’s Bureau (NCB) subscribes to the British Sociological Association’s statement of ethical practice (see below) but its guidelines (NCB 2003) go further in four areas. They state that researchers should ensure that children have been given all the information about the research study that they need to make a decision about participating. Information should be provided verbally and in writing, and a contact telephone number should be provided in case children have any questions about the study. Researchers must always seek the informed consent of children (and of any gatekeepers). Consent should be considered an ongoing process. There must be limits to any guarantee of confidentiality or anonymity. If a child protection issue arises it may be necessary for the researcher to divulge information. However, this should only happen following a discussion with the child. Contrary to several other guidelines, the NCB guidelines state that it is appropriate to compensate participants for their time and effort. This compensation is usually a gift voucher for children but the NCB indicates that if a child is more than a research participant (for example, part of an advisory group or an interview panel) then appropriate compensation should be made. Taking part in a research study can have a significant effect on a child. The NCB guidelines therefore recommend that research should end with a debriefing during which the researcher discusses the experience of taking part in the research with the participant, so that any adverse effects can be identified. Researchers should also be aware of other sources of help, advice or counselling available for children taking part in a study. The NCB guidelines are comprehensive but it is not clear how adherence to them is monitored. 10 NURSERESEARCHER 2009, 16, 3


Guidelines from Barnado’s Barnado’s Statement of Ethical Research Practice (2002) sets out guidelines for all research undertaken with adults or children by or on behalf of the organisation. The core principles of these guidelines are that Barnado’s researchers or those undertaking research on behalf of Barnado’s will: n Safeguard the interests of those involved in or affected by their work. n Report their findings accurately and truthfully. n Consider the consequences of their work or its misuse on those they study and other interested parties. n Acknowledge the boundaries of their competence. n Ensure that the research they undertake is worthwhile and that the methods of investigation are appropriate. Barnado’s outlines specific responsibilities relating to research with children. Any research project intending to involve children as participants should start by considering the potential costs and hoped-for benefits of such participation. Children should be involved or consulted in the planning and piloting of research whenever possible. Safeguards to minimise inconvenience, intrusion, embarrassment, coercion or distress should be written into the research protocol. Attention should be paid to ensuring that participation in research is positive and rewarding. If there is no direct benefit to the child from the time and expertise contributed, consideration should be given to appropriate gratuities. Feedback on research findings should be routinely provided to children. The informed consent of children to participate in research should be actively and explicitly sought. This should be written or recorded consent. Care should be taken to minimise coercion from parents, teachers or other adults, and the effect of peer group pressure should be minimised too. Written and verbal information should be provided about the study and children should be encouraged to question researchers about the aims and methods of the research. The option of withdrawing from the study at any stage should be made clear. Consent should be seen as an ongoing process. The consent of parents or guardians should be routinely sought except where: n It is clear that participating in the research involves minimal risk and will not infringe the rights or affect the welfare of participants. NURSERESEARCHER 2009, 16, 3

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n Parental or carer permission is impossible or would not protect the child. n The young people concerned are resistant to parental or carer consent being sought because they want privacy or confidentiality, and where the emotional and social maturity and particular vulnerabilities of the young people have been evaluated and the risks of participation are considered to be low. Barnado’s guidelines make it clear that guarantees of confidentiality and anonymity must be honoured unless there are clear and overriding reasons to do otherwise. The guidelines state that research data given in confidence do not enjoy legal privilege and may be liable to subpoena by a court. In relevant circumstances, research participants should be made aware of this. It is not clear from the Barnado’s guidelines how adherence to their guidelines is monitored. General ethical guidelines Guidelines from the British Psychological Society The British Psychological Society (BPS) has a set of ethical principles for conducting research with human participants (BPS 2000). These principles supplement the society’s code of conduct so violation could result in disciplinary action. Research psychologists are urged to ensure they abide by the principles. Adherence to these principles is not officially monitored but if a researcher believes another investigator is not abiding by the principles, he or she should encourage that investigator to re-evaluate the research. The principles state that participants’ confidentiality must always be upheld. Guidelines from the British Sociological Association The statement of ethical practice for the British Sociological Association (BSA) (2004) aims to raise awareness of ethical issues that may arise during the research process and to encourage researchers to take responsibility for their ethical practices. The statement sets out the ethical principles that need considering when carrying out a research study. The BSA guidelines acknowledge that there may be a need to break confidence in some situations, such as cases of child abuse. However, adherence to the guidelines does not appear to be monitored; researchers are encouraged to be self-regulatory. 12 NURSERESEARCHER 2009, 16, 3


