Life Sciences & Pharma

Scientific research and development: compliance checklist

Use this checklist to confirm your scientific research and development business (SIC division 72) meets its obligations. Work through the universal workplace items every R&D business shares, then the conditional items that depend on the type of research you do. If you answer no to any item, follow the linked guide before you proceed.

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Related guides in Compliance & Legal

Use this checklist to confirm your scientific research and development business meets its obligations. Work through each item and answer yes or no. If you answer no, follow the guide named in that item before you proceed.

Workplace health and safety is enforced by the Health and Safety Executive in Great Britain and by HSENI in Northern Ireland. The conditional regulatory duties have their own scope — each section names the body and jurisdiction that applies.

Section 1 — Every scientific research business (workplace and people)

These workplace and employment duties apply to every R&D business, whatever your discipline. Confirm each one.

  1. 1

    Have you written your risk assessments and put safe systems of work in place?

    Your general duty under the Health and Safety at Work etc. Act 1974 is to ensure, so far as is reasonably practicable, the health, safety and welfare of your people. Risk-assess laboratories, equipment, fieldwork and the substances or agents your people work with, and put safe systems of work, training and supervision in place. If not, follow "Set up and run a safe scientific research operation".

  2. 2

    Have you carried out your fire risk assessment?

    Assess the fire risk from flammable solvents, compressed gases, reactive chemicals and biological materials under the fire-safety regime for your nation — the Regulatory Reform (Fire Safety) Order 2005 in England and Wales, the Fire (Scotland) Act 2005 in Scotland, or the Fire and Rescue Services (Northern Ireland) Order 2006 in Northern Ireland.

  3. 3

    Do you hold employers' liability insurance?

    Hold at least £5 million of cover once you employ anyone and display or make available the certificate issued by your insurer.

  4. 4

    Do you meet your equality and data protection duties?

    Do not discriminate under the Equality Act 2010 (or separate NI equality law enforced by the Equality Commission for Northern Ireland); comply with the UK GDPR and Data Protection Act 2018, registering with the ICO unless exempt. The DPA 2018 provides specific safeguards for processing personal data for scientific research purposes.

Section 2 — Conditional duties (depending on your research)

These duties apply only if your research activities trigger them. Answer each one; if the condition does not apply to you, move on.

  1. 1

    If you work with hazardous chemical or biological substances, have you put COSHH controls in place?

    Assess each experiment or process, provide containment (fume cupboards, local exhaust ventilation) and arrange health surveillance where the Control of Substances Hazardous to Health Regulations 2002 require it. HSE regulates in Great Britain; COSHH (Northern Ireland) Regulations 2003 in Northern Ireland. If not, follow "Meet your scientific research regulatory duties".

  2. 2

    If you do GM work, have you notified HSE and obtained consent for higher-class activities?

    Notify HSE of your premises before first GM use, risk-assess each activity, classify it, and obtain consent for class 3 or 4 activities under the Genetically Modified Organisms (Contained Use) Regulations 2014. In Northern Ireland the equivalent 2014 Regulations apply.

  3. 3

    If you conduct regulated animal procedures, do you hold the three Home Office licences?

    Obtain an establishment licence, a project licence and personal licences under the Animals (Scientific Procedures) Act 1986. Appoint named persons 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.

  4. 4

    If you store human tissue for research, do you hold an HTA licence or Research Ethics Committee approval?

    Obtain a Human Tissue Authority licence for the premises where human tissue is stored, or confirm the material is held under a recognised Research Ethics Committee approval (which exempts you from the storage licence). The Human Tissue Act 2004 applies in England, Wales and Northern Ireland. In Scotland the Human Tissue (Scotland) Act 2006 governs this area.

  5. 5

    If you use ionising radiation, have you registered with HSE and appointed an RPA?

    Register your use of ionising radiation with the HSE, appoint a radiation protection adviser, carry out a prior risk assessment, restrict exposure and monitor doses under the Ionising Radiations Regulations 2017. In Northern Ireland the Ionising Radiations Regulations (Northern Ireland) 2017 apply.

If you answered no to anything

Work through the guide named in that item before you proceed. The two task guides — "Set up and run a safe scientific research operation" for the universal spine, and "Meet your scientific research regulatory duties" for the conditional duties — set out what to do. Start from "Which scientific research and development regulations apply to your business" if you are not sure which apply to you.

Official sources

Authoritative guidance for scientific research regulation.