.

Regulatory

Research doctor

All research within the NHS is governed by the Research Governance Framework for Health and Social Care.

All projects carried out at London North West Healthcare NHS Trust that involve staff, patients, public, carers, their data, tissue, Trust premises, facilities,  will all be subject to local and national policies. Appropriate advice and support from R&D department must be sought at the planning stage of any research to be undertaken at the Trust. No research may be undertaken without R&D NHS Permission.

Some research projects will require regulatory approval from other statutory bodies over and above the standard favourable ethical opinion and R&D NHS Permission. 

For multi centre projects, these regulatory approvals will normally be acquired by the sponsor of the project, and the local investigators will merely need to provide evidence to the ethics committee and R&D department that the relevant approvals have been obtained.


Studies involving genetic material

Applications to conduct clinical trials involving gene therapy must be submitted to the Health Research Authority (HRA). Applications for  studies requiring genetic material should be made via the IRAS application form. 

Developments in gene therapy research and their implications;

  • Researchers should be aware that all gene therapy is considered as research, and recruitment of patients into research studies takes place under strict rules set out by Gene Therapy Advisory Committee. They can be contacted through HRA.
  • HRA approval must be obtained before somatic cell gene therapy (i.e. on any cell other than the sperm or egg cells) or gene transfer research, is carried out.
  • Applications to conduct clinical trials involving gene therapy should be submitted to the HRA. Protocols submitted less than 60 days before the next full committee meeting will be considered at a subsequent meeting.

Studies involving human emryological material

The Human Fertilisation and Embryology Authority (HFEA) licenses and monitors all human embryo research being conducted in the UK.

The Human Fertilisation and Embryology Act 1990 requires the HFEA to regulate the creation, storage and use of embryos in research throughout the UK.The Act was amended in 2001 to allow the use of embryos for stem cell research and consequently the HFEA has the responsibility for regulating all embryonic stem cell research in the UK.This Act was amended again in 2008 and came into affect in April 2010 under the Act, any research must relate to one or more of the following purposes:

  • To promote advances in the treatment of infertility
  • To increase knowledge about the causes of congenital diseases
  • To increase knowledge about the causes of miscarriage
  • To enhance knowledge in the development of more effective contraception
  • Detection of genetic or chromosomal abnormalities before implantation
  • To increase knowledge about the development of embryos
  • To increase knowledge about serious disease or to enable any such knowledge to be applied in developing treatment for serious disease.

The procedures for obtaining a research licence is a five stage process and further information can be found on HFEA website.


London North West Healthcare NHS Trust requires all researchers in the Trust to be trained and certified in Good Clinical Practice (GCP) when undertaking clinical trials.The Trust encourages all researchers working on non-clinical trial projects to obtain GCP training. For information on how to access GCP training please contact the R&D Office.