A step-by-step guide to filling out a research ethics application as an IOE staff member
At IOE, UCL's Faculty of Education and Society, all research projects by staff, student or visitors which collect or use data from human participants are subject to ethics review before the project starts (including secondary data analysis and systematic reviews). The reviews are carried out by the IOE Research Ethics Committee. It is the responsibility of the project director (Principal Investigator) to ensure that ethics approval is gained prior to the start of any fieldwork.
The Research Ethics Committee reviews all ethics applications from staff and visitors. The committee includes representatives from across IOE as well as external lay members. All applications should be written in terms that can be understood by a layperson, and should provide explanations of any abbreviations or acronyms used.
If relevant questions/sections are not completed, your application will be returned to you before it is submitted to the committee. Where particular ethical issues are not addressed adequately the committee may request further information. This will lengthen the time it takes to get ethical approval, so please complete the form as fully as possible.
This guidance will help you complete your ethics application form. If you would like any further support please contact the Research Ethics Office: IOE.researchethics@ucl.ac.uk
Application form by section
- Section 1: project details
- Section 2: research methods summary
- Section 3: research participants
- Section 4: security-sensitive material
- Section 5: systematic reviews of research
- Section 6: secondary data analysis
- Section 7: data storage and security
- Section 8: ethical issues
- Section 9: attachments
- Section 10: declaration
Section 1: project details
This section provides the committee with basic information about the research.
Principal investigator (PI)
The PI is the person who has overall responsibility for the research.
Co-investigators/partners/collaborators
Provide details of IOE co-investigators and/or any external partners and collaborators. For collaborative projects you should clearly indicate who the lead partner is and in section 2 describe precisely the remit of the IOE research team’s involvement.
Start date
The project start is the date when data collection begins. For systematic reviews and secondary data analysis, this is the date when the research project begins.
End date
Ethical approval will be granted up to this date, which will be recorded on the Research Ethics Database.
Funder
Who is funding the research? The REC will be able to consider whether ethical issues arise by virtue of who is funding the research. In addition, different funders have different ethical review requirements.
Funding confirmed?
Funding is normally confirmed for a project before the ethics review process, unless you choose to request an earlier review, or a specific funder requires an earlier review. If there is more than one funder, please list them all.
The REC also reviews projects that do not have any funding attached such as self-funded projects and pilot projects undertaken in order to obtain subsequent funding.
Expedited review
Expedited review (full ethics review that is conducted quickly and at short notice) may be granted in exceptional circumstances. Our definition draws on UKRI, ESRC and UCL material on what can be considered for expedited review. The PI must firstly gain permission for an expedited review by making it clear in an email to the IOE Research Ethics Office at ioe.researchethics@ucl.ac.uk on how they meet the following:
- Access to a sample that is time-related.
- A short lead time due to the circumstances of a particular funding framework.
OR
- Fieldwork is linked to a particular event or period.
And these have been caused by external drivers which are outside the control of the researcher.
Please note expedited reviews will not be offered for:
- circumstances that are foreseeable or preventable
- claims that the applicant was unaware of the ethics application submission process and/or associated review timelines.
This request for permission will normally be reviewed by the IOE REC Chair, and the response given within 1–2 working days. If permission is not granted, then the usual standard review timeframe will be followed.
We understand that applicants and reviewers are working within competing work commitments. Please note that expedited reviews are reserved for the above situations to limit undue pressure on applicants, reviewers and the IOE REC office.
Ethics application processing timeframe:
- Expedited review – 15 working days.
- Standard review – 30 working days.
Please note these timelines may be affected by the current industrial action and action short of strike.
Code of ethics
State which code will govern the project. You do not have to be a member of the society in question to follow its ethics code. A project team may be multidisciplinary and have members who personally follow different codes: you must decide which code will apply for this project and record that on the form.
See the main codes of ethics.
Continuation
If this application is for a continuation of a previously approved project, please provide details including the ethics application reference number given with your approval (i.e. FCL 001 or REC 001), as well as details of how you have addressed any of the requirements or recommendations that were made in previous approvals.
Indicate how the project is able to continue (for example through additional funding sources) and provide detail where significant changes have been made to:
- methods
- consent procedures
- participants
- timetable
- data.
