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responsibleresearchManaging health and safety in research:

guidance for the not-for-profit sector


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The Universities and Colleges EmployersAssociation and the Universities Safetyand Health Association have workedwith the Institution of OccupationalSafety and Health, the MedicalResearch Council and others to produceuseful guidance that covers a widerange of research fields.

Responsible research is designedprimarily for researchers in the UK, butthe principle of following the Plan-do-check-review cycle when managinghealth and safety in a researchenvironment is universal.

This guide can be downloaded atwww.iosh.co.uk/ushaguide

October 2012

Responsible research: managinghealth and safety in researchThis guide aims to help anyone whoneeds to ensure good health andsafety performance in a researchenvironment. It provides heads ofdepartment, principal investigators andresearchers with:- examples of responsibilities and

management approaches- advice on safety culture and risk

assessmentcase studies showing key issues that

need to be considered.

IOSH regularly commissions

research to strengthen the

evidence base for health and

safety management. We are

therefore pleased to support

the Universities Safety and

Health Association in

publishing and hosting this

guide to responsible research,

developed not just for

occupational safety and

health researchers, but

research teams working in

every discipline.

Responsible research joins

IOSHs range of authoritative,free guidance, available at

www.iosh.co.uk/techguide.


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Contents

030408

1214183033

04

08

17

IntroductionManagement and responsibilitiesUsing a management system approach to managehealth and safety in researchSafety cultureRisk assessmentCase studiesGlossaryFurther reading and sources of information

FiguresTypical line management structure in a college,university or research organisationA health and safety management system basedon the Plan-do-check-review frameworkThe risk assessment process

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45678

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2

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Reviewing panelChair: Marion Richards, Director of Health and Safety, Sussex University (Universities Safety and Health Association)

Daniel Harrison, Safety, Health and Wellbeing Advisor, University of Westminster (University Chemical Safety Forum)

Mike Stephens, Head of Safety, Security and Resilience for the Medical Research Council (Research Councils UK)

Heidi Alderton, Assistant Safety Officer, London School of Hygiene and Tropical Medicine (ISTR)

Kevin Joyce, Health and Safety Advisor, Faculty of Engineering and Physics, University of Surrey

Mike Lockyer, Radiation Protection Officer, University College London

Portions of this document were originally produced as part of the HSC document Managing health and safety aspects of research in higher andfurther education and therefore are subject to Crown copyright. The content of Responsible research is in line with advice from the HSE formore details go to www.hse.gov.uk/managing/index.htm .

02

Forewords

This guidance updates the Health and Safety Executive (HSE)Education Schools Advisory Committee (ESAC) guidanceissued in 2000: Managing health and safety aspects ofresearch in higher and further education.

Much has changed since that guidance was introduced, andthis is reflected in the approach taken here. A lot of thegeneral health and safety guidance contained in the originalHSEESAC publication is better covered in other documents,such as Successful health and safety management(HSG65).Therefore, this new guidance focuses on the role of theprincipal investigator and aims to support researchers byproviding examples of good practice.

The reviewing panel reflected this change in emphasis,asking representatives of the broader research communitynot only to contribute to the general document but also toprovide up-to-date case studies in each of their specialisedresearch fields (see membership list below).

We hope this document will be used to promote goodpractice in all areas of research and that more case studieswill be added to complement those contained within theguidance.

Clive ParkinsonChairUniversities Safety and Health Association

Director of Health and SafetyUniversity of Surrey

This document is the latest in a series produced by and forpeople working in the higher education sector. As withprevious documents, it is produced in a partnership betweenthe Universities and Colleges Employers Association and theUniversities Safety and Health Association. This time, due tothe broad nature of the research, allied not-for-profit healthand safety associations and the Medical Research Councilhave also collaborated on the project.

It is important that such guidance should be widelyaccessible, so we have worked with the Institution ofOccupational Safety and Health (IOSH), which has kindlyedited and designed this document and is hosting it on itswebsite. These new partnerships are welcomed, andreinforce the high esteem that others place on the guidanceproduced by the sector.

As always, institutions are free to choose how they applythis guidance. However, we hope it will be of particular useto heads of department and principal investigators.

The case studies are designed to show the key issues thatneed to be considered in particular fields of research. Whileit is impossible to cover every eventuality, we hope that the

principles will be applicable across a wide range of researchfields. Indeed, the authors will welcome additional casestudies that can be added to this guidance in the future.

Professor Chris GaskellChair, Health and Safety CommitteeUniversities and Colleges Employers Association

PrincipalRoyal Agricultural College


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1 Introduction

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A typical management structure in aresearch organisation is outlined inSection 2, which also summarises thehealth and safety duties andresponsibilities for each managementlevel.

Section 3 introduces the concept ofusing a management system approachto health and safety in research, andSection 4 addresses the importance ofa positive safety culture. Section 5outlines the risk assessment andcontrol process.

Case studies in section 6 illustrate howhealth and safety can be effectivelymanaged in a range of researchdisciplines.

A glossary of terms used in thisguidance and the sources of referenceaccessed during its compilation can befound in the final sections.

Research is about investigating newavenues of knowledge, and this carriesan unavoidable element of theunknown. The outcome of researchwork can be uncertain or can differfrom what was originally predicted.

Health and safety legislation appliesjust as much to research as it does toany other area of industry. Despite theinherent elements of uncertainty, it ispossible for research workers to innovatewithout exposing themselves or othersto unnecessary health and safety-related risks. Sensible managementsystems, together with suitablepractical training for those involved, areessential to providing a framework inwhich people can work safely.

This guidance was written for highereducation institutes and researchcouncils engaged in research. However,all organisations involved in research work

in the not-for-profit sector, such asfurther education establishments,research charities and the National HealthService, may find it useful in helping tounderstand their responsibilities underhealth and safety law, and providing abasis for good practice.


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Its important to set out theresponsibilities for health and safety ina college, university or researchorganisation. Health and safety law inthe UK places responsibilities onemployers, employees and thirdparties, and everyone in theorganisation needs to know who isresponsible for what.

All researchers in a researchestablishment must:- take responsibility for their own

health and safety and ensure thatthey dont compromise the healthand safety of others by the thingsthey do or fail to do

- work safely and efficiently- follow the organisations policy,

guidance and safe systems of work- attend training and put it into

practice in the workplace- risk-assess, or assist with the risk

assessment of their work- use protective equipment as

recommended- not change research or other work

protocols without first discussingthe change with their manager andspecialist safety advisers asappropriate

- report incidents that have resultedin, or could have resulted in, injuryor damage

- assist in the investigation ofaccidents with the aim of

introducing preventative measures- report unsafe conditions or actions- work co-operatively to improve

health and safety standards andperformance.

The executive structure the layers ofmanagement between the top of theorganisation and the people doing theresearch activities will vary with eachresearch organisation, as will individualresponsibilities for health and safety ateach level.

Vice Chancellor (VC), ChiefExecutive Officer (CEO) or boardThe VC/CEO is ultimately responsiblefor:- the health, safety and welfare of all

those involved in research orproviding research support

- the health and safety of visitors toestablishments under their controlor anyone who may be affected bythe organisations activities

-

setting the organisations healthand safety policy, which should: identify the organisations

intentions, responsibilities andarrangements for managing andmonitoring health and safetyidentify how competent healthand safety advice will beobtained and show that healthand safety will be adequatelyresourced

state how effective methods ofconsultation, co-operation and

assurance of competence willbe achieved for researchers,visiting workers, students etc.

Directors of research andheads of schoolDirectors and heads should ensure that:- health and safety policies, guidance

and arrangements relevant to theexpected risks in the research orwork area are in place rememberthat directors are also employeesand are owed the same duty ofcare as all research staff

- their school or directorates health

and safety objectives are planned- comprehensive risk management,

identification and control programmesare in place, indicating how higherrisk activities such as researchinvolving hazardous equipment orsubstances, lone working orfieldwork will be managed

- reports on health and safetyperformance are fed back to theVC/CEO at agreed intervals

- individual responsibilities for healthand safety are allocated

appropriately and performance isreviewed as part of the annualappraisal

2 Management and responsibilities

04

Figure 1: Typical line management structure in a college,university or research organisation

3 Subject leader/researchprogramme leader

5 Post-doctoral researcher/research supervisor

4 Principal investigator

6 PHD student/researcher

7 Project student/trainee researcher

1 Vice-Chancellor/Chief Executive

2 Head of school/Director of research

Research support

Many research organisations willhave in-house research support

activities, such as administration,estates and facilities managementservices and procurement. Others

may use an external provider or beco-located with other researchorganisations in a research hotel,

where support services are shared.

