Ethics Policy for Research at University of Southampton

1. Introduction

The University of Southampton (UoS, ‘the University’) is strongly committed to benefiting communities across the world, through innovative research and education and the continuous pursuit of excellence in all its work. 

UoS conducts a wide range of high-quality research activities, independently and in collaboration, conforming to scientific, ethical, legal, financial and governance standards throughout the research lifecycle, while safeguarding the dignity, rights, safety, and welfare of human participants (including their tissues and data), researchers, animals, and respecting the environment and cultural heritage.

Research at the University also follows principles of integrity, objectivity, transparency, accountability, inclusiveness, and professionalism with knowledge of current best practices.

The University expects all staff, students or any other person engaged in research in the name of or on the premises of the University to be personally responsible for conducting high quality research in accordance with the ethical standards of the University. 

Researchers should familiarise themselves with the ethics principles and ethics review process outlined in this overarching Research Ethics Policy (‘the Policy’), as well as all applicable ethics sub-policies and guidance, and other related University policies including the Code of Conduct for Research which sets out the University’s commitment to research integrity. Researchers must be aware of and comply with national and international legislation, regulatory requirements, and any professional standards or codes of practice relevant to their area of research. 

2. Purpose and scope

The purpose of this policy is to provide a framework of principles and standards to be followed, responsibilities to be fulfilled and details the ethics review process, for research at UoS. The principles are applicable to all research, enterprise, consultancy projects and studies conducted at, by or in the name of the University of Southampton.

This policy is for research (funded or unfunded) across all disciplines, and applies to:

  • all employees and students at the University 
  • visiting and honorary staff
  • students on placements
  • contractors and consultants
  • research within or using University facilities
  • research conducted outside the University or overseas, by staff or students at the University
  • collaborative research, regardless of whether UoS is the lead

This policy applies to research activities, that include but not restricted to the following, which:

  • involve either human participants or their tissue or data (collected as part of research or secondary data, including anonymised data)
  • involve animals and animal byproducts
  • can impact cultural heritage and natural environment
  • can impact the reputation of the university
  • are security-sensitive (for example, any research where the researcher or research participants may be exposed to criminal activity or extreme behaviours)
  • involve service evaluations and audits in the NHS
  • involve or utilize AI based tools when using human participants or their data
  • social media and/ or data from websites or other internet sources
  • consultancy and enterprise activities involving human participants

This policy does not apply to:

  • routine audit and evaluation within the established management procedures of the University, for example, routine evaluation of teaching
  • the wider strategic interests of the University including operational decisions, business partnerships, and matters of procurement or investment
  • institutional or administrative research conducted to inform the business activity of the University (i.e., research which does not form part of the mainstream academic research undertaken within University Faculties), which is carried out by the University’s Professional Services, for example institutional research, student services, finance, or human resources. Such activity is subject to scrutiny through a separate Administrative Research Ethics and Quality Assurance (AREQA) Approval process

3. University's ethics principles

The University is committed to carrying out its research, teaching, enterprise, and other activities within a comprehensive ethical framework and this is reflected in the overarching principles listed below. The underpinning principle for any ethical review should be to ensure that in undertaking any research, consultancy, enterprise activity or project the University strives to do positive good and avoids causing harm. 

The University acknowledges that ethical issues encountered, and ethics review methodology might vary across faculties and schools of the University. Hence, in addition to these general principles, the researcher can seek recommendations from their Faculty Research Ethics Committee (FREC) or Animal committee (AC) or Animal Welfare & Ethical Review Body (AWERB).

3.1 Principles of benefit-risk

Any kind of research can have inherent risks and the possibility of resulting in harm or discomfort to participants or communities and might cause reputational risk to institutions. Researchers must strive to minimize such risks and in turn increase benefit-risk ratio, which enhances the value of research. Appropriate care should be taken to minimize risk to the researchers, any third parties, sponsors, environment and to the institution. Justification and impact are to be provided in cases where harm cannot be avoided.  

Participants must be fully made aware of any kind of risk or distress involved in the study (physical, mental, financial, etc.) and this should be clearly described in the Participant Information Sheet (PIS) and consent form (CF). If in doubt, researchers should seek professional advice from FRECs or AC or AWERB or the Research Ethics and Governance Office (REGO). Any unforeseen risks during the research should be immediately reported to FRECs and REGO.

3.2 Principle of voluntary and non-coercive research participation

Informed consent should be obtained from participants or appropriate legal guardians to ensure participants take part voluntarily, whilst fully aware of their degree of participation in the research and without force or coercion, upholding individual’s rights.

