22/04/2021 - Ensuring consent to legal parenthood is properly taken

In 2014 and 2015, all centres were asked to complete an audit of consent to legal parenthood as we had concerns that there may be errors or anomalies in some of these documents. Unfortunately, these concerns were well founded and several cases had to be resolved in the family court in order for couples to obtain a declaration of legal parenthood. Further guidance was given to all centres in February 2017 to clarify the requirements for taking consent to legal parenthood.

However, we continue to identify errors and anomalies in consent to legal parenthood across the sector. The sorts of issues we find include lack of or missing legal parenthood consent forms, using incorrect forms, and not identifying errors that could raise doubt over the validity of the consent. As a result, a few new cases have been referred to the family court. Where we continue to identify errors or anomalies in consent to legal parenthood, we are treating these very seriously and implementing proportionate regulatory action.

One of the underlying reasons for this is inadequate awareness or training of staff in this area of practice, either because they are new to the sector or have not kept up to date with recent changes, The HFEA’s Person Responsible Entry Programme (PREP) has a section on consent to legal parenthood that centres may find useful as a staff training tool or refresher.   

It is also apparent that some centres have not continued to audit this area of practice, or audits that are undertaken are not robust, as sometimes errors or anomalies noted by inspectors have been in records previously audited by the centre. It is imperative that audits of this area of practice are robust and we have the following guidance on the minimum scope and methodology we expect to see in such audits.

Auditors

Staff undertaking the audit should be properly trained, competent, and fully understand the requirements of this area of practice.

Audit Scope

The audit should include all patients who have received treatment using donor sperm, embryos created with donor sperm, or surrogacy. If all records are not included in your audit you should have a robust rationale as to why you have only audited a sample of them.

Ensure that your data extract is complete and includes frozen embryo transfers, cases where ‘donor back-up’ was planned or carried out, or where ‘split insemination’ (i.e., using partner sperm and donor sperm in the same cycle) was carried out. Using different methods to extract data can help in cross checking that the data set is complete for example, laboratory spreadsheet, clinic diary, EDI data submission.

You should audit all relevant treatments carried out since the last complete audit of records. If errors are identified in records that are audited, then a further audit should be carried out to review all records as far back as is necessary to provide assurance that no further errors or anomalies remain.

Audits should also include consent to legal parenthood obtained using electronic consenting platforms. It is expected that these platforms have been robustly validated before use.

Audit methodology

Marital status

Document what evidence has been used to establish the marital/relationship status of patients that are being treated together, or that has been used to confirm that a patient is single.

Terms such as wife/husband/partner used by patients should not be the only basis on which marriage or civil partnership status is determined. Furthermore, centres should have evidence to confirm that they have checked that patients are legally single (i.e., they are not still married to, or in a civil partnership, with another person), or that they are not married or in a civil partnership with a person other than the person they are being treated with.    

Audit requirements

If the couple are not married or not in a civil partnership record the following.

If the couple are married or in a civil partnership (and are creating embryos) record the following:

For surrogacy cases record the following:

Audit findings

Where there are any omissions, errors, or anomalies in the consent to legal parenthood forms you should ensure that this is raised immediately with the Person Responsible, that appropriate legal advice is sought, and that actions are taken to support the couples in accordance with HFEA guidance. Any anomalies should be reported to the HFEA through the incident reporting system.

Publication date: 9 April 2026