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Involving children and young people in research
SYMPOSIUM: RESEARCH
Involving children and young people in research
Another note from the past is the story of Edward Jenner and vaccination. Jenner demonstrated a cardinal characteristic of a good clinician scientist: he observed. He noted that country people who caught cowpox from their cows appeared to have protection against the much more dangerous illness, smallpox. He realized that to test this he should infect someone who had not yet suffered smallpox, with cowpox. He chose James Phipps, the 8-year old son of his gardener. He deliberately infected James first with cowpox, and later after the boy had recovered from the mild illness, exposed him to smallpox, which he did not contract. Did Jenner consult young James or his parents, or give him a choice? History does not recount this. Was the experiment unethical? We would most certainly consider it unethical today, but that was not the case in 1796. The concept of informed consent did not become a component of best research practice until the 1970s, well after the Second World War when disclosures about Nazi experimentation initiated debate on the ethics of research involving humans. For many years, conventional wisdom was that researchers should exclude children from participation because the prevalent view as that it was necessary to protect them from the dangers of research. I suggest one might view this as a classic example of paternalism, and a view based on too narrow a definition of “research” in failing to recognize that exposing patients to nonevidenced treatments also imposes major dangers. The British Paediatric Association, the forerunner of the Royal College of Paediatrics and Child Health (RCPCH), first published guidance in relation to research involving children in 1980. They made powerful statements, such as ‘research involving children is important’, ‘should be supported and encouraged’ and ‘research which involves a child and is of no benefit to that child (nontherapeutic research) is not necessarily either unethical or illegal’. To this day, the Declaration of Helsinki makes no specific provision for children, only including a stipulation that special consideration is required for research involving vulnerable populations. Children do require protection, but this should not preclude the claim of other rights, including the right to the highest standard of healthcare, to be informed, express their views, and influence decisions made about them, a topic to which I will return. Most, but not all parts of the world, now accept that researchers should offer children opportunity to participate in studies, and have their care ‘assured by research’.
Neena Modi
Abstract Attitudes to the participation and involvement of infants, children and young people in research have evolved over the years and will undoubtedly continue to change. Today we recognize that they have the right to benefit from research and have their care ‘assured by research’, as well as the right to protection from any dangers from research participation as well as protection against the dangers of receiving non-evidenced treatments. We also recognize that they can be involved in many ways, including prioritising research questions and the outcomes that are measured, helping design studies so that they are acceptable and successful, ensuring information is comprehensible, and participating in disseminating outcomes and discussing emerging issues. Here, I provide a summary of the changes that have occurred. I explain why involvement is important, discuss how to do this, and provide tips and perspectives from children and young people themselves. I provide pointers to other sources of information and advice. Finally, I consider ways in which involvement might evolve in the future.
Keywords children; patient involvement; research; young people
Introduction Many changes have taken place over the centuries in relation to societal perceptions around the involvement of children and young people in research. Here I briefly discuss these changes and the present situation. I provide insights from children and young people, and their top tips for researchers. I finish with a few areas of controversy and uncertainty, and my hopes for the future.
A few historical notes It is said the earliest example of a controlled trial is the story of Daniel and his companions at the court of King Nebuchadnezzar in the fifth century BC. Daniel argued that he and his companions should be allowed to reject the rich diet of meats and wine consumed by the other young men at court, and instead be given a diet of pulses and water. The consequence was that at “the end of ten days their countenances appeared fairer and fatter in flesh than all the children that which did eat the portion of the king’s meat”. Perhaps this provides evidence of the perspicacity of youth!
Why should we involve children and young people in research? Today, there are several reasons why we should involve children and young people in research. The perspectives of society have shifted from a focus centred upon protecting children from the dangers of research to realisation that children are entitled to benefit from research, and to the view that researcher should conduct studies with children and young people, and not solely on them, or for them. The acceptance of children as individuals with rights enshrined in statute as the United Nation Convention of the Rights of the Child was a major paradigm shift, and initiated this change in thinking. The United Nations General Assembly adopted the Convention in 1989 30 years after the Declaration of the Rights of the Child). All UN member states except for the United States have ratified the Convention. The
Neena Modi MB ChB MD FRCP FRCPCH FFPM Professor of Neonatal Medicine and Consultant, Section of Neonatal Medicine, Imperial College London, London, UK. Conflicts of interest: NM was the UK Royal College of Paediatrics and Child Health (RCPCH) Science and Research vice-president from 2009e2014, and president from 20152018. The views expressed are her own.
