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University Ethics Form Version 3

Newcastle University requires that this online ethics form is completed for all projects before any work begins. This includes research, consultancy, and teaching projects, whether the principal investigator is a student or staff member, and whether the project is funded or unfunded. Additional information and guidance can be found on the University Ethics Web Pages.

The online ethics form aims to help the principal investigator identify whether the project is considered high risk by Newcastle University and will require formal ethics review by a Research Ethics Committee.

This online ethics form must be completed as accurately as possible, but acts only as a guide to facilitate the ethics management process. Ultimately the principal investigator is responsible for ensuring their research satisfies Newcastle University's ethical expectations and has been subject to the appropriate level of ethical review. If the principal investigator thinks that the form has incorrectly identified their project as low risk, they should contact res.policy@ncl.ac.uk before commencing any project work.

You can save your answers and come back to the form (provided it has not been submitted) by clicking on the 'Resume later' button at the top of the page and completing the password fields. To return to the form, click the 'Load unfinished survey' button at the bottom of the page. Once a form has been submitted, it is not possible to return to the form.

Please read before completing the form

The time the form takes to complete will vary from project to project. If your project involves no high-risk areas and you have the information/supporting documents to hand you should be able to complete it in 10-15 minutes. However, for more complex projects i.e. which are high risk or where you must develop supplementary documents, it will take significantly longer. Please note that you are able to save the application and come back to it at any time.

Part One - Flagging High-Risk Areas

The first part of this form is designed to identify high-risk areas in your research project. There are six main areas; 'Animals', 'NHS, Health and Social Care', 'Human Participants in a Non-clinical Setting', 'Data', 'Environment' and 'International'. All the sections begin with a trigger question to determine whether the sub-questions are relevant to your project. Your answer to the trigger question does not itself flag the project as high risk, this only happens if you subsequently answer yes to any of the sub-questions (which you do not have to do to progress). If you are unsure of whether to answer yes or no, then it is best to seek further advice from the Research Office (res.policy@ncl.ac.uk), Faculty Ethics Representative or from your School, Institute or Programme Leader.

Part Two - Providing Further Information on High-Risk Areas

If your project is recognised as high risk AND the relevant approval body is a University Committee (this is the case for all risk areas except the NHS) then you will be asked to provide further information. Again you will only be asked to complete the relevant sections.

As you progress through the application you will be asked to upload all the relevant supporting documents e.g. consent forms, information sheets, risk assessments, questionnaires, protocols, etc.

Following the completion of the form, you will receive an email confirmation and your completed application will be forwarded (with documentation) to the relevant committee.

Name of Principal Researcher

This should be the name of the lead scientist on the project. If you are a student please enter your name rather than your supervisor's.

Please enter your email address

This should be your Newcastle University email address

Please enter the module code

e.g. ONC8014

Please enter your supervisor's email

Please check the format of your answer.

Project Title

Please provide the title of your research project.

Project Synopsis

Please provide a short lay synopsis of no more than 200 words. This may be cut and pasted from your research proposal.

Project start date

This should normally be in the future. If you are unsure please provide an estimate.

Project end date

The end date should not be earlier than the start date. If you are unsure please provide an estimate.

NUProjects/MyProjects reference

Please omit the dash from the project number for NUProjects reference e.g. NU000001/BH121591/KH149209

Please check the format of your answer.

Project Funder Details

	Funder name	Reference	Value to Newcastle
Primary funder
Secondary Funder
Tertiary Funder

Does your project involve collaborators outside of the University?

Yes No

Please provide a list of the collaborating organisations.

Has ethical approval to cover this proposal already been obtained?

Link to External Ethical Approval in Ethics Toolkit

Yes No

Has your faculty ethics representative agreed to accept the existing approval in lieu of a new application? You will be required to provide evidence of this.

The University will (ordinarily) accept approvals from other organisations where they are known partners (e.g. NHS trusts or other UK Higher Education Institutions) and where the approval covers all the project work including any taking place at Newcastle.

Yes No

Please upload the ethics application/approval documentation

Please upload at most 2 files

Upload files

	Title	Comment	File name

Please provide further information on the approval body

Approving body
Reference
Date of approval

Will anyone be acting as sponsor under the NHS Research Governance Framework for Health and Social Care?

Yes No

Please enter the name of the sponsor

Do you have a Newcastle upon Tyne Hospitals (NUTH) reference?

Yes No

Please enter the NUTH reference number

Will someone other than you (the principal investigator) or your supervisor (for student projects) be responsible for the conduct, management and design of the research?

Yes No

Please provide the details of the persons responsible for the conduct, management and design of the research

If the Principal Investigator is responsible enter "PI".

