FACULTY OF ENGINEERING AND ENVIRONMENT
RESEARCH ETHICS PROCEDURES
RESEARCH ETHICS PROCEDURES
AUTHOR
AUTHORISED BY
Dr Paul Greenhalgh
Faculty Director of Research Ethics
Faculty Research Ethics Committee
DATE OF ISSUE
REVISED DRAFT July 2015
LAST UPDATE
24 July 2015
FACULTY RESEARCH &
INNOVATION COMMITTEE
APPROVAL
REVIEW INTERVAL
September 2015
LOCATION OF COPIES
Faculty Research Ethics and Governance web page
Faculty ELP Organisation
Annually
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FACULTY OF ENGINEERING AND ENVIRONMENT
RESEARCH ETHICS PROCEDURES
Contents
Item
Page Number
1.0 Context
4
2.0 Faculty Research Ethics Committee
4
3.0 Scope
5
3.1 Ethical Approval and Ethics Risk Status
5
3.1.1 Green
5
3.1.2 Amber
6
3.1.3 Red
6
4.0 Project Registration
7
4.1 Online Research Ethics Approval for Staff and Postgraduate Research
7
4.2 Paper Based Registration and Approval for Undergraduate and Taught
Postgraduate Research
7
5.0 Seeking and Recording Participants ‘Informed’ Consent
5.1 Standard Procedures for Amber projects
7
7
7
5.1.1 Informed Consent
7
5.1.2 Information Sheet
7
5.1.3 Consent Forms
7
5.2 Telephone Interviews
8
5.3 Questionnaires
8
5.4 Emails to Student Participants
8
5.5 Research Data
8
6.0 Other Matters
9
6.1 Module Level Ethical Approval
9
6.2 Project Amendment
9
6.3 Ethical Incident Reporting
9
6.4 Register
9
6.5 Partnerships and Joint Projects
9
6.6 Evidence Files for Undergraduate and Postgraduate projects
7.0 In Summary
9
9
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RESEARCH ETHICS PROCEDURES
Appendices
Item
A. Research Ethics Easy Guide for Staff and Students
Page Number
10
B. Ethical Scrutiny and Risk Levels
11
C. 1. Research Ethics Registration and Approval Form
14
2. Research Proposal Form
18
D. Research Participant Consent Form
29
E. Data Protection Act requirements for the collection, storage and destruction of
personal data
30
F. Project Amendment Request Form
32
G. File of Evidence Checklist [Taught Programmes]
33
H.
Module Level Ethical Approval
34
I.
Definitions of Research
36
J.
Northumbria University Definition of Research
37
K. Ethical Incident Reporting Form
43
L. Faculty Research Ethics Committee Terms of Reference
44
M. Useful URLS
46
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RESEARCH ETHICS PROCEDURES
FACULTY RESEARCH ETHICS PROJECT REGISTRATION AND APPROVAL
1.0 Context
Northumbria University has established policies, frameworks and guidance to address Ethics in
Research. This is an ever-changing field and the University’s policies and procedures are continually
revised and updated. The fundamental principle of good research practice is that the research should
maximise benefit and minimise harm. The University Ethics Policy clarifies the obligations on
researchers, promotes awareness of ethical principles and ethical issues in the conduct of all
research activities and provides a framework for their consideration at Northumbria University. The
University Research and Ethics Governance Handbook contains detailed guidance on principles of
good research practice. There are also a number of other documents which can be accessed from
both the University and Faculty Research Ethics and Governance web pages including guidance on
Ethics Scrutiny and Risk Assessment, signposting and links to other useful sources of information and
advice.
Please note that in all of the codes described hereafter, it is the responsibility of the Researcher (the
Principal Investigator for staff research) and Supervisor (for student research), to ensure that they
have understood the codes, and have coded their project accordingly – if in doubt seek appropriate
guidance before submission. It is also their responsibility to ensure that the documents they provide
within the ethics submission have been prepared according to Faculty/University guidelines. Please
also note that it is the responsibility of the Researcher (the Principal Investigator for staff research)
and Supervisor (for student research) to have consulted Faculty/University guidance on Health &
Safety of the proposed research. This may cover reference to appropriate Standard Operating
Procedures and/or Risk Assessment documentation.
The Faculty of Engineering and Environment (E&E) is required to have in place its own procedures for
monitoring ethical issues. The Faculty procedures derive from the University policy and procedures.
They are designed to complement and supplement the University policy and procedures. The Faculty
procedures do not replace the University procedures: all research activities should be conducted in
accordance with the latest University policy and procedures and researchers should ensure they are
familiar with them. The latest information for students should be available on the University
website(see Appendix M). Information for staff is available on NUnet (see Appendix M).
2.0 Faculty Research Ethics Committee
Each Faculty has a Faculty Research Ethics Committee (FREC) that meets at least three times a
year, chaired by the Faculty Director of Research Ethics. The FREC is a sub-committee of the
Faculty Research and Innovation Committee (FRIC) and reports to the University Research Ethics
Committee (REC). The terms of reference of the FREC (Appendix L) are as follows:
Strategy and Policy Development and Approval
1. To provide written guidelines on ethical issues for use by staff and students of the Faculty
2. To advise on any issues of an ethical nature referred to it directly or by the Executive Dean of the
Faculty, Faculty Research and Innovation Committee, Faculty Student Learning and Experience
Committee or by Service Departments
3. To facilitate the appropriate development of staff and systems that support the ethical review and
governance of research and teaching activity
4. To consider annual report and annual audits on the management of ethical issues in research and
the operation of Faculty level procedures
5. To monitor the committee’s constitution to ensure compliance with third party requirements
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Monitoring and Review
6. To review the Faculty’s Ethics procedures in light of the University’s Policy and the external ethics
environment and to propose changes as required
7. To monitor the implementation of ethical policies and procedures in the Faculty
8. To receive relevant papers/information from external bodies for consideration
9. To establish relevant time-limited working groups as necessary, to progress items of business.
Reporting Relationships/Interactions with other bodies
10. To receive reports from the Faculty Research and Innovation Committee and Faculty Student
Learning and Experience Committee and University Research Ethics Committee on Ethics plans,
policies and procedures developments
11. To submit an annual report on the committee’s activities and the operation of procedures for
ethical review of research to the Faculty Research and Innovation Committee and teaching and to the
Faculty Student Learning and Experience Committee and University Research Ethics Committee
12. To advise the Executive Dean of Faculty in respect of instances of non-compliance with the
University’s Ethics Policy.
3.0 Scope
Faculty Ethics Procedures apply to all research projects carried out by staff and students (hereafter
the ‘researcher’) of the Faculty including externally and internally funded research and non-funded
research. All research projects must be registered by the researcher and have received ethical
approval prior to commencement of the research. These procedures do not cover consultancy activity
arranged through Research and Business Services (RBS), which has its own procedures; however, if
the consultancy activity involves research which may later be published, then these ethics procedures
will apply.
3. 1 Ethical Approval and Ethics Risk Status (See Appendix B for Further Guidance.)
The University operates an Ethical Scrutiny and Risk Assessment tool to determine the level of ethical
risk associated for any given research project. Research projects may be designated as red, amber
or green risk, the category determining the level of ethical scrutiny required and any additional
conditions or requirements, e.g. approval by an external body and additional insurance. The
descriptions and action required for each code are listed below. Please bear in mind that it may not
always be possible to clearly identify the risk of a project, as some aspects of the research may have
different risks associated with them. In the first instance refer to the University Research Ethics and
Governance Handbook which provides detailed explanation of some of the criteria referred to below; if
you are still unsure consult the nominated Ethics Representative for your Department. If your research
project is borderline you are advised to over-estimate rather than under-estimate the potential risk
level, for example if you feel that your project is mostly ‘green’ but has some elements of ‘amber’ then
you should code your project as ‘amber’.
3.1.1 Green
If your research does not directly involve people as participants, or gathering personal, identifiable
data of a living individual, then it is classed as ‘green’. Such projects might involve gathering data
from people indirectly, e.g. content analysis of web discussion boards, analysis of archival records,
analysis of databases held in the public domain etc., but it will not involve the direct recruitment or
participation of an individual. Typically projects involving work relating to chemicals, product design,
engineering etc. are also green.
Green projects should not raise any significant ethical issues (e.g. research that is based purely on
secondary data, research that does not involve human participants). If you think that your research
project is green then you should submit your research proposal in the normal way. Green projects do
not require additional independent ethical review. Your principal supervisor, module tutor or
Departmental Ethics Representative will check your submission to confirm its code and will either
approve it, or perhaps request some minor clarifications from you.
