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Introduction

The University is committed to ensuring that all research, and in particular, studies involving human participants, are conducted in a way that respects the dignity, rights, and welfare of participants, and which minimises risks to participants, researchers, third parties and to the University itself.

All research conducted by staff and students from Lancaster University needs to adhere to the ethical standards set out in the University’s and in accordance with research ethics guidelines specified by the research councils (RCUK), by funding bodies such as the ESRC and by relevant subject-specific professional organisations.

Before submitting an ethics application, you will need to carry out a health and safety risk assessment, if appropriate. Carrying out risk assessments are under the remit of the . If you need assistance with completing a risk assessment, you should contact your Area Safety Officer if you are a member of staff; if you are an MPhil/PhD student you should contact your supervisor.

The University has an agreed procedure for supporting students and staff in considering ethical issues in relation to their research. All Lancaster University researchers (staff and students working on funded and non-funded projects), in particular those who conduct studies involving human participants and personal data, need to submit their project for ethics review and seek ethics approval for their research. Staff, PhD and MPhil students should use REAMS, the University's online system, to determine the level of ethical review required for their research. To note, ethical approval must be obtained in writing from the FASS-LUMS Research Ethics Committee before the research activity begins (e.g. before participant recruitment, data collection, data analysis, etc.). If you are uncertain whether your study requires ethical review or not, please log on to REAMS and answer the initial questions. For additional guidance refer to the section below on 'How to apply' or contact the Research Ethics Officer, fass.lumsethics@lancaster.ac.uk.

Ethics applications are processed by Faculty-based Research Ethics Committees. The Faculty of Arts and Social Sciences and the Management School have a joint Research Ethics Committee. The FASS-LUMS Research Ethics Committee (FASS-LUMS REC)is responsible for setting standards for research ethics within the two Faculties. The REC considers and reviews ethics applications from staff, PhD students and MPhil students for funded and non-funded research projects. However, if you are applying for NHS sponsorship, you should also follow the NHS sponsorship guidance because some projects involving the NHS are required to go through a different route for ethical approval. There is additional information below in the 'How to apply' and 'Research involving the NHS' sections. Before submitting an applicaton for a project which will involve the NHS (also known as 'sponsorship 'or 'IRAS' applications); we strongly recommend that you contact the Clinical Research Governance Officers, sponsorship@lancaster.ac.uk and the Research Ethics Officer, fass.lumsethics@lancaster.ac.uk for guidance as soon as possible.

Announcements

Easter closure

The University will be closed during the Easter (spring) break each year. Ethics applications will not be reviewed during this time. Please keep in mind that the University closure and staff annual leave commitments may mean that ethics applications will take longer to process around this time.

Summer vacation

It can take longer to review ethics applications during the summer months due to staff leave and research commitments. Therefore, please help us to help you and allow extra time for your application to be fully processed and reviewed in the summer months: from mid July until mid September.

Christmas break

The University will be closed during the Christmas break each year from the end of December to the beginning of January, and ethics applications will not be processed during this time. Please help the Committee to help you; if your ethics application needs to be reviewed before Christmas, please allow plenty of time for the review process (typically about six weeks) and avoid sending 'last minute' applications.

Impact of Covid-19

Before submitting a new ethics application or an amendment to an existing ethics application for review, please read the University's guidance on the impact of Covid-19. For additional help with research and ethical considerations during the pandemic, you may find this document useful: Guidance on ethical considerations v3?.

Important Application Advice

• Projects involving social media and participants recruited or identified through the Internet require full ethics review (the Committee is following ESRC and other guidelines on this). Additionally, full ethics review is required when 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 context that is publicly available, but this does not mean that the participants/members of this context also perceive it to be public. For more advice on the ethics of internet research, see Association of Internet Researchers, ethical decision making and internet research, . 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 quick guide for important information to consider when designing your research and before you apply for ethics approval.

• Carefully consider whether your participant information sheet provides participants with enough information to enable them to make an informed decision on whether or not to participate in your research. Does it explain the study in language which participants can easily understand? Does it clearly explain any terminology?

• Centre the participants’ safety and wellbeing at the heart of your study. Consider what they are contributing to the study beyond their data. For example, if participation in your research is likely to cause distress to participants, have you got a distress protocol in place? Have you explained on your ethics application form in REAMS how distress or any other risks will be mitigated?

• Good research practice is to keep your research participants in mind at each stage and consider the short and long-term consequences of participation.

• Build research ethics into your study design. You can start an ethics application in REAMS at any time and use the guidance on the application form to help you to think about ethical issues that might apply to your research even when your research is in the 'design stage'. The Ethics Committee will not be able to see your application in REAMS until you submit it, so you can change it many times before it is submitted to the Committee for ethics review.

• Be specific. Clearly explain your research question, the aim(s) of your research and your methodology on your ethics application form in REAMS.

