How do I apply for Ethical Approval?

Once you have established that ethical approval will be required for your project, you will need to apply for and receive full ethical approval before beginning any aspect of the work involving human participants, their data or tissue. Ethical approval cannot be granted retrospectively, so it is important to consider the ethical review process, and the time it takes, when planning your project.

Which committee do I need to apply to?

The Committee you will need to apply to depends on which Faculty you are based in:

Staff based in the Faculty of Science, Engineering and Medicine (excluding Psychology) should apply to BSREC.

Staff in the Faculties of Arts and Social Sciences, and the department of Psychology, should apply to HSSREC.

The same designation applies to student research but in many cases, the review of student research is delegated to the department. Students should check with their department in the first instance to see if they have a delegated ethical review process. If the department has no review process in place, students will need to submit their application to BSREC/HSSREC.

The application and review process for both Committees is the same but each Committee is comprised of experts from their respective Faculties.

If the University of Warwick is not the sole lead organisation for the research and another Higher Education Institution (such as the lead or co-lead) has granted formal research ethics approval, it may not be necessary to also gain BSREC/HSSREC ethics approval. However, BSREC/HSSREC will require a record of this external approval along with confirmation that Warwick's role in the project is covered by this. Please submit a copy of the ethics approval granted to bsrec@warwick.ac.uk or hssrec@warwick.ac.uk, depending on which Faculty you are in, before the research commences. The BSREC/HSSREC Secretary will advise as to whether further ethical review is required. Where Warwick is the lead institution, ethical review is expected to be conducted by Warwick.

If your research involves the NHS, Social Care, work with animals, the Ministry of Defence, or Prison Services, you will need to check what approvals are required from the respective Committees below.

What types of review do I need?

BSREC and HSSREC undertake ethical review of all projects on a proportionate basis according to a risk-assessed triage process. There are two main routes through which applications will be reviewed; a Full review or a Light Touch review.

All projects involving the collection of primary data, or that are deemed high risk, are reviewed by the full Committee at BSREC/HSSREC Committee meetings.

Each Committee meets seven times per academic year and applications must be submitted two weeks and two days ahead of the meeting date (meeting dates for both Committees can be found below). All staff applications must be supported by the signature of the Head of Department (or supervisor in the case of student applications). Late submissions will not be accepted and will be deferred to the following meeting.

Applicants are not invited to present their submissions as a matter of course. However, in the event of particular issues, the Committee may request the applicant to attend to assist the Committee in its deliberations.

The Committee Secretariat will provide initial feedback on the application once this has been received and will advise if the application is valid and of sufficient quality for review at the meeting. The Secretariat endeavour to provide initial feedback to help the application achieve the best possible result when being reviewed by the Committee. This can mean that requests for changes and additional documents are made within a very short timeframe, after the submission deadline and in advance of the meeting. For this reason, it is advised to work closely with the Secretariat in advance of the submission deadline.

Applicants can expect to receive an outcome within 10 working days of the meeting.

There are no deadlines for receipt of Light Touch applications as these are reviewed outside of full meetings. It is the responsibility of the BSREC/HSSREC Secretary, in conjunction with the Chair where necessary, to determine whether a study is eligible for Light Touch review. Where Light Touch applications are deemed to require a full review, they will be referred for review at the next Committee meeting.

BSREC/HSSREC operate to a target of providing a research ethical opinion on new light touch applications within 30 working days. Please ensure you factor this into the timescales for your project.

Low Risk Studies

Any studies falling under all the following criteria may be eligible for review through the Light Touch process (reviewed by one reviewer via email):

Projects which do not:

• Recruit vulnerable participants (e.g. children, adults who by nature of the topic are vulnerable, adults unable to provide informed consent).
• Involve participants taking part in the study without their consent or knowledge at the time of data collection, or involve deception of any sort (e.g. covert observation of people in non-public places).
• Cover sensitive topics (e.g. topics which participants may find difficult, distressing or cause anxiety, topics which could lead to negative consequences for the participant).
• Involve risks of possible disclosures or reporting obligations (e.g. research that covers topics where participants may reveal sensitive information such as risk of harm to themselves or others, professional malpractice or insecure migration status that would need to be reported to relevant authorities).
• Involve exposure of participants to risks that are greater than or additional to those they encounter in their normal lifestyle risks (e.g. induce psychological distress or anxiety, or produce humiliation, or cause harm).
• Involve any invasive procedures or physical risk (e.g. studies involving taking samples from participants, studies requiring participants to test new or existing technologies).
• Involve any reasonably perceived conflicts of interest.
• Involve any dangerous/risky locations (e.g. countries with travel warnings in place, dangerous locations within or outside the UK, lone working where the researcher may be at any risk outside of usual activities).
• Involve the collection of sensitive personal data.
• Involve the use of social media data which has the potential to cause harm / distress or puts at risk the confidentiality and rights of social media users.

Examples of studies which may fall under the ‘low risk’ remit are:

• Module/teaching evaluation projects undertaking evaluation work but with the intention to turn the results into publishable research. If the researcher has any direct involvement with the students’ education, this should be acknowledged within the application and participant-facing documents. It should be clearly outlined that no coercion or pressure will be placed on students and that their education will not be affected in any way by the research
• Anonymous online surveys which do not cover any sensitive topics or recruit vulnerable participants (e.g. non-sensitive anonymous surveys recruiting participants through MTurk, Prolific, etc.)
• Studies which only involve limited numbers of participants who will be taking part in their professional capacity and discussing only professional topics (e.g. interviews with authors/artists on their bodies of work, given the topics are not sensitive or contentious)
• Studies gathering basic company information which could be gained through Freedom of Information (FOI) requests but where the researcher would prefer to contact participants with a polite request to take part in research and offer the information freely rather than through an FOI request

The Committee Secretariat will make the decision on whether a project meets these criteria and is therefore eligible for review through the Light Touch process. This decision may be made in conjunction with the Chair where necessary. Applicants cannot request that a project be reviewed through the Light Touch process, it will be determined by the Secretariat if there are any additional risks which need to be considered by the Committee. Please note that applications considered under the Light Touch remit may still be escalated by the reviewer to the Chair or Committee if additional risks are identified and if they believe that the application requires further scrutiny.

Secondary Data

Most applications involving only the collection and analysis of secondary data will be eligible for review through the Light Touch remit. These may be referred for Full Review if the topic is particularly sensitive or contentious or if any further risks are identified by the Secretariat or reviewer.

How to apply

How do I apply? Committee meeting dates and deadlines Amendments to existing approvals Committee Constitutions and ToR

Once you have determined which review process you will be eligible for (Full Review or Light Touch), you should complete the appropriate application form.

As well as the application form, you will need to provide all documents relevant to your application. For most studies directly recruiting human participants, this will include everything which will be presented to your participants such as the Participant Information Leaflet (PIL), Consent Form, recruitment materials, interview topic guide/questionnaire.

While informed consent is a process, and how this is carried out can vary a lot depending on the type of study you are conducting, we provide template Participant Information Leaflets and a template consent form which contain important governance information. You are encouraged to adapt the templates to ensure that it is suitable for your set(s) of participants but retain the required governance information.

As well as all the participant-facing documents, you will also need to provide a copy of your Research Integrity Training Certificate.

Further to this, some studies will need to provide completed Risk Assessments, copies of local approvals (for some research taking place in other countries), or other relevant permissions required to conduct the study. Work which will be conducted in other languages will need to supply copies of the translated documents for BSREC/HSSREC to hold on file. However, these can be supplied after approval has been granted so that any changes requested by the Committee do not need to be made to both versions.

Your application form and supporting documents should be attached to an email and sent to BSREC@warwick.ac.uk or HSSREC@warwick.ac.uk (depending on which Committee you are submitting to). Light Touch applications can be sent at any time. Applications for Full Review at a meeting should be sent by midnight on the submission deadline date for the meeting you are submitting to. Meeting dates and submission deadlines can be found below.