PAEDIATRICS AND CHILD HEALTH xxx:xxx
1
Ó 2019 Elsevier Ltd. All rights reserved.
Please cite this article as: Modi N, Involving children and young people in research, Paediatrics and Child Health, https://doi.org/10.1016/ j.paed.2019.11.006
SYMPOSIUM: RESEARCH
right to be involved in decisions, including research. Article 23 states that children and young people with disabilities have the right to be involved, including having appropriate communication support at healthcare appointments and opportunities to be involved in research in a meaningful way. Article 24 addresses the right to the best healthcare possible and health services that are take the specific needs of infants, children and young people into account. Article 28 is about the right to education, and services structured to avoid missing school due to medical appointments. Article 31 discusses the right to rest, relax and play, including support for children with complex health needs so that they can take part in social activities that are fun and that they enjoy.
Convention came into force in the UK in 1992. There has been an evolution in the interpretation of the Convention of the Rights of the Child, a process that continues to this day. Today, we recognize that in addition to being a component of upholding their rights, hearing the views of children and young people when designing and delivering studies, and implementing the findings, makes the research more credible, more likely to be effective, and outcomes more likely to be implemented.
How can children and young people contribute to research? Children and young people can contribute in many ways. They can participate and be involved and engaged. They can help identify issues they consider a priority, which may differ from the perspectives of researchers or even their parents. The views of children and young people who suffer from particular diseases can be especially insightful. They can help develop research materials and information sheets, and can advise on whether the proposed research design is likely to be acceptable. Identifying research priorities, commenting on study design, and developing information leaflets are examples of research involvement. Children and young people can also be research participants not just by being recruited to a clinical trial or other research study but also by completing a questionnaire or participating in a focus group as part of a research study, or to help develop a research protocol. Examples of research engagement include taking part in discussions on research, helping disseminate research outcomes, and awareness raising activities using social media. Children, young people and their parents may prioritize uncertainties that need to be resolved through research, and the outcomes they consider important, differently from doctors, nurses and researchers. This is why organisations such as the James Lind Alliance have established “priority setting partnerships” involving these different groups. They can also be involved in developing “core outcome sets”. These outcomes represent the minimum that all those involved in research consider important and recommend measuring in all studies and in the same way. They are also suitable for use in clinical audit and healthcare evaluations. The COMET (Core Outcome Measures in Effectiveness Trials) Initiative brings together people interested in the development and application of these agreed standardized sets of outcomes. Because a core outcome set exists does not mean that researchers cannot or should not measure other outcomes if these are important for a specific study. It just means that researchers will all obtain the core outcomes as well, making it easier for results to be pooled and compared. Check out their websites for more information.
Research &Us In 2015, as Vice-President of the RCPCH, I initiated work to develop an Infant, Children and Young People’s Research Charter under the aegis of the RCPCH. Staff from RCPCH led the development of “Research &Us” with children young people, families, health workers and researchers to provide clear information on how best to involve patients and families. The “What you need to know” resource outlines how we made the Charter, the benefits for children and young people, and an aide memoire on how to use it. There are case studies from researchers, resources to support the voice of children young people and families in research and an exploration of what support health professionals need to be able to engage with and involve them. “Children and young people were clear that they wanted to be given the opportunity to be involved in research design, as a research participant, and to have the chance to help other children and young people. They wanted to be able to hear from and share experiences of child health research with others.
