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Informing children and parents about research
  1. A Dawson1,
  2. S A Spencer2
  1. 1Centre for Professional Ethics, Keele University, UK
  2. 2Neonatal Unit, North Staffordshire University Hospital NHS Trust, Stoke on Trent, UK
  1. Correspondence to:
    Dr S A Spencer
    Neonatal Unit, North Staffordshire University Hospital NHS Trust, City General, Newcastle Road, Stoke on Trent ST4 6QC, UK; andy.spenceruhns.nhs.uk

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A discussion of the difficulties involved

Current international,1,2 European,3,4 and UK5,6 research frameworks require all competent participants in research to give an informed consent. An informed consent can be defined as a decision made by a competent individual, free of any undue influence, on the basis of all of the relevant information.7 Evidence exists that difficulties in obtaining an informed consent are leading to recruitment failure in essential paediatric research.8 Clinical research is vital to ensure that patients receive the best possible treatments. Such research either improves the quality of care or saves lives. For example, clear benefits can be shown from the results of childhood cancer trials.9 Research is especially important in relation to children, given the poor evidence base for much of paediatrics.3,5 It is therefore necessary to use all possible means to improve the ability of parents and children to come to an informed position regarding research proposals, so that recruitment into such research is maintained. This review outlines a series of potential impediments to realising this objective in relation to paediatric research, provides a number of recommendations for improvements in practice, as well as suggesting some future avenues for research.

CHILDREN, PARENTS, AND COMPETENCE

Obtaining informed consent is particularly challenging for research involving children and parents because of the issue of competence. Where a child can be deemed competent to understand the nature and implications of research, he/she must be fully involved in the consent process.5 There is a great deal of empirical evidence to suggest that many children are capable of much greater participation than was thought possible in the past.10,11 This has resulted in the present consensus position that where a competent child is able to give an informed consent, this is acceptable, although normally parents will also be asked when the child is under 18.5 This is often phrased in terms of gaining “assent” from the child, even though such a phrase has no legal meaning.12 As a consequence both children and parents may be involved in the consent process. This can lead to conflict, and differences have been recorded in relation to the assessment of risk and whether participation is appropriate.13 In cases of disagreement between parent and child, a parent cannot overrule a competent child’s decision, but a clinician is unlikely to go ahead with research if either the child or the parent is reluctant.5

Where neonates, young children, or older children who are not yet competent are concerned, informed consent is sought from a person with parental responsibility.12 It must be noted that fathers do not automatically have parental responsibility unless the parents were married at the time the child was born. Issues relating to competence may also arise when the circumstances surrounding the research are not conducive to the retaining of information. For example, much of paediatrics is acute, so the child is likely to be ill and the parents may be feeling confused or overwhelmed. Parents of a child newly diagnosed with cancer, for example, may be shocked by the diagnosis and yet have to quickly come to a decision about whether to include their child in a randomised trial. Consent for research on preterm neonates is also likely to present difficulties, given the fact that the mother may be tired or unwell following a difficult or unexpected delivery, and stressed about the condition of a child receiving intensive care. Yet many important neonatal trials have required consent to be obtained quickly in the first days of life.14

PROBLEMS IN INFORMATION PROVISION

Such problems in relation to competence are compounded by those arising in relation to information provision. The existing research frameworks offer guidance about what constitutes information necessary for an informed consent.1,2 Essential information includes not only that about the nature and purpose of the specific research, but also the relevant balance between possible risks and benefits, as well as information about the implications of participation (including that the study is voluntary, and that failure to consent will not jeopardise clinical care). Information about relevant methodological issues should also be included as appropriate; for example, participation in a randomised controlled trial should be preceded by explanation of such concepts as randomisation, blinding, and equipoise. Patients must also be informed about the source of project funding and any potential conflicts of interests.5

Such requirements look difficult, if not impossible, to attain, given the evidence suggesting that many patients find it difficult to understand and recall elements of the research process even a short time after agreeing to participate.15 Some such problems may relate to difficulty understanding the language used in the design of studies, and this could, perhaps, be overcome by re-wording the information provided. However, this cannot be the whole story. While it is, perhaps, not surprising that parents may struggle to understand elements of research methodology such as the role of randomisation and its benefits,14 patients’ recall of even simple events such as receiving a leaflet is remarkably low.16 In fact parental comprehension of all aspects of research is consistently judged to be poor.17 As suggested above, such problems are only likely to be magnified in an acute setting where the competent child or parents may be upset, confused, and ill.

IMPROVING INFORMATION PROVISION

Despite these findings, it might be argued that successful informed consent procedures can be put in place if only good quality and accessible information is available for both competent children and parents. There is a large literature exploring ways of improving communication through the provision and refinement of information.18 However, there are remarkably few studies looking at the informational needs of children, whether these needs are met, and if not, how they may be addressed.

The provision of an information sheet or leaflet, is now a requirement, as part of the ethical review process, and has to follow a standardised format.19 Is there any evidence that information sheets promote informed choice? While one study suggests that they make little, if any, difference,20 other studies are more positive and suggest improved satisfaction with the information received and some evidence of anxiety reduction.21,22 These studies recommend that such leaflets should be used to augment the verbal explanation given as part of recruitment, and not as a substitute for it. In producing written material it is considered to be important to seek to involve consumer and patient groups.23 Information leaflets can then be refined in the light of patients’ views and comprehension. For example, the acceptability of a potentially controversial trial can also be explored with patients at a theoretical level.23

Little attention has been paid to how children might be included in the development of leaflets designed to inform future competent child participants. Should children be engaged in the production of material to meet these specific requirements? If it is thought that they should be, how, and when, is it best to do so? There are currently no answers to these questions in the published literature. In fact, most existing research on communication issues in relation to consent for child participants in research has been carried out with consenting parents and not with competent children. Researchers have explored parental comprehension of factors relevant to giving an informed consent,24 including the factors that influence parental decision making in relation to enrolment of their child into a research study.25 Researchers need to explore these same issues, urgently, with competent children.

