Code of Conduct for Research

The following individual responsibilities apply to all those engaged in research carried out under the auspices of the University of Southampton.

As a Researcher you:

• are required to maintain the highest standards of research integrity and ethical conduct both at Southampton and when working overseas.
• are responsible for familiarising yourself with this Code of Conduct and adhering to its provisions. This includes related University regulations, policies and procedures that are underpinned by applicable UK legislation and any terms and conditions, codes of practice or guidelines issued by external funding or relevant professional bodies.
• are responsible for familiarising yourself with the Authorship, Contribution and Publishing Policy and the Research Data Management Policy.
• must ensure that you have the necessary skills and experience to carry out your duties and undertake training where necessary to ensure.
• should undertake appropriate training and development opportunities; to have the necessary skills to carry out your duties and your skills and knowledge are kept up to-date. This includes training for adequate supervision and assistance to ensure research is conducted to the highest standards.
• are expected to work collegially as set out in 'Our Southampton Behaviours'.
• by supporting and encouraging each other to strive towards and achieve the University strategy as outlined in our strategy and accept and share equitable responsibilities.
• must keep disagreements over interpretation or judgment in research within the bounds of civilised academic discourse. Personal abuse or malicious attempts to undermine the academic reputation of individuals or groups, at the University or elsewhere, is not acceptable and can constitute misconduct in its own right.
• must uphold the University’s Inclusion and Respectful Behaviour Policy, in every aspect of their work. This includes the University’s statutory obligations under the Equality Act (including the Public Sector Equality Duty) and related legislation, and supports the University’s commitment to create an inclusive University community where everyone feels welcome for who they are, free to express their identity, ideas and opinions, and feels included and supported.
• must be aware of and adhere to the University’s Conflicts of Interest Policy and associated guidance, including external requirements published by funding or governing bodies relating to Conflicts of Interest disclosures.
• must complete the Register of Interests in MyView (MyHR) ensuring it is updated, as necessary. It is important you recognise and declare research affiliations and other activities external to your University role that may be a conflict of interest. There is a short video to explain how to complete your Register of Interests and 'What is a Conflict of Interest'.
• must complete a Conflict Management Plan (CMP) with your line manager for those registered interests that are a conflict with your University role. The CMP needs to state the appropriate mitigating actions, or the activity must cease. There is a short video to explain how to complete your Conflict Management Plan.
• must submit an Annual Conflicts of Interest Declaration by August of each year if you are staff level 5 or above.
• should be aware that some Funders may have additional requirements for disclosing financial interests which are broader than the University’s Conflicts of Interest Policy and all individuals involved in a project will be required to complete an additional declaration form before the project can commence.
• should minimise risks by adhering to Trusted Research (NPSA) guidelines. This includes informal discussion in public spaces, conferences, and collaborations.

Heads of research groups:

• are responsible for the overall research performance of the group, including the career development of its members, and fostering a culture of support, openness and research integrity.
• should be aware of their responsibilities and ensure that they have the necessary training, capacity and resources to carry out their role, and request support if required.
• are responsible for ensuring compliance with this Code and all legal and ethical standards and requirements, and for obtaining appropriate approvals from all relevant bodies before commencing a research study.
• are accountable for the safety of others under their supervision and ensuring that risk assessments are completed prior to commencing research.
• are responsible for ensuring the safety, dignity, rights and welfare of all research participants, and for mitigating against or minimising risks in their research.
• should ensure that each research team member is qualified and competent to fulfil their role, and that researchers have undertaken relevant security checks (if applicable), and have adequate support, supervision and training.
• are accountable for ensuring that appropriate arrangements are in place to manage the research, financial and other resources, and any arising Intellectual Property (‘IP’).
• are responsible for supervising and checking the work of others in their group and should undertake a regular review of progress.
• should ensure that where there are collaborations with external organisations, appropriate agreements are entered into.
• when allegations of research misconduct or integrity are raised against staff, they must be passed to the Research Integrity and Compliance Office (RICO) via researchintegrity@soton.ac.uk.

