NEWCASTLE UNIVERSITY

ANNUAL REPORT OF THE UNIVERSITY ETHICS COMMITTEE

COUNCIL: 3 APRIL 2017 BACKGROUND The Committee has been operating since 2006 when it was established as a committee of Senate and Council. Following the outcome of the 2010 Governance Review, Ethics Committee became a sub-committee of Executive Board, to be chaired by the member of Executive Board with responsibility for Ethics, Professor Tony Stevenson, Deputy Vice-Chancellor. Faculty Executive Boards are responsible for assuring the University Ethics Committee (UEC) that the faculties are operating an effective ethical review process. UEC met on 19 January 2017 to review developments during the 2015-16 academic year and to consider any issues that had emerged that required the Committee’s consideration during the 2016-17 academic year. MEMBERSHIP The membership of the UEC during 2015-16 was as follows: Three members appointed by Council: Revd Canon Richard Bryant (2017) Dr Vanessa Hammond (2018) Mr Mike Davison (2018) Two members appointed by Senate: Professor Julia Newton (2016)* Dr Colin Miles (2017) The member of Executive Board with Professor Tony Stevenson responsibility for Ethics (Chair): Deputy Vice-Chancellor The three Chairs of the Faculty Ethics Professor Daniel Nettle Committees (for the research ethics Chair of Medical Sciences Ethics Committee part of the business):

Professor Daniel Zizzo Dean of Research and Innovation (HaSS Faculty)

Professor Werner Hofer Dean of Research and Innovation (SAgE Faculty)

One Student member appointed Mr Dominic Fearon** by the Students’ Union: President, Students’ Union In addition a member of Research Dr James Callaghan Enterprise Services is in attendance to Director Research and Enterprise Services provide a link to the Service supporting research: Co-opted Member: Professor Robert Wilkinson *Professor Mike Taggart was appointed to replace Professor Julia Newton with effect from 1 August 2016. **Mr Jack Taylor succeeded Mr Dominic Fearon as President of the Students’ Union for 2016-17.

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REVIEW OF POLICY AND PROCEDURES a) University Research Office (URO)

Applications through the MyProjects Proposals System (Preliminary Survey) The following table represents applications for ethical approval for funded projects during 2015-16:

Faculty NRES AWERB Faculty Already Obtained Not required Total

FMS 213 5 68 289 539 1114

SAgE 4 3 60 11 741 819

HaSS 4 0 69 5 308 386

Central 0 0 0 1 3 4

Total 221 8 197 306 1591 2323 Overall usage has been consistent between 2014-15 (2322) and 2015-16 (2323). The risk profile remains broadly similar to last year:

Faculty NRES Animals Human Data Environment International

FMS 54% 2% 41% 2% 0% 3%

SAgE 6% 5% 28% 5% 3% 53%

HaSS 5% 0% 66% 6% 0% 23%

Total 41% 2% 43% 3% 0% 11% The two notable changes were a doubling of projects with Human (non-clinical) risk (34% to 66%) and a decrease for international risk (59% to 23%) in HaSS. It is likely the reduction in international risks is as a result of mitigating actions from the last report, for example the change in question format from a single question to a gate keeper with sub-questions that provide greater clarity for researchers. Actions completed during 2015-16 i. University Ethics Policy Revised and Reapproved

The University Ethics Policy was re-drafted following consultation with the Faculty Ethics Committee. University Ethics Committee approved the final version of the policy at its meeting on 19 January 2017 and this is attached as Appendix I.

Council is asked to approve the updated Ethics Policy for Research, Teaching and Consultancy which has been approved by Executive Board and Senate.

ii. Staff Training

The Research Office carried out ethics overview training sessions in the summer of 2016, which were well attended. Training took place within faculties, including sessions to postgraduates highlighting the need for ethical review within the development of research projects. In conjunction with these generic training sessions it is intended that more tailored sessions will be delivered by Dr Simon Woods in PEALS which will be pertinent to the needs of the faculties.

iii. Review of the online approval form / process

The current two stage process of ethical review was discussed with the faculties as part of the recent overarching review of research support processes. It was felt that the current process was working effectively and did not require major revision at the

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present time but should be given time to further embed. The Research Office will continue to record suggestions and requests for improvement and review the online form as necessary.

iv. Audits to ensure appropriate ethical approvals are in place

A report was generated from My Project Proposals showing projects between August & September 2015-16 and queries were made about projects where ethical consideration was not required or where projects were set-up but where the title suggested further ethical consideration may have been required.

