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Clinical governance

The Human Fertilisation and Embryology Act [99] provided for the establishment of the Human Fertilisation and Embryology Authority (HFEA), the first statutory body of its type in the world. With the creation of the HFEA, the 1990 Act ensured the regulation, through licensing, of:

the creation of human embryos outside the body and their use in treatment and research
the use of donated gametes and embryos
the storage of gametes and embryos.

The Act was radically amended in 2008 (Human Fertilisation and Embryology Act [100]) to ensure that the legislative framework was in line with major technological, social and medical changes that had taken place since its original publication. Amendments included:

extending regulation to the creation and use of all embryos outside the human body, regardless of the processes used in their creation
increasing the scope of legitimate embryo research activities, i.e. allowing hybrid embryos to be created for research purposes
banning sex selection of offspring for non‐medical reasons
retention of a duty, when providing fertility treatment, to take account of the welfare of the child, but removal of the reference to ‘the need for a father’
recognizing same‐sex couples as legal parents of children conceived through the use of donated sperm, eggs or embryos (Birk [14]).

Human Fertilisation and Embryology Authority

The HFEA is the independent regulator of the licensing and monitoring of fertility clinics and research involving human embryos in the UK. In accordance with the Human Fertilisation and Embryology Acts ([99] and [100]), the Human Fertilisation and Embryology (Quality and Safety) Regulations ([101]) and the European Union Tissues and Cells Directive (European Parliament and European Council [59]), the HFEA provides authoritative information for the public, in particular for people seeking treatment, donor‐conceived people and donors. The HFEA also determines the policy framework for fertility issues, which are sometimes ethically and clinically complex.

European Union Tissues and Cells Directives

The European Union Tissues and Cells Directive, published in 2004 (European Parliament and European Council [59]), introduced common safety and quality standards for human tissues and cells across the European Union. The purpose of the directive is to facilitate a safer and easier exchange of tissues and cells (including human eggs and sperm) between member states of the European Union and to improve safety standards for European citizens.

Ethical considerations

Beyond the scientific processes in ARTs and cryopreservation, there are ethical considerations to keep in mind in the collection, storage and use of semen (Gong et al. [70]). The legal ownership of sperm as unfertilized gametes varies from country to country. However, ethical principles must respect the interests and welfare of those who will be born as a result of semen collection as well as the health and welfare of the donor (Gong et al. [70]).

Consent

Counselling and gaining informed consent are integral parts of all patient activities. Prior to the collection of semen for any reason, it is essential that practitioners gain fully informed consent (RCN [202]). Consent is a continuous process throughout any patient episode and the practitioner must ensure that the patient is kept informed at every stage (Stuart and White [233]). For semen collection, this includes:

informing the patient of the rationale for specimen collection
telling the patient what the procedure will involve
ascertaining the patient's level of understanding (especially if they need to be directly involved in the sampling technique)
telling the patient how long the results may take to be processed
telling the patient how the results will be made available
giving the patient information on how this may affect their care.

In the UK, if the donor is a child (i.e. under the age of 18 years), then the normal rules for gaining consent in this age group apply (Shaw [225]):

When obtaining consent, the person gaining consent must establish whether the child is legally competent (has capacity) to give consent.
All people aged 16 and over are presumed in law to have capacity unless there is evidence to the contrary.
However, as with adults, this does not mean that all 16‐year‐olds have capacity, and competence must be assessed along the following lines:
- Are they able to understand and retain the information pertinent to the decision about their care, i.e. the nature, purpose and possible consequences of undergoing or not undergoing the proposed investigations or treatment?
- Are they able to use this information to consider whether or not they should consent to the intervention offered?
- Are they able to communicate their wishes?

If a child is deemed not legally competent, consent will need to be obtained from someone with parental responsibility (Shaw [225]).