Clinic Portal
Last updated 1 July 2024.
This Frequently Asked Questions (FAQs) document is supplementary to guidance provided in the HFEA Clinic Guide, Clinic Focus articles published in May, June, July and August 2022, and the Chair’s letter published on 31 May 2022 and guidance published on the Clinic Portal. It represents a selection of the questions we have been asked by centres since the new storage legislation was enacted on 1 July 2022.
The Transitional Period ended on 30 June 2024. Clinics must follow the law and guidance that applies after this date – please see the Clinic Practical Guide on legal changes to storage limits and guidance.
Guidance that applied during the Transitional Period is retained for information and highlighted within a light grey box.
1.1 How should centres calculate consent periods?
In most cases, a consent period is 10 years from date of first storage (please see the exceptions set out in 1.2). A patient’s consent period is 10 years irrespective of the period of time to which they actually give consent to storage. For example, if a patient consents to the storage of gametes or embryos for 3 years in 2030 the end of their consent period will be 2040 and not 2033.
This consent period is used to determine the renewal period.
1.2 What are the exceptions to calculating consent periods as 10 years from date of storage?
In most cases, a consent period is 10 years from date of first storage (see 1.1)
If already subject to extended storage, then the consent period may not be calculated by reference to the date of first storage e.g.
in such cases, the consent period will begin on the day on which they first give consent to storage, after becoming competent and having capacity to give such consent.
Although these dates are used to determine the consent period which in turn is used to calculate the renewal period, the total storage period for gametes or embryos cannot exceed 55 years from date of first storage.
For more information on this please see the HFEA Clinic Guide.
2.1 For gametes or embryos where consent expired before 1 July 2022, do patients need to re-consent or go through the renewal process if they wish to continue storing?
When a patient’s consent to storage of their gametes or embryos created with their gametes has already expired or ended before 1 July 2022 the patient now needs to ‘give’ consent to storage as there is no longer effective consent in place to ‘renew’. Therefore, the patient should complete a new consent form such as a WT/MT/WPT to give consent to storage of their gametes or embryos, and the patient must be contacted in writing by 30 June 2023 to ask them to do this.
The period of consent the patient gives can be up to an amount of years that will take the storage period to the next 10-year consent period. See examples in flow charts Unlawful gamete storage prior to transitional period (version 2, 4 July 2022) (hfea.gov.uk) and Unlawful embryo storage prior to Transitional Period (version 1, 4 July 2022) (hfea.gov.uk).
Once the patient has given their consent to storage for the next 10-year consent period a centre must follow the renewal process. This may very well be soon after the patient gives their consent. For example, if there has not been effective consent to storage since May 2015, and the patient gives consent to storage in May 2023, the consent period would be limited to the remaining 2 years of the 10-year consent period (i.e. until May 2025). The renewal period will start 12 months before the end of the consent period (in May 2024) and the patient must be contacted in writing before that date to ask if they wish to renew their consent to storage.
2.2 What should clinics do if they don’t have up to date contact details for patients or are confident that contact details are out of date?
Centres should take all reasonable steps to contact patients. If centres have lost contact with patients who have their samples in storage, centres should review previous attempts to contact these patients to determine if all reasonable means have already been attempted; for example, contacting last known GP. Centres must always comply with the patient’s consent to disclosure decisions.
If centres are confident that the contact details they have for patients are incorrect they might decide not to send out the relevant paperwork because there could be a risk of breaching confidentiality for example the patient has moved and there are new occupiers of their previous address. If the centre decides to take this course of action, we would expect the centre to be able to provide a clear record of all attempts made to locate the individual concerned, including evidence that the last known address is not correct.
2.3 What steps should clinics take to establish correct contact details? Is there an obligation to keep chasing people if they don’t have an address?
Centres should take all reasonable steps to contact patients. If centres have lost contact with patients who have their samples in storage, centres should review previous attempts to contact these patients to determine if all reasonable means have already been attempted; for example, contacting last known GP. Whether centres make use of tools such as internet searches, social media or tracing agents in order to establish alternative contact details is a matter for individual centres. Centres should rely on their own legal advice on appropriate course of action in these situations.
General guidance on keeping in touch with patients can be found at paragraph 17.33 of the HFEA Code of Practice.