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3.1.2 Amber
If your research involves people taking part, from whom you gather personal data (e.g. via surveys,
questionnaires, focus groups), or if your research deals with some sensitive issues not directly related
to a specific individual (e.g. commercially sensitive, politically sensitive, or may involve environmental
impact) then it is coded as ‘amber’. If you think that your project is amber, then submit your research
proposal in the normal way. Your principal supervisor or departmental ethics representative will check
your submission to confirm its code, and will then allocate an independent reviewer to assess your
application, and give you feedback on it. Approval will typically be given subject to conditions, as a
minimum that University and Faculty ethics procedures, as described in the following sections, are
adhered to (e.g. obtaining informed consent from participants and appropriate storage of private and
confidential information).
3.1.3 Red
If your research involves the participation of vulnerable individuals; intervention studies whereby
volunteers receive clinical/medicinal/physiological interventions; where human tissue is extracted;
where there are physical safety and/or emotional wellbeing concerns for the researcher or the
participant; where NHS approval is required; or where non-human animals are being tested; then it is
coded as ‘red’. It could also be the case that some studies involving commercially sensitive or
confidential data may also be red. These examples are not exhaustive, and it is your responsibility to
discuss thoroughly all potential ethical issues with your research team, or your supervisor (as
appropriate). If you think that your project is red risk, then submit your research proposal in the normal
way. Your supervisor or your ethics administrator (for staff and doctoral students) will check your
submission to confirm its code, and will then allocate two independent reviewers to assess your
application, and give you feedback on it.
Vulnerable participants include, but are not restricted to, anyone aged less than 18 years, people
with health problems or disabilities, anyone with a reduced capacity to give informed consent.
Research involving vulnerable participants or contact with vulnerable people even if they are not part
of the research (e.g. children of participants) may require the researcher to have a Disclosure and
Barring Service (DBS) check. The University’s Human Resources section co-ordinates all DBS
checks and can provide forms for initial risk assessment and application to the DBS.
Sensitive personal data is defined under the Data Protection Act as including:
 Racial or ethnic origin
 Political opinions
 Religious beliefs
 Physical or mental health
 Sexual life
 Committing or offences or alleged offences
 Proceedings/sentence for any offence committed or alleged to have been committed
N.B. This excludes personal data such as gender or ethnicity that is used purely for monitoring
purposes, or to ensure a representative sample, that is not otherwise part of the research.
Safety concerns for researchers or participants include physical risks, emotional distress and
professional harm.
All red research projects must be approved by the FREC either at a meeting of the FREC or by
agreement of two members of the FREC if there is no suitable meeting date, such agreement to be
reported to the next meeting of the FREC.
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4.0 Project Registration
4.1 Online Research Ethics Approval for Staff and Post Graduate Research
All Staff and Post Graduate Research (PGR) projects should be submitted for approval using the
University Research Ethics Submission Portal. In the case of joint projects, only one form is required
and this should be completed by the Principal Researcher/Investigator. Depending on research
activities undertaken, further information may need to be uploaded to ensure comprehensive
recording and timely processing. Authorisation will also be provided electronically.
4.2 Paper Based Registration and Approval for Undergraduate and Taught Post Graduate
Research
All taught students must complete the Faculty Ethics Registration and Approval Form (see Appendix
C.1) for every dissertation or research project they wish to undertake. Collection of primary data
should not commence until approval has been received.
The process for approval is dependent on the ethics risk status of the proposed research. In respect
of a research project that has been determined as either amber and green risk, such approval, with
conditions as appropriate, may be provided by the one independent reviewer and Principal Supervisor
respectively,
If the project topic or methodology changes significantly then a project amendment request should be
completed (see Appendix F) and submitted to the person(s) who approved the original proposal.
5.0 Seeking and Recording Participants’ ‘Informed’ Consent
5.1 Standard Procedures for Amber Projects
FREC has established standard procedures to address ethical issues arising from Amber projects as
detailed in the following sections.
5.1.1 Informed Consent
All research participants must give their informed consent to participation in any research and their
consent must be recorded. This includes interviews, focus groups, questionnaires, observation or any
other form of participation.
5.1.2 Information Sheet
Where information is to be gathered from persons participating in the research the prospective
participants must be provided with sufficient information to enable them to make an informed decision
as to whether or not they wish to participate. An Information Sheet, which will need to be uploaded
onto the online system record, should explain clearly the aims of the research project and how any
information obtained will be used, including future dissemination. It should include the name and
contact details of the researcher. Full guidance on producing an Information Sheet is contained within
the University Research Ethics and Governance Handbook.
5.1.3 Consent Forms
The following sections provide details of how consent should be obtained, depending upon the
circumstances.
A Research Participant Consent Form (RPCF), example shown at Appendix D, or similar record of
consent, should be completed by each individual participant. Participants are asked to confirm that
they have been briefed about the particular research project and its purpose and consent to their
involvement in the research.
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The RPCF also considers issues of anonymity and confidentiality and allows for the participant to
indicate specific requirements for anonymity or confidentiality including in relation to the use of
audio/video recorded interviews.
Other means of recording consent may be appropriate, such as an audio record. Audio records may
be appropriate e.g. where the participant has poor literacy skills or where telephone interviews are
used.
5.2 Telephone Interviews
In the case of interviews conducted by telephone rather than face to face, the following are indicated
as alternative procedures for gaining consent:
a. The researcher can set up the telephone interview and send the RPCF in advance by post or
email. The telephone interview should only to be carried out once the form has been
returned by the participant
b. The researcher telephones the proposed participant and asks for permission to record and
obtain consent verbally. Once the recorder is switched on the researcher and the interviewee
go through the issues raised in the Research Participant Consent Form and record the
answers. This will then create either an audio tape or a digital sound file; either will need to be
submitted like a written form.
A report of the telephone interview should be sent to the participant for approval with an
accompanying letter which should provide the following statement or similar: “If no response to this
request for consent to use the transcribed information from the telephone interview is received within
one month of the date of this letter, consent is deemed to have been provided”.
All participants’ consents (completed forms or otherwise) should be retained with the project data.
5.3 Questionnaires
Where a researcher intends to use questionnaires to gain primary research information, the
questionnaire must be accompanied by an information sheet (e.g. in a letter or email as appropriate)
explaining the purpose of the research and must include, at the end of the questionnaire, a standard
statement - as follows: “I understand the purpose of this research and agree to participate”. The return
of the questionnaire with this statement implies that the respondent has given consent.
5.4 Emails to Student Participants
The University has established special arrangements for sending emails to students asking them to
participate in research. Emails must not be sent directly to students. All students are given the
opportunity via My Northumbria to opt out of research. Researchers who wish to email students must
first obtain ethical approval and then should contact the Secretary to the FREC who will arrange for
the email to be distributed.
5.5 Research Data (see Appendix E for further information)
All data of a personal or confidential nature must be stored securely and at the end of the project
should be retained or destroyed in accordance with University policy and procedures. Full guidance
on data protection (in accordance with the Data Protection Act) and secure storage of research data
is available on the University website (see https://www.northumbria.ac.uk/about-us/leadershipgovernance/vice-chancellors-office/legal-services-team/northumbria-data-protection/ ).
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6.0 Other matters
6.1 Module Level Ethical Approval (see Appendix H for further information)
If you are tutor for a module that you think is suitable for module level approval please complete the
Module Level Approval Form (available via the Faculty Research Ethics web page) seeking module
level approval from FREC. This is typically for project based activity which is predictable and
controlled – if approval is given then all students on the module get automatic approval for their
research activity as long as it conforms with the assessment brief and any conditions agreed as part
of the module level approval. Any project work falling outside such parameters and conditions would
require separate registration and approval using the standard procedure.
6.2 Project Amendment (see Appendix F)
Any significant change in your research topic or methodology that raises new ethical issues should be
documented using the Project Amendment Request form contained in Appendix F; approval should
be sought, using this form, from the person(s) who approved the original project unless the project risk
has increased in which case a new project registration and approval should be submitted for the
substantially new research project.
6.3 Ethical Incident Reporting
If you are unfortunate enough to experience a Level 4 incident, such as the loss of personal or
confidential data e.g. leaving a lap top, flash drive or documents on a train etc. please report it to
FREC using the Level 4 Ethical Incidents Form contained in Appendix L. N.B. Level 4 incidents are
those not covered by Health and Safety reporting procedures, that do not involve any damage or
harm to either researcher or participants.
6.4 Register
Staff and PGR student records will be processed online. A register of undergraduate and taught postgraduate student research is to be maintained by Programme Administrators.
