Frequently Asked Questions
Please read the following in conjunction with our glossary.
- A. Which research requires ethical approval?
- B. Which ethical review process should I follow?
- C. Completing the CUREC application
- D. Approved Procedures and Best Practice Guidance
- E. After approval
A. Which research requires ethical approval?
A1. Do all University of Oxford research projects involving human participants and/or personal data need ethical approval?
Research projects that involve recruitment of human participants and/or use of personal data must secure prior ethical approval where, for example, the research involves:
- participants answering questions about themselves or giving their personal opinion
- participants performing tasks eg an online survey or a computer task
- researchers using data that identifies individuals (see also FAQ A3a)
- observation of participants including use of video or photo devices (see also FAQ A5)
- participants undergoing any kind of intrusive procedure eg a blood draw
There is, however, a small group of investigative activities for which the involvement of human participants does not require ethical approval. See the Decision flowchart for CUREC (261kb) to determine whether your project needs ethical approval.
A2. My project is just an undergraduate dissertation and I am only interviewing one or two people. Surely I don't need to get ethical approval for it?
All research in the University that involves human participants needs ethical approval as explained in A1, regardless of who is doing it and how small the project may be.
A3. I'm using data about people who aren't identifiable: do I need to get ethical approval?
In general, if the data has been previously collected, and cannot be traced back to identifiable individuals, you need not obtain ethical approval. This means projects using existing data from a census, for example, do not need approval. Where data are anonymised but someone on the project can, by using a key, ascribe the data to individuals, then the project must obtain ethical approval. Where researchers identify a target population and hold any identifying information about them (eg email address) in order to administer a research procedure (eg sending a link to a web survey platform), the research must obtain ethical approval, even if the datasets collected from that procedure cannot be linked back to individuals.
A3a. I’m using data about patients and/or staff from the UK National Health Service (NHS) – do I need to get ethical approval?
Yes, you do need ethical approval (see also FAQ B3). But first you need to check whether you need permission from the NHS for that data use. (Permission may be needed for use of data whether in an identifiable or anonymised form). The Clinical Trials and Research Governance Team advises on this and provides confirmation that the University will accept the role of Sponsor for such studies. Once you have received this confirmation of Sponsorship, you may then apply for ethical approval from CUREC.
A4. The people in my study live thousands of miles away: there is no way they can be affected by publication of my study: do I still need ethical approval?
Yes. All people deserve consideration of their dignity and in fact there are special considerations surrounding research in different cultures. Please see the CUREC website for links to codes of practice in relevant disciplines such as anthropology. (See our Guidance from professional associations page.)
A5. I'm just observing people: do I still need ethical approval?
Yes. Observation may seem more intrusive to the people being observed than to the observer. Studies which involve observation normally need only to complete an application for straightforward ethical review (see individual subcommittee application pages accessed from the How to apply page, but sometimes observation can pose serious ethical questions, for example observation of at risk groups or illegal / harmful activity.
A6. I’m just asking people’s technical/professional opinion about matters related to my research, rather than seeking their personal information and/or opinions as research subjects. Do I need ethical approval to do this?
All projects where people participate as research subjects by offering their personal information, opinion or data where that information/opinion/data contributes directly to answering the project’s research question(s) need ethical approval. However, most research projects will also bring researchers into contact with other types of people: people who will show you how equipment works, provide technical or expert information about matters connected with your research, and give their views on your research (for example as part of a peer review process, or as a trainer on a methodology course you are taking).
These people do not count as “human participants” in the sense intended by CUREC’s main policy. They are not giving you information about themselves, and the opinions which they offer are not themselves the subject of the research. You need not get ethical approval of your research if your contact with people is confined to this sort of interaction.
B. Which ethical review process should I follow?
B1. Who gives ethical approval on behalf of University of Oxford?
The Central University Research Ethics Committee (CUREC) has overall responsibility for the University’s policy and procedures relating to research involving human participants and personal data. Three subcommittees provide ethical review and approval as a delegated power from CUREC itself. They scrutinise all University research projects involving human participants and personal data, unless the project requires review by an NHS research ethics committee (see our How to apply page and FAQ B2 for more details).
B2. My research involves NHS patients. Who reviews this research?
The National Research Ethics Service (NRES) (part of the UK Health Research Authority (HRA)) approves this type of research rather than CUREC. All research within the NHS requires a Sponsor. The University’s Clinical Trials and Research Governance (CTRG) team supports applicants to NRES and ensures that the University meets its requirements as research sponsor. They should be contacted when you are preparing the research application and documentation in order to access their advice, support and necessary sponsorship.