The groups from whom we heard also wanted professionals to speak about research positively and to choose words carefully. They warned against using words with potentially negative interpretations, such as “trial” or “investigate” as both made children and young people think about errors and mistakes. They wanted researchers to make sure they always give them a chance to discuss things with them so that they can ask questions, understand what is proposed, and be involved in making decisions”
Young people’s views on involvement in research In 2018, young people shared their views on what being involved in research meant to them. They identified three areas they considered of top importance and in which they wanted to be involved: i) supporting informed consent: understanding this and being involved in developing materials; ii) involvement in research design, including the question, protocol and project plan; iii) involvement in the research process, methods, delivery and monitoring. They also identified as important, how best to raise awareness of research with children and young people, and how to increase opportunities for children and young people to get involved in
RCPCH &Us RCPCH &Us is a network of children, young people and their families working in partnership with the RCPCH to improve child health. The United Nations Convention on the Rights of the Child underpins this approach. The Convention covers all aspects of a child’s life and sets out their entitlement to civil, political, economic, social and cultural rights. Members of RCPCH &Us have identified five UNCRC articles they feel should be prioritized. These are Articles 12, 23, 24, 28 and 31. Article 12 covers the
PAEDIATRICS AND CHILD HEALTH xxx:xxx
2
Ó 2019 Elsevier Ltd. All rights reserved.
Please cite this article as: Modi N, Involving children and young people in research, Paediatrics and Child Health, https://doi.org/10.1016/ j.paed.2019.11.006
SYMPOSIUM: RESEARCH
research from the start, not just in later stages such as “youthproofing” patient information leaflets or as participants. They talked about the things they felt researchers should have in mind when involving children and young people. We show their top five tips in Box 1. Other young people’s groups have identified additional areas to emphasise. Young people work and communicate differently than adults, and are not always good with email. The best approach is therefore to ask them what method of communication they prefer, and what meeting days and times, and not make assumptions. Parents like to be kept informed so it is a good idea to include them in communications. Write your information sheets in different ways for different age groups and ask children and young people from the relevant age group to review them. Use pictures, colour and short sentences in the information
sheets but beware of being condescending. Over the last 3 years young people and children have demonstrated a keen interest in being involved in research. However, a recurring theme is about being able to offer meaningful opportunities that meet their needs. They want research to be accessible, i.e. they want to understand what researchers are proposing and why so a researcher must use language that is comprehensible and clear. They feel research targeting their participation should be child and youth focused in delivery, i.e. fun and meaningful. They want their input to make a difference they can see and understand. There are now lots of publications providing guidance, frameworks, commentary and tools to support patient and public involvement in research. Having children and young people involved in shaping research has many benefits. We look forward to seeing more of them involved. The National Institute of Health Research established INVOLVE in 1996 to provide guidance and links to a number of resources to support patient and public involvement in National Health Service, public health and social care research. It is one of the few government-funded programmes of this kind in the world. Look up their website for more information.
Top tips C C C C
C
Make it matter! Make it fun and age appropriate No jargon; keep it simple and to the point Have different levels and ways for children and young people to engage and contribute Credit it them for their involvement
The future I started this article by pointing out that society’s attitude to children and young people in research has changed over the years. It is reasonable therefore to assume that attitudes and
Box 1
Top tips, questions and ideas for research consent, design and process Topic
Research consent
Research design
Research process
Top tip
Create truly age appropriate Think about how their involvement information with the help of the can improve study design target audience so that you provide the best possible chance of being understood
Questions for researchers to think about
When you ask both children and adults for consent whose opinion actually counts?
How will you encourage and support Could your child, or a friend or the involvement of children and neighbour aged 7 understand this? young people? Can you reword the jargon? Use an How will you judge whether you have online tool to help you. been successful in involving them? Do you need to change your plans or Can you work with young research your study design to meet the needs ambassadors? of infants, children and young people?
Our ideas to help
Tailor your approach to the age group Create videos, and step-by-step guides Have a checklist of questions and areas that need to be asked about or considered when discussing research participation
Go to them, don’t expect them to come to you Social media, speed networking, youth centres, school assemblies, and hospital wards provide great opportunities to reach your audience; be creative!
Explain clearly to children and young people about exactly what will happen to them and when if they take part
Break the processes down into short sharp chunks Think about different groups for different parts of the process Be honest and open about all the parts in a clear, visual way
Table 1
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Ó 2019 Elsevier Ltd. All rights reserved.
