Feature

Who regulates stem cell research in the UK?

By Wideacademy - 23.11.2017

Clinical Settings 2

Regulation is vital for medical research treatment, protecting patients and clinical trial participants while also safeguarding high quality, evidence-led research. However, regulation is only as effective as the bodies which devise and enforce it, so UK stem cell research is fortunate to benefit from robust, well-funded regulatory organisations.

The main bodies and their responsibilities, are:

The main regulatory organisations

The key organisations responsible for regulating stem cell research in the UK are the Human Tissue Authority (HTA) and the Human Fertilisation and Embryology Authority (HFEA).

These organisations are primarily responsible for setting the rules for stem cell research and licensing research facilities. They are supported in the approval and regulation of stem cell research by other organisations, such as individual Research Ethics Committees.

Regulation of stem cells for human transplantation

All tissues and cells that have the potential for human transplantation must be licensed by the HTA under the Human Tissue (Quality and Safety for Human Application) Regulations 2007.

As part of this responsibility, the HTA regulates the procurement, testing, processing, storage, distribution and import/export of the tissues and cells.

They are supported in the approval of cell therapies deemed medical products or medical treatments by the Medicines and Healthcare Products Regulatory Agency, while authorisation for individual trials and projects must be sought from Research Ethics Committees, using guidance provided by the National Research Ethics Service.

Additionally, a number of regional organisations – the West London and Gene Therapy Advisory Committee and its equivalents in Oxford, York and Edinburgh – provide ethical opinions on whether clinical trials for gene therapy and cell therapy should be authorised.

Regulation of stem cells for research only

When stem cells are to be used for research only, the establishment carrying out their procurement, storage, testing and processing must still be licensed by the HTA. The research projects themselves are approved on a case-by-case basis by Research Ethics Committees, similar to human transplantation projects.

In the case of research on stem cells gathered from human embryos, research must be authorised by the HFEA, who regulate the storage of the embryos. They require certain criteria to be met in order for a project to be granted a license. This focuses on the quality of research premises, the presence of consent by embryo donors and the purpose of the research.