B3. My research involves NHS staff, facilities, premises or data. Who approves this research?
The University can provide ethical review of research involving participants recruited by means of their status as current or former members of NHS staff, or research involving NHS facilities, premises or data (see also Decision flowchart for NHS (352kb). But first you must check whether you need NHS permission to conduct the research. To do this, complete a CUREC 1 or CUREC 1A checklist (and/or a CUREC 2 form if appropriate) and submit this together with any supporting documentation by email to the Clinical Trials and Research Governance team (CTRG) (email: email@example.com). CTRG will then review all documentation for compliance with NHS requirements (and will advise on obtaining the permission of the relevant NHS Trust or seeking Health Research Authority (HRA) approval). You may then forward the documentation to the relevant IDREC for ethical review.
B4. The University of Oxford is just one institution involved in my study. Which institution should give ethical approval?
Some research projects are conducted jointly between two or more institutions – these may be subject to more than one set of ethics approval procedures. Firstly, establish whether each institution requires its own ethics approval or whether it is prepared to accept approval given by another. If ethical approval is required from more than one institution, leave adequate time to apply to each institution and be prepared to harmonize comments from each ethics review into your finalised research protocol and supporting documents.
Where the University of Oxford is the lead institution, ethical approval from CUREC must be obtained. Compliance with CUREC policy should be prioritised in addition to accommodating the requirements of partner organisations (should multiple approvals be required). Where the University is not the lead institution, the researchers from the University of Oxford should supply to the relevant CUREC subcommittee details of the ethical application and approval notice from the lead institution, along with a CUREC 1 or CUREC 1A checklist or a CUREC 2 form (for research that raises complex ethical issues). This will then be reviewed to ensure that the approval already obtained is in accordance with the University’s policy requirements.
For joint projects falling within OxTREC’s remit:
Where the University of Oxford is the lead institution, ethical approval from CUREC (OxTREC) must be obtained. Where the University is not the lead institution, the researchers from the University of Oxford should contact the OxTREC Secretariat for further advice.
Please note that any ethical approval provided by OxTREC is subject to receiving ethical approval from the relevant local (in country) ethics committee(s). The approval notice from the relevant local ethics committee(s) should be supplied to OxTREC.
B5. I already have ethical approval from a previous institution. Do I need CUREC approval to conduct the approved research at the University of Oxford?
You may be a new member of staff, or be enrolled for a qualification at the University of Oxford and were based at another institution when you received ethical approval for your research project. In this case, you do not normally need separate CUREC approval but should supply details of the ethical application (including all documents) and approval notice from the lead institution to the relevant CUREC subcommittee for our records. We will check that these meet University of Oxford ethical review requirements, and may require you to make minor document changes.
B6. My research involves taking human tissue samples. Can it be reviewed by CUREC?
This depends on a combination of whether the tissue samples would be considered 'relevant material' by the Human Tissue Authority (HTA), and the processing/storage of the samples. The HTA expects relevant material for research to be held under the governance of either NHS ethical approval or an HTA licence. Please note that any material from humans that contains cells is considered 'tissue', including faeces, blood, urine and saliva.
Where human tissue is held in storage for less than 7 days pending transfer to an HTA licensed establishment, the storage is considered incidental to transportation and an HTA licence is not required. An example would be where tissue for use in research is collected across a number of sites and batched before being sent to an establishment licensed by HTA for storage for research. Where this applies, studies may be reviewed by CUREC.
Please refer to our Flow chart for human tissue samples (21kb) to determine where to apply
C. Completing the CUREC application
C1. Should I apply for ethical review, or should someone else apply on my behalf?
The principal researcher should be the formal applicant for ethical review. The principal researcher is defined as the student supervisor in the case of student research, or the principal investigator or grant holder in the case of staff research. This does not preclude other researchers from preparing parts of the application, particularly where such preparation functions as part of an educational qualification. For example, the IDREC would usually correspond with students regarding student research applications, even though the supervisor is named as the principal researcher.
C2. When should I apply for approval?
You must secure CUREC approval before beginning the parts of your project that involve human participants or personal data, including advertising for potential participants. However, you are permitted to carry out literature searches, information-gathering, and peer discussions before you secure approval. Grant awarding bodies may specify that you need to secure ethical approval before you apply for funding and in such cases CUREC is usually able to accommodate this. However, in general it may be more logical to apply for ethical review after funding has been secured, in case the project evolves subsequent to funder review such that the ‘ethical frame’ of the project is altered.
