Research Ethics

You will need ethics approval from FSTREC if you are an academic researcher or MPhil/PhD student and your research involves any of the following:

• Human participants (including all types of interviews, questionnaires, focus groups, records relating to humans, use of online datasets or other secondary data, observation etc.)*
• 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
• The threat to the environment
• Conflict of interest
• Research or a funding source that could be considered controversial
• Animals**
• any other ethical considerations

* If your research involves NHS staff or patients please see the University Sponsorship webpages and the 'NHS Research' section below before beginning your application.

**Animals: If your research involves animals you will need to gain approval for your project via the Animal Welfare and Ethical Review Body (AWERB). Please see the Animal Welfare and Ethical Review Body webpages and contact the secretary to AWERB, Lucy Sanderson for further details.

For undergraduate and Master's ethics approval, please speak with your supervisor who will be able to advise you on your departmental processes. Undergraduate and Master's ethics are not processed by FSTREC.

If your research involves NHS patients or material from NHS patients (e.g. blood or tissue samples, etc.) an application to the NHS REC (Research Ethics Committee) and LU Sponsorship office needs to be completed and submitted. More information for research in conjunction with the NHS can be found on the NHS sponsorship webpage. Do not fill in an application form in REAMS.

If your project is being carried out via the NHS you should use the Research Decision Tool to determine whether your project is classed as research for the NHS’s purposes, and the Ethics Decision Tool to determine if you need NHS REC approval.

If you are working with NHS staff members as participants in the study, then an application should be sent to the FHM REC in the first instance, prior to being submitted to the Health Research Authority (HRA). In order to do this, please see the guidance on the REAMS webpage under 'NHS Research and REAMS'. If you are unclear if you need HRA approval, please ask the lead R&D office of the Trust you are working with for their advice. The FHM REC may ask for a letter from your Trust or hospice, etc. to confirm that HRA approval is not needed.

If you are working with patient material you will need to follow the human tissue act guidance. The HTA covers the storage of research material. Within Lancaster University you need to inform your local Biological safety committee and follow their processes for logging and storing material.

For questions about the Sponsorship application process, please see the Sponsorship webpage or contact Rebecca Anderson (Clinical Research Governance Officer).

The goal of ethics review is to enable research that protects the safety and wellbeing of participants, researchers, and anyone else involved in the research. Lancaster University has an excellent reputation for research with proven impact, and by ensuring research is conducted in an ethical way, we can continue to be world leaders and strengthen our research community.

The Committee assess your project on its ethics, not methodology, though there is occasional crossover (e.g. how data is stored is both a methodological and ethical concern).

Find out more about research ethics at Lancaster.

IMPORTANT: Having ethics approval ensures your study has been reviewed and approved by the University. Proceeding with your research without full, valid ethics approval, or altering your research project without going through our amendments process, constitutes research misconduct. This can have serious consequences for your studies/research and beyond. Please see our pages on research misconduct for more information.

This information is applicable to new applications only. For amendments to previously approved studies, please see the Amendments section below.

All ethics applications are now made through the Research Ethics Application Management System (REAMS)*. REAMS is a dynamic system that generates its questions based on the information you provide, so you will only submit information that is directly relevant to your application.

You can watch our short video guide on how to get started in REAMS. We also have a user guide, and suggest that you use this to support you through your first couple of applications.

Once you have submitted your application, it will be allocated to a reviewer. The reviewer will send your application back to you with any changes requested. You will then make these changes and return the application to the reviewer for re-review. This may be repeated several times until the reviewer is happy with your application. It will then be recommended to the Chair for approval. The Chair may have further comments, which you will be alerted to in the same way as your reviewer comments.

If your application is particularly complex or has significant ethical considerations, it may be nominated for review at the next REC meeting (please see the Calendar tab below for when these are scheduled). This may form part of the review process and you could be invited to discuss your application with the Committee, or it may happen after your application has been approved as a case study for the REC.

Once your application has been approved, you will receive an email confirming this. Research activity cannot commence or continue until and unless you have received this email. Conducting research without receiving written confirmation of approval constitutes research misconduct and may have serious consequences. Please see our research misconduct pages for further details.

If you have any questions about the process or where your application is up to, please contact your Faculty Research Ethics Officer.

*If you have an amendment for an application approved prior to REAMS, please see the Amendments section below.

If you have already received ethical approval from a Research Ethics Committee (known as a REC or IRB, Institutional Review Board) from another university/institution in UK or abroad covering your planned study, your application can be processed via a ‘light touch review’ in REAMS. You indicate this by selecting ‘Yes, I have already received ethical approval from an external institution’ on the relevant question on the first page of the REAMS application. You will then be prompted to upload the relevant documents into REAMS for review by the Chair.