• Members of the Ethics Committee may not necessarily be from your subject area or department. Therefore keep language free from jargon and explain all acronyms used in your application.

• Lancaster researchers (staff and students) requiring multiple ethical approvals:
• Staff:
• If Lancaster is leading the research, the principal investigator is expected to submit a full ethics application to the FASS-LUMS Research Ethics Committee for review and approval before research activity begins. Also, their co-investigators from other institutions should be advised to check their own institution's requirements regarding ethical approval.
• If another University/organisation is leading the research and Lancaster staff are co-investigators: if ethical approval is obtained from the other University's/organisation's research ethics committee, that will also cover the work done by Lancaster researchers; an ethics application must also be submitted to the FASS-LUMS Research Ethics Committee before research activity begins. These applications will ordinarily receive a light touch review by the Ethics Committee Chair.
• Students: Lancaster's PhD and MPhil students are expected to submit a full ethics application to the FASS-LUMS Research Ethics Committee for review and approval before research activity begins. If another institution also requires the research to be submitted through their own research ethics committee's process (e.g. if a student is conducting research on-site at another university), they should ordinarily submit their primary ethics application to the FASS-LUMS research ethics committee. However, the Committee appreciates other institutions' requirements may differ, and in this case, you should contact the Research Ethics Officer as soon as possible to discuss the way forward.

• Applications for research involving the NHS: these are sometimes called 'IRAS' or 'sponsorship' applications - please read the guidance in the 'How to apply' and 'Research involving the NHS' sections below before submitting your application.

• Guidance for researchers (staff and students) who carry out research abroad: please be aware that there may be different legal requirements in countries abroad for hosting research, especially if the research is health-related and/or with vulnerable people. Therefore, you may need to obtain permission/approval from the authorities in those countries before carrying out your research. To note, it is the researcher's responsibility to ensure they are aware of local legal and regulatory requirements that may relate to the proposed research.

How to apply for ethics approval

Guidance for staff, PhD and MPhil student research projects (funded and non-funded).

Staff, PhD and MPhil students must submit their ethics applications in REAMS, the University’s Research Ethics Application Management System. Exceptions to this are ethics applications that require NHS Research Ethics Committee approval and 'NHS' sponsorship from Lancaster University; because some projects involving the NHS are required to go through a different route for ethical approval. Further guidance is available in the 'Research Involving the NHS' section below.

A) How to submit an application to the FASS-LUMS Research Ethics Committee (FASS-LUMS REC) in REAMS

To submit your ethics application, login to REAMS. Whether your study is externally funded or not, your project needs to be approved, in writing, by the FASS-LUMS REC before the data collection and research activity begins. For all sections of the ethics application form, be specific and concise in the information you provide. The reviewers on the Ethics Committee are academics from the different departments in FASS and LUMS. They will not necessarily be from your subject area or discipline, so make sure you explain subject-specific terminology and be as clear as you can when completing your ethics application.

Additional documents

If your research project will involve human participants, in addition to completing the ethics application form in REAMS, you will need to upload research materials of direct relevance to your application; which you may wish to prepare in advance, before you complete your application form in REAMS. The Committee strongly recommends that you use the sample documents which are available in the 'Templates and Documents' section on this page.

Research materials of direct relevance to your application may include any of the following (this list is not exhaustive):

• Advertising materials (posters, e-mails)
• Letters of invitation to participate
• Participant Information Sheets
• Consent Forms
• Data collection materials such as interview questions, questionnaires/survey questions, workshop guides, focus group scripts, demographic sheets.
• Debrief sheets

A note about projects reviewed and approved by another organisation’s Research Ethics Committee: these also require a review by the FASS-LUMS Research Ethics Committee before research commences to comply with Lancaster University's requirements. For example, if a Lancaster University researcher is a co-investigator on a research team and a member of the research team from another university has obtained ethical approval for the research project; the Lancaster researcher must also submit an ethics application to the FASS-LUMS Research Ethics Committee through REAMS. This type of ethics application is known as an 'application with external approval' and it is usually reviewed by the Committee's Chair. For this type of application, in REAMS, you will need to upload: a copy of the 'external' ethics application that the other university/organisation approved and all supporting documents (e.g. participant information sheet, consent form, interview questions, questionnaires, etc.) and a written copy of the approval letter/email. For additional information refer to the 'Important application advice' section on this page under the subheading 'Lancaster researchers (staff and students) requiring multiple ethical approvals'. If you need any more information about this, please contact the Research Ethics Officer for further guidance, email fass.lumsethics@lancaster.ac.uk.

B) What level of review is required for my project?

To determine what level of ethics review your project requires, you should log in to REAMS. REAMS has some preliminary questions to determine whether ethical review is needed and/or the level of review that is needed. If you are still unsure about whether your research needs ethical review, please contact the Research Ethics Officer atfass.lumsethics@lancaster.ac.uk. As a guide, please consider this question:

Does your research project involve any of the following (1-9)?