C3. What steps must I go through?
See our How to Apply page for full details.
First, decide whether your project is research that requires ethical review and whether it should be submitted for CUREC review or NHS ethical review. Next, check whether it has an NHS component for which NHS ethical review, HRA approval or NHS permission may be required. The correct CUREC checklist (CUREC 1 for MS IDREC/ CUREC 1A for SSH IDREC) should then be completed. The checklist will help to distinguish projects which have straightforward or complex ethical issues. If the project raises complex ethical issues, it will require further scrutiny and a different application form may be required.
For studies that require review by OxTREC: either a minimal risk application form or, for higher risk studies, a full application form should be completed. Further details are available on the OxTREC application process page.
Please also prepare your supporting documents (eg recruitment advert, Participant Information Sheet, Consent Form, sample interview/ survey questions, debrief [if necessary], protocol [for OxTREC]) which will need to be submitted at the same time as your CUREC application forms. You can find more information about supporting documents, including templates that may be useful, on our MS IDREC, SSH IDREC and OxTREC application process pages.
We strongly recommend that all researchers have completed at least some form of research ethics training before starting their project with human participants or personal data. Please see our training page for details.
C4. How soon will I hear whether my research project has approval?
The timescale for approval depends on the type of application made to the relevant subcommittee. A CUREC 1 or 1A 'straightforward' application may take up to 30 calendar days to approve. A CUREC 2 'complex' application may take up to 60 days. A CUREC 3 application could take up to 90 days. For studies that require OxTREC review: a minimal risk application may take up to 30 days to approve; full committee applications are reviewed at OxTREC meetings, which take place once every two months. Please see each subcommittee's application process pages (SSH IDREC process, MS IDREC process, OXTREC process) for more details.
The CUREC subcommittees (or DREC) aim to approve applications within a shorter time frame where possible, but extra time should be allowed in case the IDREC/OxTREC (or DREC) Secretariat needs additional information in order to be able to authorise research to start, or requests the completion of a CUREC 2 form.
Ethical review procedures operate all year round, though they may take a little longer outside term time when staff are likely to take annual leave.
C5. There are terms in the checklist/application form/on this website that I don't understand. What do I do?
C6. There are several phases to my research. Should I gain ethical approval for all of them now?
See C2 above and FAQs, Section E. If the project and ethical frame is likely to change from one phase to another, it is better to apply for further approval (either via an amendment or a new project application) closer to the commencement of each phase. Practically, it is not possible for CUREC to approve research unless it has enough information to make an appropriate assessment. If, however, you are confident that you have enough information about each phase and that the results of one will not affect another, please seek approval via a single application.
C7. For how long is approval granted?
Per project, the approval given is for the project duration proposed in the CUREC application (calculated as the time between project start and end date in the project application). This duration begins on the date of the ethics approval letter. A maximum of five years duration of ethical approval can be applied for. Should researchers wish to submit project amendments (see FAQs Section E) that extend this five-year duration, they must notify the CUREC subcommittee of this as part of the overall amendment notification, giving a brief summary of the research’s findings so far and justifying their reasons for extension.
C8. How do I find out whether the organisation funding my research requires any form of monitoring of my project?
The terms and conditions of the research funding will indicate whether any form of monitoring is required, to ensure that standards of ethical conduct are maintained after the study has received initial approval.
However, the two main funders who attach conditions relating to monitoring are:
the Economic and Social Research Council (ESRC) (see the Research Ethics Framework) and
the US National Institutes of Health, which stipulate that projects that require ethical approval must be reapproved for every year of the research funding. (Note: applications for ethical approval of research with US federal government funding, including from the NIH, are handled by OxTREC.
C9. What guidance is available on participant information and consent forms?
In addition, many CUREC-approved procedures and the Best Practice Guidance for Internet-Based Research include tailored informed consent templates.
Where it is not possible to obtain a signed consent form, a record of the information provided and consent given should be kept. A sample template is available from the Informed Consent page (under Oral Consent).
C10. My project involves Oxford students/staff members: do I need to take any special steps?
Yes. It will be important to ensure that any invitation to any students of this University to participate in a research project makes it clear that the participation or non-participation in the project will not affect the student's academic assessment in any way (see CUREC policy). The participant information should also make clear that no information arising from the research will be disclosed to the student's college, department or faculty. Similar statements should be made in relation to their employment if the participants in the research are employees of this University.