The following individual responsibilities apply to all staff responsible for the academic leadership of the University, including members of the Executive Board and Deans.

Individuals in leadership and supervision:

• are responsible for creating, promoting and maintaining a sound research environment which encourages all research to be conducted to the highest standards of research integrity, governance and ethical practice.
• should seek to foster a culture of honesty, mutual co-operation and professionalism, where all researchers are encouraged to develop their skills and openly exchange their ideas, and where inappropriate conduct is identified and properly addressed.
• should actively ensure that their research staff have access to appropriate training specific to their discipline and research practice.
• ensure their research staff receive high-quality supervision and guidance in accordance with this Code of Conduct, and all other relevant standards, policies and procedures.
• support activities to implement the Concordat to support the Career Development of Researchers.
• provide dedicated mentoring in any areas where research staff require additional assistance.

The Vice-President for Research and Enterprise has the prime responsibility for setting the strategy in relation to research and for fostering a culture of research integrity across the University.

Deans, Associate Deans, Heads of Academic Units and Institute Directors take responsibility for ensuring that appropriate strategic direction of research and supervision is provided, including providing advice on matters of research integrity and conduct.

This responsibility can be delegated to appropriate Heads of Research Groups or other senior staff, provided that it is made clear within the research group what is expected of each of its members.

International partnerships are an important part of our research portfolio, but we are required to be vigilant with whom we collaborate.

We must review the risks against the benefits of these partnerships, both at the institutional and individual levels, and be compliant with associated UK legislation and government regulatory requirements (i.e. Export Control Order 2008, National Security and Investment Act 2021, The Animals (Scientific Procedures) Act 1986, The Health and Safety at Work Act 1974, UK General Data Protection Regulation (UK GDPR) and the Data Protection Act 2018, etc).

In response to these geopolitical challenges, the University has now published a new Responsible Collaboration Statement with an Addendum (identifying specific sectors) to support and guide our researchers as they continue to establish new international research partners; its underlying principles are embodied in this Code.

All researchers are expected to consider the wider consequences of their work and to critically engage with the practical, ethical and intellectual challenges that are intrinsic to the conduct of high-quality research.

It is the responsibility of all engaged in research to observe and promote the following principles which set out the standards and values relevant to research. 

As a researcher you must:

Excellence

• strive for excellence when conducting research.
• aim to produce and disseminate work of the highest quality and ethical standards.
• promote and support responsible research practice throughout the whole research life cycle.

Openness

• be honest and open at all stages of the research process.
• be open about your work and willing to discuss results and share data with academic colleagues.
• ensure research designs, methodologies and findings are open to scrutiny, debate, further analysis and re-use (subject to appropriate confidentiality, data protection, and IP considerations).

Integrity

• demonstrate integrity and professionalism by maintaining knowledge and awareness, and complying with the University policies, relevant requirements, and guidelines.
• follow the rules and regulations of your membership body if you are a member of a regulated profession.

Accountability

• accept full responsibility for your own research conduct and any activities of those who work under your direction or supervision.
• ensure that any research undertaken complies with any agreements, terms and conditions relating to the project, and allows for proper governance and transparency.
• ensure that a research project is undertaken in accordance with a favourable outcome of an ethics review.
• ensure any associated finance for a research project is used solely for the purpose of that research project.
• ensure that conditions regarding publication, research data management and Intellectual Property rights are fully complied with.
• report any instances of research misconduct to the Research Integrity and Compliance Office (RICO) for investigation in line with the University’s procedures.

Rigour

• conduct research according to the highest standards of rigour in line with prevailing disciplinary norms and standards.

Care and respect

• understand you have a duty of care for all participants in, and subjects of research, including humans, animals, the environment and cultural objects.
• address any concerns regarding the dignity, rights, safety and well-being of those involved in research.
• always act with respect, dignity and provide duty of care to all colleagues and students.
• understand you are responsible for the stewardship of research and scholarship for future generations, and that you are contributing to their professional community.

