Frequently asked questions

Answers to popular questions about research ethics applications.

General FAQs

This is my first application for ethical approval – where do I start?

For general information on when you need to apply for ethical approval, who to contact, and how to prepare an application, members of staff should contact your Faculty Research Ethics Committee (FREC) Chair or Secretary.

Students should refer to the students research FAQs.

If you are not a member of a Faculty (for example, you work in a UWE Bristol Professional Service), please contact Leigh Taylor (FREC Officer) at researchethics@uwe.ac.uk.

Under what circumstances do I need to apply for ethical approval for my research?

All research involving human participants, their tissue and/or data must be subject to research ethics scrutiny by the University's Research Ethics Sub-Committee (RESC) or one of its Faculty Research Ethics Committees (FRECs).

If your research falls within the scope of the Health Research Authority's UK Policy Framework for Health and Social Care Research, there are special requirements relating to Ethics (see guidance) and NHS Research FAQs.

How long will my application take?

You are advised to prepare research ethics applications early as, depending on the time of year and availability of Committee members, the processes and procedures of scrutiny can take up to six weeks to complete. An application through the NHS Research Ethics Committee system may take longer than this.

What is meant by 'informed consent'?

Informed consent is an ethical requirement of the research process. Potential research participants should be given sufficient information about a study, in a format they understand, to enable them to exercise their right to make an informed decision whether or not to participate in a research study. View guidance on consent forms (DOC).

What is the difference between passive and active consent?

Active consent requires a research study participant (or their representative, e.g. a parent in the case of research on minors) to sign and return a form agreeing to participate in the research. Under passive consent, information and a consent form are provided and the ‘participant’ (or their representative) must actively refuse to participate in the research.

The lack of an objection is deemed to be consent. Put simply, if you don’t say 'no', it means that you are saying 'yes'! This is considered by some to be ethically questionable.

What do I need to include on a Participant Information Sheet?

A Participant Information Sheet should give potential recruits to a research study sufficient information to make a decision as to whether or not they wish to take part in the research. It should be written in language that could easily be understood by any person. View guidance on preparing a Participant Information Sheet (DOC).

I am working with human tissue - do I need to get ethical approval for my research?

All research using human tissue requires ethical approval. Human tissue is defined as material that has come from a human body and consists of, or includes, human cells. View policies and procedures for human tissue research.

Do I need to encrypt my research data?

If you are dealing with personal data or sensitive personal data (SPD) and there is a need to store the data or transfer it outside of the UWE Bristol secure servers, then encryption must be used. See the guidance on data protection on the staff intranet (UWE Bristol log in required) and Data Protection Protocol 4 - Encryption (PDF).

Do I need ethics approval if I am collecting data via the internet?

If your research involves human participation, then it must be subjected to research ethics scrutiny by the RESC or one of the FRECs in the same way as research by interview or questionnaire. Further guidance can be found at UK Data Archive.

Do I need to get ethical approval before I submit my bid for funding?

Before applying for a research grant, you should always check the terms and conditions applied by research funders. Some require ethical approval prior to application; most make ethical approval a condition of the award once offered.

How do I complete the ethics section on my EU proposal?

All proposals received by the Commission must describe the ethical, safety and socio-economic issues raised by the research proposed and how they will be addressed. The EU provides guidance on ethical review.

Who needs a DBS check?

The aim of the Disclosure and Barring Service (DBS) is to help protect children and vulnerable adults to support organisations recruiting people into positions of trust.

Students undertaking research as part of their programme of study/research students whose work involves one-to-one or other unsupervised contact with children or vulnerable adults will usually need to be DBS checked.

If you require a DBS check, please contact a colleague from the Graduate School:
Vicky Nash - Victoria.Nash@uwe.ac.uk
Marisa Downham - Marisa.Downham@uwe.ac.uk

Staff undertaking research work which involves one-to-one or other unsupervised contact with children or vulnerable adults will usually be checked. The need for a check should be identified by the researcher and manager on the basis of the nature of the activity involved. However, Research Ethics Committees may make recommendations regarding DBS checks for projects they review, in line with the University's policy. Members of staff requiring DBS checks should contact HR at HR@uwe.ac.uk.

Student Research FAQs

Do I need research ethics approval to conduct interviews, observations or focus groups as part of my module?

All research projects involving human participants that have specified research questions, use a recognised research methods and methodology and form part of an assessment require research ethics review (see below).

