The UK’s General Medical Council (GMC) has finally, after more than six years and some pressure, updated its Informed Consent Directive for doctors, in line with the Supreme Court Montgomery judgement in 2015. The new guidance will come into effect on November 9th 2020.
The new Informed Consent directive for medical professionals makes it a legal requirement to explain the benefits and risks of any medical procedure in a way that ensures the patient can understand and make a truly informed choice. The medical professional is also required to accept the patient’s decision, even if they believe it will not be in the patient’s best interests. This is a welcome update on behalf of the GMC, and clarifies the legal position for any medical procedure, including vaccines.
However, the World Health Organization (WHO) also has a consent policy that may, in certain situations, supercede that of individual governments.
WHO: Policy on Consent for Childhood Vaccines
Covid19 has put the vaccine agenda on the front burner throughout the world. Globally, $Billions have been poured into more than 140 companies developing a possible vaccine. World leaders, science experts and investors such as Bill Gates, have said that there will be no return to “normal” until a vaccine for COVID19 is found. This brings up crucial legal and moral questions regarding informed consent and individual choice. Children are on the front line of this debate.
As the discussion of a possible vaccine for Covid19 heats up, the question of who will be first to get the vaccine and what government policies will be put in place to enable this, becomes all the more important. All this in the context that, as of October 2020, no vaccine is available, there are no guarantees that a safe and effective vaccine will ever be produced, and it is increasingly looking as though one will not be needed.
In the event one is produced, it is likely that children will receive it, despite the vast majority of children not being susceptible to COVID19, and where a child has expressed symptoms, they have, apart from a tiny percentage of children, been mild cases.
Currently, any child under the age of 18 needs the consent of their legal guardian to undergo a medical procedure, including a vaccine. However, certain exemptions have been made to this, depending on the country and in specific situations, as outlined by the World Health Organization: https://www.who.int/immunization/programmes_systems/policies_strategies/consent_note/en/
The document outlines a series of options:
Consent: Consent is the principle wherein individuals must give their permission before receiving a medical intervention or procedure. According to the laws and regulations in place in most countries, consent is required for a range of medical interventions or procedures, from a simple blood test to organ donation, and including vaccinations. In only very few, well-described circumstances, such as life-threatening emergencies, may consent be waived. Consent derives from the principle of autonomy and forms an important part of medical and public health ethics, as well as international law. For consent to be valid, it must be informed, understood and voluntary, and the person consenting must have the capacity to make the decision.
Convention on the Rights of the Child, General Comment No. 4 (CRC/C/GC/4, 1 July 2003) and No. 15 (CRC/C/GC/15, 17 April 2013).
Assent: Assent refers to the process of children and adolescents’ participation in the decision-making process. Assent is not regulated in law like consent, and is sometimes referred to as a moral obligation, closely linked to good practice in dealing with patients. International law provides strong support for children’s rights to participate in decisions about their health and health care, and also in the planning and provision of health services relevant to them, and based on their evolving capacity.
CRC/C/GC/4, 1 July 2003 states that “adolescents need to have a chance to express their views freely and their views should be given due weight, in accordance with article 12 of the Convention.”
Legal Age of Consent:
In most countries, the legal age of consent tends to coincide with the age of majority. This is 18 years in most countries. It follows, therefore, that a child or adolescent in the age group 6 to 17 years, cannot provide consent to a medical procedure, including vaccination, and so consent is required from their legal guardian. In a growing number of countries, the age of consent for medical interventions is set below the age of majority. This allows adolescents to provide consent for specific interventions, such as access to contraceptives or HIV testing. Some countries have fixed the age of consent specifically to allow HPV vaccination at 12 years.
Opt In or Opt Out:
The document discusses the various forms of consent given. Opt In is where a legal guardian has to give written permission for their child to be given a vaccine. They are opting in. Opt Out is where, unless the legal guardian specifically states in written form, or does not send the child to school on the day the vaccine will be dispensed, they are assumed to have given permission for their child to. These opting in and out options also depend on the laws in the country. If there are any mandatory vaccine requirements to attend school, specific options for opting out are named. For example, in most states in the USA, there used to be religious, philosophical and medical exemptions. Increasingly these exemptions are being removed, making it harder for a parent or guardian to have their child opt out of ANY of the mandatory vaccines being demanded for school attendance.
An implied consent process is when the child’s presence at school is seen as the legal guardian giving consent. In practice, this could mean that if a parent doesn’t know on which day the vaccine is scheduled, a child will be vaccinated simply by being in class. This puts an extra degree of responsibility on the school and other authorities to ensure that all parents are notified ahead of time when the vaccine programme will take place.
As stated in the WHO document: Implied consent procedures are common practice in many countries. However, when children present for vaccination unaccompanied by their parents, it is challenging to determine whether parents indeed provided consent. Therefore, countries are encouraged to adopt procedures that ensure that parents have been informed and agreed to the vaccination. Comprehensive data on whether the approach countries use to deal with consent has changed or evolved over the last decades is not available.
Non-accompanied persons: Older children and adolescents may attend a vaccination session without a parent or legal guardian. This situation arises when vaccination is school-based, but may also occur when adolescents visit a health facility to be vaccinated without their parents. In such situations, obtaining consent from parents before vaccination becomes a challenge, and careful planning is needed to enable them to provide consent prior to the vaccination of their child. This is especially true for school-based vaccination programmes. Countries that use implied consent for childhood vaccination, consider the parent bringing the child for vaccination as an expression of informed consent. To allow parents to express consent, when vaccination of their child takes place in their absence, special procedures need to be put in place. Planning for vaccination must take into account the informed consent process. If written consent (or non-consent) is required for school-based vaccination, sufficient time needs to be allowed for the consent forms to be provided to parents and to be returned to the school prior to the vaccination session.
