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1. Policy Statement / Purpose

1.1 Durham University recognises that research excellence is an endeavour based upon trust and the maintenance of the highest standards of behaviour. It acknowledges that its good reputation and the good repute of its research is dependent on its integrity. This policy sets out the key behaviours and responsibilities expected by the University for any research or innovation work it sponsors, which is undertaken in its name or by its staff and student body. These expectations are intended to facilitate the conduct of University activities in a manner that manages ethical and other risks appropriately, safeguards both participants and researchers and supports best practice in the ethical conduct of these activities.

2. Scope

​​​​2.1. This policy is relevant to all University employees, students, and others undertaking Research and Innovation (R&I) activities in the University’s name.  It is particularly relevant to those involved in:

  1. any research or scholarship activities, whether funded or unfunded,

  2. other R&I activities in scope of the Work with Outside Bodies Policy, including consultancy, expert services, research commercialisation, and other impact, collaboration, knowledge exchange and public engagement activities.

2.2. Throughout the document, the term ‘researcher’ is used to mean any individual who conducts or supports research or other activity in the scope of this policy.  This includes but is not limited to:

  1. academic and research staff,

  2. postgraduate or undergraduate students conducting research or scholarship, whether for research degrees or as part of a taught programme,

  3. research assistants,

  4. research technical professional staff,

  5. professional services staff,

  6. visiting, honorary or emeritus staff,

  7. those who are not members of the University but who conduct, or support research sponsored by and / or on behalf of the University, such as independent contractors or consultants.

The terms ‘researchers’ and ‘research’ will be used to refer to all activities and those involved in them throughout this document.

2.3. The title Principal Investigator is used to refer to any person leading or with overall responsibility for a research project or group. In the case of student research, the Principal Investigator is always the supervisor. Where a research activity is collaborative across multiple organisations there will be the lead collaboration/consortium PI and local PIs which responsibility for activities within their organisation under the direction of the lead PI.

2.4. This document should be read alongside relevant University policies and guidance, including but not limited to Health and Safety, Research Data Management, Research Misconduct, Intellectual Property and Open Access; the UUK Concordat to Support Research Integrity and any other related external documents such as funder or professional bodies’ codes of conduct.

2.5 Research integrity is a complex area, encompassing statutory and legal requirements, and with drivers and expectations coming from funders, professional bodies, and 3rd sector groups as well as the University. The University considers the expectations in this document to be minimum requirements: in areas where another body has more stringent, relevant or robust requirements the University expects that these should be followed.

3. General Principles

​​​​​​​3.1. Everyone involved in undertaking or supporting research is expected to act in accordance with high ethical standards, values of mutual co-operation, openness, professionalism and the open and honest exchange of ideas.  Each person has a responsibility to uphold the core elements of research integrity as set out in the Concordat to Support Research Integrity.  These are:

  1. Honesty

  2. Rigour

  3. Transparency and open communication

  4. Care and respect

  5. Accountability

3.2 All researchers must familiarise themselves and act in accordance with both University policy and processes and with external requirements pertaining to the conduct of their work.

3.3 Equality, Diversity and Inclusion. Researchers should ensure that Equality, Diversity and Inclusion are embedded throughout the research process.  Research design and governance should ensure equitable selection of researchers, provide equal access to training and supervision, and ensure fair distribution of tasks and access to resources and development opportunities within teams/groups.  Leadership and supervision of research should monitor all research output so that it meets with Durham’s Equality, Diversity and Inclusion values and provides equitable support and opportunities for all researchers.

3.4 Legal and ethical frameworks in an international context. Where activity is to be carried out outside the UK, researchers should ensure that activities comply with the ethical and legal requirements existing in the UK, as well as those existing in the countries where the research is carried out (whichever is more robust).  Similarly, where activity carried out in the UK involves organisations or researchers based abroad, they should comply with the legal and ethical requirements existing in the UK as well as those in their country of residence.

3.5 Research Assessment. Research should be judged based on quality, reliability, reproducibility and / or authenticity rather than on the popularity of the authors, their affiliation, the journal or other output mechanisms. Any measures used for assessment should be in line with the University’s Statement on Responsible Use of Metrics and Research Metrics Policy.

3.6 Organisational Responsibilities

3.6.1 The University recognises its role in sustaining and developing an environment that fosters research integrity, and in providing researchers and others with the support and tools required to carry out their responsibilities under this policy.

3.6.2 Overall responsibility for ensuring operational support and institutional leadership for good practice in research lies with the Pro-Vice-Chancellor (Research).  All University leadership, but particularly the Executive Deans, PVC (Research) and PVC (Education), are responsible for developing a culture which is supportive of research integrity and of researchers. 

3.6.3 Heads of Departments / Units have a particular role to play in ensuring that local processes and culture support good research governance and practice, and their responsibilities are set out in more detail in 3.8.

3.6.4 Guidance and support are provided by University Professional Services; Research & Innovation Services, Academic Registry & Student Services, Human Resources and Organisation Development, Library and Collections, Computing & Information Services and the Durham Centre for Academic Development, and Academic and Research leaders in faculties and departments especially Research ethics committee members.

3.6.5 The University’s Ethics Committee oversees the operation of the University’s Ethics Framework on behalf of Council.  Further information on the roles and responsibilities of ethics committees, ethics review processes and guidance for faculties and departments on the conduct of ethics review is available on SharePoint. 