Number of Projects

Queried Projects

% Queried Projects

Primary Project Risk

FMS 178 5 2.8% Human x4, Animals x1

SAgE 125 2 1.6% Environment x2

HASS 76 1 1.3% Human (non-clinical)

Central 1 0 0% NA

Total 380 8 2.1%

The faculties have identified the mitigating reasons why all the projects did not require ethical consideration beyond the electronic form. For example, where projects were identified as having potential human involvement it was found those projects involved staff training and not direct participation by patients. The project identified as potentially involving animals did not involve animals directly, and the methodology would not have required involvement of Animal Welfare and Ethical Review Body (AWERB). Going forward Research and Enterprise Services (RES) will utilise a report available through MyProjects to regularly monitor projects for ethics compliance.

b) Faculty of Medical Sciences (FMS)

Summary of FMS Review Activity Three different types of review procedure are followed in FMS. The first, an iterative process, involves two reviewers with the application being sent to each for independent comment and to confirm the appropriateness of any changes made as a result of the review process. The second process is the consideration by the Postgraduate Taught (PgT) Panels set up specifically to provide proportionate review of PgT proposals. The third is the highly responsive mode delivered by the Psychology Sub-Committee and lead by Dr Jenny Read together with support from local colleagues which is limited to undergraduate student projects, the majority of which are required by the Psychology degree programme. Each of these modes of review activity have continued to operate effectively and have successfully delivered outcomes appropriate to the context and researchers that they support. The number of amendments submitted that required review decreased to 52 from 64 in the previous year. This was probably due to the training/awareness sessions, highlighting good practice in application preparation, that were provided to staff through 2014-15. Taught Programmes By September 2017 the Faculty will have commenced delivery of new taught programmes at undergraduate level in the area of Sport & Exercise Science. It is likely that some of this delivery will require ethical consideration. In addition the Faculty will hold responsibility for further undergraduate programmes in Pharmacy, Food & Nutrition, Nutrition with Food Marketing, Biology, and Biology (Cellular & Molecular). With this in

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mind the route for module level ethical review and approval has been reviewed to ensure that both Health & Safety and ethical considerations are dealt with appropriately. Audit Activity The Newcastle Joint Research Office (NJRO) has maintained routine checks on projects that need to be set up (provided with a Finance account for the award and the facility to draw down funding) and where confirmation of ethical approval to proceed with the project is still outstanding. This occurs in projects (a) where the funding has been awarded to facilitate the process of obtaining all the permissions necessary prior to the commencement of the research activity itself or (b) where there are preliminary developments or investigations necessary which do not require any ethical approval but will be used to determine the nature of the main study itself. Where there is a delay between project set up and commencement of the research activity the NJRO team flag the project for subsequent review to check and ensure that ethical review requirements have been fulfilled. In addition, a snap-shot of cases where initial reading of the proposed project would suggest that further ethical review either by an NHS/Social Care Research Ethics Committee (NHS REC), the AWERB or the Faculty’s Research Ethics Committee would be required but has not been flagged, have been followed up with the PI concerned. In each case an explanation of the position has been verified and noted. A further audit of those projects where tissue samples were to be taken is currently in progress. This is with a view to ensuring that where any invasive techniques are required, they are carried out in accordance with the University’s Healthy Volunteer Policy. This aspect is particularly important in terms of health & safety, but is also relevant in adhering to current and forthcoming requirements from the HTA as outlined below. Human Tissue Authority (HTA) Code of Practice and Standards The HTA produces codes of practice to give professionals practical guidance on human tissue legislation. In 2014-15 it consulted on draft Codes of Practice and Standards and these are due to be in place by April 2017, including a Code of Practice and Standards on Research (Code E). This revised code introduces a potential need for researchers using tissue samples from volunteers to seek a NHS REC approval and rather than approval through a university review process. We will need to take this into account in our ethical review questions, particularly those in the preliminary section. Actions for 2016-17 The Faculty will continue to monitor its review process to ensure that it meets the needs of researchers. In addition, the following specific actions will be followed through:

Establish a review of ethical consideration in the Faculty’s teaching and learning contexts;

Support the Lay Member in investigating the users’ views of the process. c) Faculty of Humanities & Social Sciences (HaSS)

Summary of HaSS Review Activity

The proportion of applications requiring full ethical review by the Faculty Ethics Committee decreased in 2015-16, which had until last year been increasing over the previous three academic years (16.2% in 2012-13, 21.8% in 2013-14, and 34.5% in 2014-15 and 17.9% in 2015-16). This is largely related to the refinement of the preliminary ethics form,

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ensuring that low risk projects are not referred for full review (e.g. through the addition of extra screening questions for international research). The use of human participants in a non-clinical setting is the key trigger in HaSS. There was a peak of applications hitting the “international” trigger in 2014-15, an issue which was addressed approximately a year ago with amendments to the preliminary application form.

Actions for 2016-17 The Faculty has identified the following actions for 2016-17:

Continue to address training needs of staff involved in ethical review in the Faculty; Continue to review turnaround statistics for the processing of applications by ethics

convenors; FLTSEC to keep ethics procedures for the consideration of UG/PGT applications

under review; Continue to revise and update the information available on the web in line with

operational improvements in the process and developments on the central University ethics site;

Support the further development of the electronic processes for on-line submission of ethical approval forms in conjunction with Research Enterprise Services.

d) Faculty of Science, Agriculture & Engineering (SAgE)

Summary of SAgE Review Activity

The Faculty Ethics Committee considers applications for full ethical review in the areas of environmental impact, the use of human participants, tissue and data. The Committee provides an expedited review for international projects where there is no perceived risk or need for in-depth ethical review, and is able to sign off the majority of these applications as a Chair’s action. Projects involving the use or observation of animals are redirected to the University’s AWERB. Projects which require external ethical approval under the Department of Health’s Research Governance Framework are redirected to an NHS Research Ethics Committee.

The majority of applications relate to work involving social science research methods and human participants. As anticipated, the number of International Projects requiring full ethical review has decreased significantly during 2015-16. Cyber Security Working Group A Working Group including representatives from Computing Science, Electrical & Electronic Engineering (EEE), Research Enterprise Services (RES) and the SAgE Faculty Office has been established to consider the risks associated with Cyber Security research. These types of projects do not involve working with human participants or personal data, and are therefore classified by the University’s online ethics system as low risk. The aim of the Working Group is to interrogate the ethical issues involved in simulating cyber security attacks and identify best practice for this type of research. Consideration will be given to revising procedures in light of this, including possibly adding a new question to the ethics form to flag these types of projects as potentially high risk. Guidance for staff and students will also be produced, suggesting potential safeguards to help minimise risks.

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e) Animal Welfare and Ethical Review Body The University is licenced to conduct research using animals under the provisions of the Animals (Scientific Procedures) Act (ASPA) 1986. The Animal Welfare and Ethical Review Body is charged with advising the Establishment Licence Holder (the Registrar) on ethical considerations and all aspects of animal welfare relating to research conducted under the Act. Executive Board has extended this responsibility to cover all animal research conducted by members of the University, whether regulated or not, and in particular to include activities conducted abroad. Summary of all applications for ethical review

Category 2014 2015 2016 New Home Office Project Licences 10 12 17 Amendments to existing Home Office Project Licences 7 12 11 Minor amendments to existing Home Office Project Licences approved via fast track process

23 31 49

Minor amendments to existing Home Office Project Licences approved via fast track process