Please cite this article as: Modi N, Involving children and young people in research, Paediatrics and Child Health, https://doi.org/10.1016/ j.paed.2019.11.006
SYMPOSIUM: RESEARCH
frameworks for interaction will continue to evolve, so I urge you to keep an open mind. There are also areas of controversy. One such area is that of remuneration for participation in research. Some adults feel this might pose a danger and go against the principle of autonomous decision making, if for example a child or young person was pressurized to join or felt tempted to join because of the remuneration, even though he or she did not really want to participate. However, young people themselves also have divided opinions. Some think remuneration is important; others express an altruistic view, pointing to acts like blood donation, which we consider a gift in the UK. Another issue arises from studies involving long-term follow-up or routine health data. If your parents agreed to your enrolment in a study, or the use of your health data, when you were a baby, or young child, when and how should researchers seek your personal agreement? It is certainly unwise to accept the view that young people lack maturity. For example, recent evidence challenges the notion “older is wiser” showing that millennials are about seven times less likely than the over 65 year old age group to believe and propagate “fake-news”. One interpretation of this observation is that the digital literacy of the young better prepares them to make rational decisions. Research is changing in many ways. Data science, machine learning and artificial intelligence are raising questions that were the realm of science fiction just a few decades ago. I predict that engaging and involving young people may help drive thinking so that societal perspectives are better able to keep pace with technological and scientific advances (See Table 1). A
Royal College of Paediatrics and Child Health Ethics Advisory Committee. Guidelines for the ethical conduct of medical research involving children. Arch Dis Child 2000; 82: 177e82. The James Lind Library, https://www.jameslindlibrary.org/; https:// www.jameslindlibrary.org/. United Nations General Assembly in New York; The Office of the United Nations High Commissioner for Human Rights. Resolution 25, session 44, convention on the rights of the child. November 20 1989, http://www.ohchr.org/EN/ProfessionalInterest/Pages/CRC. aspx (accessed 19 August 2019). University of Oxford, Nuffield Department of Medicine, Teaching children unbiased testing; https://www.ndm.ox.ac.uk/andy-oxmanteaching-children-unbiased-testing; (accessed 19 August 2019). World Medical Association. Declaration of Helsinki, Ethical principles for the conduct of research involving human subjects. http://www. wma.net/en/30publications/10policies/b3/; (accessed 19 August 2019).
Acknowledgement With thanks to Emma Sparrow, Children and Young People manager at the Royal College of Paediatrics and Child Health, and to children, young people and families from RCPCH &Us and the Young Person’s Advisory Group North England for sharing their voices and views in this paper.
Practice points FURTHER READING British Paediatric Association Working Party on Ethics of Research in Children. Guidelines to aid ethical committees considering research involving children. Arch Dis Child 1980; 55: 75e7. Modi N, Clark H, Wolfe I, et al. For the writing group of the Royal College of Paediatrics and child health Commission on child health research. A healthy nation: strengthening child health research in the UK. Lancet 2013; 381: 73e87. Modi N, Vohra J, Preston J, et al. Working Party of the Royal College of Paediatrics and Child Health Guidance on clinical research involving infants, children and young people: an update for researchers and research ethics committees. Arch Dis Child 2014; 99: 887e91. National Institute for Health Research, The young persons’ advisory group; https://www.invo.org.uk/ypag-the-young-personsadvisory-group/; (accessed 19 August 2019). Royal College of Paediatrics and Child Health. Children’s Research Charter: what you need to know. 2016, https://www.rcpch.ac.uk/ sites/default/files/What_you_need_to_know.pdf (accessed 19 August 2019).
PAEDIATRICS AND CHILD HEALTH xxx:xxx
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Infants, children and young people have the right to benefit from research and have their care ‘assured by research’ They have the right for protection from any dangers from research participation as well as protection against the dangers of receiving non-evidenced treatments Incorporating the views of children and young people when designing and delivering studies, and implementing findings, makes the research more credible, more likely to be effective, and outcomes more likely to be implemented. There is a lot of information available on how you can involve children and young people in research, audit and other ways to improve healthcare and patient outcomes. Around the world, people differ in their attitudes around involving the perspectives of children and young people in research, but these are also changing everywhere; you might find it interesting to think about the changes over the coming years you feel might be important.
Ó 2019 Elsevier Ltd. All rights reserved.