3.6.6 The University will support researchers to comply with the requirements of this policy by ensuring that it provides:

  1. a supportive governance framework, with its research integrity expectations embedded within its policies and processes.

  2. appropriate training and guidance for staff and students on the principles of ethical research practice and good research governance.

  3. a fair and transparent mechanism for investigating allegations of research misconduct.

3.6.7 The University recognises that applying the principles of research integrity is not always straightforward, and researchers may confront situations in which the correct course of action is not clear, or where, with the benefit of hindsight, they would have acted differently (for example when making decisions in the field).  The University stands by researchers who act in good faith and in accordance with the principles of this policy, encouraging them to seek advice and support as needed.

3.7 Researcher Responsibilities

3.7.1 This section summarises key responsibilities under this policy.  Later sections of the policy translate the principles of research integrity into expected behaviours and responsibilities in relation to specific thematic areas.

3.7.2 All researchers should:

  1. Take personal responsibility for ensuring that they act in accordance with the principles of the Concordat to Support Research Integrity.

  2. Engage in and training and development activities to ensure they have current awareness of expectations around research integrity and governance practices.

  3. Understand and apply the expected standards of rigour and integrity relevant to their research.

  4. Understand and comply with ethical, legal and professional frameworks, obligations and standards as required by statutory and regulatory authorities, and by the University, funders and other relevant stakeholders.

  5. Design, conduct and report research in ways that embed integrity and ethical practice throughout.

  6. Ensure that their research is subject to appropriate and active consideration of ethical issues.

  7. Comply with open research practices while minimising risks by adhering to Trusted Research guidelines.  This includes consideration of Trusted Research in relation to informal discussion in public spaces, conferences, and collaborations.

  8. Collaborate to maintain a research environment that encourages research integrity and promotes good conduct in research while inappropriate conduct is identified and addressed.

  9. Declare conflicts of interest and act to manage them.

3.7.3 In addition, Principal Investigators have overall responsibility for project activity, and for ensuring that applicable standards and requirements relevant to their project are met.  PIs may delegate responsibilities to other researchers, but must ensure that their researchers have sufficient training, resources and support to fulfil any additional responsibilities.

3.7.4 More detailed behaviours and responsibilities in the following areas for both researchers and principal investigators are set out in later sections of this policy:

  1. Leadership, Supervision, Training and Development

  2. Research Design and Management

  3. Collaborative Working

  4. Governance, Ethics & Risk

  5. Competing Interests

  6. Intellectual Property

  7. Peer Review, Monitoring & Audit

  8. Publication & Authorship

  9. Reporting Concerns

3.8 Head of Department / Unit responsibilities

3.8.1 Heads of Department should:

  1. create a culture which fosters and supports the behaviours required of researchers and encourages researchers to embed good research practice as a routine part of their work.

  2. ensure that good research practice is integral to the local research strategy or policy.

  3. ensure that researchers are aware of relevant policies and procedures through clear and transparent communication

  4. work with the faculty and relevant services as required to ensure that researchers have access to sufficient training, resources and support to meet the University’s expectations and the requirements of their role.

  5. Ensure appropriate provision of and access to support, career development opportunities, training, and mentoring processes to facilitate the career development of researchers.  These should provide training and mentoring of new researchers in line with the principles of the Concordat to Support the Career Development of Researchers. Particular attention should be given to research assistants, research associates and student researchers, ensuring that they are aware of their responsibilities and supported to fulfil the expectations placed upon them. 

  6. establish clear departmental guidelines, policies and procedures that

    1. ensure that projects within their department undergo all forms of appropriate risk assessment and review in accordance with the University’s policies, including health and safety risk assessment, trusted research/governance and ethics review.

    2. support researchers to ensure the confidentiality and security of sensitive data or materials, such as personal data or human tissue, in line with University and statutory requirements.

    3. ensure that, where potential conflicts of interest are declared by members of the department, they are appropriately recorded and managed.

    4. enable internal peer review to the standards required by the University.

    5. support compliance with discipline-specific professional standards (where appropriate),

    6. are fully compatible with other University policies and standards, including equality diversity and inclusion.

  7. For proposed projects within the department, check that the human, physical and financial resources identified by the PI are available to carry out the proposed work and work with the faculty and / or relevant services to facilitate access to agreed resources (subject to securing appropriate funding where applicable).

  8. ensure that University procedures for the monitoring and audit of finances relating to research projects are adhered to within their department.

  9. monitor and review departmental processes for suitability and effectiveness.

4. Leadership, supervision, training and development

4.1 Training and support for good research practice and career development of researchers is provided through Durham Centre for Academic Development, as well as other services including Library and Collections, Research and Innovation Services, and Organisation Development.

4.2 Role & Responsibilities of Researchers - leadership and development

All researchers should:

  1. ensure that they have the necessary skills and knowledge to undertake their work in line with the University’s standards, or where they do not, raise any needs with their PI or manager.

  2. undertake training in order to carry out their duties and to develop their knowledge and skills throughout their career and ensure that skills and knowledge are kept up-to-date.

  3. be willing to engage actively with peer review and / or research mentoring processes, both as reviewer and reviewee, as part of good practice in ensuring high quality research.

  4. be willing to engage actively with opportunities for collaboration, share best practice and learning points with other teams and departments, and engage with the broader University to highlight issues and suggest improvements.