C11. My proposed research involves interaction with children or adults at risk. What additional measures should I consider? (For example, will I need safeguarding clearance?)
This will depend on the nature of the contact involved. Researchers need to be sensitive to Safeguarding issues, and follow the guidance set out in the University's 'Safeguarding Code of Practice'. This includes ensuring that a safeguarding risk assessment of the proposed research has been completed (a pro forma risk assessment is available at www.admin.ox.ac.uk/personnel/cops/safeguarding/safetrain/. Research participants must be informed how they can report concerns about any member of the University with whom they will be interacting. Researchers should also take responsibility for complying with safeguarding regulations and research practices which relate to the setting(s) (country, institution) of their research.
Those working with at risk groups are encouraged to complete the relevant online training provided by the Oxford Safeguarding Children Board. As well as such compliance, researchers should consult guidance from the relevant professional associations. For example, for research settings in the UK, detailed guidance on circumstances in which criminal records disclosures can or must be obtained, can be found on Personnel Services' Disclosure and Barring Service (DBS) web page.
In many cases when research is being undertaken in schools, the schools will indicate what kind of safeguarding checks are needed.
For all DBS applications, guidance and advice please contact The Vetting & Screening Office at Security Services (email: firstname.lastname@example.org, phone: 01865 (2)82152 or 01865 (2)82788).
C12a: My project includes children aged 16-17 as research participants. Do they class as "competent youths"?
In the UK and many EU countries, children are legally defined as anyone who has not reached their 18th birthday. So in many countries, children are not legally competent to give consent to take part in major research. Instead parental or legal guardian consent is required. However, 16-17 year olds may, in certain research projects, which do not raise complex ethical issues, be classed as "competent youths". They are still technically children but are considered to have sufficient understanding of the research and its implications for them that they can make up their own minds about taking part, and have that opinion honoured. However, this class of "competent youth" is not automatic and must be decided on a per-project and (as appropriate) per-individual basis.
To decide this, the following factors will be relevant:
Youths cannot usually be classed as "competent youths" if outside the EU. This is because expectations of parental authority and young people's autonomy, and the areas of life in which these apply, can vary considerably between cultures. In considering whether the class applies to youths outside the EU, researchers should be guided by cultural expectation plus any relevant legislation and (regulatory) standards. The class could also apply to youths outside the EU who are enrolled at a university (where greater autonomy is likely).
If the research is "unproblematic" in ethical terms, it is likely the class of competent youth applies. However, if, in the overall context of the research project, anything looks to be of significant ethical concern, eg the project design, area of enquiry, or research procedures, the class may not apply.
If the research involves procedures that would require parent/legal guardian consent outside of a research setting, the class would not apply.
Projects fitting under one of CUREC's procedures concerning children (see Approved procedures) would normally support the use of the class.
Examples of research where the class of "competent youths" would apply and would not apply are found in our Best Practice Guide on Competent Youths.
C12b. Can a project including "competent youths" be approved on the basis of a checklist or do I need to complete a CUREC 2 full application?
Please see our guidance on "competent youths". If the class can be applied to all participants under 18, then the CUREC 1 or 1A checklist is sufficient. Any participants under 18 to whom neither the class of "competent youths" nor an approved CUREC procedure applies, would trigger completion of a CUREC 2 full application.
C13. Can I reward participants for taking part in research?
Adult participants may be offered compensation for the 'inconvenience of taking part' and any reimbursement should reflect the time spent undertaking study activities. In addition to this, reasonable travel costs may be reimbursed. Children recruited in schools may receive a sticker or certificate as a 'thank you'. If a child takes part in a study with their parent present, the parent may be given a token gift voucher or book token and they can choose whether or not to give this directly to the child.
It is not recommended that compensation values be stated on recruitment adverts (posters, websites, social media, etc), as this can be construed as inducement to participate. It is preferable to state 'You will be compensated for your time'. Compensation values may then be included within the more detailed participant information.
D. Approved Procedures and Best Practice Guidance
D1. Is my project fully covered by a CUREC-approved procedure?
Sometimes the answer to this will be clear, for example, if your supervisor/project leader completed the procedure with your project and others in mind. Sometimes you may find that an existing procedure appears to cover your project fully, even though it was written for another set of projects. It is up to you to ensure that the procedure you cite covers the whole duration of your project and all its ethically sensitive aspects. Remember your project may be audited to check that this is the case. If in doubt discuss this with your supervisor, colleagues, or CUREC subcommittee secretariat.
