This page has been set up as a resource for researchers. It aims to provide answers to some of the most frequently asked questions about the Research Ethics Committee system. If you have a query which you feel is not covered, please contact: firstname.lastname@example.org
- Do projects involving only the analysis of existing data need ethical approval?
Yes, and no; it depends on the nature of the data you are accessing and where you have accessed it from. As you will see under the UCL exemptions (1 and 2) some existing data does not need ethical approval under UCL's existing ethics policy. However, for research that does not fall within these two exemptions, ethical approval will be required. See the 'Do I need ethical approval' webpage for more information.
- What types of research require ethical approval?
All research involving human participants or the collection and/or use of their data requires ethical review, unless it is classed as exempt. See the ‘Do I need ethical approval’ webpage for the list of current UCL exemptions.
- How do I download the ethics application form?
If this is your first application you will need to register your personal details on the Registration Form and a personal account will be established for you. For existing users log into your account using your email address and password and add a ‘new project’ to your account. A unique Project ID for your proposal will be issued immediately which you should make a note of. Once you have entered your personal and project details, a zip folder will appear containing a ‘non-high’ and ‘high’ risk application form together with supporting guidelines for you to download to your computer. See the 'Applying to the UCL REC' webpage for details on the application process and links to the ethics database.
As always, if you have any specific questions or difficulties, please do not hesitate to contact the Research Ethics Team.
- What are the criteria for submitting an application for review as non-high risk?
Applications are suitable for review as non-high risk provided they are not using methods, recruitment protovols or topics that could be classed as high ethical risk, such as:
- Vulnerable groups
- Intrusive interventions (including MRI)
- Overseas clinical trials
- Sensitive topics
- Real risk of harm to either participants or researchers
- Scraping data
- Deception, involving actively misinforming or purposefully not fully informing participants what their participation entails or the true purpose of the research
- Covert methods; actively hiding the observation of, or other data collection from participant(s), where the participant(s) would otherwise have a reasonable expectation of privacy (applies both in person and online).
- How soon after the Committee meets will I hear the result?
High Risk: The UCL REC will endeavour to convey decisions to the applicant within a week of the meeting, unless there are queries that need to be raised with the applicant, or there is a need for an opinion from outside of the UCL REC.
Non-high Risk: As there are no set meetings or deadlines, applications are considered on a rolling basis with applications being reviewed in order of submission. At peak times (particularly during dissertation months) applicants can experience delays due to the volume of submissions. It is therefore suggested that you submit your application for review as early as possible to provide sufficient time.
- Is it possible for projects to be reviewed urgently?
Yes, this is called expediated review. This is available for Non-high Risk and Team Review but not for High Risk applications, which will be automatically assigned to the next committee meeting. In the very rare exception that a High Risk application needs earlier review, you must submit a clear justification for why the review cannot wait until the next meeting.
Requests for expediated review are not automatically accepted, and so when submitting a request for expediated review you must provide a justification for why an urgent review is needed. Our guiding principle is to promote and create an ethically sound research culture at UCL and not to place obstacles or delays in the way of researchers, and so we will do our best to accommodate you within reason. However, it is important to note that urgent applications take time to arrange and put pressure on the system, as well as delaying the review of other applications, therefore, this route should only be used for cases where there is a genuine need for urgent review.
To assist us in identify these requests easily you are requested to be clear in the subject of your email that you are requesting an urgent review. For those with a very short timeline, we recommend that you submit your request to us while you are writing your application so that we can review the justification and (if accepted) begin the process of arranging an urgent review.
- My research project will develop over time - will this affect the review?
If you are doing long term research in multiple stages it is recommended that you consider submitting separate applications for each stage. This will ensure that you can start the earlier stages and will not have to amend the approval as the research changes and develops - it will also make the review simpler to complete. If you cannot do this you must bear in mind that you will need to submit a request for a modification to your project whenever changes are needed - see Responsibilities after approval.
