03 February 2015
Dear Colleague
April 2015 update to the Code of Practice and consent forms
On 1 April 2015, we will publish an update to the Code of Practice, consent forms, General Directions and licence conditions. I am writing to tell you about those changes, which relate primarily to consent.
Informed consent is one of the most important principles in healthcare and a fundamental feature of the Human Fertilisation and Embryology Act 1990 (as amended). It is your statutory responsibility to ensure that you obtain properly informed consent from your patients.
Many of you attended our recent series of workshops on consent. This letter summarises the key points from the workshops. At the workshops Kate Gallafent QC gave a compelling presentation about your crucial role in ensuring patient consent is taken properly and the serious consequences for patients and licensed clinics when mistakes happen, as highlighted by a number of recent court cases.
Who can complete the consent forms?
The person who fills in the consent form must be the person giving consent. You should not pre-complete consent forms on behalf of the person giving consent. Only in limited circumstances stipulated by the HFE Act can someone else sign on the consenter’s behalf.
Consent to storage periods
A person giving consent to the storage of their gametes and embryos should be free to choose how long they wish to store for within the time permitted by regulations. At the workshops, clinic staff were told not to link a patient’s consent to their clinics’ own payment policies or NHS funding. Consent should remain separate from any contractual agreement you have with your patient.
Recording consent
It is clear that the quality of the conversation you have with patients about consent and the time you dedicate to the consent taking process is critically important. You should treat patients as individuals and, in every case, be able to demonstrate that you provided all relevant information to each patient and you offered them counselling. You should ensure that your patients are aware that if they were to die or become mentally incapacitated, their sperm, eggs, or embryos cannot be used in treatment unless consent to posthumous use has been provided and their partner has been named. If challenged in court, a simple checklist approach to recording consent may not be enough to show that you effectively carried out your statutory duties. You should be able to demonstrate that a conversation between you and your patient took place and that the information you provided to them was tailored to their situation.
To help you with this, we have designed a template to record the information that you provide to your male and female patients giving consent. This enables you to capture notes and records which could, if done properly, help you demonstrate that you have met the requirements of the Act before asking patients to give consent. We recommend this is retained in patients’ medical records. The template is at Annex 5.
Consent forms
At the workshops, we also discussed the HFEA consent forms. We have taken on board your suggestions as far as possible within the scope of the legislation and made a number of improvements to the forms. Whilst we have made efforts to improve the consent forms, the forms themselves cannot hold all the relevant information a patient needs to provide informed consent. There is no shortcut. It is important to dedicate time with your patients to ensure that they understand all their options and that their wishes are reflected in the consent they give.
We have spent time working with professionals and patients to make the HFEA consent forms easier for patients and clinic staff to use. We have reviewed the forms to make sure the language used is patient-focused, consistent, easy to understand and more user-friendly. The most significant change to the consent forms is within the storage sections which have been amended to make it clear who can qualify for storage beyond the 10 year standard storage period. The revised consent forms are at Annex 7.
Guide to consent
To help you use the consent forms we will shortly publish a new edition of the guide to consent. The guide will clarify how you should use the storage consent forms. We will make it clear that a patient consenting to store their sperm, eggs or embryos should always state the total amount of time they are consenting to on the relevant consent form. We will also make it clear what forms patients should use if they change their mind about how long to store for. For example, if a patient wishes to change their consent to store for a period within the10-year standard storage period, they should complete a new copy of the same form. However, if a patient wishes to extend their storage period beyond 10 years (up to a maximum of 55 years), they should complete the relevant extension form (LGS or ES form).
Please read the full report of the consent workshops and prepare to use the new consent forms from 1 April 2015.
Code of Practice update
The most significant changes to guidance relate to consent. We decided to take a fresh look at our consent guidance following the High Court case of Mrs Elizabeth Warren, who sought permission for the sperm of her deceased husband, Warren Brewer, to remain in storage for a period of up to 55 years. Mr Brewer had stored his sperm before undergoing chemotherapy treatment, and provided written consent, both to storage and to the posthumous use of his sperm by his wife, but had not provided written consent to store for an extended period beyond 10 years.
Consent to storage
Mrs Warren’s case raised important questions about how licensed clinics obtain consent to storage and use, particularly where posthumous storage and use is likely to become a real question for the patients involved. We have amended our guidance to include more explicit requirements for clinics to provide clear information about maximum storage periods available. New guidance also reinforces the point made above that a person giving consent to the storage of their sperm, eggs and embryos should be free to choose how long to consent to store for within the storage period permitted by the regulations.
We have also introduced new guidance to highlight the importance of providing information about the consequences of posthumous use and the legal requirements for extending storage beyond 10 years. We have explained the requirements that need to be met to extend storage. You should seek the written medical opinion on premature infertility whilst the gamete provider is alive. However, if the gamete provider (who has provided consent to extended storage) dies before a medical opinion is in place, the medical opinion may be sought after death based on evidence that the person would have satisfied the premature infertility criteria when they were alive.
Other changes
Along with the amended consent forms and new guidance there are updates to:
- General Directions 0002 on the annual research return form which has been trialled for the 2014 data return
- General Directions 0007 on consent to allow clinics to hold electronic copies of signed patient consent forms
- Licence condition T50 and T52 on HTLV anti-body testing and donor screening for genetic conditions.
Details of all the changes are set out in the following annexes:
Annex 1: Summary of changes to Code of Practice guidance notes
Annex 2: Summary of changes to consent forms
Annex 3: Summary of changes to General Directions
Annex 4: Licence condition updates
Annex 5: Record of information provided before obtaining consent (male and female versions)
Annex 6: The updated guidance notes and directions (updates appear in red text)
Annex 7: The updated consent forms
Annex 8: The Revision Control sheet (sets out updates in detail)
Please review the consent forms, guidance, General Directions and amended licence conditions and ensure your staff are aware of the changes. If you have any questions about them, please contact your Inspector in the first instance.
The consent requirements under the HFE Act are complex and extensive, as you are all very aware. However, IVF presents many options for patients which they need to carefully consider, with your professional help and support. I hope that the changes we have made will make it easier for you but, most importantly, clearer for patients and donors.
Page last updated: 01 April 2015