Legal update: Informed consent - are you informed?

It is a licence condition for all UK fertility clinics that treatment using embryos or donated gametes shall not be provided unless the woman being treated, and any man or woman being treated with her, have been given a suitable opportunity to receive proper counselling and have been provided with relevant information (1).

What do these requirements mean, and what happens when they are not fulfilled?

The recent decision in the High Court in the case of Re E & F (Assisted Reproduction: Parent) has brought these questions into focus for clinics and fertility services in relation to the issue of parentage (2). Inevitably not all couples being provided with fertility services will remain in a relationship after treatment. In some situations, they may not be in a relationship at all — for example where there is a surrogacy arrangement in place.

Where children have been born as a result of fertility treatment, parentage may subsequently be disputed, particularly where there has been a breakdown in adult relationships or communication. In those circumstances it will be crucial to understand the precise legal framework of the treatment undertaken. Sometimes treating clinics will be expected to participate in the legal proceedings.

Why is it important to provide sufficient information about parentage to all people undergoing treatment with donated embryos or gametes?

The status of legal parenthood has particular importance for children born following fertility treatment where there may be no biological link. It determines who can be named on the birth certificate as a parent. A legal parent of a child is obliged to maintain the child financially; social or psychological parents are not (3). Legal parenthood may determine whether a person has or can acquire parental responsibility for a child, and on what terms (4). It also affects the child's relationships with extended family. Disputes about parentage can therefore have wide ranging implications for the children concerned.

When things go wrong

In circumstances where clinics have not complied with the licence conditions regarding counselling, or the provision of appropriate information, the validity of patient consent to the treatment concerned, or the lawfulness of the treatment itself, is affected. This, in turn, has an impact upon legal parentage. In particular, the agreed fatherhood conditions and agreed female parenthood conditions will only apply where the treatment is properly carried out under its licence (5).

In the case of E & F, the court concluded that the clinic did not comply with its licence conditions to provide sufficient information, or a proper opportunity to receive counselling, to both parties, and kept inadequate records, and therefore the treatment provided was not offered under the strict terms of that licence.

When must counselling be offered?

In practice, many clinics require patients using donated gametes to have received counselling before undergoing treatment. Therefore this usually takes place prior to consent being taken. However, the requirement to provide a suitable opportunity to receive proper counselling is not only relevant at the beginning of the process. The counselling must be specific to the treatment, and must also be offered in specific circumstances. The original counselling which the woman being treated was offered at the outset of the process is not sufficient to comply with its licence conditions if the nature of the treatment subsequently changes, for example, to include an agreed father or agreed second female parent. The obligation on a clinic to offer counselling and record each patient's response is just as onerous at this stage of the process as at the outset.

What information must be offered and when?

In some clinics counselling is combined with the giving of information, in other cases information may be provided separately by nurses or other clinicians. The Human Fertilisation and Embryology Authority's 8th Code of Practice, which provides clinics with guidance on how to meet their legal requirements, states in particular that clinics should provide information to people seeking treatment about legal parenthood, and clinics should explain that there is a difference in law between the legal status of 'father' or 'parent' and having 'parental responsibility' for a child.

The level of information that clinics are expected to provide requires a degree of understanding about the difference between parentage and parental responsibility. Parental responsibility and how it differs from parentage is not always a simple concept to grasp. These requirements raise questions about whether clinical staff involved in the provision of the mandatory information have sufficient understanding of the legal concepts involved to be able to provide that information clearly to patients for the purposes of giving informed consent.

The Code of Practice also states that clinics should normally offer counselling after the individual or couple has received information about the services to be provided and before they consent to treatment. If the possibility of treatment with donated gametes or embryos arises, it says clinics should offer separate counselling about the implications of treatment with donated material. The provision of counselling should be clearly distinguished from the provision of information.

Recording requirements

Keeping clear written records is an important part of licence conditions and the Code of Practice guidance. This can be difficult to comply with in day-to-day clinical practice, but without clear recordings of what information has been given and by whom, and when offers of counselling have been made, the certainty which children need about their legal parentage may be in jeopardy through lack of clarity about what has taken place.

For the future

The Human Fertilisation and Embryology Act 2008 is still relatively new, and cases concerning interpretation of its provisions are still reaching the courts. Clinics can assist patients to avoid uncertainty and litigation by taking this opportunity to review their practices in relation to the provision and recording of information, in particular to ensure there are robust systems in place that are consistent with the statutory requirements and HFEA's Code of Practice.

Marisa Allman is a barrister at Zenith Chambers and specialises in financial and private law children matters.