Research Ethics Committee FAQs
By clicking on the following hyperlinks, you can find responses to frequently asked questions (FAQs) relating to the University Research Ethics Committee processes and procedures. Alternatively scroll down to review the FAQs in turn.
Does my project need to reviewed for research ethics?
At what stage of my project should I obtain ethical review?
Can my project be reviewed at School or Department level?
If I am submitting my project through the Exceptions procedure, who should I contact in my School?
What do I need to include in my submission?
What should I write in the Information Sheet?
Is there specific paperwork that I need to use?
My project needs to go to the NHS REC as well. How does that work with Uni REC approval?
I’ve missed the deadline for submissions. Can I get Chair’s action?
I am a student. Do the same rules apply to me as with staff?
What should I do if I uncover something about a participant’s health during the course of my study?
I need to recruit a specific cohort of participants, and know someone who has access to this data. Can I use to?
Do I need to gain written consent (adults)?
Do I need to gain written consent (children)?
What about deception?
I have submitted my project and have a letter back from the Research Ethics Committee asking for changes to my project. Where do I send this?
My project has been approved and I have started it but now I wish to make an amendment. What do I need to do?
I have received a monitoring memo from the Research Ethics Committee about my project that was approved last year. How long should my report be?
I have received ethical approval for my study, but whilst carrying out the research a problem has arisen that was not anticipated. Do I need to tell anyone?
I can’t find an answer to my query.
Section 1 – fundamentals
Does my project need to reviewed for research ethics?
If your project is research and is being conducted under the auspices of the University, then you will need to obtain ethical approval from the University of Reading Research Ethics Committees.
What constitutes ‘research’ can be a grey area, but in essence it is a project with the intention of obtaining new generalisable knowledge, normally set around a hypothesis (research question). Some projects may be defined as audit (assessment against predetermined standards) or service evaluation (assessing current service levels). In such cases, research ethics approval is not required but requirements for data protection and consent should still be adhered to.
At what stage of my project should I obtain ethical review?
Ethical review should be obtained before data collection or recruitment is initiated. This includes feasibility or pilot studies.
Can my project be reviewed at School/Department level or does it need to come to the full University Research Ethics Committee?
The University Research Ethics Committee operates an Exceptions procedure whereby projects that fulfil the exceptions criteria can be approved by the Head of School (or authorised Head of Department). For some Schools/Departments, this will be with reference to a School Research Ethics Committee or internal review group.
The exceptions criteria are as follows:
- do not involve participants who are patients or clients of the health or social services (unless such participation is purely for the purposes of audit);
- do not involve subjects whose capacity to give free and informed consent may be impaired within the meaning of the Mental Capacity Act 2005;
- do not involve questions that might reasonably be considered to be impertinent or likely to cause distress to any of the participants;
- do not involve any element of risk to the researchers or participants;
- do not involve subjects in a special relationship with the investigator.
Please note, that some external funding bodies may require that the project is reviewed by the University Research Ethics Committee rather than a devolved committee. If this is the case, then the project should be submitted to the University Committee in the normal way. Depending on the funding body, Schools/Departments who do not have an ethics review group may still be required to submit externally funded research projects to the University Research Ethics Committee.
If I am submitting my project through the Exceptions procedure, who should I contact in my School?
Follow this link to access the most up to date details for research ethics contacts in Schools.
Section 2 – paperwork and procedure
What do I need to include in my submission?
Project proposal – this should include background (why are they carrying out the research, what is already known), research aims, methodology, details of recruitment (where and how), sample size and justification of size (power calculations as necessary)
Information Sheet for participants
Consent Form for participants
Any questionnaires/surveys that may be used in the study
It may also be appropriate to include:
Advert for recruitment (this could include posters, email messages intended to be sent etc)
Letters to/from other parties (GPs/ head teachers etc)
Information sheet for children (simplified version)
Interview schedule (even if semi-structured)
MRI safety information (if MRI study)
Genotyping factsheets (if relevant)
IRAS form (if NHS application)
What should I write in the Information Sheet?
Who you are, contact details (NOT personal mobile), background to research (lay terms!), why they have been approached, how they have been approached (if through a third party), what you are asking them to do (include no of visits, time taken, remuneration amounts, Uni REC standard wording for approval of projects), that they can withdraw at any time without giving a reason, what they need to do next
Is there specific paperwork that I need to use?
All projects that come to the University Research Ethics Committee need to have a project submission form (link), complete with checklist, signed by the Head of School. If your project is going through the School ethics procedures, you should check with your School if there is a standard submission form that you need to complete. A template application form, and examples of Information Sheets and Consents forms, can be found on the REC website. These are strongly recommended as templates that you can adapt for your use.
My project needs to go to the NHS REC as well. How does that work with Uni REC approval?
Projects involving NHS patients require approval by an NHS Research Ethics Committee. For more information about applying to NHS committees, please contact Mike Proven (), who acts as the University’s ‘Sponsor Representative’.
In order to expedite approval by the University Research Ethics Committee and to avoid ‘double jeopardy’, the University Committee recommends that approval from the NHS committee is obtained before submission to the University Committee. It is still possible that the University Committee may request additional minor changes, or University specific changes. Minor changes to paperwork can usually be approved via the Chair of the NHS REC, so it is unlikely that you would need to resubmit your project to the NHS REC.
By exception, the University Committee may accept applications that are still in process with the NHS committee, for example because of critical timing issues. If you have a particular problem with dates of meetings of the NHS REC and the Uni REC, please speak to the secretary.