38 69 59

Total number 78 124 130

The committee fast track process requires review of the application by the Named Animal Care and Welfare Officer or their deputy, and the Named Veterinary Surgeon or their deputy, and these individuals make a recommendation to the Chairman of the committee, who makes a final decision as to whether to approve or reject the application. Applications processed in this way are reported to the full committee at its next meeting. Scheduled reporting of interim (1 and 3 year) and final reports (5 years) on Project licences continued to be received and reviewed. All quarterly veterinary reports were received and reviewed. The committee also received reports on the annual return of procedures to the Home Office (which details the animals used for research during the preceding year), the summary of animals acquired for research purposes in the preceding year, and the details of non-human primates used in research in the preceding year. An external review of the Comparative Biology Centre (CBC) was conducted during 2015-16 which had made a number of recommendations regarding the structures of the Centre. In relation to AWERB, the report had recommended that it should increase promotion of the three R activities (i.e. reduction, replacement, refinement) in relation to the use of animals in experiments and that the body should seek to engage on a more personal level with staff. These recommendations are in the process of being addressed. The University responded positively to an invitation from the Animals in Science Committee to co-ordinate a regional AWERB hub, the only institution in the North of England to do so. An inaugural hub meeting was held in July 2016 in the Comparative Biology Centre. The Committee was represented on the selection Committee to appoint the new Director of the Comparative Biology Centre. The appointment of Dr Kathy Murphy was finalised in September 2016. On taking up the position Dr Murphy became the University’s Named Veterinary Surgeon. The committee’s main concerns during 2015 was the very slow process of the granting of Project licences by the Home Office. The committee reviewed its processes in 2016 with the aim of better matching the new Home Office requirements for Project licence content.

Professor Tony Stevenson, Deputy Vice-Chancellor and Chair of UEC 16 February 2017

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    Appendix I 

NewcastleUniversityEthicsPolicyforResearch,TeachingandConsultancy

1. Purpose 

The purpose of this document  is to promote awareness of ethical principles and ethical  issues, clarify the 

rights and obligations of the staff and student body at Newcastle, and to outline the ethical framework for 

their consideration.  

Ethical  consideration  of  activities  is  part  of  the  overall  governance  framework  at  the  University.  As  a 

responsible public body, Newcastle aims to maximise the benefit and minimise the potential harm to all those 

involved  in  its  activities,  whether  as  project  leaders,  facilitators,  participants,  funders  or  in  any  other 

significant capacity. The key means by which it does this are: 

Through the application of a robust and proportionate ethical review process. 

By adopting and implementing legislation, best practice guidance, funder requirements, concordats 

and other key standards.  

Generating its own internal standards outlining its expectations. 

Providing support such as guidance, training and signposting to the staff and student body to enable 

them to both understand and meet their obligations.  

Embedding a culture across the institution in which ethical working is the norm. 

Communicating  the  University’s  ethos  and  standards  beyond  the  institution  to  related  parties; 

including research participants, funders, collaborators and the public. 

Ensuring all relevant activities are compliant with the University’s standards 

This policy attempts  to  strike a balance between  the need  to ensure  that ethics  is duly  considered and 

ensuring that the processes do not impose an undue burden on the units, services and staff responsible for 

implementing them. 

2. Scope 

This policy applies to all members of the University including; staff, students (undergraduate & postgraduate) 

and any other person or body which  represents  the University.  It applies equally  to work undertaken at 

Newcastle University,  its branch campuses and at other  locations. The key activities covered by the policy 

include: 

Research activities 

Teaching and learning activities 

Consultancy and other external work 

 

NB. This policy does not relate to acceptance of Corporate Gifts and Donations.  

See: http://www.ncl.ac.uk/alumni/get‐involved/fundraising‐guidelines/ethical‐policy/ 

This policy does not relate to consideration of any ethical issues relating to strategic projects requiring a 

specific business case. Such issues should be considered via University Executive Board.  

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3. OrganisationalStructure&Responsibilities

 

*The Faculty of Medical Sciences Ethical Review Committee has devolved responsibility for the review of undergraduate 

projects under its remit to the School of Psychology Ethical Review Committee 

University Council is the senior body responsible for ethics in the University it has overall responsibility for 

setting policy and ensuring it is adhered to. 

University Senate  is the supreme governing body for all academic matters and  is kept  informed of ethics 

matters in the University. 

Executive Board is a joint committee of the Senate and Council and has central oversight of the day to day 

business of the University.   

University Ethics Committee is Chaired by the Deputy Vice Chancellor and established as a sub‐committee 

of University Executive Board. It has one statutory meeting per annum and is responsible for: 

‐ Institutional oversight of the ethics process relating to research, teaching and consultancy / external 

activities. 