Once you have sent your completed application, it will be checked by the Secretariat to ensure that the application is complete and will be reviewed through the appropriate process.

The forthcoming meetings and application submission dates for BSREC are listed below.

Researchers are reminded that they must meet the relevant deadline for the application to be considered at the corresponding meeting.

Applications requiring a full review received outside the meeting deadline will not be accepted and will be deferred to the next meeting.

Deadline for applications 2024-25

BSREC Meeting Dates 2024-25

Tuesday 27 August 2024

Thursday 12 September 2024

Tuesday 22 October 2024

Thursday 7 November 2024

Tuesday 7 January 2025

Thursday 23 January 2025

Tuesday 11 February 2025

Thursday 27 February 2025

Tuesday 25 March 2025

Thursday 10 April 2025

Tuesday 20 May 2025

Thursday 5 June 2025

Tuesday 24 June 2025

Thursday 10 July 2025

For queries, please contact BSREC@warwick.ac.uk .

The forthcoming meetings and application submission dates for HSSREC are listed below.

Researchers are reminded that they must meet the relevant deadline for the application to be considered at the corresponding meeting.

Applications requiring a full review received outside the meeting deadline will not be accepted and will be deferred to the next meeting.

Wednesday 31 st July 2024

Deadline for Applications 2024-25

HSSREC Meeting Dates 2024-25

Monday 23 September 2024

Wednesday 9 October 2024

Monday 18 November 2024

Wednesday 4 December 2024

Monday 20 January 2025

Wednesday 5 February 2025

Monday 10 March 2025

Wednesday 26 March 2025

Monday 22 April 2025

Wednesday 7 May 2025

Monday 9 June 2025

Wednesday 25 June 2025

Monday 14 July 2025

Wednesday 30 July 2025

If you have any queries regarding an application please contact hssrec@warwick.ac.uk

Any amendments which researchers need to make to approved studies should be submitted to the Committee which approved the study. Amendments are processed differently depending on whether they are Substantial Amendments or Non-Substantial (Minor) Amendments.

Please note there may be other review bodies that also need to be notified of any changes made to the study. Researchers should submit amendments to all review bodies from whom you have received approval.

Substantial Amendments include the following:

• changes to the design or methodology of the study, or to background information that is likely to have a significant impact on its scientific value;
• addition of a new group of participants or data set;
• significant changes or additions to the procedures undertaken by participants;
• changes likely to have a significant impact on the safety or physical or mental integrity of participants, or to the risk/benefit assessment for the study;
• significant changes to study documentation such as participant information sheets, consent forms, questionnaires, letters of invitation, letters to other key stakeholders
• transfer of the project to another organisation;
• addition/inclusion of significant new payments/incentives for participants e.g. gift tokens, vouchers etc.
• any other significant change to the project as outlined in the original ethics application.

Non-Substantial (Minor) Amendments include the following:

• minor changes to the study documentation, e.g. correcting errors, updating contact points, minor clarifications;
• changes to the research team, including the Principal Investigator;
• changes in funding arrangements or receipt of additional funding;
• extension of the study beyond the period specified in the original application form;
• updates to existing PILs for ongoing studies, e.g. to include updated GDPR information

To make a Substantial Amendment to a BSREC or HSSREC approved project:

1. Complete the Substantial Amendment Application Form. This is to provide the Committee with a summary of the changes you wish to make to the study. This form should be signed by the researcher (and supervisor where applicable for student projects). Electronic signatures are acceptable.
2. Submit a revised copy of the original application form, updating the date and version number on the first page, and highlighting any changes or additions (this document should be a live document detailing how the project will be conducted). Please ensure all sections are updated as appropriate. For example, if the amendment involves a new questionnaire for participants to complete, then the recruitment section, informed consent section and data section of the original application form should be updated to detail the arrangements for the new questionnaire.
3. Submit copies of any new or changed documents, highlighting the changes so it is easy for these to be identified and reviewed.
4. Please electronically submit your application for substantial amendments to a project to bsrec@warwick.ac.uk or hssrec@warwick.ac.uk, depending on which Committee originally approved your project.