If available, the original reviewers will assess continuations.
Country fieldwork will be conducted in
If you are conducting your research abroad you will need to give details here and provide further information later in the form such as Research Methods Summary and Ethical Issues.
If you are travelling overseas for research, you must confirm your travel insurance and submit it to ioe.researchethics@ucl.ac.uk at least a week before travelling. If you are travelling on any UCL business you will need to register your trip with UCL. To register, and for more information about travel insurance, please see the Travel on UCL Business page.
Please check the Foreign and Commonwealth Office website for travel advice and confirm the status they give to the country you intend to travel to. If you are planning to visit a country or city where the FCO advises against all travel the IOE will not normally sanction your travel. If the FCO advises against all but essential travel, a detailed account of how the risks associated with your travel are going to be mitigated will need to be provided to your Head of Academic Department.
External Research Ethics Committees
If the proposal has gone through a rigorous ethics review process in another institution of equal standing to IOE, it does not need to be reviewed again within the IOE. This is most likely to occur when it goes through the NHS system (Integrated Research Application System) or another university’s system (where they are the lead investigators).
Please provide information about that process for our records as the external approval does need to be recorded by the IOE Research Ethics Committee. Where relevant, a UCL data protection registration number will be issued as part of this process.
Please submit the ethics form and all documents supplied to the external research institution, including a copy of the approval letter issued by the external research ethics committee, together with your IOE Staff Ethics Application Form to ioe.researchethics@ucl.ac.uk. Please note sections 2–8 of the IOE Staff Ethics Application Form do not need to be filled out in this case.
Please note the processing time for such requests is the same as the ethics application review timeframes (please refer to guidance on expedited reviews if needed):
- Expedited review – 15 working days.
- Standard review – 30 working days.
Section 2: research methods summary
In this section you need to provide the committee with a full understanding of your research project. This should include clear information on:
- the aims and background
- the rationale and justification for the research
- the study design (including data collection and analysis methods)
- a justification for the methods to be used and topics/questions to be asked of participants.
- To assist the Research Ethics Committee members in understanding the project, please ensure that your explanation is written in lay language and any acronyms or abbreviations explained.
Please ensure you tick all methods that will be used in your research and follow the directions for which section to complete next. This information is recorded on the ethics database and enables the committee to consider the different ethical issues that may arise depending on methods.
Section 3: research participants
Many research projects at the IOE are likely to have human participants, but not all. For example, if a systematic review is a project in its own right (rather than part of a bigger project) there may be no human participants.
For research where there are participants, please ensure that you tick all relevant boxes. Research participants are those from whom you are collecting data (through questionnaires, interviews focus groups and observations) as well as those whose personal data may be used (including for secondary analysis) and participants in action research. Not all research will involve direct interaction with participants.
Research involving children
Ensure that you are clear about the ages of the children and provide more detailed information under question 2.
Research involving adults
Describe them briefly (e.g. teachers, parents, adult learners, patients) and provide more information under question 2.
Research involving unknown participants
If you do not yet know who the participants will be tick the ‘unknown’ box and explain clearly why this is.
Research involving vulnerable participants
If you intend to conduct research with vulnerable participants (such as those in care, children, people in custody, participants with mental health difficulties) this should be covered in the ethical issues section.
Research requiring external ethical approval
Not all research at the IOE can be ethically approved by the Research Ethics Committee; some must be ethically reviewed by other specialist ethics committees:
- Research involving NHS patients, service uses (those using NHS services) and NHS premises must be ethically approved by the NHS Research Ethics Service (RES). Please note the following exceptions: Research involving NHS or social care staff recruited as research participants by virtue of their professional role does not usually require NHS ethical approval and so should be submitted to the Institute’s REC. Research activities defined by NRES as not requiring ethics review within the NRES processes include audit and service evaluation.
- Under the Mental Capacity Act 2005 (MCA 2005) any research that proposes to involve the recruitment of participants aged 16 and above who lack capacity to consent to take part in the research or who later lose capacity during the research must have ethical approval by a recognised appropriate body such as the Social Care Research Ethics Committee or certain National Research Ethics Service RECs.
- Social research funded by the Department of Health and therefore requiring review by the Social Care Research Ethics Committee (SCREC).
