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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.

To ensure research is beneficial and minimises harm, it needs to be conducted ethically. UCL's ethical review processes aim to ensure this while remaining sensitive to researchers' needs. All human-involved research carries some risk. Even if the risk is small, it is important to consider issues around privacy, equality, diversity, and health and safety. Researchers should always consider the ethical implications of any work that has the potential to:

  • Harm to the mental or physical health of participants (e.g., volunteers, UCL staff, students)
  • Jeopardise the safety risks to those affected by the research (e.g., volunteers in sensitive situations or abroad)
  • Compromise the privacy of individuals whose data is involved in the study
  • Include the use of sensitive methods (e.g., genetic research, interviews, questionnaires, randomized control trials) or subjects (e.g., recreational drugs, environmental impact) that need to align with UCL’s high public reputation
  • Have an environmental impact
  • Carry a risk of actual or perceived conflicts of interest for researchers or the university

Accepted ethical standards


Several ethical standards have been accepted throughout the UK and abroad which all researchers and ethical committees are expected to meet:

Informed consent

All participants need to be fully informed about the study and what is being asked of them, including the potential risks, benefits, and exclusion criteria, so they can make a fully informed decision about whether or not to participate. Participation needs to be voluntary and not due to any inducement, coercion, or perceived pressure.

Consent is required for all study participants, except where justified for covert research or deception. Exceptions will be considered on an individual basis by UCL's Research Ethics Committees.

Benefit not harm

Research involving human participants needs to benefit society, with risks to participants balanced against the potential benefits.

Confidentiality

All participants have the right to confidentiality, with only the researcher knowing who has participated. Data should be anonymised in the final report so it cannot be attributed to an individual participant.

There are exceptions, for instance, where participants wish to be identified or their identities cannot realistically be kept confidential. In such cases, written consent is required from the participant.

Why is ethics review important?


Ethical review primarily aims to protect participants, who are a valuable part of the research process. It is essential that they, and their data, be treated with due care and respect. Being ‘ethical’ means following a set of core values and principles, such as integrity, compliance with the law, respect for human rights, and minimising risks to people’s safety and well-being.

UCL's Research Ethics Committees aim to ensure that any potential ethical risks arising from research are limited and proportional to the benefits and protect researchers. Careful consideration of research ethics principles and potential risks can help inform your research methods, increase participant recruitment, and enhance the quality of your research. Without ethical approval (except for exempt projects), risks include:

  • Harm to participants (either directly or indirectly)
  • Impact on a research participant settlements in the event of a claim and UCL's insurance profile; researchers may bear personal responsibility for any claims
  • Funders might not provide support for your research
  • Your results may not be accepted for publication
  • It could amount to research misconduct and may lead to disciplinary action (see UCL’s procedure for investigating misconduct in academic research).

All studies that require ethical approval need to have it in place before the research begins.

    When do I need to apply for ethical approval?


    All UCL research, including pilot studies, involving human participants or the use of their data requires ethical approval from the university's Research Ethics Committees. This includes: 

    • Studies involving NHS staff as research participants in their professional role
    • Studies on NHS premises with healthy volunteers not recruited as NHS patients and not subject to any legal requirements
    • Overseas clinical trials
    • Mechanistic studies using drugs to investigate a physiological process in healthy volunteers
    • Studies involving CE-marked medical devices not modified or used for new purposes. 

    Data from human participants

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

    • Secondary research data, human data, and records (e.g., genetic, financial, personnel, criminal, or administrative records)
    • Samples from participants such as blood and DNA
    • Collection and analysis of passive or ‘big’ data from sensors and other digital ‘tracking’ tools, or other online generated content.

    Retrospective consent

    UCL's Research Ethics Committees cannot approve retrospectively. If you are unsure about the need for ethical approval, speak to your Head of Department, Local Ethics Lead, or supervisor. When contacting UCL Ethics Committees for an opinion, you should provide information about the research, project type, or exemption category, and explain how your research meets the criteria.