To make a Non-Substantial (Minor) Amendment to an approved project:

Non-substantial amendments do not require review by Committee members but notification should be sent to the BSREC/HSSREC Secretariat: bsrec@warwick.ac.uk or hssrec@warwick.ac.uk. The original application form, date and version number should be updated, with any changes highlighted for BSREC/HSSREC to hold on file. The Secretariat will confirm receipt of the notification and you will be able to continue with your study.

If you are unsure whether your amendment will be classed as minor or substantial, please contact the Secretariat in the first instance for further advice.

Terms of Reference

Authority

• The Committees derive their authority from the overarching University Research Governance and Ethics Committee.

Remit

• To ensure that all non-NHS research in the Faculty of Science, Engineering and Medicine (excluding Psychology) (BSREC) and in the Faculties of Arts and Social Sciences (including Psychology) (HSSREC) and related studies that involve human participants, their data, or tissue is conducted according to the highest ethical standards, and in line with relevant legislation and guidance concerning ethical approval.

• Monitor and discuss any problems arising from non-University ethics committee processes.

Functions

• To review and approve applications from the Faculty of Science, Engineering and Medicine (excluding Psychology) (BSREC) and in the Faculties of Arts and Social Sciences (including Psychology) (HSSREC) staff and students for studies that involve human participants, their data, or their tissue.
• Co-opt additional members whose particular expertise is required for certain proposals.
• Ensure that all researchers, whether staff or students, are aware that they must submit an application to carry out research and related activities with human participants to an appropriate research ethics committee.
• Oversee mechanisms in departments for reviewing student research not submitted for full committee ethical review and promoting good ethical conduct
• Report regularly to the University Research Governance and Ethics Committee.
• Deal with urgent applications arriving between meetings by Chair’s action, the Chair consulting with specialist expertise as required. Chair’s actions will always be submitted for ratification at the subsequent meeting of the Sub-Committee.

Conflicts of Interest

BSREC and HSSREC are committed to providing an independent research ethics opinion on all projects it reviews. In order to do this, it requires our dedicated Committee members and pool of close readers to undertake these reviews.

Close readers are advised that unless they are involved with, or are a co-applicant on the particular project that they have been asked to review, then there are no foreseen Conflicts of Interest. To ensure reviewers are allocated to projects with the relevant expertise, it is inevitable that close readers will be asked to review projects of their colleagues, or individuals they may have published papers with previously. BSREC and HSSREC do not declare this a conflict of interest unless the close reader feels they would be unable to provide an independent, objective review of the application.

Close readers will remain anonymous to the applicant and this information will not be disclosed by BSREC or HSSREC. Where a close reader feels they do have a conflict of interest, they must declare this to the BSREC/HSSREC Secretary and the review will be reallocated to another reviewer. Any conflicts arising from items on the Committee meeting agenda should also be declared at the beginning of any meeting.

Modus Operandi

• All papers and submissions to the Committee are to be kept confidential.
• A quorum of four members is required to act on behalf of the whole Committee, at least 3 of which should be academic members.

Register Interest- New members

If you are interested in becoming a BSREC or HSSREC close reader or a Committee member, please contact the BSREC/HSSREC Secretary: BSREC@warwick.ac.uk or HSSREC@warwick.ac.uk to discuss the role further. Training for new reviewers will be provided.