2.4 Does the RNE and RNE (TP) statutory notices need to be sent to both gamete providers?
In cases of embryo storage centres are required to send each gamete providers an RNE statutory notice before the start of the renewal period. In many cases, gamete providers might live together and have the same address. Centres should still send each gamete provider their own RNE notice, separately, to ensure that they meet their legal obligations.
2.5 When contacting patients about renewing consent to store embryos, should clinics contact both patients if a couple have split up and they used donor gametes to create those embryos?
If patients who stored embryos as a couple subsequently part ways and are no longer planning to seek treatment as a couple, centres are only required to contact patients who provided the gametes from which embryos are made. This means that if a couple used donor gametes to create embryos before separating, the partner who provided their gametes is the only person who should be contacted and asked for renewed consent, at the appropriate time.
2.6 What should centres do in the case of recipients of donated gametes or embryos when the consent to storage period is approaching the end?
Only gamete providers can renew consent to storage. However, we would expect centres to make the recipients of donated embryos aware of the approaching end of consent to storage with sufficient notice so that the recipient can complete any further treatment should they wish to. This was the case prior to 1 July 2022 for recipients of donated gametes or embryos.
3.1 Should clinics issue statutory notices when sending out treatment forms to re-consent patients under the new provisions?
When centres simply ask patients to re-consent using the updated consent forms, it is not necessary to issue a statutory notice to the patient.
Centres are only required to send statutory notices to patients when a patient’s consent period is drawing to a close (at least 12 months before the end of the consent period).
3.2 What does ‘additional storage’ mean in the context of the new consent forms?
If patients do not wish to consent to 10 years storage, either at the first time they give consent to storage or at a renewal of storage they can complete the relevant sections of the consent forms with a period less than 10 years. The centre must contact the patient in sufficient time before the end of this consent period to ask patients if they wish to consent to an additional period of storage up to 10 years.
Where a period of additional storage is to be provided the relevant consent forms explain: ‘Any period you specify below will be in addition to your existing storage period. The total number of years of storage should not exceed 10 years from date of first storage or most recent renewal.’ Therefore, patients who wish to indicate a further period of additional storage (in addition to a previous storage period), should specify the number of years, not a cumulative total number of years.
Centres will be aware that this differs from the previous approach where patients were asked to enter a cumulative total number of years storage, rather than an ‘additional’ figure.
3.3 Who should fill out the new GS form?
The GS form is to be completed by people who want to store eggs or sperm for their own potential future treatment who do not already have a partner. Patients who already have a partner with whom they wish to have treatment should complete one of the treatment forms (WT, MT, WPT, MGI etc.).
3.4 How should the new MGI and WGI forms be used?
The WGI and MGI consent forms are for patients having artificial insemination treatment, or their partners, using fresh or stored sperm. The treatment would not involve the creation of embryos outside the body. Treatment may be intrauterine insemination (IUI) or gamete intrafallopian transfer (GIFT) using partner sperm.
The MGI/WGI consent forms have been updated to include questions about storage, posthumous use and use in the event of mental incapacity, in the same way as the other treatment forms (the MT/WPT/WT etc.)
3.5 How should consent be renewed where they have gametes or embryos in storage that were stored on different dates?
Centres may have several samples stored over a short time, for example, sperm samples stored by an oncology patient. Centres should accurately calculate the consent period and renewal period for each sample in the bring forward system.
In some cases, it may be reasonable to use one renewal consent form (RG or RE) to include more than one set of gametes or embryos in storage. However, the consent periods and dates on which gametes or embryos may be removed from storage and disposed of must be clear to the patient(s) and the processes should be documented in the centre’s SOP.
3.6 What is the renewal process for patients with several samples in storage?
Centres may have several samples stored over a short time for example sperm samples for an oncology patient. Centres should accurately calculate the consent period and renewal period for each sample in the bring forward system. In some cases, it may be reasonable to use one renewal consent form (RG or RE) to include more than one set of gametes or embryos in storage. However, the consent periods and dates on which gametes or embryos may be removed from storage and disposed of must be clear to the patient(s) and the processes should be documented in the centre’s SOP.
3.7 How are consent periods of patients storing gametes or embryos under the 1991/1996, 2009 or 2020 Coronavirus Regulations affected by re-consenting under the new storage laws?
Patients who have gametes or embryos in storage on 1 July 2022 already subject to a period of extended storage of more than 10 years since date of first storage. due to satisfying the requirements for extension under either the 1991/1996. 2009 or 2020 Coronavirus Regulations, can re-consent under the new storage laws by completing a new treatment form.