Informed consent is a continuous process, and researchers must respect the participants’ right to withdraw from the study at any point without any untoward repercussions. 
 

3.3 Principle of privacy and confidentiality

The confidentiality of information supplied by research participants is paramount in any type of research. Every effort must be made while collecting, handling, and storing sensitive, classified and/or personal data, to secure and protect it from unauthorised access and use. Care should be taken to ensure data can be linked back to individuals only by authorised personnel, who are explicitly approved and identified in the Research Ethics Application, and when agreed by the participants via PIS/CF. It is essential that all data is retained for defined and definite periods and then disposed of appropriately, in line with legal and University requirements (University Research Data management Policy)

3.4  Principle of competency

Only a competent team with appropriate training, experience, and/ or qualifications should plan, conduct, evaluate, monitor, and manage research at all stages, to evaluate the ethical implications that are encountered during research. In the case of student-research, a study should be undertaken only if the student is deemed competent to conduct the research under the supervision of a supervisor.

3.5 Principle of transparency, accountability, and responsibility

All stakeholders involved in research should disclose any existing conflict of interest prior to ethics approval being obtained and manage it appropriately. To ensure accountability, research should be carried out in a fair, open, unbiased, and transparent way. Every effort should be made to make research more inclusive, such as by using interpreters, translated PIS and CF or any other illustrations. It is the responsibility of all researchers to make sure research is conducted in line with the University's research ethics approval process and in compliance with any organisational or legal requirements.

All University researchers have the responsibility to protect the rights, dignity, well-being, health, safety and privacy of both research participants and researchers themselves, the welfare of animals, the integrity of the natural environment and cultural heritage, and to ensure that the public perception of research and the reputation of the University remains positive. Any incentives or rewards for participation in research should be disbursed fairly and appropriately. Roles and responsibilities of all members of the research team must be clearly defined and documented.

3.6 Principle of common ethical standards

The same high ethical and professional standards shall apply to all research, regardless of where it is conducted, in any mode, under the name of the UoS.

3.7 Principle of environmental and social responsibility 

Researchers should follow principles of environmental sustainability and social responsibility to ensure the outcomes of their research for society, community, or the natural environment, do not cause undue harm.   Respect for the health and conditions of communities, natural ecosystems and biodiversity should be fundamental to research design and practice. Researchers, whose research is in the areas of high environmental, cultural, and social sensitivity, that carries a potential reputational risk, need to consider all probable ethical issues, and seek advice from their FREC chair, who will provide advice and/or escalate to REGO, if required.

3.8 Principle of ethical conduct of research when using Artificial Intelligence (AI)

In addition to the above general principles, there are specific ethics principles that need to be followed for studies which involve AI, either as the subject of research (like AI-infused medical devices) or in the form of a tool that supports the research (like ChatGPT) or the development of AI-enabled tools / technology.

Here are some of the principal stakeholders in research involving AI and AI-centric ethics principles that are to be considered based on their role, as a minimum:

  • Data-Providers: Those who provide data to develop the AI tool need to consider at least non-discrimination, fairness, and diversity.
  • End-users: Those who might use the AI-enabled technology (for example, a financial agent or a doctor reliant on a decision-support system) or those who would be on the receiving end of an AI-enabled technology for example, an applicant for a loan, a patient using an automated diagnostic tool) would consider non-discrimination and fairness, accountability, and transparency, explainability and interpretability, reliability and safety and human autonomy.
  • Developer: the person developing the AI-enabled tool - all of those stated above.
  • Researcher: the person deploying an AI-enabled technology as part of their research protocol - all of those stated above.

As a minimum, the ethics application needs to show an awareness of who is affected by which of these, and what mitigations are in place.
 

4. Compliance with this policy

This Policy operates in alignment with all other related University policies, procedures, and regulations. Any breach of this Policy, whether deliberate or through negligence, will be treated seriously, and may result in disciplinary action under the University’s Procedure for Investigating Cases of Alleged Misconduct in Research (applicable to staff), or Regulations Governing Academic Integrity (applicable to all students). Visitors breaching this Policy may have their visitor status reviewed or withdrawn.  For further information on misconduct, please see procedures for investigating cases of alleged misconduct in research 2023-24.

5. Responsible conduct of research at the University of Southampton

All members of the University are responsible for ensuring that their research is conducted in accordance with the University’s values and policies, and relevant common law and legislation. The responsible conduct of research constitutes carrying out the research with high ethical, scientific, regulatory, governance, professional and legal standards while upholding the fundamental values of research through all the stages of research: planning and designing, applying for funding and approvals, conducting, monitoring, analysing, and publishing.