FAQs

I am collaborating on a project which has received ethical approval from another institution. Do I still need to obtain ethical approval from Warwick? I have recently taken up a position at Warwick and am continuing to work on a project which has ethical approval from my previous institution. Do I need to obtain further approval from Warwick? I have collected some data as part of an evaluation (e.g., of teaching practice). I now want to use this data as part of a research project. What should I do? I am about to carry out an evaluation (e.g., of teaching practice) and think that the results might be useful for a future research project. However, I’m not sure at this stage whether they will be useful or not. What should I do? What documents do I need to submit with my ethics application? I haven't developed my questionnaire/survey tools/interview questions yet - what do I do? Do I have to use the BSREC/HSSREC Participant Information Leaflet/Consent Form templates in my application? Does my Head of Department/Supervisor need to sign the application form? I am based in the Faculty of Science or Medicine, but my research is more social science/arts based, can I submit to HSSREC instead? /I am based in the Faculty of Social Sciences/Arts/Psychology but am conducting research related to medicine/engineering should I submit to BSREC instead? How much information do I need to provide in my application? Do participants need to sign a consent form for studies only involving questionnaires? My study involves online surveys that will be completed anonymously, can participants still withdraw? What is personal data? What is Pseudonymised data? What is anonymous data? Is it possible to anonymise images of faces? I am receiving data from another organisation to use in my research, who is best placed to anonymise that data? Do I need ethical approval to send research data to a third party? Which online survey tools do BSREC/HSSREC recommend using to distribute questionnaires in studies? Can I obtain consent from participants on an ‘opt-out’ basis? What are the best ways to receive electronic consent? An organisation supplying me with data for my study has asked me to sign a confidentiality agreement, should I sign it? My Study involves children, do I need to get consent from their parents as well as the children themselves? Do I have to provide details for participants to be able to make a complaint? Is it enough for me to state that I will comply with the Data Protection Legislation in the application? How long should research data be stored for? Can I pay participants for taking part in my study? Can I use social media to recruit to my study? Do posts on social media count as publicly available data? Do I need a date and version number on all study documents? What is best practice when collecting demographic data such as gender, age or ethnicity? Can I publish my service evaluation?

I am collaborating on a project which has received ethical approval from another institution. Do I still need to obtain ethical approval from Warwick?

If the University of Warwick is not the sole lead organisation for the research and another Higher Education institution (such as the lead or co-lead) has granted formal research ethics approval, it may not be necessary to also gain ethics approval from Warwick. However, BSREC/HSSREC will require a record of this external approval along with confirmation that Warwick's role in the project is covered by this. Please submit a copy of the ethics approval granted to bsrec@warwick.ac.uk or hssrec@warwick.ac.uk depending on which Faculty you are in, before the research commences (or your role in the research commences). The BSREC/HSSREC Secretary will advise as to whether further ethical review is required. Where Warwick is the lead institution, ethical review is expected to be conducted by Warwick.

I have recently taken up a position at Warwick and am continuing to work on a project which has ethical approval from my previous institution. Do I need to obtain further approval from Warwick?

As above, if a project already has ethical approval from a similar institution, Warwick would not seek to duplicate that approval. You may be able to contact your previous institution to see whether the approval can be carried over so that you can complete the project without having to duplicate ethical review. You would just need to send evidence of the existing approval to bsrec@warwick.ac.uk or hssrec@warwick.ac.uk depending on which Faculty you are in. However, you should consider how far into the project you are and how much work will be conducted under your role as a Warwick member of staff. For example, if you are one year into a five-year project, it would be advisable to gain ethical approval from Warwick.

I have collected some data as part of an evaluation (e.g., of teaching practice). I now want to use this data as part of a research project. What should I do?

If the data was collected for part of an evaluation, or another reason other than research purposes, and you now find that this data will be useful for a research project, you should submit a secondary data application to BSREC/HSSREC to be able to use the data for research. In most cases, this will be reviewed through the Light Touch route. Please consider what consent was gained to be able to use the data for research and how feasible it is to gain consent if this was not in place.

I am about to carry out an evaluation (e.g., of teaching practice) and think that the results might be useful for a future research project. However, I’m not sure at this stage whether they will be useful or not. What should I do?

If you are not sure at this stage, it will be difficult to complete an ethics application because detailed information about the project is required to be able to conduct ethical review. It may be best to conduct the evaluation, as you would do normally, but include a statement at the start of the evaluation asking students/participants to consent to their data being used for future research purposes, subject to ethical review. This way, if the data does prove useful, you can then submit a secondary data application for ethical review and will have consent in place to use the data for research purposes.