Organisations sharing premises or

services, or using externalcontractors, should have clearmemoranda of understanding

about the responsibility andarrangements for health, safetyand security


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- the composition of general orspecific health and safetycommittees or special interestgroups is established and tradesunion representatives are consultedon health and safety matters

- systems are in place for identifyingtraining needs and providingappropriate training and supervisionfor research staff and others in theworkplace

- the general and specific health andsafety arrangements for contractors,visiting workers and visitors areexplicit and communicatedeffectively

- appropriate permits and licences areobtained before the research, andrecords of authorisation, training,incidents and maintenance are kept

- appropriate planned, preventativemaintenance regimes are in place

- policy and guidance details howhealth and safety management will

be monitored using appraisal,reporting arrangements, inspection,health surveillance, incident andwork-related ill health reports,incident type analysis and audit

- the sanctions for not followingorganisational and school ordirectorate policy or codes ofpractice are made clear to all.

Programme leader/research leaderThe programme or research leader is

responsible to the head of school ordirector of research for the safe andlegal conduct of research under theirremit. This responsibility cannot bedelegated. As with all people workingin the research environment, theprogramme leader is responsible fortheir own safety and the safety ofothers who may be affected by theirunsafe acts or omissions. Programmeleaders should ensure that:- they employ competent researchers,

training needs are assessed and

training is available, both in generalhealth and safety issues (such asrisk assessment) and specific

techniques or situations wherethere is significant risk (such as theuse of lasers or conducting researchin the community)

- special permission or licensingarrangements required for the workare in place

- appropriate supervision is availablefor researchers and researchsupport workers, depending on therisk of the activity and the age andexperience of the individual

- programmes of work have beenrisk-assessed and the health andsafety of researchers and others willnot adversely be affected by knownor emerging risks

- individual responsibilities for healthand safety are allocatedappropriately and performance isreviewed as part of the annualappraisal. Only principalinvestigators meeting the requiredstandards are allowed to supervise

PhD students- consideration is given to the health

and safety management, trainingand communication arrangementsfor researchers with disabilities or forthose whose first language isntEnglish

- robust emergency plans are in placefor the workplace and researchactivities which pose high safetyrisks

- they are made aware of reported

incidents and near misses and willensure that appropriate actions aretaken to prevent a recurrence

- they are informed about theoutcome of safety performancemeasures such as inspections, safetytours, health surveillance,compliance with risk controlsystems and safe systems of work,training events attended, work-related injury and ill-health figures

- they take the appropriate actionsrecommended by audit findings of

non-conformance

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- they set an example by their ownbehaviour and are prepared to takeaction if health and safety iscompromised by the things theirresearchers do or fail to do.

Principal investigators (PIs)PIs are generally experts in their field ofresearch and are expected to have up-to-date knowledge about the risksassociated with their research area.They are responsible to the programmeleader and the director or head ofschool for the health and safety oftheir researchers and others who maybe affected by the research activities.PIs should:- be aware of the legal requirements

for their area of research and beable to identify and manage therisks in their field of work

- ensure that all people under theirdirection have adequateinformation about the risks and risk

controls that apply to their work,and that relevant training andsupervision arrangements are inplace

- ensure their research supervisorsand post-doctoral researchers aretrained in risk assessmenttechniques and are competent tosupervise others in their researchactivity

- monitor workplace safetycompliance and draw their

managers attention to deficienciesin health and safety management,such as unsafe acts or conditions,failure to follow safe systems ofwork, a lack of plannedmaintenance or inadequate facilities

- enforce health and safety standardsand codes of practice and set agood example to their research staffand others in the workplace.


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Post-doctoral researchers/researchsupervisorsPost-doctoral researchers and researchsupervisors should be competent in theresearch area and aware of the risksinherent in the techniques, equipmentand methods they use. They should betrained to:- carry out risk assessments and

communicate information on risksand control measures to theirresearchers and others affected bythe research

- understand the institutions policies,procedures and committeestructures

- be effective supervisors supportive, good at coaching andmentoring, excellent role modelsand take appropriate actions whenmade aware of health and safetymanagement failures

- contribute to the investigation ofaccidents and near misses that have

affected their research teams

- use safe laboratory and workpractices and safe systems of workand reinforce the importance ofgood housekeeping andoccupational hygiene.

Although post-doctoral researchersmay be given day-to-day responsibilityfor ensuring that research is carried outwithout causing unacceptable risks tohealth and safety, the overall healthand safety responsibility flows throughthe line management chain andultimately rests with the VC/CEO of theorganisation.

Project students and traineeresearchersTrainee researchers cant be assumedto be aware of the health and safetyrisks of the research or workplace andmust be trained and supervised untilthey are competent to work withoutdirect supervision.

Research support workersIts important to establish the risks theresearch poses to the health and safetyof research support staff and otherswho may be affected in theorganisation. As with researchers,responsibility for the health and safetyof employees flows up the linemanagement chain to the VC or CEOof the employing organisation. Therisks the research activity could presentto cleaners, maintenance staff,engineers, technicians and so on mustbe assessed and adequate risk controlmeasures put in place before theresearch project starts. Researchsupport workers must be informedabout relevant risks, associated riskcontrol measures and their personalresponsibility for health and safety.They should also be competent todischarge their duties without causingharm to themselves or others.

A reasonably foreseeable risk is one that, if realised, couldresult in injury or damage, and which could be predictedby a reasonable person with the necessary skills andknowledge.

Legal courts dealing with health and safety cases have todetermine whether an unplanned incident was reasonably

foreseeable. Employers must seek to identify and evaluateforeseeable risks.

This is not always as easy to judge as it first seems; issuesof strict liability can complicate some cases, and case lawhas evolved to help determine what is reasonablyforeseeable. For instance, frivolous acts which result ininjury or damage, by employees that have beenappropriately trained and provided with the correctequipment, and where the employer has no expectation

that the employee would act in this way, would notnormally be considered foreseeable.

Reasonable foreseeability


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Health and safety legislationin the UKThe Health and Safety at Work etc Act1974 (also referred to as HASAW orHSW) is the primary piece of legislationcovering occupational health andsafety in the United Kingdom.

Statutory instruments (generallyregulations) are the secondary type oflegislation made under specific Acts ofParliament. These include therequirement to address the risks posedby working with dangerous substances,equipment, noise, ionising radiation andso on. Most of this legislation is goal-setting it sets out the standard to beachieved and leaves it up to the duty

holder to decide how to do this.Regulations are generally accompaniedby codes of practice or guidance, whichcan be used to help direct the researchorganisation towards compliance.

The HSW Act and associatedregulations are criminal laws. Thereforea breach of health and safetylegislation is generally a criminaloffence that carries penalties includingfines, imprisonment and a range oforders such as community,compensation, remedial action anddisqualification.

The HSE is the independent regulatorof occupational health and safety

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The HSW Act and other safety legislation impose certainduties and responsibilities on employers and duty holderswith respect to the health, safety and welfare of theiremployees and others who may be affected by their activity.

Some of these duties are absolute and must be compliedwith, such as the duty of employers to undertake asuitable and sufficient risk assessment of work-relatedrisks. But some are qualified bythe phrases so far as ispracticable and so far as is reasonably practicable. Themeanings of thesephrases have been established by caselaw.

To carry out a duty so far as is reasonably practicablemeans that the degree of risk in a particular environment oractivity can be balanced against the time, trouble, cost andphysical difficulty of taking measures to avoid the risk. Thegreater the risk, the greater the rigour that may beexpected to control it.

The duty to take reasonably practicable measures is one of

the most widespreadrequirements in modern UK healthand safety law. One example can be seen in Section 13 ofthe Workplace (Health, Safety and Welfare) Regulations1992, where it states that reasonably practicable measuresshould be put in place to stop people falling or being struckby falling objects in the workplace.

