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31 May 2012

Dear Colleague,

Changes to CD consent form and some Register forms

On 1 August 2012 we will be updating the HFEA CD consent form and a small number of the HFEA Register forms. Each update and its rationale is set out below. Clinics can view the updated forms and some guidance documents in advance of their implementation on our website and the links to these are also below.

We recognise that with each update to an HFEA form there are consequent costs to clinics. In order to minimise these costs, we have delayed some necessary changes until now and have also taken this opportunity to incorporate other changes requested by clinics. Through this system we commit to a maximum of one change to HFEA consent forms and Register forms each year.

Consent to the disclosure of information for researchers

Clinics will be familiar with collecting consent to the disclosure of information for researchers from patients. The requirement to obtain consent is now being extended to include patients receiving donor treatment and donors.

These groups were excluded previously because of concerns about whether the disclosure of their identifying information was permitted by law. The Authority’s decision to extend the consent regime was taken following the receipt of legal advice on the interpretation of ‘identifying donor information’ in section 33A2(h) of the Human Fertilisation and Embryology Act 1990 (as amended).

The Authority’s decision will allow research to take place that requires identifying information from all patients and donors.

The HFEA Consent to Disclosure of Information (CD) forms have been updated by removing the instructions for patients receiving donor treatment and donors not to complete questions about disclosure of information to researchers. We have also taken the opportunity to improve the clarity of some consent questions based on feedback from clinic staff. The document providing guidance on these consent forms has also been updated to reflect the change.

Transitional arrangements

Patients receiving donor treatment and donors who register (or re-register) from the 1 August 2012 will complete the updated CD form as part of their registration. Consent given on the CD form should be reported by clinics to the HFEA via the donor information form and patient and partner registration forms.

If a patient receiving donor treatment or a donor who registered before 1 August 2012 approaches a clinic wishing to consent to disclosure of their information to researchers, clinics can collect this on the CD form and report it to the HFEA using the Consent Variation form, which has been updated to allow for this. Clinics do not need to re-register donors or patients solely for the purpose of reporting this consent to the HFEA.

The identifying information of patients receiving donor treatment and donors will not be disclosed for research purposes unless they consent to this on the CD form.

Ethnicity information

We are updating and simplifying the ethnicity codes used by clinics to complete the donor information form and patient and partner registration forms. From 1 August 2012 the codes available to clinics will be the Office of National Statistics’ 17 high-level codes.

This will mean a reduction in the number of codes available to clinics. If a donor wishes to give further information about their ethnicity, we suggest clinics encourage donors to record this additional information in the donor’s Pen portrait/ Personal description.

The donor information form

The donor information form is currently used to collect information about the screening tests a donor undergoes. The existing list is a mixture of mandatory (as required in standard licence condition T52) and non-mandatory tests. From 1 August 2012 we will only ask clinics to report non-mandatory screening tests a donor undergoes. The Inspectorate will continue to monitor compliance with licence condition T52 (mandatory donor screening requirements).

The donor registration form also collects information about donors’ skin tone. Feedback from clinics is that the information collected can at times be useful for patient-donor matching but is not approached consistently. The HFEA needs to collect this information in order to fulfil its obligations under HFEA Disclosure of Donor Information Regulations 2004. However, some clinics answer it in relation to ethnicity and others do so independent of ethnicity. Therefore, we are providing guidance for clinics (in the form’s guidance document) to complete this question linked to the relevant ethnicity.

The HFEA donor registration form structure is split into six sections, some of which relate to factual information that is usually completed by clinic staff and other sections that cover questions that have a more personal touch and for which donors usually provide the information themselves. To make this form structure flow more easily for clinic staff and donors completing the form, we have taken the opportunity, whilst other changes are being made to the form, to group the more factual questions in the first part of the form and the more personal questions in the second part of the form.

To view updated forms, guidance and ethnicity codes in advance of implementation on 1 August 2012, please view the following HFEA webpage: New forms and guidance documents

Professor Lisa Jardine CBE
Chair

Page last updated: 17 August 2012

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