There is strong evidence that the usefulness and clarity of written material can be improved,26–28 and publications are available to help with this task.29,30 However, it is not clear that this material is of any assistance in improving communication with children. For example, while the Consumers for Ethics in Research (CERES) leaflet suggests that children should be required to give a consent if they are competent, there is no discussion as to whether this will be equally or more difficult than gaining an informed consent from an adult.31 In the general literature concerning the production of written materials for gaining consent,29,30 there is virtually no exploration of the role of written materials in the comprehension of research and subsequent informed consent in competent children.32 On the other hand, there are many good examples of written materials, such as leaflets and websites, that have been prepared for children to help them understand chronic condition such as asthma, diabetes, and cancer.33–35 Although there is little current evidence of the evaluation of such materials, they might provide a model for leaflets and web resources for competent children in relation to clinical research.

There is, therefore, an urgent need for more empirical research on competent children’s comprehension of information relating to research and their views about the acceptability of research. In fact, even the studies with adults might be open to some criticism, as they are generally small scale and involve rather subjective outcome measures (such as self reported “satisfaction” or “sense of being fully informed”). Further work is needed using larger sample sizes, more robust methodologies, and the inclusion of competent children.

Another obvious issue is whether children are more likely to understand and retain information presented in a video or multimedia format. Unfortunately little work has been done with children, and the results from studies with adults are inconclusive. On the one hand, some studies suggest that the provision of information in the form of a video results in increased knowledge and retention of information in comparison with leaflets,36,37 whereas other studies have found no additional benefits beyond written information.38,39 The evidence in relation to the use of videos on willingness to participate in research is also equivocal.36,37 There has been very little research on patients’ reception of information via multimedia formats. One published study compared outcomes in relation to information provided to children via written information sheets or multimedia software in relation to enuresis. It found no significant difference between the two groups. However, the study is of limited value, as it did not explicitly explore whether there was any difference in comprehension between the two groups as a result of the intervention.32 Once again there is a need for further research in this area.

HOW MIGHT THE CONSENT PROCESS BE IMPROVED?

Many of the difficulties in obtaining an informed consent for research with children, relate to the problem of imparting information in a stressful or even emergency situation. The low levels of knowledge and understanding of research methodology in the general population compound this difficulty. This raises the question whether there are any ways to better inform this patient population and, if so, whether this would assist those who were subsequently asked to participate in research to give an informed consent.

Much of the general literature published on information provision procedures relates to attempts to test or obtain consent at the point of participation in a specific research project.18 However, one investigation into the impact of an information leaflet on understanding of medical research outside of a specific research context provided some evidence of benefit.40 The leaflet was judged by the majority of participants to provide welcome information about research and to have had the desired effect in raising the profile of research. It also revealed a general willingness to participate in research. Whether prior exposure to such a leaflet actually helps with the obtaining of an informed consent to a specific project has not yet been tested.

Other possibilities for the education of parents and children about research in general could include the use of video presentations in waiting areas and in antenatal clinics/classes for expectant mothers. Perhaps there is also a role here for the media and for schools. If clinical research is important for the continued development of medicine and wellbeing of society, perhaps it should be given as high a priority as information about drugs, AIDS, sex education, and other lifestyle health issues.

SOME PRACTICAL IMPLICATIONS OF THESE ISSUES RELATING TO INFORMED CONSENT

Much of the research presented in this paper shows the existence of real problems in gaining informed consent, despite the requirement to do so. This fact presents two very practical dangers. The first is that despite signing a consent form, the participants may later complain that they did not at the time understand the implications of what they were signing.41 This concern provides a practical motivation to consider ways to improve information provision to add to the ethical justification already discussed above.

The second practical concern is that given the existence of both the requirement to gain an informed consent, and the evidence about the problems in gaining an informed consent, researchers are likely to be increasingly cautious about recruiting into trials. In a situation where responsibility lies with the researcher to ensure that the participants are competent, have fully understood the relevant information, and have given an informed consent,6 many researchers will choose not to enrol patients in research because of concerns about attaining these ends, despite believing that participation in the research will be in the patients’ best interests. Are we really protecting these patients by denying them the opportunity to take part in research? While it is clearly the case that children need to be protected from unethical research, it also needs to be accepted that one consequence of insisting on gaining informed consent will be that recruitment into trials involving children will become more difficult,8 and past successful research9 will become more difficult to emulate. The overall result will be that children will be harmed, as vital research will not be performed.

CONCLUSION

There is a strong imperative to ensure that informed consent is obtained from every competent research participant, whether adult or competent child. However, there are a number of barriers to obtaining informed consent. Therefore there is a clear need to develop better methods of imparting information at the time of recruitment into studies and a need to explore methods of increasing both the knowledge and understanding of medical research in all consumers of health care services, so they will be better prepared to make an informed choice should the opportunity to participate in research arise. It has been noted that the information needs of competent children who are also required to make informed choices about research has largely been neglected. This requires urgent remedy. Finally, it needs to be acknowledged that the imperative to seek an informed consent may result in much less research in vulnerable groups. This is potentially harmful and it is not clear that this is a price worth paying.

A discussion of the difficulties involved

REFERENCES

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Footnotes

  • Competing interests: none declared

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