So far as is practicable, without the word reasonably,implies a stricter standard. This duty embraces whatever istechnically possible in light of the knowledge that the dutyholder had, should have had, or had access to at that time(ignorance is no defence). The cost, time andtrouble

involved must not betaken into account. Again referring tothe risks of falls, Section 13 of the Workplace Regulationsgoes onto stipulate: Sofar as is practicable, every tank,pit or structure where there is a risk of a person in theworkplace falling into a dangerous substance in the tank,pit or structure, shall be securely covered or fenced.

For most research sectors, the risk control measuresrequired from the employer are reasonably practicable.

Absolute, so far as is practicable and so far as is

reasonably practicable responsibilities

legislation in the UK. It initiates orrecommends enforcement actionagainst employers who breach theirstatutory health and safety duties.

Additionally, an employee who isharmed at work may make a civil claimfor compensation against theiremployer. An employer has a legal dutyto protect the health and safety oftheir employees at work (so far as isreasonably practicable) and to abide bythe statutes governing occupationalhealth and safety. If they fail in theseduties they may be liable to a claim fordamages by the person who has beenharmed or suffered loss.


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The Management of Health and Safetyat Work Regulations 1999 requireemployers to have suitablearrangements in place for theeffective planning, organisation,control, monitoring and review oftheir risk identification and controlsystems. At the time of publicationthere is an approved code of practiceand guidance supporting theRegulations, which recommends thatthese arrangements are incorporatedinto an overall organisational healthand safety management system. This isalso the approach recommended by

the HSE document Successful healthand safety management(HSG65).

The case studies in this guidanceillustrate how to manage health andsafety in various researchenvironments, based on the Plan-do-check-review management systemframework.

In a system intended to manage thehealth and safety aspects of a researchproject, this means putting in placeorganisational health and safety policyand guidance and:

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3 Using a management system approach

to manage health and safety in research

Continualimprovement

DoImplement the health and safetymanagement processes and plans.

Undertake the planned activities which

represent the practice of the system

ReviewIdentify whether the system formanaging risk in the researchenvironment is working as intended

and meets the needs of theorganisation. This can be done throughindependent audit or internal review.

The information gathered can be usedto shape health and safety plans for

the next period of research activity

CheckUse reactive data such as near miss, injuryand ill-health figures, and active data such

as routine inspections, training data and theexistence, quality and awareness of riskassessments, to systematically identify trends

and non-conformances for corrective action.

Instances of good practice should also be

noted and positive feedback given tothose involved

Define the health and safetyarrangements, the organisationalstructure and the health and safety

responsibilities of managers,

researchers and others inthe organisation

Indicate how appropriate levels ofcompetence and effectivecommunication, co-operation and

consultation will be achieved

- Planning the health and safetyarrangements for the activity Plan

- Implementing the planned healthand safety controls and carrying outthe activity Do

- Checking that the arrangementsand controls put in place to stopinjury, damage and ill health areworking as planned Check

- Reviewing the activity to ensurethat the health and safetyarrangements were adequate andproportionate and then feeding anychanges into the next researchactivity Review.

PlanPlan a system of hazard identification,risk assessment and risk control,emergency preparedness and response.

Consider issues such as security,research authorisation and sustainabilityduring the planning process.

Allocate responsibilities for theoperational control arrangements for

research activities

Policy setting

Publish a statement of commitmentto, and allocation of resources for,health and safety management

Figure 2: A health and safety management system based on the Plan-do-check-review framework


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Research often involves the use of materials, equipment,data or processes which could be harmful to people orthe environment if access to them was not controlled, orif the organisation did not have measures in place toprevent their escape or loss.

Organisations undertaking research must plan and deploysecurity arrangements that will prevent accidental access,loss or escape and the deliberate misappropriation of

research materials etc.

Safety legislation and guidance may give direction on thesecurity required for specific research activities and someresearch is governed by notification, authorisation,permitting or licensing schemes. For example, researchersare not allowed to buy drug precursors or chemicalweapon precursors unless their organisation has theappropriate Home Office licence; counter-terrorism officerswill visit organisations planning work with high riskbiological or radioactive materials to make sure security isadequate before the research can proceed.

Security measures and the authorisation or permissionrequired for the research project should be determined atthe planning stage. The project risk assessment shouldconsider whether the general security arrangements areenough or if moreneeds to be done.

The UK environment agencies*, the Department forEnvironment, Food and Rural Affairs (Defra:www.defra.gov.uk), the Home Office

(www.homeoffice.gov.uk), the HSE (www.hse.gov.uk)and the National Counter Terrorism Security Office(NaCTSO: www.nactso.gov.uk) are all involved in variousaspects of security in research, and the relevant agencyshould be contacted if the researcher needs securityadvice. The HSEs role is limited to advisingon mattersrelating to restricting access to prevent inadvertentexposure or loss of sensitive materials.

Security

Many research projects need specific permits, approvals orauthorisation before they can proceed. Specialist advisersin a range of disciplines can advise on how to meet therequirements of regulators and enforcing authorities, andhow to conduct the research with the risks controlled sofar as is reasonably practicable.

The requirement to have access to specialist advisers, aswell as the responsibilities and duties of these advisers,may be detailed in safety guidance or regulation. Forexample, the guidance supporting the GeneticallyModified Organisms Regulations states that organisationsconducting research involving genetically modifiedorganisms (GMOs) should appoint a competent person,such as a Biological safety officer to advise on thenotification requirements, containment and safe use ofthe organisms. Research organisations must consult with a

Radiation protection adviser if they need advice oncomplying with the Ionising Radiation Regulations 1999,or if the activity of the radioactive substances usedexceeds certain levels.

In many research organisations, projects involving the useof GMOs or radioactive substances are approved by

specialist safety committees, with the specialist advisergiving their expert opinion on the particular risks inherentin the project and what risk controls or authorisation,permits etc are required before the research can proceed.

In addition to radiation protection advisers and biologicalsafety advisers, research organisations may employ orhave access to the services of specialist advisers forresearch involving such things as lasers, chemicals, humantissues or the transport of dangerous goods.

Specialist advisors and safety committees

*There are three environment agencies in the UK: the Environment Agency (www.environment-agency.gov.uk), the Northern IrelandEnvironment Agency (www.doeni.gov.uk/niea) and the Scottish Environment Protection Agency (www.sepa.org.uk ).


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By law, emergency plans must be put in place for researchactivities where failures or dangerous incidents present asignificant risk to researchers, research support workers,maintenance workers and other building users, if notalready addressed by the organisations general emergencyplans.

Some statutes contain an explicit requirement for acontingency plan. For example, the Ionising RadiationRegulations 1999 require the development of acontingency plan to secure, so far as is reasonablypracticable, the restriction of exposure to ionisingradiation and the health and safety of people who may beaffected by such an incident. The plan should bedocumented within the local rules.

Its also good research practice to make sure contingencyplans are in place to prevent emergencies or otherunplanned events resulting in research sample or dataloss. Several universities have experienced catastrophicevents such as major fires and floods that have causedirrecoverable loss of data, samples, artefacts andmaterials, and signalled the end of particular researchprojects.

Contingency arrangements such as alarms, emergencygenerators and off site data and sample storage can helpameliorate potential loss.

Emergency planning and business continuity

Nanotechnology is a term for the research, developmentor use of physical substances with at least onecharacteristic dimension of 1100 nm. These can bedefined as nanomaterials and their properties may differfrom those of the same materials with micron- or mm-scale dimensions. Nanomaterials such as nanotubes,nanodevices, nanowires and nanoparticles can bephysically and chemically manipulated for specificapplications and are used in a variety of researchenvironments.

Research into the properties of nanomaterials hasindicated that some may cause hazardous physical effects

when inhaled or ingested. However, the extent of therisk they pose to human health has not been fullyestablished.

The HSE recommends a precautionary approach whenworking with nanomaterials, meeting the legislativerequirements of the Control of Substances Hazardous toHealth Regulations (human health risk assessment andcontrol) and, where appropriate, the Dangerous andExplosive Atmospheres Regulations. Many approaches toidentifying and controlling nanotechnology risks arepresented in the HSE document, Risk management ofcarbon nanotubes, which is available on the HSE website.

The UK Nanotechnology Safety Forum has worked withthe HSE, the Environment Agency and the Institute ofOccupational Medicine to produce Working safely with

nanomaterials in research and development(www.safenano.org/UKNanosafetyPartnership.aspx),which offers unified safety guidance.