	Name	Position	Organisation	Email
Conduct
Management
Design

*Please note that this question changed on 01/06/25 to capture activity with all animals*

Does your proposed research involve the use of non-human animals i.e. the observation, capture or manipulation of animals OR their tissues (i.e. materials from animal such as skin, blood, bone, and other bodily fluids)?

For further guidance, please see Ethics Toolkit - Animals

Yes No

Which types of non-human animals does your research involve? (please select all that apply)

Select all that apply

a. Vertebrates (other than a human, e.g. mammal, bird, reptile, amphibian, etc.)
b. Cephalopod (e.g. octopus, squid, cuttlefish)
c. Decapod crustacea (e.g. lobster, crab)
d. Any other invertebrate animals not listed above

Does the research involve the viewing, usage or transfer of sensitive data or personal data as defined by the General Data Protection Regulation (GDPR) or data governed by statute such as the Official Secrets Act 1989 / Terrorism Act 2006, commercial contract or by convention e.g. client confidentiality? (If you are unsure please tick YES and complete the sub-questions).

If you are unsure please tick YES. You will then be presented with a range of sub-areas the University considers higher risk. Please select any which are relevant.

Note: This question relates to the nature of the data rather than the collection methods which should be covered elsewhere.

For further guidance, please see Ethics Toolkit - Data

Yes No

Will the study involve any of the following?

Select all that apply

a. The study involves sharing of sensitive or personal data outside the UK or European Economic Area.
b. The study involves collection or analysis of sensitive data which will be identifiable within the project outputs and could potentially cause harm.
c. The study involves collection or analysis of personal data without explicit consent.
d. The study involves collection or analysis of information covered by the Official Secrets Act 1989, Terrorism Act 2006, commercial contract or licence?
e. The study involves the collection, viewing or dissemination of materials which could be considered; extremist, sensitive, or terrorism related?

Will the study potentially cause a direct or indirect negative impact on local communities, cultural heritage or the environment?

If you are unsure please tick YES. You will then be presented with a range of sub-areas the University considers higher risk. Please select any which are relevant.

For further guidance, please see the Responsible Research Innovation and Ethics Toolkit - Environment

Yes No

Newcastle University is committed to Responsible Research Innovation and minimising the unintended negative consequences on people, places and the environment.

Defence and security research and innovation: is the project funded by, or are you collaborating with a military / defence and security sector organisation? If so, please click here and provide more information about the aims of the project by completing the online form.

All other projects: does the research involve any of the following scenarios?

Select all that apply.

Select all that apply

a. The research is expected to lead to emissions (e.g. gases, chemicals, ionizing particles, noise) above the permissible level according to UK regulations (or local regulations in the case of non-UK research).
b. The research is expected to lead to a negative impact on the landscape or areas of historical or cultural significance, including artefacts.
c. It is expected that the research might cause harm through environmental fieldwork such as sampling or monitoring a site.
d. The research will be conducted in a protected area such as an Environmentally Sensitive Area (ESA) or area of Special Scientific Interest (SSI).

Will the research be conducted outside of the UK or European Economic Area (EEA), or will it involve international collaborators outside the EEA?

If you are unsure please tick YES. You will then be presented with a range of sub-areas the University considers higher risk. Please select any which are relevant.

Overseas projects can pose additional risks for the project because of the different legal jurisdictions, cultural norms and potential risks to the researchers themselves. If your project is outside the UK or EEA then please notify us here.

For further guidance, please see Ethics Toolkit - International

Yes No

Please answer the following:

Select all that apply

Will there be an increased risk to researchers and participants where they are working remotely?
Will the research involve political sensitivities e.g. offend specific public interests or the rights and reputations of others?
Are the ethics review procedures for any international partner(s) outstanding and / or will NOT be met?
Will the work undertaken overseas be governed by standards which are NOT equivalent to those in the EEA?

You have:

- Ethical approval in place AND your faculty ethics representative has agreed to accept this in lieu of a new application. The University therefore does not require any further ethical review for this project. Should your project change you may need to apply for new ethical approval.

Please complete the declaration and save a copy of the form for your records.

Your project has been flagged as requiring further review from an NHS Research Ethics Committee.

You will need to submit an application to the appropriate external health authority ethics committee through the National Research Ethics Service (NRES) - see http://www.hra.nhs.uk/research-community/ for further information.

You will now be directed to complete the declaration.

Your project has been flagged as requiring further review from the Animal Welfare Ethics Review Body. (AWERB)

You will now be prompted to provide some additional information in the next section of the form.

If your research work ONLY involves the use of invertebrate animals (excluding Cephalopods or Decapod crustacea), your application will not undergo a full ethical review by AWERB and you are not required to provide additional information, please complete the remaining AWERB additional questions with “N/A”.

