How to apply for research ethics approval
Do I need to submit a research ethics application?
Normally all research projects require ethical review because of a procedure or subject matter within it. These are some examples:
- Human participants (including all types of interviews, questionnaires, focus groups, records relating to humans, use of online datasets or other secondary data, observation, etc.).
- Research involving animals.
- Social media and/or data from internet sources that could be regarded as private.
- The risk to members of the research team, such as: lone working; travel to areas where researchers may be at risk; risk of emotional distress.
- Human cells or tissues other than those established in laboratory cultures.
- Threat to the environment.
- Conflict of interest.
- Research or a funding source that could be considered controversial.
- Studies with data collection using online resources, even those that do not collect or store identifiable data, to ensure participants are giving informed consent (e.g. are adequately warned of sensitive questions or images), that there are adequate safeguards against children taking part where appropriate, and that data storage meets current data protection regulations.
Where research projects involve information freely available in the public domain (e.g. published biographies, newspaper accounts) and the analysis of datasets, either open source or obtained from other researchers, you may need to apply for ethical review if you are not able to verify that the data are properly anonymised and informed consent was obtained at the time of original data collection.
Some projects relating to health and social care research require ethical review by the National Research Ethics Service (NRES) and therefore fall outside the remit of the University’s ethical review process. A decision tool which may help you to judge whether your application must be submitted to NRES can be found at: http://www.hra-decisiontools.org.uk/ethics/index.html
Data Management Plan
How to submit a research ethics application
Making an application depends on whether Phoenix has been rolled out to your faculty or school. Select one of the options below.
For applications via Phoenix
This is the latest version of the Phoenix Applicant Guidance - please ensure if you download this guidance, to check here if there is an updated version available. (Version control number will increase with each update.)
The Phoenix Applicant Guidance includes information for applicants, academic supervisors, module leaders and research team members supporting a research ethics application.
The ethical review process can take a minimum 6-8 weeks.
To log into the research ethics online application system:
Go to Phoenix
A data management plan (DMP) is a requirement for ALL research ethics applications. The application will be sent back to you if a DMP is not uploaded to support the application.
Supporting documentation and information required
Further information on the supporting documentation and information required to be submitted with your application (whether via Phoenix or paper-based) is set out below.
Data Management Plans and Data Protection
A data management plan (DMP) is a requirement for all research ethics applications. If this document is not uploaded to Phoenix or included with your Legacy application, your application will be sent back to you causing a delay.
Please read Data Management Planning guidance for further information on how to plan and write your DMP, which is part of study and research support from the University library.
This is a basic University of Leeds Data Management Plan template.
Data protection at the University
Please go to Data Protection at the University for further information and guidance.
Approaching and recruiting research participants
By law, participants must be told a certain amount of information if their personal data is to be used for research. Information about the legal requirement, including a template privacy notice, is available on the data protection webpage setting out information for researchers.
In addition, the expectation is that researchers will obtain, and record, the informed consent of participants. To achieve this, participants must be given clear information about the research project's aims, the risks and benefits, and the nature of their involvement. Researchers must be satisfied that this information has been correctly understood, and participants must be given sufficient time to reflect on the information given.
A participant's right to withdraw without giving a reason at any time must also be clearly explained and understood. In no circumstances should coercion, disproportionate payment or the expectation of any other inappropriate reward be used to influence consent.
There may be circumstances under which it would not be practicable to obtain participants' fully informed consent in advance - examples might include projects involving the use of covert or participant observation or projects which depend upon participants being unaware, at least initially, of the true object of investigation. Under such circumstances, researchers should carefully consider the justification for a methodology which precludes the establishment of informed consent in advance and be prepared to explain this in their grant application or application for ethical approval, as appropriate. In any case, the expectation is that participants will consent to the use of their data in the research.
The consent form is key to allowing the storage and wider sharing of the data you collect. The more your data is re-used, the more impact it can have. It should be possible for participants to opt out of being contacted for follow up study.