6.5 Partnerships and Joint Projects
In the case of projects carried out with other organisations or individuals there should be absolute
clarity, as part of the agreed working arrangements, as to the responsibility for all ethical issues e.g.
ethical approval requirements and procedures, obtaining informed consent, storing confidential data
and information, intellectual property rights, insurance and indemnity.
6.6 Evidence Files for Undergraduate and Post Graduate Research Projects
Researchers should compile a file (hard copy for campus based programmes; electronic copy for
distance learning programmes) containing records of participant consent and other supporting
documentation to verify that the research has conformed to the University and Faculty Ethics policies
and procedures and conditions of ethical approval. (See Appendix G for list of Evidence File
contents; N.B. not all items are necessarily required.)
7.0 In Summary
It is the responsibility of the researcher not only to ensure that they register the research project and
gain ethical approval before commencing their research, but also to ensure that the research is
conducted in an ethical manner subject to any conditions imposed upon it as part of the approval
process and in accordance with University and Faculty policies and procedures. If you are still in any
doubt about how to progress your research project through the registration and approval process see
Appendix A - Research Ethics Easy Guide for Staff and Students. If you require any further
clarification, refer to your principal supervisor, module tutor or Departmental Research Ethics
representative.
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APPENDIX A – RESEARCH ETHICS EASY GUIDE FOR STAFF AND STUDENTS
STAGE 1: RESEARCH DESIGN
Researcher writes a proposal for their research project, identifying ethical issues associated with their
research, particularly in relation the research methods, and how they will deal with them. Researcher
should discuss these matters with their Principal Supervisor or Research Mentor early on. Documents
may need to be prepared in advance of formal registration and approval (for further advice refer to
University and Faculty Ethics Procedures)
STAGE 2: ETHICAL SCRUTINY AND RISK ASSESSMENT FOR RESEARCH PROJECTS
Using the University’s Ethical Scrutiny and Risk Levels guide, determine the category into which your
research project falls which will, in turn, determine the level of approval that is required. There are 3
ethical risk categories:
RED - High Risk [vulnerable people, human tissue, personal data, risks to participants etc.]
AMBER - Medium Risk [informed consent from participants, commercial sensitivity etc.]
GREEN - Low Risk [no participants involved, secondary data only, no sensitive data etc.]
N.B. there may still be a need for separate Health and Safety risk assessment & approval
STAGE 3 – SUBMISSION FOR REGISTRATION AND APPROVAL
STAFF & POST GRADUATE RESEARCHERS: submit proposal using University Ethics on-line approval
system, follow instructions and upload documents where required; select Departmental Ethics
Representative, Principal Supervisor or Research Mentor as Administrator
UNDERGRADUATE AND TAUGHT POST GRAD: complete and submit paper based registration and
approval form to Principal Supervisor or Module Tutor where appropriate (refer to Faculty Ethics
Procedure and dissertation/project handbook for further guidance)
STAGE 4 – REGISTRATION AND APPROVAL
GREEN projects may be approved by the Principal Supervisor or Research Mentor without conditions
AMBER projects are subject to consideration by one independent reviewer, such as Module Tutor,
Second Marker, Departmental Ethics Representative, and may be approved with conditions
RED projects must be referred to Faculty Research Ethics Committee for consideration
N.B. all on-line approvals are subject to monitoring and oversight by Faculty Research Ethic Committee
and periodic audit; copies of all staff and PGR paper based approval documentation should be submitted
to the EE PGR administration via: rn.ethicssupport@northumbria.ac.uk; all undergraduate and post
graduate taught project registration and approval documentation should be copied to the relevant
programme administrator with the original paperwork being retained by the student in the evidence file.
STAGE 5 – CONDUCTING THE RESEARCH PROJECT & PROJECT AMENDMENT
As researcher you must ensure that you conduct the research in and ethical manner that conforms with
any conditions of approval; Principal Supervisor to ensure that the research conforms with University &
Faculty Ethics, Governance, Health and Safety and other relevant procedures and policies. If there is
significant variation to the research topic or methodology a project amendment request needs to be
submitted for approval
STAGE 6 – RECORDING & SUBMITTING PARTICIPANT CONSENT AND OTHER DOCUMENTS
It is the researcher’s responsibility to record and submit, on request, evidence of participants’ consent
plus any other documentation necessary to verify that the research has been conducted in an ethical
manner, such documentation, in electronic or hard copy, to be submitted on request either concurrent
with the dissertation or project submission or at a later date.
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APPENDIX B – ETHICAL SCRUTINY AND RISK LEVELS
RISK LEVELS.
Northumbria University seeks to ensure that ethical standards are maintained in
research by and throughout the University. Faculties, on behalf of the University, are
responsible for ensuring all students and staff conducting research, and all research
conducted on University staff, students, and premises, is in accordance with the
University’s ethical standards. In order to help you determine the level of ethical
scrutiny and risk for your research projects, we have devised a question and answer
self-evaluation form to help your assessment and subsequently inform you about the
level of ethical review required.
There are 3 levels of ethical and risk scrutiny:
RED
High risk; requires high level of scrutiny
AMBER
Medium risk; requires internal review
GREEN
Low risk; may not require internal review if
compliant
with
Faculty
governance
procedures
Please refer to the Glossary of Terms if required.
Self-assessment: ethical scrutiny and risk level for your research projects
Does your research specifically involve one of the following?









Medicinal products
Clinical trial
Animal subjects
Children or vulnerable adults
NHS staff, patients, premises or equipment
Human tissue
Concerns around safety or discomfort for the participants or researchers
Sensitive subjects such as trauma
Data which comes under the Official Secrets Act
If YES, follow guidance for RED result
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If NO, does your research involve any of these?






Non-vulnerable adults
Personal data referring to a living individual
Secondary data not in the public domain
Environmental issues
Commercially sensitive information
Pharmacologically active substances
If YES, follow guidance for AMBER result
If NO, is your research


completely based on secondary data which has been previously published
and/or
desk or lab-based and does not involve people in data collection?
If YES, follow guidance for GREEN result
GUIDANCE
RED
High risk; requires high level of scrutiny. Review internally and externally
Other considerations: indemnity arrangement, external legislation and
sponsorship
Your research involves one of the following: medical products, clinical trials, animal
subjects, human tissue, children, vulnerable adults, NHS staff, patients, premises or
equipment, sensitive subjects, data which comes under the Official Secrets Act or
safety concerns for researcher or participants.
What to do next
Your project proposal will require a high level of ethical scrutiny by two independent
reviewers, and possible external peer review. There may also be legislative
requirements to comply with e.g. MHRA, NHS REC, Human Tissue Act and
EudraCT. Indemnity arrangements may also need to be reviewed in light of the
additional risk involved.
If your Faculty Research Ethics Committee is unable to resolve the issue, the
proposal should be reviewed by the University Research Ethics Committee.
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AMBER
Medium risk; requires internal review
Other considerations: Informed consent and confidentiality
Your research involves eithernon-vulnerable adults, personal data of a living
individual, secondary data not in the public domain, environmental issues,
commercially sensitive information or pharmacologically active substances.
It does not involve medical products, clinical trials, animal subjects, children,
vulnerable adults, NHS staff, patients, premises or equipment, sensitive subjects,
data which comes under the Official Secrets Act or safety concerns for researcher or
participants.
What to do next
Your project proposal has some ethical implications and will be reviewed by one
independent reviewer appointed by your Faculty Research Ethics Committee. Some
factors to be considered include considering obtaining informed consent forms from
organisations or people involved, permission to use data from the Data Controller, as
well as confidentiality/anonymity issues.
GREEN
Low risk; may not require internal review if compliant with Faculty
governance procedures
Other considerations: none
Your research is completely based on the analysis of secondary data (currently in
the public domain with no restrictions of access, not commercially or personally
sensitive, and does not relate to specific people the analysis of which is not likely to
lead to adverse representation); is desk or lab-based; is a small-scale pilot only
involving members of the research team; or does not involve people in data
collection; or data from living individuals (other than members of your research
team).
What to do next
Your project proposal does not need to be reviewed by your Faculty Research Ethics
Committee, however, you need to be ethically aware and ensure that you have not
breached plagiarism or copyright regulations and have adequately referenced your
material. It is recommended that you refer to Northumbria Research Ethics Policy.
