YOUNG PEOPLE & CONSENT

Much of what we explored in our last article – Consent to Treatment – focused on adults and how they can give or withhold informed consent regarding medical treatment. But what about young people and children when it comes to medical procedures?

Here the situation can be more complicated – in terms of determining if the young person or child has the capacity to consent; the situations in which they might be asked to do so and when parental consent is and isn’t needed.

This is something that parents need to familiarise themselves with, particularly in light of media reports of government proposals to extend the COVID-19 vaccination programme to schoolchildren as soon as possible. 

In this article we explore the concept of Consent to Treatment as it applies to Young People (16 & 17 year olds) and in our next article we look at Children and Consent.

YOUNG PEOPLE (16 AND 17 YEAR OLDS)

At the time of writing, the COVID-19 vaccines are only authorised for temporary emergency use and the vaccine rollout has focused on older members of the population first. But with younger people being “called for their jab” every day, parents should be aware that the temporary emergency use is for “anyone over 16”. Equally, parents need to understand how 16 and 17 year olds are treated when it comes to giving consent. The NHS website tells us that:

“People aged 16 or over are entitled to consent to their own treatment. This can only be overruled in exceptional circumstances. Like adults, young people (aged 16 or 17) are presumed to have sufficient capacity to decide on their own medical treatment, unless there’s significant evidence to suggest otherwise.”

This can be very helpful if, for instance, your sixteen year old breaks an arm at football practice and needs to give consent for it to be treated before you are able to reach the hospital.

However, it is a different matter if that same sixteen year old is told by their teacher to join a line of classmates to receive a COVID-19 vaccination. Here a lot more factors come into play:

  • did the school notify you as parent that the vaccination was going to be administered?
  • did your child pass on that notification if it had been given to them to hand to you?
  • did you have the opportunity to discuss this with your child?
  • what information did the school give to your child prior to the vaccination e.g. lessons, homework, age-appropriate patient information?
  • what relationship does your child have with their teacher and what is the culture of discipline and authority in the school?
  • what is the group dynamic with your child’s classmates like?
  • how mature is your child compared to others of their age?

The NHS and the school may deem your child to have capacity to consent but can you be sure that the other criteria for consent to treatment were met? Was the consent given voluntarily (without the mistaken assumption that it was compulsory due to be told by the teacher and without peer pressure from classmates)? Was it informed (having been given complete information in order for your child to be able to personally assess the risks and benefits for their own health rather than consenting because they had been led to believe it was necessary for the good of others for instance)?

While the NHS website provides the public with a basic outline of consent to treatment for young people, the guidance that health practitioners receive from the Department of Health provides us with more details that could be of use:

By virtue of section 8 of the Family Law Reform Act 1969, people aged 16 or 17 are presumed to be capable of consenting to their own medical treatment, and any ancillary procedures involved in that treatment, such as an anaesthetic. As for adults, consent will be valid only if it is given voluntarily by an appropriately informed young person capable of consenting to the particular intervention. However, unlike adults, the refusal of a competent person aged 16–17 may in certain circumstances be overridden by either a person with parental responsibility or a court.

Section 8 of the Family Law Reform Act 1969 applies only to the young person’s own treatment. It does not apply to an intervention that is not potentially of direct health benefit to the young person, such as blood donation or non-therapeutic research on the causes of a disorder. However, a young person may be able to consent to such an intervention under the standard of Gillick competence.

In order to establish whether a young person aged 16 or 17 has the requisite capacity to consent to the proposed intervention, the same criteria as for adults should be used. If a young person lacks capacity to consent because of an impairment of, or a disturbance in the functioning of, the mind or brain then the Mental Capacity Act 2005 will apply in the same way as it does to those who are 18
and over (see chapter 2). If however they are unable to make the decision for some other reason, for example because they are overwhelmed by the implications of the decision, then the Act will not apply to them and the legality of any treatment should be assessed under common law principles. It may be unclear whether a young person lacks capacity within the meaning of the Act. In those circumstances, it would be prudent to seek a declaration from the court. More information on how the Act applies to young people is given in chapter 12 of the Mental Capacity Act (2005) Code of
Practice.

If the 16/17-year-old is capable of giving valid consent then it is not legally necessary to obtain consent from a person with parental responsibility for the young person in addition to the consent of the young person. It is, however, good practice to involve the young person’s family in the decision-making process – unless the young person specifically wishes to exclude them – if the young person consents to their information being shared.

The first thing to note from this guidance is that consent must be voluntary and informed – just as for adult consent to treatment

A key question to consider, regarding how voluntary and informed the consent is, is whether any information provided at school through lessons, special presentations etc. is truly impartial and informative to assist the young person in weighing the choice or whether it is biased and intended to coerce them into consenting to having one of the, still in trials, COVID-19 vaccines. Parents may wish to take a keener interest in the study materials and homework that is being given to their children around the virus and treatments.

A second important point regarding a young person’s ability to give consent is that it only applies to their own treatment i.e. something that is of direct benefit to their own health. If a treatment is not of benefit to them, then they cannot give consent without first being individually assessed for what is known as Gillick Competence – a concept we explore in depth in our following article – Children and Consent.