4.3 Role & Responsibilities of Principal Investigators - leadership and development

Principal Investigators should also:

  1. be aware of their responsibilities for management and supervision and ensure that they have the necessary training, time and resources to carry out that role, requesting support if needed.

  2. create and maintain a research climate within their research group where good conduct in research is promoted, questions and concerns can be raised without stigma, and inappropriate conduct is identified and addressed. 

  3. direct and supervise projects in an exemplary manner, specifying lines of accountability within their research group for the organisation and management of the activity.

  4. ensure that the project team is aware of and capable of conducting their responsibilities and providing relevant direction and where needed signposting to sources of training, resources and support.

  5. encourage and enable the career development of their researchers, providing training and mentoring in line with departmental processes and adherence to the Concordat to Support the Career Development of Researchers, especially our commitment to 10 days of CPD per year.

5. Research Design and Management

5.1 All projects should have a clear aim and should be designed to deliver the research in a way which is rigorous, transparent, efficient, effective and fair. Timescales, resources and methodologies should be justifiable and proportionate to the project. The University supports peer review as an effective means of ensuring that this is the case.

5.2 Management of projects should be carried out responsibly, in line with best practice, funder or other applicable terms and conditions, and with an appropriate degree of transparency. This includes ensuring that projects are subject to sound data management, financial management and recruitment practices. Open research practices should be designed into activities and conducted where appropriate.

5.3 Role & Responsibilities of Researchers designing and managing research

All researchers should, in addition to the points in 5.1 and 5.2:

  1. ensure projects address pertinent questions and, in the case of research projects, either add to existing knowledge about the subject in question or develop methods for research into it.

  2. Ensure that the design is justified and appropriate for the question(s) being asked, and addresses the most important potential sources of bias and criticism.

  3. Aim to identify risks, both potential and actual, at the outset of the project and strategies for their effective management. This includes risks to the University, the research, the health, safety, wellbeing and mental health of researchers and research participants. You should also consider risks to the public, the environment, national security, and risks that the proposed research might produce outputs that could be misused for purposes that are illegal or harmful. See also section 7 for further information on ethics, governance and risk.

  4. consider how data will be gathered, analysed and managed at an early stage in the design of the project, and how and in what form relevant data will be made available to others paying particular attention to data protection requirements for personal data and sensitive personal data. 

  5. comply with the University’s Research Data Management Policy, and any other legal, ethical, funding body and organisational requirements for the collection, use, storage, retention and disposal of data.

  6. ensure that activities are designed in compliance with all ethical, legal and professional frameworks, obligations and standards that apply to the activity. This includes but is not limited to those for health and safety, equality diversity and inclusion, trusted research, management of finances, intellectual property and environmental sustainability.  Further information about ethics and governance requirements follows in section 7.

  7. adhere to the agreed design of the research project and keep accurate and secure records throughout the research process. This should include research results and details of experimental methodology. This is to ensure that final results are authentic and verifiable, protect researchers from misconduct allegations, and demonstrate compliance with legal and funder requirements.

  8. comply with the University’s guidelines regarding the management of finances, purchasing or procurement of materials, equipment or other resources and the hiring of staff, details of which may be obtained from HR and Finance and Procurement

  9. raise any concerns regarding research management or quality at the earliest opportunity, in line with the procedures for reporting concerns set out in section 12.

5.4 Role & Responsibilities of Principal Investigators designing and managing research

Principal Investigators should also:

  1. ensure that all relevant University, legal, ethical or other requirements have been considered in the design of the project and that the research team is aware of these.

  2. set out in detail the design and conduct of the project, including consideration of data management requirements line with the University’s Research Data Management Policy.

  3. ensure that all relevant risks have been considered, and put in place plans to effectively manage potential sources of bias and risk.

  4. consult with all relevant University services at the planning stage and ensure that sufficient resources are available to carry out the proposed project to the relevant standards.  This includes but is not limited to

    1. human resources - including relevant skills and experience; and

    2. financial resources - taking into account the full cost of the activity including, where applicable, costs such as licensing requirements and disposal of materials and equipment at the end of the project.

  5. ensure the project design has been understood and agreed by all key potential stakeholders involved within the research prior to beginning, and work with relevant University services to ensure that appropriate agreements are in place including matters such as intellectual property and acknowledgement of contributions.

  6. ensure peer review has taken place where applicable.

  7. attempt to resolve any issues prior to the start of the project.

  8. Be prepared to make the original research designs (also known as study protocols) available to peer reviewers and journal editors when submitting research reports for publication.

  9. Consider requirements for monitoring and audit at an early stage in the design of the project, and put in place appropriate arrangements for monitoring project activities including finances and compliance with agreed standards and protocols.

  10. proactively respond to allegations / concerns about research management and output quality, ensuring all concerns are investigated, escalated in a timely manner and responded to professionally. 

6. Collaborative Working

6.1 When establishing new research collaborations appropriate due diligence should be undertaken. Researchers should consider whether their collaboration will expose them, their research, data or intellectual property to risk, and put in place appropriate risk assessment and mitigation measures where required.

6.2 The University encourages practices that foster equitable collaborations. Work with Lower and Middle Income Countries (LMICs) should take account of recommendations for researchers in the Cape Town Statement on Fostering Research Integrity through Fairness and Equity.

