The government announced this week that 12 to 15-year-olds will be offered a single dose of vaccine against COVID-19. The recommendation is based on data from clinical trials, and long before it was made there were children and young people rolling up their sleeves to have the vaccine administered. These young people were part of important studies to test the vaccine and their contribution paved the way for this week’s announcement.
Whether or not to allow children to take part in health and social care research, including vaccine research, is something that has to be scrutinised by the Health Research Authority’s Research Ethics Committees (RECs).
Here Dr Bob Phillips, a member of our Leeds East REC and a researcher based at the University of York, blogs about the ethics of allowing children to take part in health and social care research in general, including to test the COVID-19 vaccine.
‘There’s often a nervousness around involving children in research – and that’s sort of understandable because we have a role to look after children. However, we need to flip that around and think what would happen if we didn’t do research involving children? Where are the clinicians left if we don’t do research involving children? Where are the patients left if we don’t? If we don’t do research, then children will either not get care, or they’ll get stuff that’s based on guess work – that’s the alternative! It isn’t just that if we don’t do the research the disease will go away. So, it’s with these thoughts in mind that a REC will need to approach any study they are asked to review that involves children. To help with the decision, ethics committees which look at research involving children always have a specialist in child health as one of their members.
As a consultant in paediatric oncology and a REC member, I firmly believe that research involving young people and children is to be welcomed. But first there are a number of checks that a REC will need to make first to check that this is high quality and necessary research. Firstly, the research needs to be asking a meaningful question, leading to meaningful outcomes with a method likely to give the answer. In order to get to that question, the researchers need to involve patients in the design of the study – so a REC will be looking for good evidence of all these points.
What is different about children’s research versus research in adults?
One of the main differences about involving children in research is that adults are able to understand and make a measured assessment about whether or not they want to take part in research. The younger a person is, the less and less this person is able to make a decision about their inclusion in research. So it is really obvious that a two-year-old or a baby won’t be able to make a decision about whether they want to take part in research but this becomes less obvious when you are dealing with a 10 year old, or a 14 year old or a 15 year old. People aged 16 years upwards should usually be deciding for themselves, supported by their family.
We as REC members look at how researchers plan to communicate about their research to participants, not just what they put in their Participant Information Sheet, but how they plan to do this. It would be a very simplistic view to think all children will progress in blocks corresponding to their age. We generally recommend that researchers might begin with a cartoon for primary school children to help explain the research so they can decide if they want to be involved. Then we’d suggest something aimed at middle school and high school children rather than tight age bands. We’d want researchers to be aware about the children’s intellectual development.
Clinical trials and the law
For clinical trials of an investigational medical product (CTIMPs), like vaccine trials, the law will say that the parent has to consent if the child is under 16. If the parent of a 12-16 decides that a child should do the study but a child doesn’t want to do research then I as a researcher wouldn’t put that child onto that study if it was a meaningful ‘I don’t want to take part’ from the child. If it was something like ‘I don’t like needles’ then it might involve exploring if there was anything we could do to give them a fair chance to take part - not persuading them but looking at their reasoning. If they were still very adamant that they really, really didn’t like to have injections we’d not add them to the study and these conversations would need to take place before the child arrived for the study.
Vaccines trials in healthy volunteer children
Ethically a study involving COVID-19 in healthy volunteer children would apply the same rules as we did for vaccines for meningitis B, new meningococcal vaccines or the malaria vaccines which are being developed. There has to be a very sound scientific study that will give us an answer that makes a meaningful difference to public health. The balance is that if we don’t do the study, we end up either just using the vaccine without it being studied and that means that we don’t know actually really how effective it is and we haven’t got a really good way of capturing any side effects or adverse effects that come out of it. It might also mean we end up with an inequity because they’ll be some places where clinicians carry out more vaccines than others on the basis of their beliefs, if there’s no evidence from research out there. So on the whole not doing the research is a greater risk than doing research.
RECs have a tough job to do but they play a very important role in weighing up the risks and the advantages and making sure any research involving children is of the highest quality.
The vast majority of children and their families want to take part in research
My experience shows the vast majority of the time children and young people and families want to be involved with good quality research that is going to improve care for others with their condition. It might not benefit themselves, but it will certainly do something for others coming forward. Without research we wouldn’t be at the 85% of children living five years after a childhood cancer diagnosis we’d still be at the 20% or so that it was in the 1970s. Without research we can’t improve health care and make progress. I salute the children and young people and their families who have taken part in health and social care research over the years whether it be for cancer, COVID-19, mental health or autism. And I’m proud to play a role in supporting that research along with my fellow research ethics committee members. Ultimately we need research as it might actually make a difference to our lives.'