Patients should complete the section ‘Additional storage prior to renewal’. This is because the date that the patient’s consent period expires will be the date the extended period of storage ends (for example, in the case of those extending under the 2020 Coronavirus Regulations, 12 years from date of first placed in storage or under the 2009 Regulations 10 years from the date of the most recent MPS). This date will determine when the renewal process begins.
3.8 How should patients storing gametes or embryos under the 1991/1996, 2009 or 2020 Coronavirus Regulations use the treatment forms to re-consent under the new law?
Patients should select ‘Yes’ to question 4.3 and where they are asked to ‘Specify the number of years’ should enter zero years. Centres should make clear to patients that the consent expiry date they previously had in place will not change, and this should be documented in their medical record. Centres will then be required to start the consent renewal process 12 months before the consent expiry date.
4.1 How long can a treatment centre store embryos before transferring them to a research centre after a patient gives consent for embryos to be used for that purpose?
Please see the June 2023 edition of Clinic Focus.
4.2 How should storage periods be calculated for gametes and embryos that are being stored for research or training purposes?
Gametes can be stored for use in training or research for up to 55 years from the date they are first placed in storage. This maximum storage period applies whether the gametes were first placed in storage before or after 1 July 2022. In all cases, gametes may only be stored for the period specified in the consent given by the gamete provider.
Embryos can be stored for use in training or research for up to 10 years from the date that consent is given. The consent of both gamete providers is needed to store embryos, for any purpose. Where consent to storage of an embryo is given by different persons on different days, consent is taken to be given on the last of those days.
4.3 Is there an HFEA consent to research form?
As was the case before 1 July 2022, consent for use and storage of gametes or embryos in research should be recorded on centre’s in-house consent forms.
Centres should note that consent forms in use by HFEA research centres storing gametes or embryos before 1 July 2022 will need to be reviewed and revised to incorporate the changes which came into effect on 1 July 2022. PRs of research centres should ensure that the information and forms that they provide on storage for research are up to date and in line with the new provisions.
4.4 What steps should clinics take for patients who want to consent to the use of their embryos in research but there was no effective consent to storage in place on 1 July 2022?
These embryos can be donated for use in a research project, however if embryos are currently in storage without effective consent, the centre should first ensure that effective consent to storage is put in place. This must happen before the end of the Transitional Period (30 June 2024) at which point it will no longer be lawful to store the embryos without effective consent. The patient can give consent to embryo storage by completing an MT/WT.
Once there is effective consent to storage (for treatment purposes) in place, the patient can then donate their embryos to research, if they wish, by completing in-house research project consent forms to include consent to storage for research purposes provided by the research centre.
5.1 Should clinics re-consent donors who consented to 55 years under old provisions?
Donors who donated prior to 1 July 2022 may have given a consent to storage for 55 years, but centres cannot assume that this consent will remain effective following the changes to the Act made on 1 July 2022.
In order to consider that the consent to storage for 55 years is effective under the new requirements, the Person Responsible would have to be assured that the donor would still wish to give their consent to storage for 55 years had they been provided with proper information and an opportunity for counselling in relation to the storage periods that take effect from 1 July 2022. That is would the donor have still given their consent to storage for 55 years had they been informed that this would be for all patients and not just for those who were prematurely infertile, or likely to become prematurely infertile. Centres may have evidence in the donor’s records that can provide this assurance, for example records of discussions with the donor during their interactions with the centre. See section 7 in the HFEA Clinic Guide.
5.2 Does the 10-year posthumous storage period apply to donated gametes and embryos?
No. If a donor dies their gametes, or embryos created with their gametes, can be stored and used until the end of the period of time to which the donor consented (up to 55 years from date of first storage), as long as the donor has not placed a restriction on use after death. This is different to situations where patients die whilst storing gametes or embryos for use in their own treatment. In these cases, gametes and embryos can only be stored for up to 10 years from date of their death, as long as they have consented to posthumous use and storage, and named their partner.
6.1 What steps should clinics take where patients return old consent forms after 1 July 2022? Do patients need to re-consent under the new provisions?
Storage of gametes and embryos will continue to be lawful for material stored prior to 1 July 2022, using the old consent forms, until the defined renewal period. However, patients who had gametes or embryos in storage before 1 July 2022 may want to re-consent to storage under the new law before their consent expiry date in order to benefit from the new provisions. Patients must do this on new HFEA consent forms effective from 1 July 2022.
