Ethical approval
Under the University's Research Ethics Policy, the following research proposals by staff and students require ethical approval by the appropriate committee:
- Research involving human participants (e.g. interviews, questionnaires, blood sampling);
- Research involving non-human sentient creatures (restricted to research falling outside the scope of the Animals (Scientific Procedures) Act 1986);
- Research involving harmful or criminal, or sensitive or extremist subject matters or research protocols;
- Research where the nature of the collaboration (e.g. the source of the funding) raises concerns that it may be inconsistent with the University's values. Further information about collaborations that require ethical approval because they may conflict with the University's core values are provided in the Ethical Research Collaboration Policy
If your research does not fall into one or more of these categories, ethical approval by a University committee is not required.
What committee should I go to?
My research has / may need external approval:
My research involves health, social care or community care services, people, data or facilities.
- Check with the (HRA) whether your research requires HRA approval.
My project falls under the auspices of another professional association which has a code of ethics.
- Get advice from the relevant association and comply with the research ethics guidelines of that association. NB an application to the relevant Çï¿ûÊÓƵ research ethics committee will still be required.
I am a co-researcher in a project which has external ethical approval (e.g. from another university).
- Contact researchethics@gre.ac.uk for advice.
- Evidence of the external approval and relevant information (e.g. the ethics application, participant information sheet, consent form and questionnaire) will need to be provided for consideration by the University Research Ethics Board (UREB).
- If the project involves gathering data from Çï¿ûÊÓƵ students or staff, you will also need to complete a UREB and submit it to UREB.
My research involves human tissue
The Human Tissue Act 2004 regulates the storage and use of human tissue for research purposes. It applies to human tissue whether or not it is sourced from the NHS. Human tissue includes blood and other material, other than gametes, which consists of or includes human cells (for further information on what constitutes human tissue, see the Human Tissue Authority’s list of ). Failure to comply with the Act can lead to imprisonment and/or a fine.
The legislation requires that the storage of human tissue for research purposes must be done either under a licence issued by the or as part of a project which has received ethical approval from an NHS Research Ethics Committee (NHS REC). Storage includes storage for any length of time. University research ethics committees like Greenwich’s University Research Ethics Board (UREB) are not authorised to approve the storage of human tissue for research purposes.
Because the Çï¿ûÊÓƵ does not hold an HTA licence, you must submit an application to an NHS REC if your project will involve the storage of human tissue for research purposes. NHS RECs can approve applications for research involving human tissue irrespective of whether it is sourced from NHS patients. Applications should be submitted via the (IRAS). Once your application has been approved by the NHS REC, you should submit a copy to UREB for information.
Where human tissue is stored under approval from an NHS REC, you must ensure that the material is stored for no longer than the duration of your project’s approval, or apply in good time to the NHS REC to extend the approval.
There are some exceptions to the requirement that human tissue must be stored under an HTA licence or under NHS REC approval:
- Where the storage is incidental to transport to another organisation (the transportation should take place in a matter of hours or days and in less than a week);
- Where the human tissue is stored with the intention of rendering it acellular. This should take place in a matter of hours or days and in less than a week. NB this exemption does not cover using human tissue for research purposes prior to rendering it acellular;
- Where the human tissue has been received from an HTA-licenced tissue bank with generic NHS REC approval.
Faculty Research Ethics Committees
Students should discuss their ethics application with their supervisor.
Under the University's Research Ethics Policy, Faculty Research Ethics Committees can consider the following under delegated authority:
- Research proposals from undergraduates, taught postgraduate students and postgraduate research students, subject to the exceptions below.
The following must always be referred to the University Research Ethics Board (UREB):
- Research proposals from staff.
- Any research activity involving vulnerable people, e.g. children, the elderly, prisoners or people in care (see the Research Ethics Policy);
- Any research activity involving harmful or criminal, or sensitive or extremist subject matters or research protocols (see the Research Ethics Policy);
- Any research activity involving protected animals (see the Research Ethics Policy);
- Any research activity involving physically invasive procedures (see the Research Ethics Policy);
- Any research activity where there are ethical concerns about the nature of the collaboration (e.g. the source of funding) (see the Ethical Research Collaboration Policy);
- Any research activity by postgraduate research degree students which involves collecting personal data which is 'special category' data in the sense of the General Data Protection Regulation (race, ethnic origins, political opinions, religious beliefs, trade union membership, genetics, biometrics, health, sexual life, sexual orientation), personal data about criminal convictions or offences, or personal financial information.
