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Ethics and Governance

Welcome to Northumbria University's research ethics and governance web page. This page has been developed to accommodate Northumbria University's policies, practices and guidance around research ethics and in order to promote best practice for the ethical conduct of research. 

 

Guidance from the University for undertaking your research during COVID-19

Securing an amendment

You do not have to submit an amendment if the only change to the project is moving from face to face interactions to remote interaction providing your project meets the requirements detailed below.

  • You use the University’s preferred platform of Microsoft Teams for interviews, or you use a telephone
  • Online data collection is secure - please refer to the guidance here
  • Working in a remote manner does not constitute a substantial change. A substantial change to a research project is one that alters the potential risk or harm to participants. For example, if your research deals with sensitive issues you will need to submit an amendment. This is because (i) you may be less readily able detect stress in the participant or refer them to support services (ii) securing a confidential space may be more difficult in a ‘lockdown’ scenario.

Any member of staff who is unsure whether an amendment is required should consult their Department Ethics Lead. Any student who is unsure about how to proceed should consult their Supervisor.

 

 

 

 

Pausing your research

If you need to pause your research, you need to notify all participants that you have recruited to the study whether the study has commenced or not.  Communications with participants who have already been engaged in the study should be as comprehensive as possible and enable any planned debriefing etc. You do not need to submit an amendment in order to pause your study.

 

 

 

Doctoral students

If you are a student with time constraints around conducting your research and cannot conduct remote participant interactions, you should change your research to involve secondary data analysis where possible. You should discuss your approach with your supervisor.

If you are a final year PGR student you may apply for an amendment.

 

 

 

 

Re-starting research with human participants for staff and final year PGR students

If you are a member of staff or final year PGR student you may, in exceptional circumstances, apply to undertake research with human participants. Please note that this is not yet applicable to undergraduate, postgraduate taught or first/second year PGR students. The process for this is set out here. Please contact ethicssupport@northumbria.ac.uk before submitting an application.

 

 

Remote working and data protection

Please refer to the guidance here

 

 

Sources of useful information

 

Internet mediated research

For further information from Research and Innovation Services click here (internal link)

 

 

 

Additional information from external agencies for undertaking research during the COVID -19 pandemic

National Institute for Health Research (NIHR) 

This guidance from the Department of Health and Social Care provides information on the impact on COVID-19 on research funded or supported by NIHR.

NHS Health Research Authority (HRA) 

This guidance relates to Research Ethics Committee (REC) and NHS arrangements. As the situation is still evolving, please check back at the link for updates. 

Examples of substantial and non-substantial amendments can be found here.

With effect from 25 March 2020, the HRA has stopped reviewing applications for individual undergraduate and master’s student projects from now until further notice. Click here for further details which relates to health and social care research projects conducted by undergraduate and master’s students.

HRA have changed how they operate to prioritise COVID-19 related research. They have also published guidance to support sponsors, sites and researchers during this time.

Recruiting patients to COVID-19 clinical trials

CMOs and NHSE Medical Directors have produced this letter regarding the recruitment of patients to COVID-19 clinical trials.

Medical Research Council (MRC)

Please check here for updates relating to COVID-19 guidance.

Support and guidance for those conducting research with human participants, their tissues or data can be found here.

Medicines and Healthcare products Regulatory Agency (MHRA) 

This guidance relates to the management of clinical trials. 

Human Tissue Authority (HTA)

The HTA has produced guidance and key information to support professionals working at HTA licensed establishments.

Nuffield Council on Bioethics

Nuffield Council on Bioethics has produced this guidance.

UKRI COVID-19 support for researchers and innovators

UKRI have produced this helpful guidance.

