FAQs

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Research projects that involve recruitment of human participants and/or use of personal data or sensitive data (known as 'special category' 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 to determine whether your project needs ethical approval:

 

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.
 

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 in the research team 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.
 

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.
 

Yes. All people deserve consideration of their dignity and in fact there are special considerations surrounding research in different cultures. Please see our guidance from professional associations page for links to codes of practice in relevant disciplines such as anthropology.
 

Yes. Observation may seem more intrusive to the people being observed than to the observer. Studies that involve observation normally need only to complete an application for straightforward ethical review, but sometimes observation can pose serious ethical questions, for example observation of at risk groups or illegal/harmful activity.
 

All research projects where people participate 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 policy. They are not giving you information about themselves, and the opinions that 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.
 

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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. CUREC delegates responsibility for the ethical review and approval of such research to three subcommittees. 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 Where and how to apply page and FAQ B2 for more details).
 

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.

If your study includes both NHS patients and healthy volunteers, then the NRES approval covers the entire study. You do not need to seek additional ethics approval from CUREC for the inclusion of healthy volunteers.
 

CUREC 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 premises or data. However, 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: karl.shepherd@admin.ox.ac.uk). 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.
 

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 harmonise 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.
 

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. Alternatively, you may be based at another University, but wish to recruit University of Oxford staff and/or students to participate in your study. In either 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. Please note that you must obtain any other local permissions necessary to recruit University of Oxford staff and/or students for your research (eg heads of department, course directors, student societies).

If the research is to be advertised on posters in University/college noticeboards, the researchers must also obtain the appropriate local approval to advertise there (eg for colleges, from college bursars/senior tutors, or if in University departments, from local departmental administrators/building managers/communications staff as appropriate). Any poster should include a reference as to which ethics committee has reviewed and approved the study.
 

Some healthy volunteer studies including use of human tissue may be reviewed by CUREC. However, 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. Please note that any material from humans that contains cells is considered 'tissue', including (but not limited to) faeces, blood, urine and saliva.
For full information as to when and where to apply for ethical review, please read BPG 15 Ethics review of research with human tissue, in collaboration with our flow chart for human tissue samples:

If you are still unsure, please contact the Medical Sciences IDREC or OxTREC Secretariat or the Human Tissue Governance team

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The principal researcher or principal investigator should be the formal applicant for ethical review. This person is the student's 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.
 

You must secure CUREC approval before beginning the parts of your project that involve human participants or personal data, including advertising and recruitment of 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.
 

See our Where and 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. Check whether the project has an NHS component for which NHS ethical review, HRA approval or NHS permission may be required. If the study can come to CUREC, then 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 that 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 material (poster advert, email invitation, social media text etc), 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 the MS IDRECSSH 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.
 

The timescale for approval depends on the type of application made to the relevant subcommittee. A CUREC 1 or 1A 'straightforward' application can take up to 30 calendar days to approve. A CUREC 2 or CUREC 3 'complex' application may take up to 60 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 processMS IDREC processOxTREC 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.
 

See C2 above and FAQs 'After approval' section. 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.
 

Per project, the approval given is usually for the project duration proposed in the CUREC application (calculated as the time between project start and end date in the project application). However,applicants to the MS IDREC will be granted a minimum approval period of one year. 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 'After approval' section) 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.
 

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.)
     

Our glossary provides a definition of informed consent. Please also see our page on informed consent, where template consent forms/scripts are available for use in your ethics application. 

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').
 

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. Please note that you must obtain any local permissions necessary to recruit University of Oxford staff and/or students for your research (eg heads of department, course directors, student societies).
 

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 on the Personnel Services website. 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 that 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 (screening@admin.ox.ac.uk, 01865 (2)82152 or 01865 (2)82788).
 

In the UK and many EU countries, children are legally defined as anyone who has not reached their 18th birthday and are therefore considered as not legally competent to give consent to take part in major research. Instead parental or legal guardian consent is required. However, 16 and 17 year olds may, in certain research projects that 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.
 

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.
 

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.
 

The GDPR is a legal framework that outlines requirements for the collection and processing of personal information of individuals within the European Union (EU) and replaces the Data Protection Act (DPA).

The GDPR applies to the processing (collection, storage, analysis etc) of personal data. Personal data is information that relates to a living individual who can be identified from that information, whether directly or indirectly, and in particular by reference to an identifier. It includes, for example, a name, an identification number (eg pseudonymised data), location data, audio/video recording or an online identifier, such as the IP address. It could also include information that identifies an individual’s characteristics, whether physical, physiological, genetic, cultural or social. Sensitive personal data (relating to race, ethnicity, sexual orientation, politics, religion, health, trade union membership, genetics, sexual life, biometrics (where used for ID purposes), or criminal activities) is referred to as special category data under the GDPR.

It will generally be obvious whether your project falls within the scope of the GDPR, but this may not always be the case.

For more detailed information, please refer to the University guidance on data protection and research.

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It is up to you to ensure that the procedure you cite covers the whole duration of your proposed 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.
 

Usually only one. However, 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.
 

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As your project progresses, there may be reasons to make changes (eg to principal investigator (PI), duration, or procedures). Changes to your project constitute project amendments. These must be notified to the relevant IDREC or OxTREC for approval.

For amendments submitted to the SSH IDREC or OxTREC, please send a description of the content of the amendment.

For amendment requests to the MS IDREC, please complete the amendment form below.

You will also need to send any new or revised documentation, which must have changes highlighted, preferably using MS Office Word tracking. If your original application required either departmental or CTRG review, revised documentation must first be sent to the department and/or CTRG for continued approval.

You must not carry out your study with the changes applied until you receive confirmation from the relevant IDREC or OxTREC. If the changes are significant and the project substantively altered, you may need to complete a new application.

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 use the following 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, or other requirements expected of, 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, eg 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 (OxTREC only)
  • 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
     

Retrospective scrutiny of research projects (or amendments to research projects that 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 or faculty 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.
 

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/OxTREC manager may forward the incident report and advise on the committee view, as appropriate.
 

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.

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