- Research which involves human participants and which is funded or sponsored by the Ministry of Defence (MOD) must secure approval from the MOD Research Ethics Committee (MODREC).
- Research that involves prisons, youth offending or probation services requires approval through the National Offender Management Service (NOMS) or NHS committee.
Section 4: security-sensitive material
Some projects may collect or encounter security-sensitive research material. This may be more likely if your project is within any of the following categories:
- It is commissioned by the military.
- It is commissioned under a European Union (or other) security programme.
- It involves the acquisition of security clearances.
- It concerns terrorist or extreme groups.
If your project involves security-sensitive material, please provide further details in Section 8 Ethical Issues. Once your application has been received, you may be asked to provide more information and you may be required to follow specific data storage and other practices.
Section 5: systematic reviews of research
A systematic review is a literature review that asks one or more specific research questions. It uses systematic and explicit research methods to review relevant research in relation to these research questions.
In a systematic review, the findings of existing research studies themselves become raw data for analysis and interpretation. These data usually come from reports and information that are already in the public domain, for example published theses, papers and other publications.
Systematic reviews are often considered to have a low risk of potential harm. The following points might be helpful in judging this for your own project.
Systematic reviews are often conducted alongside some form of consultation
If you intend to collect new data from people alongside your review of the literature, such as by the use of focus groups, you should consider the ethical concerns that could arise (e.g. if you plan to report what individual people say) and complete the rest of the application form with this in mind.
Will you be contacting the original research team?
If you require clarification on certain matters and decide to contact the original research team you should consider what issues may arise from this. Will this only be clarification or will new data be obtained? Is there the potential for breaching participant confidentiality?
Further information
Systematic reviews that are not collecting any new data or analysing secondary data are not required to complete the ethical issues section (Section 8 Ethical issues). This light touch approach is appropriate where the potential for risk of harm to participants and others affected by the research is minimal.
Section 6: secondary data analysis
Light touch review
Secondary data analysis is eligible for light touch review if the following criteria are met:
- The appropriate permissions have been gained.
- The data have been or will be anonymised.
- ‘Technical and organizational measures’ to ensure that they process only the personal data necessary for the research purposes, in particular ensuring compliance with the principle of data minimisation, e.g. the use of pseudonymisation, are put in place.
- The processing is not carried out of the purposes of measures or decisions with respect to a data subject (except in The context of ‘approved medical research’),
- The processing is not likely to cause substantial damage or distress to an individual.
- The analysis is within the remit the data was collected for.
This light touch approach is appropriate where the potential for risk of harm to participants and others affected by the research is minimal. Approval of these applications is confirmed by the Chair or Deputy of the Research Ethics Committee.
Full review
A full review is necessary where the data are:
- sensitive or may infringe an individual’s privacy
- ‘special category personal data’ under data protection legislation
- at individual level
- to be linked to an individual or identification is reasonably likely.
Special category personal data
Special category personal data mean personal data consisting of information relating to:
- data which reveals racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership
- data concerning health (the physical or mental health of a person, including the provision of health care services)
- data concerning sex life or sexual orientation
- genetic or biometric data processed to uniquely identify a natural person. Note: Collecting and using special category personal data requires a further basis (meaning a specific justification) under GDPR Article 9(2) and the Data Protection Act 2018.
UCL’s view is that the most appropriate legal basis to rely upon when processing ‘special category personal data’ for research purposes is Article 9(2)(j), i.e. where the processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes.
Reliance on this condition requires UCL to ensure that the processing meets the public interest test and ‘appropriate safeguards’ are in place. These ‘appropriate safeguards’ include:
- using ‘technical and organizational measures’ to ensure data minimisation, e.g. pseudonymisation
- using anonymised data where possible
- not processing in ways that are likely to cause substantial damage or distress to individuals
- not supporting measures or decisions with respect to individuals
- having the assurance that research ethics committee approval is in place where needed.
Section 7: data storage and security
In this section you will need to explain how data will be stored and managed both during and after the research, as well as who will have access to the data. This must be provided so that UCL can register all projects that are collecting or using data from human participants. The registration process for staff is managed by the Data Protection team at UCL, and the Research Development Administrator will liaise with the team on your behalf.
