LLC Research Ethics Checklist

The purpose of this form is to help staff and student researchers decide whether or not their research requires further formal ethics review via the LLC Research Ethics Committee (REC).

The checklist should be completed by the Principal Investigator, except in the following cases:

Postdoctoral Research Fellowships and Visiting Scholars - the applicant in collaboration with the proposed mentor/academic sponsor.
Postgraduate research (PhD and Masters by Research) – the student together with the supervisor/supervisory team.
Taught Masters dissertation/project work and Undergraduate dissertation/project work – the student together with the supervisor.

Please scroll down the form and read the relevant guidance before you start completing the form. If you click on a link whilst you are completing the form, you are liable to lose the data already entered. To avoid this, you can copy/paste the URL into a new browser tab, or use Ctrl + Click to open the link in a new tab. You can also click 'Save Draft' at the bottom of the page to save your progress at any point.

Project details

Researcher name *

Level at which research is being undertaken *

Supervisor name

Supervisor email address

Researcher email address *

Affiliated subject area *

Affiliated subject area Other...

Proposed project title *

Project start date (this must be a future date) *

Day

Month

Year

Project summary

Project description *

Please provide a brief description (max 500 words) of your research project, including its aims, research question(s), and research methods.

Participants

Human participants are defined as including: Living human beings; Human beings who are recently deceased*; Embryos and foetuses; Human data and records, such as, but not restricted to, medical, genetic, financial, personnel or criminal records.

*How ”recently deceased” is defined is context-specific and dependent on the type of research. In health and social care contexts, for example, medical records become usable without consent after 50 years, but in some cases certain categories of medical data which are donated for research can be used immediately.

Even in cases where it is determined that a human subject who has died but would not be considered recently deceased, there are still potential ethical issues relating to living relatives. In cases where there is a possibility for the research to cause harm to living relatives, there are often ways to mitigate such harm (such as informing or discussing with relatives). The need to do so would also be context-specific and dependent on the sensitivity of the data, or how public the data/information already is.

Participants grid

	Yes	No
Does your research involve human participants, as defined above? *	Does your research involve human participants, as defined above? - Yes	Does your research involve human participants, as defined above? - No

Personal data

"Personal data is data that relates to living people from which they can be directly or indirectly identified - direct identifiability being from the data itself, or indirect identifiability being from the combination of the data with other available data."

"Data that has been pseudonymised (with identifiers separated) may still be personal data, depending on how hard it is to reconnect the identifiers with the dataset. Robust controls that separate the two - for example, a legal agreement that prevents reidentification and controls access to the identification key - will help protect the data so that it may be possible to classify it as not personal data to those that do not have access to the key. It is also worth noting that the action of anonymising counts as processing personal data for the purposes of GDPR."

(UK) GDPR and Research: An Overview for Researchers: UKRI-020920-GDPR-FAQs.pdf.

Personal data grid

	Yes	No
Does your research involve personal data/information and/or data that has the potential to compromise the privacy of individuals? *	Does your research involve personal data/information and/or data that has the potential to compromise the privacy of individuals? - Yes	Does your research involve personal data/information and/or data that has the potential to compromise the privacy of individuals? - No

Sponsorship

Please refer to “Health and social care research: sponsorship guidance”: Health and social care research: sponsorship guidance | The University of Edinburgh.

Sponsorship grid

	Yes	No
Does your research require sponsorship? *	Does your research require sponsorship? - Yes	Does your research require sponsorship? - No

Confidentiality

Confidentiality grid

	Yes	No
Does your research involve confidential corporate data or information? *	Does your research involve confidential corporate data or information? - Yes	Does your research involve confidential corporate data or information? - No

Potential risks to participants and researchers

Potential risks grid

	Yes	No
Is it likely that your research will induce any psychological or physical harm in participants, researcher(s), and/or others? *	Is it likely that your research will induce any psychological or physical harm in participants, researcher(s), and/or others? - Yes	Is it likely that your research will induce any psychological or physical harm in participants, researcher(s), and/or others? - No
Is it likely that your research findings will adversely affect participants or particular groups of people *	Is it likely that your research findings will adversely affect participants or particular groups of people - Yes	Is it likely that your research findings will adversely affect participants or particular groups of people - No
Is it likely that your research will adversely affect the environment or society? *	Is it likely that your research will adversely affect the environment or society? - Yes	Is it likely that your research will adversely affect the environment or society? - No

Security

Does your research project fit into any of the following security-sensitive categories? *

Security grid

	Yes	No
Your research project is commissioned by the military *	Your research project is commissioned by the military - Yes	Your research project is commissioned by the military - No
Your research project is commissioned under an EU security cell *	Your research project is commissioned under an EU security cell - Yes	Your research project is commissioned under an EU security cell - No
Your research project involves the acquisition of security clearances *	Your research project involves the acquisition of security clearances - Yes	Your research project involves the acquisition of security clearances - No
Your research project concerns groups which may be construed as terrorist or extremist *	Your research project concerns groups which may be construed as terrorist or extremist - Yes	Your research project concerns groups which may be construed as terrorist or extremist - No

Conflict of interest

The University Policy on the Conflict of Interest defines conflict of interest as “a situation in which an employee has a private or personal interest which is likely to appear to influence the objective exercise of an aspect(s) of their University duties.”

