Fertility Regulations Flashcards
When was the committee of inquiry into human fertilisation established? What was its aim?
The committee of inquiry into human fertilisation and embryology was established in July 1982.
It’s warm was “to consider recent and potential developments in medicine and science related to human fertilisation and embryology, to consider what policies and safeguards should be applied including consideration of the social, ethical and legal implications of these developments; and to make recommendations”.
The committee of inquiry into human fertilisation and embryology published the Warnock report in 1983. Summarise the Warnock report.
The issues raised in the Warnock report reflect mainly fundamental moral and often religious questions. It used a utilitarian approach where possible.
Arguments against IVF:
- if more embryos are brought into existence than are transferred it is held to be morally unacceptable to allow them to die.
- whether the country can afford such expensive treatment which benefits only a few and whether money could be better spent, that is, with beneficial effects for more people elsewhere.
Summary of recommendations:
- the embryo of the human species should be afford some protection in law.
- research conducted on human in vitro embryos and the handling of such embryos should be permitted only under licence. We recommend that any unauthorised use of an in vitro embryo would in itself constitute a criminal offence.
- the committee recommended the establishment of a new statutory licensing authority to regulate both infertility services and research centres using human embryos.
Results:
- In 1985 the Voluntary Licensing Authority was set up by the MRC and RCOG.
- In 1990 the human fertility and embryology act went through in the UK.
What was the Human Fertilisation and Embryology Act 2008?
It was an act to amend the 1990 act and the surrogacy arrangements act of 1985.
What does the HFEA 2008 act cover? How does the HFEA help centres comply with the act?
The HFEA 2008 act covers the use and storage of sperm, eggs and embryos for human application, as well as all research involving the use of human and admixed embryos.
One of the ways the HFEA helps licensed centres comply with the act is by publishing the code of practice (8th edition). The HFEA have a duty under the act to maintain a code that gives guidance about licensed activities and the people who carry them out.
The guidance on the code also serves as a useful reference for patients, donors, donor-conceived people, researchers and those working in the fertility sector.
The code consists of regulatory principles for licensed centres, guidance notes and a glossary.
List the regulatory principles in the HFEA 2008 code of practice, 8th edition.
1) . Treat prospective and current patients and donors fairly and ensure that all licensed activities are conducted in a non-discriminatory way.
2) . Have respect for the privacy, confidentiality, dignity, comfort and wellbeing of prospective and current patients and donors.
3) . Have respect for the special status of the embryo when conducting licensed activities.
4) . Take account of the welfare of any child who may be born as a result of the licensed treatment provided by the centre and of any other child who may be affected by that birth.
5) . Give prospective and current patients and donors sufficient, accessible and up-to-date information to enable them to make informed decisions.
6) . Ensure that patients and donors have provided all relevant consent before carrying out licensed activities.
7) . Conduct all licensed activities with skill and care and in line with good clinical practice, to ensure optimum outcomes and minimum risk for patients, donors and offspring.
8) . Ensure that all premises, equipment, processes and procedures used in the conduct of licensed activities are safe secure and suitab,e for the purpose.
9) . Ensure that all staff engaged in licensed activity are competent and recruited on sufficient numbers to guarantee safe clinical and laboratory practice.
10) . Maintain accurate records and information about licensed activities.
11) . Report all adverse incidents (including serious adverse events and serious adverse reactions) and near misses to the HFEA, instigate all complaints properly and share lessons learned appropriately.
12) . Ensure that all licensed research by the centre meets ethical standards and is done only where there is both a clear scientific justification and no viable alternative to the use of embryos.
13) . Conduct all licensed activities with regard for the regulatory framework governing treatment and research involving gametes or embryos within the UK.
Who holds responsibility in a centre according to the HFEA?
HFEA guidelines provide guidance on appointing the person responsible, this is usually the license holder. They detail the qualifications this person must hold and their responsibilities.
The person responsible is ultimately responsible for ensuring that all licensed activities are conducted with proper regard for the regulatory framework that governs treatments and research involving gametes or embryos.
What does the HFEA require with regards to staff management processes?
The centre should establish documented procedures for staff management.
Staff records should be kept including job description, training qualifications etc.
Training, assesment etc is required of staff.
Does the HFEA give guidance on counselling?
The HFEA gives guidance on counselling including the offer of counselling, the provision of counselling and counselling records and confidentiality.
What information is the centre required to provide to gamete providers prior to consent?
Prior to giving consent gamete providers must be provided with information about:
The nature of the treatment,
It’s consequences and risks,
Any analytical tests if they are to be performed,
The recording and protection of personal data and confidentiality,
The right to withdraw and vary their consent,
The availability of counselling.
If no consent is in place because the person is unable in law to provide it, or is deceased what should happen regarding gamete procurement, storage and usage?
The gamete should not be procured, stored to used.
The centre should obtain written, informed consent before it uses a patient’s gametes for their own treatment or their partners treatment. For what other use would this consent be required?
For the use of the patients gametes for research and training.
When a women is to undergo an egg or embryo transfer the centre should…..
Obtain her consent for the proposed number of eggs or embryos to be transferred.
Record her consent in the medical records.
Written consent to the storage of gametes, embryos or human admixed embryos must…..
Specify the maximum period of storage (if less than the statutory period of storage).
State what should be done with gametes, embryos or human admixed embryos if the person giving consent dies or cannot, because of mental incapacity, withdraw or vary the terms of consent.
True or false. Patients have a right to decide what identifying information is disclosed and to whom.
True.
True or false? Consent is needed from any person who could be identified through disclosure of information about a persons treatment or the storage of gametes or embryos.
True.