Research involving nanotechnology


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The Control of Artificial Optical Radiation (AOR) at WorkRegulations 2010 require employers to protect the eyesand skin of researchers and others in the researchestablishment from exposure to hazardous sources ofartificial optical radiation.

AOR includes light emitted from all artificial sources in allits forms such as ultraviolet (UV), infrared and laserbeams, but excludes sunlight.

Hazardous light sources likely to be present in researchenvironments are UV transilluminators, fluorescencesystems and Class 3B and Class 4 lasers, as defined inBritish Standard BS EN 60825-1. Many other artificial light

sources can cause harm, and some sources which are notnormally hazardous can cause eye and skin damage if notused properly.

The law requires that hazardous optical radiation risks tothe skin and eyes of researchers is controlled to as low alevel as is reasonably practicable.

Further guidance on the regulations, their requirementsand practical control measures can be found in theGuidance for employers on the Control of Artificial OpticalRadiation at Work Regulations 2010, available on the HSEwebsite (www.hse.gov.uk).

Working with sources of optical radiation

Under these Regulations, specified injuries, diseases anddangerous occurrences must be reported to the HSEwithin a defined time. The most common reports will befor anyone who is injured in connection with work and isabsent from work or cant carry out their normal dutiesfor more than seven days (not including the day of injury).

Certain occupationally-acquired diseases must also be

notified this does not include minor common infectionsthat circulate in the community.

Dangerous occurrences that require reporting are rare inthe research community but would include incidentswhich have or could have resulted in the release orescape of a substance such as a chemical or biologicalagent likely to cause severe human harm.

Reporting of Injuries, Diseases and Dangerous

Occurrences Regulations (RIDDOR) 1995

11


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4 Safety culture

- researchers have the opportunity tocontribute to the development ofsafe systems of work andappropriate risk control measures

- researchers are made aware of theimportance of reporting accidents,near misses and dangerousoccurrences

- reporting systems are easy to useand those reporting incidents arenot punished for occasional slipsand lapses

- it is recognised that accidents andnear misses can be used as learningopportunities and can signpost thatmore training is required or thatsystems of work should bemodified.

Supporting safe research- Recruitment, selection, training and

awareness processes andprogrammes employ and developsafe researchers.

- Researchers have the knowledge,skills, tools and equipment to worksafely.

- Researchers appreciate why safeworking is important andunderstand what sanctions are inplace for those who worknegligently and compromise healthand safety.

- Researchers and their supervisorshave access to specialist help andadvice.

the organisation, senior management,heads of school and research directors.The policy should include:- allocated responsibilities and clear

arrangements- a high level of visibility from senior

managers with respect to supportfor health and safety

- a health and safety committeechaired by a member of theexecutive group

- a just reporting system- a commitment to learn from

incidents, audits and performancereviews and to make any changesrequired for the ongoingimprovement of health and safetymanagement.

Leading by example- Principal investigators, team leaders

and supervisors use safe workpractices and take action whenhealth and safety is compromised

by researchers actions or omissions.- Good safety performance is

recognised and rewarded.- Project proposals consider health,

safety and environmentalrequirements at the planning stage.

- Where necessary, specialist safetyadvisers are consulted and informresearch project proposals.

Practicable guidance andwork systems

In a positive culture, guidance andwork systems set out how the researchshould be carried out and how to actin emergencies. In particular:

The safety culture of an organisationdepends on the collective output of thehealth and safety related beliefs,attitudes and behaviours of the peoplewithin it. In a research organisation,the attitudes and behaviours of seniormanagers are particularly influential.

A positive safety culture expects andallows people to behave safely becauseit is the correct thing to do; it is thenormal way of operating within theorganisation. Safe behaviour is onevisible output of such a culture. This isimportant in a research environment,since a lot of research is done outsidenormal working hours when daytimelevels of supervision and support areunlikely to be available. Researchsupervisors need to be able to rely ontheir researchers to be mindful of theirown safety, for example by followingresearch protocols and safe systems ofwork, wearing personal protective

equipment and using safety equipmentproperly, whether or not theirsupervisor is present.

A research report and guidancedocument published by IOSH (Safetyculture, advice and performance andPromoting a positive culture a guideto health and safety culture) identifysome elements that underpin a positivesafety culture. In a university or otherresearch organisation, these include:

A comprehensive healthand safety policyThis should be drawn up inconsultation with staff representativesand endorsed by the executive body of


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The Researcher Development Framework (RDF:www.vitae.ac.uk/CMS/files/upload/Vitae-Researcher-Development-Framework.pdf) is a tool for planning,promoting and supporting the personal, professional andcareer development of researchers in higher education. Itarticulates the knowledge, behaviours and attributes ofresearchers and encourages them to realise their potential.

The RDF is structured in four domains encompassing theknowledge, intellectual abilities, techniques and professionalstandards needed to do research. It includes the personalqualities, knowledge and skills required to work with othersand ensure the research has a wider impact. Each domaincontains three sub-domains with associated descriptions ofdifferent aspects of being a researcher.

The Research governance and organisation domaindetails the knowledge of standards and professionalismneeded to do effective research, including:- health and safety- ethics- principles and sustainability- legal requirements- intellectual property rights and copyright- respect and confidentiality- attribution and co-authorship- appropriate practice- research strategy- project planning- delivery- risk management.

Researcher Development Framework

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Recognising the work pressuresresearchers are exposed to is animportant feature of health and safetymanagement in the research

environment.

Researchers generally have to workirregular hours, often without thesupport of colleagues. Programmeleaders and principal investigators alsohave to meet publication and researchproposal deadlines and may spend alot of time looking for funding for theirresearch. Research grants are usuallygiven for a specified amount of time,

and this may cause anxiety to grant-funded researchers as they reach theend of a project. Researchers are moremobile than other staff, as they gain

experience and qualifications and moveto other research projects andorganisations. High-quality research isusually international and this mayinvolve extensive travel and work withresearchers for whom English is nottheir first language. Additionally,research programmes are subject toexternal quality assessments which candetermine future support or fundingallocations.

Research organisations should havemechanisms in place to identify andmanage cases of work-related stress.The culture of the organisation should

also allow researchers who feel theyare under too much pressure to accesshelp and support without fearingdetriment to their career.


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All research tasks and projects shouldbe evaluated for foreseeable healthand safety risks before the work starts.The employer must then ensure thatsignificant risks are recorded and thatreasonably practicable risk controlmeasures have been put in place.These control measures should be builtinto systems of work and researchprotocols. Risk assessments should becarried out by competent people.

The process of risk assessment is nodifferent in research than in any otherjob. For many social science researchprojects the risks will not be specialistin nature and general guidance on riskassessment, which can be found in HSEpublications, will help identify sensibleprecautions.

However, in the case of practicalresearch which might involvehazardous substances, equipment or

processes, you might need to considerless well-known hazards, especiallywhere new materials and processes arebeing used. Programme leaders, PIs,

research supervisors and their teamsmight be the only people who knowthe work well enough to make validjudgments about risk, and should beprepared to justify their conclusions.

Where risk in a research project isunavoidable, a hierarchy of risk controlsolutions should be considered:- Can less hazardous materials,

equipment or processes be used?- Can risks be mitigated at source

using engineering controls such asequipment guards and interlocks?What collective protective measurescan be put in place?

- Can suitable systems of work bedesigned, specifying what isrequired in terms of training, rules,procedures and supervision?

- What individual protective measuresare required, such as personalprotective equipment, prophylaxisor health surveillance?

Carrying out initial risk assessmentsbefore committing to the project willhelp determine whether existing

resources and facilities are enough toprovide any necessary safeguards. Ifessential systems or facilities such asinterlocked access to rooms with lasersor a Class III microbiological safetycabinet are required to control risks,then the project cant start until theseare in place. If existing resources cantprovide essential safety features, thenthe project must be altered accordingly.

Risk assessments should also considerthe skills and experience of projectteam members. If some team membersare yet to be recruited, the desiredskills and competences will help informthe recruitment process and anytraining needs. The risk assessment willalso inform the development ofresearch guidance and safe systems ofwork, and the risks and controlsidentified should be incorporated intoresearch work protocols.

5 Risk assessment

14

The HSE defines training as helping people to learn howto do something, telling people what they should orshould not do, or simply giving them information.

