In a world where we are talking more and more about research, it’s everyone’s responsibility to ensure that we conduct ethical research. One way in which we do this is by seeking ethical approval from a Research Ethics Committee (REC). Research Ethics Committees are composed of a variety of individuals with different experiences of research, who are independent of the organisations which are responsible for the management and conduct of the research, as well as funders and individual researchers. They review research applications and give an opinion about whether the research is ethical.

The Health Research Authority (HRA)

The Health Research Authority (HRA) provides approvals and opinions for research studies involving the National Health Service (NHS) and Health and Social Care (HSC), that is being led by researchers based in England.

For most researchers who apply to the HRA, the Research Ethics Committee review forms part of the overall HRA approval process. For some projects that do not require HRA approval, such as research tissue banks and research databases, or research taking place outside the NHS, a review by a Research Ethics Committee itself may still be required.

HRA approval brings together the HRA’s assessment of governance and legal compliance with the independent ethical opinion by a Research Ethics Committee. Before researchers begin their application and submit their project for approval, there are a number of planning and preparation activities that need to be completed.

Healthcare research with children and young people

Healthcare research involving children and young people is essential if we are to increase our understanding of childhood conditions and improve healthcare for those individuals. However, healthcare professionals, researchers and parents or carers often feel uneasy about asking children to take part in research, often because of the potential risks or burdens that may be imposed on children participating in research. In 2015, the Nuffield Council on Bioethics published a report, looking at how children and young people can ethically be involved in research. They also made recommendations about the roles and responsibilities of children, their parents or carers, researchers, and other people involved in the process.

Ethical considerations in research with children and young people needs to occur at all stages of the research process. Ethical considerations should be considered as an ongoing and reflexive part of the research process throughout research projects, and not just as the first hurdle to be overcome. Finding children and young people to participate in research has often been negotiated through parents, carers and families. However, researchers need to consider the ethical issues that arise in relation to access being both granted and denied. If parents or carers give their approval for research to be carried out with their children, researchers need to ascertain whether the children themselves have been consulted about their participation, and if they’re really happy to take part. Likewise, if children and young people want to take part in research, but parents or carers do not wish for their child to participate, then the situation must be handled carefully, respecting and honouring the voice of the young person and their family.

On Wednesday 8th November 2017, I joined Jen Preston and Sammy Ainsworth from Alder Hey’s Clinical Research Facility for a training course at the Manchester HRA office. Jen and I delivered a session to attendees about ensuring research really does involve young people. Attendees were mostly members of Research Ethics Committees from the North West and Greater Manchester area. The course was facilitated by Hugh Davies, a Paediatrician and Chair of the Oxford A Research Ethics Committee, and Bob Phillips, an Honorary Consultant in Paediatric Oncology and NIHR Fellow at the University of York.

There was a significant emphasis on ensuring that children and young people are involved in research in a meaningful and collaborative manner, not for the sake of involvement because it’s ‘what everyone else says we should be doing’. In our session, Jen and I focused heavily on the work of GenerationR, the national Young Persons’ Advisory Group network in the United Kingdom (UK), made up of five local groups across the UK (Birmingham, Bristol, Liverpool, London and Nottingham). The groups are funded by the National Institute for Health Research (NIHR) and/or other NHS organisations, through various different channels.

In essence, GenerationR support the design and delivery of paediatric research in the UK. Young people involved in GenerationR are aged anywhere between 8 and 24, and have a variety of experiences – including acute and chronic conditions. There’s also a mix of young people who just have a general interest in healthcare. During regular meetings throughout the year, young people have the opportunity to learn about health and clinical research, support and work in partnership with researchers in the delivery of healthcare research, and provide input and collaborate with organisations such as the European Medicines Agency (EMA) and the HRA, to promote young people’s involvement in research.

How do young people help researchers to make their research better?

There’s a long list of ways in which young people can help researchers to improve the quality of research. Young people working with GenerationR have said that GenerationR enables them to:

  • Talk to researchers about research in language that young people understand – this helps researchers to think about their work differently;
  • Advise researchers on whether their study sounds good for young people, informing researchers about what is really important to young people;
  • Help researchers with developing the participant information sheets they produce to explain their project to young people and their families;
  • Reassure researchers that it is a good project and that they should not be afraid to ask young people and families to take part; and
  • Demystify research so it doesn’t seem scary!

What’s important to young people when it comes to their involvement in research?

Young people feel that it’s important for those who participate in research to receive the results of the project once it has been analysed and published. The results should also be described and explained in a way that young people and families can understand. In addition, young people also like to hear feedback from researchers, particularly around how their work has influenced the direction of the research, and ultimately, the results that will inform future work and practice. They also feel that getting involved in research enables them to be better educated about things that may impact them in the future, as well as satisfying them with the knowledge that they are actively helping future generations.

Participant information sheets

One of the activities that young people are often involved with is the co-design and review of participant information sheets (sometimes called patient/parent information leaflets). Over the years, I’ve seen the full spectrum of information sheets – ranging from the fabulous, easy-to-understand ones, to those that are in excess of 45 pages of text – often with distorted clipart graphics inserted to supposedly make them ‘child friendly’. No, no, no! Just because written participant information sheets have been the ‘norm’, doesn’t mean that’s how it should be. This is where involving young people in their design is so, so important. When it comes to participant information sheets, I strongly believe that the visual appearance of the documents is just as important as the content. In the documents, build an easily understandable research story, which takes individuals on a journey through the research project, but keeps the writing to a minimum. If you do need to write additional information, you could provide a summary sheet with further links for people to look at. You should also avoid using jargon full stop, and never use a long word when a short one will do! There are also others ways of informing young people and families about your research project, using creative methods of information delivery, such as animations, videos and interactive modules.