‐ Implementing the policy set by University Council 

‐ The  strategic  management  of  ethics  relating  to  research,  teaching  and  consultancy  /external 

activities at Newcastle 

‐ Monitoring compliance with the policy  

‐ The operational framework for ethics relating to the aforementioned activities in the University. 

The University Registrar has overall responsibility for: 

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‐ Ethical conduct of the staff and student body 

‐ Ensuring the institution’s compliance with legislation  

‐ Research which comes under the Animal Scientific Procedures Act 1986 (this is covered under the 

remit of the Animal Welfare Ethical Review Board) as dictated by the Home Office. 

Faculty Executive Board(s) are responsible for: 

‐ Monitoring compliance with the University policy across their academic units 

‐ Adequate resourcing of ethics support and services within the faculty 

‐ Promoting responsible ethical conduct within their faculty 

‐ Ensuring  that  University  Ethics  Committee  is  kept  aware  of  the  requirements  of  key  external 

stakeholders, such as research funders. 

‐ Assuring Senate and Council that they are operating an effective ethical review process. 

‐ Putting in place structures which support the staff and student body. 

Faculty Ethics Committee(s) are responsible for: 

‐ Formal ethical consideration of activities which represent an enhanced ethical risk.  

‐ Ensuring that all work under their remit has appropriate ethical approval  in place, either through 

direct review or by accepting the review of another body.  

‐ Overall operational management of ethics support and services within their faculty. 

‐ Provision of faculty specific advice and guidance about ethical matters. 

‐ Ensuring that reviewers have access to appropriate training to enable them to discharge their duties 

competently and with confidence.  

Ethics Committee Members / Ethics Reviewers are responsible for: 

‐ Reviewing applications submitted to their committee 

‐ Identifying ethical issues involved in the activity 

‐ Ensuring that any issues have been fully considered  

‐ Protecting the interests of the project team, participants, the University and of the wider community. 

Animal Welfare  Ethical  Review  Board  (AWERB)  is  responsible  for  the  formal  ethical  consideration  of 

activities conducted by University staff/students that involve animals, specifically: 

- The review of any projects involving animal work as covered by the Animal Scientific Procedures Act 

1986 (ASPA). 

- The review of activities involving animals (not under ASPA) but which give rise to concerns for animal 

welfare, specifically where those activities are unregulated by UK law. 

- The provision of guidance to the Establishment Licence holder (the Registrar) 

‐ The promotion of the ethical principles of reduction, replacement and refinement (the 3Rs) in animal research. 

(AWERB explicitly do not cover activity that is only agricultural at the University farms.  Animal welfare in this environment is covered by UK Government codes of practice.)  

 Research & Enterprise Services are responsible for: 

‐ Co‐ordinating the University’s requirements and those of significant others (e.g. funders)  

‐ Provision of general (University wide) resources, advice and guidance  

‐ Management of the University ethics processes 

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‐ Providing  support  to  the  faculty  ethical  review  committees  and  AWERB  in  regards  to  ethical, 

governance and integrity issues 

‐ Ensuring all appropriate governance and ethics  requirements are  in place before any contractual 

work begins (specific to funded projects). 

‐ Managing the ethical appeal process on behalf of University Ethics Committee 

Staff are responsible for: 

‐ Familiarising themselves with all of the appropriate University, legal and funder policies / guidance 

relating to their activity.  

‐ Identifying any relevant actual or potential ethical issues. 

‐ Ensuring projects receive ethical approval from the appropriate body before work begins. 

‐ Ensuring that the scientific methodology of the activity has received adequate peer review.  

‐ In their capacity as academic supervisors, they are responsible for ensuring that all student projects 

have received appropriate ethical consideration. 

‐ Module  Leaders  /  Degree  Programme  Directors,  are  responsible  for  ensuring  appropriate 

consideration of ethics in their programmes and by their students. 

Students are responsible for: 

‐ Familiarising themselves with all of the appropriate University, legal and funder policies and guidance 

relating to their activity.  

