Research Ethics
The FHM Research Ethics Committee (FHMREC) oversees ethical review of proposed research that is not reviewed through research ethics mechanisms outside the University, such as the NHS Research Ethics Service.
A new Research Ethics Application Management System (REAMS) launched on the 1st of November 2021. Please see below for more information.
A research project being conducted by FHM staff and/or postgraduate students should be submitted to the FHMREC for ethical review if it involves human participants (including secondary analysis of data gathered from humans) or other possible ethical risk factors, and is not being reviewed externally.
The aim of the committee is to ensure that ethical considerations and issues are addressed in the conduct of research. The committee seeks to support and encourage the process of ethically conducted research in FHM. The committee structure includes members from all of the FHM divisions providing diversity in perspectives and speciality knowledge (see "committee membership" for members' expertise).
Note: During the summer months, it can take longer to review applications due to staff leave and other commitments. Therefore please help us to help you and allow extra time for your application to be fully processed and reviewed in summer.
Faculty of Health & Medicine Research Ethics Information accordion
You will need ethics approval from FHMREC 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 MA 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 FHMREC.
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 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 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. All applications submitted to FHMREC that require ethical review are heard at a REC meeting, which are held once a month throughout the year (details can be found on the Committee calendar below). The reviewer will review your application and present it at the REC meeting. You may be invited to attend the meeting if the reviewer and/or Committee feel they would benefit from discussing your application with you.
Once the Committee has discussed your application and agreed on the feedback, 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.
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
Doctorate in Clinical Psychology: You will be required to write both a thesis proposal and a research protocol as part of your course. These documents should both be included in your REAMS application. Please make sure the information in your application is congruent with the information in your proposal and protocol, and update them both accordingly if any part of your research project changes.
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 FHMREC 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?
Tab Content: Committee membership
Chair
- Professor Laura Machin: Qualitative research methods; research on sensitive topics; recruitment of hard-to-access populations; elite interviewing; NHS ethical approval processes
Deputy Chair
- TBC
Committee members
Biomedical and Life Sciences
- Dr Allyson Clelland: Quantitative research methods; use of embryonic/fetal material; EDI and inclusion experience; using surveys
- Dr Muhammad Munir: Quantitative research methods, the ethical aspect of working with experimental animals, research requiring ethics approval with reference to infectious diseases
- Dr Rachael Rigby: Quantitative research methods, ethical aspects of working with experimental animals, ethical aspects of working with human tissue, research requiring NHS ethics approval
- Dr Amy Saunders: Quantitative research methods, ethical aspects of working with experimental animals, ethical aspects of working with human tissue, research requiring NHS ethics approval, research conducted under the Human Tissue Act.
Division of Health Research
- Dr Maddy French: [on leave for 2023-24] Mixed methods researcher; case study methodology; research into palliative and end-of-life care, social deprivation, and inequities
- Dr Andrew Harding: Qualitative research methods; case studies; gerontology/ageing; dementia; information-giving
- Dr Abigail Morris: Mixed methods research; intervention development and evaluation; research on sedentary behaviour and physical activity; research in workplace health and wellbeing
- Professor Ceu Mateus: Quantitative research methods, health economics, research requiring NHS ethics approval
- Dr Heather Robinson: Ethical considerations in relation to research involving people with serious mental illness (SMI) and/or carers of people with SMI; online data collection; quantitative research methods; randomised controlled clinical trials
- Dr Yakubu Salifu: Qualitative research; individual/dyad/focus group interviews; thematic analysis; health research in resource-limited context, research in palliative and end-of-life care
- Dr Luis Filipe: Quantitative methods researcher, health economics, research on hospital efficiency, ageing, resource allocation, people’s preferences for health services/policies, education/health trade-offs, and general policy analysis
Doctorate in Clinical Psychology
- Dr Katy Bourne: Lecturer in Clinical Psychology
- Dr Sarah Parry: Qualitative and participatory methods; children's mental health; unusual sensory experiences; early-onset psychosis
- Dr Buket Kara: Mixed methods research, mental health, resilience, child development, adolescent development, health inequalities, interventions, cross sectional studies, longitudinal studies
- Dr Daniela Di Basilio: Mixed-methods research, qualitative methods, cross-sectional studies, use of digital health to support people with long-term conditions, severe mental health conditions.