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APPENDIX C. 1 – RESEARCH ETHICS REGISTRATION AND APPROVAL FORM
Faculty of Engineering and Environment
RESEARCH PROJECT: ETHICS REGISTRATION AND APPROVAL FORM
Section One: Registration [To be completed by researcher]
Title of research project/dissertation
Researcher’s name
Please only complete the following if researcher is a student:
Programme of study
Academic Year
Module code (if applicable)
Principal Supervisor or Module Tutor
Start Date
Brief outline of research topic:
Short description of proposed research methods including identification of participants:
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Ethical considerations in the research project
YES
NO
1. Does your research involve an external organisation or partner?
2. Does your research involve human participants?
3. If yes to Q.2, will you inform the participants about the research?
4. Will you obtain their consent using the standard consent form?
5. Is any deception involved?
6. Do any participants constitute a ‘vulnerable group’?
(refer to definition of Vulnerable People)
7. Will the research involve the following information?
Commercially sensitive
Personally sensitive
Politically sensitive
Legally sensitive
8. Is the research likely to have any significant environmental impacts?
9. Are there likely to be any risks for the participants in your research?
10. Are there likely to be any risks for you in conducting the research?
11. If yes [to 5, 6, 7, 8, 9 or 10 above] have you identified steps to address the
issues and mitigate any risks to participants, yourself or the environment?
Statement to explain how any issues identified above will be addressed and what steps will be
taken to mitigate such risks or adverse impacts
Ethical category of research project
Based on the above Ethical Considerations and with reference to the University’s Ethical Scrutiny
Risk Assessment tool, identify the Ethical category of your research project (refer to
http://www.northumbria.ac.uk/static/5007/respdf/riskassesmenttool for further guidance):
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[Please tick as appropriate]
vulnerable participants; human tissue; sensitive data; risks to participants & researchers etc.
Red
human participants requiring informed consent; commercially sensitive information etc.
Amber
no participants involved; secondary data only; no sensitive data
Green
I have read the University and the Faculty Ethics Policy and Procedures and confirm that the
answers I have given above are correct. Where issues arise under items 5, 6, 7, 8, 9 or 10
[above] I have described in writing how I intend to approach these issues in the research.
Researcher’s signature
Date
Section 1 Ethics Registration to be submitted to Principal Supervisor or Module Tutor and
allocated to a reviewer as follows:
Green risk - may be approved by Supervisor
Amber risk - to be submitted for approval by one independent reviewer
Red risk - to be submitted for approval by two independent members of Faculty Research
Ethics Committee
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Section Two: Approval
Supervisor/Module Tutor’s name
confirming ethical risk status
Ethical approval [Please tick as appropriate]
Green - Ethical approval is given without conditions (supervisor may approve)
Amber – (to be approved by one independent reviewer) Ethical approval is
given with the following conditions:







Information to be provided to all participants
Participant consent to be obtained using the standard Research
Participant Consent Form or otherwise in accordance with Faculty
procedures
Data to be stored and destroyed securely in accordance with University
guidelines
Adherence to Data Protection Act
Anonymity to be offered to participants
Commercial confidentiality to be provided to organisations(s)
Other (please state):
Red - Project is referred to FREC for approval.by two independent reviewers
Please e-mail the submission to PGR Faculty Support
Name & role of reviewer 1:
……………………………………….
Signature
……………………………………….
Date
……………………………………….
Name & role of reviewer 2:
……………………………………….
Signature
……………………………………….
Date
……………………………………….
Outcome of Review
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APPENDIX C. 2 – RED RISK RESEARCH PROPOSAL LONG FORM
This form should only be used for complex Red Risk research projects. Depending on your research
study, you may need to include supporting documentary evidence as part of this form. Please refer to
the University Research Ethics and Governance handbook, or those provided by your Faculty or
Service Department for information about the type of evidence you need to provide.
Project title:
Submitter information
Name:
Status:
Staff
PG research
PG taught
Amber
Green
Undergraduate
Department:
Email:
Principal Supervisor (if relevant):
Risk status:
Red
Please list your co-investigators:
Data Source
Tick all relevant boxes that apply to your proposed research and then make sure that you also
complete all of the relevant sections.
1. People and/or personal data of a living individual
Participants are defined as including living human beings, human beings who have recently died,
(cadavers, human remains and body parts), embryos and foetuses, human tissue and bodily fluids,
human data and records (such as but not restricted to medical, genetic, financial, personnel, criminal
or administrative records including scholastic achievements. Personal data is defined as any
identifiable information that affects a person's privacy such as information which is biographical in a
significant sense or has the relevant individual as its focus rather than some other person or some
transaction or event. This includes video/audio and photographic materials.
PLEASE COMPLETE SECTIONS: 1, 6, 7, 8, 9
_________________________________________________________________________
2. Human Tissue
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Any material that has come from a human body that consists of, or includes human cells, with the
exception of hair and nails from living people, and live gametes and embryos created outside the
human body.
PLEASE COMPLETE SECTIONS: 2, 6, 7, 8, 9
_________________________________________________________________________
3. Animal Subjects
Any vertebrate other than humans (mammals, birds, reptiles, fish, amphibia) and the invertebrate
species, Octopus vulgaris.
PLEASE COMPLETE SECTIONS: 3, 7, 8, 9
_________________________________________________________________________
4. Secondary data (not in public domain)
Secondary data involves the use of existing data (not in the public domain) with the permission of the
Data Controller for purposes other than those for which they were originally collected. Secondary data
may be obtained from many sources, including surveys, computer databases and information
systems.
PLEASE COMPLETE SECTIONS: 4, 7, 8, 9
_________________________________________________________________________
5. Environmental Data
Any outdoor fieldwork in rural, coastal, marine or urban environments and the temporary or long term
effects the research study may have on people, animals or the natural or built environment.
PLEASE COMPLETE SECTIONS: 5, 7, 8, 9
_________________________________________________________________________
6. Data in the public domain
Data which is obtained from secondary sources which are in the public domain (e.g. existing
databases, archives) and which does not involve the direct involvement of human participants.
PLEASE COMPLETE SECTIONS: 7, 8, 9
_________________________________________________________________________
7. None of the above
Please explain:
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1. PEOPLE AND/OR PERSONAL DATA
If you are involving human participants, or are gathering personal data about a living individual, then
please complete all of the sub-sections in section 1.
A: RESEARCH AIMS
Briefly state your research aims/questions:
B: STUDY DESIGN AND DATA ANALYSIS
Please provide a description of the study design, methodology (e.g. quantitative, qualitative), the
sampling strategy, methods of data collection (e.g. survey, interview, experiment, observation), and
analysis
Ci SAMPLE
Provide details of the sample groups that will be involved in the study and include details of their
location (whether recruited in the UK or from abroad) and any organizational affiliation. For most
research studies, this will cover: the number of sample groups; the size of each sample group; the
criteria that will be used to select the sample group(s) (e.g. gender, age, sexuality, health conditions).
If the sample will include NHS staff or patients please state this clearly. If this is a pilot study and the
composition of the sample has not yet been confirmed, please provide as many details as possible.
Will your study involve vulnerable people? Refer to the University ‘Policy on Research Involving
Children and Vulnerable Adults’ for definitions and examples of “vulnerable”.
Yes
No
If yes: Describe what role, if any, parents/carers/consultees will take in the study:
Cii If you will be including personal data of living individuals, please specify the nature of this data,
and (if appropriate) include details of the relevant individuals who have provided permission to utilise
this data. Upload evidence of these permissions in the supporting documentation section.
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Ciii. RECRUITMENT
Describe the step by step process of how you will contact and recruit your research sample and name
any organisations or groups that will be approached. Your recruitment strategy must be appropriate to
the research study and the sensitivity of the subject area. You must have received written permission
from any organisations or groups before you begin recruiting participants. Copies of draft requests for
organisational consent must be included in the ‘Supporting Documentary Evidence’. You must also
provide copies of any recruitment emails/posters that will be used in your study.
Will you make any payment or remuneration to participants or their carers/consultees?
Yes
No
If yes: Please provide details/justifications. Note that your Faculty may have specific guidelines on
participant payments/payment rates etc. and you should consult these where appropriate:
Civ. RESEARCH TEAM – DBS CLEARANCE
If you, or any members of the research team, will have regular contact on an individual basis with
children or vulnerable adults as part of this research study, the relevant DBS (Disclosure and Barring
Service) clearance may have to be obtained in advance. Check at the DBS website
https://www.gov.uk/disclosure-barring-service-check/overview and then complete the sections below
Will you, or any member of your research team, require DBS clearance?
Yes
No
If yes:Provide details of the DBS clearance that has been obtained
Name
Type of DBS clearance
Reference
Date of DBS check
(State: standard,
enhanced, enhanced
with lists)
Click here to enter a date.