Please cite this article as: Modi N, Involving children and young people in research, Paediatrics and Child Health, https://doi.org/10.1016/ j.paed.2019.11.006
Involving children and young people in research
Another note from the past is the story of Edward Jenner and vaccination. Jenner demonstrated a cardinal characteristic of a good clinician scientist: he observed. He noted that country people who caught cowpox from their cows appeared to have protection against the much more dangerous illness, smallpox. He realized that to test this he should infect someone who had not yet suffered smallpox, with cowpox. He chose James Phipps, the 8-year old son of his gardener. He deliberately infected James first with cowpox, and later after the boy had recovered from the mild illness, exposed him to smallpox, which he did not contract. Did Jenner consult young James or his parents, or give him a choice? History does not recount this. Was the experiment unethical? We would most certainly consider it unethical today, but that was not the case in 1796. The concept of informed consent did not become a component of best research practice until the 1970s, well after the Second World War when disclosures about Nazi experimentation initiated debate on the ethics of research involving humans. For many years, conventional wisdom was that researchers should exclude children from participation because the prevalent view as that it was necessary to protect them from the dangers of research. I suggest one might view this as a classic example of paternalism, and a view based on too narrow a definition of “research” in failing to recognize that exposing patients to nonevidenced treatments also imposes major dangers. The British Paediatric Association, the forerunner of the Royal College of Paediatrics and Child Health (RCPCH), first published guidance in relation to research involving children in 1980. They made powerful statements, such as ‘research involving children is important’, ‘should be supported and encouraged’ and ‘research which involves a child and is of no benefit to that child (nontherapeutic research) is not necessarily either unethical or illegal’. To this day, the Declaration of Helsinki makes no specific provision for children, only including a stipulation that special consideration is required for research involving vulnerable populations. Children do require protection, but this should not preclude the claim of other rights, including the right to the highest standard of healthcare, to be informed, express their views, and influence decisions made about them, a topic to which I will return. Most, but not all parts of the world, now accept that researchers should offer children opportunity to participate in studies, and have their care ‘assured by research’.
Neena Modi
Abstract Attitudes to the participation and involvement of infants, children and young people in research have evolved over the years and will undoubtedly continue to change. Today we recognize that they have the right to benefit from research and have their care ‘assured by research’, as well as the right to protection from any dangers from research participation as well as protection against the dangers of receiving non-evidenced treatments. We also recognize that they can be involved in many ways, including prioritising research questions and the outcomes that are measured, helping design studies so that they are acceptable and successful, ensuring information is comprehensible, and participating in disseminating outcomes and discussing emerging issues. Here, I provide a summary of the changes that have occurred. I explain why involvement is important, discuss how to do this, and provide tips and perspectives from children and young people themselves. I provide pointers to other sources of information and advice. Finally, I consider ways in which involvement might evolve in the future.
Keywords children; patient involvement; research; young people
Introduction Many changes have taken place over the centuries in relation to societal perceptions around the involvement of children and young people in research. Here I briefly discuss these changes and the present situation. I provide insights from children and young people, and their top tips for researchers. I finish with a few areas of controversy and uncertainty, and my hopes for the future.
A few historical notes It is said the earliest example of a controlled trial is the story of Daniel and his companions at the court of King Nebuchadnezzar in the fifth century BC. Daniel argued that he and his companions should be allowed to reject the rich diet of meats and wine consumed by the other young men at court, and instead be given a diet of pulses and water. The consequence was that at “the end of ten days their countenances appeared fairer and fatter in flesh than all the children that which did eat the portion of the king’s meat”. Perhaps this provides evidence of the perspicacity of youth!
Why should we involve children and young people in research? Today, there are several reasons why we should involve children and young people in research. The perspectives of society have shifted from a focus centred upon protecting children from the dangers of research to realisation that children are entitled to benefit from research, and to the view that researcher should conduct studies with children and young people, and not solely on them, or for them. The acceptance of children as individuals with rights enshrined in statute as the United Nation Convention of the Rights of the Child was a major paradigm shift, and initiated this change in thinking. The United Nations General Assembly adopted the Convention in 1989 30 years after the Declaration of the Rights of the Child). All UN member states except for the United States have ratified the Convention. The
Neena Modi MB ChB MD FRCP FRCPCH FFPM Professor of Neonatal Medicine and Consultant, Section of Neonatal Medicine, Imperial College London, London, UK. Conflicts of interest: NM was the UK Royal College of Paediatrics and Child Health (RCPCH) Science and Research vice-president from 2009e2014, and president from 20152018. The views expressed are her own.