Sound research design and management is crucial to successful research outcomes. Suitable research design should be used to structure the research, and to outline how the key parts of the research project will work together. 

The process of research design should examine all the potential risks and ethical issues, how data will be collected, what techniques and instruments will be used and how records will be analysed.

As a researcher you should:

• ensure the proposal is designed to add to existing knowledge in accordance with state-of-the-art knowledge of the subject in question, or to develop methods for research into it.
• seek appropriate advice on sound research design from more senior and experienced colleagues when appropriate.
• ensure the research design is appropriate for the question(s) being asked and addresses the most important sources of bias.
• produce a clear and detailed research plan or protocol setting out the design and conduct of the study, including how records will be gathered, analysed, and managed.
• plan for documenting the research in line with FAIR Principles (Findable, Accessible, Interoperable and Re-usable) to enable appropriate reporting in line with these principles.
• consider how data may be reused in the future including sharing it with collaborators, making it available to other researchers, or through open access.
• ensure all necessary skills and experience, and sufficient resources meeting the relevant standards, will be available to conduct the research within the research team, or through collaboration with specialists in relevant fields.
• monitor progress regularly. If necessary, there should be an opportunity to refine the research design and/or methodology where justifiable.
• keep documentation for the rationale for the study and any subsequent modifications or if appropriate, express this clearly in study protocols.
• ensure that any subsequent alterations to the design are subject to appropriate review and scrutiny where the research design has been approved by the Faculty Research Ethics Committee (FREC) and/or a favourable opinion from a regulatory body.

As a researcher you:

• must familiarise yourself with the terms and conditions of any funding agreement (grant or contract and whether from public, government funding bodies, industry or other), to ensure that you fully understand the implications of those terms, and that you accept these terms as the basis for your research.
• must ensure you observe and fully comply with the terms and conditions of any grant or contract once the funding has been accepted.
• must adhere to all Financial Regulations and Procedures including those related to purchasing or procurement of resources for research, the hiring of research project staff and expenses.
• must use and manage financial resources responsibly, in accordance with the terms and conditions of the funding body and the University and co-operate with any financial monitoring and audit.
• should report any concerns, irregularities or events which can result in unforeseen finance consequences to the Faculty Finance team when these become apparent.

Additionally, where there is more than one Funder for any project you:

• must read the terms and conditions of the different funders to ensure there is no conflict.
• must ensure the rules against double recovery of funding for research are complied with.
• should ensure that relevant funders are made aware of and consent to any other funding received for the same piece of research.

As a researcher you:

• should pay particular attention to any additional legal and ethical requirements when conducting or collaborating in research internationally, including regulatory considerations for working overseas.
• must ensure that research projects based outside of the UK comply with the UK’s legal and University ethical requirements, as well as the laws and regulations of the country where the study is taking place or data is collected.
• should consider early in the research design process if the research project has the appropriate insurance cover. This applies to research conducted in the UK, at overseas institutions (where UK insurance is not always recognised in some countries) and that aboard vessels in international waters. Please contact insure@soton.ac.uk for advice.
• should seek advice when University insurance is not covered when the research undertaken in countries where UK insurance is not recognised. Please contact insure@soton.ac.uk for advice.
• should seek advice when the research is not conducted in a country at all (e.g. on research cruises in international waters, albeit the jurisdiction then is that of the ship). Please contact insure@soton.ac.uk for advice.
• must be aware of cultural sensitivities and differences when undertaking research in other countries or regions with different cultural expectations and economic circumstances compared to the UK and apply the principle of benefit-sharing to the research study.

Similarly, researchers and organisations from abroad involved in research undertaken under the auspices of the University of Southampton, must comply with both the UK’s ethical and legal standards, and those of their own country. Further guidance on research integrity in cross-boundary research and research involving people in low and middle income countries.