The sections below detail all other policies and procedures relating to research ethics at Northumbria, as well as contact information for queries:

Contacts

As set out in our Management of Research Misconduct Policy formal allegations should be made to the Chair of the Research Ethics Committee, Professor George Marston

Northumbria University’s Research Integrity and Ethics Contact: Laura Hutchinson, Research Policy Manager, Research and Innovation Services

General Ethics Support queries, contact ethicssupport@northumbria.ac.uk 

Ethics Directors: 

Faculty of Arts, Design and Social Sciences, Research Ethics Director: Professor Mark Blythe

Faculty of Business and Law, Research Ethics Director: Dr Russell Warhurst

Faculty of Engineering and Environment, Research Ethics Director: Dr Ian Forbes

Faculty of Health and Life Sciences, Research Ethics Director: Professor Nick Neave

Ethics Online - research ethics approval system

Ethical approval must be obtained for all research projects prior to the commencement of the research.

Online Research Ethics and Governance Approval:

Access the system here Ethics Online

Staff and Postgraduate Research Students can access the User Guide here.

Undergraduate and Postgraduate Taught Students can access the User Guide here

Everyone can access Ethics Online FAQs here.

For System Support:

If you are an Undergraduate or Postgraduate taught student, please contact your Module Tutor or Supervisor

If you are a Postgraduate research student, please contact your Supervisor

If you are a member of staff, please contact your Department Ethics Lead or Faculty Ethics Director. 

A support model detailing how to manage issues in the system can be found here (Northumbria staff only)

Business Case for an amendment to Ethics Online - to ensure that any future system developments are both cost effective and impact all system users, changes will only be made on receipt of a completed business case which is then approved by all Faculty Research Ethics Directors and Research and Innovation Services. Before completing the business case, you should consider if the proposal is appropriate as a change to the system or better solved by effecting policy/best practice within your department/faculty

**Please note that the Ethics Online System has recently been restored following the cyber incident. Applications are still live in MyForms (the workaround system which was developed) and coordinators and reviewers will still need to process submitted applications in this system**

Documentation and Guidance

Click on the link to access the appropriate document:

For guidance relating to the NHS, please refer to the NHS-related Guidance tab below

For further information please contact ethicssupport@northumbria.ac.uk

Concordat to Support Research Integrity

The Concordat to support research integrity was revised in October 2019, representing a renewed ambition to further strengthen the original Concordat, published in 2012. It provides the principles and commitments to ensure that research produced by, or in collaboration with, UK universities, research institutes and others undertaking research is underpinned by the highest standards of rigour and integrity.

The new Concordat, released in October 2019, retains the five core commitments of the 2012 version. All those engaged with research must be able to make these commitments:

  • Maintaining the highest standards of research integrity
  • Ensuring that research is conducted according to appropriate
  • Embedding a culture of research integrity
  • Dealing with allegations of research misconduct
  • A commitment to strengthening research integrity

Concordat to support research integrity - October 2019 (pdf)

Northumbria University's contact for matters related to Research Integrity: Rachel Lawlor, Deputy Director, Research and Innovation Services

Ethics in Research Policy Statement

Northumbria University strives to uphold the highest standards of ethical practice in research and academic integrity. Irrespective of the nature and ethical complexity of a research project, staff and students are expected to ensure that their conduct is driven by the ethical imperative of respect, the intent to do no harm and to contribute to society’s knowledge and practice through engagement in research that has beneficent intent.

Northumbria University’s Ethics in Research Policy Statement 19-20 (pdf) can be viewed here.

Intellectual Property and Commercialisation

For information on IP and Commercialisation and to contact the team at Northumbria please click here

Legal Agreements for Research Projects

There are various legal contracts that will need to be in place during the lifetime of a research project.  The main ones are funding contracts, collaboration agreements, and contract research contracts.

All contracts relating to research are dealt with by the Legal Services Team within the Vice-Chancellors Department and Research and Innovation Services will work with Principal Investigators to ensure that Legal Services are instructed in respect to contractual arrangements.

Principal Investigators do not have authority under the University’s Financial Regulations to sign and enter into contracts on behalf of the University, hence ALL contracts must be reviewed by Legal Services and once finalised,  Legal Services will arrange for an authorised signatory within the appropriate Faculty to approve and sign off the contract.

From a research governance perspective, specific reference has been given to the following types of contracts  and the process for each  that must be followed:

Student Placement /Student Project Non-Disclosure Agreements

Material Transfer Agreements                                                                  

NHS Related Guidance

This area contains all NHS-related guidance relating to ethical approval for research within the National Health Service.