Where approval by UREB is required, postgraduate research degree students (including staff studying for postgraduate research degrees) must first receive approval from their Faculty Research Degrees Committee before gaining approval from UREB.
UREB Chair's Action
- Although my research aims or methods involve human subjects the subject-matter of my project is completely uncontroversial. For example – it is a simple, brief questionnaire where there is no risk to the participant or researcher, the effort required is minimal and the level of intrusion is non-existent or very low.
- My project is an extension to an existing project, oris a new project re-using existing data.
- I want to make an amendment to a currently approved project, for example there are changes to the method of participant recruitment, there are changes in the method of data collection, or I wish to extend the project’s timeframe.
- I require approval in between UREB meetings to meet funder’s requirements or for other urgent reasons.
These may be approved by Chair's Action. Contact the Board for advice on researchethics@gre.ac.uk.
Go through the UREB, by completing the application form and the process below.
Complete the form electronically and send one copy by email to: researchethics@gre.ac.uk.
The information collected on the form will be kept as a record of research proposals, and processed within the terms of the Data Protection Act 2018.
The closing date for receipt of applications is two weeks prior to the meeting of the Board (view Board meeting dates).
Advice on completing the form
What might be the ethical issues and risks that arise in my research?
These are some examples of what might be an ethical issue or risk in research. This is not an exhaustive list – you may identify other issues in your own research project. You need to explain how you will deal with each of the issues or risks you identify.
Matters around subject-matter
- Controversial / contentious / sensitive / embarrassing / upsetting subject-matter
Matters around the research collaboration
- The nature of the collaboration (e.g. the source of the funding) raises concerns that it may be inconsistent with the University's values. Further information about collaborations that require ethical approval because they may conflict with the University's core values are provided in the Ethical Research Collaboration Policy.
Matters around participants
- Children or young people are involved (under 18)
- Vulnerable people are involved (elderly, physically or mentally ill, people with learning difficulties, in care, bereaved, prisoners, others)
- Participants are my own students or colleagues
- Participants are an over-researched group
- Participants do not understand English / might not adequately understand verbal explanations or written information / have low functional literacy
Matters around researchers
- There is a conflict of interest for the researcher
Matters around recruitment of participants
- Participants may be approached in a public space
- Participation is not voluntary, or there is coercion or incentive to participate
- Researcher or Faculty / Department / University has a financial interest in the project
- The participant may not be able to withdraw from the project
- Deception is involved
The nature of the participants
- Participants may disclose that they have broken the law
Risks or hazards to participants or researchers
- Physical or mental risk or hazard
- Fear or pain / distress / discomfort to the participant or researcher
- Taking of samples e.g. blood, saliva
- Physical contact
- Food or drink is to be administered
- Risk to personal safety e.g. physical or verbal attack; disability or health problems; delayed access to personal or medical assistance; failure of routine or emergency communications; security of accommodation and support; getting lost, or stranded by transport; cultural or legal differences
- Inconvenience or changes in lifestyle for participants
Location of participation
- The project or interaction is out in the open, at another organisation's premises, abroad / overseas
- Natural physical hazards - effects of the natural environment, climate, landscape, plants, animals e.g. extreme weather; earthquakes and volcanoes; mountains, cliffs and rock falls; glaciers, crevasses and icefalls; caves, mines and quarries; forests including fire; marshes and quicksand; fresh or seawater, tidal surges
- Environmental impact e.g. pollution and waste, deposition of rubbish, disturbance of eco-systems, trampling, harm to animals or plants
Confidentiality issues
- Covert observation of participants
- Recording or filming / photography of participants (whether covert or otherwise)
- Issues of confidentiality and privacy, or lack of anonymity (see section on personal data)
- Security of personal data, retention and disposal of the data (see section on personal data)
Other health and safety issues
You may consider whether you need to complete a separate Health & Safety Risk Assessment form, as well as answering this question on your application form. Your professional body may also require this (as an example, the ).
