Do I need ethical approval?

Find out more about the importance of ethical review, if your research study requires ethical approval, and how to apply for ethical approval at UCL.

Overview

In order for research to result in benefit and minimise the risk of harm, it must be conducted ethically. UCL's review processes are intended to ensure this whilst remaining sensitive to the needs of researchers.

All research involving humans carries some degree of risk. Even if the risk is very small or even negligible, it is important to always consider if the research you are doing raises issues related to privacy, equality, diversity, health and safety. A researcher must, therefore, consider the ethical implications of any work that:

• Has the potential to damage the mental or physical health of human participants, (e.g., volunteers, UCL staff and students) or others who may be affected
• Has the potential to jeopardise the safety of people affected by the research (e.g., volunteers working in sensitive situations or abroad)
• Has the potential to compromise the privacy of individuals whose data is involved in the work
• Involves methods (e.g., genetic research, interviews, questionnaires, randomised control trial) or subject matter (e.g. recreational and controlled drugs, human impact on the environment) that are sensitive and therefore need to be managed consistently with UCL’s high public reputation
• Has the potential for environmental impact
• Carries risk of an actual or perceived conflict of interest on the part of researchers and/or the university.

Accepted ethical standards

There are a number of ethical standards that have been accepted throughout the UK and abroad which all researchers and ethical committees are expected to comply with:

Informed consent

All participants must be fully informed of the study and what is being asked of them, including the potential risks/benefits and exclusion criteria, in order to make a fully informed decision about whether or not to participate in the research. This must be an active step on behalf of the participant and not due to any inducement, coercion, or perceived pressure to participate. This is required of all participants in a research study, except where there is a justification for covert research or deception (such cases will be considered on an individual basis by the ethics committee).

Benefit not harm

Research involving human participants must have a benefit to society and the risks involved to participants must be balanced against the potential benefit to the overall community.

Confidentiality

All participants have the right for their participation to remain confidential in that only the researcher will be aware of who has participated. Generally, all data will also be anonymous in the final report so that nothing can be attributed back to an individual participant. There are exceptions, for instance where participants wish to be identified or they cannot realistically have their identities kept confidential, but written informed consent must be obtained from the individual participant in advance.

Why is ethical review important?

The aim of ethical review is primarily to protect participants. They are a valuable part of the research process both directly and indirectly and therefore it is essential that they, and their data, be treated with due care and respect.

Being ‘ethical’ means acting in accordance with a set of core values and principles, in particular, integrity, compliance with the law, respect for human rights, and avoiding unnecessary risk to people’s safety and well-being.

The UCL REC seeks to ensure that any potential ethical risks arising from research are limited and are strictly in proportion to the importance of the intended benefits.

Another aim of ethical review is to protect you as the researcher. In addition, careful consideration of research ethics principles and potential risks can help inform your research methods or increase participant recruitment, and as a result, enhance the quality of your research.  

If ethical approval is not obtained when it should have prior to commencing a study (not including exempt projects):

• There is the risk of harm to participants (either directly or indirectly) if the risks have not been appropriately considered and/or relevant approvals obtained
• There could be an impact on a research participant's settlement in the event of a claim and could damage UCL's insurance profile. the individual researcher bears personal responsibility for any claim
• Funders are unlikely to provide support for your research
• Publishers are unlikely to accept your results for publication
• It could amount to research misconduct and may lead to disciplinary action. See UCL’s procedure for investigating and resolving allegations of misconduct in academic research for further information.

It is expected therefore that all studies that require ethical approval have that approval in place before the research begins.

When do I need to apply for ethical approval?

Unless exempt, all research, including pilot studies, by UCL staff and students involving human participants or the collection and/or use of their data requires ethical approval from the UCL Research Ethics Committee (REC). This includes: 

• Studies involving NHS staff recruited as research participants by virtue of their professional role
• Studies on NHS premises, involving healthy volunteers not recruited as NHS patients and not subject to any legal requirements
• A clinical trial conducted overseas
• A 'mechanistic' study in which a drug is used to investigate a physiological process in healthy volunteers
• A study involving a CE-marked medical device that has not been modified or is not being used for a new purpose. 

Definition of data from human participants

The Economic and Social Research Council (ESRC) define data derived from human participants to mean all data derived from a human participant, either collected by a researcher as part of a project or accessing pre-existing data. This includes:

• The use of secondary research data, and human data and records (e.g., genetic, financial, personnel, criminal, or administrative records)
• Samples taken from participants such as blood samples and DNA
• The collection and/ or analysis of passive or ‘big’ data, that is, data collected through the use of sensors and other digital ‘tracking’ tools or other online generated content.

When don't I need to apply?

If your work is not classed as ‘research’ or your research falls under the exemption criteria, then you do not ordinarily need to seek approval from the UCL REC unless any of the following apply:

• Your faculty or departmental ethics committee requires that you apply for local approval;
• Approval is specifically required by another external body e.g. in order to obtain research permission, research funding, or to publish results.