Guidelines from the Royal College of Nursing The Royal College of Nursing (RCN) published updated guidance relating to the ethical issues of carrying out research with human subjects in 2007. This guidance does not relate specifically to children but includes a paragraph addressing whether research with vulnerable groups is possible, stating that undertaking research ethically with vulnerable people is more difficult but that sometimes there is no viable alternative. The RCN’s guidance states that informed consent must be obtained but does not address this issue in relation to children. The RCN guidance also states that personal information should be kept confidential. Discussion Several themes emerge from the ethical guidelines reviewed: informed consent; making payments to children; limiting the guarantees of confidentiality; protecting children who are research participants; and monitoring adherence. Each of these themes will be discussed below. Informed consent For a person to be capable of giving informed consent, three main elements need to be considered. The person needs to be capable of making that particular decision (they must be competent); must be acting voluntarily – that is not being coerced; and must be provided with sufficient information to enable them to make an informed decision (DH 2001). In relation to consenting to take part in a research study, the National Research Ethics Service (2007) states that children under the age of 16 can give their consent to take part in a research study if they satisfy the criteria of Gillick competence: n They have been counselled and do not wish to involve their parents. n They have sufficient maturity to understand the nature, purpose and likely outcome of the proposed research. In the guidelines reviewed in this paper, there are areas of agreement relating to consent but also some areas of inconsistency. One area that all the guidelines agree on is that consent is an ongoing process; it is not enough simply to obtain consent at the beginning of a study. However, the issue of whether parents or children should give consent appears to be more complicated. The NURSERESEARCHER 2009, 16, 3

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RCPCH (2000) guidelines indicate that informed consent should normally be obtained from the child and parent unless the child is Gillick-competent. This concurs with the MRC (2004) guidelines, which suggest that where children have sufficient understanding and intelligence to understand what is proposed, it is their consent and not that of their parents that is required by law. However, Barnado’s (2002) and the NCB (2003) guidelines state that informed consent should always be given by the child, with parental consent being obtained whenever possible. Obtaining informed consent from the child is in line with the United Nations Convention on the Rights of the Child (United Nations 1989), which makes it clear that children should be involved in decisions that affect them. This has been reinforced by the Children Act 1989 (England) and the Children (Scotland) Act 1985. The (English) National Service Framework for Children and Young People states that children, young people and their families should be active partners in decisions about their care (DH 2004). In practice many researchers obtain the child’s assent to take part in a research study. Assent is defined as the child’s permission or affirmative agreement to participate in research (Broome and Richards 1998). Unlike consent, assent is not a legally mandated process. However, assent still requires children and young people to have an understanding of the research process and to be informed about what they are expected to do (Lindeke et al 2000). Further, Piercy and Hargate (2004) state that assent is an opportunity given to children to express their opinions and concerns surrounding participation in research, providing them with a formal means to be included or excluded. When these definitions are considered, there appears little to distinguish assent from consent. In the light of the advice given in several ethical guidelines (Barnado’s 2002, NCB 2003, MRC 2004) perhaps rather than asking when the child’s consent is required, the question researchers should be asking is, when is parental consent needed? An exception to this is the clinical trial. In 2001, the European Union adopted the European Parliament and Council (2001/20/EC) as a framework for good management in trials of medicines for human use. The subsequent UK Medicines for Human Use (Clinical Trials) Regulations became law in 2004 (HM Government 2004). The EU Clinical Trials Directive states that the 14 NURSERESEARCHER 2009, 16, 3