Data Protection team contact: data-protection@ucl.ac.uk.
The questions in section 7f ask you to confirm that you have appropriate organization and technical measures in place to ensure security for the data you are using in compliance with data protection legislation.
You are advised to refer to UCL’s Data Protection Policy and Information Security Policy when answering this question.
In addition, the Information Commissioner’s Office (ICO) has a very helpful, plain English guide to GDPR (The Guide to Data Protection) that breaks down each Principle and provides examples.
Data security and sharing
Please ensure that you address the following in relation to all hard copy and electronic data:
- How and where will the data be stored both during and after the research?
- How will you ensure the safety and security of the data?
- How will you prevent accidental disclosure – e.g. by encryption of data on laptops, not taking printed confidential materials out of premises, storing files in locked cabinets in locked rooms?
- Who will have access to the data both during and after the study? This includes, for example, transcribers.
- Will you be collecting ‘special category’ data as defined by data protection legislation (see secondary data analysis section above)? What steps have you taken to ensure that only special category personal data which is necessary to the research is collected?
- How long will such data be kept for? Please clarify what data will be destroyed, when and how, as well as what data will be retained.
- If data are to be retained, please clarify for what purpose, such as for further analysis and/or archiving.
General data security guidance
Antivirus software
All devices that have access to the internet can be targeted by hackers and malware programmes, therefore it is important that all devices used have antivirus software installed. It is important to ensure that this is regularly updated. It is advisable to also ensure the firewall on your device is turned on for additional protection.
Personal computers
Many people use personal devices such as home computers and laptops for work purposes and it is important to ensure that the data on these devices are secure. The device should be password protected and if others have access to the device, such as other family members, it is best practice to create different users so that only you have access to the data. You should also consider password protecting those files.
Personal devices can be stolen or lost and so it is good practice to only store what is necessary on them. If you no longer need data then this should be removed. In addition, if you decide to sell or gift your laptop, for example, you should ensure that all data has been wiped from the device. Deleting files is not enough as it is possible to still recover the data so you should look at wiping software to ensure that no data remains.
Wifi and public internet access
Though your personal device such as a laptop may have antivirus software to protect it you should be careful on how you access the internet. For example, wifi available in cafes and other stores are likely to be targeted and so it is advised that you do not use these options. Private password protected wifi options are best.
Never use public computers such as internet cafes or those available in other stores or airports to access data as these systems are not secure and could easily leave the data open to attack from viruses or use by others.
Further guidance
Please visit the UCL Information Security Group for further guidance on all security issues.
Section 8: ethical issues
In this section consider the issues that may arise in this research and how you will manage them. Please ensure your answer to this section is written in terms understandable to a lay person.
To assist you, a list of issues that you may need to consider has been included in the application form at the start of the section. This list is not exhaustive, nor will every issue apply to every project. It is intended to help you think about things which may happen, and to help Research Ethics Committee members to review your proposal.
When completing the application form, certain answers/sections specifically ask you to address the issues raised in Ethical Issues section. Please ensure that all of these are addressed there.
Participants and recruitment
Ask the following:
- Who you intend to collect data from and how?
- Who the potential participants are and how you will identify them?
- How you will approach potential participants?
- Any approvals / necessary permissions (such as from gatekeepers) and how these will be managed.
If you are planning to carry out research in regulated education environments such as schools, or if your research will bring you into contact with children and young people (under the age of 18), or adults classed as vulnerable, you will need to have a Disclosure and Barring Service (DBS) check before you start. The DBS was previously known as the Criminal Records Bureau (CRB). If you do not already hold a current DBS check, and have not registered with the DBS update service, you will need to obtain one through UCL.
Further information can be found in UCL DBS Checks and Criminal Convictions Policy.
Informed consent
Ask the following:
- How will you inform participants about the research and gain their informed consent to participate?
- If you do not intend to gain informed consent, please explain why.
- How will you inform children about the research? Have you ensured that the consent form is easy to understand for children of this age?
- You are requested to attach copies of information leaflets etc. which you intend to use – if you do not intend to use information leaflets, please explain why not.
- How will you document participants’ consent?
- Will you need to get consent from participants on more than one occasion, or only at the outset of the project?
- Have you gained consent for future use of data?