    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. to obtain research permission, research funding, or to publish results.

    Work not classed as ‘research’ 

    UCL ethical approval is not required if your work does not constitute ‘research’, such as staff or student performance reviews, or tests within normal education requirements. The following are also not classified as ‘research’:

    Literary of artistic criticism

    Evaluating, analysing, and interpreting literature or artwork, providing critique or opinion, or not collecting new data or recruiting participants. This excludes psychological interpretations of publicly available data, like analysing speeches for signs of dementia or autism.

    Audit/quality assurance projects not involving access to or collection of private or sensitive data

    An audit is defined as assessing service levels against pre-determined standards, typically involving the analysis of existing data to improve the current service. Audits do not involve randomisation or changes for for evaluation of the service.

    Service evaluation

    Similar to an audit, but without pre-determined standards, service evaluation defines or judges the current service level (e.g., rehabilitation programs, public services) to benefit service users. Participants are usually those who use or deliver the service, and the review does not involve changes during the evaluation (e.g. no randomisation of service users into different groups).

    Note: Using existing participant data during a service evaluation for research requires ethical approval, ensuring:

    • The data is completely anonymous
    • Participants cannot be identified in any resulting reports
    • No substantial damage or distress is caused from data usage

    The Health Research Authority Research Ethics Service (HRA REC), distinguishes research from audit and service evaluation via a decision toolkit available on their website. The toolkit does not cover studies involving NHS staff, facilities, data, or other resources which may also require HRA approval. Contact the UCL/UCLH Joint Research Office at uclh.randd@nhs.net for guidance on your study requirements and to meet all governance and ethical standards.

    Research classed as exempt

    Before assessing if your research is exempt, read the guidelines and requirements below:

    Exemption guidelines and requirements
    • Exemptions apply to submissions to UCL's Research Ethics Committees but not to Institute of Education (IOE) REC submissions
    • Some departments have local arrangements in place to review all research, including exempt studies
    • Exemptions do not apply to research involving vulnerable participants as defined by UCL guidelines.

    Even if research is exempt from UCL Research Ethics Committee approval, you are still required to:

    • Abide by the ethical guidelines relevant to your discipline
    • Applying for Data Protection Registration
    • Undertaking a risk assessment as per UCL procedures

    Heads of Department have the final say on exemptions from UCL Research Ethics Committee approval.

    Research is exempt if it involves:

    • Public domain information (e.g., published biographies, newspaper accounts of an individual's activities, and published minutes of a meeting) that does not require review under the Data Protection Act
    • Anonymised public domain records and datasets (e.g., from the Office for National Statistics or the UK Data Archive) where appropriate permissions have been obtained and individuals cannot be identified from the information provided
    • Purely observational studies of public behaviour (non-invasive and non-interactive) unless the individuals are identifiable and at risk of harm
    • Non-sensitive, anonymous educational tests and surveys with non-vulnerable participants not inducing psychological stress or anxiety
    • Educational tests, surveys, and interview procedures on human participants in the public arena (e.g. public officials, candidates for public office, artists)
    • Taste and food quality studies with wholesome, safe food without additives or ingredients, agricultural, chemical, or environmental contaminants, at a level declared safe by the relevant national food safety agency.

    Collaborative research within the UK

    For UCL researchers working on a project led by a Principal Investigator (PI) from another UK university and ethical approval has been granted by that institution (with the UCL co-researcher and their role included on the application) granted, additional UCL ethical approval will not be required if the university is the project sponsor. 

    Co-researchers need to ensure the PI gains ethical approval from their institution and local permissions if the study is based overseas before data collection can commence. If you join a collaborative project led by a PI from another UK university part-way through the study, you will need to inform the relevant UCL Research Ethics Committee immediately to ensure the exemption still applies.

      Applying for UCL ethical approval


      Depending on the nature and location of your research, you may need ethical approval from one or more committees, including UCL or external committees (UK and overseas). Visit our Apply for ethical approval page for more information.

      Further information