Frequently Asked Questions

A1. Do all University of Oxford research projects involving human participants need ethical approval?

Yes. All projects which involve human participants, that is people participating in a direct way by for example answering questions about themselves or their opinions, or performing tasks, or being observed, or which involve data about identified or identifiable people must secure ethical approval from an appropriate body. All research brings researchers into contact with other people: people will show you how equipment works, provide information about matters connected with your research, and give their views on your research. These people do not count as human participants in the technical sense. 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.

A2. Why do all research projects involving human participants need ethical approval?

To make sure that participants' dignity and privacy are protected and to minimise risk to participants. Many funding bodies will not fund projects involving human participants unless they have been subject to University ethical scrutiny procedures and the University itself seeks to ensure that its research does not expose participants, staff, or students to unnecessary or undue risk.

A3. My project is just an undergraduate dissertation. Surely I don't need to get ethical approval for it?

ALL research in the University which involves human participants needs ethical approval, no matter who's doing it.

A4. I'm using data about people but the people aren't identifiable: do I need to get ethical approval?

If no-one on the project can identify the individuals whom the data are about then you need not get ethical approval. This means projects using census data, for example, need not get approval. If the data are anonymised but if anyone on the project can, by using a key, ascribe the data to individuals then the project must get ethical approval.

A5. All the people in my study are dead: do I need to get ethical approval?

Not normally. Make sure all the people really are dead (don't just assume they are) and think if the information provided by those people contains sensitive information about the living. If in doubt consult the relevant IDREC officer.

A6. 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. See the CUREC website for links to codes of practice in relevant disciplines such as anthropology. [See Find out more on the CUREC website.]

A7. 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 just the first stage of scrutiny, but sometimes observation can pose serious ethical questions, for example if the people observed are in embarrassing situations.

B1. Who gives ethical approval?

The University has set up a Central University Research Ethics Committee (CUREC) (see http://www.admin.ox.ac.uk/curec/ for further details) which is mainly concerned with policy decisions. Below it are two Interdivisional Research Ethics Committees (IDRECs), one located within the Social Sciences Division and broadly covering research in that division and in the Humanities and Mathematical, Physical and Life Sciences Divisions, and one within the Medical Sciences Division broadly covering research in that division. Between them those committees scrutinise all research projects involving human participants, unless the project involves clinical research within the EU in which case an NHS research ethics committee is likely to be the body which scrutinises projects and gives approval (http://www.nres.nhs.uk/). Clinical research outside the EU comes under the remit of OXTREC which works in conjunction with CUREC's Medical Sciences IDREC.

Note: Some departments have established a departmental research ethics research committee (DREC) or designated an officer to review checklists and applications as a preliminary step before submission of documentation to the appropriate IDREC. DRECs must be satisfied to their own requirements, which cannot be less than those of CUREC, that a project meets the appropriate standards, before the project is sent to the relevant IDREC for approval, or (where applicable) approved under delegated powers. Please check with your department to confirm whether any such preliminary approval is necessary.

If you are a PGCE student, see also question B4 below.

B2. Who can use the CUREC/1A checklist?

CUREC approved a checklist for use by staff and student researchers primarily in the Social Sciences and Humanities for use from March 2011. Called the CUREC/1A, this checklist is a much shorter form tailored specifically for non-medical research requiring ethical review under the University's procedures. Researchers in the Social Sciences and Humanities may choose to complete either the original CUREC/1 checklist or the CUREC/1A. Procedures are unchanged, and therefore on completion of the checklist, researchers will need to follow the instructions on the checklist about the next steps, which might require the completion of a CUREC/2 full application form if a higher risk is identified by the checklist. Researchers in the Medical Sciences will continue to use the original CUREC/1 checklist. Comments on the forms are welcomed and should be sent to the CUREC secretary.

B3. My research involves NHS staff, and/or NHS premises or facilities. Who approves this research?

Following a change to the remit of NHS research ethics committees on 1 September 2011, the University now conducts the ethical review of research involving participants recruited by means of their status as current or former members of NHS staff, and/or NHS premises or facilities. Complete a CUREC/1 or CUREC/1A checklist (and, if appropriate, a CUREC/2 form) and submit this together with any supporting documentation by email or in hard copy to the Clinical Trials and Research Governance team (CTRG), Joint Research Office, Block 60, Churchill Hospital, Old Road, Headington, Oxford OX3 7LJ, email: carol.cornelius@admin.ox.ac.uk. CTRG will then review the documentation for compliance with NHS requirements (including the permission of the relevant NHS Trust) and forward it to the relevant IDREC for ethical review.

B4. I am a PGCE student. What ethical procedures do I need to follow?