The University recognises that research is increasingly globalised and collaborative by involving individuals and institutions within and beyond the UK. 

As a researcher you should:

• be mindful of the procedures for the conduct of research adopted by organisations involved in collaborative working and work to ensure compliance with common research standards and procedures.
• ensure that research projects in Low- and Middle-Income Countries (LMICs) which may be funded by Official Development Assistance (ODA) governments or other official agencies have the following appropriate considerations:
  • general need/recognition that the research is co-designed and co-delivered on equal basis with local partners.
  • importance of recognising Indigenous, cultural and traditional rights.
  • compliance with the Nagoya protocol, CITES (the Convention on International Trade in Endangered Species of Wild Fauna and Flora) and The International Union for Conservation of Nature (IUCN) Red List of Threatened Species; and
  • compliance with all import and exports requirements of all countries involved when shipping i.e. biological samples (human, animal) artefacts.
• ensure all parties are clear about their respective roles and responsibilities, and agree uniform collaboration principles; consensus should be reached on:
  • confidentiality
  • provenance of intellectual ideas
  • ownership and publication of research
  • authorship contribution (significant research input) and correct affiliation where research was conducted as per Authorship, Contribution and Publishing Policy
• recognise that subject to legal and ethical requirements, roles and contributions may change during the lifespan of the research.
• contact the Research Contract Team via riscontracts@soton.ac.uk as early as possible to ensure that appropriate agreement(s) can be put in place.

Export controls can apply to the digital or physical export of any strategic goods, data, technology, documents, materials, software, or know-how from a destination within the UK to a destination outside the UK.

Export controls are needed for a variety of reasons, including national security and international treaty obligations. In the UK, the Export Joint Control Unit (ECJU) undertakes the control of strategic goods and technology.

Export control rules apply to commercial export and all kinds of academic activity, including teaching and research. This can extend to academic fieldwork, virtual teaching to students abroad, taking a laptop on a trip, discussing research via electronic means, and presenting at international conferences. 

Exports to a destination outside the UK may require an appropriate export control licence. Failure to comply with Export Controls is a criminal offence which can lead to unlimited fines or a prison sentence for the individual involved.

As a researcher you should:

• be aware of and comply with the UK Export Control Order 2008 and apply for export control licence as required under the UK’s regulatory framework of Strategic Export Controls relevant to your field of study.
• be aware that an export of your research (software, technology, radioactive substances) may come under the category of a dual-use items (non-military items which may also be used for military purposes).
• check that any export of your research is not listed on the UK Consolidated list of strategic military and dual-use items that require export authorisation. There is helpful Goods Checker tool to determine if an export licence is required.
• check that any export of your research, knowing the Control List entry reference (or 'rating') that apply to your specific goods, software or technology can use be exported using an existing Open General Export Licence (OGEL), using the OGEL checker tool.
• be aware that you have a personal responsibility to adhere to Export Control regulatory requirements.

Researchers can find further information on Export Control Joint Unit (ECJU) website and the Research Integrity and Compliance Office (RICO) SharePoint site and can seek support assessing or applying for a license from the Research Integrity & Compliance Office (RICO) via exportandsecurity@soton.ac.uk.

The current geopolitical landscape has seen unprecedented change globally over recent years. This has impacted research in the UK with international research collaborations under UK Government scrutiny. 

The National Security and Investment (NSI) Act 2021 was introduced to protect the UK’s intellectual property, sensitive research, people and infrastructure from potential theft, manipulation and exploitation and interference by hostile entities.

The National Protective Security Authority (NPSA) and the National Cyber Security Centre (NCSC) and designed in partnership with the academic sector, created a Trusted Research Evaluation Framework (TREF) to support the integrity of the system of international research collaboration.

It provides guidance to researchers, University staff and funding organisations to help keep sensitive research and intellectual property secure from theft, misuse or exploitation.