informed consent of the parents or legal representative must be obtained before a minor (a child under the age of 16 years) can take part in a clinical trial. This appears to contradict moves towards ensuring that children’s rights to be involved in decisions are upheld. However, the directive does state that minors should be given information about the study and that their refusal to take part should be respected. It is pertinent to note that case law in England and Wales regarding consent for medical treatment following the Gillick v West Norfolk (1985) contradicts many of the principles discussed in this section. The current legal position advocated by Lord Donaldson is that children can consent to treatment but not refuse (Re W 1992). If they refuse treatment their wishes can be overruled by their parents. Indeed, the criteria for competence laid down by Lord Donaldson in Re R (1991) were that what was required was: ‘…not merely an ability to understand the nature of the proposed treatment… but a full understanding and appreciation of the consequences both of the treatment in terms of intended and possible side effects and, equally important, the anticipated consequences of a failure to treat.’ This level of competence is greater than that expected from adults. In Re C (1994) the ruling stated that adults should be able to comprehend and retain information about the treatment, believe it and weigh it in the balance to arrive at a choice. A similar level of competence is required by the Mental Capacity Act 2005. An additional discrepancy between the level of competence currently required by adults and children is that, following Lord Donaldson’s ruling in 1991, children have to be permanently Gillick-competent (Re R 1991). However, the Mental Capacity Act 2005 states that: ‘The fact that a person is able to retain the information relevant to a decision for a short period only does not prevent him from being regarded as able to make the decision.’ There are clearly legal anomalies in this area that need clarifying and challenging. Making payments to children Making payments to children taking part in research studies is an area where the guidelines differ. There is agreement that travel expenses should be NURSERESEARCHER 2009, 16, 3

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paid. However, there is no consensus about whether the time and effort of participants should be rewarded. Some guidelines state that there should be no financial inducements (RCPCH 2000, MRC 2004), while others say they should be considered (Barnado’s 2002, NCB 2003). The NCB (2003) states that research participants should be compensated for their time with a modest reward such as a gift voucher, and that if a child is more than a participant he or she should be paid for the time they spend on the project. Other guidelines state that no inducements should be provided so that the child is not coerced into taking part in the study (RCPCH 2000, MRC 2004). This is an area where further debate is needed. Limiting the guarantees of confidentiality Whether there should be limits to the guarantees of confidentiality is addressed in several of the guidelines (Barnado’s 2002, NCB 2003, BSA 2004, MRC 2004) but other guidelines state that confidentiality should always be guaranteed (BPS 2000, RCPCH 2000, RCN 2004). Safeguarding children is everybody’s responsibility. If, while participating in a research study, a child divulges that they or others are at significant risk of harm or the researcher observes or receives evidence of incidents likely to cause serious harm, the researcher must divulge this information to the appropriate authorities. This should occur only after discussion with the child. The child should be informed that this will happen before data is collected; this should also be stated in the child’s information leaflet. Protecting children who are research participants Several of the guidelines outline steps that should be taken to ensure that children taking part in a research study are protected. All researchers should undergo security screening including a criminal records review (NCB 2003, BSA 2004, MRC 2004). Researchers should be appropriately trained (NCB 2003, BSA 2004, MRC 2004) and be aware of the limits of their expertise (Barnado’s 2002, NCB 2003, BSA 2004). A research encounter should end with a de-briefing (BPS 2000, NCB 2003, BSA 2004). Researchers should be aware of local facilities that can offer children support and advice if they are upset by taking part in a research study (NCB 2003, BSA 2004). Researchers 16 NURSERESEARCHER 2009, 16, 3