‐ Highlighting any actual or potential ethical issues arising from their work and bringing them to the 

attention of their supervisor and then (if required) the relevant review committee.  

‐ Ensuring ethical approval from the appropriate body is in place before beginning work. 

4. EthicalRisks&Principles 

The University sees the following principles as fundamental.  

Welfare:   Those undertaking the activity should have the welfare of participants as a goal of their activity.  

Autonomy:  Those  undertaking  the  project  should  be  honest,  act  to  protect  others  (as  well  as themselves) and ensure they have informed consent from participants. 

Justice: there should be a fair distribution of effort, costs and benefits.  

The range of the University’s activities  is exceptionally broad and the potential ethical hazards equally so. 

The University has based  its ethical  review  framework on  that used by  the Economic &  Social Research 

Council. Its key areas of concern are: 

1. Patients, staff or other resources of the National Health Service / Social Care Providers 

2. Humans in a non‐clinical setting where there are enhanced risks 

‐ This includes the use of Human Tissues such as blood, saliva and bone 

3. Animals as defined by the ‘Animals Scientific Procedures Act’ or any animal involved in an atypical or 

non‐regulated activity 

4. The viewing, transfer or usage of sensitive / regulated data 

5. Significant damage to the environment or which takes place in a protected area 

6. Work  outside  the  European  Economic  Area  where  the  legal  framework  or  design  creates  an 

enhanced risk 

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These areas are covered in detail on the University Ethics Form and in the associated guidance in the Ethics 

Toolkit.  There  are  however  additional  considerations  which  although  not  covered  explicitly  should  be 

examined. These include the origin of funding (Appendix One), the end‐use of outputs for illegal / immoral 

purposes (Appendix Two), ensuring the risks of the activity are proportionate to the potential benefits, and 

ensuring the activity (especially research) is designed according to the best scientific practice. 

The University wishes to support  its staff and student body to undertake purposeful and well considered 

activities. In order to do so it provides toolkits / resources and expert review and advice via its various ethical 

review committees. Where the guidance is not clear or where there is a conflict the University expects the 

responsible individual (in concert with the appropriate committee) to balance qualitatively different values. 

In such cases, they are obliged to make judgements that cannot be derived from first principles and should 

be prepared to draw upon objective advice.   

5. EthicalReviewProcess 

The  ethical  review  process  varies  depending  on  the  risk  profile,  body  responsible  for  the  approval  and 

whether  the  project  is  externally  funded.  However  all  projects  start  the  process  in  the  same way,  by 

completing the University Ethics Form(s). The form should ordinarily be completed by the project lead. They 

can delegate the responsibility for completing the form but the project lead remains responsible overall 

NB. The University will normally only review work undertaken by its own staff and student body so the form 

should be completed to explicitly show what the ethical approval is being asked to cover. 

The process works  in two parts.  In the preliminary part a series of multiple choice questions prompts for 

further details on the scope of the project, mapped around the University high risk areas. From the responses 

a risk profile is built up and depending on this the approval request will be directed in one of five ways: 

a. The project already has approval in place 

The University adheres to a principle of single review i.e. it will accept ethical review from other 

committees (e.g. other Universities)., but only where the scope of the application covers the work 

at Newcastle and its staff and student body and where it is confident of the standards of the other 

organisation’s processes and procedures. This must be agreed on a case by case basis with the 

relevant Faculty Representative (the academic unit of the Newcastle principal investigator drives 

the responsible faculty). 

b. The project is low risk 

I.e. there are no significant ethical issues (and therefore no further review is needed)  

c. The project involves the NHS / Social Care 

These are reviewed by committees governed by the Health Research Authority. 

d. The project involves animals 

These are reviewed by the Animal Welfare Ethical Review Board. 

e. The project involves (any other) high risk area 

These are reviewed by the relevant Faculty Ethical Review Committee 

In the cases where (a) approval is in place, (b) the project is low risk or (c) the project involves NHS / Social 

Care then the applicant leaves the University process after the preliminary stage. In the first two cases 

ethical approval is granted by default, and there is no further action required. Those projects involving the 

NHS, however, should seek (and gain) approval from the Health Research Authority before beginning work. 