Complete the CUREC/1B checklist and submit it to the Partnership Administrator. If the form indicates that your research requires you to complete a CUREC/2, download the CUREC/2 form and submit it in the first instance to the Education Department Research Ethics Committee, via the Partnership Administrator . For further advice on the completion of the forms, please contact the Partnership Administrator or see the online information in the Ethical Approval section of the PGCE WebLearn pages.

B5. Oxford University is just one institution involved in my study and I already have ethical approval from another institution. Do I still need approval from Oxford University?

Some research projects are conducted jointly between two or more universities, and are therefore subject to more than one set of ethics scrutiny procedures. Where Oxford University is the lead institution, ethical approval must be sought through Oxford University’s CUREC procedures, whatever the requirements of partner organisations. Where Oxford University is a junior partner, the Oxford University researchers should send to the IDREC details of the ethical application and approval notice from the lead university, along with a CUREC/1 or CUREC/1A checklist. This will then be reviewed to ensure that the approval already obtained is in accordance with Oxford University’s requirements.

 Researchers involved in a joint project that requires review by OXTREC should contact the  OXTREC administrator for advice.

C1. I cannot access the forms and protocols on the CUREC website.

A change was made in September 2012 to the way in which access to restricted University web pages is managed. University staff and students should now be able to use their single sign-on username and password to access all pages marked with a padlock on the CUREC website from any location. If you don't have access to the internet or are having difficulty accessing the CUREC website for another reason, please contact the CUREC secretary who will email you the forms.

C2. Should I apply, or should someone else apply on my behalf?

The principal investigator of the research project, the supervisor of the student carrying out the research, or the student researcher (under the guidance of the supervisor) is the formal applicant, though other researchers may prepare some parts of the application.

C3. When should we apply for approval?

You must secure approval for your project before you begin any part of your research which involves human participants. You should do literature searches, gather information, and discuss your plans with your supervisor or colleagues before you secure approval, but you need approval before carrying out a pilot study if that involves human participants. Grant awarding bodies may specify whether you should apply for ethical approval at the same time as you apply for financial support, or whether you need to secure approval before you apply for funding. CUREC has no view on this provided approval is secured before research starts. In general it may be sensible to wait until funding has been secured before submitting the paperwork but if time is likely to be of the essence once funding has been obtained, you should have the paperwork ready to submit as soon as possible.

C4. What steps must we go through?

First fill in a CUREC checklist. This is the first stage of ethical approval and is designed to separate projects which don't need ethical approval (for example those which are audit, not research); those which need ethical approval from a body other than CUREC (normally an NHS committee); those which pose low risks to participants and which require review by the appropriate IDREC officer; and those which pose greater risks to participants and which must undergo further scrutiny.

C5. How soon will I hear whether my research project has approval?

You should submit your CUREC checklist to the IDREC (or DREC), together with any supporting documentation indicated on the form, at least 30 days before you wish to start your research project. Normally you will receive a reply within two weeks, but extra time should be allowed in case the IDREC (or DREC) officer needs additional information in order to be able to authorise research to start, or requests the completion of a CUREC/2 form.

If the IDREC (DREC) officer or the CUREC checklist indicates that you should also complete the CUREC/2 form, a full review by the IDREC will normally take place within 60 days of receipt of the completed 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.

C6. There are terms in the checklist/application form/on this website that I don't understand. What do I do?

Use the CUREC glossary and guidance.

C7. There are several phases to my research. Should I gain ethical approval for all of them now?

CUREC has no view on this beyond the practical one that it cannot approve research unless it has enough information to make an appropriate assessment. Your funding body may have a view. There is no point in applying for future research phases if there is a strong chance that your design may change between application and starting research.

C8. For how long is approval granted?

The approval will remain in force for five years from the date that approval was granted, assuming that there are no changes to the research project (see question F1 below).

C9. 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 which attach conditions relating to monitoring are:

• the Economic and Social Research Council (see the Research Ethics Framework) and
• the US National Institutes of Health which stipulate that projects which 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).

C10. What guidance is available on participant information and consent forms?

A: The glossary on this website provides a definition of informed consent. There is a rubric for the content of participant information and consent forms, indicating the areas that these documents ought to cover. Template opt-out and film consent forms are available and many of the protocols also include sample documents (oxonly). Where it is not possible to obtain a signed consent form, a record of the information provided and consent given should be kept.

Researchers should obtain permission for use of personal data in their own research and should also anticipate possible further uses of that data and seek separate permission on behalf of future researchers. The Data Archive website provides further guidance on drafting and examples of forms to cover future use.

Students admitted on or after 1 October 2007 and successfully completing specified programmes are required to deposit both a print and a digital copy of their thesis. The digital copy should be deposited by the author in the Oxford University Research Archive (ORA). If a thesis is to be deposited online, students and their advisers must ensure that participants give their consent for publication of their personal data in the resulting thesis. Template wording for inclusion in participant information is available. For more information on the digital deposit requirements, see the ORA website.