Centres should therefore ask patients if they wish to re-consent to storage of their gametes or embryos under the new law, and inform them that they can do so by completing the new consent forms.
6.2 Do patients need to be sent hard copies, or can they be contacted over email with the relevant statutory notices?
The appropriate renewal notices can be sent to patients via post or email as long as contact is in writing.
6.3 Which renewal of consent forms should clinics use during the transitional period?
In response to requests from centres, on 1 August 2022 we issued two further renewal of consent forms for use exclusively within the Transitional Period (TP).
The ‘Renewal of consent to storage of your eggs or sperm for treatment (Transitional Period) (RG(TP))’ and the ‘Renewal of consent to storage of your embryos for treatment (Transitional Period) (RE(TP))’, should be used where renewal of consent to storage is required during the TP (1 July 2022 to 30 June 2024). These consent forms are tailored to the specific provisions laid out for renewing consent to storage during the TP. Both can be found on the Consent forms page of the clinic portal. The TP version of the renewal of consent forms will be withdrawn at the end of the TP, on 1 July 2024.
If patients have already re-consented using the standard consent renewal forms published on 1 July 2022 they do not need to re-do these forms. However, centres should ensure that patients understand when storage of their gametes or embryos will no longer be lawful, and when subsequent renewal of consent will be needed.
6.4 What is the difference between questions 6.1 and 6.2 of WT/ MT form (relating to posthumous use)?
6.1 relates to patient’s decision in circumstances where only gametes in storage, there are no embryos already created in storage. The patient is deciding if they wish to consent to the posthumous creation of embryos and the subsequent use and storage of embryos created after their death.
6.2 relates to patient’s decision in circumstances where there are embryos created prior to death already in storage. The patient is deciding if they wish to consent to the post humous use and continued storage of embryos created before their death.
6.5 How many years should patients enter on the MD/WD/ED at questions 3.2 and 3.4 when consenting to their gametes or embryos being stored for someone else’s treatment?
Patients should include the period for which gametes or embryos have already been stored when calculating the total period to which they consent to storage for donation purposes. For example, if embryos have been in storage for 10 years for treatment purposes, and patients subsequently want to consent to storage for donation purposes for the maximum storage period possible, they should enter 55, rather than 45, years.
6.6 How many years should patients put in the ‘additional storage’ section box?
Where patients have previously consented to less than 10 years storage, either at the first time they give consent to storage or at a renewal of storage, they can complete the ‘additional storage’ section of the consent forms with a period less than 10 years.
Where a period of additional storage is to be provided the consent forms explain that ‘Any period you specify below will be in addition to your existing storage period. The total number of years of storage should not exceed 10 years from date of first storage or most recent renewal.’
Therefore, patients who wish to consent to a period of additional storage (in addition to a previous storage period), should specify the number of years from the date they sign the form up to 10 years from the that material was placed in storage, or consent was renewed, not a cumulative total number of years.
Example
Using e-consent platforms
If centres send patients electronic versions of renewal of consent forms at the appropriate times, they must still ensure that they are also meeting their legal requirements to provide patients with relevant information and to make them with an offer of counselling. General guidance on seeking electronic consent from patients can be found in the Code of Practice in Guidance Note 5.
7.1 How should the new withdrawal of consent forms be used?
Following feedback from centres that it would be more useful to have separate WC forms we have taken the opportunity to separate out the Withdrawal of Consent form into three different forms to be used depending on what the patient is withdrawing their consent to. These changes are unrelated to the legal changes governing gamete and embryo storage
New: Withdrawing your consent to the storage of your own eggs, sperm and embryos (WCS) Use this form for patients who wish to withdraw consent to the storage of eggs, sperm or embryos created with their gametes for use in their own treatment and these will be removed from storage and disposed of. Use this form for patients who wish to give consent to the use of their eggs, sperm or embryos for use in training, if they no longer wish to use or store these for their own treatment.