Protecting participants' personal data
Confidentiality and anonymisation
The storage and use of research data (including research participants' personal data) must comply with the University's Code of Practice on Data Protection and the University's Information Protection Policy. If it is possible to identify a living individual from the data, either directly or indirectly, the data is classified as personal data.
When planning your research project, it's important to think about what personal data needs to be collected and why. Don't collect personal data if you don't need it. For example, ask participants to indicate their age range, or provide their year of birth rather than their date of birth if you don't need to know that amount of detail. On screening questionnaires (e.g., PAR-Qs), if possible, group the exclusion criteria so that a single yes/ no answer can be given, to avoid participants having to specify which exclusion criteria apply. This reduces the sensitivity of the data and is less likely to cause embarrassment for research participants.
To anonymise data means to take away any means of identifying individuals from the data, whereas to keep something confidential means not sharing it (or sharing it within limited, pre-agreed channels). For example, interview transcripts could be confidential, but the participants could be anonymised in the published research findings.
Pseudonymisation takes the most identifying characteristics of the data and replaces them with one or more artificial identifiers, or pseudonyms, for example by replacing a name with a unique number. This makes research participants less identifiable but means it still possible, with a cipher, to identify individuals.
Think about what you are going to do with the data and/ or research results. Avoid promising confidentiality on the information sheet or consent form if the data (or quotations) will be shared anonymously. Make sure that any possibility of deductive disclosure of identities (that is, when someone is nominally anonymised but recognised because of other information such as a rare job title) has been identified and addressed. Participants should be made aware of any limits to anonymisation.
The process of anonymisation involves removing aspects of data from which a living person can be identified:
Direct identifiers include name, initials, contact details (including partial postcodes), IP addresses, photos, videos, audio recordings, unique identifying numbers (e.g., car registration plates, NHS numbers), dates relating to an individual.
Indirect identifiers include gender, location, socioeconomic data, ethnicity, unusual details (e.g., rare disease, behaviour), small denominators, very small numerators (may present a risk if present in combination with others in the list).
It might not be possible to identify individual participants' data yourself once all the identifiers have been removed. If the data is going to be fully anonymised, make sure participants are aware of any limits to withdrawal beforehand. If withdrawal is only possible up until a certain point a clear deadline for withdrawal should be provided in the participant information.
Further information
- The University's Information Protection Policy defines and specifies the controls needed for confidential and highly confidential material.
- MRC guidance on identifiability, anonymisation and pseudonymisation
Templates for participant information sheets and consent forms, and tips
If you are going to be using a participant information sheet and consent form, examples of the forms you will be using need to be included with your application for ethical review. The templates below may be helpful.
- Guidance Template Participant Information Sheet
- Easy-read participation information sheet
- Template Participant Consent Form
- Easy-read participant consent form
- Consent for questionnaires/surveys (includes example introductory paragraph)
Tips
You should consult the Gunning Fog index to check the readability of your forms for English writing. The index estimates the years of formal education a person needs to understand the text on the first reading.
Remember to take any funder requirements about research data management into account when planning your informed consent documents, as set out in the Research Data Management Policy.
You should mention that the project has ethics approval and provide your ethics reference and date of approval in all the participant-facing documentation. For example:
This research project has been received research ethics approval from [insert name of Faculty/School Research Ethics Committee] on [date], [ethics application project ID number]
Working with potentially vulnerable participants
The Policy on safeguarding children, young persons and adults in vulnerable circumstances must be complied with. Note that paragraph 15 of the Policy states:
No research using (or otherwise engaging) children, young persons or adults in vulnerable circumstances may be carried out without the permission of the relevant faculty ethics committee and the head of the school concerned. The head of the school concerned shall be responsible for ensuring that a satisfactory written risk assessment is completed and that control measures specified therein are affected.
In most cases, researchers working with vulnerable people will need to secure Disclosure and Barring Service (DBS) clearance. The DBS offers organisations a means to check the criminal record of researchers to ensure that they do not have a history that would make them unsuitable for work involving children and vulnerable adults.
You may also wish to consult guidance issued by FRECs on recruiting from peers (i.e., family, friends, colleagues) and on using on using students as research participants.