D. CONSENT
Please indicate the type of consent that will be used in this study:
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Informed consent
Please include copies of information sheets and consent forms in the ‘Supporting Documentary
Evidence’. If you are using alternative formats to provide information and /or record consent (e.g.
images, video or audio recording), provide brief details and outline the justification for this approach
and the uses to which it will be put:
Informed consent in line with sections 30-33 of the Mental Capacity Act
If the study involves participants who lack capacity to consent, procedures in line with sections 30-33
of the Mental Capacity Act will need to be put in place. Please outline the intended process for
seeking consent and include copies of information and consent forms in the ‘Supporting Documentary
Evidence’. If you are using alternative formats to provide information and /or record consent (e.g.
video or audio recording), provide brief details:
If using an alternative consent model (e.g. for ethnographic research)
Provide a rationale that explains why informed consent is not appropriate for this research study and
detail the alternative consent arrangements that will be put in place. Add any relevant supporting
documentation to the ‘Supporting Documentary Evidence’ section.
E. RISK
Please refer to any Risk Assessments (RA) you have consulted to ensure the safety of the research
team and your participants. Please state the level of risk for each RA. If none have been consulted
please explain how any potential risks will be managed.
F. TASKS AND ACTIVITIES FOR RESEARCH PARTICIPANTS
I.
Provide a detailed description of what the participants will be asked to do for the research
study, including details about the process of data collection (e.g. completing how many
interviews / assessments, when, for how long, with whom). Add any relevant documentation
to the ‘Supporting Documentary Evidence’ section of this form.
II.
Provide full details of all materials that will be used (including consent documentation). If you
are using newly developed or unpublished materials these must be provided as Supporting
Documentary Evidence
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If the task could cause any discomfort or distress to participants (physical, psychological or
emotional) describe the measures that will be put in place to reduce any distress or
discomfort. Please give details of the support that will be available for any participants who
become distressed during their involvement with the study.
2. HUMAN TISSUE
If your research study uses human tissue, all of the questions in this section must be completed.
A. SAMPLES
Provide details of the type of human tissue samples (e.g. blood, oral fluids, urine, saliva) and the
number of samples the research study will collect and/or examine.
Will this research study use samples that have been collected by another organisation or institution?
Yes
No
If yes:Where applicable ( e.g. commercially available cell lines) provide details of the supplier
(company or institution name, address and telephone number). Appropriate letters of permission
should be included as supplementary evidence. Describe any measures that will be put in place to
meet the supplier’s terms and conditions. (Note: arrangements about anonymising data, data storage
and security should be provided in section 6). N.B. Primary cell lines and stem cells require consent
documentation and compliance with HTA regulations.
Describe how the sample will be taken or collected and provide the names and university/company
affiliation of the researchers or technicians involved in taking or collecting samples. If your study
involves blood samples, name the trained phlebotomist who will be taking the blood samples.
Provide a schedule that shows the type of sample(s) (e.g. blood, oral fluids, urine, saliva) and the
number of samples that will be taken from participants over your chosen period of time.
If the task could cause discomfort or distress to participants (physical, psychological or emotional)
describe the measures that will be put in place to reduce any distress or discomfort.
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Explain how the samples will be disposed of, or transferred to another facility after your research has
ended.
3. ANIMAL SUBJECTS
If your research study uses animal1 subjects or biological material from animals, all of the questions in
this section must be completed. If the study has the potential to cause distress or harm to animals,
you must consider the 3 Rs (replacement, refinement and reduction) and apply these principles to the
study.
A. Sample
Describe how animals, or biological material from animals, will be used in this study. Your description
should include: the species; the number of animals or the number of samples that will be used in the
study; and if the study will take place in the natural environment or in research premises.
B. Source of sample
Provide the contact details (company or organisation name, address and telephone number) of the
supplier who is providing the animals or animal tissue. If it is a commercial supplier, include a copy of
the letter or email confirming the supplier’s Schedule One status under ‘Supporting Documentary
Evidence’. If the supplier is a University, include a letter or email confirming that the animal was culled
under Schedule One conditions under ‘Supporting Documentary Evidence’.
C. Licenses
Does your work require licensing under the Animals (Scientific Procedures) Act 1986?
Yes
No
If yes: Provide details of the licenses that you currently hold or will be applying for:
1
Any vertebrate, other than humans (mammals, birds, reptiles, fish, amphibia) and the invertebrate
species, Octopus vulgaris
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4. DATA FROM SECONDARY SOURCES
If your research will be using data from secondary sources (i.e. data about people that has not been
gathered by you from the research sample and which is in the public domain) then the following
sections must be completed.
A. DATA SOURCE
Describe any measures that will be put in place to meet the supplier’s terms and conditions. (Note:
arrangements about anonymising data, data storage and security should be provided in section 6).
Where permissions are required to access data, provide evidence of the relevant permissions you
have obtained in the supporting documentary evidence.
If your research involves the cooperation of external organisations then relevant permission
should be provided in the ‘Supporting Evidence Section’.
5. ENVIRONMENTAL DATA
If your research study involves taking samples from the urban or natural environment (e.g. (soil,
water, vegetation, invertebrates, geological samples etc.) all of the questions in this section must be
completed.
A. SITE INFORMATION
List the locations where the data collection will take place including, where appropriate, the map
reference. State if the location is protected by legislation (e.g. Area of Outstanding Natural Beauty
(AONB), Site of Special Scientific Interest (SSSI), National Park etc).
B. PERMISSION AND ACCESS
Do you need permission to include the location(s) in the research study or to gain access to the
site(s)?
Yes
No
If yes: State the job title and contact details (address and telephone number) of the person you will
contact to request permission. If you have already received permission, please include a copy of the
letter or email confirming access under ‘Supporting Documentary Evidence’.
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C. SAMPLES
Provide details of: the type of sample(s) you will collect (soil, water, vegetation, invertebrates etc); the
size of each sample; and the spread of sampling across the location(s). Explain how the samples will
be disposed of after the research is complete
Briefly explain why collecting the sample(s) is essential to the research study.
D. COLLECTION
Describe how you will reach the site and any potential pollution, noise, erosion or damage that could
occur. Detail the measures you will take to reduce any impacts.
Detail any impacts caused by extracting the sample (e.g. disturbance of animal or bird populations;
use and disposal of chemicals in the field; trampling or removal of vegetation; visual or aesthetic
impacts caused by markers left on the site). Detail the measures you will take to reduce any impacts.
6. Data security and storage
A. ANONYMISING DATA
Describe the arrangements for anonymising data and if not appropriate explain why this is and how it
is covered in the informed consent obtained.
B. STORAGE
Describe the arrangements for the secure transport and storage of data collected and used during the
study. This should include reference to ‘clouds’, USB sticks.
C. RETENTION AND DISPOSAL
Describe the arrangements for the secure retention and disposal of data when the research study is
complete.
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7. Intellectual property
Please provide details of any Intellectual Property issues or commercial implications arising from the
proposed study. Please describe the agreements that are in place to protect / exploit the Intellectual
Property.
8. Timescale
Proposed start date of data collection: Click here to enter a date.
Proposed end date of data collection: Click here to enter a date.
9. Supplementary information
Please tick the boxes that relate to the supplementary documentation that you will attach as part of
your submission:
Participant information sheet
Consent form(s)
Debrief sheet
Participant recruitment email/poster
Unpublished (in-house) questionnaire(s)
Interview / observation / focus group schedules
Risk Assessments / Standard Operating procedures
Permission letters (e.g. from school, organization, team etc.)
Other documents. Please specify below:
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APPENDIX D - RESEARCH PARTICIPANT CONSENT FORM
Faculty of Engineering and Environment
RESEARCH PARTICIPANT CONSENT FORM
Name of participant
Organisation
Researcher’s name
Title of research project/dissertation
Programme of study
[Only if researcher is a student]
Supervisor’s name
[Only if researcher is a student]
Brief description of nature of research and involvement of participant:
Standard statement of participant* consent (please tick as appropriate)
I confirm that:
I have been briefed about this research project and its purpose and agree to participate*
I have discussed any requirement for anonymity or confidentiality with the researcher **
I agree to being audio recorded/filmed/photographed ***
*
Participants under the age of 18 normally require parental consent to be involved in research.
*** Delete as appropriate
**Specific requirements for anonymity, confidentiality, data storage, retention and destruction
Signed
Date
Standard statement by researcher
I have provided information about the research to the research participant and believe that he/she
understands what is involved.
Researcher’s signature
Date
……………………………………….
……………………………………….