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In cases where (d) animals are involved or (e) which is high risk for another reason, the applicant will be 

prompted to provide additional information. This will then be sent to the appropriate ethical review 

committee for consideration and decision.  

‐ No work should start until the project has received ethical approval and all relevant permissions e.g. 

from external bodies are in place.   

‐ Where significant changes are subsequently made to a project it is the responsibility of staff members 

to ensure that further ethical review is sought.  In the case of student projects it is the responsibility 

of the student to bring changes to the attention of their supervisor and then (if required) the relevant 

review committee.  

6. RightofAppeal 

In  cases where  a member  of  staff  is  dissatisfied with  the  opinion  of  one  of  the  faculty  ethical  review 

committees then in the first instance the applicant should appeal this to Chair of that Committee. This must 

be done via the Faculty Ethics Co‐ordinator / Committee Secretary. The Chair can reject, uphold or ask for an 

alternative review from within their own committee or the equivalent committee in another faculty. If the 

applicant is still dissatisfied then the matter can be referred for consideration by the Chair of University Ethics 

Committee. Their decision is final. No work should start until the appeal has been resolved. 

7. Sanctions 

Any deliberate or negligent breach of the University Ethics Policy, whether through omission, misdirection or 

fraud  is a serious disciplinary matter. Significant breaches of  this policy will be  investigated by University 

Ethics Committee, or its agents and where deemed necessary these will be dealt with (in the case of staff) 

under  the  Disciplinary  Procedure  or  (in  the  case  of  students)  under  the  relevant  academic  conduct 

regulations.  

Where an  investigation  finds  that a breach has  indeed occurred  then  the University will  (in  line with  its 

contractual responsibilities) inform any relevant funders or professional associations. Additionally where a 

breach  concerns  a  staff member  substantively employed elsewhere  the University may pass  the  factual 

details  of  the  case  to  the  primary  employer  (this  is  specifically  relevant  to  Clinical  Staff  with 

honorary/associate contracts). 

8. Monitoring,Compliance&Disclosure 

Responsibility for the implementation, operation and support of the policy as well as compliance to it is 

devolved to the Faculty Ethical Review Committees and the Research & Enterprise Services (RES). 

Institutional compliance will be monitored through periodic audit at both institutional and faculty level. Any 

highlighted issues will be brought to the attention of University Ethics Committee at its next scheduled 

meeting. If an issue is significant i.e. it has a direct effect on the wellbeing of participants or staff and / or a 

potentially significant reputational impact then it will be brought to the attention of the Chair of University 

Ethics Committee within 10 working days. 

Where a member of staff or student is aware of activities being carried out without the appropriate ethical 

approval he/she is encouraged to disclose this information to his/her Manager or Tutor/Supervisor in 

accordance with the University’s policy on Public Interest Disclosure. 

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9. Summary

This document outlines the broad process and ethos of the University, it should be read in conjunction with 

other key documents such as the Code of Good practice in Research, The Concordat to Support Research 

Integrity, Student Regulations and any other subject specific documentation.  

Approved by Executive Board: 21 February 2017 Approved by Senate: 7 March 2017 Approved by Council:

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AppendixOne:Funding 

Given the very wide range of ethical issues that can arise in considering whether or not to accept funding 

for specific university activities, it is difficult to formulate a policy that can be used in all cases. 

Nevertheless, the University takes the view that some guidance to staff is essential, particularly in view of 

the fact that some large donors are now beginning to insist that specific ethical policies must be in place.  

The guidance below is intended to direct staff in their dealings with external funders. It should be 

emphasised that the guidance below is not intended to prevent individual members of the university 

carrying out an activity, but is intended to ensure that the interests of the University are safeguarded 

where it acts as a corporate body accepting funding or sponsoring an activity.  

Considerations 

The key questions that must be asked about the acceptance of any funding for any purpose in the 

University are: 

What are the motives of the sponsor?  

To what extent are these motives consonant with the University's main mission of furthering 

excellence in Scholarship, Teaching and Research? 

To what extent are any restrictions placed on publication and exploitation of the results of the 

funded work likely to lead to ethical problems and difficulties? 

Will accepting funding lead to a bias (perceived or actual) in the design of the activity or 

dissemination of the outcomes? 

