What if I need to use animals for my research?
Experimentation on animals is highly regulated in the UK and if you do need to use animals for your research you will need a personal licence, for which you will have to undergo training, and a project licence which gives the details of your research. In addition the establishment where you carry out the experiments needs to be licensed under a Certificate of Designation.
- Personal licence
The training that you must undergo before obtaining a licence is organised into modules. Even if you are an experienced researcher with a qualification in laboratory science from outside the UK, you will still be required to complete one or more modules to ensure that you are familiar with UK regulations. You can find out more about applying for a personal licence on the Home Office website
- Project Licence
If you will be working on a project which is already running, the project licence should have been granted. However, if you plan to alter the number or type of animals which will be used, or the experimental procedures, you will need to apply for an amendment to the licence. If you are starting up a different project, you or your group leader must apply for a new project licence
- Certificate of Designation
Every establishment where scientific procedures on animals will be performed must hold a Certificate of Designation. The holder of this is responsible for ensuring that training is available for staff, and appropriate standards of animal welfare are upheld. If you are unsure whether the place where you work/intend to work holds a Certificate of Designation, you should contact the administration.
Ethical considerations
Co-ordinated by the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), the relevant research councils and major charitable funding bodies have published guidelines for using animals in bioscience research. This is available online here.
Animal rights extremist groups
The animal rights movement is very active in the UK, and contains some extremist elements. Although legislation exists to prevent the harassment of people carrying out legitimate animal research, in some cases it may be advisable not to discuss your research in public.
You can find out more about UK government policy on animal experimentation at the home office Animals in Scientific Procedures site
What about working with humans or human tissue?
Working with humans or human tissue
All medical doctors must be registered with the General Medical Council and this also produces guidance on good medical practice. In addition, any research involving human subjects or using human tissue or biological samples is subject to strict regulations and guidelines. On 1 May 2004, the Medicines for Human Use (Clinical Trials) Regulations 2004 came into force, and these help to protect the rights, safety and well-being of clinical trials subjects.
The MRC have produced a series of guidelines outlining good clinical and laboratory practice, as well as the legal and ethical issues surrounding the use of humans and human tissue in research.
Research using human embryos/embryonic stem cells
The Human Fertilization and Embryology Authority and the Human Tissue Authority regulate research involving human embryos, including work on human embryonic stem cells.
The first version of an Interim UK Regulatory Route Map for Stem Cell Research and Manufacture has been released jointly by UK regulators as a reference tool for those who wish to develop a programme of stem cell research and manufacture, ultimately leading to clinical application. You can access this online on the Department of Health’s Gene Therapy Advisory Committee pages
What about safety in the laboratory?
Safety in the laboratory is primarily the responsibility of the employer, and different institutes often differ slightly in their policies, although all must adhere to the Control of Substances Hazardous to Health Regulations (COSHH) You may find it useful to be aware of some of the types of additional training or record-keeping that may be necessary in certain lines of scientific research.
Working with radioactivity
Most universities and institutes have their own local policies on the use of radioactivity, so check with your employer what these are. You may be required to undergo a training course before you start to work with any sources of radioactivity, and when you do start work you will need to be monitored to ensure that you are not being overexposed.
If you would like to know more about regulations regarding health and safety at work you can visit the homepage of the Health and Safety Executive
What are the regulations regarding Genetically Modified Organisms (GMOs)?
There are strict regulations controlling the generation and use of Genetically Modified Organisms (GMOs) in order to protect the environment and ensure the health and safety of researchers and the public at large. The legislation depends on whether the GMOs are contained, for example in a laboratory, or released into the environment.
The Health and Safety Executive (HSE) regulates the use of contained GMOs and places legal requirements on anybody who works with GMOs in a contained unit. These requirements focus on risk assessment and accurate record keeping, and can be read in detail on the HSE website
The Department for Environment Food and Rural Affairs (DEFRA) is responsible for regulations regarding the deliberate release of GMOs into the environment and you can find more information on the DEFRA website
What about safety for pregnant women in the lab?
The laboratory environment may be associated with extra risks for women who are pregnant or breastfeeding; for example, exposure to radioactivity, solvents or teratogenic substances. If you are pregnant or have given birth within the last six months you should notify your employer and they must carry out a risk assessment specific to you, taking into account any advice given to you by your doctor or midwife. Any identified risks to you or your child must be removed or controlled. You can contact the Health and Safety Executive for more details on this subject.