must also consider whether children are involved in more than one study (MRC 2004). In relation to research ethics committees, members should have a breadth of research knowledge (RCPCH 2000, MRC 2004). Monitoring adherence There is a requirement for healthcare researchers to submit proposed studies to a health research ethics committee. These committees arose as a result of unethical incidences such as: the Nazi medical experiments; the Tuskegee syphilis study (1932-1972); and the Jewish Chronic Disease Hospital study (1963). In all these situations vulnerable people were harmed because of unethical research practices. The Tuskegee Syphilis Study, for example, began in the 1930s and continued for 42 years, and used poor, uneducated African-American men as subjects. The researchers compared the health and longevity of an untreated syphilitic population with a non-syphilitic but similar population. However, these men did not even know they were in a study or that they had syphilis, nor were they given appropriate medication for their disease when it became available. The public outcry against this study led to the Belmont report (Ryan et al 1979). The recommendations of the Belmont report remain the basis of today’s ethical codes and guidelines. The key principles outlined in the Belmont report are: respect for persons (obtaining informed consent); protection of vulnerable people from coercion; beneficence; and justice. Research ethics review committees were first set up in the United States following the discovery that a physician at the Jewish Chronic Disease Hospital in Brooklyn, New York, was experimentally injecting live cancer cells into elderly debilitated patients without proper informed consent. The resulting inquiry resulted in an order to all institutions receiving funding from the US government to set up ethics review committees. This, in turn, led to the earliest European research ethics committees being established. Today, health research ethics committees monitor adherence to ethical principles laid down in the Nuremberg Code (International Military Tribunal 1948) and the Declaration of Helsinki (World Medical Association 2008). For researchers working in other disciplines, there is not always the need to seek ethical approval from a research ethics committee. The ultimate responsibility NURSERESEARCHER 2009, 16, 3

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for ethical behaviour lies with the researcher. However, the ethical disasters mentioned previously demonstrate that unethical research is sometimes carried out. Research ethics committees are often seen as bureaucratic but at least each study is subject to ethical review, thus offering some protection to vulnerable participants. An interprofessional debate is needed to decide whether all research with children should be subjected to ethical review, and if so how this should be managed. Any system for ethical review needs to be more than a tick-box exercise and to take into account resource issues such as time and cost. The primary purpose of any such process should be to avoid ethical disasters and to protect children from potentially harmful situations. Conclusion Key ethical principles for undertaking research with or on children have emerged from this review of guidelines in the UK. In relation to informed consent, it has been suggested that children’s consent should always be sought and parental consent sought whenever possible. The exception to this is in relation to clinical trials where parental consent is always required. All the guidelines are clear that travel expenses should be paid but there is a need for a debate to obtain consensus about paying or rewarding children for taking part in a research study. Healthcare researchers should submit their proposals to a research ethics committee for ethical scrutiny. Other researchers do not currently need to do so. An interprofessional debate is needed to decide whether such ethical scrutiny should be a requirement for all research involving children. While it is not stated in all the guidelines reviewed, researchers have a clear responsibility to divulge information if there is the potential for a child to be harmed. Before passing on any information, this should be discussed with the child. Steps need to be taken to protect participants from harm. Researchers should therefore have undergone a criminal record check and have the appropriate training and expertise in the research methodologies being used. Ending a research encounter with a debrief interview is also recommended. Researchers should also be aware of local support mechanisms that are available if a participant becomes upset during or after taking part in a study. This review of ethical guidelines has identified many areas of consensus but 18 NURSERESEARCHER 2009, 16, 3


has also revealed some areas where further debate is needed before there can be an interprofessional approach to the ethics of research with or on children. This debate needs to take place to ensure that children are protected from harm and their voices are heard n Alison Twycross PhD, MSc, DMS, CertEd (HE), RGN, RMN, RSCN, is principal lecturer in children’s nursing, Faculty of Health and Social Care Sciences, Kingston University and St George’s, University of London, UK

Acknowledgement I would like to thank Robert Stanley, senior lecturer, Faculty of Health and Social Care Sciences, Kingston University and St George’s, University of London, for his comments on an earlier draft of this paper. This article has been subject to double-blind review

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