APPENDIX E - DATA PROTECTION ACT REQUIREMENTS FOR COLLECTION,
STORAGE AND DESTRUCTION OF PERSONAL DATA
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As a minimum, personal and confidential data should only be obtained if it is required for the
purposes of the research and should not be used for any other purpose. Such data should
usually be coded with the identifying details and the data itself stored separately.
Data should be locked away when not in use and any computer facilities used should be
password protected. Requests for devices to be encrypted can be made through the IT
Helpline. If staff or post-graduate researchers require facilities to ensure secure storage e.g.
a lockable cupboard, they should contact the secretary to the FREC.
Data Protection
Audio and visual recordings of an individual fall under the definition of “personal data” as
defined under the Data Protection Act 1998 (DPA). Therefore any time you use your device
to capture such data, you must ensure that it is processed in accordance with the DPA. The
seventh principle of the DPA states:
“Appropriate technical and organisational measures shall be taken against
accidental loss or destruction of, or damage to, personal data.
This principle extends to the use of personal devices used for the purpose of undertaking
research as a representative of the University.
Device Security
It is the device owner’s responsibility to understand the security features provided by the
smart phone/device and to ensure that they are used sufficiently to keep data secure. This
includes:
1. Ensuring that the device has installed and configured a tracking and/or remote wiping
service (e.g. ‘Where’s My Droid’ for Android devices, ‘Find My Phone’ for Windows devices
or ‘Find My iPhone’ for iPhones).
2. Ensuring that the device has up-to-date anti-virus software installed and that it does not
block the use of the above.
3. Ensuring that the device ‘software updates’ service is installed and active to ensure that the
latest versions of points 1 & 2 are installed at all times.
4. Ensuring that the device includes an automatic locking mechanism which requires a PIN,
password and automatic lock to help protect the device when not in use.
5. Where personal data (as defined by the Data Protection Act 1998) or confidential information
is being collected, automatic saving of the device content to personal cloud services is
disabled.
6. Automatic syncing with any other personal device is disabled.
7. Information stored on the device is transferred onto your University account at the earliest
opportunity and then deleted from the device itself.
8. You do not take a device containing any sensitive information anywhere that would be
considered a ‘high risk’ environment where phones are at risk of being lost or stolen.
9. The device is wiped and returned to the ‘manufacturer’s settings’ prior to disposal, including
where it is sold or exchanged.
Loss or theft of your device
In the unfortunate event that your device is lost or stolen you must:
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



Report the loss to the police and obtain a crime reference number.
Use the remote wiping service to ensure that any data held on there is removed.
Report the theft to your service provider so that they can also take preventative
action against the phone being accessed
Notify your Faculty immediately, or at the earliest opportunity of the loss (i.e. next
working day if lost at night) and assist them with any investigation, should one be
necessary.
Monitoring of your Device
The University cannot actively monitor the content of your personal devices, so the onus is
on you to ensure the privacy, integrity and confidentiality of any data you store on them.
Use of Personal Cloud Services
Personal data as defined by the Data Protection Act (1998) and University confidential
information may not be stored on personal cloud services
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APPENDIX F – PROJECT AMENDMENT REQUEST FORM
Faculty of Engineering and Environment
PROJECT AMENDMENT REQUEST FORM
Title of research project/dissertation
Researcher’s name
Date of original ethical approval
Principal Supervisor or Module Tutor
Date of submission of request
Description of change
Reasons for change
Anticipated implication
Acceptance/Rejection
Signature:
Date
Follow up action required
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APPENDIX G - FILE OF EVIDENCE CHECKLIST [TAUGHT PROGRAMMES]
Faculty of Engineering and Environment
EVIDENCE FILE CHECKLIST
TO BE SUBMITTED ON REQUEST
Student Number
Module Code
Please tick the list below to indicate the contents of your evidence file; note that this will vary
depending on your topic and methodology – you are not expected to tick all items listed. You should
include all copies of both paper and electronic data where not bound into the dissertation of project
report. Bulky items e.g. concrete or soil samples, should not be included but retention/storage should
be discussed with your supervisor.
Evidence to be included
YES
NO
NOT
APPLICABLE
Records of meetings with supervisor
List of participants/respondents
All signed participant consent sheets
Information/briefing sheets for participants
Dates and locations of interviews / data
collection activities
All completed (original) questionnaires
All notes from Interviews, researcher diary, lab
note book etc.
Electronic data
Data collection / observation /experimentation
records
Notes on /early drafts of mathematical
calculations
Notes on /early drafts of drawings and sketches
Copies of source materials (when not available
through the library/Web, such as internal
company reports)
Notes made on /about private source materials
Others: (please list, continue on a separate
sheet if necessary)
In compiling this evidence file I understand the data will be destroyed, in accordance with University
Procedure, after the Examination Board (unless previously agreed with supervisor).
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APPENDIX H - MODULE LEVEL ETHICAL APPROVAL FORM
Faculty of Engineering and Environment
MODULE LEVEL ETHICAL APPROVAL FORM
Module Tutor:
Module Title:
Department
Title of Research Project:
Start Date of Research Project:
End Date of Research Project
Comments
Brief description of the proposed
research methods including, in
particular, whether human subjects will
be involved and how.
Who will conduct the data collection
and analysis (e.g. individual students
or groups)
How will informed consent of research
participants be acquired?
(If appropriate attach draft informed
consent form)
Will the research involve an
organisation(s)?
(If appropriate attach draft
organisational consent form)
How will research data be collected,
securely stored and anonymity
protected (where this is required)
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How will data be destroyed after the
end of the project? (Where data is not
to be destroyed please give reasons)
Any other ethical issues anticipated?
Outline method for ethical approval
and monitoring of student research
within the module
Are there any significant Health and
Safety issues arising from the
research?
Has a Health and Safety Risk
Assessment been completed,
submitted and approved?
Module Tutor
On the understanding that the research will be conducted in conformity with the above, agreeing that any
significant change in the research project will be notified and a further Research Level Ethical Approval
Form be submitted, and that any research activity that goes beyond that described above would require
separate registration and approval using the standard Faculty Research Ethics procedure.
Date: ………………………………Staff Signature:…………………………………………….
Director of Research Ethics
I confirm that I have read this form and I believe the proposed research will not breach University policies.
Date:………………………………Signature:………………………………………….
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APPENDIX I - DEFINITIONS OF RESEARCH
From the UKRIO Code of Practice For Research, 2009:
“Research… is to be understood as original investigation undertaken in order to gain.
knowledge and understanding. It includes work of direct relevance to the needs of
commerce, industry, and to the public and voluntary sectors; scholarship; the invention and
generation of ideas, images, performances, artefacts including design, where these lead to
new or substantially improved insights; and the use of existing knowledge in experimental
development to produce new or substantially improved materials, devices, products and
processes, including design and construction. It excludes routine testing and routine analysis
of materials, components and processes such as for the maintenance of national standards,
as distinct from the development of new analytical techniques. It also excludes the
development of teaching materials that do not embody original research”
From the ESRC Research Ethics Framework:
‘Research’ is defined as any form of disciplined inquiry that aims to contribute to a body of
knowledge or theory. ‘Research ethics’ refers to the moral principles guiding research, from
its inception through to completion and publication of results and beyond – for example, the
curation of data and physical samples after the research has been published.
From the NHS Patient Safety Agency:
Research: The attempt to derive generalizable new knowledge including studies that aim to
generate hypotheses as well as studies that aim to test them.
N.B. it makes clear
distinctions between Service Evaluations and Clinical Audits!
From the Frascati Manual: Proposed Standard Practice for Surveys on Research and
Experimental Development, 6th edition, 2002:
“Research comprises ….creative work undertaken on a systematic basis in order to increase
the stock of knowledge, including knowledge of man, culture and society, and the use of this
stock of knowledge to devise new applications."
It is used to establish or confirm facts, reaffirm the results of previous work, solve new or
existing problems, support theorems, or develop new theories. A research project may also
be an expansion on past work in the field. To test the validity of instruments, procedures, or
experiments, research may replicate elements of prior projects, or the project as a whole.
The primary purposes of basic research (as opposed to applied research) are
documentation, discovery, interpretation, or the research and development (R&D) of
methods and systems for the advancement of human knowledge. Approaches to research
depend on epistemologies, which vary considerably both within and between humanities and
sciences. There are several forms of research: scientific, humanities, artistic, economic,
social, business, marketing, practitioner research, etc.
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APPENDIX J – NORTHUMBRIA UNIVERSITY DEFINITION OF RESEARCH
WHEN DO I NEED ETHICAL APPROVAL?
