Preliminary Ethical Assessment Form
As part of its assurances 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 identify high risk
projects which may require further full ethical review. Additional guidance can be found at:
http://www.ncl.ac.uk/res/research/ethics_governance/ethics/index.htm
SECTION 1: Applicant Details
Name of Researcher (Applicant):
Academic Unit:
Email Address:
Supervisor Name (if applicable):
Supervisor Email (if applicable):
Module Code(if applicable):
SECTION 2: Project Details
Project Title:
Project Synopsis:
Has ethical approval to cover this
proposal already been obtained?
If YES, please confirm:
YES
NO
Approving Body:
Reference Number:
Date of Approval:
Will anyone be acting as sponsor
under the NHS Research
Governance Framework for
Health and Social Care?
Do you have a NUTH reference?
YES
NO
If ‘Yes’ please enter the name of the sponsor: ......................
YES
NO
If ‘Yes’ please enter the reference: ......................
If you already have approval then you do not need to complete the rest of the form. Please
go directly to the Declaration in Section 8.
SECTION 3: Animals
YES
NO
“Does your research involve the observation, capture or
manipulation of animals or their tissues?”
If you answered NO to this question, please go to Section 5
If you answered YES to this question, please complete the rest of the questions below.
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The Animals (Scientific Procedures) Act defines “protected
animals” as:
“any living vertebrate other than man….. in its foetal, larval or
embryonic form…….from the stage of its development when—
(a)in the case of a mammal, bird or reptile, half the gestation or
incubation period for the relevant species has elapsed; and (b)in
any other case, it becomes capable of independent feeding.”
YES
NO
In practice 'Protected' animals are all living vertebrates (other
than man), including some immature forms, and cephalopods (e.g.
octopus, squid, cuttlefish).
Using the definition above, does your programme of research
involve you or any related party?
a. Observing ‘protected animals’ within their natural or an
artificial environment? Observation can be passive i.e. bird
watching, active i.e. GPS tagging of individual animals, it
can relate to an individual animals or collection of animals
i.e. a school of fish, direct or indirect.
b. Capturing ‘protected animals’ (permanently or temporarily)?
c. Manipulating ‘protected animals’? Manipulation covers any
experimentation within a laboratory environment, handling,
care, husbandry or other interaction with animals.
d. Using any data obtained by the observation, capture or
manipulation of protected animals?
If you answered YES to Section 3, you will need to submit an application to the Animal
Welfare Ethical review Board. Please continue with the rest of the form.
SECTION 4: NHS, Health & Social Care: Facilities, Staff & Patients
YES
NO
“Will the study involve participants recruited by virtue of
being service users, their dependents, their carers or
human tissues or the use of NHS & Health / Social Care
Facilities or otherwise require REC approval? (If you are
unsure please tick ‘Yes and complete the sub-questions)
If you answered NO to this question, please go to Section 5
If you answered YES to this question, please complete the rest of the questions below.
Will the study involve any of the following?
YES
NO
a. Patients and users of the NHS?
b. Relatives or carers of patients and users of the NHS?
c. Foetal material, Human Tissues or IVF involving NHS
patients?
d. The recently dead in NHS premises?
e. Requires the use of, or access to NHS premises of facilities
(labs, clinics) or the study is a clinical trial?
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f.
Participants aged 16 or over who are unable to give
informed consent e.g. people with learning disabilities. For
a full list see the Mental Capacity Act 2005?
g. Human participants (users) in a social care setting within
the UK and N. Ireland?
h. Intergenerational studies in social care, involving adults,
children, or families as research participants?
i.
Or will the study come under the remit of GAFREC?
If you answered YES to any of Section 4, you 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/hra/ for the process. Please continue with the
rest of the form.
SECTION 5: Human Participants in a Non-Clinical Setting
Does the research involve human participants e.g. use of
questionnaires, focus groups, observation, surveys or labbased studies involving human participants? (If you are
unsure please tick ‘Yes’ and complete the sub-questions)
YES
NO
If you answered NO to this question, please go to Section 6
If you answered YES to this question, please complete the rest of the questions below.
Does the study involve any of the following?