Work not classed as ‘research’ 

You do not need to apply for UCL ethical approval if your work does not constitute ‘research’, such as staff or student performance reviews, or tests within normal education requirements. The following would also not be classed as ‘research’.

Literary or artistic criticism

The evaluation, analysis, and interpretation of literature or artwork; providing a critique or opinion, not collecting new data/recruiting participants.

This does not include psychological interpretations of publicly available data such as analysing speeches and concluding that the language used indicates dementia onset at a particular age or autistic features, etc.

Audit/quality assurance projects that do not involve access to or collection of private or sensitive data

An audit is defined as assessing the level of service being provided against a set of pre-determined standards. This generally involves analysing existing data with results usually being used/distributed locally in order to effect change to improve/change the level of service currently being provided in the body being audited, though the process of conducting the audit does not involve randomization or changes prior to/for the purposes of evaluation of the service. 

Service Evaluation

Service evaluation* is similar to an audit but there are no pre-determined standards and so the review is designed and conducted to define or judge the current level of service (a system supplying a need, such as a rehabilitation programme, public services) and is undertaken to benefit those who use a particular service.

The participants will therefore normally be those who use the service or deliver it or assess its function. The review does not involve any change to the service being delivered during/for the purposes of the review (e.g. no randomisation of service users into different groups). 

Note: In order to use data already collected from participants during a service evaluation for research, this would require ethical approval, and in addition:

• The data would need to be completely anonymous
• It should not be possible to identify participants from any resulting report
• Using the data should not cause substantial damage and distress.

The NHS Ethics Review Procedure, i.e. the Health Research Authority Research Ethics Service (HRA REC), distinguishes research from audit and service evaluation in a decision toolkit available on the NHS Health Research Authority website

Please note, the HRA REC decision toolkit does not relate to studies involving NHS staff, facilities, data, or other resources which may also require HRA approval. If you believe this may apply to your project, please contact the UCL/UCLH Joint Research Office to discuss your study requirements, or email uclh.randd@nhs.net to ensure all governance and ethical requirements are met.

Research classed as exempt

Before assessing whether your research is exempt you must read the exemption guidelines and requirements:

Exemption guidelines and requirements

• These exemptions apply to the requirement to apply to the UCL REC. They do not apply to staff and students submitting to the Institute of Education (IOE) REC
• Some departments have local arrangements in place to review all research, including exempt studies, so it is important that you are aware of them
• The exemptions do not apply to research involving vulnerable participants as defined in our guidelines If research is exempt it means that you are exempt from applying for ethical approval from the UCL REC, however, it does not mean that you are exempt from:
  - Abiding by the appropriate ethical guidelines appropriate to your discipline
  - Applying for Data Protection Registration
  - Undertaking a risk assessment as per UCL Risk Assessment procedures
• Heads of Department have final judgment as to whether a particular activity should be exempt from the requirement for approval by the UCL REC.

Research is classed as exempt:

• Research involving information freely available in the public domain, e.g., published biographies, newspaper accounts of an individual's activities and published minutes of a meeting. Whilst still personal data under the Data Protection Act would not require ethics review.
• Research involving anonymised records and data sets that exist in the public domain, e.g., datasets available through the Office for National Statistics or the UK Data Archive where appropriate permissions have already been obtained and it is not possible to identify individuals from the information provided.
• Studies of public behaviour that are purely observational (non-invasive and non-interactive) unless the recorded observations identify individuals (names, photographs) which could place them at risk of harm, stigma, or prosecution
• Research involving the use of non-sensitive, completely anonymous educational tests and surveys when the participants are not defined as "vulnerable" and participation will not induce undue psychological stress or anxiety
• Research involving the use of educational tests, surveys, and interview procedures on human participants in the public arena (e.g. elected or appointed public officials, candidates for public office, artists).
• Taste and food quality evaluation and consumer acceptance studies, if the food consumed is wholesome without additives or contains a food ingredient, agricultural, chemical, or environmental contaminant, for a purpose and at a level declared safe by the relevant national food safety agency.

Collaborative research within the UK

For UCL staff or student researchers involved as co-researchers on a project led by a Principal Investigator (PI) from another UK university and ethics approval has been granted by that institution (with the UCL co-researcher named on the application along with an account of their role on the project) then, provided that a UK university is the sponsor for the project (taking responsibility for the whole study), additional ethical approval through the UCL REC will not be required.  The co-researcher must ensure that the PI gains ethical approval from their own institution before the commencement of data collection as well as local ethics/research permission if the study is based overseas.

How do I apply for UCL ethical approval?

Depending on the nature and location of your research you may need to apply for ethical approval from one or more ethics committees, including within UCL or external committees (both in the UK and overseas). To find out more visit our Apply for ethical approval pages.

Further information

• Codes of conduct
• Committees and governance
• Guidance, training, and resources
• Responsibilities after ethical approval
• Information for external researchers