PAEDIATRICS AND CHILD HEALTH xxx:xxx
1
Ó 2019 Elsevier Ltd. All rights reserved.
Please cite this article as: Modi N, Involving children and young people in research, Paediatrics and Child Health, https://doi.org/10.1016/ j.paed.2019.11.006
SYMPOSIUM: RESEARCH
right to be involved in decisions, including research. Article 23 states that children and young people with disabilities have the right to be involved, including having appropriate communication support at healthcare appointments and opportunities to be involved in research in a meaningful way. Article 24 addresses the right to the best healthcare possible and health services that are take the specific needs of infants, children and young people into account. Article 28 is about the right to education, and services structured to avoid missing school due to medical appointments. Article 31 discusses the right to rest, relax and play, including support for children with complex health needs so that they can take part in social activities that are fun and that they enjoy.
Convention came into force in the UK in 1992. There has been an evolution in the interpretation of the Convention of the Rights of the Child, a process that continues to this day. Today, we recognize that in addition to being a component of upholding their rights, hearing the views of children and young people when designing and delivering studies, and implementing the findings, makes the research more credible, more likely to be effective, and outcomes more likely to be implemented.
How can children and young people contribute to research? Children and young people can contribute in many ways. They can participate and be involved and engaged. They can help identify issues they consider a priority, which may differ from the perspectives of researchers or even their parents. The views of children and young people who suffer from particular diseases can be especially insightful. They can help develop research materials and information sheets, and can advise on whether the proposed research design is likely to be acceptable. Identifying research priorities, commenting on study design, and developing information leaflets are examples of research involvement. Children and young people can also be research participants not just by being recruited to a clinical trial or other research study but also by completing a questionnaire or participating in a focus group as part of a research study, or to help develop a research protocol. Examples of research engagement include taking part in discussions on research, helping disseminate research outcomes, and awareness raising activities using social media. Children, young people and their parents may prioritize uncertainties that need to be resolved through research, and the outcomes they consider important, differently from doctors, nurses and researchers. This is why organisations such as the James Lind Alliance have established “priority setting partnerships” involving these different groups. They can also be involved in developing “core outcome sets”. These outcomes represent the minimum that all those involved in research consider important and recommend measuring in all studies and in the same way. They are also suitable for use in clinical audit and healthcare evaluations. The COMET (Core Outcome Measures in Effectiveness Trials) Initiative brings together people interested in the development and application of these agreed standardized sets of outcomes. Because a core outcome set exists does not mean that researchers cannot or should not measure other outcomes if these are important for a specific study. It just means that researchers will all obtain the core outcomes as well, making it easier for results to be pooled and compared. Check out their websites for more information.
Research &Us In 2015, as Vice-President of the RCPCH, I initiated work to develop an Infant, Children and Young People’s Research Charter under the aegis of the RCPCH. Staff from RCPCH led the development of “Research &Us” with children young people, families, health workers and researchers to provide clear information on how best to involve patients and families. The “What you need to know” resource outlines how we made the Charter, the benefits for children and young people, and an aide memoire on how to use it. There are case studies from researchers, resources to support the voice of children young people and families in research and an exploration of what support health professionals need to be able to engage with and involve them. “Children and young people were clear that they wanted to be given the opportunity to be involved in research design, as a research participant, and to have the chance to help other children and young people. They wanted to be able to hear from and share experiences of child health research with others.
