Research involving human embryos has always been controversial. The regulatory framework governing embryo research in the UK reflects a political compromise - allowing research but only under a licence granted by the Human Fertilisation and Embryology Authority (HFEA).

Notwithstanding such controls, however, the use of human embryos in research is still opposed by many. Both applications for and awards of HFEA research licences are scrutinised and sometimes contested by those fundamentally opposed to embryo research. This has sometimes led to a precautionary approach on the part of the regulator, reflected in a reluctance to grant licences in novel and contentious areas, though recent changes in the law have helped to clarify the HFEA’s remit in this area.

We advise universities, companies and clinics in relation to applications for HFEA research licences, HFEA licence committee procedures, regulatory investigations and litigation relating to research.

Our experience includes the following:

• Advising on the regulation and licensing of human embryonic stem cell research, including the relevant consent requirements and ethics approval;
• Advising on the regulation and licensing of mitochondrial DNA therapies;
• Acting in relation to the creation of human-animal hybrid embryos for research;
• Advising on intellectual property protection;
• Advising on consent, import, export, and storage requirements relating to embryos and stem cell lines; and
• Chairing an inquiry into a stem cell research governance matter.

See also:
Clinical trials
Human Tissue and Cells
Regulation
Cell-Based Therapies and ATMPs