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 Taught Master's ethics approval, please speak with your supervisor who will be able to advise you on your departmental processes. Undergraduate and Taught 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. 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 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 assesses your project on its ethics, not methodology, though there is an 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 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 applies 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.

FINAL NOTE: The length of time required for each ethics application review is related to the complexity of ethical issues raised by your planned research. Additionally, it depends on the quality of your ethics application and the speed at which you are able to respond to requests for revisions or clarification from the reviewers/ethics committee. Please note that these times might be exceeded during periods of high demand and staff absences, particularly around University closure periods (Christmas and Easter). Due to limited staff availability, applications submitted in August will take longer to process.

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 Social Media Guidance for Researchers for important information to consider when designing your research and before you apply for ethical approval.

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?

Thematic applications (sometimes called thematic programmes) are broader than standard ethics applications and seek approval for a definable programme of closely related research activities. Procedures and ethical safeguards are described up front, but specific experimental treatments/conditions and sampling processes may not yet be known at the time of application. Thematic applications are most useful when each study is a minor variation on a common design and when the ethical considerations are tightly controlled. This route reduces paperwork and speeds up approvals: you submit one REAMS application to define the overall “envelope” (methods, participants, data and security) and then add each discrete study via a simple Amendment with the study-specific participant-facing documents. If any future study would sit outside this thematic framework, a new full REAMS application may be required.

1. Eligibility and scope

Use the thematic programme route when you plan several closely related studies that share the same participant population, methods, and data-handling. Thematic applications are broader than standard applications and are intended for definable programmes of work in which procedures and ethical safeguards can be clearly described, even if specific experimental treatments/conditions and sampling details are not fully known in advance. This route is not suitable for projects that may involve substantial changes in risk profile (e.g., moving from adults to under-18s, introducing deception or intrusive procedures, or starting to collect special category data) unless those elements are included in the initial envelope. The suitability of a thematic application is considered on a case-by-case basis; it is most appropriate for long-term projects where ethical considerations are clearly defined and tightly controlled, even if individual treatments or samples vary within that framework.

2. Preparing your initial REAMS application (the umbrella)

2.1 In the Project Title field, insert “THEMATIC” followed by your project title (for example: “THEMATIC – AI detection mini-studies”).

2.2 Set a generous risk/method envelope using the form’s checkboxes. Select “Yes” for any option that any study might need over the life of the programme (e.g., Human Participants; data relating to humans; online sources; audio/video; use of gatekeepers; encryption of portable devices). Where asked about encryption, confirm compliance with ISS standards.

2.3 Participant numbers: provide a programme-level range (minimum and maximum expected across all studies).

2.4 Participant Information: describe programme-wide personal data collected, storage, retention and deletion plans. If any study will deviate, you will explain those study-specific details in the Study Summary Paragraph for that Amendment and in the participant-facing information for that study.

2.5 Programme statement in free text: in response to the question “Are there any other ethical issues?”, answer “Yes” and paste the programme statement provided in Appendix A. Briefly explain why this project is suitable for a thematic review.

2.6 Uploads: under Project Documentation, upload master participant-facing templates (Participant Information Sheet, Consent Form, Debrief, and advertising templates). Ensure your files are clear, accessible and ready to be adapted for each study.

2.7 Declaration: complete the standard declarations and confirm that you will submit an Amendment if anything changes.

3. Adding each new study (via Amendment)

3.1 Create a REAMS Amendment on the approved programme record and title it “Add Study N: <Short Study Title>”.

3.2 Upload study-specific participant-facing materials for Study N only (PIS, Consent, Debrief, any adverts). When revising documents, highlight changes so the reviewer can see what has changed.

3.3 In the same free-text box used for the programme statement (the “other ethical issues” question), append a one-paragraph “Study N summary (Thematic programme)” (see Appendix A). Keep this summary brief (around 150 words) and focus only on what is specific to this study. Avoid repeating information that is already covered in the main thematic application or in the participant-facing materials. Confirm explicitly that the study remains within the programme envelope and that no risk-related answers in the form need to change.

3.4 Do not change checkboxes or other risk-relevant answers when adding a new study. If a new study would require a change to any of those answers, it falls outside the existing envelope and you must submit an Amendment to this thematic REAMS application for review and approval before implementation. The Chair or Committee may advise that a new full REAMS application is more appropriate if the change is substantial

3.5 The Amendment will be reviewed for Chair sign-off when it remains clearly within the agreed envelope.

4. What counts as “within the envelope”

Typically within the envelope: per-study sample sizes (within your programme maximum), minor recruitment source changes (e.g., university panels vs. online panels), scheduling/site details, and study-specific scripts or questionnaires. Audio/video recording is acceptable per study if it was included in the original envelope and the associated security measures (e.g., encryption) are followed.

Outside the envelope (requires at least an Amendment and possibly a new application): introducing under-18s or other vulnerable groups when not covered; adding deception or covert observation; introducing intrusive procedures or human tissue; collecting special category data or identifiable data when not covered; starting audio/video recording or using non-encrypted devices when these were not approved; or exceeding the programme-level maximum participant number.

5. Common pitfalls to avoid

• Under-specifying the envelope (e.g., excluding audio/video and later needing it).
• Forgetting to increase the maximum participant number to cover all planned studies.
• Introducing a new risk factor (e.g., vulnerable groups or deception) without submitting a new full application.
• Making substantive changes to participant-facing documents without clearly highlighting the changes.

Appendix: Text snippets to paste in REAMS

These are to be pasted into the application within REAMS, in the free-text box that appears in response to the question “Are there any other ethical issues?”, answer “Yes”:

1. Thematic programme statement:

THEMATIC PROGRAMME (within REAMS)

This application defines the permitted methods, participant groups and data-handling practices for a set of closely related studies. Each discrete study will be added later by Amendment as Study 1, Study 2, etc., with the Programme Register updated and participant-facing materials uploaded for the specific study. No risk-relevant answers in the form will change across studies. If a future study would fall outside this envelope, a new full REAMS application will be submitted.

1. Study summary paragraph:

Study N summary (Thematic programme): <Short study title>. Aim: <one sentence>. Participants: <number/age/source>. Methods: <e.g., online survey/interview; any audio/video>. Consent: <written/e-consent; no deception>. Risks & mitigations: <brief>. Data: <identifiers/special category?>; storage/retention: <brief>. This study remains within the programme envelope; only participant-facing materials are added/updated.