As a researcher you should:

• be aware that if your research falls within one of the NSI Act 17 sensitive areas of the economy. This includes licensing any intellectual property (IP) to an external entity to the University, including spin-out companies where the University has a stakeholder share.
• be aware that you have a personal responsibility to adhere to the NSI Act requirements and making a notification to the UK Government Investment Screening Unit (ISU).

For further advice and guidance, contact the Research Integrity and Compliance Office (RICO) at exportandsecurity@soton.ac.uk or the Research Integrity and Compliance Office (RICO) SharePoint site.

It is the University’s policy to encourage and facilitate the successful utilisation of Intellectual Property (IP) to the benefit of the University, its researchers and as part of its contribution to society. 

As a researcher you should:

• understand and comply with the terms relating to IP and confidentially in any sponsored research, grant, contract or collaboration agreement.
• respect IP created by others, use it only with appropriate permissions and fully comply with all relevant IP licences.
• keep lab notebooks and other records for evidencing the creation of new IP during your research.
• comply with the University’s Intellectual Property Regulations.
• be aware of relevant legislation such as Copyright, Designs and Patents Act 1988.

Further information on any aspects of IP and copyright can be obtained from enterprisecontracts@soton.ac.uk.

The University provides a full range of insurance policies which protect the University’s assets and liabilities and extend to liabilities of researchers undertaking authorised research on behalf of the University.

The University also provides professional indemnity cover which provides indemnity in respect of legal liability to third parties for breach of professional duty due to negligent acts, error, or omission in connection with the University business.

The University’s Insurance Office is responsible for providing advice on all matters relating to the University’s insurance policies and claims, and for arranging necessary insurance cover for research projects. More information is available on the Insurance webpage or by contacting insure@soton.ac.uk.

As a researcher you:

• must ensure the dignity, rights, safety, and well-being of all involved in research, including researchers themselves.
• must avoid unreasonable risk or harm to research participants, the environment or animals.
• should observe the University’s Health and Safety Policies and undertake prior risk assessments.
• should only commence and continue a research project if the anticipated benefits justify the risks involved.
• should ensure that your research study conforms to all appropriate health and safety legislation and good practice, especially if it involves potentially hazardous or environmentally harmful material.
• should ensure that sufficient insurance and indemnity has been arranged with the Insurance Team. 

Further information and advice is available on the University Healthy and Safety website which has links to Health and Safety SharePoint site.

A risk assessment of the planned study should be undertaken before the research commences. 

As a researcher you should:

• identify any potential risks to the University or the health, safety or well-being of researchers or research participants.
• identify any potential risks to animals, the environment, cultural heritage and/or society.
• determine whether the proposed research might produce results that could be misused for illegal or harmful purposes.
• seek help and advice when needed on risk assessments from the University’s Health and Safety Office at healthandsafety@soton.ac.uk or the Research Integrity and Governance Team at rgoinfo@soton.ac.uk.
• take sufficient steps to eliminate or minimise any identified risks.

Effective and accurate management of research data and records constitutes a foundation of good research practice.

As a researcher you must:

• keep full, clear, and secure records of your procedures and results, including interim findings where applicable.
• ensure you understand and adhere to the University’s Research Data Management Policy.
• be mindful of relevant legislation and funding body policies, and plan for documenting the research in line with FAIR Principles (Findable, Accessible, Interoperable and Re-usable) to enable appropriate reporting in line with these principles.
• comply with the University’s Open Access Policy.
• destroy research data in accordance with the University’s Recommended Practices for Destruction of Data as well as any relevant legal, ethical and funder requirements.
• give special consideration to confidentiality and security when storing, managing or destroying research data.
• observe the following research data principles and standards:
  • Collect all research data accurately, efficiently and according to the agreed design of the research project.
  • Generated research data is compliant with the University’s Research Data Management Policy and a Research Data Management Plan is in place. This is recommended practice, and may be mandatory from the funder – information and funders templates can be found at DMPonline.
  • Accurately manage all research data throughout the research life cycle.
  • Store all primary and secondary data in a secure, durable, and auditable format appropriate for the type of research data.
  • Securely store all significant research data for a minimum of 10 years in line with the University’s Research Data Management Policy.
  • Comply with any requirements from the funder or Sponsor for an increased retention period, or where the research is of major social, environmental or heritage importance.
• ensure that, in cases of research collaboration, an agreement is drawn up between the participating institutions regulating data ownership and publication of research outcomes. Please contact Research Contracts at riscontracts@soton.ac.uk for advice and information.