Along with a fully completed application form, you will need to submit any relevant supporting documents such as: Participant Information Leaflets, Consent Forms, questionnaires, interview schedules/topic guides, invitation emails, leaflets, posters, draft recruitment emails/social media posts, and any other participant-facing documents relevant to the project. Depending on the project, you may also need to provide a Risk Assessment, copies of local ethical approval (e.g., if the research is taking place in another country), evidence of any permissions required to carry out the study (e.g., if permission is required from a gatekeeper to access a certain set of participants). The Committee will need to review anything which will be presented to participants.

The Committee will need to see what is being presented to participants to be able to make an informed decision. If only desk-based work is required to be able to develop these materials, think about the timing of when you are applying for ethical review and whether you should submit your application when the project is more developed. However, if you need to conduct work with human participants to be able to develop materials (e.g., you will hold a focus group to develop a questionnaire), please explain this clearly within the application form and provide as much information as you are able to at this stage. Once the application has been approved, you can conduct the work to develop the next stage of materials, final versions of these can then be submitted as an amendment once they have been developed.

For interviews, draft versions of interview topic guides can be accepted as it is understood that interviews are often conversational and researchers will not stick rigorously to a script. However, the Committee will still need to see the kinds of topics that will be covered.

Do I have to use the BSREC/HSSREC Participant Information Leaflet/Consent Form templates in my application?

No, it is not mandatory to use the BSREC/HSSREC templates available, but it is strongly recommended that you refer to these for guidance on what to include in each document. There is also certain governance information in these templates which must be included, such as details of the Head of Research Governance for independent complaints, the DPO for data concerns and the University’s Research Privacy Notice.

While it will be useful to use the existing templates as a starting point, it is advised that you must keep your participants in mind when drafting any materials which they will be presented with. For example, is the language appropriate for their literacy levels? The Participants Information Leaflet(s) and Consent Forms should be written for your participants, not for the Committee.

For applicants who are members of staff, your Head of Department (or equivalent) will need to sign your application form. For student projects, only the Supervisor will need to sign the application form (no HoD signature is required for student projects). It is acceptable to type the HoD/Supervisor’s name in the signature box and cc. them into the email submitting the application to confirm their approval.

I am based in the Faculty of Science or Medicine, but my research is more social science/arts based, can I submit to HSSREC instead? /I am based in the Faculty of Social Sciences/Arts/Psychology but am conducting research related to medicine/engineering should I submit to BSREC instead?

No, Committee review is determined by the Faculty in which you are based, not by the type of research. Each Committee is comprised of members with various expertise, including SEM representation on HSSREC and Arts/Social Sciences representation on BSREC. However, if your project requires specialist knowledge, it may be considered by the other Committee at the discretion of the Chair/Secretariat.

The application needs to provide enough detail so that another researcher will understand exactly how the project will work, with particular focus on the aspect of the study involving human participants. The reviewers will be mainly interested in what you are doing with the human participants/their data/tissue and how any potential harms or risks are being mitigated against. The more detail provided will reduce the number of queries the committee may have about the project. This needs to be clear and written in a lay manner so that a non-specialist in the field can understand the study. Technical terms should be avoided where possible.

No, questionnaires are usually considered self-consenting so it is not necessary for participants to complete a separate consent form for you to keep. Instead, a statement should be included in the introduction to the survey to state that by completing the survey, participants are consenting for their data to be used in the study. An information leaflet should still be provided to explain what the study is about, and what will happen to the data etc., but this can be built into the introduction and doesn’t need to be a separate document. It should be clear to participants how they can withdraw from the study if they change their mind (e.g., by closing their browser). It should also be clear whether participants can withdraw their data after participating, which for anonymous surveys will often not be possible. Please see the template abridged PIL for guidance on what to include at the start of a questionnaire/survey.

My study involves online surveys that will be completed anonymously, can participants still withdraw?

Participants need to be aware that they can withdraw participation from a study at any time without giving a reason but it needs to be clear how they do this. For online surveys, participants can change their mind at any time by closing the browser. However, it must be made clear that once responses have been submitted, it will not be possible to withdraw data from the study as responses are anonymous and it will not be possible to identify individual responses.