To ensure a research study is conducted in a responsible and ethical way, stakeholders  involved in research should fulfil the responsibilities associated with their role in the research process The responsibilities of supervisors, researchers, University Research Ethics Committee (UREC), Faculty Research Ethics Committees (FREC), Animal Welfare & Ethical Review Body (AWERB), Animal  Committee, Research Ethics & Governance Office (REGO),  are outlined in Appendix-1.

6. University research ethics review and approval process

The purpose of an ethics review is to ensure that all proposed research meets the high ethics and professional standards expected by the University, and that the research is conducted responsibly. A competent, thorough, consistent, and independent ethics review process is a mandatory requirement for research at or under the name of the University. UREC has overall responsibility for the ethics review process at the University, whilst the task of conducting ethics review and granting approval for individual projects and studies lies with the FRECs or AC or through an approved external body (for example, National Research Ethics Service (NRES)).

The University has one animal committee (subcommittee of AWERB) which covers the University as a whole and one Faculty Research Ethics Committee (FREC) for each of the University’s five Faculties.  FRECs have the freedom to operate combined ethics committees where appropriate and may, also, operate sub-committees. Each Faculty should ensure their arrangements for review are adequate to cover all relevant aspects of the research and studies undertaken by its staff, visitors, or students. These arrangements will be reviewed annually by UREC.

Overview of possible scenarios that require University Faculty Ethics review is outlined in Table-1 under Appendix-2.

6.1 Submission for ethics review and approval

The University uses the Ethics and Research Governance Online II (ERGO II) system (accessible at https://ergo2.soton.ac.uk), to review and approve research projects, from an ethics and regulatory perspective. ERGO II helps in maintaining oversight of research/ research-type activity happening within the University. The system also ensures that appropriate insurance cover is in place for all staff and students involved in research.  

Research requiring ethical approval should not commence until ethical approval has been granted.

Retrospective ethics approval is not permitted and will not be granted under any circumstances.

If any research that requires ethics approval is conducted without prior internal approval from either FREC/ FREC- sub-committee/ AWERB, or in deliberate contravention to the decisions of the FREC, will not be covered by the University’s indemnity arrangements. Serious consequences from noncompliance may follow regardless of whether harm to participants has occurred. This will also constitute a breach of this ethics policy and may result in disciplinary action.

Appendix-3 outlines the ethics Approval Process Flow for students.
Appendix-4 outlines the research that needs external ethics approval.

6.2 Amendments

If there is any need to make changes to the research project after ethics approval has been granted, researchers' are required to apply for an amendment for their project through ERGO II. Amendments should not be implemented until full ethical approval is obtained.

For amendments that require NHS REC/HRA approval, please see guidance on amendments.

6.3 Module-level approval

For some low-risk undergraduate and postgraduate student research projects, a module level approval may be appropriate. This is a light-touch review and approval process, which is used to manage large cohorts of very similar, student research projects which primarily have an educational purpose.

Module leaders are responsible for acquiring approval for their module level ethical review.  This means that students do not need to submit an individual ethics application if their project falls within the scope of their module level approval application, as their projects will be managed by the module convener.

Module-level approval applies only to those projects that follow the approved module level protocol.  Any projects that do not follow a module level approved protocol must go through ethics approval individually on ERGO II.

Module level approval is not suitable for any research which will be published, so these studies must obtain ethics approval individually on ERGO II.

All new module-level approval processes are approved by UREC. Once they have been approved, the responsibility for oversight of module level applications moves to the relevant FREC. Updates on module level approvals are included as part of annual FREC reports. 

6.4 Gatekeeper approval

Gatekeepers are individuals, institutions or organisations who control access to potential research participants. Researchers who require access to potential participants within a specific group or organisation will need associated gatekeeper approval to access these individuals. Researchers must obtain written gatekeeper approval before recruiting participants or collecting any data. Permission will be required to enter the property under the responsibility of the gatekeeper; this property can be a physical location, access to information or people or a domain on the web or a social media group.

Gatekeeper approval must be obtained from a representative in an appropriate position of authority in an organisation and this should be in writing. Gatekeeper approvals must be considered early in the research planning stage as alternative methods of recruitment may need to be considered if these prove too difficult or time consuming to obtain, or approval is not granted by the gatekeeper. Gatekeepers may require evidence of ethics approval ahead of their consideration and when not available, the gatekeeper can grant a conditional approval, while ethics approval is being obtained.

For further guidance, please see gatekeeper approval.