6.3 To ensure collaborations run smoothly, standards and processes at the collaborating organisations should be suitable for the conduct of the activity, fulfil relevant ethical, legal and contractual requirements, and there should be a clear demarcation of roles and responsibilities.

6.4 Researchers should be able to robustly justify their research practices, and should not undertake activities which they are not comfortable with.  If there is a significant difference of understanding concerning what constitutes acceptable practice which could affect the project’s integrity, collaborators should reasonably and dispassionately attempt, as professionals, to seek a mutually acceptable solution.

6.5 If support in finding a mutually acceptable solution is required, then in the first instance the academic department’s designated ethics contact should be contacted and the best methods of resolving it explored. In the case of funded activity advice may also be sought from Research and Innovation Services.

6.6 Role & Responsibilities of Researchers working collaboratively

All Researchers should:

  1. strive to uphold principles of fairness and equity in collaborations.

  2. Work with the University to undertake appropriate due diligence and risk assessment in relation to new collaborations, including consideration of Trusted Research.

  3. consider and address any additional legal and ethical requirements and other guidelines that may apply to collaborative projects, including those involving community partners, other organisations, or which take place overseas.

  4. be aware of relevant standards and procedures followed by any collaborating organisations and any contractual requirements involving partner organisations, ensuring these are appropriate for the conduct of the work, and that any requirements different to the standards set by Durham are addressed.

  5. agree responsibility for any shared responsibilities or costs e.g. insurance for samples.

6.7 Role & Responsibilities of Principal Investigators working collaboratively

Principal Investigators should also:

  1. Work with relevant University services to ensure that agreements with collaborators are in place before work begins and that they detail the expectations, responsibilities and obligations of all parties, and address issues relating to the ownership of IP (potential & background), Trusted Research, open research, publication, attribution of authorship and contribution.

  2. Ensure processes are in place to deal with anticipated and unanticipated issues that may arise from working collaboratively.  Where possible, the parties involved should agree jointly in advance how issues might be addressed, communicating decisions to all members of the research team.

7. Ethics, Governance & Risk

7.1 The safety and wellbeing of those involved, including participants and the project team, is the paramount consideration in any activity.

7.2 Work must always be undertaken within the law and University policy.  This includes ensuring that appropriate insurances and statutory obligations e.g. data protection, health and safety, trusted research and export controls are considered, managed and implemented.

7.3 All projects must identify relevant ethical considerations and, where appropriate, undergo full ethical review (and secure favourable opinions) before any work starts.

7.4 Researchers should seek to identify ethical considerations and potential risks during the planning stage of the project (see 5.3), however ethics and risk assessment should be an ongoing process throughout the life of the project.  Where ethical issues or other risks are identified after project start, or where there are significant amendments to the design or execution of the project, further checks or re-approvals may be required.

7.5 Ethics review and an initial check of governance requirements is undertaken via the University’s Ethics and Research Integrity Portal. Where ethics review is being carried out by a body external to the University, relevant documentation including confirmation of approval should be submitted via this portal.

7.6 Staff and students are expected to adhere to any external requirements for ethical review which apply to their project, for example:

  1. Heath Research Authority Research Ethics Committee (NHS REC) review for health and social care research where this is required under the Governance Arrangements for Research Committees (GAfREC).

  2. Ministry of Defence Research Ethics Committee (MODREC) for research involving human participants when it is funded, sponsored by or includes employees or participants of the Ministry of Defence.

7.7 Ethical considerations

The University expects the following factors to be considered in ethical assessment, and projects which include these factors need to undergo ethics review by the appropriate body. Note that this list is not exhaustive, and where a researcher believe that their project may raise ethical issues not covered by the considerations below, they should submit an application for ethics review, indicating that it involves ‘other’ ethical considerations.

7.7.1 Humans & Personal Data

Any projects involving people, their data or tissues, particularly those which are high risk either due to their participant profile, design or methodology, require ethics review. This may include projects which involve

  1. human participants or subjects;

  2. lay input to project design or delivery (e.g. participatory research) or use of lay volunteers to undertake research (e.g. citizen science);

  3. use of data from social media, whether researchers are actively engaging with social media users, observing online behaviour, or collecting existing data from social media sites for use in research.

  4. secondary data including personal data that is not in the public domain, or use of which raises other ethical considerations;

  5. human tissues or samples from humans.

See 7.10 for additional responsibilities relating to research involving people, their data or tissues.

7.7.1.1 For the avoidance of doubt, where the researcher is a subject of their own research, for example where they are undertaking research using their own body, about themselves or using autoethnographic methods (which may also reflect on their relationships with others), this should be considered as research involving human participants.

7.7.1.2 Ethical approval is not normally required for activities involving humans or personal data if any of the following exemptions apply:

  1. The activity is not classed as research or scholarship, and does not involve vulnerable groups, sensitive topics or risk to safety or wellbeing of those involved; e.g. internal programme or module reviews; collecting feedback on a service or event, where this information will be used solely for evaluation purposes.  If it is anticipated that the data could be used for research, then ethics review should be undertaken.

  2. Activities where personal data collection is limited to interaction with individuals who are providing expert advice in a professional capacity.

  3. Use of secondary data involving only information that has been published or is otherwise available in the public domain (this does not include data gathered from social media, which will always require ethics review), so long as

    1. There are no ethical concerns regarding the source of the information.  Where existing datasets are utilised, it must be clear that the data was gathered with appropriate consent and that re-use for research purposes is permitted.

