Regulations and Safety
Some areas of research require extra consideration because of the use of sensitive or dangerous material, and you may need to be aware of specific regulations governing your research. If you plan to work with animals you will need a special licence and if you will use human subjects or tissue, you should be aware of the ethical and legal aspects surrounding your work. Safety is also an issue in scientific research and here you can read about some of the health and safety policies regarding working with radioactivity and genetically modified organisms, and also about working in the laboratory whilst pregnant or breastfeeding.
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.
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
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
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
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
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.