The groups from whom we heard also wanted professionals to speak about research positively and to choose words carefully. They warned against using words with potentially negative interpretations, such as “trial” or “investigate” as both made children and young people think about errors and mistakes. They wanted researchers to make sure they always give them a chance to discuss things with them so that they can ask questions, understand what is proposed, and be involved in making decisions”
Young people’s views on involvement in research In 2018, young people shared their views on what being involved in research meant to them. They identified three areas they considered of top importance and in which they wanted to be involved: i) supporting informed consent: understanding this and being involved in developing materials; ii) involvement in research design, including the question, protocol and project plan; iii) involvement in the research process, methods, delivery and monitoring. They also identified as important, how best to raise awareness of research with children and young people, and how to increase opportunities for children and young people to get involved in
RCPCH &Us RCPCH &Us is a network of children, young people and their families working in partnership with the RCPCH to improve child health. The United Nations Convention on the Rights of the Child underpins this approach. The Convention covers all aspects of a child’s life and sets out their entitlement to civil, political, economic, social and cultural rights. Members of RCPCH &Us have identified five UNCRC articles they feel should be prioritized. These are Articles 12, 23, 24, 28 and 31. Article 12 covers the
PAEDIATRICS AND CHILD HEALTH xxx:xxx
2
Ó 2019 Elsevier Ltd. All rights reserved.
Please cite this article as: Modi N, Involving children and young people in research, Paediatrics and Child Health, https://doi.org/10.1016/ j.paed.2019.11.006
SYMPOSIUM: RESEARCH
research from the start, not just in later stages such as “youthproofing” patient information leaflets or as participants. They talked about the things they felt researchers should have in mind when involving children and young people. We show their top five tips in Box 1. Other young people’s groups have identified additional areas to emphasise. Young people work and communicate differently than adults, and are not always good with email. The best approach is therefore to ask them what method of communication they prefer, and what meeting days and times, and not make assumptions. Parents like to be kept informed so it is a good idea to include them in communications. Write your information sheets in different ways for different age groups and ask children and young people from the relevant age group to review them. Use pictures, colour and short sentences in the information
sheets but beware of being condescending. Over the last 3 years young people and children have demonstrated a keen interest in being involved in research. However, a recurring theme is about being able to offer meaningful opportunities that meet their needs. They want research to be accessible, i.e. they want to understand what researchers are proposing and why so a researcher must use language that is comprehensible and clear. They feel research targeting their participation should be child and youth focused in delivery, i.e. fun and meaningful. They want their input to make a difference they can see and understand. There are now lots of publications providing guidance, frameworks, commentary and tools to support patient and public involvement in research. Having children and young people involved in shaping research has many benefits. We look forward to seeing more of them involved. The National Institute of Health Research established INVOLVE in 1996 to provide guidance and links to a number of resources to support patient and public involvement in National Health Service, public health and social care research. It is one of the few government-funded programmes of this kind in the world. Look up their website for more information.
Top tips C C C C
C
Make it matter! Make it fun and age appropriate No jargon; keep it simple and to the point Have different levels and ways for children and young people to engage and contribute Credit it them for their involvement
The future I started this article by pointing out that society’s attitude to children and young people in research has changed over the years. It is reasonable therefore to assume that attitudes and
Box 1
Top tips, questions and ideas for research consent, design and process Topic
Research consent
Research design
Research process
Top tip
Create truly age appropriate Think about how their involvement information with the help of the can improve study design target audience so that you provide the best possible chance of being understood
Questions for researchers to think about
When you ask both children and adults for consent whose opinion actually counts?
How will you encourage and support Could your child, or a friend or the involvement of children and neighbour aged 7 understand this? young people? Can you reword the jargon? Use an How will you judge whether you have online tool to help you. been successful in involving them? Do you need to change your plans or Can you work with young research your study design to meet the needs ambassadors? of infants, children and young people?
Our ideas to help
Tailor your approach to the age group Create videos, and step-by-step guides Have a checklist of questions and areas that need to be asked about or considered when discussing research participation
Go to them, don’t expect them to come to you Social media, speed networking, youth centres, school assemblies, and hospital wards provide great opportunities to reach your audience; be creative!
Explain clearly to children and young people about exactly what will happen to them and when if they take part
Break the processes down into short sharp chunks Think about different groups for different parts of the process Be honest and open about all the parts in a clear, visual way
Table 1
PAEDIATRICS AND CHILD HEALTH xxx:xxx
3
Ó 2019 Elsevier Ltd. All rights reserved.