YES
NO
a. The study involves children, or other vulnerable groups; as
defined in Section 59 of the Safeguarding Vulnerable
Adults Act 2006 as those who are relatively or absolutely
incapable of protecting their own interests, or those in
unequal relationships e.g. participants who are subordinate
to the researcher(s) in a context outside the research?
b. The study requires the co-operation of a gatekeeper for
initial access to the groups or individuals to be recruited
e.g. students at school, members of a self-help group, or
residents of a nursing home?
c. It is necessary for participants to take part in the study
without their knowledge and consent e.g. covert
observation of people in non-public places?
d. Deliberately misleading participants in any way?
e. Discussion of sensitive topics e.g. sexual activity or drug
use?
f.
The administration of drugs, placebos or other substances
(e.g. food substances, vitamins) to the study participants
g. Invasive, intrusive or potentially harmful procedures of any
kind?*
h. Obtaining blood or tissue samples?*
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i.
Pain or more than mild discomfort?
j.
Psychological stress, anxiety, harm or negative
consequences beyond that encountered in normal life?
k. Prolonged or repetitive testing. i.e. more than 4 hours
commitment or attendance on more than two occasions?
l.
Financial inducements (other than reasonable expenses
and compensation for time)?
* Please Note: Depending on the details of this project, this may require NHS approval. You
will be given further clarification if the project is awarded. You are also advised to consult the
JRO Policy Regarding the Participation of Volunteers in Research Projects.
If you have answered YES to any of questions in Section 5: You need to submit an
application to the appropriate Faculty Ethics Committee before your project progresses.
Please continue with the rest of the form.
SECTION 6: Data
YES
NO
Does the research involve the usage or transfer of
Sensitive personal data as defined as by the Data
Protection Act 1998 or data governed by statute such as
the Official Secrets Act, commercial contract or by
convention e.g. client confidentiality? (If you are unsure
please tick ‘Yes’ and complete the sub-questions)
If you answered NO to this question, please go to Section 7
If you answered YES to this question, please complete the rest of the questions below.
YES
NO
a. Will the study involve the sharing of sensitive data outside
the European Economic Area?
b. Will the study involve the collection or analysis of sensitive
data which will be identifiable within the project outputs and
could potentially cause harm?
c. Will the study involve the collection or analysis of personal
data without explicit consent?
d. Will the study involve the collection or analysis of information
covered by the Official Secrets Act, Terrorism Act,
commercial contract or license?
If you have answered YES to any of questions in Section 6: You need to submit an
application to the appropriate Faculty Ethics Committee before your project progresses.
Please continue with the rest of the form.
SECTION 7: Environment
Will the study cause direct or indirect damage to the
environment or emissions outside permissible levels or be
conducted in an area of special scientific or cultural
interest? (If you are unsure please tick ‘Yes’ and complete
the sub-questions)
If you answered NO to this question, please go to section 8
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NO
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Preliminary Ethical Assessment Form
If you answered YES to this question, please complete the rest of the questions below.
YES
NO
a. Is the research expected to lead to emissions to land, air or
water above the permissible level according to UK
regulations (or local regulations in the case of non-UK
research)?
b. Is the research expected to lead to a detrimental effect to the
landscape or cultural heritage, including artefacts?
c. Is it expected that the research might cause harm through
environmental fieldwork such as sampling or monitoring a
site?
d. Will the research be conducted in an environmentally
sensitive area or area of special scientific interest?
If you have answered YES to any of questions in Section 7: You need to submit an
application to the appropriate Faculty Ethics Committee before your project progresses.
Please continue with the rest of the form.
SECTION 8: International Projects
YES
NO
Will the research be conducted outside of the European
Economic Area (EEA) or will it involve international
collaborators outside the EEA?
If you have answered YES to any of questions in Section 8: You need to submit an
application to the appropriate Faculty Ethics Committee before your project progresses.
Please continue with the rest of the form.
SECTION 9: Declaration
By signing this declaration you confirm that;
* I certify that the information contained in this application is accurate.
* I certify that the research will be undertaken in line with all appropriate local standards and
regulations.
* I certify that I have discussed this form with my project supervisor and that they agree with the
answers given
Name of Principal Investigator:
Signed:
Date:
If you have any queries about this or any other ethical issue, please contact your Faculty
Ethics Coordinator or appropriate Grants and Contracts team.
-------------------------------------------------------------------------------------------------------------------------For office use only:
Date received in G&C:
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Requires full approval: YES/NO
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