Please see the guidelines on ethical review of evaluation studies and evaluation research (PDF) for the requirements for ethical review of evaluation projects.

Does a research project using questionnaires in an online survey require research ethics review?

Yes, research projects involving human participants includes the use of data collection methods which are not face-to-face such as online surveys and postal surveys (see below).

If I am using secondary data, anonymised data that has previously been collected, do I need research ethics approval?

No, only where secondary datasets contain personal, identifiable data would you need to obtain research ethics approval for its use in a research project.

I am an undergraduate doing a dissertation – do I need to complete the Faculty Research Ethics application form?

You will need to provide your supervisor with information about your research project in accordance with module requirements. Your supervisor will then assess whether your project is ‘low risk’ or not.

If the project raises no significant ethical issues and is considered 'low risk', your supervisor can approve it and you will not need to submit an application to the Faculty Research Ethics Committee (FREC).

If your supervisor decides that the project should be reviewed by FREC, then you will need to complete a full ethics application form and submit it to FREC.

If your research involves staff, patients or NHS premises, see NHS related items below.

I am a Masters level student doing a dissertation – do I need to complete the Faculty Research Ethics Application form?

You will need to provide your supervisor with information about your research project in accordance with module requirements. Your supervisor will then assess whether your project is ‘low risk’ or not.

If the project raises no significant ethical issues and is considered ‘low risk’, your supervisor can approve it and you will not need to submit an application to the Faculty Research Ethics Committee (FREC).

If your supervisor decides that the project should be reviewed by FREC, then you will need to complete a full ethics application form and submit it to FREC.

If your research involves staff, patients or NHS premises, please see below.

I am a PhD/Professional Doctoral student– do I need to complete the Faculty Research Ethics Committee Application form?

Yes, if your research involves human participants, you will need to complete a full application to the Faculty Research Ethics Committee (FREC) so that your research project can be independently reviewed and approved. If your research involves staff, patients or NHS premises, please see below.

My research project involves patients in the NHS, how do I get ethics approval?

You will need to apply to an NHS Research Ethics Committee for approval via the online Integrated Research Application System (IRAS). You will also need NHS Research and Development approval for your project from the hospital trusts where your project will take place.

Additionally, you must advise the FREC Officer, Leigh Taylor at leigh.taylor@uwe.ac.uk, that you will be applying for NHS REC approval using the Health Research Authority and IRAS. Your IRAS application will need authorisation from the Chair of Faculty Research Ethics Committee and Associate Dean for Research before you submit it.

My research project involves staff in the NHS (or NHS data/premises), how do I get ethics approval?

Since your research involves human participants, you will need research ethics approval. Your supervisor will assess whether your project is ‘low risk’ or not.

If the project raises no significant ethical issues and is considered ‘low risk’, your supervisor can approve it and you will not need to submit an application to the Faculty Research Ethics Committee (FREC). If your supervisor decides that the project should be reviewed by FREC, then you will need to complete a full ethics application form and submit it to FREC.

As your project involves NHS staff, you will also need NHS Research and Development approval and will need to contact the relevant Research and Development Office and apply for Research and Development approval via the IRAS.

Your IRAS application will need authorisation from the Chair of Faculty Research Ethics Committee and Associate Dean for research before you submit it.

Where can I get advice on ethical review of my research?

Your supervisor can advise you on ethical issues relating to your research. They can help you complete an application to the FREC or to an NHS REC using IRAS. The FREC application form can be found on the applying for approval ethics page. Details of how to apply for NHS REC approval or NHS Research and Development approval can be found on the IRAS web pages. There is also an IRAS helpline.

Why does my research need ethical review and approval?

The primary purpose of research ethics review is to protect human participants who take part in research.

My research project involves using human tissue - how do I get approval for this?

Research using human tissue is strictly regulated and there are separate University guidelines on this type of research which you need to understand and familiarise yourself with. These guidelines can be found on the Health and Social Care research page. Your supervisor can advise on this type of research and what kind of ethics approval is needed.

NHS Research FAQs

I'm planning to conduct my research in the NHS. How do I get ethical approval?

If your project is research and involves NHS patients, service users, organs, tissue, data or other bodily material, the requirements of the Department of Health Governance Arrangements for Research Ethics Committees (GAFREC) will apply. For specific details of the scope of NHS REC review, see the governance arrangements for research ethics committees.