Health and safety law requires that employers providewhatever information and training is needed to ensure, sofar as is reasonably practicable, the health and safety oftheir employees. Research organisations have a duty toensure that researchers, whether or not they areemployees, have sufficient information and training to beable to do their research competently and withoutincreasing risks to their own or others health and safety.

The skills required for particular tasks or duties should beassessed before recruitment and efforts should be madeto employ or contract suitable people. Once researchers

have been appointed, their manager or supervisor shouldassess their capabilities, training, knowledge andexperience, and ensure that the demands of the job dontexceed their ability to do their work without creatingunacceptable risks to themselves and others.

Training needs analysis should be repeated at regularintervals and when new techniques or equipment areintroduced. Refresher training should be provided whereappropriate.

Where gaps in knowledge or competence are identified,training and awareness programmes should be put inplace and, if training is identified as a risk controlmeasure, it should be compulsory for the researcher toattend. Managers or supervisors should be informed iftheir researcher fails to attend training, and make surethose who have received training put it into practice inthe workplace.

Its important to record all training and information givento researchers. The delivery and receipt of information,

formal training and on-the-job training should be signedoff by both trainer and trainee. Records of all trainingshould be kept with the researchers personal file andshould be accessible to their manager.

Information and training


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OH is about how work and the work environment canaffect an employees health, and how an employees

health can affect their ability to do the job.

An OH service can provide expert advice on the need forspecific health controls in work that poses a risk to health for example work in clinical environments, laboratories,workshops, with research animals or overseas fieldwork.These controls include health screening to assess fitnessfor work, vaccinations, and periodic health surveillanceduring work. An OH service will also provide advice onsuitable methods for assessment and detection of healthrisks and can undertake any medical screening orsurveillance required.

The OH provider should be able to advise on specific legalrequirements for medical certification or health

surveillance of staff engaged in certain work activities,such as researchers or other staff who are designated asclassified workers under the Ionising RadiationRegulations 1999.

Advice on health precautions for those with pre-existingconditions or disabilities that may make them unusuallysusceptible to work-related illness or injury can also beobtained from the OH provider.

Occupational health (OH)

PIs and supervisors need to takeresponsibility for all assessmentsassociated with their projects, but theymay occasionally need to ask researchworkers to risk-assess some aspects ofthe work. The research supervisor or PIshould check that the researchersdoing this have been trained in riskassessment practice and that theassessments have been done to asatisfactory standard.

In some fast-changing researchenvironments, dynamic risk assessmentand risk control solutions may berequired. Dynamic risk assessment is acontinuous process of identifying

hazards and evaluating risks as theycome up, taking appropriate actions toeliminate or reduce the risk. Theresearcher continually monitors andreviews the changing circumstances inthe research environment. The actionstaken should be documented toimprove overall knowledge of risk andrisk controls in similar projects.

The risk assessment will also helpestablish what sort of personalprotective equipment is required, andwhether specific occupational healtharrangements should be in place, forexample interventions such asvaccination, or health monitoring and

surveillance, such as regular respiratoryfunction tests.

An important part of risk control inresearch is that buildings, rooms,equipment etc used during theresearch should be designed andmaintained to ensure they dontcompromise health and safety. Theplanned, preventive maintenance ofgeneral plant and specialist equipmentis an essential feature of a saferesearch environment and should beconsidered at the design andprocurement stage of researchplanning and resourcing.


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Occupational hygienists use science and engineering toassist in the prevention of ill health caused by the workenvironment, specialising in the assessment and control ofrisks to health from workplace exposure to hazards.Hygienists help employers and employees to understandthese risks and minimise or eliminate them.

With good occupational hygiene science and practice,some occupational health risks can be eliminated andothers brought under control. In certain instances, somelevel of exposure will remain and occupational hygiene

techniques can be used to either verify that they arebelow a safe exposure level (ie that current controlmeasures are adequate) or to indicate the level ofexposure experienced.

Occupational hygienists may be able to advise on a rangeof health risks in the workplace, including chemicalhazards, physical hazards such as heat, cold, noise orergonomics, psychological hazards, and new andemerging technologies such as nano and greentechnologies.

Occupational hygiene

Hazardous waste is defined and listed in the WasteFramework Directive 75/442/EEC, as amended by91/156/EEC.

The list classifies wastes according to what they are and howthey were produced, providing codes for all wastes includinghazardous waste. Known as EWC codes, they can be foundin the European Waste Catalogue, available on theEnvironment Agencys website. The UK environment agenciesproduce technical guidance, in a document called WM2, onthe interpretation of the definition and classification ofhazardous waste. WM2 (www.environment-agency.gov.uk/business/topics/waste/32200.aspx) putswaste into one of three categories:- Always hazardous absolute entry (red)- Never hazardous- May or may not be hazardous, depending on

concentration mirror entry (blue).

Any waste regarded as dangerous (ie having a riskphrase and possessing any of the hazardous propertiesH1-H15) should be considered as potentially hazardousand the requirement for special arrangements for its

disposal should be assessed.

For most chemical substances used in research, theavailable disposal routes will depend on the finalconcentration of the hazardous substance in the waste which means that most are mirror entries in WM2.

For waste consisting of substances with one or more ofthe hazardous properties H1-H15, the maximumconcentration allowed to be disposed of through normaldrains/routes is listed in the guidance document WM2. Allwaste that contains substances above the thresholdconcentration for each type of hazard must be disposed

of by licensed waste contractors.

Hazardous waste


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Research risk assessments shouldconsider and specify what happens atthe end of projects and procedures,such as arrangements for wastedisposal and decommissioningequipment or controlled areas.

Once a risk assessment has beencompleted, its findings, and associatedrisk control systems, should becommunicated to all those involved inthe project. Researchers and researchsupport workers should be informedabout the hazards and risks they maybe exposed to and how they can worksafely. Its important to establish that

the proposed control measures arepracticable and dont increase riskelsewhere in the research orestablishment. Risk assessments shouldbe monitored, reviewed and revised atspecified intervals or after an accidentor near miss. They should also berevised to capture any new risks aftersignificant changes to the researchtask, equipment, techniques etc.

The risk assessment process can beused to identify, evaluate and controlmore than health and safety risks.Research Councils UK has published itsPolicy and code of conduct on the

governance of good research conduct(www.rcuk.ac.uk/documents/reviews/grc/goodresearchconductcode.pdf),which sets out the safety and otherpotential research risks that must beaddressed such as conduct, ethics,integrity and data management.

Risk assessment records should be keptfor at least three years after beingsuperseded or after work has stopped.

Describe the task oractivity and identify thehazardsThese may be specific to

the research, such as

sharps, or general hazardssuch as wet floors or heavy

loads. Information on thetypes of hazard associatedwith research can be found

in legislation, sectorguidance, safety datasheets, manufacturers

equipment information,research documents,research forums and from

health and safetyprofessionals

Review and reviseMonitor the research and the risk assessment to ensure that the assessment reflects the actual work taking place. The assessmentshould also be reviewed and revised after any changes to control measures or the research, after an incident, when new

information becomes available or within agreed timeframes. Risk assessments for work in some research areas, such as syntheticchemistry, may have to evolve constantly to keep pace with the research

Evaluate the risksConsider which peoplecould be harmed by thehazards, how they could be

harmed and how likely it is

that harm could occur. Youwill have to think about the

risks to trainees, new orexpectant mothers,cleaners, contractors,

visitors etc, as well as tostaff and colleagues. Themagnitude of the risk (eg

low, moderate or high) isdetermined by how likely itis that harm could occur

and how serious theresulting harm would be

(eg type of injury or illhealth, numbers affected,likelihood of spread)

Control the risksWhat is already in place tocontrol the risks identified?

Are these measuressufficient or does more

need to be done? It is likelythat there will be some riskcontrols in place: the

building should be fit forpurpose and will probablyhave engineering risk

controls such as fumehoods in place. Health andsafety information and

training programmes shouldalready be available.However, you may have to

develop training and safesystems of work or buy inspecialised equipment or

expertise to help controlspecific risks

Record and implementRecord your significantfindings and implement your

control measures. Theresearch should not start

until risks to health andsafety are controlled so faras is reasonably practicable.