Conflict of interest may also include cases where the source of funding raises ethical issues, either because of concerns about the moral standing or activities of the funder, or concerns about the funder’s motivation for commissioning the research and the uses to which the research might be put.

The University policy also states that the responsibility for avoiding conflict of interest, in the first instance, lies with the individual, but that potential conflict of interest should always be disclosed, normally to the line manager or Head of Department. Failure to disclose a conflict of interest or to cease involvement until the conflict of interest has been resolved may result in disciplinary action and in serious cases could result in dismissal.

Please refer to the University Policy on Conflict of Interest: Conflict of Interest (ed.ac.uk).

Conflict of interest grid

	Yes	No
Does your research involve any real or perceived conflict of interest? *	Does your research involve any real or perceived conflict of interest? - Yes	Does your research involve any real or perceived conflict of interest? - No

Animals

Animals grid

	Yes	No
Does your research involve animals? *	Does your research involve animals? - Yes	Does your research involve animals? - No

Any other ethical issues

Any other ethical issues grid

	Yes	No
To the best of your knowledge, does your research raise any other ethical issues which may require review by a Research Ethics Committee? *	To the best of your knowledge, does your research raise any other ethical issues which may require review by a Research Ethics Committee? - Yes	To the best of your knowledge, does your research raise any other ethical issues which may require review by a Research Ethics Committee? - No

If you have answered 'yes' to the above question, please provide more information below, and please contact your local Subject Area Research Ethics Lead (SAREL) for further guidance. Details of who your SAREL is can be found here: Contacts | The University of Edinburgh.

other issues *

If you have answered “Yes” to any of the above questions:

If you have answered “Yes” to any of the above questions, your research project is required to go through ethics review by the LLC Research Ethics Committee (REC). You are required to submit a “Research Ethics, Integrity and Governance Application” which can be found here:

Submitting applications for ethical review including link to application form | The University of Edinburgh

Applications should be submitted in a timely manner and in adherence to LLC guidelines. You should not undertake any research associated with this project until you have secured a favourable opinion (“approval”) from the LLC Research Ethics Committee.

If you have any ethics-related queries, please contact your local Subject Area Research Ethics Lead (SAREL) in the first instance. Details of who your SAREL is can be found here: Contacts | The University of Edinburgh.

If you have not answered “Yes” to any of the above questions:

If you have not answered “Yes” to any of the above questions, your research project is not required to go through ethics review by the LLC Research Ethics Committee (REC). You are not required to submit a “Research Ethics, Integrity and Governance Application.”

However, before beginning your research, please note the following:

Publishers are increasingly making requests for evidence of formal ethics review for publication. You should consider whether or not ethics review by a REC would be beneficial to the publication of your research.
If there is a change to your research which potentially raises new ethical issues, you should stop the research and re-assess whether or not ethics review by a REC is required.
There are research governance processes that are separate from research ethics. This Research Ethics Checklist does not ensure that research governance requirements are being fulfilled. Therefore, even where a research project does not require review by a REC, researchers should ensure that their research adheres to all University policies (where applicable) including but not limited to:

Copyright

If your project requires the use of copyrighted material, please refer to Ethics and copyright. ‘use of’ here means for publication, be it screenshots of a film, a graph from a secondary source, or reproduction of text (prose, poetry, etc) which goes beyond fair dealing. ‘use of’ does not refer to analysis of copyrighted sources as part of the research (eg, research where poetry, novels or films are the primary sources).

Research data and materials storage

Researchers are responsible for ensuring that project data and/or project materials are stored securely to reduce the risk of their damage, loss, leakage or theft. For guidance on data storage, including OneDrive, DataStore, sensitive data storage and long-term data storage, please refer to: Data Protection, Data Management and UK General Data Protection Regulation (UK GDPR) | The University of Edinburgh.

Collaborative research

Collaborative research includes research undertaken with another academic Institution or external partner; e.g., NGO, businesses, as well as field assistants and local researchers. It does not include company-sponsored dissertations. Please note that other University of Edinburgh students and/or supervisors are not considered collaborators.