C11. 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 also the policy document set out on this website). The participant information should also make it 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.

C12. My proposed research involves interaction with children. Will I need Criminal Records Bureau (CRB) clearance?

This will depend on the nature of the contact involved. Detailed guidance can be found on the CRB website (http://www.crb.gov.uk/) on the procedures involved in obtaining clearance. It is not possible in these FAQs to specify when a CRB check might be required and researchers should themselves take responsibility for seeking relevant advice on this matter from their own professional associations, etc. In many cases when research is being undertaken in schools, the schools will indicate when CRB checks are needed. For research involving one-to-one contact with children it should be assumed that a CRB check will be needed unless external guidance to the contrary can be produced. Checks can be undertaken via the University Marshal's office (see Security Services in the University phone book, but note that the office cannot give guidance on when a check might be needed). Similar considerations apply in the case of research involving vulnerable adults.

D1. The checklist showed that my study was audit not research. What now?

You do not need to submit the checklist for review and can proceed with your study with no further reference to CUREC, unless the nature of your study changes and comes under CUREC's remit.

D2. The checklist showed that my research project needs to be scrutinised by the NHS. What now?

You can proceed with your study with no further reference to CUREC, unless the nature of your study changes and comes under CUREC's remit. Start NHS ethical review procedures (http://www.nres.npsa.nhs.uk/). You should however send a copy of the NHS documentation approving your project to the relevant IDREC officer so that the University has full details of all approved research involving human participants.

D3. The checklist showed that my research project needs no further University scrutiny. What now?

Send your checklist to the appropriate IDREC officer (or DREC officer) electronically and/or as a signed paper version. He or she will review the checklist and then write to you to confirm the outcome of that review, normally approving the start of the research project. In some cases, however, the IDREC officer may request further information, ask for completion of the CUREC/2 form or request that an application is made via the NHS or OXTREC procedures. If your research project is approved, you can proceed with your study with no further reference to CUREC, unless the nature of your study changes (see question F1).

You should submit your CUREC checklist at least 30 days before you wish to start your research project. The IDREC (or DREC) officer will need sufficient information in order to be able to authorise research to start; if the officer has to request additional information, this may cause a delay.

D4. My checklist showed that my project needed further scrutiny: what should I do?

Check to see if the problematic aspects of your project are fully covered by a protocol which has been approved by IDREC/CUREC.  If it is, cite the protocol number and submit the checklist to the IDREC for approval.

If there is no protocol covering the problematic aspects of your research, consider whether there should be. If the ethically contentious aspect of your methodology is widely used in your discipline, then it is likely that other researchers will run into the same problem. Consider writing a protocol and submit it to IDREC. Once it is approved, it will be mounted on the CUREC website. Individual research proposals may cross refer to it and their principal researchers need not fill in a full application form.

If a protocol would be inappropriate or you do not have time to devise one, complete a full application form (CUREC/2) (available on CUREC website) and submit it and your checklist to the appropriate IDREC electronically and/or as a signed, paper version (or DREC, as appropriate). If the application is approved, you may start your research: if it's not, you must change your research procedures to meet the committee's concerns and resubmit your proposal. Be aware that your study may be audited (see question F4) later for its compliance with research ethics procedures.

D5. My research project needs full scrutiny but I need approval in a hurry: what should I do?

Submit your form as soon as possible, making sure that you've completed all the sections and supplied all the documents so that there is no delay whilst these are chased up. Tell the IDREC (or DREC, as appropriate) that you need urgent approval and the committee will do its best to get a decision as soon as possible. Please don't ask for urgent approval unless you really need it, as it will cause delays for those who do.

D6. The questions on CUREC's forms seem to be completely irrelevant to my research: what should I do?

Do your best to complete the forms so as not to delay the start of your project. Send suggestions for improvements of the forms to CUREC so that they can be adapted better to suit researchers' needs.

D7. Which IDREC should I submit my form to?

If your department has established a departmental research ethics committee (DREC), the form should be submitted to the DREC officer in the first instance, who will be able to offer advice.

If there is no source of advice at departmental level, choose whichever seems more appropriate of the IDREC based in the Social Sciences Division and that based in the Medical Sciences Division according to the nature of your research, not the division which your department is in. Researchers in the Humanities or Mathematical, Physical and Life Sciences divisions may find that their work is best dealt with by the Social Sciences Division IDREC. Ask the IDREC officers if in doubt.

D8. Can I submit my application for ethical review by email?

Yes, you can submit the form(s) and any supporting documents by email or as signed hard copies (or both). If you are sending the documents by email only, the checklist, and any email from the head of department or nominee separately endorsing its submission, must be sent from a University of Oxford email address (i.e. as a minimum, the checklist and supporting documents must be submitted by the head of department or nominee indicating his/her approval from a University of Oxford email account).