Given that only a tiny handful of 16 and 17 year olds have died within 28 days of a positive RT-PCR test for the virus that causes COVID-19 (which is not the same as having died of COVID-19), it is reasonable to ask the question “does having a COVID-19 vaccine have a direct benefit on my child’s health?”  If the risk of death was statistically zero before, then how can a vaccine be of benefit?

The government, NHS, vaccine manufacturers and school may suggest that a reduction in symptoms is the benefit. But in order to determine that we need to understand how many young people were hospitalised or had severe symptoms and what is the probability of the young person actually becoming ill from COVID-19 in the first place (as opposed to just testing positive for the virus).

As you can see, these are detailed questions that need research in order to be answered accurately. Will young people get the opportunity to ask them, either in the classroom or on vaccination day? Will teachers and healthcare workers arranging the vaccination day have taken these questions into account and arranged for each young person to be assessed for Gillick Competence before being asked to consent? Can Gillick Competence even be applied in this scenario – where it is not the young person but the school, NHS or government that is initiating the treatment conversation?

The third nugget of information in the above extract is that children may not have capacity if they are “overwhelmed by the implications of the decision”. The mental health of many young people has been affected over the last year or so due to lockdowns, social distancing and the constant bombardment of news stories regarding the pandemic. “Don’t kill Granny” and other such messages have left young people confused about whether they are a danger to other people or not. Can a young person really be relied upon to make an informed decision in their best interests under those circumstances?

Or should parental consent be required in the exceptional circumstances that we find ourselves in? Just as the media would have you believe there are “anti-vaxxers” who are against the treatments simply because they are vaccines, there are just as many “vaccine zealots” who believe that vaccination of the entire population (even those at no risk from the disease) is the only way back to normality. 

We believe the truth (as always) lies somewhere in the middle and that young people stand a better chance of making a voluntary and informed decision if they have been able to do their own research and ask questions without peer or authority pressure. 

Essential Context for Understanding this report

These reports contain a complete listing of all suspected adverse reactions that have been reported to the MHRA via the Yellow Card scheme for COVID-19 vaccines. This includes all reports received from healthcare professionals, members of the public, and pharmaceutical companies.

This information does not represent an overview of the potential side effects associated with the vaccines. A list of the recognised adverse effects of the COVID-19 vaccines is provided in the information for healthcare professionals and the recipient information here. Conclusions on the safety and risks of the vaccines cannot be made on the data shown in the report alone. When viewing the report, you should remember that:

  • Reporters are asked to submit Yellow Card reports even if they only have a suspicion that the vaccine may have caused the adverse reaction. The existence of an adverse reaction report does not necessarily mean that the vaccine has caused the reaction.

  • It may be difficult to tell the difference between something that has occurred naturally and an adverse reaction. Sometimes reactions can be part of the condition being treated rather than being caused by the vaccine.

  • Many factors have to be considered when assessing whether a vaccine has caused a reported adverse reaction. When monitoring the safety of medicines and vaccines, MHRA staff carry out careful analysis of these factors.

  • It is not possible to compare the safety of different vaccines by comparing the numbers presented in the vaccine reports. Reporting rates can be influenced by many factors including the seriousness of the adverse reactions, their ease of recognition and the extent of use of a particular vaccine. Reporting can also be stimulated by promotion and publicity about a product.

For a vaccine to be considered safe, the expected benefits will be greater than the risk of having harmful reactions. It is important to note that most people receive vaccinations without having any serious side effects.

Risks and benefits of medicines

For a medicine to be considered safe, the expected benefits of the medicine will be greater than the risk of suffering harmful reactions. It is important to note that most people take medicines without suffering any serious side effects.

All medicines can cause reactions. The patient information leaflet accompanying the medicine, or available from your pharmacist, lists the known side effects associated with the medicine. Healthcare professionals such as doctors and pharmacists can also provide this information. Information on side effects of medicines can be found on the NHS website.

Monitoring the safety of medicines and vaccines

Information collected through the Yellow Card scheme is an important tool in helping the MHRA and CHM monitor the safety of medicines. Yellow Card reports of suspected adverse reactions are evaluated, together with additional sources of evidence such as worldwide literature, in order to identify previously unidentified hazards or side effects.

If a new side effect is identified, information is carefully considered in context of the overall side effect profile for the medicine or vaccine, and how it compares with other medicines used to treat the same condition.

The MHRA will take action, if necessary, to ensure that the product is used in a way that minimises risk, while maximising patient benefit. Such changes may include, for example, restricting the indication, or special warnings and precautions. Rarely, a drug may need to be withdrawn from the market if the risk of side effects is considered to outweigh the benefits of treatment. Please see our How we monitor the safety of medicines section for further information.

Use of Yellow Card data for publication

If you wish to copy or circulate the information contained within a report to anyone else, please ensure that a copy of these guidelines is also provided.

The MHRA and CHM encourage the use of data from the Yellow Card scheme in research and for publication, but wish to ensure that the limitations of interpretation of the data are made clear.

If you propose to publish information based on Yellow Card data, the MHRA is most willing to provide advice on how the Yellow Card information might be best used and presented. The MHRA is also willing to provide feedback on manuscripts prior to publication. Please write to the Deputy Director, Safety and Surveillance Group by email.