New: Withdrawing your consent to use of your eggs, sperm or embryos in someone else’s treatment (WCU) Use this form for patients who wish to withdraw consent to use (not storage) of eggs, sperm or embryos in someone else’s treatment. If a patient wishes to withdraw their consent to use of their fresh eggs, sperm or embryos in training they should complete another treatment consent form indicating they do not wish to consent to use in training. If a patient wishes to withdraw their consent to use of their stored eggs, sperm or embryos in training or research they should complete a ‘Withdrawing your consent to the storage of your own eggs, sperm and embryos’ (WCS) form indicating that these are to be removed from storage. If a patient wishes to withdraw consent to use of their fresh eggs, sperm or embryos in research they should contact the centre so that they can follow the procedures for withdrawing consent to use of gametes or embryos in research.
New: Withdrawing your consent to legal parenthood (WCP) Use this form for patients who wish to withdraw consent to legal parenthood.
7.2 How quickly do we have to remove gametes from storage when consent is taken to have been withdrawn?
Information on when consent is taken as having been withdrawn is provided in various sections of the Clinic Guide; end of the renewal period (section 3.6), after death (section 3.4), or after loss of capacity (section 3.5).
The law requires that gametes are removed from storage and disposed of when consent to storage has been taken to have been withdrawn. Centres should have robust systems in place for establishing when consent has been withdrawn and the subsequent processes for removing gametes or embryos from storage for disposal.
Once consent is taken as having been withdrawn, retaining the relevant gamete sample(s) in storage will be unlawful.
Taking into consideration that removing material from storage must be done carefully (e.g., confirming the correct sample for discard, witnessing the discard) and safely (i.e., handling liquid nitrogen) by staff trained to carry out these processes, it is expected that these steps are undertaken in a planned manner with sufficient time to ensure no errors occur. It is expected that these are carried out as soon as reasonably possible after the withdrawal of consent (or end of consent). For example, centres would not be expected to carry this out at midnight on the day consent ends, but conversely should not delay disposal of material until a pre-set date that might be weeks or months later.
7.3 Are patients who wish to withdraw consent to storage of their embryos required to fill out WCS form?
Centres should ask patients who do not wish to continue storing their embryos to complete a WCS form, even if they have been informed by patients in person, on the phone or over email that this is the case. However, if patients do not return a WCS by the end of the renewal period consent will be taken as withdrawn at that point.
7.4 Are centres required to remove embryos from storage as soon as consent is taken as withdrawn?
The law says that it is not unlawful to continue to store embryos for six months after consent to storage of embryos is considered to be withdrawn. Therefore embryos can remain in storage for this period after which they must be removed from storage and disposed of.
When consent is taken as withdrawn, centres must take all reasonable steps to give notice of the fact that consent has been taken as withdrawn to each person whose gametes were used to bring about the creation of the embryo.
This extra six-month period of lawful storage will come to an end before the full six months has elapsed if the centre receives consent to the disposal of the embryos from each person notified. There is no comparable provision for gametes.
7.5 Can consent be renewed and/or embryos be used in treatment during the six months of lawful storage, after consent has been taken as withdrawn?
No. During this six-month period embryos cannot be used in treatment and consent to storage can no longer be renewed.
7.6 Is there a special version of the WCS form to withdraw consent to storage for some embryos in storage such as aneuploid embryos?
No. The WCS form can be used by the patient to specify withdrawal of consent to storage for specific embryos for example if they have aneuploid embryos, or if they wish to withdraw consent to storage for use in training. Centres should make a clear record on the space on the consent form to document which embryos (and why) are covered by the WCS form.
The Transitional Period ended on 30 June 2024. Clinics must follow the law and guidance that applies after this date – please see the Clinic Practical Guide on legal changes to storage limits and guidance.
8.1 Where consent expires during the transitional period, are clinics required to keep those gametes or embryos in storage until the end of the transitional period?
The storage of the gametes or embryos during the transitional period (ie between 1 July 2022 and 30 June 2024) will not be unlawful merely because there is no effective consent to storage by the relevant person. This applies to any gametes or embryos for which consent to storage expires during the transitional period.
Centres are not legally required to keep gametes or embryos in storage for the duration of the transitional period. However, given the requirement to contact patients without effective consent in place before 1 July 2023, and the fact that patients have until 1 July 2024 to renew consent, centres should not discard gametes or embryos prior to 1 July 2024 unless the patient has specifically confirmed that they do not wish to renew or have actively withdrawn consent to storage.
8.2 Where consent expired before 1 July 2022, are clinics required to keep those gametes or embryos in storage until the end of the transitional period?
The storage of the gametes or embryos during the transitional period (ie between 1 July 2022 and 30 June 2024) will not be unlawful merely because there is no effective consent to storage by the relevant person.