Not all projects undertaken within the NHS are research. The HRA has two useful decision tools on its web pages to help you to determine whether your project is research and whether it needs NHS REC approval. See Is my study research? and Do I need NHS REC approval? You are advised to seek guidance from the NHS Trust Research and Development Office if, having considered the published guidance, you are unsure whether your project should be classified as research.

What ethical and other arrangements must be put in place for the use of NHS patient data by UWE Bristol researchers?

For all UWE Bristol research, undertaken either by staff or by students:

  • to use identifiable NHS patient data NHS REC approval is required
  • collect the minimum personally-identifiable information needed for the purposes of the research project.
  • consent must in all cases be obtained from participants before their identifiable data can be accessed by researchers
  • someone from the direct care team must contact participants and ask if they can pass their contact details on to the researcher who can them arrange consent and, if given, access or be given access to the patient’s data.
  • even if employed by the NHS, with access to patient data, a UWE Bristol researcher (unless part of the patient’s direct care team) should not access patient records until this consent to contact them has been obtained by a member of their direct care team.

How do I apply for NHS REC approval?

You will need to complete the IRAS (Integrated Research Application System) form. Before you begin your application, you must contact Leigh Taylor at researchethics@uwe.ac.uk.

Students requiring NHS REC approval must discuss this with their supervisor.

What is IRAS (Integrated Research Application System)?

IRAS is the Integrated Research Application System. It is a single system for applying for the permissions and approvals for health and social care and community care research in the UK. IRAS FAQs are available on the IRAS help pages.

Do I need the NHS Trust Research and Development approval?

If your research involves undertaking the research on the premises of an NHS organisation, with NHS patients or with NHS staff, then you should contact the local NHS Trust Research and Development office (see NHS/HSC Research and Development review or permission) as you will need permission from the relevant NHS Trust Research and Development office before access to these are approved.

Note: You will need to obtain FREC ethics approval for your research in addition to this permission.

What is a Research Passport and how do I apply for one?

The Research Passport is a mechanism for pre-engagement information about a researcher to be shared with relevant NHS organisations in which the applicant intends to conduct research. It includes an occupational health assessment, employment/student screening and DBS check.

Human Resources deal with Research Passport applications for all members of staff, contact hr@uwe.ac.uk. Student applications for all faculties are handled by Leigh Taylor at leigh.taylor@uwe.ac.uk.

Please note: If you are a PhD student and also a member of staff (i.e. you have a contract of employment with UWE Bristol), your Research Passport application will be handled by Human Resources. All other PhD students, e.g. those who are self-funded, bursary-funded or sponsored by an employer, should contact Leigh Taylor at leigh.taylor@uwe.ac.uk who will deal with your Research Passport application.

My research participants include vulnerable adults. What ethical approval do I need?

Under the Mental Capacity Act 2005, social care research, for example involving people lacking capacity in England and Wales, requires approval from the National Social Care REC or NHS REC.

The Research Ethics Service has flagged a number of NHS RECs in England and Wales to review new applications for approval under the Mental Capacity Act (MCA). Members of these RECs have had additional training in issues relating to the MCA

Applications should be booked with the Central Booking Service so they can be allocated to an appropriate REC.

The application form, available via the IRAS, incorporates specific questions about compliance with the Act in Part B Section 6 of the form.

Does the Mental Capacity Act apply only to research ‘in or with’ the NHS?

The Act applies to any intrusive research within England and Wales, wherever it takes place, except for clinical trials of investigational medicinal products. This may include research in health, social care, criminal justice and many other settings. It is not limited to research undertaken within NHS organisations or other public bodies.

Do projects that are not classified as research require approval under the Mental Capacity Act?

No. The provisions of Sections 30-34 of the Act apply only to studies that are designed and presented as research. It is the responsibility of the researchers’ employers or sponsors/funders to determine whether a project should be presented as research.

What is a research sponsor?

The Research Sponsor takes ultimate responsibility for the conduct and integrity of the research, ensuring that research projects have adequate indemnity/insurance arrangements, are registered, are approved by the appropriate bodies and are subsequently monitored.

Who acts as a research sponsor?

UWE Bristol will normally act as research sponsor for research conducted by its staff and students. However, there are circumstances when this may not automatically apply – see research sponsorship guidance (PDF).