Observation
Observation is a method which raises a variety of ethical issues depending on the individual nature of the research and observation. One of the more prominent issues is whether you as the researchers will seek consent (from gatekeepers and/or individuals) for the observation, though the possible issues that could arise go beyond issues of consent.
Best practice is that informed consent should be obtained from all participants in advance of the observation. However, it is recognised that there may be occasions when this is not feasible or appropriate. As the researcher you should ask yourself why, in such circumstances, it is not appropriate to seek informed consent from participants. One possible example could be that the observation is taking place in a public space and it is not possible to obtain consent from all those being observed.
Even where it may not be possible to seek consent, this does not preclude you as the researcher informing those involved that observation is taking place. Could you place signs in the area to let people know that observational research is taking place or, if the research is taking place in a specific company, could you arrange for an email to all staff to inform them ahead of time about the observation? This would allow those who do not wish to be included to either avoid the area or to inform you as researcher that they do not wish to be included.
Covert research
There may be situations where it is not appropriate to inform participants either in full or at all about the study as it may either affect the behaviour of participants and/or make it impossible to collect the data. In which case, is it possible to seek consent for the use of the data after it has been collected? For example, in psychological experiments you may need to have an element of deception in order to test the hypothesis, and so after the data has been collected it would be expected that you would debrief participants; explaining the deception and reasons for it and then seek their consent again based on this new information.
The ESRC Framework for Research Ethics (Updated January 2015, page 31–2) states that:
Covert research may be undertaken when it may provide unique forms of evidence that are crucial to the research objectives and methodology or where overt observation might alter the phenomenon being studied. The broad principle should be that covert research should not be undertaken lightly or routinely. It is only justified if important issues are being addressed and if matters of social significance which cannot be uncovered in other ways are likely to be discovered. Normally, social scientists should ensure that research participants are aware of and consent to arrangements made with regard to the management and security of data, the preservation of anonymity, and any risk that might arise during or beyond the project itself, and how these might be minimised or avoided. Disciplinary professional ethics codes may be helpful here. Where the research design is such that valid consent cannot be obtained from participants before data is gathered, REC review of the protocol should take place at the highest level. Wherever practically possible participants should be fully debriefed about the true aims and objectives of the research and given the opportunity to withdraw their data from the study (e.g. experimental studies involving deception). Researchers should also ensure they have received the relevant permission from gatekeepers where necessary to undertake the research, for example from the relevant public sector organisation to undertake research on public sector property.”
Studies such as these must apply to the Research Ethics Committee for ethical approval, including studies conducted by students.
Opt-in/opt-out sampling
When seeking to recruit participants the most often used approach is opt-in sampling. This means that following receipt of information about the research (such as information sheets or letters) the potential participants take an active step in agreeing to participate. This is often in the form of returning signed consent forms or completed questionnaires, for example:
Opt-in sampling
Option 1:
- Information sheets sent to potential participants.
- Signed consent form/completed questionnaire/s returned to researcher.
- Individual included in research as participant.
Option 2:
- Information sheets sent to potential participants.
- No response received, returned unsigned or incomplete.
- Individual not included in the research.
![opt-in and opt-out sampling opt-in and opt-out sampling](https://www.ucl.ac.uk/ioe/sites/ioe/files/styles/large_image/public/research-ethics-01.png?itok=_z78KkW3)
Using this approach, if you need to seek additional approval from parents/carers or gatekeepers such as schools, you need to wait until this permission has been given before approaching individuals/collecting data. An example process for this is below.
Option 1:
- Information sheets sent to parent(s) or carer(s) or child.
- Parent/carer returns signed consent form.
- Consent form discussed with child.
- Child agrees to take part in the research.
- Data collection begins.
Option 2:
- Information sheets sent to parent(s) or carer(s) or child.
- Parent/carer does not return signed consent form or returns unsigned.
- Child is not included in the research.
![opt-in and opt-out sampling opt-in and opt-out sampling](https://www.ucl.ac.uk/ioe/sites/ioe/files/styles/large_image/public/research-ethics-02.png?itok=LIzi6Nic)
Opt-out sampling
Another method that is used is opt-out sampling, whereby information is sent to all potential participants and gatekeepers/parents as above, but researchers deem participants to have agreed to take part unless they specifically state otherwise.