Researchers must ensure that the correct permissions and agreements are in place if engaging in collaborative research. Please refer to UK Research and Innovation guidance: Our expectations for research collaboration – UKRI and University guidance: Research Governance Compliance & Risk Team | The University of Edinburgh.

Researchers involved with collaborative research projects, especially those collaborating internationally, are encouraged to engage with Ethical Action in Global Research: A toolkit: Home 2 | Ethics (ed.ac.uk).

Researchers should bear in mind that besides a Data Management Plan for the research (and other data and UK GDPR-related requirements), other data-related agreements may be needed, such as a data transfer agreement. More information on data transfer can be found here: International data transfer | The University of Edinburgh.

Impact and Engagement (I&E)

You may not know at the outset of your project all of the I&E activities which you will run/be involved in. If you develop new plans, then you should consider them in light of the guidance on research ethics and KEI: “Research Ethics and Knowledge Exchange and Impact (KEI)”: Research Ethics and Impact & Engagement (I&E) | The University of Edinburgh and re-assess whether or not such activities need to go through ethics review by a REC.

Risk Assessments

Researchers should ensure that all Risk Assessments are completed where needed.

Travel Risk Assessment: this should be completed if the research project involves any travel, even within the UK (including any travel in Scotland outwith your normal commute to and from the University).

Fieldwork Risk Assessment: This should be completed if you are conducting any fieldwork, even on campus, in Edinburgh, or elsewhere in the UK.

Link to University Travel and Risk Assessments: Travel plan and Risk Assessments | The University of Edinburgh.

Insurance

Researchers should ensure that they secure University insurance for any travel and/or fieldwork connected to their research project. Link to University Insurance: Travel insurance | The University of Edinburgh.

Student projects [UG, PGT, PGR, PhD]: I have completed this Checklist together with my supervisor and/or supervisory team *

Yes

N/A (not a student application)

Hidden question fields

Participants *

	Yes	No
Does your research involve human participants, as defined above? *	Does your research involve human participants, as defined above? - Yes	Does your research involve human participants, as defined above? - No

Personal data *

	Yes	No
Does your research involve personal data/information and/or data that has the potential to compromise the privacy of individuals? *	Does your research involve personal data/information and/or data that has the potential to compromise the privacy of individuals? - Yes	Does your research involve personal data/information and/or data that has the potential to compromise the privacy of individuals? - No

sponsorship *

	Yes	No
Does your research require sponsorship? *	Does your research require sponsorship? - Yes	Does your research require sponsorship? - No

Confidentiality *

	Yes	No
Does your research involve confidential corporate data or information? *	Does your research involve confidential corporate data or information? - Yes	Does your research involve confidential corporate data or information? - No

Potential risk questions *

	Yes	No
Is it likely that your research will induce any psychological or physical harm in participants, researcher(s), and/or others? *	Is it likely that your research will induce any psychological or physical harm in participants, researcher(s), and/or others? - Yes	Is it likely that your research will induce any psychological or physical harm in participants, researcher(s), and/or others? - No
Is it likely that your research findings will adversely affect participants or particular groups of people? *	Is it likely that your research findings will adversely affect participants or particular groups of people? - Yes	Is it likely that your research findings will adversely affect participants or particular groups of people? - No
Is it likely that your research will adversely affect the environment or society? *	Is it likely that your research will adversely affect the environment or society? - Yes	Is it likely that your research will adversely affect the environment or society? - No

Does your research project fit into any of the following security-sensitive categories? *

	Yes	No
Your research project is commissioned by the military *	Your research project is commissioned by the military - Yes	Your research project is commissioned by the military - No
Your research project is commissioned under an EU security cell *	Your research project is commissioned under an EU security cell - Yes	Your research project is commissioned under an EU security cell - No
Your research project involves the acquisition of security clearances *	Your research project involves the acquisition of security clearances - Yes	Your research project involves the acquisition of security clearances - No
Your research project concerns groups which may be construed as terrorist or extremist *	Your research project concerns groups which may be construed as terrorist or extremist - Yes	Your research project concerns groups which may be construed as terrorist or extremist - No

Conflict of interest *

	Yes	No
Does your research involve any real or perceived conflict of interest? *	Does your research involve any real or perceived conflict of interest? - Yes	Does your research involve any real or perceived conflict of interest? - No

animals *

	Yes	No
Does your research involve animals? *	Does your research involve animals? - Yes	Does your research involve animals? - No

other issues *

	Yes (please provide details below)	No
To the best of your knowledge, does your research raise any other ethical issues which may require review by a Research Ethics Committee? *	To the best of your knowledge, does your research raise any other ethical issues which may require review by a Research Ethics Committee? - Yes (please provide details below)	To the best of your knowledge, does your research raise any other ethical issues which may require review by a Research Ethics Committee? - No

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This article was published on 10 Jan, 2024