Life Sciences & Pharma

Meet your scientific research regulatory duties

Scientific research carries conditional regulatory duties on top of the universal workplace spine. This guide takes you through the five duties that apply depending on the type of work you do: COSHH for hazardous substances, GMO contained-use notification, animal research licensing, human tissue storage licensing, and ionising radiation controls. Each section tells you whether it applies to your operation.

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Related guides in Compliance & Legal

The duties in this guide are conditional — they depend on the type of research your laboratory carries out. A biotechnology lab working with genetically modified organisms and hazardous chemicals will trigger several of them; a social-science research team working from an office may trigger none. Read each section heading and if the condition applies to your work, follow the duty it describes. These duties sit on top of the universal workplace spine, not instead of it.

A. If you work with hazardous chemical or biological substances in the laboratory

The Control of Substances Hazardous to Health Regulations 2002 (COSHH) require you to assess and then prevent or adequately control exposure to hazardous substances — chemicals, biological agents (including those classified under COSHH Schedule 3), fumes, dusts and vapours. In a research laboratory that typically means assessing each experiment or process, providing fume cupboards, local exhaust ventilation and containment, and arranging health surveillance where the regulations require it. COSHH does not cover asbestos, lead or radioactive materials, which have their own regulations. The HSE regulates in Great Britain; in Northern Ireland the equivalent Control of Substances Hazardous to Health Regulations (Northern Ireland) 2003 apply.

B. If you carry out contained-use work with genetically modified organisms

Biotechnology laboratories carrying out contained-use work with genetically modified micro-organisms or larger GMOs must comply with the Genetically Modified Organisms (Contained Use) Regulations 2014. The first time premises are used for GM activities, you must notify the HSE, carry out a risk assessment and assign each activity to a class. Higher-class activities (class 3 and 4) require the HSE's consent before they may begin; class 2 activities require consent for the first use of the premises at that class. A genetic modification safety committee must advise on risk assessments. This regime applies only if you do GM work. In Northern Ireland the equivalent Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2014 apply.

C. If you conduct regulated procedures on protected animals

Any scientific procedure that may cause a protected animal pain, suffering, distress or lasting harm is regulated under the Animals (Scientific Procedures) Act 1986 (ASPA). You need three Home Office licences: an establishment licence for the premises, a project licence for the programme of work (assessed against the 3Rs — replacement, reduction and refinement — and a harm-benefit analysis), and a personal licence for each individual who carries out procedures. You must also appoint named persons (including a Named Veterinary Surgeon and a Named Animal Care and Welfare Officer) and maintain an animal welfare and ethical review body. ASPA is administered by the Home Office and applies across the whole of the United Kingdom.

D. If you store relevant human material for research

The Human Tissue Act 2004 regulates the removal, storage and use of relevant human material. If you store human tissue for research you generally need a licence from the Human Tissue Authority (HTA) for the premises where the material is stored. A key exception applies: storage for a specific research project that has approval from a recognised Research Ethics Committee does not require an HTA storage licence. Licensed establishments must meet the HTA's standards on consent, governance, traceability and premises, and appoint a Designated Individual responsible for compliance. The Human Tissue Act 2004 applies in England, Wales and Northern Ireland. In Scotland, the Human Tissue (Scotland) Act 2006 governs this area.

E. If you work with ionising radiation or radioactive substances

Laboratories using ionising radiation sources — X-ray equipment, sealed radioactive sources or open radioactive materials — must comply with the Ionising Radiations Regulations 2017 (IRR 2017). You must register your use of ionising radiation with the HSE (or notify, where the regulations require it), appoint a radiation protection adviser (RPA), carry out a prior risk assessment, restrict exposure so far as is reasonably practicable and keep doses below the statutory limits, classify and monitor workers where needed, and maintain dose records. Most R&D firms do not trigger this regime. The HSE regulates in Great Britain; in Northern Ireland the Ionising Radiations Regulations (Northern Ireland) 2017 apply.

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    1. Work out which of these duties your research triggers

    Read each section heading — if the condition applies to the work your laboratory does, you carry that duty.

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    2. Put COSHH controls in place for hazardous substances

    If you work with hazardous chemicals or biological agents, assess each experiment or process, provide containment (fume cupboards, LEV) and arrange health surveillance where COSHH requires it.

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    3. Notify HSE for GMO contained use and obtain consent for higher-class work

    If you do GM work, notify HSE of your premises, risk-assess each activity, classify it and obtain consent for class 3 or 4 activities before they begin.

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    4. Obtain Home Office licences for animal research

    If you conduct regulated procedures on protected animals, obtain establishment, project and personal licences from the Home Office.

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    5. Obtain an HTA licence if you store human tissue for research

    If you store relevant human material, obtain a licence from the Human Tissue Authority unless the material is held under a recognised Research Ethics Committee approval. In Scotland, follow the Human Tissue (Scotland) Act 2006.

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    6. Register with HSE and appoint an RPA for ionising radiation

    If you use ionising radiation sources, register with the HSE, appoint a radiation protection adviser, restrict exposure and monitor doses.

What to do next

With these conditional duties in place alongside the universal workplace spine, confirm the whole picture with the scientific research and development compliance checklist.

Official sources

Authoritative guidance on the regulatory duties for scientific research.