Preliminary Ethical Assessment Form
The University must ensure that all its projects undergo appropriate ethical review before
commencement. This covers both internally and externally funded projects, including
postgraduate and undergraduate projects. In addition to the institutional requirement, main
research funders (e.g. Research Councils) now require assurances that projects have been
through an appropriate ethical review and that the research will be conducted within a
research governance framework embedded within the institution. The University has a 2
stage approach, requiring ALL projects to undergo a preliminary ethical assessment
process. Further guidance can be found at www.ncl.ac.uk/
Please complete the following Preliminary Ethical Assessment Form.
SECTION 1: APPLICANT DETAILS
Name of Researcher (Applicant):
Email Address:
Faculty & School:
Contact Address:
Telephone Number:
SECTION 2: PROJECT DETAILS
Project Title:
BH Reference:
YES
Has ethical approval to cover this
proposal already been obtained?
If YES, please confirm:
NO
Approving Body:
Reference Number:
Date of Approval:
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 4
SECTION 3: APPROVAL
Question 1: Animals or Other Organisms
Does the research involve the use of animals of other organisms
covered by the Animals (Scientific Procedures) Act?
YES
NO
If you answered YES to Question 1, you will need to submit an application for Full Ethical
Review to the University Ethical Review Committee. Please continue with the rest of the
form.
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Preliminary Ethical Assessment Form
Question 2: NHS Facilities, Staff and Patients
Does the research involve any of the following?
YES
NO
Patients and users of the NHS
Relatives or carers of patients and users of the NHS
Foetal material and IVF involving NHS patients
The recently dead on NHS premises
The use of, or potential access to, NHS premises or facilities
NHS staff recruited as research participants by virtue of their
professional role
Participants aged 16 or over who are unable to give informed
consent (e.g. people with learning disabilities; see Mental Capacity
Act 2005)
If you answered YES to any of Question 2, you need to submit an application for Full Ethical
Review to the appropriate external health authority ethics committee through the National
Research Ethics Service (NRES) – see http://www.nres.npsa.nhs.uk for the process. You
can skip to the declaration in Section 4.
Question 3: Overseas Research
Will the research be conducted outside of the UK?
YES
NO
If you answered YES to Question 3, you will need to submit an application for Full Ethical
Review. You can skip to the declaration in section 4.
Question 4: Human Participants in a Non-Clinical Setting
Does the research involve human participants (e.g. use of
questionnaires, focus groups or observation)?
YES
NO
If you answered NO to Question 4, please go directly to the declaration in Section 4.
If you answered YES to Question 4, please complete Question 5.
Question 5: Human Participants in a Non-Clinical Setting – Further Information
YES
Does the study involve other vulnerable groups (e.g. children,
those with cognitive impairment, or those in unequal relationships
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NO
Preliminary Ethical Assessment Form
(e.g. your own students))?
Will the study require 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, and residents of a
nursing home)?
Will it be necessary for participants to take part in the study
without their knowledge and consent at times (e.g. covert
observation of people in non-public places)?
Will this programme/project involve deliberately misleading
participants in any way?
Will the study involve discussion of sensitive topics (e.g. sexual
activity, drug use)?
Are any drugs, placebos or other substances (e.g. food
substances, vitamins) to be administered to the study participants
or will the study involve invasive, intrusive or potentially harmful
procedures of any kind?*
Will blood or tissue samples be obtained from subjects?
Is pain or more than mild discomfort likely to result from the
study?
Could the study induce psychological stress or anxiety or cause
harm or negative consequences beyond the risks encountered in
normal life?
Will the study involve prolonged or repetitive testing?
Will financial inducements (other than reasonable expenses and
compensation for time) be offered to participants?
Will the research involve administrative or secure data that
requires permission from the appropriate authorities before use?
Will the research involve members of the public in a research
capacity (i.e. participant research)?
Will the research involve respondents to the internet or other
visual/vocal methods where respondents may be identified?
Will research involve the sharing of data or confidential
information beyond the initial consent given?
If you answered NO to all of the sections in Question 5: Your project does not require Full
Ethical Approval. Please go to the declaration in section 4
If you have answered YES to any of Question 5: You will need to describe more fully how
you plan to deal with the ethical issues raised by your research by completing the Full
Ethical Approval application form (after your project has successfully been awarded). This
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does not mean that you cannot do the research - only that you will need to seek and
satisfy an ethical opinion from a Faculty Research Ethics Committee.
SECTION 4: DECLARATION
I certify that the information contained in this application is accurate.
Name of Principal Investigator:
Signed:
Date:
You should send copies of this form to the appropriate Grants & Contracts team, along with
the blue form. If you do not submit it with the blue form, you will be asked for it before the
application can be considered any further.
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:
Requires full approval: YES/NO
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