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Full Ethical Approval Form
As part of its assurance and compliance processes the University ensures that all appropriate
projects, including student research and consultancy projects, undergo appropriate ethical
review before commencement. This form is used to elicit more detail where a project has been
identified as high risk and must be considered for approval by one of the University ethical
approval committees. Additional guidance can be found on the University ethics toolkit.
This form is to be used where preliminary ethical assessment has indicated that full ethical
review is required. You will be asked to transcribe the high risk flags from your preliminary
application and then be prompted to provide additional information.
If you have not completed a preliminary ethics assessment then you should do so through the
MyProjects Proposals system (for externally funded projects) or use the Preliminary Assessment
form (for unfunded projects).
Once completed a copy must be emailed to the relevant committee along with any supporting
documentation. No research should begin until approval has been granted.
Section 1: Applicant Details
This section must be completed in all instances.
Applicant Name
Contact Email
Academic Unit
Applicant Type
□Staff
□Undergraduate
□Postgraduate Taught
□Postgraduate Research
Section 2: Project Details
This section must be completed in all instances.
Project Title
MyProjects Reference
Already has ethical approval
Project Funder(s)
Other organisations involved
MyProjects Ref (where known)
Proposed Start / End Date
(dd/mm/yyyy)
Category
High risk flags – from Preliminary
form
Supervisor name & email
(Student Research projects only)
Who is responsible for the overall
management of the research?
□Yes
□ No
Start Date
End Date
__/__/____
__/__/____
□ Staff Research
□ Postgraduate Research
□ Course
□ Animals
□ Environment
□ International (non EEA)
□ NHS
□ Data
□ Humans Non-Clinical
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Name & post.
Who designed the research?
Name & post.
Who is conducting the research?
Name & post.
Is this a re-approval of an existing
project?
Has Peer Review taken place
□Yes
□ No
Ref:
□Yes By:___________________________ □ No
Section 3: Project Outline & Proposed Research methods
This section must be completed in all instances.
Project outline & aims
In everyday language, briefly explain the aims of this research including the anticipated benefits and
risks. 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.
Section 4: Animals
Complete this section only if the project was flagged ‘animals’ at the preliminary stage
Home Office (HO) License
Will the work be covered by an existing Home Office license?
If so, what is the reference?
If the work is not covered by a Home Office license, do you intend to apply
for one?
Have you discussed you project with the Director of the Comparative
Biology Centre or the Home Office?
IF your project uses wild caught animals, have you obtained the
appropriate permissions
□Yes
Ref:
□Yes
□ No
□Yes
□ No
□Yes
□ No
□ No
Why is it necessary to use animals in this project? Please use no more than 500 words.
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What are the kinds of animals to be used and how many of each? Please use no more than 300
words.
What will happen during and after the project? Please use no more than 500 words
Who will be carrying out the project? Briefly describe the relevant experience / expertise of the
persons involved? Please use no more than 500 words
Where will the animal be housed or located? If 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 are to be made on the animals, how frequently and by whom? What actions will be
taken if there are any adverse effects on the animals? Please use no more than 500 words
Section 5: Human participants in a Non-Clinical Setting
Complete this section only if the project was flagged ‘Human Participants in a Non-Clinical Setting’
at preliminary review
Participant Details
Does this research
specifically target
participants recruited
who are:
Select all that apply
□ Adults (over the age of 18 years and competent to give consent)
□ Children/legal minors (anyone under the age of 18 years)
□ People from non-English speaking backgrounds
□ Persons incapable of giving informed consent
□ Prisoner or parolee
□ Recruited through a gatekeeper
□ Welfare recipients
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How many participants
do you plan to recruit?
From what 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 that will include 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 and its aims and hypotheses)?
Will you provide participants with written debriefing too?
Yes
No
NA
If using a questionnaire, will you give participants the option of
omitting questions that they do not want to answer?
If an experiment, will you describe the main experimental procedures
to 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.
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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. Please use no more than 300 words.
A copy of your consent form must be provided with your submitted application
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. Please
use no more than 300 words.
A copy of your debriefing sheet must be provided with your submitted application
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 risk assessments or other
supporting documents. Please answer as fully as possible. Please use no more than 300 words.
Section 6: Data
This section must be completed in all instances
Please describe how data will be accessed, how participants' confidentiality will be protected and
any other considerations. Information must be provided on the full data lifecycle, from collection to
archive.
Alternatively please send a copy of your data management plan to the ethics committee. Please
note that you plan to do this in the box below. If you do not have a data management plan, funderspecific plans are available from the Digital Curation Centre. See https://dmponline.dcc.ac.uk/
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Section 7: Environment
Complete this section only if the project was flagged ‘environment’ at preliminary review.
Please provide the locations in which your research will take place, together with the anticipated
risks (destruction of habitat or artefacts/emissions, etc.), potential damage and mitigating measures
planned. Please use no more than 700 words.
Section 8: International (non EEA)
Complete this section only if the project was flagged ‘International (non EEA)’ at preliminary review.
Overseas: For any research conducted outside the 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) where your research will take place.
Have the appropriate local ethical considerations
been complied with and relevant permissions
sought?
□Yes (awarded) - Please note in ‘Permissions’
□Yes (pending) - Please note in ‘Permissions’
□ No
□ No - not required
Section 9: Permissions
This section must be completed in all instances
Please use the table below to record details of licenses or permissions required and / or applied for
e.g. LEA, governing body, etc. Ensure you include the reference, status and the date it was granted
(if applicable).
Permission / License
Award Body
Reference
Date of
Status e.g. Granted
Number
Permission
/ Pending
Section 10: Risk Considerations & Insurance
This section must be completed in all instances
Newcastle University must have in place appropriate insurance cover for its legal liabilities for
research studies. Dependent upon the nature of the research and how it is governed cover will
either come under Clinical Trials Insurance or Public Liability Insurance. Please refer to the
supplementary guidance “When does the Insurance Office need to be notified of a research
proposal?” for clarification.
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What are the potential risks to researchers themselves? This may include: personal safety issues,
such as those related to lone or 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 attach any risk
assessments or other supporting documents. Please use no more than 300 words.
Please attach a risk assessment or any other appropriate documents as required.
Section 11: Supporting documentation
This section must be completed in all instances
Please supply copies of any applicable and documents in support of your answers. Ensure that
attached files have appropriate file names.
Document
Attached
Participant consent form
Participant information sheet
Participant debriefing document
Questionnaire(s)
Outline protocol
Project risk assessment
Travel risk assessment
Original ethical assessment (re-approval only)
Data management plan
Peer review evidence (Internal / non funded)
Local permissions / licenses (non EEA)
Other ethical review forms
Others (please list):
None
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Section 11: Declaration
This section must be completed in all instances
I certify that:
the information contained within this application is accurate.

the research will be undertaken in line with all appropriate, University, legal and local
standards and regulations.

I have attempted to identify the risks that may arise in conducting this research and
acknowledge my obligation to (and rights of) any participants.

no work will begin until all appropriate permissions are in place.
Name of Principal Investigator:
Signed:
Date:
Please forward a copy of your completed application together with any relevant attachments to the
appropriate ethics committee.
Animal Welfare Ethics Review Board:
Paul.Dearden@ncl.ac.uk
Faculty of Humanities & Social Sciences:
Wendy.Davison@ncl.ac.uk
Faculty of Medical Sciences Ethics Committee:
fmsethics@newcastle.ac.uk
Faculty of Science, Agriculture & Engineering Ethics Committee:
SAGE.Ethics@newcastle.ac.uk
Any general ethics queries can be directed to:
res.policy@ncl.ac.uk
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