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FACULTY OF ENGINEERING AND ENVIRONMENTRESEARCH 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 pageFaculty ELP Organisation

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ContentsItem 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

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

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7.0 In Summary 9

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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

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D. Research Participant Consent Form

E. Data Protection Act requirements for the collection, storage and destruction of personal data

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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

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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 Ethic s 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 Approval1. To provide written guidelines on ethical issues for use by staff and students of the Faculty2. 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 Departments3. To facilitate the appropriate development of staff and systems that support the ethical review and governance of research and teaching activity4. To consider annual report and annual audits on the management of ethical issues in research and the operation of Faculty level procedures5. To monitor the committee’s constitution to ensure compliance with third party requirements

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https://intranet.northumbria.ac.uk/facultiesandservices/rbs/sa/ethgov/


Monitoring and Review6. To review the Faculty’s Ethics procedures in light of the University’s Policy and the external ethics environment and to propose changes as required7. To monitor the implementation of ethical policies and procedures in the Faculty8. To receive relevant papers/information from external bodies for consideration9. To establish relevant time-limited working groups as necessary, to progress items of business.

Reporting Relationships/Interactions with other bodies10. 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 developments11. 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 Committee12. 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 GreenIf 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

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https://intranet.northumbria.ac.uk/facultiesandservices/rbs/sa/ethgov/tool/?view=Standard


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 AmberIf 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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https://www.northumbria.ac.uk/static/5007/research/reghandbook.pdf


4.0 Project Registration

4.1 Online Research Ethics Approval for Staff and Post Graduate ResearchAll 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 ResearchAll 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 ProjectsFREC has established standard procedures to address ethical issues arising from Amber projects as detailed in the following sections.

5.1.1 Informed ConsentAll 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 SheetWhere 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 FormsThe 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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https://nuweb2.northumbria.ac.uk/ci/index.php/resethics/resethics


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 InterviewsIn 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 QuestionnairesWhere 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 ParticipantsThe 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/leadership-governance/vice-chancellors-office/legal-services-team/northumbria-data-protection/ ).

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https://www.northumbria.ac.uk/about-us/leadership-governance/vice-chancellors-office/legal-services-team/northumbria-data-protection/

https://www.northumbria.ac.uk/about-us/leadership-governance/vice-chancellors-office/legal-services-team/northumbria-data-protection/


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 ReportingIf 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 RegisterStaff 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 ProjectsIn 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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http://www.northumbria.ac.uk/sd/academic/ee/about/studentsupport/ethics1/


APPENDIX A – RESEARCH ETHICS EASY GUIDE FOR STAFF AND STUDENTS

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STAGE 1: RESEARCH DESIGNResearcher 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 3 – SUBMISSION FOR REGISTRATION AND APPROVALSTAFF & 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 AdministratorUNDERGRADUATE 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 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 4 – REGISTRATION AND APPROVALGREEN projects may be approved by the Principal Supervisor or Research Mentor without conditionsAMBER projects are subject to consideration by one independent reviewer, such as Module Tutor, Second Marker, Departmental Ethics Representative, and may be approved with conditionsRED projects must be referred to Faculty Research Ethics Committee for considerationN.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: [email protected]; 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 AMENDMENTAs 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 DOCUMENTSIt 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.

mailto:[email protected]


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:

REDHigh risk; requires high level of scrutiny

AMBERMedium risk; requires internal review

GREENLow 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 projectsDoes 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 publishedand/or

desk or lab-based and does not involve people in data collection?

If YES, follow guidance for GREEN result

GUIDANCE

REDHigh risk; requires high level of scrutiny. Review internally and externallyOther 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 nextYour 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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https://eudract.ema.europa.eu/

http://www.legislation.gov.uk/title/human%20tissue

http://www.nres.nhs.uk/

http://www.mhra.gov.uk/Howweregulate/index.htm


AMBERMedium risk; requires internal reviewOther 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 nextYour 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.

GREENLow risk; may not require internal review if compliant with Faculty governance proceduresOther 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 nextYour 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 projectBased 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):

[Please tick as appropriate]Red vulnerable participants; human tissue; sensitive data; risks to participants & researchers etc.

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http://www.northumbria.ac.uk/static/5007/respdf/riskassesmenttool


Amber human participants requiring informed consent; commercially sensitive information etc.

Green no participants involved; secondary data only; no sensitive data

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 SupervisorAmber risk - to be submitted for approval by one independent reviewerRed 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 reviewersPlease 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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mailto:[email protected]


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 Undergraduate

Department:

Email:

Principal Supervisor (if relevant):

Risk status: Red Amber Green

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.


_________________________________________________________________________

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.


_________________________________________________________________________

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

(State: standard, enhanced, enhanced with lists)

Reference Date of DBS check

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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III. 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:

4. DATA FROM SECONDARY SOURCES

1 Any vertebrate, other than humans (mammals, birds, reptiles, fish, amphibia) and the invertebrate species, Octopus vulgaris

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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 INFORMATIONList 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’.