Option 1:
- Information sheet sent to potential participants.
- No response received.
- Individual included in research as participant.
Option 2:
- Information sheet sent to potential participants.
- Individual contacts researcher to refuse.
- Individual not included in research as participant.
![opt-in and opt-out sampling opt-in and opt-out sampling](https://www.ucl.ac.uk/ioe/sites/ioe/files/styles/large_image/public/research-ethics-03.png?itok=fv76zAwB)
A further example of the process for studies involving children using the opt-out method for parental consent is below.
Option 1:
- Information sheets sent to parent/s or carer and child.
- No response received from parent/carer.
- Child agrees to take part in the research.
- Child is included in research as participant.
Option 2:
- Information sheets sent to parent/s or carer and child.
- Parent/carer contacts researcher to refuse permission for their child to be included.
- Child not included in the research.
![opt-in and opt-out sampling opt-in and opt-out sampling](https://www.ucl.ac.uk/ioe/sites/ioe/files/styles/large_image/public/research-ethics-04.png?itok=7UimgDy1)
Choosing opt-in or opt-out
It is recognised that using the opt-in sampling method can lead to lower response rates and potentially a less representative sample of participants, such as those in the harder to reach areas. It can be for such reasons that a researcher may choose to adopt an opt-out approach instead.
Both methods are accepted by ethics committees, and the researcher will need to decide which the most appropriate method for their particular research is. If you choose to use opt-out sampling, the reason for doing so would need to be explained in the ethics application.
Many committees will prefer the use of opt-in as one of the principles of informed consent is that participants must participant willingly and without coercion (see the ESRC Framework for Research Ethics) and using opt-in sampling helps to demonstrate this with the active step participants and gatekeepers need to take in order to show their agreement to participate. Those that do not take that step are simply excluded from the study as their consent has not been given. In addition, if participants do not wish to take part they do not need to take an active step in order to do this, they can simply not respond. On the other hand, opt-out requires individuals to actively refuse to participate, which some may feel unable to so and may feel some pressure to participate.
For example, are potential participants being asked to indicate their refusal to participate as a group (and so publically indicating their refusal), or through an organisation they are working for or seeking services from? Consider also the relationship of the gatekeepers and whether their involvement could lead to possible participants feeling pressured to accept. There are, by its very nature, more ethical implications to be considered for opt-out sampling than opt-in and these would need to be addressed in the ethics application.
The decision to use opt-in or opt-out consent should be made on the basis of appropriateness for your study. In both cases all relevant parties must still be provided with clear and detailed information regarding the study, as would normally be expected in ensuring informed consent. The differences lie in the process for taking or assuming consent.
Research with children
See Research with Children: Guidance on Data Protection Issues.
Benefits of the research
Ask the following:
- Who will benefit from this research?
- How will participants benefit, now or in the future?
- Who else might benefit, now or in the future?
- Will you offer participants financial incentives (e.g. shopping vouchers, entry in a prize draw) to take part in the research? If so, how much will you offer and how will you ensure that the payment does not unduly influence their decision to take part and their responses to your questions?
- Will you offer to meet participants’ expenses (e.g. travel costs, child care costs) to take part in the research?
Risks of the research
Consider the following:
- Please address any risks that may arise for participants as a result of participation, and how these will be managed. ‘Risks’ includes physical, mental and emotional risks, including distress.
- Where sensitive topics/events that are likely to cause distress are part of data collection, please clarify the experience of the researcher/s concerned in managing these.
- Clarify whether there are any risks for the researchers, such as working alone in a hazardous place, and describe how these will be addressed.
- Are there risks to anyone else?
Anonymised data, pseudonymised data and disclosure
Ask the following:
- What personal data will be anonymised and how will this be done?
- Will personal data be pseudonymised?
- What level of anonymity or confidentiality will you promise the participants and how will this be guaranteed?
- Is the nature of the research (such as topics to be discussed) likely to divulge information that could necessitate disclosure to other parties, for instance issues relating to child protection? If so, clarify the possible foreseen issues and describe how these will be addressed and how participants will be informed of the potential for disclosure.
Post research
Ask the following:
- Who will you inform about the findings of the research, and how?
- Will you tell participants about the results? If so how will this be done?