Please cite this article as: Modi N, Involving children and young people in research, Paediatrics and Child Health, https://doi.org/10.1016/ j.paed.2019.11.006
SYMPOSIUM: RESEARCH
frameworks for interaction will continue to evolve, so I urge you to keep an open mind. There are also areas of controversy. One such area is that of remuneration for participation in research. Some adults feel this might pose a danger and go against the principle of autonomous decision making, if for example a child or young person was pressurized to join or felt tempted to join because of the remuneration, even though he or she did not really want to participate. However, young people themselves also have divided opinions. Some think remuneration is important; others express an altruistic view, pointing to acts like blood donation, which we consider a gift in the UK. Another issue arises from studies involving long-term follow-up or routine health data. If your parents agreed to your enrolment in a study, or the use of your health data, when you were a baby, or young child, when and how should researchers seek your personal agreement? It is certainly unwise to accept the view that young people lack maturity. For example, recent evidence challenges the notion “older is wiser” showing that millennials are about seven times less likely than the over 65 year old age group to believe and propagate “fake-news”. One interpretation of this observation is that the digital literacy of the young better prepares them to make rational decisions. Research is changing in many ways. Data science, machine learning and artificial intelligence are raising questions that were the realm of science fiction just a few decades ago. I predict that engaging and involving young people may help drive thinking so that societal perspectives are better able to keep pace with technological and scientific advances (See Table 1). A
Royal College of Paediatrics and Child Health Ethics Advisory Committee. Guidelines for the ethical conduct of medical research involving children. Arch Dis Child 2000; 82: 177e82. The James Lind Library, https://www.jameslindlibrary.org/; https:// www.jameslindlibrary.org/. United Nations General Assembly in New York; The Office of the United Nations High Commissioner for Human Rights. Resolution 25, session 44, convention on the rights of the child. November 20 1989, http://www.ohchr.org/EN/ProfessionalInterest/Pages/CRC. aspx (accessed 19 August 2019). University of Oxford, Nuffield Department of Medicine, Teaching children unbiased testing; https://www.ndm.ox.ac.uk/andy-oxmanteaching-children-unbiased-testing; (accessed 19 August 2019). World Medical Association. Declaration of Helsinki, Ethical principles for the conduct of research involving human subjects. http://www. wma.net/en/30publications/10policies/b3/; (accessed 19 August 2019).
Acknowledgement With thanks to Emma Sparrow, Children and Young People manager at the Royal College of Paediatrics and Child Health, and to children, young people and families from RCPCH &Us and the Young Person’s Advisory Group North England for sharing their voices and views in this paper.
Practice points FURTHER READING British Paediatric Association Working Party on Ethics of Research in Children. Guidelines to aid ethical committees considering research involving children. Arch Dis Child 1980; 55: 75e7. Modi N, Clark H, Wolfe I, et al. For the writing group of the Royal College of Paediatrics and child health Commission on child health research. A healthy nation: strengthening child health research in the UK. Lancet 2013; 381: 73e87. Modi N, Vohra J, Preston J, et al. Working Party of the Royal College of Paediatrics and Child Health Guidance on clinical research involving infants, children and young people: an update for researchers and research ethics committees. Arch Dis Child 2014; 99: 887e91. National Institute for Health Research, The young persons’ advisory group; https://www.invo.org.uk/ypag-the-young-personsadvisory-group/; (accessed 19 August 2019). Royal College of Paediatrics and Child Health. Children’s Research Charter: what you need to know. 2016, https://www.rcpch.ac.uk/ sites/default/files/What_you_need_to_know.pdf (accessed 19 August 2019).
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Infants, children and young people have the right to benefit from research and have their care ‘assured by research’ They have the right for protection from any dangers from research participation as well as protection against the dangers of receiving non-evidenced treatments Incorporating the views of children and young people when designing and delivering studies, and implementing findings, makes the research more credible, more likely to be effective, and outcomes more likely to be implemented. There is a lot of information available on how you can involve children and young people in research, audit and other ways to improve healthcare and patient outcomes. Around the world, people differ in their attitudes around involving the perspectives of children and young people in research, but these are also changing everywhere; you might find it interesting to think about the changes over the coming years you feel might be important.
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Please cite this article as: Modi N, Involving children and young people in research, Paediatrics and Child Health, https://doi.org/10.1016/ j.paed.2019.11.006