Recording the significantfindings helps to identifyareas where precautions are

needed and determinerelevant informationthat needs to be provided

to the workers involved. Thefindings of the riskassessment should be used

to inform research protocolsand/or safe systems of work.You should be able to show

that people involved in theassessed activity are awareof the risks and are able to

work safely

Record and implementRecord your significant

findings and implement yourcontrol measures. Theresearch should not start

until risks to health andsafety are controlled so faras is reasonably practicable.

Recording the significantfindings helps to identifyareas where precautions are

needed and determinerelevant informationthat needs to be provided

to the workers involved. Thefindings of the riskassessment should be used

to inform research protocolsand/or safe systems of work.You should be able to show

that people involved in theassessed activity are awareof the risks and are able to

work safely

Figure 3: The risk assessment process


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These case studies are examples of goodpractice currently adopted in researchorganisations and should help guide youthrough the management of health andsafety and risk in a variety of researchareas. For the purpose of the case studiesit is assumed that the researchorganisation has a comprehensive suiteof health and safety-related policy andguidance in place.

The first case study is a risk assessmentof a social science research project,where researchers are gathering dataout in the community. Risk assessmentsare part of the planning stage of theresearch project. The rest are set out tofollow the health and safetymanagement framework describedearlier.

6 Case studies

18

Research activityThe ALICE (Adolescent Lifestyles in Central England) studyis part of a project comparing young peoples lifestylesand health behaviours in different counties. Datacollection will take place over a three month period andwill be repeated after 12 months.

Pupils in S1S3 in the first year of the study will completea paper questionnaire in one study period describing theirlifestyle and noting which of a random series of 50 filmsthey have seen. Survey assistants will travel by pre-arranged transport to study locations from one of twopick-up points and will assist in taking consent andproviding advice about the procedures around completingthe questionnaire. In some instances, where the pupilsneed help, survey assistants will aid in the completion ofquestionnaires.

The hazards inherent in this research activity areassociated with working out in the community, eg

exposure to antisocial behaviour and lone working.

What are the risks?The risks relevant to this research project are:- travel-related incidents low risk- violence or aggression from subjects or others

encountered during the data collection process riskwill vary with location and peer group interviewed

- psychological stress through exposure to verbal abuse,working in an unsafe environment, revelation of childprotection issues moderate risk (risk to researcherswill be lower if they are experienced)

- fatigue as the result of travel, interview length,numbers interviewed at location moderate risk

- musculoskeletal disorders from unsafe manual

handling practices low risk.

Who could be harmed?The persons exposed to the risks are the interviewers andthe adolescents interviewed (eg if they reveal childprotection issues). With no risk controls in place thisproject would be moderate risk.

What risk controls are in place?General controlsTraining: defensive driving, lone working safety, dealingwith violence and aggression, child protection issues andappropriate response, interview techniques and manual

handling.

Emergency procedures are in place (via mobile phones andlone worker alarms and well-practiced procedures forlone-working emergencies) and the researchers will followthe health and safety emergency arrangements of theschools they visit.

Case study 1

A risk assessment of a social science research project


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Travel risk controlsTransport is arranged from the research unit but in theevent of transport or other problems, assistants must beable to contact the days team leader and must have a listof telephone numbers and their mobile phone.

Location risk controlsFieldwork will be conducted in secondary schools duringschool hours. Out of hours the team members shouldwait in pairs at designated meeting points. Researchersare identified by uniforms and ID badges.

Study subject risk controlsThe questionnaire asks questions about drinking andsmoking among an under-age population. These areemotive topics and researchers must refer extremelyemotional interviewees to the team leader. Interviewersshould not visit schools attended by any subject known tothem. Neither can they interview, nor access anyinformation revealed by, such subjects. Researchersworking with children and vulnerable adults have been

trained in child protection issues and are CRB orequivalent checked.

Trauma risk controlsInstances or threats of violence and aggression will bereported to the team leader and to the head of theschool.

Survey assistants are issued with lone worker alarms.Planned, rehearsed response measures are in place.

If any survey assistant has concerns about the child or

their handling of the situation then it is their responsibilityto discuss this with their team leader. The research groupleader runs debrief sessions where researchers who havebeen exposed to traumatic or upsetting situations orinformation can discuss these issues with colleagues andthe team leader.

Other identified risksManual handling risks researchers are trained and usetrolleys for shifting loads. Researchers withmusculoskeletal problems are not allowed to lift or shiftloads.

Residual riskWith these controls in place the project is assessed as lowrisk and no further risk controls are required for theresearch to proceed.

Record and implement controlsThe risk assessment is recorded and the researchers areinformed of the findings of the assessment. The trainingneeds of the researchers are checked and relevant trainingis offered before the research study takes place.

Lone worker alarms are issued and researchers arereminded of the procedure for their use and the measuresin place for responding to them.

Researchers are given the opportunity to clarify any of theissues raised by the risk assessment and the controlmeasures associated with the research.

Risk assessment reviewThe risk assessment will be reviewed and revised:- if the research project changes significantly- following the occurrence of an unplanned incident

during the project- following the first set of data collection to ensure it

has captured and mitigated all the significant risksattached to this project.

If there were any incidents, note what corrective actionswere taken if necessary, amend research protocolsaccordingly.

Planned review date: ________________________

Case study 1 continued...


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Case study 2

Research involving novel chemical substances

Research activitySynthesis of novel Ergot Alkaloid for use in pharmacologystudy (subject to licensing under Home Office regulationof precursor chemicals in UK).

PlanConsider any licence requirements or restrictions onprocurement as a result of legislation.

Undertake a comprehensive risk assessment includingassessments considering the Control of SubstancesHazardous to Health (COSHH) requirements:- consider the chemistry and apply fundamental

chemical properties (eg exothermic acid-basereactions). Also consider mixtures at intermediate stepsas well as separately

- assess the planned processes in order to consider saferalternatives or removing steps, eg the procurement ofintermediates. Also consider applying administrative

constraints, eg restricting lone working and/or accesscontrol

- consider the risks to others who may be affected bythe research, eg cleaners and maintenance engineers

- consider what equipment and level of local exhaustventilation (LEV) will be necessary and that theequipment is properly serviced and maintained

- consider whether researchers are appropriately trainedin the techniques and safety equipment to be used inthe research project and are competent to conductdynamic risk assessments

- consider storage of materials, particularly to reduce

the quantity of hazardous or dangerous materials keptin the laboratory to a minimum, in line with COSHHand regulatory guidance on dangerous substances andexplosive atmospheres

- plan the provision of emergency equipment,instruction and training for researchers and otherswho will work in the local area (eg fire fighting, firstaid, spillages).

DoEnsure that:- the risk controls identified by the risk assessment are

put in place before the work starts- adequate information and supervision is provided,

either through technician level or laboratory managerdepending on team

- access to hazardous substances and equipment iscontrolled

- researchers work in accordance with the experimentalprotocols and safe systems of work

- new or emerging risks are identified, evaluated andcontrolled, so far as is reasonably practicable

- adequate provision is made for disposal considerquantities and concentrations

- any incidents and spillages are reported through theappropriate internal means.

Check- Ensure that exposure controls are adequate, for

example using air sampling (instantaneous/continuousas appropriate) and engaging health surveillance (seeEH40).

- Practise emergency procedures. Consider what willhappen to LEV used in the event of an emergency will it continue to operate as normal, or will it shutdown, or have a reduced flow, or deploy its firedampers? Is LEV or other critical safety equipment onan uninterrupted power supply?

- Check waste streams and ensure that necessaryarrangements are being followed.

-

Review risk assessment periodically, after anunplanned event or before implementation of a newprocess.

Review- Were the competencies and resources identified at the

outset appropriate or sufficient?- Were there any incidents? If so, what actions were

implemented and will these be required in future? Ifthis is the case, they should be written into theresearch protocols and standard operating procedures.


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This legislation, known as the COSHH Regulations(www.hse.gov.uk/coshh/index.htm ), requires employersto prevent or otherwise control the exposure of theiremployees (and others at risk) to hazardous substancesused or present in the workplace. There are various sortsof hazardous substances:

- chemicals and products containing chemicals- fumes and vapours- dusts and mists- nanomaterials- gases and asphyxiating gases- biological agents.