- Do I have to give participants an Information Sheet?
All participants need to be given adequate information about the study so that they can make an informed decision about whether to participate. This is generally done in writing so that you and your participants have a record of all the relevant information about the study, and what participation involves. In most cases this is supplementary to, rather than replacing, a discussion between the researcher and the potential participant.
We refer to this as an 'information sheet' as it is the written record of information about the study. A template information sheet is provided on the 'Applying to the UCL REC' webpage in order to help you in preparing the written information you are going to give to participants. Please note that this template is a guide that is provided to help you, it is not prescribing the way you must set out the information or inform participants about your study. For example, the information can be presented in a letter or email rather than as template 'Information Sheet'. Another example is for very young children, where standard written information sheet would not be appropriate, as they either cannot read and/or are too young to understand the information in as an adult would. For these situations you need to think of ways to present the information to the child participants in a way that they can understand, such as using images or creating a small booklet - see 'Research with children' webpage for more information.
However you design your 'information sheets', the important thing is that your participants have adequate information (in a way that they can easily understand) about why, how, when, with who, and where the study is taking place; in effect everything they are agreeing to, including the risks and how their data will be managed.
- What about participants who can't consent on their own behalf?
For studies involving individuals aged 16 or over, who do not have the capacity to consent to participate in the proposed study, approval by an NHS Research Ethics Committee is required. Please note that it is illegal to undertake research with individuals over 16 who lack the capacity to consent to take part in your research unless you have approval from an NHS REC.
Please note that for research involving children under legal age of consent, you will need to obtain the (legally recognised) consent from a parent or guardian. This will be needed in addition the child's personal consent to participate. See the 'Research with children' webpage for more information.
- Do I always need my participants to complete a consent form?
No, for example, self-completion questionnaires do not require the completion of consent form, as submission of the completed questionnaire can imply consent to participate, and you should make this clear in your Information Sheet.
For some questionnaires you may need to ask participants to tick consent clauses before they complete the questionnaire, for example if you are asking permission to share their data with other researchers after the study, or you wish to use quotes form their responses in a published article. These do not require a separate consent form, but they do require participants to directly confirm their consent to these points as these are additional consents to the completion of the questionnaire. It can also assist you to have a record should any disagreements on these points arise later on.
- If the participants cannot read or write, how can they give their consent to participate in the research?
Particular difficulties may arise when consent needs to be recorded in illiterate populations. The application of safeguards to protect such participants from possible exploitation is illustrated by the trial of vaccines for leprosy in Point 1.1 (obtained from the Nuffield Council on Bioethics website which contains some excellent information on issues surrounding the obtaining of informed consent):
Towards an appropriate consent process: research into leprosy in Venezuela
In one study of a vaccine against leprosy carried out in rural Venezuela, researchers and prospective participants had no previous experience of an informed consent procedure. A process was designed in which the principal researcher visited communities where the research was to be conducted and explained it to community leaders. Following the approval of the community leaders, the research was explained to the community, followed by a question and answer session.
One to two months later members of the Ministry of Health visited the communities and asked individual participants if they understood what the research was about and whether or not they wished to participate. As many participants were not literate, their decision was recorded by a government worker, or in the presence of such a worker, without any of the researchers being present. Individual decisions were recorded and each participant either signed a form or gave a fingerprint.
Information sheets and consent forms must be designed to assist participants to make informed choices. We recommend that the information provided should be accurate, concise, clear, simple, specific to the proposed research and appropriate for the social and cultural context in which it is being given. Where it is inappropriate for consent to be recorded in writing, genuine consent must be obtained verbally. The process of obtaining consent and the accompanying documentation must be approved by a research ethics committee and, where only verbal consent to research is contemplated, include consideration of an appropriate process for witnessing the consent.
- Are there special rules if I am researching people that I already know (e.g. my students or people in my own workplace)?