C. SAMPLES

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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 DATADescribe the arrangements for anonymising data and if not appropriate explain why this is and how it is covered in the informed consent obtained.

B. STORAGEDescribe 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.

7. Intellectual property

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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 EnvironmentRESEARCH 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 researcherI have provided information about the research to the research participant and believe that he/she understands what is involved.

Researcher’s signature ……………………………………….Date ……………………………………….

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APPENDIX E - DATA PROTECTION ACT REQUIREMENTS FOR COLLECTION, STORAGE AND DESTRUCTION OF PERSONAL DATA

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 ProtectionAudio 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 SecurityIt 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.

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Loss or theft of your device In the unfortunate event that your device is lost or stolen you must:

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 DeviceThe 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 ServicesPersonal 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 EnvironmentPROJECT 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 EnvironmentEVIDENCE 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 activitiesAll completed (original) questionnaires

All notes from Interviews, researcher diary, lab note book etc.Electronic data

Data collection / observation /experimentation recordsNotes on /early drafts of mathematical calculationsNotes on /early drafts of drawings and sketchesCopies 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 EnvironmentMODULE 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:…………………………………………….

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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:………………………………………….


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:

1. Funded ‘formal’ research projects (Research Councils, EU, Charity funded projects etc).2. Unfunded ‘formal’ research projects (research conducted by staff, researchers).3. Project/dissertation work conducted by undergraduate and postgraduate students.4. Postgraduate research projects (PhD, MPhil, Prof. Doc etc).5. 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).

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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REDHigh risk; requires high level of scrutiny

AMBERMedium risk; requires internal review

GREENLow 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 projectsDoes 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 publishedand/or

desk or lab-based and does not involve people in data collection?

If YES, follow guidance for GREEN result

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http://www.northumbria.ac.uk/static/5007/2008pdf/glossary.pdf


GUIDANCE

REDHigh risk; requires high level of scrutiny. Review internally and externallyOther 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 nextYour 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.

AMBERMedium risk; requires internal reviewOther 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 nextYour 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.

GREENLow risk; may not require internal review if compliant with Faculty governance proceduresOther 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 nextYour 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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https://eudract.ema.europa.eu/

http://www.legislation.gov.uk/title/human%20tissue

http://www.nres.nhs.uk/

http://www.mhra.gov.uk/Howweregulate/index.htm


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 yourmethodology 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 peer-reviewed 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 mustinclude 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 / NO9. 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 Approval1. To provide written guidelines on ethical issues for use by staff and students of the Faculty2. 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 Departments3. To facilitate the appropriate development of staff and systems that support the ethical review and governance of research and teaching activity4. To consider annual report and annual audits on the management of ethical issues in research and the operation of Faculty level procedures5. To monitor the committee’s constitution to ensure compliance with third party requirements

Monitoring and Review6. To review the Faculty’s Ethics procedures in light of the University’s Policy and the external ethics environment and to propose changes as required7. To monitor the implementation of ethical policies and procedures in the Faculty8. To receive relevant papers/information from external bodies for consideration9. To establish relevant time-limited working groups as necessary, to progress items of business.

Reporting Relationships/Interactions with other bodies10. 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 developments11. 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 Committee12. To advise the Executive Dean of Faculty in respect of instances of non-compliance with the University’s Ethics Policy.

Constitution and MembershipQuorum: 50% +1 membersFrequency of meetings: A minimum of 4 meetings per annumSecretary: Morena Calingasan, Faculty Support AdministratorParent Body: Faculty Research and Innovation Committee

Ex-officio MembersChair Director of Research Ethics Dr Paul GreenhalghAssociate Dean Research and Innovation Professor John WoodwardAssociate Dean Learning & Teaching (or nominee) Dr Simon RobsonFaculty Registrar (or nominee) Muriel Theillere, Quality Support ManagerFaculty Health & Safety Officer Steve Colvin

Nominated Members (to be confirmed)Departmental representative ABE Graham Capper Departmental representative CSDT Dr Julie HortonDepartmental representative GEO Dr Emily CooperDepartmental representative MCE Dr Michael Lim

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Departmental representative MIS Jackie AdamsonDepartmental representative PEE Dr Hoa Le Minh2 R & I Champions 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):


University Ethics and Governance Policies and Procedures:

https://intranet.northumbria.ac.uk/facultiesandservices/rbs/sa/ethgov/policies/?view=Standard

Ethics (risk based) Diagnostic Tool:


Ethics Online Approvals System (PGR and Staff only):


University Ethics and Governance Handbook 7th Edition 2014-15:


Faculty Ethics home page:

https://intranet.northumbria.ac.uk/facultiesandservices/rbs/sa/ethgov/school_ethics_pages/?view=Standard

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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https://www.northumbria.ac.uk/sd/academic/ee/about/studentsupport/ethics1/






https://intranet.northumbria.ac.uk/facultiesandservices/rbs/sa/ethgov/policies/?view=Standard