Personal data refers to data which relate to a living individual who can be identified:

from those data, or

from those data and other information which is in the possession of, or is likely to come into the possession of, the data controller, and includes any expression of opinion about the individual and any indication of the intentions of the data controller or any other person in respect of the individual. Further guidance from the Information Commissioner’s Office can be found here.

Pseudonymised data means replacing any identifying characteristics of data with a value which does not allow the data subject to be directly identified. E.g., replacing the participant’s real name with a false name or participant number. The researcher or data controller will keep a key separately to the data which links the real name to the false name/number. This is different to anonymous data and only offers limited protection, as it still allows identification by an indirect means. It is therefore still classed as personal data and should follow the same guidance.

Anonymisation is the process of removing personally identifiable information from data sets so that an individual cannot be identified by the remaining data set. Simply redacting an individual’s name does not necessarily make the data anonymous. There is still a risk of indirect re-identification if the data set could be linked to a data subject by a combination of other data, e.g., age, postcode, medical condition, job title. The more information included in each data set, the greater the risk of identification when combined. Small data sets and specific characteristics e.g., ethnicity or gender may also increase the chance of identifying individuals. The Information Commissioner’s Office guidance on the principles of anonymising data can be found here.

Whilst blacking out eyes of photographs or digitally blurring images can distort features, it is entirely possible that a subject could still be identified by friends or family. Since complete anonymity of faces is almost impossible to achieve, informed consent should always be sought from participants. Applicants should be aware of promising anonymity where this may not be possible.

I am receiving data from another organisation to use in my research, who is best placed to anonymise that data?

Researchers should not be sent, or have access to any identifiable, personal data that is outside of their professional/clinical role, without the appropriate permissions in place e.g., consent from the organisation or Confidentiality Advisory Group approval (CAG) for large NHS patient datasets. The data should be anonymised by an individual at the organisation supplying the data, who has appropriate permissions to access this data, before this reaches the researcher or University. The terms of use for this data should be outlined in a Data Sharing Agreement provided by the organisation releasing the data. Researchers should contact R&IS for any agreements to be signed off by an appropriate individual on behalf of the University, and not by the researcher themselves.

Not necessarily. It would be the responsibility of the researcher receiving the data to check with their organisation on the ethical review requirements for secondary analysis of previously collected data. However, before any research data is sent to a third party, it is your responsibility to note the terms in which this data was originally collected. This relates to what purpose the data were originally collected for (i.e., was this limited to use for research purposes), the consent given for the data collection (i.e. was it specified that the data would not be shared with third parties) and in what format the data will be transferred (i.e. anonymised, identifiable). You do not need individual consent to share anonymous research data with a third party but you must make sure there is no chance any individuals can be identified from the data set. Please contact R&IS to discuss data sharing agreements before any data is transferred out of the University. To use research data for commercial purposes, please contact Warwick Ventures.

The University recommends using Qualtrics or Bristol Online Surveys to distribute online surveys/questionnaires. These tools have been approved by the University’s Information Governance team as secure for hosting data. Please note Survey Monkey is not currently a University-approved service.

Opt-out consent is permissible in certain projects where the participants are not considered vulnerable or the study is not investigating a sensitive/intrusive topic. The process must be clearly detailed in and justification for why this is considered appropriate should be provided.

There are multiple acceptable approaches to gaining electronic consent. This may be advisable when research is being conducted remotely and where there will be no opportunity for participants to physically sign consent forms. Recording verbal consent using an Information and Data Compliance (IDC) approved platform such as MS Teams is one option. Asking participants to print a consent form, sign it, scan it, and return it is another option. Using 'e-consent' signatures is another option. The HRA and MHRA have published useful guidance on this topic which can be accessed here.

An organisation supplying me with data for my study has asked me to sign a confidentiality agreement, should I sign it?

No, all research agreements/contracts should be signed off by an appropriate individual on behalf of the University, not the researcher or the supervisor. Please contact R&IS for guidance.

My Study involves children, do I need to get consent from their parents as well as the children themselves?

