Fertility Regulations Part Two Flashcards
Who is the father / other legal parent?
The other partner in a marriage is to be treated as the legal father (or other legal parent) even if the pregnancy was brought about by the sperm of a donor.
This is void if it can be proven that the partner did not consent to the placing of the embryos/sperm and eggs within the mother.
Both parents should receive proper counselling prior to consent and treatment.
Who are the legal parents in surrogate cases?
In surrogate cases the intended parents will not be the legal parents upon birth of the child. They will need to obtain parenthood by parental order or adoption.
The husband or civil partner of the surrogate mother at the time of insemination or transfer will be the legal parent of any child born as the result of her treatment unless they were judicially separated or the partner did not consent.
What is the HFEA guidance on multiple births?
- strategy to minimise multiple births
- limits on egg and embryo transfer
- consent and provision of information regarding risks associate with multiple births should be given
HFEA directions require centres to have a documented strategy to minimise multiple births. Its purpose is to reduce the annual rate of multiple births resulting from treatment at the centre.
What does the HFEA say regarding the welfare of children?
No treatment services regulated by the HFEA may be provided unless account has been taken of any child who may be born as a result (including the need of that for supportive parenting) and any other children who may be affected by the birth.
Centres can refuse treatment of they deem there is risk. Should give patients a chance to respond, give them info on anything they can do to change the decision.
Describe the guidelines for preimplantation genetic screening (PGS) for specific diseases.
An embryo may be tested to establish whether it has a particular abnormality only if:
- that abnormality may affect its capacity to result in a live birth
- there is a particular risk that it has that abnormality and where the authority is satisfied that there is a significant risk that a person with that abnormality will have or develop a serious medical condition.
What is the advice regarding pre-implantation genetic diagnosis?
Pre-implantation genetic diagnosis can be carried out for a heritable condition only in two circumstances:
1) . Where there is a particular risk that the embryo to be tested may have a genetic, mitochondrial or chromosomal abnormality and the authority is satisfied that a person with the abnormality will have or develop a serous disability, illness or medical condition.
2) . Where there is a particular risk that any resulting child will have or a develop a gender-related serious disability, illness or medical condition. A condition is gender related if the authority is satisfied that it affects only one sex or affects one sex significantly more than the other.
What is the difference between PGD and PGS?
PGD will usually look at one gene where are PGS will screen for a number genetic disorders.
Is selection of sex for social reasons acceptably?
The law requires that the centre should not, for social reasons:
- select embryos of a particular sex
- separate sperm samples, or use sperm samples that have been separated for the purpose of sex selection
- participate in any other practices designed to ensure that a resulting child will be a particular sex
The law requires that any intended recipient of any donated tissue from a child born following tissue typing must be…….
- a sibling of any child born as a result of treatment
- suffer from a serious medical condition that could be treated by umbilical cord stem cells, bone marrow, or other tissue of any resulting child
Describe donor recruitment, assessment and screening.
Donors must be recruited on the basis of their age, health and medical history.
Donors must be negative for CMV, HIV1, HIV2, HCV, HBV and Syphilis.
A validated testing algorithm must be applied to exclude the presence of active Treponema pallidum.
Clear storage that separates unscreened and positively tested gametes or embryos is required.
Sperm donors must be negative for chlamydia.
Other infection testing for individuals from high risk areas of the country may be required.
If donors of gametes or embryos ask, centres must provide the following information about any children born as a result of their donation - number, sex, year of birth.
How should egg sharing be conducted?
Need to consider the selection of egg providers and the benefit for egg providers.
Counselling, information and consent should be provided.
There should be an agreement between the egg provider and the licensed centre, and the egg recipient and the licensed centre.
What are the rules regarding payments for donors?
If the person responsible, or the license holder gives or receives any money or benefit for the supply of gametes, embryos or human admixed embryos that is not authorised by the applicable HFEA directions, they have committed a criminal offence. Conviction may result in prison time, a fine or both.
What are the rules regarding surrogacy?
Patients providing gametes in surrogacy arrangements must be registered as donors and fulfil all counselling requirements etc.
The prospective parents will require parental orders.
What are the requirements regarding procuring, processing and transporting and embryos?
There should be a documented system in place that ensure the identification of all gametes and embryos from procurement to use.
There should also be a documented system in place for ratifying that the gametes and/or embryos meet appropriate specifications of safety and quality for use and for their transportation/distribution.
Patient selection and procurement requires the clinician to document the reason for use of the gametes or embryos created based on the patients medical history. The centre may not produce embryos unless the intention is to store or use the resulting embryos or unless there is another reason to do so.
If sperm is produced at home the centre must provide instructions.
The centre must have a system of receipt of samples and keep registered data such as consent ID and characteristics.
Packaging must preserve the sample and prevent contamination of the sample and handlers.
Procedures should be followed regarding processing and disposal of gametes and embryos as well as distribution and recall of gametes and embryos.
All forms need to be filled out for imports and exports of gametes and embryos.
What are the regulations regarding storage of gametes and embryos?
Centres should establish documented procedures to ensure that all storage of gametes and embryos comply with licensing conditions, regulations and relevant patient and donor consent.
The centre should store gametes and embryos in a designated area and access to this area should be restricted to staff authorised under the centres license.
No gametes or embryos should be placed in storage unless the people who provided them have been screened in accordance with current professional guidelines.
Ovarian and testicular tissue are subject to the same storage regulations as sperm and eggs (HFEA 2008).
If treatment involves the creation of embryos in vitro the centre should give those seeking storage information on storage and subsequent embryo use.
The law requires centres to obtain written consent before they store gametes or embryos. Gametes stored without consent cannot be used unless the gamete provider becomes competent and consents to such use.
If someone wants storage for more than 10 years the conditions for extended storage should be satisfied before the centre gains consent.
If one of the gamete providers withdraws consent to the storage of embryos intended for treatment, the law requires that the centre take all responsible steps to notify the recipient or recipients.
Storing gametes or embryos beyond the relevant period is a criminal offence.