All processing of non-anonymised Personal Data, including its collection, storage and destruction, must comply with the terms of the Data Protection (Fundamental Rights and Freedoms) (Amendment) Regulations 2023.

The UK data protection legislation accounts for research activities and in cases where compliance with certain obligations will cause a significant detriment to the stated research aim, and a lack of adherence to those obligations do not cause distress or damage to participants, researchers may be able to rely on the exemptions in law. Advice on this must be sought from the Information Governance team before commencing.

Unless there are ethically and legally justified reasons for doing otherwise, as a researcher you must: 

• understand your obligations under the University’s Data Protection Policy.
• ensure an adequate data risk assessment is undertaken, with a data management plan and an IDPR (Initial Data Protection Review) and Data Protection Impact Assessment (DPIA) if applicable.
• not use personal data for purposes other than stated on the information sheet provided to participants, unless there is explicit approval from the Faculty Research Ethics Committee (FREC).
• not store personal data for longer than is necessary.
• ensure personal data is stored fairly, lawfully, and transparently in respect of data subject (participant) rights.
• personal data must be kept confidential and not disclosed to third parties except in circumstances where there is a legal or statutory obligation, or where the disclosure is necessary for the research (i.e. collaborations with third parties where there is a written agreement in place) and where the conditions above are fully met. 

Further advice can be sought from the Research Information Governance Team via data.protection@soton.ac.uk or researchdata@soton.ac.uk.

As a researcher you must:

• be aware of any confidential information you may be in receipt of from other researchers, collaborators, and funders.
• manage confidential and/or restricted information with care.
• not use or disclose confidential information to others without the consent of the party who owns it.
• ensure you are aware of any confidentially provisions which apply to specific projects involving commercially sensitive data or IP, and of any obligations in respect of these provisions.

All researchers are expected to publish and disseminate the results of their research in an open, honest, transparent, and accurate manner, and via all appropriate media such as journal papers, books, reviews, software, data repository or conference proceedings. Only in the most exceptional circumstances of security or confidentiality should research findings be withheld from academic scrutiny, sharing or further use.

As a researcher you must:

• ensure your publications conform to appropriate discipline specific professional standards.
• comply with the University’s Authorship, Contribution and Publishing Policy.
• clearly acknowledge and attribute all sources used in the research in line with your specific discipline citation and referencing convention.
• ensure that any inconsistencies or errors in your published material are rectified in a timely manner.
• be aware of the guidelines provided by Committee on Publication Ethics (COPE) and International Committee of Medical Journal Editors (ICMJE), as well as other discipline specific recommendations or standards.
• make all publications and research outputs available to other researchers and to the public in accordance with the University’s Open Access Policy.
• follow the examples of good practice as set out below:
  • In any publication, the authors must be able to identify their contribution to it, be familiar with its content, and accept personal responsibility for it.
  • In all aspects of research, the contributions of formal collaborators and all others who directly assist or indirectly support the research (including research students, research staff and professional services staff) should be properly acknowledged with their permission.
  • Funders of research should be clearly acknowledged and any competing interests listed.
  • The sequence in which authors are listed should be agreed by all authors, following disciplinary conventions or publisher’s requirements.
  • Intentional failure to acknowledge the contributions of others is regarded as unprofessional conduct, and instances other than minor omissions will be treated as research misconduct.
  • Any person who has not made an intellectual, scholarly or practical contribution, and has not participated in a substantial way in conceiving, executing or interpreting at least part of the relevant research, should not be included as an author of the publication derived from that research (so called ‘honorary authorship’).
  • A researcher who submits substantially similar work to more than one publisher should disclose that fact to the publishers at the time of submission.
  • Publications should include sufficient methodological information to allow other researchers to reproduce original procedures used.
  • Researchers should observe any conditions set by funding or other bodies regarding the publication of their research and its findings.
  • Authors should declare any potential or actual conflicts of Interest, which may be financial, commercial, personal, academic, or political.
  • Authors should be clear about how they have manipulated published images and data.
  • Publications should acknowledge the limitations of data and sources and should only share conclusions which are supported by the results.
  • Be aware if the use of Generative Artificial Intelligence (Gen AI) tools are appropriate for your research. It is important to understand that these tools recognise patterns but do not understand the content. Whilst it can lead to biases and inaccuracies in the content they generate, it may breach security of confidential and sensitive data. You will need to check with each journal their rules for using GenAI.

The University encourages peer review as an important part of good practice in the assessment of applications for research grants, review of research proposals, and the publication and dissemination of research findings.

Researchers must not use AI to support peer review without explicit permission. Uploading confidential manuscripts into generative tools may breach trust or policy.

The University aims to provide a competent, rigorous, and independent process of ethical review, which is proportionate to the anticipated risks involved in a research project.

As a researcher you:

• should consider all ethical and regulatory issues before any research work commences.
• should ensure that you are fully aware of and comply with all ethical and legal obligations and guidelines as required by relevant stakeholders, including seeking ethical review, and approval and authorisation for research where appropriate.
• must observe the University’s Ethics Policy at all times.
• must ensure you act and conduct your research to the highest ethical standards.
• should be aware that the Guidance on the use of secondary data for research purposes may require ethical review where there are ethical considerations.
• must register all research requiring ethical review on the University’s electronic ethics and governance platform ERGO II irrespective of whether the research will be ethically reviewed internally or by an external body.
• must not commence research and data collection, including recruitment of participants or fieldwork, until ethical approval has been granted by the Faculty Research Ethics Committee (FREC) and/or other relevant external body (i.e. Health Research Authority (HRA) NHS Research Ethics Committee). Further governance reviews by the University’s Research Ethics and Governance Office (REGO) and Insurance Office may be required as appropriate.
• must contact risethics@soton.ac.uk if you are in doubt about the need for ethical review.

If a staff member intends to carry out staff non-scientific research (i.e. a survey for University purposes which is not intended for publishing) this would require ethical review through Administrative Research Ethics and Quality Assurance (AREQA).

The University is committed to protecting the rights, welfare, safety, and dignity of all those involved in research, and to promoting and achieving the highest ethical standards.

Where research involves the participation of individuals as the subjects of investigation, as a researcher you must:

• ensure the research complies with the University’s Ethics Policy.
• complete the accredited Good Clinical Practice Training or enquire via risethics@soton.ac.uk and ensure that all clinical research involving human participants is undertaken in line with the principles of Good Clinical Practice for Clinical Trials.
• ensure that clinical medical device trials are undertaken in line with the appropriate ISO standards.

Where research studies involve human biological material, as a researcher you must:

• comply with the relevant Human Tissue Authority (HTA) Code of Practice and Standards E: Research as required for the University of Southampton’s HTA Research Licence.
• abide by the University Use of Human Tissue in Research policy.
• ensure all human ‘relevant’ samples collected comply with the HTA Code A: Guiding Principles and the Fundamental Principle of Consent as required under the Human Tissue (HT) Act 2004.
• check if the human samples being donated or collected are considered 'relevant material under Human Tissue Act 2004’ (the list is not definitive); for any query concerning (whether or not) human material being collected for research purposes is ‘relevant’ please contact RICO via researchintegrity@soton.ac.uk.
• adhere to the University’s Biological Material Safety Policies and have the appropriate approval to ensure any biological material used in research does not pose a risk to human health.
• ensure you have appropriate research ethical approval to collect or purchase all human relevant and non-relevant material.