Once complete the finished form will be forwarded to the 'Animal Welfare Ethics Review Body' automatically.

Your project has been flagged as requiring further review from the School of Psychology Ethical Review Committee.

You will now be prompted to provide some additional information in the next section of the form.

Once complete the finished form will be forwarded to the School of Psychology Ethical Review Committee automatically.

You may wish to discuss your project with your supervisor before continuing with the form.

Your project has been flagged as requiring further review from the Faculty of Medical Sciences Ethics Committee.

You will now be prompted to provide some additional information in the next section of the form.

Once complete the finished form will be forwarded to the Faculty of Medical Sciences Ethics Committee automatically.

Your project has been flagged as requiring further review from the Faculty of Science, Agriculture and Engineering Ethics Committee.

You will now be prompted to provide some additional information in the next section of the form.

Once complete the finished form will be forwarded to the Faculty of Science, Agriculture and Engineering Ethics Committee automatically.

Your project has been flagged as requiring further review from the Faculty of Humanities and Social Sciences Ethics Committee.

You will now be prompted to provide some additional information in the next section of the form.

Once complete the finished form will be forwarded to the Faculty of Humanities and Social Sciences Ethics Committee automatically.

Based on your responses your project has been categorised as (ethically) low risk and no further review is required before you start work. You will receive a formal approval email on submission of this form. Should your project change you may need to apply for new ethical approval.

Project Outline & Aims

In everyday language, briefly explain the aims of this research including the anticipated benefits and risk. In cases where the use of technical or discipline specific terms is unavoidable please explain their meaning clearly.

Please use no more than 500 words

Proposed Research Methods (Experimental Design)

In everyday language, please provide an outline of the research methods in a clear step by step chronological order. Noting any pertinent information such as whether the research involves overseas partners and how you will handle the research data.

Please use no more than 500 words

Will the work be covered by an existing home office licence?

This can be an establishment licence, personal licence or project licence. Additional guidance is available here. If you are unsure please contact awerb@newcastle.ac.uk.

Yes No

Home Office Reference:

Licences and Permissions

	Yes	No
Do you intend to apply for a Home Office Licence
Have you discussed the project with the Director of the Comparative Biology Centre?
Have you discussed the project with a Home Office representative?
If your project uses wild caught animals, have you obtained the appropriate permissions? (Enter "no" if not applicable)

Why is the use of animals necessary in this project?

Please use no more than 500 words

What kinds of animals will be used and how many of each?

Please use no more than 500 words

What will happen to the animals during and after the project?

Please use no more than 500 words

Who will be carrying out the project? Briefly describe the relevant experience and expertise of the persons involved?

Please use no more than 500 words

Where will the animals be housed / located? If the animals are being observed in the wild or in establishments such as zoos, has permission been obtained from the appropriate authority? For any work outside the UK, do the standards of animal care and accommodation comply with UK codes of practice? If not explain how they differ.

Please use no more than 500 words

What checks will be made on the animals, how frequently and by whom? What actions will be taken in the event of any adverse effects on the animals?

Please use no more than 500 words

Participant Details

Does the research specifically target participants who are:

	Yes	No
Adults (over 18 years old and competent to give consent)
Children / Legal minors (anyone under 18 years old)
People from non-English speaking backgrounds
Persons incapable of giving consent
Prisoners or parolees
Recruited through a gatekeeper
Welfare recipients

How many participants do you plan to recruit?

Only numbers may be entered in this field.

From which source and, by what means do you plan to recruit your participants?

Please use no more than 250 words.

Participant Information

	Yes	No
Will you inform participants that their participation is voluntary?
Will you inform participants that they may withdraw from the research at any time and for any reason?
Will you inform participants that their data will be treated with full confidentiality and that, if published, it will not be identifiable as theirs?
Will you provide an information sheet which includes the contact details of the researcher / research team?
Will you obtain written consent for participation?
Will you debrief participants at the end of their participation (i.e. give them an explanation of the study aims and hypotheses)?
Will you provide participants with a written debriefing too?

Participant Information II

	Yes	No	Not applicable
If you are using a questionnaire, will you give participants the option of omitting questions that they do not want to answer?
If your work is experimentally based, will you describe the main experimental procedures to the participants in advance so that they are informed about what to expect?
If the research is observational, will you ask participants for their consent to being observed?

Participant Consent

Please describe the arrangements you are making to inform potential participants, before providing consent, of what is involved in participating in your study and the use of any identifiable data, and whether you have any reasons for withholding particular information. Due consideration must be given to the possibility that the provision of financial or other incentives may impair participants’ ability to consent voluntarily.