Research outside the UK
Consider the following:
- If the work involves data collection outside the UK, are there any special issues arising because of the country/ies where the work takes place? Issues might include different values and traditions which affect approaches to gaining informed consent, and making arrangements for speakers of other languages.
- Are there additional permissions/authorisations that need to be obtained? This includes any local ethical approvals.
- If research is to be conducted abroad please check the Foreign and Commonwealth Office and UCL's International Travel Policy & Procedures for full details on the processes to be followed, including completing and submitting a full risk assessment form.
Please note, that not all travel will be authorised by the IOE.
Section 9: attachments
You are required to attach all necessary supporting documents to your application, in particular copies of any external ethical approval (if appropriate) and recruitment documents such as information sheets and consent forms. If these are not available please state the reason.
Please note that attachments relating to the recruitment of participants (where the research involves participants) are essential for review and so applications submitted without these will not be forwarded to the Research Ethics Committee for review until they have been submitted.
Specific guidance on writing information sheets and consent forms is available on IOE's Research Ethics staff pages, but in summary they should:
- cover all aspects of the research
- be understandable by all (including translation if necessary)
- include contact details for the researcher
- clearly state that participants can withdraw at any time, without reason and without any impact on them
- be clear about what will happen to their data if they decide to withdraw
- be provided to participants in advance to give them sufficient time to consider all the information before giving their consent.
Section 10: declaration
Finally, you will need to sign (electronic is fine) and date the declaration to ‘confirm that to the best of my knowledge the information in this form is correct and this is a full description of the ethics issues that may arise in the course of this project’.
Risk assessments
You will need to complete a risk assessment on RiskNet after you have received ethics approval for your study.
The Safety Services Team provide a wealth of knowledge around risk assessments, providing guidance on all aspects of the Risk Assessment Process, examples of some of the areas below:
- Creating a new risk assessment.
- Updating an existing risk assessment.
- Creating a new risk assessment from an existing risk assessment.
- Adding an attachment to a risk assessment.
They also provide more focused guidance for travel/field trips.
Ethics review timetable
Your application will be checked and complete applications are sent to the Research Ethics Committee.
Standard
Feedback normally takes 30 working days from submission of the application.
Expedited
In exceptional circumstances and when project timelines are very tight, expedited review can be requested. It is normally conducted within 15 working days of the ethics application.
Light touch
This normally applies to cases such as secondary analysis and systematic review when the first reviewer decides that the project raises no substantive ethics issues.
Committee response
Approved: The research is fully approved and can commence immediately.
Revision required: The application is incomplete and/or raises concerns so further information and/or changes need to be made and submitted before full approval can be granted.
Rejected: The application is considered to raise fundamental concerns that means it cannot be approved by the committee.
Where further information or amendments have been requested by the committee, the PI should address these and submit their response with any supporting documentation as soon as possible. This will then be resubmitted for further consideration by the committee.
Approval is issued for the life of the project on the basis of the information provided within the application. Changes in the research design, instruments, setting or participants require ethical review and must be submitted for approval prior to the changes taking effect.
As part of the Research Ethics Committee’s Ethics Review Monitoring Process a small number of current projects will be audited each year to ensure ethical requirements are being met.
Post approval and standard conditions of approval
Throughout the project PIs should record how they have met any requirements or recommendations set and also how they have addressed any ethical issues that arise (accurate recording is important for audit).
Standard conditions
A decision by IOE's Research Ethics Committee to approve a research project does not imply an expert assessment of all possible ethical issues nor does it detract in any way from the ultimate responsibility which researchers must themselves have for all research which they carry out, including its effects on people involved.
The IOE's Research Governance and Ethics Committee and Research Ethics Committee address themselves to ethical matters and depend upon information supplied by the researcher. This information is expected to be properly researched, full, truthful and accurate. It is the PI's responsibility to notify the Research Ethics Committee or the Research Ethics and Governance Administrator if any of the following occur:
- A complaint of any kind from any person involved or affected by your research. Such people include participants, parents/carers, gatekeepers, junior researchers and also members of the group being researched who may be affected by the research reports.
- Changes in the research design, instruments, setting or participants.
- Any other events during the course of the research which give rise to ethical concerns.