Other sources of information
- ICO guidance on valid consent
- SRA Code of Practice for the safety of social researchers
- Using oral history recordings
- UK Data Service guidance
- MRC & Wellcome Trust guidance on feeding back health-related findings
- You should consult the Gunning Fog index to check the readability of your forms for English writing. The index estimates the years of formal education a person needs to understand the text on the first reading.
Participants' capacity to consent
The Mental Capacity Act provides a framework to empower and protect people who may lack capacity to make some decisions for themselves. The Mental Capacity Act make clear who can take decisions in which situations, and how they should go about this. Anyone who works with or cares for an adult who lacks capacity must comply with the MCA when making decisions or acting for that person. This applies whether decisions are life changing events or more every day matters and is relevant to adults of any age, regardless of when they lost capacity. The underlying philosophy of the MCA is to ensure that those who lack capacity are empowered to make as many decisions for themselves as possible and that any decision made, or action taken, on their behalf is made in their best interests.
- NHS Health Research Authority guidance
- MRC guidance - consent arrangements: Adults unable to give consent
- Mental Capacity Act
Protecting participants' personal data
Confidentiality and anonymisation
The storage and use of research data (including research participants' personal data) must comply with the University's Code of Practice on Data Protection and the University's Information Protection Policy. If it is possible to identify a living individual from the data, either directly or indirectly, the data is classified as personal data. The Information Protection Policy defines and specifies the controls needed for confidential and highly confidential material.
When planning your research project, it's important to think about what personal data needs to be collected and why. Don't collect personal data if you don't need it. For example, ask participants to indicate their age range, or provide their year of birth rather than their date of birth if you don't need to know that amount of detail. On screening questionnaires (e.g., PAR-Qs), if possible, group the exclusion criteria so that a single yes/ no answer can be given, to avoid participants having to specify which exclusion criteria apply. This reduces the sensitivity of the data and is less likely to cause embarrassment for research participants.
To anonymise data means to take away any means of identifying individuals from the data, whereas to keep something confidential means not sharing it (or sharing it within limited, pre-agreed channels). For example, interview transcripts could be confidential, but the participants could be anonymised in the published research findings.
Pseudonymisation takes the most identifying characteristics of the data and replaces them with one or more artificial identifiers, or pseudonyms, for example by replacing a name with a unique number. This makes research participants less identifiable but means it still possible, with a cipher, to identify individuals.
Think about what you are going to do with the data and/ or research results. Avoid promising confidentiality on the information sheet or consent form if the data (or quotations) will be shared anonymously. Make sure that any possibility of deductive disclosure of identities (that is, when someone is nominally anonymised but recognised because of other information such as a rare job title) has been identified and addressed. Participants should be made aware of any limits to anonymisation.
The process of anonymisation involves removing aspects of data from which a living person can be identified:
Direct identifiers include name, initials, contact details (including partial postcodes), IP addresses, photos, videos, audio recordings, unique identifying numbers (e.g., car registration plates, NHS numbers), dates relating to an individual.
Indirect identifiers include gender, location, socioeconomic data, ethnicity, unusual details (e.g., rare disease, behaviour), small denominators, very small numerators (may present a risk if present in combination with others in the list).
It might not be possible to identify individual participants' data yourself once all the identifiers have been removed. If the data is going to be fully anonymised, make sure participants are aware of any limits to withdrawal beforehand. If withdrawal is only possible up until a certain point a clear deadline for withdrawal should be provided in the participant information.
Further information
Health and safety
Before you begin your research project, you will need to consider whether there are any health and safety issues to take into account and if any risk assessments are required. The health and safety section provides further information and guidance.
Reimbursement of research participants
Protocol on the Reimbursement of Research Participants
If the payment is to be made:
- While undertaking research, particularly social science or medical research, to volunteers required to take part in tests, submit to measurements or be interviewed, OR
- Is in relation to the use of 'lay' people or 'users' in research invited to attend meetings to give their views on various matters to inform the research process and direction
AND
- The payment is a small sum to cover out of pocket expenses and as compensation for time spent
Then the amount should not be subject to tax or NI.