D9. This all looks a bit complicated: do I really need to bother?

Yes. If you do not you may expose participants to serious risk, the University and yourself to litigation, and yourself to disciplinary measures.

D10. I need a letter for my funding body to show the University has approved my research: what should I do?

When you complete a checklist or an application form or submit a protocol application you will always receive a letter from the IDREC (or DREC, as appropriate) telling you of the outcome of the scrutiny procedure.

D11. My project was not approved: what do I do now?

The IDREC will tell you why your project was not approved. Sometimes this will be for reasons over which the committee has no discretion, for example if you are failing to comply with the provisions of the Data Protection Act. Sometimes it will be for reasons over which the committee is required to exercise its judgement, for example it may judge that the project entails risks out of proportion to the benefits it may bring. The IDREC's comments will help you revise your research procedures and you may then resubmit your application form, highlighting the elements you have changed to address the concerns of the committee. If the IDREC fails your application again you may submit it to CUREC for a final decision only if you dispute the IDREC's judgement in matters where it can exercise discretion and not, for example, if you are failing to comply with statutory requirements.

E1. Is my project fully covered by a CUREC protocol?

Sometimes the answer to this will be clear, for example if your supervisor/project leader completed the protocol with your project and others in mind. Sometimes you may find that an existing protocol 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 protocol 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 IDREC officers.

E2. Who can submit a protocol for approval?

Students may not submit protocols for approval, but any member of staff or visitor of doctoral status may.

E3. How do I submit a protocol for IDREC approval?

If your protocol describes a general project under which several subprojects will be conducted, submit a completed application form (CUREC/2) making clear in question 1 that yours is a protocol application. Complete the form such that all anticipated sub projects are covered. If possible complete the application form for the protocol at the same time as seeking approval for a specific project which will fall under the protocol but which is presented in full detail. It can be hard for the committee to take a view on generic elements without any concrete examplar and approval might be delayed.

If your protocol covers a research practice normal in your discipline (e.g. gaining consent by only verbal means, asking people to opt out rather than opt in to research) but does not at this stage refer to a particular sequence of intended sub projects submit a statement identifying the ethically contentious aspects of methodology, why the method should be used despite its being contentious, and what safeguards must be put in place to ensure that this departure from ethical norms should not pose a risk to participants. If the method outlined in the protocol conforms with a code of practice of a scholarly or professional association, append details of that code of practice.

Note that approval of protocols, like individual projects, is valid only for a certain period (maximum five years). After this period lapses you must resubmit your protocol. This ensures that protocols reflect the most recent ethical views and current research practice.

F1. My research was approved by IDREC/CUREC but my plans have changed. What should I do?

If your plans have changed so much that you are planning what amounts to a different project then start the approval process again.

If your have modified (rather than abandoned) your original proposal and you had to complete only the first stage of the approval process (completion of the checklist): review the answers that you gave on the checklist. If any of your planned changes would alter any of the responses so as to require completion of CUREC 2/full scrutiny by an IDREC then you must start the approval process again with a new checklist and application form. If none of your planned changes would alter any of the responses then you may make the changes and need not tell IDREC about them.

If your have modified (rather than abandoned) your original proposal and you had to complete both stages of the approval process (completion of the checklist and the application form): review the answers that you gave on both forms. If your planned changes would increase the risks that you expose any participant to then resubmit your forms with the changes highlighted and don't start your modified research until you secure IDREC approval. If your changes reduce risk to participants or have no bearing on risk you need not tell IDREC of them.

If the principal researcher/supervisor of the project changes you must always tell IDREC but you need not wait for approval of the change.

F2. 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. What should I do?

Retrospective scrutiny of research projects is not acceptable except in exceptional cases. If it is at all possible you should inform IDREC/CUREC 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 to CUREC approval procedures as soon as you can, even if this is after the research is completed.

F3. 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 accident book and if necessary alerting the departmental safety officer. Serious adverse events must be reported to the IDREC which approved your application within seven days. Before continuing with your research think whether changes to your method or 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 vulnerable.

F4. My research project has been chosen for audit by IDREC. What does this mean?

A sample of projects covered by checklist alone and by checklist and form will be audited each year by IDREC. They are chosen at random, not because they are suspect. You need not stop research but the IDREC will ask you for information which will enable them learn more about the ethical aspects of your research. The IDREC is not auditing your rate of progress or on the scholarly or scientific aspects of your work but just the ethical aspects. Audited project leaders will be asked for information about their project to substantiate the information they gave on the checklist and application form and to show how the project was in fact carried out. The process will not be overly intrusive but is necessary to ensure that the checklist and form are responsibly filled in and that CUREC has a clear understanding of research in the University and to see if the University's approval and monitory procedures need to be changed to encourage good practice and/or make researchers' lives easier. IDREC and CUREC welcome constructive criticism during audit or any other time.