This applies to any gametes or embryos for which consent to storage expired before the start of the transitional period.
Centres are not legally required to keep gametes or embryos in storage for the duration of the transitional period. However, given the requirement to contact patients without effective consent in place before 1 July 2023 and that patients have until 1 July 2024 to renew consent, centres should not discard gametes or embryos prior to 1 July 2024 unless the patient has specifically confirmed that they do not wish to renew or have actively withdrawn consent to storage.
8.3 Do centres have to use Transitional Period-specific renewal forms and Statutory Notices?
Yes, the requirements relating to contacting patients whose gametes or embryos are due to expire during the transitional period, and the dates by which this should happen, are set out in the law. Centres should use the appropriate forms in order to meet these legal requirements.
8.4 What should centres do when one but not the other partner has completed a WCS for embryos for which consent is due to expire in the transitional period?
If one partner has completed a WCS before 30 June 2024 the clinic should still send the NWC(TP) to the other gamete provider. If the other gamete provider does not complete a WCS the centre should consider keeping the embryos in storage until 31 December 2024.
8.5 Are clinics required to keep embryos in storage for an extra six months after the end of the transitional period?
Where consent to storage of embryos is due to expire in the transitional period, storage will remain lawful for a period of six months after consent is treated as withdrawn at the end of the transitional period (i.e., until 31 December 2024). This additional period of six months will come to an end if the centre receives consent to the disposal of the embryos from each person notified.
Whilst the law does not expressly require centres to keep embryos in storage for this additional period, centres may want to consider the risks of legal challenge from patients if they decide to remove material from storage and dispose of it before they are legally required to do so.
9.1 Are clinics required to keep embryos in storage for an extra six months after the end of the renewal period?
In relation to embryos in storage for treatment purposes, storage will remain lawful for a period of six months after consent is treated as withdrawn (i.e., six months after the expiry of the renewal period). This additional period of six months will come to an end if the centre receives consent to the disposal of the embryos from each person notified.
Whilst the law does not expressly require centres to keep embryos in storage for this additional period, centres may want to consider the risks of legal challenge from patients if they decide to remove material from storage and dispose of it before they are legally required to do so.
9.2 What are the obligations for clinics where patients are approaching the 55-year limit for storage of their gametes or embryos?
Centres should give patients notice that have gametes or embryos in storage when the storage period is approaching the statutory limit of 55 years.
Embryos must not be kept in storage for treatment purposes longer than 55 years. There is no 12-month cooling off period or extra six months of lawful storage (as provided for by the renewal provisions). Once embryos have been in storage for 55 years, they must be removed from storage and disposed of.
10.1 Are clinics required to provide patients with information about the new provisions?
Patients should be made aware of the legal changes to gamete and embryo storage and their options under the new law. This includes patients who might have previously not indicated a wish to extend storage, but who should still be provided with relevant information and given the opportunity to re-consent under the new provisions.
11.1 If a patient (who has consented to the use of their gametes or embryos in the event of their death or mental incapacity) dies after losing capacity, when does the lawful storage period end?
If a patient who loses capacity to renew consent to storage subsequently dies, the maximum period for which gametes or embryos can be kept in storage is 10 years (depending on the length of the period to which the patient consented to storage in the event of their mental incapacity). This period is calculated from the date on which they were certified as having lost mental capacity, not the from the date on which they died. The new provisions do not allow for a subsequent/additional 10 year storage period to begin upon a person’s death if gametes or embryos are already in storage following the patient’s loss of mental capacity.
12.1 What are the new requirements relating to posthumous surrogacy arrangements?
The new legislation which came into force on 1 July 2022 did not make any changes concerning what is required with respect to posthumous surrogacy arrangements. The information that should be discussed with patients is not different to that before 1 July 2022. The introduction of the new legislation, which coincided with the recent legal case in the high court (Mr Jennings Clinic Focus June 2022), gave us the opportunity to update the consent forms to make it clearer to patients what steps they might have to consider taking if they wish to have their material used after their death.
12.2 If an egg provider undergoing treatment consents to the use of their eggs or embryos with a surrogate in the event of their death, when do they need to have screening?
The additional screening must be conducted before donation takes place, and before the patient’s death, but this does not need to be before the patient’s own treatment. Screening before treatment should be carried out in accordance with Standard Licence Condition T50.
