Consent and Participant Information Guidance

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).

Those who are able to give consent on behalf of children / young people, to take part in a CTIMP, in the UK are:

• Parent or someone with parental responsibility (agreement of only one parent is required).
• Personal legal representative i.e. a person not connected with the conduct of the trial who is suitable to act as the legal representative by virtue of their relationship with the child / young person, and is available and willing to do so.
  A legal representative should only ever be approached if someone with parental responsibility cannot be contacted prior to the proposed inclusion of the child / young person, by reason of the urgent nature of the treatment provided as part of the trial. If a personal legal representative is not available:
• Professional legal representative i.e. a doctor responsible for the medical treatment of the child / young person if they are independent of the study, or a person nominated by the healthcare provider.

You must ensure that parents or legal representatives:

• Understand that you are asking them to give consent on behalf of the child / young person.
• Understand the objectives, risks and inconveniences of the trial and the conditions under which it is to be conducted.
• Have been informed of the right to withdraw the child / young person from the trial at any time.
• Have a contact point where further information about the trial can be obtained.

Children and young people should be involved in the decision-making process whenever possible. You should ensure that they receive information about your trial, which is understandable to them (visit 'Children's / young people's wishes and assent' below).

Young people over 16 are presumed to be capable of giving consent on their own behalf to participate in Clinical Trials of Investigational Medicinal Products (CTIMPs).

Any young person, over 16, who is not capable of giving consent, should only be included in a CTIMP in the UK in line with the adult provisions of the Medicines for Human Use (Clinical Trials) Regulations. For guidance visit 'Principles> Adults lacking capacity (England and Wales)> CTIMPs' or 'Principles> Adults lacking capacity (Northern Ireland)> CTIMPs

There is no statute in England, Wales or Northern Ireland governing a child's right to consent to take part in research other than a Clinical Trial of an Investigational Medicinal Product (CTIMP), i.e. consent for non-CTIMPs.

Consent for treatment

• However common law presumes that young people aged between 16 and 18 are usually competent to give consent to treatment.
• Case law suggests that if a young person has sufficient understanding and intelligence to understand fully what is proposed, and can use and weigh this information in reaching a decision (i.e. they are 'Gillick competent'), he or she can give consent to treatment.
• When a child or young person is not competent, the Children Act and the Children Act (Northern Ireland) Order permits parents (and those with parental responsibility) to consent to medical treatment on their behalf. Consent of only one parent is required.
• When a young person is believed to be competent, consent from those with parental responsibility is not legally necessary. However, the involvement of parents in decision-making is encouraged in most circumstances.

Consent for research

• 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 / 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.

Children and young peoples' competence may well be reflected in their ability or otherwise to understand and assess risk.

Competence to understand will be heavily influenced by how the information is presented to the child or young person, and the language used. You must ensure that you maximise a child / young person's chances of understanding what is involved in your study.

Even when a child or young person is competent, it is still normally good practice to involve the family in the decision-making process: however, if the young person objects, you should respect their privacy.

You should be aware that the voluntariness of a child's or young person's decision making is difficult both to determine and to secure.

Providing information in a format that is understandable to children and young people, and doing so in a manner that fosters true voluntary decision-making, are skills that require specific experience and expertise.

If a child or young person is not deemed to be sufficiently competent to give consent themselves to participate in non-CTIMP research; you are encouraged to inform them to the fullest of their understanding and enable them to participate in an assent process whenever this is appropriate.

Even when a child or young person is deemed not competent to make a decision for themselves, or in situations where they are not legally empowered to do so (e.g. in a Clinical Trial of an Investigational Medicinal Product (CTIMP), it is important that:

• You give the child / young person information about your study, which is understandable to them and which explains what is involved and the potential risks and benefits.
• Staff with experience of working with children / young people should provide this information.
• If the child or young person is capable of assessing the information provided you must consider their explicit wishes. This includes their refusal to take part, or desire to withdraw from the study.
• It is usually inappropriate to ask very young children (e.g. under 5's) to sign an assent form, however their views should be considered.

Whenever practical and appropriate, a child's assent should be sought before including them in your research.

When is it appropriate to seek assent from a child? You have to make an informed judgment to determine when seeking assent is appropriate; the age of a child can only be taken as a guide. We would usually consider it inappropriate to obtain written assent from very young children.

Consider also the child's developmental stage, knowledge of illness and experience of health care.

How are decisions usually made in the family? How much autonomy does the child normally exercise? From observation does the child wish to be involved in the discussions?

What are the parents' views and can they help with this decision? They know the child best.

Although there is a danger that children can be asked to exercise greater autonomy than normal, this must be balanced with the potential loss of trust associated with denying their assent.

Such judgment needs a framework of considerations for analysis, a record of observations and discussions and a documented decision.

In circumstances where seeking assent at the outset is not appropriate, you could provide the child with information as and when required (i.e. 'drip feeding').

Clinical Trials of Investigational Medicinal Products (CTIMPs)
If a young person, aged 16 or over, is deemed not to be competent to give consent to participate in a Clinical Trial of an Investigational Medicinal Product (CTIMP); you must proceed in line with the Medicines for Human Use (Clinical Trials) Regulations. For guidance visit 'Principles> Adults lacking capacity (England and Wales)> CTIMPs' or 'Principles> Adults lacking capacity (Northern Ireland)> CTIMPs

Other intrusive research (non-CTIMPs)
If a young person, aged 16 and over, is deemed not to be competent to give consent themselves to participate in a non-CTIMP; you must proceed in line with the Mental Capacity Act (in England and Wales) or Mental Capacity Act (Northern Ireland). For guidance visit 'Principles> Adults lacking capacity (England and Wales)> non-CTIMPs' or 'Principles> Adults lacking capacity (Northern Ireland)> non-CTIMPs'.