FACULTY OF ENGINEERING AND ENVIRONMENT
RESEARCH ETHICS PROCEDURES
RESEARCH ETHICS PROCEDURES
AUTHOR / Dr Paul GreenhalghFaculty Director of Research Ethics
AUTHORISED BY / Faculty Research Ethics Committee
DATE OF ISSUE / REVISED DRAFT July 2015
LAST UPDATE / 24 July 2015
FACULTY RESEARCH & INNOVATION COMMITTEE APPROVAL / September 2015
REVIEW INTERVAL / Annually
LOCATION OF COPIES / Faculty Research Ethics and Governance web page
Faculty ELP Organisation
Contents
Item / Page Number1.0 Context / 4
2.0 Faculty Research Ethics Committee / 4
3.0 Scope / 5
3.1 Ethical Approval and Ethics Risk Status
3.1.1 Green
3.1.2 Amber
3.1.3 Red
4.0 Project Registration
4.1 Online Research Ethics Approval for Staff and Postgraduate Research
4.2 Paper Based Registration and Approval for Undergraduate and Taught Postgraduate Research
5.0 Seeking and Recording Participants ‘Informed’ Consent
5.1 Standard Procedures for Amber projects
5.1.1 Informed Consent
5.1.2 Information Sheet
5.1.3 Consent Forms
5.2 Telephone Interviews
5.3 Questionnaires
5.4 Emails to Student Participants
5.5 Research Data
6.0 Other Matters
6.1 Module Level Ethical Approval
6.2 Project Amendment
6.3 Ethical Incident Reporting
6.4 Register
6.5 Partnerships and Joint Projects
6.6 Evidence Files for Undergraduate and Postgraduate projects / 5
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7.0 In Summary / 9
Appendices
Item / Page NumberA. Research Ethics Easy Guide for Staff and Students / 10
B. Ethical Scrutiny and Risk Levels / 11
C. 1. Research Ethics Registration and Approval Form
2. Research Proposal Form / 14
18
D. Research Participant Consent Form
E. Data Protection Act requirements for the collection, storage and destruction of personal data / 29
30
F. Project Amendment Request Form / 32
G. File of Evidence Checklist [Taught Programmes]
H. Module Level Ethical Approval
I. Definitions of Research
J. Northumbria University Definition of Research
K. Ethical Incident Reporting Form
L. Faculty Research Ethics Committee Terms of Reference
M. Useful URLS / 33
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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
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.
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.
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.