Lancaster Medical School
- Dr John Appleby Research ethics; reproductive ethics, medical innovation; research involving children
- Dr Jemma Kerns: Laboratory based studies involving human tissue (with the NHS), ethical aspects of working with human participants, medical devices.
- Dr Keira Markey:
- Dr Anastasia Ushakova: Quantitative methods; research using NHS routinely collected data; longitudinal studies; big observational datasets; NHS ethics; mixed methods research
- Dr Paul Hendrickes: Quantitative methods, ethical aspects of working with human tissue, ethical aspects of working with experimental animals, exercise research in humans
Postgraduate representatives
- Beth McGladrigan
- Phoebe Sharratt
Lay members
- Gillian Mawby
- Sarah Marden
- Nicola Platt
FHM Associate Dean for Research
Tab Content: Committee Calendar
Dates for the academic year 2024-25
Please note that the deadline for applications is at the close of play on the dates given below. Applications received after 5.30pm on the day of the deadline may be rolled over to the next meeting. Also meeting dates are set at the start of the academic year, but are subject to change based on teaching schedules so please check with the FREC Research Ethics Officer if you have concerns around deadlines and project start dates.
- 15th August 2024 (deadline for submissions: 29th July 2024) - CANCELLED
- 12th September 2024 (deadline for submissions: 26th August 2024)
- 17th October 2024 (deadline for submissions: 30th September 2024)
- 14th November 2024 (deadline for submissions: 28th October 2024)
- 12th December 2024 (deadline for submissions: 25th November 2024)
- 16th January 2025 (deadline for submissions: 30th December 2024)
- 13th February 2025 (deadline for submissions: 30th January 2025)
- 13th March 2025 (deadline for submissions: 24th February 2025)
- 17th April 2025 (deadline for submissions: 31st March 2025)
- 15th May 2025 (deadline for submissions: 28th April 2025)
- 19th June 2025 (deadline for submissions: 2nd June 2025)
- 24th July 2025 (deadline for submissions: 7th July 2025)
- 21st August 2025 (deadline for submissions: 4th August 2025)
Tab Content: Documentation and Guidance 1
The following provides guidance on where to find further information about issues that may apply to your project, regardless of whether you are a staff member, research student or UG/PG, applicant.
FHM Research Ethics Committee Information and Documents
- FHM REC Terms of Reference
- Reciprocal approval of externally approved projects
- Guidance on ethical considerations
- Lancaster University Research Ethics, Integrity and Governance
- University Integrity Reports
- Research Misconduct
Templates, examples and guidance
- FHMREC sample opt out sheet
- FHM Sample Participant Information Sheet (PIS)
- FHM Sample Consent Form
- Transcriber confidentiality agreement
- FHM Reviewer pro-forma
- Debrief sheet - guidance
- Accessible consent form example
- Accessible media release form example
- Accessible visual consent form example
Lancaster University Researcher safety policies, principles and guidance
- FHM DHR Lone Researcher Core Principles
- FHM DHR Lone Researcher Policy
- Lancaster University Safety Office
- Lancaster University Guidance on Safety in Fieldwork
- FHM Student Health and Safety Handbook
Guidance on social media research
GDPR and Data management
Tab Content: Documentation and Guidance 2
NHS Sponsorship
Research with Children
- Guidance on research with children
- Research with children: ethics, safety and avoiding harm | NSPCC Learning
Transcription
Please note that Lancaster University currently only has a data-sharing agreement with Nvivo and Microsoft (OneDrive and Teams) for transcription services. All other systems are not supported. A list of suggested software from ISS can be found here: Guidance from ISS on transcription software and technology.
If you are using a transcriber external to your research team they will have to sign a Confidentiality Agreement for the Transcription of Qualitative Data. See Sample transcriber confidentiality agreement for a template of this agreement.
Intellectual Property
For queries relating to Intellectual Property please email the Intellectual Property Team (ext. 93298).