    2. Usage is within reasonable expectations of creator/publisher when making this information publicly available.

    3. Analysis will not reidentify individuals (where data has been anonymised) or create personal data that is not in the public domain, e.g. through the combination of multiple datasets relating to the same cohort.

    4. The project will not involve using automated processes to profile individuals or make decisions about them.

Where exemptions are applied to student projects this should always be confirmed by the supervisor.

7.7.2 Animals

Any project involving animals, as defined by the Animals (Scientific Procedures) Act or in scope of the Animal Welfare (Sentience) Act, or where work involving other animals raises significant ethical concerns, requires ethical review.  This includes projects that involve

  1. Living animals, whether through observation, capture and / or manipulation.

  2. Using animal tissues that raise ethical concerns.

  3. Using secondary data from research involving animals, where the source of the data could raise ethical concerns.

All projects involving animal tissue or secondary data from research involving animals should undertake due diligence regarding the source of the tissue or data.

See 7.11 for additional responsibilities relating to research involving Animals.

7.7.3 Data, Materials & Resources 

Any project involving the following require ethical review:

  1. viewing or dissemination of materials subject to the Counter Terrorism and Security Act 2013, or that are otherwise illegal.

  2. data, materials or resources that may have involved the exploitation or harm of individuals in its production, or otherwise have been unethically obtained.

7.7.4 Impact of the research process or outputs: 

Any project involving the following require ethical review:

  1. a significant potential risk to a physical environment or material culture (including artifacts). This could include use of environmentally hazardous agents, fieldwork that includes a significant risk of damage or disruption to the local environment, or methods of analysis which involve a material change or risk of damage to the object of study.  

  2. potential adverse impact on a community which is not directly involved in the research;

  3. cultural, governance or legal frameworks which are unfamiliar to the individual undertaking the work, such that there is a potential risk to the conduct of the project or the viability of future research.

  4. development of products/technologies relating to arms manufacture, fossil fuel extraction, alcohol, tobacco, gambling, or pornography;

  5. other significant issues relating to the potential use (or misuse) of products or technologies developed during the project, i.e. where this could cause harm. This includes dual use research of concern, where outputs intended to provide a benefit also have the potential to be used for harmful purposes.

7.7.5 Safety of the Project Team

Any project posing a significant risk to the safety and well-being - whether physical, psychological, emotional or reputational - of the project team requires ethical review.  This includes travel to or activity in areas considered to be of acute political sensitivity, or otherwise deemed to be high risk, as well as lone working in risky situations. Potential issues arising from the combination of the research and the location in which it is to be carried out should be considered, for example where the subject of the research may bring the researcher into conflict with local authorities.

7.7.6 Collaborator or Funding Source 

Any project where any of the following may apply requires ethical review:

  1. the funder or collaborator’s ethos and values are at odds with the University’s;

  2. the funder or collaborator has a poor ethical track record that has not been addressed, for example in relation to human rights violations or significant environmental harm;

  3. a third party may exert influence which conflicts with the principles of academic freedom, e.g. in restricting publication or influencing research design, or could adversely impact future research or relationships.

  4. the funding may have been obtained in an unethical way.

7.8 Research involving people, their data or tissues

7.8.1 This section applies to research involving any of the following:

  • Human participants: this refers to individuals taking part in a study as a participant or subject, providing data and input.

  • Patient and Public Involvement (PPI): this is an active partnership between the researchers and the public, and is ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them as in Patient and Public participation. For example, community based participatory research or citizen science.

  • Human material (human tissue)

  • Personal data

7.8.2 Researchers undertaking work involving any of the above should comply with all legal, ethical and other applicable requirements and guidelines, such as Data Protection regulations, Health Research Authority guidance for clinical and other health research, and Human Tissue Authority requirements.

7.8.3 Appropriate care should be taken when research projects involve potentially vulnerable participants, such as older participants, children or those with mental illness, and covert studies or other forms of research which do not involve full disclosure to participants. The dignity, rights, safety, and wellbeing of participants must be the primary consideration in any research study. Research should be begun and continued only if the anticipated benefits justify the risks involved. 

7.8.4 Factors which may raise particular risks to be considered include:

  1. Potentially vulnerable groups, e.g. children / minors, prisoners, those with cognitive impairment or those in unequal relationships;

  2. Requirement for co-operation of a gatekeeper for initial access (e.g. students at school, members of a self-help group, nursing home residents);

  3. Requirement for participants to take part without full knowledge and consent (e.g. involving covert observation or deception of participants);

  4. Sensitive topics (e.g. sexual activity, drug use, politics, illegal activities);

  5. Administering drugs, food or other substances to participants;

  6. Obtaining tissue samples (including blood) from participants;

  7. Any invasive, intrusive or potentially harmful procedure;

  8. Prolonged or repetitive testing;

  9. Any significant risk to the safety or well-being - whether physical, psychological, emotional or reputational - of participants.  ‘Significant risk’ is defined as outside that which a normal person would be exposed to in daily life. 

  10. Members of the public who are acting as researchers or as co-producers in the design or delivery of the research

  11. Offering financial recompense to participants beyond reasonable expenses.

  12. Conflicts of interest in the relationship between the researcher and participants, or for participants in relation to participation in the research.