The policy of the University is not to accept funding for any aspect of its activities where; 

the motives of the funder are believed to be inconsistent with the University's main aims and 

objectives 

the suppression of the results of any funding is likely to lead to substantial ethical difficulties 

undertaking the activity could materially damage the reputation of the University and its faculty 

Before engaging in any activity the project/activity lead should consider a potential funder’s declared 

ethical policy and its ethical record. They should also consider the nature of the activity and the potential 

applications of the outcomes. These issues should be considered as part of the ethical review process at 

application stage.  

In cases where an issue is known or suspected, the project lead should first raise any concerns with their 

Head of Academic Unit. If the Head of Unit agrees that further review is needed then the matter will be 

referred to the relevant Faculty Ethical Review Committee who will then give an opinion in line with their 

standard review process. In problematic cases this Committee has the option to escalate the matter to 

University Ethics Committee. There will be some cases, for example where the work poses a significant risk 

to the reputation of the University, where the issue is strategic rather than ethical. In these cases the final 

decision will be taken by the appropriate Executive Committee. 

AppendixTwo:EthicalApplicationofOutputs 

The University has a moral and (in some cases) legal responsibility to ensure that its activities contribute 

positively to the wider community. The motivation of external parties for working with the University, and 

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their likely application of any outputs should be considered at the earliest possible opportunity and, in 

particularly sensitive areas, throughout the duration of the activities. 

One of the key areas the University is concerned about is the transfer of technology or knowledge which 

can be used in the development of Weapons of Mass Destruction Programmes or have military applications 

which might: 

‐ contravene the UK’s international commitments (e.g. breach of applicable arms embargoes or 

other sanctions)  

‐ be used for internal repression or the abuse of human rights 

‐ provoke or prolong armed conflicts or aggravate existing tensions in the destination country 

‐ be used aggressively against another country 

‐ adversely affect the national security of the UK or allies 

‐ be to a destination where the behaviour of the buyer country raises concerns with regard to its 

attitude to terrorism or respect of international law 

‐ be diverted or re‐exported under undesirable conditions 

‐ In the case of developing countries, seriously hamper the sustainable development of the recipient 

country. Exports can also be refused on other national security grounds or where an export is 

contrary to stated Government policy. 

Useful resources can be found on the www.ncl.ac.uk/research webpages, specifically the ‘Higher Education 

Guide on Export Controls and the ATAS Student Vetting Scheme’. 

In cases where an issue is known or suspected, the project lead should first raise any concerns with their 

Head of Academic Unit. If the Head of Unit agrees that further review is needed then the matter will be 

referred to the relevant Faculty Ethical Review Committee who will then give an opinion in line with their 

standard review process. In problematic cases this Committee has the option to escalate the matter to 

University Ethics Committee. There will be some cases, for example where the work poses a significant risk 

to the reputation of the University, where the issue is strategic rather than ethical. In these cases the final 

decision will be taken by the appropriate Executive Committee. 

In the context of the above, the University’s PREVENT guidelines should also be referred to which state 

that, in accordance with the provisions contained within the Counter Terrorism and Security Act 2015, the 

University has a duty to have due regard to the need to prevent people from being drawn into terrorism. In 

the case of Newcastle University ‘People’ are our staff and students or those who represent the University. 

See further: https://internal.ncl.ac.uk/prevent/about/ 

AppendixThree:PolicyregardingtheparticipationofvolunteersMaterial from Research & Enterprise Services webpages and appendices.  Available at: 

http://www.ncl.ac.uk/res/assets/documents/VolunteerPolicy09092015docx.pdf 

AppendixFour:ConsiderationofresearchatBranchCampuses. 

Material from Research & Enterprise Services webpages.  Available at: 

http://www.ncl.ac.uk/res/assets/documents/UniversityGuidanceonthePreliminaryEthicalApprovalofInternationalResearchandResearchatInterna.pdf  

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Appendix 6: Newcastle University Ethical Approval Process 

 

Abbreviations: MyPP: MyProjects Proposals (the University’s proposal generation system for research, commercial and teaching projects) HRA: Health Research Authority AWERB: Animal Welfare Ethical Review Board   

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