The employer or responsible person has a duty to identifywhat substances are involved in work or the workplaceand what sort of health hazard they represent. Theyshould then carry out a risk assessment to determine

whether exposure could occur, what the effects of thatexposure could be on the people in the workplace andhow exposure can be prevented or controlled.

The Regulations also require employers etc to make sure:- the control measures theyve put in place are used and

that they continue to be effective- they provide information, instruction and training for

employees and others- monitoring is carried out for hazardous substances- health surveillance is provided for employees at risk of

exposure to some substances- there are plans in place to deal with emergencies.

More guidance on COSHH is available on the HSE website(www.hse.gov.uk).

The Control of Substances Hazardous to Health

Regulations 2002 (as amended)


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Case study 3

Research involving hazardous biological agents

Research activityA PhD student, who has never worked with highlyinfectious agents or at containment level 3, wants totravel to Pakistan to collect blood samples and skinbiopsies potentially containing Mycobacterium leprae aspart of their research into Mycobacterium drug resistance.Mycobacterium leprae is categorised as Hazard Group 3in the Advisory Committee on Dangerous Pathogens(ACDP)Approved list of biological agents(www.hse.gov.uk/pubns/misc208.pdf ).

Plan- Consider any licence and legislative requirements, such

as ethics approval, Human Tissue Authority (HTA:www.hta.gov.uk). The HSE must be informed if this isthe first time this biological agent has been used inthe organisation. The Home Office must be informedif the biological agent is listed in Schedule 5 of theAnti Terrorism Crime and Security Act 2001. Defra

must be informed if the organism is a specified animalpathogen.

- Undertake an overseas risk assessment prior to travel.Guidance on undertaking research activities overseascan be found in the document Guidance on healthand safety in fieldwork(www.ucea.ac.uk/en/publications/index.cfm/guidance-on-health-and-safety-in-fieldwork).

- Arrange shipping of the biological samples back to theUK via your institutes recognised shipper.

- Consider the potential issues that could come up, eg iffoetal calf serum is identified as being present in the

sample media, then a Defra import licence may berequired.- Consider the laboratory and storage space

requirements for the samples.- Undertake comprehensive risk assessments for all

techniques that are to be used.- Seek occupational health advice prior to travel and

before beginning work on these samples, eg HepatitisB vaccination may be required.

- If samples are to be retained at the end of the studyensure that this requirement is included in the ethicalapproval application.

- Consider anonymised coding of samples if they are to

be retained at the end of the study.- Identify the health and safety information and level of

training required by researchers involved in this project.

DoEnsure that:- the controls identified by the risk assessment are in

place before the research project starts- adequate training and supervision is provided for work

in the containment level 2 or 3 laboratory- clear protocols and/or standard operating procedures

are provided for experimental work and that researchersare aware of these and know how to work safely

- samples are packaged according to International AirTravel Association guidelines and are registered underHTA as soon as they arrive

- the names of people working in the containment level3 laboratory are recorded

- any incidents are reported through the appropriateinternal means.

Check- Practice emergency spill procedures for spills both

inside and outside the microbiological safety cabinet(MSC).

- Make sure MSCs and other safety measures areworking as planned each time they are used.

- For HTA check that appropriate records of disposal ofsamples are kept number of samples disposed,disposal route used and the person responsible for thedisposal.

- Check all project workers have appropriate knowledgeof the code of practice for working at containmentlevel 2 or 3.

- Check all project workers are aware of the procedures

for decontaminating both the MSC and laboratory inthe event of an emergency. If this is not contractedout then researchers should be competent to carry outthe decontamination.

Review- Review all risk assessments and codes of practice

periodically, before any changes are made toexperimental technique or following an unplannedevent.

- Were there any incidents? If so, what actions wereimplemented and will these be required in the future?If this is the case, they should be written into the

research protocols and standard operating procedures.


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The Control of Substances Hazardous to HealthRegulations (www.hse.gov.uk/coshh/index.htm ) set outthe health and safety requirements for working withsubstances that are hazardous to health. Biological agentsare classed as hazardous substances in the Regulations ifthey are capable of creating a human health risk.

The COSHH Regulations classify biological agents into one

of four hazard groups (HGs) based on their ability toinfect healthy humans, with HG1 agents being the leastharmful and HG4 agents the most harmful.

The classification is based on whether:- the agent is pathogenic for humans- the agent is a hazard to employees- the agent is transmissible to the community- there is effective treatment or prophylaxis available.

More information on the classification of biological agentscan be found in the Advisory Committee on DangerousPathogens publication The approved list of biologicalagents (www.hse.gov.uk/pubns/misc208.pdf ). Therelevant industry standard for managing the risks of workwith biological agents is Biological agents: managing therisks in laboratories and healthcare premises(www.hse.gov.uk/biosafety/biologagents.pdf ).

Guidance on using a management system approach tomanage the risks of working with biological agents can befound in the CEN Workshop agreement laboratory bioriskmanagement standard(ftp://ftp.cenorm.be/PUBLIC/CWAs/wokrshop31/CWA15793.pdf).

Biological agent hazard groups

The HSE expects all research establishments to notify it oftheir first use of any HG2, HG3 and HG4 biological agent.Notification of subsequent use of a few specific HG2agents and all HG3 and HG4 biological agents is alsorequired. Further information on notification to the HSEcan be found atwww.hse.gov.uk/forms/notification/cba1notes.htm .

Sites holding or intending to hold agents listed inSchedule 5 of the Anti Terrorism Crime and Security Act

2001 and the Security of Pathogens and Toxins(Exceptions to Dangerous Substances) Regulations 2002must notify the Home Office. The Home Office willarrange, via the National Counter Terrorism Security Office(NaCTSO), a site visit by the relevant Counter Terrorism

Security Adviser (CTSA) to conduct a survey and providecommensurate security advice and guidance. Qualifyingsites must be able to demonstrate to the CTSA that theyare operating securely before they are granted authorityby NaCTSO on behalf of the Home Office. Furtherinformation on Home Office notification can be found atwww.nactso.gov.uk/AreaOfRisks/PathogensToxins.aspx.

Defra must be informed if the organism is a specifiedanimal pathogen. A Defra licence may be required for the

importation of some animal-derived materials. Furtherinformation on notification and licensing is available atwww.defra.gov.uk/animal-diseases/pathogens.

Notification of use of biological agents


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Case study 4

An engineering research project

Research activityA request is made to investigate satellite propulsionsystems using ionised gas. The project will entail workingwith a high vacuum chamber to simulate the spaceenvironment; high voltage equipment for ionisation andion acceleration; and compressed gases including argon,xenon and hydrogen.

Plan- Carry out a first pass high-level hazard analysis

(preliminary hazard analysis) to identify the majorhazard issues, eg: high voltage equipment (if voltage potentials

above 5 KV then ionising radiations regulationsapply)

high vacuum systems (potential for vacuumchamber to become pressurised and become apressure system)

asphyxiant gas explosive gas high noise levels.

- Assemble a team with appropriate cross-functionalknowledge to scope an initial design concept andsafety system. The safety system should follow the riskcontrol hierarchy of elimination, substitution,engineering controls, procedural controls, PPE (seesection 5 for more detail). This is considered goodpractice and is a requirement of the COSHHRegulations.

- Undertake a detailed hazard analysis on the proposeddesign consider using formalised methodologies

such as failure mode and effects analysis (see Hazard

analysis techniques box for more detail). Modify thedesign accordingly.

- If purchasing new equipment, does it carry theappropriate CE marking?

- If equipment is in-house or a bespoke design, does itmeet the essential safety requirements of the relevantlegislation (eg directives on machinery, low voltage,pressure equipment, ATEX)? Consider assessment againstappropriate harmonised standards, eg EN61010-1.

- Undertake a comprehensive risk assessment asrequired by regulation and organisational policy andguidance, considering hazardous and dangeroussubstances, ionising radiations, noise levels, electricalsafety, pressure systems, ongoing maintenancerequirements etc: consider storage of materials, particularly to

reduce the quantity of hazardous or dangerousmaterials kept in the laboratory to a minimum, inline with COSHH and regulatory guidance on

dangerous substances and explosive atmospheres the outcome of risk assessment may indicate that

occupational health involvement is required, eghealth surveillance, audiometry. (Note: this wouldbe unlikely for this particular research project.)

- Consider what level of training and supervision will berequired, taking into account the experience andcompetency levels of the people involved.