- Equipment hazards - storage, handling and use of equipment and materials e.g. tools; machinery; vehicles; manual handling; noise; work at height; electricity; fire; vacuum; high pressure; high temperature; ultra violet; laser; vibration
- Chemical hazards - storage, handling, use, and disposal of chemical reagents, intermediates, products and waste e.g. toxic by inhalation or ingestion; irritant; corrosive, flammable; explosive; oxidising; radioactive; include routes of exposure e.g. skin contact; skin sensitisation; sensitisation by inhalation; toxic by ingestion or inhalation. All work with radioactive materials MUST be approved by the Radiation Protection Supervisor (contact the Safety Unit at safetyunit@gre.ac.uk).
- Biological hazards - storage, handling, use, and disposal of biological agents, intermediates, products and waste; "any micro-organism, cell culture or human endoparasite including any which have been genetically modified, which may cause infection, allergy, toxicity and other hazards to human health". This includes bacteria, viruses, fungi and parasites; Include routes of exposure e.g. Blood borne infection; skin contact, skin sensitisation; sensitisation by inhalation; toxic by ingestion or inhalation. Work involving Class 2 agents or above must be approved by the University Biological and Genetic Modification Safety Committee before materials are obtained and work commences. If work involves genetically modified organisms, GMO Risk Assessment form must be completed. Contact the Safety Unit at safetyunit@gre.ac.uk.
- Covid-19 - during the Covid-19 pandemic, a risk assessment should be carried out where a project involves in person contact with participants (see the University's Covid Safe Arrangements page for further guidance).
Am I collecting personal data in research?
Personal data is data relating to living individuals, whether hard or soft copy, for example in research this could be:
- Names, contact details, other factual information
- Answers to questions, for example in questionnaires or interviews, whether factual or opinion
- Names and signatures on consent forms
- Photographs, film, video, audio, transcripts of interviews etc.
- Human biological material, e.g. blood, tissue
- Test results e.g. heart rate, blood pressure
How will you deal with that data?
- Gain consent for collecting and processing the data
- Participant consent form (see below)
- Provide enough information about the project for the participant to be able to give informed consent
- Participant information sheet (see below)
- Security of the data
- Hold it in a secure location, whether electronic or hard copy
- Locked cabinet, password-protected files and shared drives, encrypted lap-top
- Be particularly aware of movable storage media, e.g. USB sticks, lap-tops
- Do not share the data except with co-researchers
- Be aware if you are carrying or transferring data abroad, particularly outside the EEA
- Transfer the data in a secure manner
- Package and address correctly, avoid email if possible
- Guard against unauthorised access or accidental loss, damage, or destruction of the data
- Hold it in a secure location, whether electronic or hard copy
- Retention of the data
- Decide how long you need to keep it, and for what reason. Don't keep it any longer than necessary
- Decide how long you need to keep the administrative records associated with the project, and for what reason. Don't keep them any longer than necessary
- Disposal of the data
- Dispose of it securely, whether electronically or in hard copy
- Confidentiality of the data
- Anonymise the data once collected, for example:
- Separate the data from the identifying details of the participant
- Give the data a code and attach the code to the separate contact details
- Allow participants to choose codes / passwords so that they could be allowed access to their data if necessary / withdraw from the project within certain timescales
- Anonymise the data once collected, for example:
- Ensure that data is published only in anonymised form
- Ensure that the data never causes damage or distress to individuals
- Ensure that it is never used to support measures or decisions relating to particular individuals
- Never use the data you have collected, nor the contact details of participants, for another purpose other than a research purpose
- Do not use the contact details for marketing reasons to those participants
For more information, refer to the Data Protection .
Participant Information Sheet
Your participant information sheet should include:
- Enough information, in lay language, for the participant to understand what the project is about and what is required of them so that they can give informed consent
- Who they can contact for more information (business contact details) and who is the organisation overseeing the research
- A date by which participants are able to withdraw their data from the study
- Assurances that their data will be held securely and treated correctly.
Participant Consent Form
A Participant Consent Form should normally accompany all research applications. The researcher can adapt this template to suit the needs of the research: for example, so that it can be better understood by young participants or those whose first language is not English.
For persons under 18 years of age the consent of the parent(s), guardian(s) or those acting in loco parentis must be obtained or an explanation given to the UREC as to why this has not been obtained. The consent of the child/young person should also be obtained. In some studies witnessed or verbal consent may be appropriate.
The consent form must be signed by the actual investigator concerned with the project after having spoken to the participant to explain the project and after having answered his or her questions.