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Research risk assessment
It's the responsibility of the principal investigators (PI) and researchers to identify reasonably foreseeable risks associated with their research and control the risks so far as is reasonably practicable.
All participants and research assistants have the right to expect protection from physical, psychological, social, legal and economic harm at all times during an investigation. Certain research may also present reputational, legal and / or economic risks to the University.
As part of the ethical approval process for research involving human participants you are required to identify potential risks associated with your research and the action you will take to mitigate risk. You may be asked to submit your risk assessment.
The risk assessment process is a careful examination of what could cause harm, who/what could be harmed and how. It will help you to determine what risk control measures are needed and whether you are doing enough.
Risk assessment responsibility
The PI and researchers need to take responsibility for all assessments associated with their projects. Occasionally you may need research workers or students to risk assess an aspect of the work and you will need to check the assessments are adequate and sign them off.
Risk assessors need to be competent and you’ll need to ensure they have adequate training and resource to do the assessments. There is risk assessment training available and help and advice help and advice help and advice from your Health and Safety adviser and safety specialists (for health and safety risks), or the REO Research Governance team for other risks. In some cases, the hazards are so unique to the research that the PI and their team might be the only people who know the work well enough to make valid judgements about the risk and justify their conclusions.
Risk assessment process
The risk assessment process is a careful examination of what could cause harm, who/what could be harmed and how. It will help you to determine what risk control measures are needed and whether you are doing enough.
To simplify the process you can use the health and safety risk assessment templates, risk estimation tool and guidance for all risks associated with your research project. Please refer to the research risk estimation guidance under how to carry out a risk assessment below to assist you.
Research risks
Typical risks that need to be considered as part of research ethics are:
- Social risks: disclosures that could affect participants standing in the community, in their family, and their job.
- Legal risks: activities that could result in the participant, researchers and / or University committing an offence; activities that might lead to a participant disclosing criminal activity to a researcher which would necessitate reporting to enforcement authorities; activities that could result in a civil claim for compensation.
- Economic harm: financial harm to participant, researcher and / or University through disclosure or other event.
- Reputational risk: damage to public perception of University or the University/researchers’ reputation in the eyes of funders, the research community and / or the general public.
- Safeguarding risks: Risk to young people, vulnerable adults and / or researcher from improper behaviour, abuse or exploitation. Risk to researcher of being in a comprising situation, in which there might be accusations of improper behaviour.
- Health and safety risks: risks of harm to health, physical injury or psychological harm to participants or the researcher. Further information on health and safety risks is given below.
Health and safety risks
The potential hazards and risks in research can be many and varied. You will need to be competent and familiar with the work or know where to obtain expert advice to ensure you have identified reasonably foreseeable risks. Here are some common research hazards and risks:
- Location hazards Location hazards Location hazards and risks are associated with where the research is carried out. For example: fire; visiting or working in participant’s homes; working in remote locations and in high crime areas; overseas travel; hot, cold or extreme weather conditions; working on or by water. Also hazardous work locations, such as construction sites, confined spaces, roofs or laboratories. For overseas travel, you will need to check country / city specific information, travel health requirements and consider emergency arrangements as part of your research planning, by following the University’s overseas travel health and safety standard .
- Activity hazards Activity hazards Activity hazards and risks associated with the tasks carried out. For example: potentially mentally harmful activities; distressing and stressful work and content; driving; tripping, or slipping; falling from height; physically demanding work; lifting, carrying, pushing and pulling loads; night time and weekend working.
- Machinery and equipment Machinery and equipment Machinery and equipment . For example: ergonomic hazards, including computer workstations and equipment; contact with electricity; contact with moving, rotating, ejecting or cutting parts in machinery and instruments; accidental release of energy from machines and instruments.
- Chemicals and other hazardous substances . The use, production, storage, waste, transportation and accidental release of chemicals and hazardous substances; flammable, dangerous and explosive substances; asphyxiating gases; allergens; biological agents, blood and blood products. You’ll need to gather information about the amount, frequency and duration of exposure and carry out a COSHH or DSEAR assessment which will inform whether you may need health surveillance for yourself and / or your research participants.
- Physical agents Physical agents Physical agents . For example: excessive noise exposure, hand-arm vibration and whole body vibration; ionising radiation; lasers; artificial optical radiation and electromagnetic fields. You’ll need to gather information about the amount, frequency and duration of exposure inform whether you may need health surveillance for yourself and / or your research participants.
When to carry out a risk assessment
Carrying out initial risk assessments as part of the planning process will help you identify whether existing resources and facilities are adequate to ensure risk control, or if the project needs to be altered accordingly. It will also help you to identify potential costs that need to be considered as part of the funding bid.
Once the project is approved, research specific risk assessments need to be carried out before work starts.
The research may need ethical approval if there is significant risk to participants, researchers or the University.