I’ve missed the deadline for submissions. Can I get Chair’s action?
Researchers are responsible for checking in advance when the deadlines for paperwork are, and the Chair is usually unsympathetic to researchers who have simply missed the deadline through poor time mismanagement. However, if you feel there is a genuine reason why the deadline has been missed and your project cannot wait until the following month, please contact the secretary of the REC.
I am a student. Do the same rules apply to me as with staff?
All of the guidance applies to staff and students. However, students cannot be named as PIs – your supervisor should be listed as the PI, but your details can be included on the paperwork. The secretary will endeavour to copy you into all correspondence between your PI and the REC.
Section 3 – common problems
What should I do if I uncover something about a participant’s health during the course of my study?
You should be aware in advance what medical problems might arise. For example, if you are taking blood tests, you know what are you testing for and therefore should be aware about what the consequences of the results are. You should inform participants in the Information Sheet that if any medical problems are uncovered, the participant and their GP will be notified. GP’s details should be requested on the Consent Form before the study has started, along with the participant’s date of birth.
If you are carrying out a survey or interview about a sensitive topic, you may uncover signs of depression or anxiety. For projects of this nature, it may be advisable to issue all participants with a help sheet at the onset of the project. Then it is their choice if they wish to seek help, and who to approach. If you believe the participant is suicidal, then some form of intervention is required. The University has a number of clinical psychologists who can advise on this matter.
If you are carrying out fMRI scans as part of your project, these projects have their own procedures set out in the Rules for Operation, and these should be referred to.
I need to recruit a specific cohort of participants, and know someone who has access to their contact details. Can I use this information to contact potential participants?
You cannot directly use a list of names of people that has been given to you unless the participants have agreed to have their data used in this way, or else you will be in breach of the Data Protection Act. However, you could ask the third party to contact the people on the list on your behalf, and ask potential participants to contact you directly if they are interested in the study. It is important that you make it clear to people that their personal information has not been shared.
Do I need to gain written consent (adults)?
In most cases written consent should be obtained. This is to protect the researcher, the School and the University. However, there are some cases where consent may not be needed. If you are issuing an anonymous survey then you may be able to assume consent be completion of the questionnaire. This should be stated in the information given to participants before they complete the questionnaire (‘consent to take part in this research project is assumed by completion of this questionnaire’). However, if there may be a need to contact the participant again (perhaps because the results have shown a medical problem or possible signs of abuse) then you will need to obtain consent, but could use keyed anonymity. This is where the questionnaire is labelled with a number, and a file containing who that number relates to is kept separately. If you want to give people the option of withdrawing their answers from a project, then you will also need to have a way to identify which questionnaire is theirs.
If your participants are illiterate, obtaining consent can be difficult. An Information Sheet should be read out to them and they should be given the chance to ask questions. A consent form can also be read out to them, the researcher can complete their name for them, and they can indicate their consent with a cross. If your research is taking place in a country that has political sensitivities and participants will be reluctant to sign any documentation, then please speak to the Secretary for advice.
Do I need to gain written consent (children)?
If the child is fairly young, then consent will need to be gained from a parent or guardian. Children should be given a simplified Information Sheet, perhaps with pictures if appropriate, and should be involved in an assent process. The research should be explained to them and they should be given the choice not to take part or to stop at any time.
If you are doing research with teenagers (up to 18), then you may also want to consider consent from both teenager and parent/guardian. If your research is invasive, consent should be obtained from both; however, if you are issuing a simple survey asking teenagers about their progression routes, it is probably sufficient to gain consent from the teenager only. Be careful if your cohort is older teenagers – this age group in particular may take affront to having to get parental consent to take part in a research study.
What about deception?
Where possible, information sheets should give all details upfront. However, there are occasions where a level of deception can be acceptable (in order not to bias the results of the research). Whether this level of deception is acceptable is the decision of an Ethics Committee, be it School or University level Committee. Projects with a level of deception should include a debrief sheet or similar in order to inform people what the deception was and why it was necessary.
Section 4 – approval and monitoring of projects
I have submitted my project and have a letter back from the Research Ethics Committee asking for changes to my project. Where do I send this?
Unless your letter specifically says that your project needs to be resubmitted to a future meeting of the Committee, revised paperwork can be sent directly to the secretary, either in hard copy or via email. The Chair will then review the changes and you should receive a response from the secretary as soon as possible. In order to avoid delays, revised paperwork should have the modifications clearly highlighted, with a cover letter if the Committee have asked specific questions.
My project has been approved and I have started it but now I wish to make an amendment. What do I need to do?
Any amendments need to be approved by the REC. For minor amendments, this can usually be done via Chair’s action. Revised paperwork with a letter detailing the changes can be sent to the secretary (email preferred) and you should not continue with the project until a favourable response has been received.
I have received a monitoring memo from the Research Ethics Committee about my project that was approved last year. How long should my report be?
The Committee does not require a lengthy report. An electronic response answering the three questions detailed in the memo is sufficient.
I have received ethical approval for my study, but whilst carrying out the research a problem has arisen that was not anticipated. Do I need to tell anyone?
An incident reporting procedure in human interventional studies is in place at the University, which outlines the appropriate course of action depending on the severity of the incident. With the exception of minor incidents, these should be reported to the University Research Ethics Committee.
I can’t find an answer to my query.
Please contact the Secretary to the REC for advice (MikeProven, x7119, )
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October 2012