7.8.5 Where activities involve children or vulnerable adults, sufficient arrangements to ensure safeguarding or participants must be put in place.  This may include a requirement for researchers to complete a Disclosure and Barring Service check or equivalent. For more information refer to University policy and guidance on Safeguarding.  Where participants are outside the UK, applicable requirements in the relevant country must be adhered to as per 3.4, and ethics committees should also be satisfied that those working with potentially vulnerable participants are suitable and that researchers have access to relevant knowledge and expertise in relation to safeguarding.

7.8.6 Activities involving collection or use of identifiable personal data may require a Data Protection Impact Assessment. Guidance on data protection and good practice in relation to handling of personal, data can be obtained from Information Governance.

7.8.7 Activities involving collection or use of human material should be notified to the University’s Human Tissue Board, and a Risk Assessment Covering the Integrity of Human Materials should be submitted for human material to be stored at the University.

7.9 Research involving non-human animals

7.9.1 Researchers undertaking work involving non-human animals should comply with all legal, ethical and other applicable requirements and guidelines, including Home Office licensing requirements. They should also ensure that animal-derived materials are responsibly sourced and used, where this is within their control.

7.9.2 The University subscribes to the Concordat on Openness on Animal Research, and encourages researchers to be open about the use of animals in research and take up opportunities to engage with the public about this where appropriate, seeking advice and training on public and media engagement where required.

7.10 Role & Responsibilities of Researchers – ethics and risk

7.10.1 General responsibilities

All researchers should:

  1. ensure that ethical risks are identified and addressed and that projects undergo ethical review in line with this policy.  

  2. consider and put in place procedures to safeguard the health, safety and wellbeing of the project team, participants and any others involved.  Where work is to be undertaken outside the University, researchers should comply with the University’s processes for risk assessment and approval of offsite work and travel, as well as considering mitigation for any other relevant risks such as lone working.

  3. Ensure that all research which involves potentially hazardous or harmful material, or which might cause harm to the environment, complies with all legal requirements and other applicable guidelines for acquisition, use, storage and disposal.  Advice can be sought from the Health and Safety service as required.

  4. comply with trusted research guidelines, report any risks to and seek guidance from the Trusted Research and Export Controls Manager in Research and Innovation Services, and take action to minimise those risks.

  5. comply with any review instituted in accordance with the University policy in areas such as ethics or health and safety and abide by the outcome of such review.

  6. be mindful of ethical and governance considerations throughout the life of the project and ensure that any additional risks are identified as they arise.

  7. where they are a member of a regulated profession, ensure that the project complies with any standards set by their regulating body.

  8. raise any concerns regarding risks or issues, including deviation from required standards, at the earliest opportunity.

7.10.2 Responsibilities of researchers working with people

All researchers working with people should:

  1. Satisfy themselves that participants are able to give informed consent, on the basis of adequate accurate information provided in an appropriate form through suitable procedures.  Where applicable, this includes provision appropriate to the needs and capacities of vulnerable individuals and groups who may require consent to be given by a gatekeeper.

  2. Where applicable, inform participants that data may be disseminated not only in a report but in different forms for future publications or for use in future research, albeit not in an identifiable form (unless previously agreed to), and subject to limitations arising from ethical, legal or other requirements.

  3. Put in place appropriate measures for storage and handling of personal data, in order to ensure its confidentiality and security, in line with data protection legislation and University policy and guidance on data protection.

  4. Put in place appropriate measures for storage and handling human material, where relevant, in line with University requirements established by the Human Tissue Board.

  5. Where research involves children or adults at risk, ensure that appropriate safeguarding arrangements are in place.

  6. Ensure that co-production and other forms of public involvement in research adheres to appropriate methodology and ethical frameworks.

  7. Ensure the fair, equitable and respectful treatment of those involved or participating in research.  Payment of those involved or participating in research should take account of relevant University guidance. The University also provides guidance on the rights and responsibilities of individuals involved or participating in research.

  8. Register health and social care research in a publicly accessible database so that trusted information about the studies is available for the benefit of all.

  9. When conducting Clinical Trials, comply with the principles of Good Clinical Practice, and with the requirements of Clinical Trials Regulations, including those for publication and transparency.

  10. Suspend activity if participants or others involved are subject to unreasonable risk or harm, and report issues to the approving ethics committee and other relevant bodies (e.g. funder) as required.

7.10.3 Responsibilities of researchers working with non-human animals

All researchers working with non-human animals should:

  1. Consider the 3Rs (replacement, reduction, refinement) in the design and delivery of the project, ensuring that animals are used only where necessary, that any pain and distress are kept to a minimum, and that high standards of animal welfare are maintained.

  2. Where undertaking experimental procedures on animals, follow the PREPARE guidelines when planning research, in conjunction with the ARRIVE guidelines for transparent reporting and dissemination of outputs from research involving animals and / or animal material.

  3. Suspend activity if animals are subject to unreasonable risk or harm or licence infringement, and report issues to the approving ethics committee and other relevant bodies (e.g. Home Office, funder) as required.

7.11 Role & Responsibilities of Principal Investigators – ethics and risk

Principal Investigators should also:

  1. ensure that all relevant ethical, legal and other governance requirements are appropriately identified and addressed, providing guidance and support to other members of the project team.

  2. ensure that relevant activities have ethical approval before work starts, and that the project has been reviewed and approved by all appropriate University or external ethical, regulatory or peer review bodies, and has secured all necessary statutory permissions.    