If you have any queries, please contact ethicssupport@northumbria.ac.uk

Clinical Trials

The Clinical Trials Toolkit provides practical advice to researchers in designing and conducting publicly funded clinical trials in the UK. Through the use of an interactive routemap, this site provides information on best practice and outlines the current legal and practical requirements for conducting clinical trials.

The Toolkit is primarily focused on Clinical Trials of Investigational Medicinal Products (CTIMPs) and the regulatory environment and requirements associated with these. However researchers and R&D staff working on trials in other areas will also find useful information and guidance of relevance to the wider trials environment.

ClinicalTrials.gov is a registry and results database of public and privately supported clinical studies of human participants conducted around the world. This web-based resource provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.

If you require a User Account, please contact ethicssupport@northumbria.ac.uk

NHS Research Passport

This is a national scheme which allows Northumbria University researchers to access the NHS to undertake research projects without having duplicate pre-engagement checks.

Applicable only for those engaged in a research project with the NHS but dependent on the nature of the research undertaken.

The responsibility of the researcher to ensure their completed Passport application is forwarded to the NHS Trust where they are carrying out the research activity to be validated.

A research passport should be applied for once a researcher is:

  1. Named on a grant application; or
  2. Appointed at interview to undertake NHS specific research; or
  3. A current member of staff starting a new NHS project.

However, it is always the duty of the researcher to initiate the application.

Application process:

A standard research passport application form is completed by the Researcher, the Principal Investigator of the research project and by HR

DBS clearance and health clearance are required as part of the process

For advice on the process and/or to progress a Research Passport Application please open a ticket via MyHR.

For Research Passport Flowchart, click here.

NHS Related Research Links

Clinical Trials Toolkit - NIHR

Health Research Authority 

HRA Approval: the new process for the NHS in England

HRA Participant Information Sheets and Informed Consent templates and guidance

Please include this NU-specific Privacy Notice link in your Participant Information Sheets

NHS Trust R&D Approvals process

Ministry of Defence Research Ethics Committee - MoDREC

The Ministry of Defence Research Ethics Committee (MoDREC) ensures that all research involving human participants either undertaken, funded or sponsored by MoD meets nationally and internationally accepted ethical standards.

 

MoDREC is commissioned to review research projects involving human participants. It safeguards the rights, dignity and welfare of the individuals volunteering to participate in research studies.

 

The Committee is an independent body comprising of non-MOD (expert and lay) members and is supported by appropriate MoD advisers.

 

Prior to final review by MoDREC, scientific and technical rigour is assured through assessment by a Scientific Advisory Committee (SAC).

 

For further guidance, please check here.

Integrated Research Application System (IRAS)

Integrated Research Application System (IRAS) is a single system for applying for Health Research Authority (HRA) permissions and approvals for health and social care / community care research in the UK. IRAS enables you to enter information about your project once instead of duplicating information in separate application forms and uses filters to ensure that the data collected and collated is appropriate to the type of study, and consequently the permissions and approvals required.

If you are unsure whether you should complete an IRAS form, please check with your supervisor in the first instance and then your Departmental Ethics Lead.

Before submitting to the IRAS system, first follow Northumbria University’s Internal Approval Process for IRAS submission here.

Northumbria's IRAS Internal Approval Form can be found here.

Once internally approved, complete your submission to the NHS Integrated Research Application System here.

Training Resources

The University offers the following training resources in Ethics and Governance:

Academic Staff

Academic staff must complete the mandatory Ethics Training module (incorporating Ethics Reviewer training from January 2020) every three years.

The training course is available on the e-Learning Gateway on the Staff Portal.

If you are unable to access the e-Learning Gateway, you can access the content via the internal Ethics and Governance page here.

 

Postgraduate Research Students

All postgraduate research students must complete Ethics Training before they commence their research.Students can access the training on Blackboard via the Researcher Development at Northumbria organisation site. Click here to access Blackboard.


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