All research activity conducted by staff, researchers and students within the University must be
subject to appropriate ethical scrutiny and review, proportionate to the potential ethical ‘risks’ of the
research. In order to avoid disproportionate review, or to ensure that ethical consideration is not
bypassed, it is important that all ‘researchers’ understand what is meant by the term ‘research’, and
follow the correct steps to ensure that appropriate procedures are followed.
WHAT IS ‘RESEARCH’?
There are numerous definitions of research, for example:
“….original investigation undertaken in order to gain knowledge and understanding”
(UKRIO Code of Practice For Research, 2009)
“… any form of disciplined inquiry that aims to contribute to a body of knowledge or theory”.
(ESRC Research Ethics Framework)
It is recognised that within the University there are different types of ‘research’ activity, and not all may
require ethical scrutiny. These are as follows:
Funded ‘formal’ research projects (Research Councils, EU, Charity funded projects etc).
Unfunded ‘formal’ research projects (research conducted by staff, researchers).
Project/dissertation work conducted by undergraduate and postgraduate students.
Postgraduate research projects (PhD, MPhil, Prof. Doc etc).
Small-scale exploratory (‘pilot’) work within a research team to inform a methodology or
research question.
6. Audits and survey evaluations that gather large quantities of data but which are primarily
designed to measure existing standards and practices (Service Departments).
1.
2.
3.
4.
5.
Only the first 4 categories listed above would normally require scrutiny by an Ethics Committee,
however it must be noted that all of the activities should only be undertaken after appropriate Health &
Safety and other relevant guidelines have been consulted (e.g. CoSHH, Data Protection Act, Official
Secrets Act etc).
RISK LEVELS.
Research activity which falls under cases 1-4 can then be further defined in accordance to its
perceived level of risk. Please refer to the Ethics Diagnostic Tool at this link for further information.
Northumbria University seeks to ensure that ethical standards are maintained in research by and
throughout the University. Faculties, on behalf of the University, are responsible for ensuring all
students and staff conducting research, and all research conducted on University staff, students, and
premises is in accordance with the University’s ethical standards. In order to help you determine the
level of ethical scrutiny and risk for your research projects, we have devised a question and answer
self-evaluation form to help your assessment and subsequently inform you about the level of ethical
review required.
There are 3 levels of ethical and risk scrutiny:
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RED
High risk; requires high level of scrutiny
AMBER
Medium risk; requires internal review
GREEN
Low risk; may not require internal review if
compliant with Faculty governance procedures
Please refer to the Glossary of Terms if required.
Self-assessment: ethical scrutiny and risk level for your research projects
Does your research specifically involve one of the following?









Medicinal products
Clinical trial
Animal subjects
Children or vulnerable adults
NHS staff, patients, premises or equipment
Human tissue
Concerns around safety or discomfort for the participants or researchers
Sensitive subjects such as trauma
Data which comes under the Official Secrets Act
If YES, follow guidance for RED result
If NO, does your research involve any of these?






Non-vulnerable adults
Personal data referring to a living individual
Secondary data not in the public domain
Environmental issues
Commercially sensitive information
Pharmacologically active substances
If YES, follow guidance for AMBER result
If NO, is your research


completely based on secondary data which has been previously published
and/or
desk or lab-based and does not involve people in data collection?
If YES, follow guidance for GREEN result
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GUIDANCE
RED
High risk; requires high level of scrutiny. Review internally and externally
Other considerations: indemnity arrangement, external legislations and sponsorship
Your research involves one of the following: medical products, clinical trials, animal subjects, human
tissue, children, vulnerable adults, NHS staff, patients, premises or equipment, sensitive subjects,
data which comes under the Official Secrets Act or safety concerns for researcher or participants.
What to do next
Your project proposal will require a high level of ethical scrutiny by two independent reviewers, and
possible external peer review. There may also be legislative requirements to comply with e.g. MHRA,
NHS REC, Human Tissue Act and EudraCT. Indemnity arrangements may also need to be reviewed
in light of the additional risk involved.
If your Faculty Research Ethics Committee is unable to resolve the issue, the proposal should be
reviewed by the University Research Ethics Committee.
AMBER
Medium risk; requires internal review
Other considerations: Informed consent and confidentiality
Your research involves either non-vulnerable adults, personal data of a living individual, secondary
data not in the public domain, environmental issues, commercially sensitive information or
pharmacologically active substance.
It does not involve medical products, clinical trials, animal subjects, children, vulnerable adults, NHS
staff, patients, premises or equipment, sensitive subjects, data which comes under the Official Secrets
Act or safety concerns for researcher or participants.
What to do next
Your project proposal has some ethical implications and will be reviewed by one independent
reviewer appointed by your Faculty Research Ethics Committee. Some factors to be considered
include considering obtaining informed consent forms from organisations or people involved,
permission to use data from the Data Controller, as well as confidentiality/anonymity issues.
GREEN
Low risk; may not require internal review if compliant with Faculty governance
procedures
Other considerations: none
Your research is completely based on the analysis of secondary data (currently in the public domain
with no restrictions of access; not commercially or personally sensitive, and does not relate to specific
people; the analysis of which is not likely to lead to adverse representation); is desk or lab-based, is a
small-scale pilot only involving members of the research team, or does not involve people in data
collection, or data from living individuals (other than members of your research team).
What to do next
Your project proposal does not need to be reviewed by your Faculty Research Ethics Committee,
however, you need to be ethically aware and ensure that you have not breached plagiarism or
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copyright regulations and have adequately referenced your material. It is recommended that you refer
to Northumbria Research Ethics Policy.
Some Examples:
a) Our research team is conducting some pilot work. We are exploring reaction times to
computer generated visual and verbal stimuli but are not sure exactly which stimuli will
work best, or how best to present and record it. We are thus trying out different ways of
displaying and recording the stimuli using the members of our team, so that we can refine
our research question and methodology. Do we need ethical approval?
Not normally! If pilot research of this kind is being conducted solely within a research team, then
ethical approval is not required. However, if the pilot entails more ‘red’ research however, then
ethical approval may be required. Of course, as soon as participants external to the research
team are recruited, then appropriate ethical approval must be sought.
b) Our Service Department is conducting a user-satisfaction survey of our current facilities
and provisions. We will be circulating a questionnaire to all of our Service users to enable
us to improve our future provision, do we need ethical approval?
No! A service evaluation would not normally require ethical approval, though your
methodology should conform to relevant guidelines (e.g. the ‘Data Protection Act’ the ‘Freedom of
Information Act’ etc). However, if the survey is being conducted by a student as part of their final year
dissertation, then ethical approval must be obtained).
c) Our Service Department conducted a recent survey concerning customer satisfaction. The
results of this survey were somewhat surprising and we would like to present our data at a
National Conference of Service providers. Can we do this?
No! The dissemination of such data is classed as ‘research’ and in order to be able to present your
data you would need to have obtained ethical approval of the original survey, you would have to have
obtained the informed consent of all of the participants and debriefed them afterwards about the aims
and outcomes of your project. Retrospective ethical approval for projects that have been completed is
not possible.
d) I am an academic, and am currently working on a new mathematical theorem that could
overturn an existing paradigm, I hope to be able to publish my new theorem in a peerreviewed journal. Do I need ethical approval
No! This is research but this does not entail collecting data from / about other individuals, or using
secondary data not in the public domain, and so does not require approval by an Ethics Committee
beforehand.
e) I am a member of staff and am conducting some research as part of a module that I am
currently delivering– do I need ethical approval?
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This depends on what the data is being used for. It is common for academics to conduct data
collection within a teaching session in order to generate some ‘real’ data that can then be used to
illustrate methodological/practical/statistical issues. This data is only ever be used within such
sessions and will not be disseminated. Such data collection falls under the remit of ‘Health & Safety’
and should of course conform to the ‘Data Protection Act’ etc. In some instances however the
academic might consider disseminating this data, e.g. at a conference, at a workshop, in a journal
publication, in a report etc. If you think that the data collection exercise you plan to conduct as part of
a taught session might in the future be disseminated/published etc, then you must obtain ethical
approval for your research, you can then disseminate/publish your findings.
f) I am conducting some research with colleagues in other institutions and they have
received ethical approval from their institution – do I need to obtain ethical approval as
well?
If you can provide the original ethics application prepared by your collaborators - this must
include mention of the collaboration, along with the signed letter of ethical approval from their
institution, then you will not need to obtain additional ethical approval. As levels of ethical scrutiny
may differ slightly between institutions, then your ethics coordinator will review the submission and
discuss any issues with you as necessary.
g) My dissertation student is undertaking secondary data collection only – does this need
ethical approval?