How to carry out a risk assessment
The University standard on risk assessments provides guidance, tips on getting it right, as well as resources and the forms to help you produce suitable and sufficient risk assessments and must be used.
- Risk assessment template (.dotx)
- Flow chart to research risk assessment (.pdf)
- Research risk assessment: Risk estimation tool (.pdf)
- Example of a Social Science research risk assessment (.pdf)
Refer to carrying out a risk assessment carrying out a risk assessment carrying out a risk assessment for step by step guidance.
Risk assessments must relate to the actual work and must be monitored by the PI. If there are significant changes to the activities, locations, equipment or substances used, the risk assessment will need to reviewed, updated and the old version archived. Risk assessments should also consider the end of projects, arrangements for waste disposal, equipment, controlled area decommission and emergencies.
Things to consider:
- The risks may be specialist in nature or general. Information can found from legislation, sector guidance, safety data sheets, manufacturers equipment information, research documents, forums and health and safety professionals.
- Practical research might involve less well-known hazards. Do you or your team have the expertise to assess the risk adequately? Do you know who to go to for expert advice?
- The capabilities, training, knowledge, skills and experience of the project team members. Are they competent or are there gaps?
- In fast changing research environments, is there a need to carry out dynamic risk assessments? Are they understood and recorded?
- The right personal protective equipment for the hazards identified and training in how to use it.
- Specific Occupational Health vaccinations, health surveillance and screening requirements identified and undertaken. With physical agents and substances you’ll need to make an informed decision about the amount, frequency and duration of exposure. If you need help with this contact Health and Safety.
- Associated activities: storage, transport/travel, cleaning, maintenance, foreseeable emergencies (eg spillages), decommissioning and disposal.
- The safe design, testing and maintenance of the facilities and equipment.
- Planned and preventative maintenance of general plant and specialist equipment.
These risk assessments relate to the actual work and must be monitored by the PI. If there are significant changes to the activities, locations, equipment or substances used, the risk assessment will need to reviewed, updated and the old version archived. Risk assessments should also consider the end of projects, arrangements for waste disposal, equipment and controlled area decommission and emergencies.
Training
If you would like training on completing a risk assessment, please book onto our Risk Assessment Essentials course via HR Organiser. If you are unable to access this, please email [email protected]
- Carrying out a risk assessment Carrying out a risk assessment Carrying out a risk assessment
- People especially at risk People especially at risk People especially at risk
- IOSH/USHA/UCEA guidance on managing health and safety in research (.pdf)
- Research governance: Ethical approval
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COMMENTS
To simplify the process you can use the health and safety risk assessment templates, risk estimation tool and guidance for all risks associated with your research project. Please refer to the research risk estimation guidance under how to carry out a risk assessment below to assist you. Research risks
Risk Assessment is determining: • the overall risk of a study. • the risk of a change to a study. • a device risk classification that is different from an overall study risk determination. 11 What are research risks? Physical - drug toxicities, exposure to radiation, research injuries Psychological – emotional distress, anxiety in
Total Risk – The risk of an event occurring without consideration for internal controls Manageable Risk – The risk that can be mitigated through internal controls • Not static • Based on a multitude of factors Remaining Risk–The risk that remains after considering current controls • Not static • Based on a multitude of factors 5
―Common methodologies for Risk assessment and management‖, the authors use the Risk register for risk identification [Turnbull, 2001]. The risk assessment is done using two dimensions: likelihood and impact. In their application example for R&D projects they reduce the assessment dimension to likelihood to simplify the process.
involved in a research project, please consider submitting a risk form for your project. Please note that the risk form not only captures the risk assessment but also functions as a compliance checklist, ensuring your research project adheres to necessary guidelines. Contact Details If you require any further support, please reach out to us at
Research Project/ Grant Application Approval requirement. Prior to completion or submission, if there is any aspect of the risk assessment or management process associated with your proposed research that you feel unsure about then it is the responsibility of the PI to seek
E. Examples of Research Studies with Suggested IRB Decisions F. Additional Resources . A. Introduction to Risk Assessment and Reduction and the Role of the IRB . Risk Assessment involves the consideration of physical and psychological risks along with the protection of privacy. The student researcher, adult sponsor and qualified scientist must ...
As projects progress, risk ratings may change. Some risks will drop off your risk assessment entirely, while new risks may emerge along the way. Tip: Designate someone from the project team to monitor each risk : management.
for ensuring that a risk assessment is undertaken before a project commences and advising on safety guidance and procedures appropriate and specific to the project. The risk assessment is designed to identify potential hazards, assess risks and put appropriate control measures in place to mitigate those risks before the research commences.
The risk assessment enables approvers of the research application to make an informed decision on any potential risk. It consists of 12 ‘yes’ or ‘no’ questions designed to flag risk and capture key information relevant to the project.