  3. ensure that the project fulfils all requirements of health and safety and environmental legislation, and is in accordance with the University Health & Safety Policy and local H&S arrangements

  4. ensure that, in the event of any significant amendments, projects are resubmitted for further approval where required, and that the University is notified of any risks or issues identified after approval.

  5. ensure that the project has sufficient arrangements for insurance and indemnity before the research begins.

8. Competing Interests

8.1 An undeclared or unmanaged interest can adversely affect the delivery and impartiality (or perceived impartiality) of the activity and of its outcomes and result in a conflict of interest. Interests could be personal, business, roles of authority, financial, secondary employment or engagements within other organisations which may result in position to have undue influence on process or decisions. Competing interests must be identified, declared and addressed to avoid poor practice in research or potential misconduct. It is important to note that a potential conflict of interest will not necessarily preclude any work from taking place if it has been declared, recognised and managed appropriately.

8.2 Role & Responsibilities of Researchers – managing interests

All researchers should:

  1. ensure that any actual, potential or perceived conflicts of interest (i.e. personal or organisational considerations, including but not limited to rivalry or financial matters) are identified, declared and addressed in line with the University’s Policy on Conflicts of Interest, as well as funder or other applicable policies, at the earliest possible juncture.

  2. abide by any direction given by the University or any relevant ethics committee in relation to managing a conflict.

8.3 Role & Responsibilities of Principal Investigators – managing interests

Principal Investigators should also:

  1. where a conflict of interest can be adequately addressed through declarations and/or special safeguards relating to the conduct and reporting of the project, ensure that this is reflected in the design and delivery of the work.  If it cannot be addressed in this way, and is of a type and severity that poses a risk of compromising the validity or integrity of the work, then advice should be sought via Research and Innovation Services about continuing with the work.

9. Intellectual Property and Copyright

9.1 Any contracts or agreements relating to research should include provision for ownership and use of intellectual property (IP). 

9.2 There is an expectation that any intellectual property discovered or developed using public or charitable funds should be disseminated to have a beneficial effect on society at large.  Any delay in publication and dissemination pending protection of intellectual property should be kept to a minimum.

9.3 Advice on Intellectual Property can be obtained from the Research Commercialisation team in RIS, and advice on copyright can be obtained from the University Library.

9.4 Role & Responsibilities of Researchers around IP

All researchers should:

  1. notify the University of any intellectual property created in the course of their activity, in line with the University’s Intellectual Property Policy

  2. adhere to requirements for confidentiality and any other conditions relating to intellectual property in line with any commitments to third parties, funder and University requirements (including requirements set out in the Intellectual Property policy), and obtain appropriate approval before disclosing confidential information, especially relating to current research and development work.

  3. ensure there is no prior disclosure of the project or findings when this might invalidate any intellectual property rights that could result. 

  4. acknowledge underpinning research work and all substantial help and advice received.

  5. comply with relevant legislation and guidelines for use of copyright material, and ensure that these do not conflict with open access terms or other conditions of funding agreements.

9.5 Role & Responsibilities of Principal Investigators around IP

Principal Investigators should also:

  1. ensure that interactions with sensitive content are covered by an appropriate agreement. 

  2. prior to publication, consider whether the project contains intellectual property that may have commercial value to the university and in such cases, consult Research & Innovation Services before public disclosure or submission of work for publication.

10. Peer Review, Monitoring and Audit

​​​​​​​10.1 All activities can benefit from regular review and audit. Peer review is encouraged and supported at all stages of the project; this includes both peer review of research proposals and peer review of outputs for publication. The University expects that all substantive proposals receive at least internal peer review but supports external peer review for complex applications.

10.2 Projects may also be monitored or audited by the University, funders and or other relevant bodies either as part of their ordinary quality control processes or in response to an allegation of misconduct or an issue.

10.3 Role & Responsibilities of Researchers – peer review and audit

All researchers should:

  1. cooperate with any legitimate internal or external monitoring and audit of their research projects and undertake such when required. 

  2. adopt peer review as an important part of good practice in research design and in the publication and dissemination of research and research findings.

  3. follow guidelines of any organisation for which they carry out peer review as well as ethical guidelines for peer reviewers, recognising the obligations of peer reviewers to be thorough and objective in their work and to maintain confidentiality.

  4. Be aware of and seek to avoid status bias and implicit (or unconscious) bias when carrying out peer review.

  5. report any pressure, direct or indirect, to breach these obligations.

  6. not retain or copy any material under review without express written permission from the organisation which requested the review.

  7. not make use of research design or findings from a paper under review without express permission of the author, and not allow others to do so.

  8. ensure that all records and project documentation are kept in formats and structure which facilitate University / funder audit and review.

10.4 Role & Responsibilities of Principal Investigators - peer review and audit

Principal Investigators should also:

  1. ensure any requirements for monitoring and audit are reflected in the design of a project (see also 5.4i).

  2. where appropriate ensure that proposals / applications receive at least internal peer review at the design / submission stage.

  3. be prepared to act as peer reviewers for meetings, journals and other publications, grant applications and ethics review of research proposals, and support others who do so.

  4. ensure that they and the project team fully engage with any audit and review process.