D2. How many Approved Procedures may I follow?
In order to stay within the CUREC 1 or CUREC 1A frame, it is usually not possible to fully apply more than one Approved Procedure to your research.
There may be some exceptions, depending on the exact procedures and whether they are to be applied simultaneously, or in tandem. If you intend to follow two or more approved procedures, please consult the relevant IDREC Secretariat to determine whether or not a CUREC 2 form needs to be completed.
Even where Approved Procedures do not fully cover a project, they can be used as part of a CUREC 2 application to mitigate issues as far as they pertain to the Procedure(s) in question.
D3. How many Best Practice Guidance documents may I follow?
You can follow as many Best Practice Guidance documents as are suitable for your study.
E. After approval
E1. My research was approved by IDREC/OxTREC but my project has changed. What should I do?
Changes to your project (eg to personnel, duration, or procedures) constitute project amendments. These must be notified to the relevant IDREC or OxTREC for approval. Please send a description of the content of the amendment along with new or revised documentation. NB: revised documents must have changes highlighted, using MS Office Word tracking. The committee response will be:
- either an email confirming your amendment has been noted and filed (for minor amendments)
- or a formal letter of confirmation of the change and approval thereof (for major amendments)
- or a notification that the amendment does alter previous ethical consideration of your project and does require the submission of a new application to ensure full consideration of the ethical implications of your amendment.
The IDREC/OxTREC follow the below guidelines for classification of amendments:
Major Amendments (requiring, as a minimum, review by IDREC/OxTREC Secretariat and issue of a formal approval letter)
- changes to the design or methodology of the study, or to background information affecting its academic value (including addition of participants);
- changes to the procedures undertaken by participants (including any change relating to the safety or physical or mental integrity of participants, or to the risk/benefit assessment for the study);
- significant changes to study documentation such as protocol, participant information sheets, consent forms, questionnaires, letters of invitation, information sheets for relatives or carers;
- appointment of a new chief/principal investigator;
- change of territory for international studies;
- a change to the insurance or indemnity arrangements for the study;
- temporary halt of a study to protect participants from harm (or resulting from a concern or complaint made), and the planned restart of a study following a temporary halt;
- any other significant change to the terms of the REC application
Minor Amendments (requiring check by IDREC/OxTREC Secretariat and acknowledgement via email)
- minor changes to the application form or other study documentation, e.g. correcting errors, updating contact points, minor clarifications;
- changes to the research team (subject to confirmation of additional researchers having undertaken appropriate training in research ethics);
- changes in funding arrangements;
- changes in the logistical arrangements for storing or transporting samples;
- inclusion of new sites or locations for the research (but note the need for a major amendment (above) in the case of a change of territory for international studies);
- extension of the study beyond the period specified in the application form;
- changes to contact details for the chief/principal investigator or other study staff
E2. When I was in the field for reasons outside my control I had to alter my plans in a way which increased/altered the risk to participants without first securing permission from CUREC. What should I do?
Retrospective scrutiny of research projects (or amendments to research projects which have already received ethical review approval) is not acceptable except in exceptional cases, and then only with a letter of support from the researcher's Head of Department stating why it was not possible for this to be submitted in advance. If it is at all possible, you should inform the CUREC subcommittee of your new plans before undertaking them. If you are in a very remote area this may not be possible. Do your best to ensure that your revised project and any documents you will give to participants meet CUREC's standards, which you will be familiar with from your initial application. Submit your project for CUREC review as soon as you can, even if this is after the research is completed.
E3. Something has gone wrong in my project and a participant has been harmed. What should I do?
Your first priority will be the welfare of the person who has been harmed. If the event takes place within the University you will need to follow normal safety procedures such as making a report in the departmental accident book and if necessary alerting the departmental safety officer. Any such adverse event must be reported to the CUREC subcommittee that approved your application within seven days. Before continuing with your research, think whether changes to your methodology, equipment or personnel are necessary to prevent further adverse events. Remember to treat emotional distress seriously, as well as physical harm, especially where participants are at risk. The IDREC Officer may forward the incident report and advise on the Committee view, as appropriate.
E4. My research project has been chosen for audit. What does this mean?
A sample of approved CUREC projects may be monitored each year by the relevant CUREC subcommittee to review whether the research is being (or was) conducted within the scope of the ethical approval granted. This is also to help CUREC understand how to improve its processes and encourage good practice among the University researcher community. CUREC and its subcommittees welcome constructive criticism during monitoring or at any other time.