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UCL Research Ethics

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Do I need UCL ethical approval?

Unless it is deemed exempt, all research (including pilot studies) by UCL staff and students involving human participants or the collections and/or use of their data requires ethical approval.

This includes the following: 

  • 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        [click to expand]

ESRC’s Framework for Research Ethics 2015 defined Data derived from human participants’ to mean all data derived from a human participant, either collected by a researchers as part of a project, or accessing pre-existing data.  This includes:

  1. The use of secondary research data, and human data and records (such as, but not restricted to medical, genetic, financial, personnel, criminal or administrative records and test results including scholastic achievements);
  2. Samples taken from participants such as blood samples and DNA (see Human Tissue Act 2004 or the Human Tissue Authority website);
  3. 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 on-line generated content.  Examples of this include accessing data on mobile phone usage, tracking journeys through travel cards, use of online applications such as through online stores or social media. 

Remember: The UCL REC cannot grant approval retrospectively and so if you are note sure if your project needs ethics approval, you should speak to your Head of Department and/or local Ethics Lead (or supervisor).  If you wish to contact the UCL REC for an opinion, you need to provide information about the research, which project type (non-research) or exemption category applies and an explanation of why you believe your research meets the criteria.  

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Projects that do not require ethical approval from the UCL REC

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, 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’. [Click the headings to expand and read the guidance.]

Literary or artistic criticism

The evaluation, analysis and interpretation of literature or artwork; providing a critic 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 to 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) distinguishes research from audit and service evaluation in a decision toolkit available at 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 via www.ucl.ac.uk/jro 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 (see below). 

Exemptions:

  1. Research involving information freely available in the public domain. For example, 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.
  2. Research involving anonymised records and data sets that exist in the public domain. For example, 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.
  3. 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.
  4. Research involving the use of non-sensitive, completely anonymous educational tests, survey and interview procedures when the participants are not defined as "vulnerable" and participation will not induce undue psychological stress or anxiety.
  5. Research involving the use of educational tests, survey and interview procedures on human participants in the public arena (e.g. elected or appointed public officials, candidates for public office, artists).
  6. 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.
Exemption guidelines and requirements          [click to expand]: 
  1. These exemptions apply to the requirement to apply to the UCL REC.  They do not apply to staff and students submitting to the IOE REC.  
  2. Some departments have local arrangements in place to review all research, including exempt studies, and so it is important that you check what your local arrangements are.
  3. The exemptions do not apply to research involving vulnerable participants as defined in our guidelines.
  4. If your study is not exempt from ethical approval you will need to submit an application to the UCL Research Ethics Committee. Please follow the steps on our → Applying to UCL REC page.
  5. If research is exempt it means that you are exempt from applying for ethical approval from the UCL REC.  It does not mean that you are exempt from:
  • abiding by the appropriate ethical guidelines appropriate to your discipline.  All research must maintain the same ethical standards, including those of confidentiality, benefit not harm and informed consent, regardless of whether an application needs to be made;
  • applying for Data Protection Registration;
  • undertaking a risk assessment as per UCL Risk Assessment procedures.

 Note: Department Heads have final judgment as to whether a particular activity should be exempt from the requirement for approval by the UCL REC. 

Collaborative research within the UK

For UCL staff or student researcher 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 additional ethical approval through the UCL REC will not be required.  The co-researcher must ensure that the PI gains ethical approval from his/her own institution before the commencement of data collection as well as local ethics/research permission if the study is based overseas.

 

    Page last updated: September 2021