If a patient, having received information regarding the additional testing, subsequently chooses not to proceed with screening, they should understand that posthumous surrogacy would not be possible in the unfortunate event of their death and their recorded consent should reflect this decision. Centres must keep a clear and detailed record of discussions and the rationale for decisions made.
If the patients undergoes the required additional screening tests after the gametes or embryos are stored (but before death), and these are to be used in surrogacy posthumously then we would expect clinics to risk assess each case individually and ensure the surrogate is fully informed of if any potential risks are identified. This is in line with the process that would be used when patients use donated embryos.
Section 13 provided further information to support clinics at the end of the Transitional Period, as well as information based on recent questions about renewal of consent and statutory notices. Now the Transitional Period has ended (30 June 2024), clinics must follow the law and guidance that applies after this date – please see the Clinic Practical Guide on legal changes to storage limits and guidance.
13.1 When is the end of the Transitional Period and where do I go to find out what should happen before that date?
The Transitional Period ended on 30 June 2024. Clinics should review the March 2024 Clinic Focus for a reminder of what should have happened before and after this date.
13.2 Who needs to renew their consent during the Transitional Period?
Paragraph 3.2.3 of the Clinic Guide sets out information about renewal of consent where consent ends during the Transitional Period. The February 2023 Clinic Focus sets out detailed information about what clinics must have done by 30 June 2023 in order for patients to renew consent by the end of the Transitional Period.
As set out in that guidance, only patients whose Consent Period ends during the Transitional Period need to renew their consent during the Transitional Period. Please see the definition of Consent Period in sections 1.1 and 1.2 of this FAQ. It is very important to note that it is not defined as the period of time a patient has consented to if that period is less than 10 years. For example, a patient who consents to store material for 3 years will not have reached the end of their Consent Period at the end of that 3 years.
It is important to be aware that some patients will have reached the end of the period of storage to which they consented (for example, they consented to less than 10 years storage) without having reached the end of the Consent Period. These patients should be given an opportunity to give additional consent to storage but they do not renew their consent and must not complete renewal of consent forms.
This is because the Consent Period has a definition set out in law and does not correspond to how long a patient consents to.
For example:
Please see section 10.5 of the Clinic Guide for more information.
13.3 Who should Statutory Notices be sent to?
Statutory Notices must be sent to the patient(s) who have provided the gametes which are in storage. In the case of embryos in storage, both gamete providers must be sent the Statutory Notice(s) provided the embryo was not created with donor gametes. Please see section 2.4 of this FAQ.
For example:
13.4 What Statutory Notices should be sent to patients?
Clinics must send HFEA Statutory Notices to patients. These can be found on the consent form page of the Clinic Portal. On this page you can also find Consent Forms: A Guide for Clinic Staff which sets out how each Statutory Notice should be used. There is also a summary in section 3.12.3 of the Clinic Guide.
HFEA Statutory Notices have been drafted to comply with the requirements set out in law and it is mandatory for clinics to use them.
13.5 What requirements are there in relation to record-keeping for Statutory Notices?
General Direction 0007 mandates the use of HFEA Statutory Notices. In addition, paragraph 11 sets out that clinics must maintain a record that they have complied with their statutory requirements to issue notices to patients as part of the renewal process. In practice, this means that clinics must maintain a record that HFEA Statutory Notices have been sent at the appropriate time to:
Donors should never be issued Statutory Notices. Please see section 13.2 of this FAQ for more information about who Statutory Notices must be issued to.
13.6 How should we calculate the dates when Statutory Notices should be issued and other relevant dates during the renewal of consent process?
If they have not already, before the end of the Transitional Period, clinics should ensure their systems are compliant with the laws relating to the storage of gametes and embryos (please see 17.64 – 17.67 of the Code of Practice for more information about bring-forward systems).
This involves ensuring that Consent Periods, Renewal Periods and other key dates are calculated correctly so that Statutory Notices can be sent at the required times and so patients can renew consent in line with the law.
An example of a renewal process:
It is important that bring-forward systems reflect the precise dates of the Consent Period and Renewal Period, as well as key dates such as the final day on which it is lawful to store the gametes or embryos. They must also ensure Statutory Notices are sent in time. Discrepancies of even a single day may mean that centres are not compliant with the law. For example, if the RNE Statutory Notice in the above example was sent on 7 November 2032 it would not have been sent before the end of the Renewal Period.