To meet this criterion, your approval must be from an ethical perspective and not simply logistical. If your approval is to use a research site only (e.g. you have approval to conduct a research project in a school from a school official, or you have been given permission to access participants via a healthcare setting), whether it is in the UK or abroad, this does not constitute ethical approval.

The more information you can provide, the better are your chances of a speedy approval. Externally approved ethics applications are usually fast-tracked through the Faculty’s ethics process, and are reviewed by the Chair of your Faculty Research Ethics Committee.

Please contact your Faculty Research Ethics Officer if you need any further information. 

This information is applicable to new applications only. For amendments to previously approved studies, please see the Amendments section below.

In addition to completing your REAMS application, you may need any supporting documents, such as (but not limited to):

• Advertising materials (posters, e-mails)
• Letters of invitation to participate
• Participant information sheets
• Consent Forms
• Questionnaires, surveys, demographic sheets
• Interview schedules, interview question guides, focus group scripts
• Debriefing sheets, resource lists

We have templates available in the Documentation tab below if you are unsure how these documents should look. All supporting documents will be fully reviewed as part of your application.

Please note the following:

• Your participant information sheet (PIS) must include the Lancaster University GDPR statement as shown in the template. If this is not present, you will be asked to include it. Please see the Lancaster University GDPR guidance and the Lancaster University Research Data Management Guidance for more details.
• Please also consider accessibility and who you are planning to include in your participant group(s). Some participant groups, such as children, those with English as a second or other language, those with a learning disability, dyslexia, or those with accessibility concerns, may need participant-facing materials modifying in order to effectively communicate the information. This could include simplified language, translated documents, larger text and/or accessible fonts, and/or pictorial representations of concepts such as Makaton. If using multiple versions of participant-facing documents, please upload all versions.

It is entirely your responsibility as the applicant to submit applications in good time so that any data collection can start as planned and only after ethics approval has been obtained. Conducting research without full ethical approval is considered research misconduct and will be investigated by the university.

New applications:

Please allow at least six weeks, but ideally eight, for new applications to receive a full review. This is to ensure that reviewers – who review applications around their own research and teaching workloads – have enough time to give your application the attention it deserves. Complex applications may take longer and should be submitted as soon as possible in order to allow adequate processing time.

Applications that have already received approval from an external institution (e.g. NHS REC, another university if they are leading on the project):

These can go straight to the Chair. Please allow two weeks for review.

Amendments, secondary data analysis:

These can go straight to the Chair. Please allow two weeks for review.

During busy teaching periods and University holidays, you may find the process takes longer. If you have concerns about the timeline of your application, please contact your Faculty Research Ethics Officer.

Projects involving social media and participants recruited or identified through the internet require ethics review (following ESRC and other guidelines). This is particularly important if the understanding of privacy in these settings is contentious or where sensitive issues are discussed, and where quotes and visual images the researcher intends to use may be identifiable. For example, as part of your study, you may be using data from an online source that is publicly available. However, this does not mean that the participants/members of this source also perceive it to be public. For more advice on the ethics of internet research, see the Association of Internet Researchers website.

Any study involving online interviews, online ethnography or any other use of data from private or semi-private internet sources is considered to involve contact with human participants and therefore needs a full ethics review. Please read the Guidance on using social media for research and Social Media Guidance for Researchers for important information to consider when designing your research and before you apply for ethical approval.

Please see the document Amendment Guidance for Research Ethics Application Management System (REAMS) for guidance on how to submit an amendment to a previously approved application in REAMS.

For questions about the logistics of the application process, or ethical issues and application content, please contact the FSTREC Research Ethics Officer.

For applications that require both HRA approval and FREC approval, please see the guidance on the REAMS webpage under 'NHS Research and REAMS'.

• Your reviewer may not necessarily be from your subject area or department. Keep language free from jargon and explain all acronyms used.
• Be specific. You may feel like you are repeating yourself or over-explaining, but it is much better to put in too much information than too little.
• Build ethics into your study design, rather than shoehorning ethics in as an afterthought. Good research practice is to keep your participants or research subjects in mind at each stage and consider the short- and long-term consequences of participation.
• Centre the participants’ safety and wellbeing at the heart of your study. Consider what they are contributing to the study beyond their data: are they being appropriately compensated for their time? Have you got a distress protocol in place, if needed? Is there an appropriate debrief and have the withdrawal terms been clearly stated?