Please use no more than 300 words

Participant Consent II

Participants should be able to provide written consent. Please describe the arrangements you are making for participants to provide their full consent before data collection begins. If you think gaining consent in this way is inappropriate for your project, please explain how consent will be obtained and recorded. (A copy of your consent form must be provided with your submitted application)

Please use no more than 300 words

Participant Debriefing

It is a researcher’s obligation to ensure that all participants are fully informed of the aims and methodology of the project, that they feel respected and appreciated after they leave the study, and that they do not experience significant levels of stress, discomfort, or unease in relation to the research project. Please describe whether, when, and how participants will be debriefed. (A copy of your debriefing sheet must be provided with your submitted application)

Please use no more than 300 words

Potential risk to participants and risk management procedures

Identify, as far as possible, all potential risks (small and large) to participants (e.g. physical, psychological, etc.) that may be associated with the proposed research. Please explain any risk management procedures that will be put in place and attach any relevant documents in the section below. Please answer as fully as possible.

Please use no more than 300 words

Please upload any appropriate documents here. Typically you should include anything the committee would need to complete its full review.

E.g. Consent form(s), Information Sheet(s), Debriefing Document(s), Questionnaire(s) and risk assessment(s).

Please upload at most 10 files

Upload files

	Title	Comment	File name

Please describe how data will be accessed, how participants’ confidentiality will be protected and any other relevant considerations. Information must be provided on the full data lifecycle, from collection to archive.

Alternatively please upload a copy of your data management plan below.

If you do not have a data management plan, University approved funder-specific plans are available from the Digital Curation Centre.

Please upload a copy of your data management plan (if required).

Please upload at most one file

Upload file

	Title	Comment	File name

Please provide the locations in which your research will take place, together with a summary of the perceived risks and benefits of the study and any mitigating actions planned.

Please use no more than 500 words

For any research conducted outside the European Economic Area (EEA) the researcher is responsible for ensuring that local ethical considerations are complied with and that the relevant permissions are sought. Please state the location(s) in which your research will take place?

Have the appropriate local ethical considerations been complied with and relevant permissions sought?

Choose one of the following answers

Yes (awarded) - Note in the next section
Yes (pending) - Note in the next section
No - Intending to comply / apply
No - Not required

Please use the table below to record details of any licences or permissions required and / or applied for e.g. Local Authority District, Natural England etc. Ensure you include the reference, status and the date it was granted (if applicable).

If have not applied for a licence but you intend then please include but mark the status as 'to be applied for' or 'pending'. Evidence of any granted permissions should be provided to the relevant ethics committee via the upload question below..

	Permission / Licence	Awarding Body	Reference Number	Date of Permission	Status e.g. Granted / Pending
1
2
3
4
5

Please upload any granted permissions here.

Please upload at most 5 files

Upload files

	Title	Comment	File name

What are the potential risks to the researchers themselves? This may include: personal safety issues, such as those related to lone working, out of normal hours working or to visiting participants in their homes; travel arrangements, including overseas travel; and working in unfamiliar environments. Please explain any risk management procedures that will be put in place and note whether you will be providing any risk assessments or other supporting documents.

Please use no more than 300 words. If you prefer you can upload any relevant risk assessments (travel, project etc.) below.

Please upload any relevant/related documents.

Please upload at most 3 files

Upload files

	Title	Comment	File name

Does your study involve human samples which are considered “relevant materials” as defined by the Human Tissue Act (2004)*?

*Relevant materials are material, other than gametes, which consists of or includes human cells. This may include for example, blood, urine, saliva, or tissue samples e.g. biopsies. For further information please refer to: https://www.hta.gov.uk/guidance-professionals/hta-legislation/relevant-material-under-human-tissue-act-2004. If you are still unsure, please contact Maria Camacho Encina (maria.camacho-encina@ncl.ac.uk) or Chris Morris (c.m.morris@ncl.ac.uk) for advice.

Yes No

Will you be storing the material for more than 7 days prior to either:

processing the material to remove the cellular component, or
transferring the material elsewhere (to non-Newcastle University premises)?

Yes No

Does your study involve material requiring storage under the Human Tissue Act, and have you agreed on a location with Dr. Chris Morris (c.m.morris.ac.uk)?

This type of material may only be stored at approved storage locations on Newcastle University premises and collections will be subject to audit. This location must be approved by the Designated Individual named on the University’s research HTA licence.

Yes No

Please provide the location:

You must contact Dr Chris Morris (c.m.morris @ncl.ac.uk) to arrange a suitable storage location before the work begins.

Thank you. Based on your responses your materials will not come under the Human Tissue Act.

Please upload any documents (not uploaded elsewhere in the application) which you think are relevant to the consideration of your application.

Files must be under 10240 KB each

Please upload at most 5 files

Upload files

	Title	Comment	File name

Please confirm you want to clear your response?