As an adolescent, the concepts of assent and consent become more nuanced and may require interpretation in the law. As the document states, it may be that the legal guardian wants the child to be vaccinated, but the teenage child doesn’t agree, or it could be vice-versa. The rights of both parents/guardians and the child need to be considered by the health workers.
The document states that evidence shows that a higher vaccine uptake is achieved when the strategy is one of opting out rather than having to opt in. Therefore, in most countries, especially for older children, an opting out approach tends to be the norm. Informed consent is still a central and crucial legal and moral aspect of this process. This is clearly stated and ratified in the Universal Declaration of Human Rights.
Article 6 – Consent
1. Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice.
2. Scientific research should only be carried out with the prior, free, express and informed consent of the person concerned. The information should be adequate, provided in a comprehensible form and should include modalities for withdrawal of consent. Consent may be withdrawn by the person concerned at any time and for any reason without any disadvantage or prejudice. Exceptions to this principle should be made only in accordance with ethical and legal standards adopted by States, consistent with the principles and provisions set out in this Declaration, in particular in Article 27, and international human rights law.
3. In appropriate cases of research carried out on a group of persons or a community, additional agreement of the legal representatives of the group or community concerned may be sought. In no case should a collective community agreement or the consent of a community leader or other authority substitute for an individual’s informed consent.
Article 7 – Persons without the capacity to consent
In accordance with domestic law, special protection is to be given to persons who do not have the capacity to consent:
(a) authorization for research and medical practice should be obtained in accordance with the best interest of the person concerned and in accordance with domestic law. However, the person concerned should be involved to the greatest extent possible in the decision-making process of consent, as well as that of withdrawing consent;
(b) research should only be carried out for his or her direct health benefit, subject to the authorization and the protective conditions prescribed by law, and if there is no research alternative of comparable effectiveness with research participants able to consent. Research which does not have potential direct health benefit should only be undertaken by way of exception, with the utmost restraint, exposing the person only to a minimal risk and minimal burden and, if the research is expected to contribute to the health benefit of other persons in the same category, subject to the conditions prescribed by law and compatible with the protection of the individual’s human rights. Refusal of such persons to take part in research should be respected.
The WHO document clearly outlines the responsibilities and challenges of both informed consent and assent when addressing medical procedures for younger people, especially children between the ages of 6-17. Given that vaccines are a central part of every country’s public health policy, the need to constantly enforce informed consent should be a central consideration of a country’s health strategy. The need for clarity in this regard, and why it is stated so clearly in the Universal Declaration of Human Rights, is that the issue has been terribly abused over decades. Both, adults and children have been used as part of medical experimentation by governments and medical authorities. The most egregious and well known incident in recent history was the Nazi regime during WW2, but there have also been many instances of institutionally backed abuse of people being used for medical research in the US and the UK. The Tuskegee Syphilis study that was finally ended in 1972 went on for 40 years in full knowledge of the US authorities, and is but one tragic example.
Vaccine policy has also demonstrated the willingness to take short cuts with informed consent policies. In a large part of the developing world, parents are unaware they have a choice in the matter. They are simply told their child needs vaccinating and they comply. There is very little monitoring of the effects of vaccine programmes and no opportunity for discussion or recourse, unless there are serious adverse effects that simultaneously involve large groups of children. In Western countries, parents generally take their child to the doctor, and informed consent is achieved by the default of the parent taking the child to the clinic. Doctors in general practice have used the lack of time to justify lack of effort to explain the risks and benefits of any specific vaccine. There is an unspoken, and unquestioned belief that the vaccine programme is a good thing. The contents of the vaccine package inserts are rarely discussed, or even made available to the legal guardians, and complete safety is therefore assumed.
As a result, on a global level, it is estimated that in only 1 out of 100 cases in which adverse effects occur, is there any acknowledgement or monitoring of that adverse effect, or agreement that there might be any association with the vaccine.
b The race for the COVID19 vaccine continues at pace. In the event that one is produced that is deemed to be both safe and effective, it will be distributed in schools. It is imperative that parents and school health authorities are aware of what is happening and that the opportunity for informed consent is given. Parents need to know their right to choose whether or not to have their child vaccinated. Older children who are allowed to choose, need to understand their rights and what truly informed consent means. At what age a child is old enough to make such an important decision needs to be determined. The COVID19 vaccine is being rushed to market, with enormous emotional, practical and financial pressure behind it. On the projected timescale there isn’t time to fully test it, and the population is already being told that life cannot return to normal until the entire planet has been vaccinated. This is a monumental decision even for fully informed adults.
This issues surrounding the COVID19 vaccine have been politicised. Decisions about health that should be the guardian’s domain are being challenged. The BBC children’s series Get Well Soon present vaccines as a fun and necessary thing. In the US public schools a cartoon character has a conversation with Dr Fauci about how children can help persuade their parents about the importance of the COVID19 vaccine. Recently in one school in Manchester, UK, children were being encouraged to tell the school authorities if their own parents were speaking out against having the Covid19 vaccine. On WikiHow children are taught how to lie to their parents if they want a vaccine that the parents are not in favour of them having. The article goes on to encourage the child to report their parents to the authorities.
What should be an open debate where genuine and relevant questions can be asked has now become a no go area. The mere desire for more information leads to a label of “anti-vaxxer”.
The question of parental rights v. child rights and how the state is allowed to intervene in this relationship, is a very important one. It is crucial, in these extreme times, when opinions may be divided on many issues, that children are not put into the terrible position of being asked to betray their own parents. Informed consent must mean truly informed consent. It is a legal mandate.