- Ensure that adequate emergency equipment andinstruction and training is given to researchers andothers that will work in the local area or who willprovide support during emergencies (eg fire fighting

involving high voltage and pressure systems).


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DoEnsure that:- risk controls identified by the risk assessment are in

place before the work starts- equipment is purchased, built, installed and

commissioned to appropriate specifications- adequate provision is made for maintenance- access to hazardous equipment is controlled- adequate information and training is given and that

appropriate levels of supervision are provided- any incidents are reported through the appropriate

internal means.

Check- Confirm at appropriate intervals that equipment safety

systems operate correctly.- Check project workers have appropriate knowledge of

equipment and safety systems.

- Check work is being carried out in accordance withthe risk assessment and agreed protocols.

- Check that required maintenance is being carried out.- Practise emergency procedures.- Check risk assessment periodically, after an unplanned

event or before implementation of a change toexperimental protocol or equipment design.

Review- Were the competencies and resources identified at the

outset appropriate or sufficient?- Were there any incidents? If so, what actions were

implemented and will these be required in future? Ifthis is the case, they should be written into theresearch protocols and standard operatingprocedures.

Case study 4 continued...

Hazard analysis techniquesThere are several available techniques for hazard/riskanalysis. These can be complementary and it might benecessary to use more than one of them. The basicprinciple is that the chain of events is analysed step by step.

Preliminary hazard analysis (PHA) can be used early inthe development process to identify the hazards, hazardoussituations and events that can cause harm when few of thedetails of the design are known.

Fault tree analysis (FTA) is especially useful early in thedevelopment stages of safety engineering, to identify andprioritise hazards and hazardous situations, and to analyseadverse events.

Failure mode and effects analysis (FMEA) and failuremode, effects and criticality analysis (FMECA) are

techniques for systematic identification of an effect orconsequence of the failure of individual components. Thesetechniques are more appropriate as the design matures.

Hazard and operability study (HAZOP) is typically used inthe later stages of the development phase to verify andthen optimise design concepts or changes.

For more detail see (shop.bsigroup.com/en):- BS 8444-3, IEC 60300-3-9, Guide to risk analysis of

technological systems- BS EN 61025, Fault tree analysis (FTA)- BS EN 60812, Procedure for failure mode and effects

analysis (FMEA)- BS IEC 61882, Hazard and operability studies (HAZOP

studies) application guide.


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Case study 5

Research using unsealed radioactive sources

Research activityIn vitro assay for small molecule inhibition of recombinantviral RNA polymerase enzyme activity using a P33-labelledradioactive nucleotide triphosphate.

Plan- Consider legislative requirements and their impact on

how and where the procedure will be conducted.- Conduct a comprehensive risk assessment is use of

radiation essential? Include COSHH and EAconsiderations: measure the reaction kinetics including the enzyme

Km in trial experiments; include measurements ofwaste stream partitioning

plan materials required what format will beused; eg 12 well, 96 well or 384 well plates?

what equipment will be needed, eg centrifuge,multichannel pipettes, plate washer? (all havepotential for contamination)

how many compounds will be tested with howmany repeat readings per compound?

minimise reaction volumes compatible withreproducibility

add the radioisotope once and as the final stepto a master reaction mix.

- Minimise exposure to radioactivity using theprinciples: time distance shielding containment

ensure awareness of local rules use of best available techniques (BAT) to minimise

waste trial runs using dye label to determine any

unexpected potential for spillages, aerosolgeneration etc

frequent monitoring of self and designated workarea before, during and after the procedure

appropriate personal dosimetry.

DoEnsure that:- risk controls identified by the risk assessment are in

place before the work starts- researchers are competent and have had previous

theoretical and practical instruction on correct andsafe handling of radioisotopes, including minimisingexposure, knowledge of waste streams and use ofappropriate PPE

- proposed radioisotope usage and waste production iswithin the limits of the department/instituteallowances laid down in the Environmental PermittingRegulations Permit for Open Sources

- radioisotope stock is stored securely in a locked fridge- any spillages, accidents or incidents are dealt with

according to the local rules.

Check- Ensure that shielding is adequate and work is

contained in trays.- Rehearse emergency procedures in scenarios to make

sure contingency measures are adequate to deal withspillages.

- Check records of radioisotope use and contaminationmonitoring.

Review- Are the protocols reproducible, can economies of scale

be used?- Do any aspects of the procedure require revision?- Can the signal-to-noise ratio be maintained using less

radioisotope?- Review the risk assessment frequently, and revise

following changes to the experimental protocol.- If there were any incidents during the project, what

actions were implemented? If they will be required infuture, they should be written into the researchprotocols and standard operating procedures.


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If you intend to start work with radioactive substances forthe first time, you will need to let the HSE know at least28 days before you start work. Details on how to notifythe HSE using Form IRR6 are on its website(www.hse.gov.uk/radiation/ionising/notification.htm).This is a requirement of the Ionising Radiation Regulations1999 (IRR99).

Normally you will also need to have been grantedcertificates or permits of registration and/or authorisationunder the Radioactive Substances Act 1993 or theEnvironmental Permitting (England and Wales) Regulations2010 by the relevant UK environment agency. Yourradiation protection adviser (RPA) will advise you on theplanning, risk assessment and authorisation requirementsof research involving radioactive substances.

For the purposes of work with ionising radiation, theregulators of radioactive substances are the Environment

Agency (in England and Wales), the Scottish EnvironmentProtection Agency and the Northern Ireland EnvironmentAgency. EPR10 exemption orders apply in England, and inScotland/Northern Ireland as stand-alone legislation.Otherwise RSA93 still applies in these two countries,where permits are referred to as authorisations.

The loss or theft of, or significant spills or releases of,radioactive materials must be reported to the relevantenvironment agency (and to the HSE if the amount ofradioactive material released or spilled exceeds that incolumn 4 of Schedule 8 of IRR99). Your RPA will advise onwhat levels of contamination or escape must be reportedand to whom. Emergency response information, as well asother detailed guidance for the safe use of radioactivesubstances, should be written into your local rules.

Radioactive substances: notification, registration

and authorisation

Under IRR99, radiation employers must carry out a riskassessment before beginning any activity involving workwith radioactive substances. For any areas designated ascontrolled, they must prepare written local rulessummarising the arrangements for controlling work withionising radiations. Local rules may also be considered

appropriate for supervised areas, depending on the natureof the work carried out there. Where local rules apply, aradiation protection supervisor who is trained in the useof ionising radiation must be appointed to ensure that thearrangements set out in the rules are followed.

Local rules


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Case study 6

Research on genetically modified plants

Research activityThis project involves the development and application oftransgenic technology to investigate the circadian clock ina cereal. Homologues of the well-characterisedArabidopsis circadian clock genes are present in theimportant cereal crop barley. The researchers propose tostudy and manipulate the circadian clock function inbarley by the construction of transgenic plants withaltered clock gene expression.

The project involves:- transformation of barley embryos with Agrobacterium

vectors- tissue culture/regeneration of barley plants- growth/characterisation/harvesting of plant tissue and

seeds- use of containment laboratories and glasshouse facilities.

Plan- Conduct a comprehensive risk assessment to address

all relevant issues concerning the construction andgrowth of transgenic plants.

- Consult organisational policies setting out therequirements of the Genetically Modified Organisms(Contained Use) Regulations 2000, as amended, theEnvironmental Protection Act 1990 and the GeneticallyModified Organisms (Risk Assessment) (Records andExemptions) Regulations 1996. The first two statutesgive guidance on possible hazards, risks and risk controlrequirements. The last statute requires that a record ofthe project risk assessment is kept for 10 years.

-

Ensure the assessment addresses the safe use ofsubstances hazardous to health and the potentialenvironmental harm from genetically modified (GM)bacteria used to create the GM plants.

- Submit the risk assessment findings to the geneticmodification safety committee for review andapproval. If the genetically modified plant is likely tobe more hazardous than the parent then the HSE mustbe notified of the project and the notification fee paid.

- Identify suitable laboratory and greenhouse researchwork areas.

- Identify the knowledge and competences required byresearchers to undertake this project safely. Ensure

appropriate training is available if required.- Identify safety-related information and levels of

supervision required by researchers.- Identify GM waste treatment requirements and

disposal route.

DoEnsure that:- all appropriate co

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