It depends on the age of the children, their competency and what you are asking them to do. Good practice is usually to obtain consent from the parents as well but this depends on the nature of the study. The approach taken should be appropriate, detailed and justified within the application. If you are working with schools, they may have their own guidance and practices which are recommended. You should make in clear within the application that you have discussed this with the school/provider and are following their recommendation. The MRC/ESRC provides further guidance on this.

Yes, the current contact for complaints is the Head of Research Governance/Deputy Director of Research & Impact Services. Contact details can be found in the template Participant Information Leaflet.

Is it enough for me to state that I will comply with the Data Protection Legislation in the application?

No, the application needs to detail exactly how you will ensure compliance with the data protection regulations/principles and how you will mitigate any risk of accidental disclosure of data, especially where this is personal or special category data. The application form asks specific questions about this, which should be answered in full.

University policy is that research data should be reviewed after 10 years to see if the data needs to be retained or can be deleted. This applies to research data which would be necessary to back up publications resulting from the data if the published results were challenged. Similarly, consent forms should be retained for this period of time in case of a challenge. Consent forms should be stored separately to research data.

For student projects or projects where the results will not be published, research data can be deleted as soon as it is no longer required. This will often be after the student has completed their course and the final grade is given.

Please note that research data is separate from personal data collected to run the study (e.g., names and contact details of participants to arrange interviews). Personal data should be deleted as soon as it is no longer required.

Yes, a small token as a ‘thank you’ can be offered to research participants but this must be appropriate and proportionate to the amount of time/level of involvement required from the participant in the study. Payments must not be excessive so that they could be seen as a bribe or to coerce people into taking part in a study. In some cases cash rewards can be appropriate and preferable (e.g., giving participants autonomy over how to spend their reward - cultural circumstances and customs should also be taken into account). In other cases, vouchers may be more appropriate as a small token of thanks for taking part. Researchers should give consideration to which vouchers are most appropriate for their participants. Please see the University's current procurement contract which recommends Love2Shop Vouchers which can be spent in a number of outlets. The chance to be included in a prize draw is also another common incentive used in research although researchers should be as transparent as possible about participants' chances of winning. See further guidance from the Heath Research Authority.

Please note that researchers should not pay participants using their own money. If a project is not funded, and the researcher does not have a spending allowance to cover the cost, the researcher's department should be contacted in the first instance to see if funding can be provided to cover any payments to participants.

Social media can be used as a method of recruitment but consideration should be given to whose account will be used to advertise the study, how this will be done, and where the advertisement will be placed. Using personal accounts should be avoided where possible. The advertisement text used will need to be reviewed by BSREC/HSSREC. Permissions must be sought from the administrator of any specific groups targeted, before posting any recruitment materials.

Further information on the use of social media in research can be found here.

No, quotes and opinions posted on social media do not always count as publicly available data, and in many cases should not be used for research purposes without permission/consent from the individual, regardless of privacy settings. Studies gathering information this way must also be subject to ethical review.

Further information on the use of social media in research can be found here.

Yes, this is for audit purposes, and so it is easy to keep track of documents should amendments be required to the study as it progresses. It also makes sure that the study team are using the correct and latest version of information leaflets and consent forms.

You should first consider whether it is necessary to collect this personal data. If it is not required for your research, in keeping with the principle of data minimisation, it would be best practice to not collect it. However, if this is required information you should allow a free text response where possible. Further guidance can be found here.

Yes, while a Service Evaluation is distinct from a “research activity”, it can be beneficial and even recommended to publish your findings. Published outputs need to be appropriately contextualised and described, and it is important that service evaluation activity is not misrepresented as research. While research activity seeks to derive new and generalisable knowledge, the goals of a service evaluation are more narrow, and this should be clearly communicated in any publications.

Director

Dr. Navdeep Bains
Director of Research & Impact Services

Please contact Karen Julian,
Departmental Administrative Officer & PA to the Director
Tel: (024) 765 24760
Email: Karen dot Julian at warwick dot ac dot uk

Contact Us

Research & Impact Services
University House
University of Warwick
Coventry
CV4 8UW
Tel: (024) 765 75732
R&IS Staff