One example of how researchers are evaluating innovative participant information sheets is through the NIHR-funded study called TRECA (Trials engagement in children and adolescents). TRECA acknowledges that printed information sheets which are currently used in most research studies have been widely criticised for being too long, technical and lacking in visual appeal. Multimedia information (MMI) resources involving text, audio, video and animations have the potential to better inform children, adolescents and their parents about research trials, potentially leading to their increased engagement in research. The TRECA study has developed a series of MMIs which are currently being investigated in existing research studies, to see whether they are better than existing participant information sheets. Watch this space for some interesting findings, as I suspect that the future of information sheets will change drastically as a result of TRECA!

During the workshop, we provided an example of a participant information sheet to attendees, asking them to review it against a simple checklist that young people use when they conduct reviews of participant information sheets themselves:

  • Does the participant information sheet tell you what the study is about? What will happen during the study? (Yes or No)
  • Does the participant information sheet tell you why the study is being done? (Yes or No)
  • Does the participant information sheet tell you where the study will take place?  (Yes or No)
  • Does the participant information sheet tell you when the study will begin and possibly finish? (Yes or No)
  • Does the participant information sheet tell you who will lead the study, and who else is involved? (Yes or No)
  • Is the information clear?
  • Is the information presented well? For example, is it colourful, and does it have pictures that mean something?
  • Does the information leaflet have too many scientific or complicated words that young people won’t understand?
  • Do you have any major concerns or worries about the study?
  • Do you have any other comments about the study or the participant information sheet?

The following checklist encapsulates six qualities that should underpin any research project:

  1. Research question: Is the research question fit for purpose, and suitable for the issue at hand?
  2. Purpose: Is there a clear purpose for this proposed research, backed up by previous research?
  3. Methodology: Is the methodology appropriate for the research question, and will the specific methods described enable the researcher to answer the research question(s)?
  4. Validity: Based on the proposal, will the results you obtain from your research be the best available approximation of the issue at hand?
  5. Meaningful: Will the results from the proposed research address a current and pertinent issue that is relevant to society?
  6. Publishable: Will the research results be published, both in academic settings, and in other forms that are accessible to patients, their families, and other members of society?

Informed consent and assent

Informed consent forms an important discussion point for any individual participating in research. With children and young people, it is particularly important to distinguish between consent for healthcare research and for consent to medical treatment (including clinical research trials involving investigational medicines). The Medicines for Human Use (Clinical Trials) Regulations prohibit children under the age of 16 from giving consent to take part in a Clinical Trial of an Investigational Medicinal Product (CTIMP). Young people over 16 years old are presumed to be capable of giving consent on their own behalf to participate in Clinical Trials of Investigational Medicinal Products (CTIMPs). However, there is no statute in England, Wales or Northern Ireland governing a child’s or young person’s right to consent to take part in research other than a Clinical Trial of an Investigational Medicinal Product (CTIMP). In the absence of law relating specifically to research, it is commonly assumed that the principle of ‘Gillick competence‘ can be applied not only to consent for treatment, but also to consent for research.

A child or young person’s right to give consent is dependent upon their capacity to understand the specific circumstances and details of the research being proposed, which in turn will relate to the complexity of the research itself, and how well it is explained to them. Conceptual issues, for example relating to children’s human rights and to their agency as competent research participants, sit alongside legal requirements, including frameworks such as the Fraser Guidelines, based on the Gillick Ruling, which are not intended for, but which tend to be applied to, research. At the moment, we tend to see children and young people up to the age of 16 providing their assent to participate in research, in addition to obtaining consent from legal parents or guardians.

Guidance often mentions children’s assent. However, in my opinion, it is not a useful concept for several reasons, and is often confusing for both participants and researchers:

  • Assent refers to the agreement of those who have no legal right to consent. However the Gillick Ruling does not specifically exclude any child as too young to be Gillick competent. Children, therefore, who can make informed Gillick competent decisions are giving consent, rather than assent.
  • Assent refers to an agreement by children who understand some, but not all the main points required for consent. However, this raises the question of whether a partly informed decision can count as a decision at all.
  • Assent can be taken to mean ’at least not refusing’. However, that is very different from actually assenting, or positively agreeing to participate in research. Children may be too afraid, confused, or ignored to refuse to participate. So the term assent may be misused to cover children’s refusal, which really should not be happening.

A checklist for you to follow when applying for ethical approval

Hugh Davies has an incredible amount of experience, and has kindly shared guidance on his website called ‘Reviewing Research‘. In this guidance, Hugh shares a checklist which researchers should use when applying for ethical approval:

  • Is the purpose of the project defined by a clear research question, built on what is known already?
  • Will the method described provide meaningful and valid answers to the research question?
  • Will there be a fair and open access to the design of the project and the results that will be obtained?
  • Will all the research team have appropriate experience, training, probity and accountability to carry out their tasks?
  • Is there appropriate patient and public involvement in the project from its inception?
  • Is there a realistic and fair balance of benefits and harms for all parties with an interest in the project?
  • Is there valid consent in the project – a fair choice with comprehensible and adequate information?
  • Does access to, and handling of personal information meet current standards?
  • Is payment and recompense fair?
  • When relevant, are there fair post-trial arrangements?

Written by simonrstones

Simon Stones BSc (Hons) is an award-winning patient leader, advocate and researcher from Manchester in the UK, who was the winner of the international WEGO Health Award for Patient Healthcare Collaborator in 2017. He is a passionate advocate and ambassador for people living with invisible illnesses, inspired and empowered by his own journey with arthritis, fibromyalgia, and inflammatory bowel disease since childhood. He is currently an Associate Fellow of the Royal Commonwealth Society, and a trustee of Fibromyalgia Action UK and RAiISE.

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