11. Publication & Authorship

11.1 ​​​​​​​The University respects the researcher’s academic freedom and their right to select the most appropriate route and method for dissemination of results. The University expects that researchers will select the most appropriate publication strategy. 

11.2 Guidance on sharing your research and open research is available from the University Library.

11.3 Role & Responsibilities of Researchers around authorship

All researchers should:

  1. publish and disseminate the outcomes of the project in an appropriate form and in a manner that reports the findings accurately and without selection that could be misleading. This includes sharing negative or null results (as appropriate) to ensure the accuracy of the research record.

  2. ensure that research data relating to publications is available to other researchers, subject to adherence to any ethical, legal or contractual restrictions.

  3. be willing to accept and present alternative points of view; not discourage or suppress appropriate publication or dissemination, nor attempt to influence the presentation or interpretation of findings inappropriately.

  4. select reputable outlets which maximise the exposure and impact of the work, both to the academic community and society more broadly.  Researchers should avoid predatory academic publishers that offer publication in return for a fee without providing appropriate peer review, editorial oversight or academic rigour.

  5. undertake training where appropriate in the publication and dissemination of projects that involve: confidential or proprietary information; issues relating to patents or intellectual property; findings with serious implications for public health; contractual or other legal obligations; and/or interest from the media or the general public.

  6. appropriately acknowledge anyone who has directly or indirectly assisted their work in line with University guidance on authorship and acknowledgements, and with funder or other stakeholder requirements. This includes collaborators, funders, participants, research technical professionals and other research-performing and research-enabling staff. Sources should be cited appropriately.

  7. adhere to any conditions set by funding or other bodies regarding the publication of data or findings, including the timing and manner of publication (e.g. open access).

  8. ensure that reports are not submitted to more than one potential publisher at any given time (i.e. duplicate submission) or publish findings in more than one publication without disclosure and appropriate acknowledgement of any previous publications.

  9. if subjected to attempts to influence the presentation or interpretation of findings inappropriately, or discouraged from publication or dissemination of findings, discuss this with their department’s Director of Research, Head of Department or the PVC (Research) so that the matter can be resolved.

11.4 Role & Responsibilities of Principal Investigators around authorship

Principal Investigators should also:

  1. take overall responsibility for the project’s publication strategy.

  2. in the case of academic publications, ensure contributors are included as corresponding authors where appropriate. The University recommends the use of the ICMJ definitions; whilst these are widely used, there might be additional discipline specific standards or practice which this recommendation does not exclude or diminish.

  3. be as open as possible with collaborators, funders, academic community and public regarding their research. Where there are reasons for restriction such as confidentiality requirements or the need to secure first use of research results then these should be discrete in their scope and application.

12. Reporting Concerns

12.1 Any unacceptable or improper behaviour or incidences of poor research practice, whether intentional or not, must be addressed at the earliest possible juncture.

12.2 The spectrum of inappropriate behaviour ranges from minor misdemeanours which may happen occasionally and inadvertently, to significant acts of misappropriation or fabrication.  The Research Misconduct Policy includes a definition of behaviours that could be considered research misconduct, which include:

  • Fabrication

  • Falsification

  • Plagiarism

  • Misrepresentation

  • Mismanagement or inadequate preservation of data and / or primary materials

  • Breach of duty of care. 

12.3 All individuals have a responsibility to act in good faith with regards to any concerns or allegations received regarding research misconduct or poor practice, and to raise any concerns regarding the conduct of research via the appropriate procedure indicated below.

12.4 Poor practices or concerns regarding research quality should normally be raised with the principal investigator in the first instance, or another appropriate department or faculty ethics officer. These include weak procedures or inadequate record-keeping, which may jeopardise the integrity of the research do not normally require formal disciplinary action and might only require further training or development. Honest errors and differences of interpretation or judgement of data do not constitute misconduct. It is expected that minor / early stage issues can be reported and resolved informally.

12.5 Potential instances of research misconduct may also be raised informally with the PI in the first instance, but if this is not appropriate, allegations are not taken seriously, or if the allegations are serious (such as any potential case where the law may be being broken or where there is a potential danger to the life, wellbeing or material reputation of any of those involved in the activity), then these concerns should be raised immediately through the appropriate procedure as set out in the Research Misconduct Policy.

12.6 Concerns about bullying and harassment or other grievances may be raised in line with the Staff Concerns Policy, or the Policy and Procedure for Student Complaints of Harassment and Bullying Against Staff.

12.7 If there is a concern of malpractice related to research but which may not constitute research misconduct, for example regarding financial, procedural or governance issues, the concerns may be raised under the University's Public Interest Disclosure Policy (Whistleblowing).

12.8 Role & Responsibilities of Researchers on reporting potential misconduct

All researchers should:

  1. report any concerns regarding poor practice or perceived misconduct to an appropriate person in line with the guidance above.  Where researchers are unclear on what action to take, they should seek advice from Research and Innovation Services.

  2. proactively monitor the research and research team to identify potential issues.

  3. seek advice from Research and Innovation Services if they are uncertain whether work they are involved in could breach the standards set out in this policy.

  4. take any allegations of poor practice / misconduct seriously, responding to them in a timely and professional manner and escalating as appropriate.

13. Related Information

13.1 Policies and statements

13.2 Additional guidance

13.3 External links

14. Version Control

Approval date: 4 February 2025

Approved by: Senate

Contact for further information: research.policy@durham.ac.uk.