Yes, whenever there is a pre-existing relationship between researcher and potential participants then the ethical issue of potential pressure to participate arises; meaning that participants may feel obligated or pressured to agree to participate in your research, when they may have refused to do so for someone unknown to them. As the researcher it is your responsibility to ensure that steps are taken to counteract this and to reassure them that they should not feel such pressure and they are free to refuse to participate without any consequences.
You must consider and demonstrate clearly to the committee:
- How you are going to communicate clearly to your potential research participants that there is no pressure to participate.
- What additional arrangements you intend to put in place to ensure that this is the case.
- What additional practical arrangements you intend to put in place to ensure that those who do agree to participate can change their mind at any point without having to give a reason, even after they have participated in the research activities.
- When is written evidence of permission from participating organisations required?
Written evidence of permission (on letterhead or via a organisation's email) should always be obtained by the researcher unless there are justifiable circumstances why this is not possible/necessary. These might include where the individual participant is senior enough within their organisation that their own consent can also be taken as evidence of permission from the organisation, or where the security or safety of the participant/organisation would be compromised by this. In such circumstances a real and substantive justification must be given and this will be considered on a case by case basis by the committee.
- How does risk assessment tie in with ethical review?
Formal risk assessments are often needed for research involving fieldwork, especially those undertaken overseas, as well as local assessments for studies on UCL premises. You should check with your department what the local arrangements are and read the guidance on the UCL Safety Services website on risk assessments.
For ethical review, if the research has the potential to place either the participants or researchers at risk, then the ethics committee will require assurances that an appropriate risk assessment has been undertaken and risks are being managed effectively. This means that you will need to ensure all risks are clearly described within the ethics application form, as well as the strategies for minimising the risks and/or how these risks will be managed. It is important as the reviewers need to be fully understand the risks and strategies in place to manage them in order to reach an informed decision about the ethics of the project.
This will not normally require you to submit a copy of the completed risk assessment form with the application form, but the Committee may request this if they feel the information will assist them in assessing whether the risks to participants and researchers are warranted.
- Are there special requirements if I want to record my participants?
Your participants will need to be told that you intend to record them and should be free to decline this aspect of the research unless participation isn't possible without you recording them (in which case they will not be able to participate). You should Participants need to be told if you intend to record them and this should be clearly stated in the information sheet as well as the consent form. Where recording is not essential, you should offer participants the right to refuse this. Where it is essential to record participants, then this must be explicit in the information sheet so that they are aware that if they do not wish to be recorded, then they cannot participate in the research.
You must also be clear what will happen to the recordings during and after the study, including where they will be stored and who will have access to them, this includes transcribers. You also need to state if and/or when the recordings will be deleted.
- What bodily materials fall under the auspices of the Human Tissue Act 2004?
Please refer to the Human Tissue Authority guidance on what constitutes relevant material for the purposes of the Human Tissue Act 2004.
- Where can I get information about UCL's human tissue licences?
You can also access the list of UCL Biobanks on the UCL Human Tissue Biobank website, where you will also find guidance for reseachers.
- What is the definition of a sponsor used by the UCL REC?
For the purposes of an application to the UCL REC your sponsor is the organisation who takes responsibility for the study or project. This is not the same as a funder, although the sponsor could also be the organisation that funds the study. If you are a staff member or a student member your sponsor will normally be UCL. If UCL is not the sponsor you will need to explain this in your ethics form. Research can have more than one sponsor and, in such cases, you must outline what responsibilities are being taken on by each sponsor.
- I think my research needs NHS ethical approval, can I apply to the UCL REC?
No, the UCL REC like all university RECs, cannot review research that falls under the remit of the Health Research Authority Research Ethics Service. To find out about what research requires NHS ethics review see the guidance on the 'Which committee do I apply to?' webpage.
- I need to make a change to my research, can I amend my ethical approval?
Yes, you just need to submit a request for a modification request to your project whenever changes are needed - see Responsibilities after approval.
Page last updated: September 2021