The Sponsor takes primary responsibility for ensuring that the design of the study meets applicable standards and that arrangements are in place for appropriate research conduct and reporting.

Any research requiring sponsorship must have an organisation willing and able to take on the responsibilities of the research Sponsor. The responsibilities of Sponsors are set out in more detail in the UK Policy Framework for Health and Social Care Research 2025 written by the Health Research Authority (HRA) and the health departments in Northern Ireland, Scotland and Wales have developed the policy framework, following public consultation.

The University can act as a research Sponsor; however, this does not constitute blanket acceptance for all University-led research projects. The risks attached to assuming the role of the Sponsor vary and are assessed and considered on an individual project basis. Any requests for Sponsorship should be made via ERGO II.

Sponsorship in principle is required for all high-risk studies including human challenge, drug or medical device trials and should be requested via ERGO II before submission of grant applications. For sponsorship queries contact rgoinfo@soton.ac.uk.

In the case of medical device trials, the University may also be acting as the legal manufacturer. It is essential that you contact REGO via rgoinfo@soton.ac.uk as early as possible to determine who is the legal manufacturer and how the responsibilities will be delegated. Further guidance and information can be found at REGO Medical Devices SharePoint site.

The legal manufacturer must demonstrate that the product meets requirements of the United Kingdom Medical Device Regulations (UKMDR) and the European Union Medical Device Regulations (EUMDR), as well as registering with the Medical and Healthcare products Regulatory Agency (MHRA).

Any Research undertaken by the University can be subject to monitoring and audit by the University and/or external regulatory bodies and competent authorities, to ensure that it is carried out in accordance with good practice, and all legal and ethical requirements.

As a researcher you should co-operate with monitoring and audit of your research studies and any outcomes.
 

Adverse Events (AEs) are negative events that occur as a result of carrying out the research project and may include incidences that cause harm (i.e. to the environment, participants, University reputation and the integrity of the research). In clinical research, researchers should follow the reporting guidelines in accordance to Good Clinical Practice for Clinical Trials.

As a researcher you must:

• report any adverse events and incidents that occur during, or result from, a research project to the Research Ethics and Governance Office (REGO) via rgoinfo@soton.ac.uk.
• be familiar with any relevant legal or regulatory requirements and time frames to report adverse events directly to external regulatory bodies, competent authorities, or funders.
• promptly report any accidents, incidents, dangerous occurrences and ‘near misses’ during the course of research in line with the University’s Health and Safety Policy. 

Queries on reporting requirements can be sent to the REGO Team via rgoinfo@soton.ac.uk.

The use of animals in research is governed by the Animal (Scientific Procedures) Act 1986 and this Act is enforced by the Animals in Science Regulation Unit (ASRU).

The University is a signatory to the Concordat on Openness on Animal Research and is committed to the highest standards of animal welfare, including the principle of 3Rs:

1. Replacing animals with alternative methods wherever possible
2. Reducing the number of animals used
3. Refining procedures whenever possible

As a researcher you must:

• ensure that research involving animals has prior approval from the University’s Animal Welfare and Ethical Review Body (AWERB) , and appropriate Home Office licences for the University, the study project, and the investigator.
• be familiar with The University of Southampton policy for using animals in research and education and comply with all legal and ethical requirements and applicable guidance.
• maintain the highest standards of care for all animals involved in research.
• ensure other types of research involving animals not covered by ASPA receive an appropriate ethics review and approval by AWERB or the Animal Committee. Advice and information can be sort at awerb@soton.ac.uk and AWERB website and ethics applications are submitted in ERGO II.