1. Human participants (including all types of interviews, questionnaires, focus groups, records relating to humans, use of internet or other secondary data, observation, etc.)
2. Animals - the term animals shall be taken to include any non-human vertebrates, cephalopods or decapod crustaceans. If your research involves animals, you will need to gain approval for your research project via the Animal Welfare and Ethical Review Body (AWERB). Refer to the Animal Welfare and Ethical Review Body webpages and contact the secretary to AWERB, Lucy Sanderson for further details. Applications for research involving animals only do not need to be submitted in REAMS. However, research involving animals plus any other risk factors, including but not limited to human participants, will need to be submitted to both AWERB (for the animal strand) and to the FASS-LUMS Research Ethics Committee via REAMS (for the rest of the research).
3. Risk to members of the research team, e.g. lone working, travel to areas where researchers may be at risk, including at risk of emotional distress
4. Human cells or tissues other than those established in laboratory cultures
5. Risk to the environment
6. Conflict of interest
7. Research or a funding source that could be considered controversial
8. Social media and/or data from internet sources that could be considered private
9. Any other ethical considerations

If you have answered 'Yes' to any of the above (1-9) you will need to submit an ethics application to the FASS-LUMS Research Ethics Committee for review. If you are not sure whether your project requires ethical review you should login into REAMS which will guide you. If you need more information about this and/or assistance, please contact the Senior Research Ethics Officer, Debbie Knight, at fass.lumsethics@lancaster.ac.uk.

C) What happens when I submit my ethics applicaton?

You can submit an ethics application at any time. When you submit an ethics application in REAMS you will receive an automatic email to acknowledge receipt of the application. To note, if you are a student (Phd or MPhil) in REAMS you will be prompted to request your supervisor's signature. Your application will not be submitted to the Committee for review until your supervisor has 'signed' it in REAMS, and you will receive an automatic email to acknowledge receipt of the application when both your and your supervisor have signed the application in REAMS.

Depending on their level of risk, research projects involving human participants submitted to the FASS-LUMS REC will be reviewed by either one or two reviewers from the REC. The reviewer(s) will provide comments and feedback on the application form in REAMS, and they may ask for any clarification of your application if needed.

Depending on the research project's complexity and the ethical issues it raises, your application may be discussed by the full committee at one of its monthly meetings, and you may be asked to attend the meeting. The Research Ethics Officer will contact you if your application will be discussed at a committee meeting. Please ensure you are available to attend the meeting if required to do so. Committee meeting dates are listed below on the 'Committee Calendar' tab.

Projects submitted to the FASS-LUMS REC through REAMS which involve existing data only or the evaluation of an existing project with no direct contact with human participants will usually be processed by Chair’s action.

If you have any questions about the ethics review process, please contact the Senior Research Ethics Officer, Debbie Knight, at fass.lumsethics@lancaster.ac.uk.?? For enquiries relating to the REAMS system, please email reams-support@lancaster.ac.uk.

Help and support

Further information is available on the 'Additional Information and Guidance' tab on this page.

For any questions about the logistics of the application process or other questions about ethical issues in relation to your research, please contact the Senior Research Ethics Officer, Debbie Knight, email fass.lumsethics@lancaster.ac.uk, office address: Room D22, FASS Building, Lancaster University. For technical queries relating to the REAMS system please email reams-support@lancaster.ac.uk.

If you are applying for NHS sponsorship you should follow the NHS sponsorship guidance. All other applicants (staff, PhD and MPhil students) should continue to submit their ethics applications to the FASS-LUMS Research Ethics Committee in the usual way by following the guidance in the ‘How to apply’ section of this webpage.

Before you submit an application for research that will involve the NHS (for example, but not limited to, NHS staff, patients, patients' data, GP practices and care homes) please contact the Clinical Research Governance Officers, email sponsorship@lancaster.ac.uk, for further guidance. It would also be helpful if you let the FASS-LUMS Research Ethics Officer know, email fass.lumsethics@lancaster.ac.uk.

If, after an ethics application has been approved, the design of a research project changes the researcher should apply to the FASS-LUMS REC for further ethics review and approval by submitting an amendment in REAMS before any proposed changes are implemented. (For example, if alternative or additional research methods will be used or the sample population changes). For further information about changes and submitting amendments to the Committee for review please follow the amendments guidance on the REAMS webpage.

If you are unsure about whether your proposed changes require ethics approval please contact the Research Ethics Officer for advice, email fass.lumsethics@lancaster.ac.uk.

Ethics applications by Undergraduate and Master's students are dealt with at departmental level. Undergraduate (UG) and Master's coursework and dissertations that involve the generation of data with human participants need to be ethically approved before human participants are approached and before any data is generated. Responsibility for ethical review of Undergraduate and Master's projects lies within the Departments. If you are an Undergraduate or Master's student, you should contact your department for further information.