Yes! All student dissertations require ethical approval. The approval process differs according to the
level of ethical risk involved in the research project. All dissertation work conducted by U/G and PGT
students must have received ethical consideration. The use of secondary data can fall under the
green or amber category (depending upon whether or not it is in the public domain), and will have
different requirements for review.
h) I am a member of staff conducting some research using analysis of secondary data which is
currently in the public domain, do I need ethical approval?
In this case your project is ‘green’ and you do not need to seek ethical approval. However, if the
secondary data is not currently in the public domain you will need permission from the Data Controller
to access and use this data, and you will need to obtain ethical approval from the University.
i) I am being employed as a consultant by a company who have asked me to conduct some
research with their employees, do I need ethical approval?
This depends on what the data is being used for. Normally, consultancy work is not classed as
‘research’ (even though various research methods might be used to obtain the data required by the
organization) and so does not require ethical approval. However, as in case e) if you wanted to
publish your findings then the consultancy is classed as ’research’ and you must obtain ethical
approval – this can be complicated as data sharing agreements need to be put into place and clear
understanding between the researcher and organization in terms of what can and cannot be
published etc.
j) A student/member of staff is interested in photographing people sitting on public seating
with the intention of selecting some images for showing in a public exhibition. Does this need
ethical approval?
Yes but...
Openly taking panoramic photographs when both the photographer and the subject are in “public
spaces” and where there can be a presumption that images will be taken (eg visible CCTV cameras
and warning notices) is usually acceptable. However, train stations, shopping malls, pavements with
identified ownership, university campuses, etc are not public areas and approval must be obtained
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from the designated authority before starting to take pictures. Furthermore, there are some premises,
criminal courts, police stations, military installations, the airside of airports, etc that if photographed
might attract unwished for attention. For simplicity, it is best to avoid sites of “strategic importance”
and to be prepared, if requested to do so by a police officer, to immediately delete these images.
There are some other spaces where photography is constrained by law. For example, if using a
tripod, without paying a “fee” in Paris or on Hampstead Heath. If general “panoramic” images are not
sufficient and close-ups are sought then the student/member of staff must obtain informed consent
from those people included in the image. However, as asking for such permission might change
behaviour it might be acceptable to ask for permission retrospectively; irrevocably deleting
immediately, and in the present of the people concerned, those images for which approval was not
obtained. This protocol would need specific approval from the Ethics Committee which would expect
contact details and the intentions for publication to be left with those in the photograph together with a
reminder that, if they so wish, they can withdraw their consent later. If children or other vulnerable
people are to be knowingly included in the images then the application will also need additional
scrutiny before approval may be given.
k): I am conducting some research in which I would like to include some reflections and
insights from personal experiences (or from experiences of family and friends). Do I need to
obtain ethical approval?
This will depend on the level of personal disclosure, the people that this disclosure may directly or
indirectly affect, and the nature of the information shared. If the personal elements of the research
project relate to people other than the researcher (e.g. members of the family or named professionals
or organisations), then you need ethical approval. If the shared information only relate to you (the
researcher), you need ethical approval if the disclosure puts the researcher or other people or
organisations in a vulnerable position or “at risk”, e.g. by disclosing activity that may be considered
unlawful, such as drug-taking, or by sharing information that is likely to cause undue distress or harm.
Note that it is the professional responsibility of the individual to make a decision as to whether
or not their planned activity falls under the 1- 4 category. If an activity is undertaken which
does fall under 1-4 and is not submitted for ethical consideration, or the appropriate Health &
Safety guidelines not be consulted, then the individual will not be covered by the University
insurance policy should any adverse events occur. In addition, the individual could also find
themselves facing disciplinary action on grounds of academic misconduct. If in any doubt
contact your Department Ethics Coordinator or Faculty Ethics Director for advice before
proceeding.
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APPENDIX K – Ethical Incident Form
Faculty of Engineering & Environment
REPORTING AN ‘ETHICAL’ INCIDENT
This form is to be used when an ethical ‘incident’ occurs which is not covered by the Faculty
Health & Safety Policy
1. Project Title:
2. Project Code allocated on approval:
3. Principal Investigator:
4. Date incident reported:
5. Complainant’s details:
6. Full details of the incident
7. Immediate action taken as a result of the incident?
8. Follow-on action taken as a result of the incident?
Has ADRI been informed?
YES / NO
9. Comments by Chair of the Faculty Ethics Committee
Signature of Investigator:Date:
……………………………………………..
Signature of Chair of FREC: Date:
……………………………………………..
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APPENDIX L- Faculty Research Ethics Committee Terms of Reference
Terms of Reference 2014/15
The Faculty Research Ethics Committee is a sub-committee of the Faculty Research and Innovation
Committee.
Under the following headings, the specific responsibilities of the Committee are:
Strategy and Policy Development and Approval
1. To provide written guidelines on ethical issues for use by staff and students of the Faculty
2. To advise on any issues of an ethical nature referred to it directly or by the Executive Dean of the
Faculty, Faculty Research and Innovation Committee, Faculty Student Learning and Experience
Committee or by Service Departments
3. To facilitate the appropriate development of staff and systems that support the ethical review and
governance of research and teaching activity
4. To consider annual report and annual audits on the management of ethical issues in research and
the operation of Faculty level procedures
5. To monitor the committee’s constitution to ensure compliance with third party requirements
Monitoring and Review
6. To review the Faculty’s Ethics procedures in light of the University’s Policy and the external ethics
environment and to propose changes as required
7. To monitor the implementation of ethical policies and procedures in the Faculty
8. To receive relevant papers/information from external bodies for consideration
9. To establish relevant time-limited working groups as necessary, to progress items of business.
Reporting Relationships/Interactions with other bodies
10. To receive reports from the Faculty Research and Innovation Committee and Faculty Student
Learning and Experience Committee and University Research Ethics Committee on Ethics plans,
policies and procedures developments
11. To submit an annual report on the committee’s activities and the operation of procedures for
ethical review of research to the Faculty Research and Innovation Committee and teaching and to the
Faculty Student Learning and Experience Committee and University Research Ethics Committee
12. To advise the Executive Dean of Faculty in respect of instances of non-compliance with the
University’s Ethics Policy.
Constitution and Membership
Quorum: 50% +1 members
Frequency of meetings: A minimum of 4 meetings per annum
Secretary: Morena Calingasan, Faculty Support Administrator
Parent Body: Faculty Research and Innovation Committee
Ex-officio Members
Chair Director of Research Ethics
Associate Dean Research and Innovation
Associate Dean Learning & Teaching (or nominee)
Faculty Registrar (or nominee)
Faculty Health & Safety Officer
Dr Paul Greenhalgh
Professor John Woodward
Dr Simon Robson
Muriel Theillere, Quality Support Manager
Steve Colvin
Nominated Members (to be confirmed)
Departmental representative ABE
Departmental representative CSDT
Departmental representative GEO
Departmental representative MCE
Graham Capper
Dr Julie Horton
Dr Emily Cooper
Dr Michael Lim
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Departmental representative MIS
Departmental representative PEE
2 R & I Champions
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Jackie Adamson
Dr Hoa Le Minh
Dr Paul Vickers and Professor Bob Giddings
In recurrent attendance:
Officers (for a specific area of work in Faculty remit or to provide professional advice and guidance)
invited to be recurrent attendees e.g. Director of Post Graduate Research.
Two PGR Student Representatives nominated by Faculty PGR students.
In attendance:
Academic and professional support staff from within the Faculty or from central services as invited by
the Chair
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APPENDIX M – USEFUL URLs
University Ethics and Governance home page (residing within RBS):
https://intranet.northumbria.ac.uk/facultiesandservices/rbs/sa/ethgov/
University Ethics and Governance Policies and Procedures:
https://intranet.northumbria.ac.uk/facultiesandservices/rbs/sa/ethgov/policies/?view=Standard
Ethics (risk based) Diagnostic Tool:
https://intranet.northumbria.ac.uk/facultiesandservices/rbs/sa/ethgov/tool/?view=Standard
Ethics Online Approvals System (PGR and Staff only):
https://nuweb2.northumbria.ac.uk/ci/index.php/resethics/resethics
University Ethics and Governance Handbook 7th Edition 2014-15:
https://www.northumbria.ac.uk/static/5007/research/reghandbook.pdf
Faculty Ethics home page:
https://intranet.northumbria.ac.uk/facultiesandservices/rbs/sa/ethgov/school_ethics_pages/?view=Sta
ndard
Faculty of Engineering and Environment Ethics and Governance home page:
https://www.northumbria.ac.uk/sd/academic/ee/about/studentsupport/ethics1/
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