6.4.1 External researchers conducting research involving University staff or students or facilities

When a researcher from outside of the University of Southampton wishes to access the University’s staff or students for participation in a research study, or use facilities in a research project, they must identify an appropriate gatekeeper within the University.

For studies targeting staff or students within a specific school or faculty, an appropriate gatekeeper could be a Head of School or Associate Dean of Research (staff) or Associate Dean of Education or Dean of Faculty (students).

For studies where the intention is to recruit staff or students from across multiple faculties of the University or use university’s facilities, gatekeeper approval must be requested from more senior members of staff, such as the Vice President of Research or Vice President of Education.

Mass emailing is NOT considered an acceptable method of recruitment of research participants. For further information, please see mass emailing guidance.

6.5 Research involving human tissues

Any research project involving human tissue or fluid samples must undergo a robust ethics review process and it must comply with the Human Tissue Act 2004. All studies must be registered on the ethics online platform ERGO II. For further guidance on research using human tissues, please see The Human Tissue Authority.

7. Data management and data protection

The University Research Data Management Policy outlines the requirements to ensure that research data is stored, retained, accessed and disposed securely, in accordance with all legal, statutory, ethical, contractual and funding requirements. All the research conducted at or by the University must abide by this policy, and applicable legislation, including  University’s data protection policy, UK - General Data Protection Regulation (UK-GDPR) and Data Protection Act (DPA) 2018.

8. Collaborative research

Collaboration between researchers and/or third parties is common practice, to ensure the necessary resources/ expert-personnel needed for a study. There are many ethical, governance and legal concerns that need to be considered while planning collaborations involving exchanging ideas and techniques, responsibility and ownership of materials and data, transparency, accountability, joint publications, managing research findings, conflicts of interest, intellectual property rights, commercialising findings from research. Relevant stakeholders should be engaged, made aware of the University’s Ethics Policy, other relevant policies, and guidance, and duly informed of all decisions and changes taken throughout the project. If the researchers from UoS are collaborating with overseas researchers, it is expected the former are aware of and follow international export control laws.

Research that may raise significant ethical issues or pose a reputational risk to researchers or the University, or their partners, should be referred to the appropriate FREC chair for advice and/or review.

8.1 Joint research project with another institution

This policy and its principles should be adhered to by all collaborators (for example, academic, business, third party, public sector) and project partners providing funding or in-kind contribution.

Where a joint research project with another institution is led by principal investigator from UoS, they must seek ethics approval on ERGO II, as with any other research project.

In cases where UoS is not the lead and the lead institution has carried out the ethical review for the project, it is a requirement that the UoS researcher submits an ethics application on ERGO II, providing evidence to the external ethics approval from the collaborating institution and all other relevant documents, in accordance with UoS requirements.  The application will be reviewed to ensure the research aligns with the University's standards and policy requirements, and in the event that issues are identified, changes may be requested. It is the responsibility of researchers to discuss with their collaborators in advance to ensure that they are aware of UoS standards and policy requirements.

The UoS applicant should ensure that the roles, responsibilities, rights, and ownership of materials and data of all the researchers involved in the research are accurately detailed and unambiguous. 

9. Research conducted outside the UK

The University of Southampton is committed to complying with all relevant laws, regulations, and procedures. These obligations are shared between the University and individual academics. There may be disparities between countries in terms of facilities, infrastructure, expertise, societal and cultural opinions, principles, and standards, IPR laws, regulatory approvals, ethics review processes, etc., that need to be considered when planning and conducting any international research. They must respect and seek local advice, where necessary, about their societal and cultural opinions, customs, and routine practices. The University Ethics Policy and standards apply to research conducted in any country, even where local standards in a country may not necessarily require it. If in doubt, please seek advice from respective FREC chair.

If any research involves an overseas element, it is the responsibility of the researcher to be aware of, and compliant with local laws and regulations, as well as UoS standards and policy requirements before commencing any project. As a minimum, researchers should: 

  • Seek local ethics approval if there is an institutional or national system that requires it.
  • Seek local management approval from any organisation that may host the research, such as a hospital, business, government department, charity, or school.
  • Understand and follow both UK’s and other involved countries’ statutory and regulatory requirements while planning and conducting international research.
  • Conduct rigorous safety risk assessment especially when the researcher will be in a vulnerable situation and seek advice from the respective FREC chair.
  • Consider data protection issues and cyber security risks. Researchers should familiarise themselves with guidance before they travel. 

10. Public involvement and engagement

Researchers collaborate with members of the public and patients in a variety of ways and not all these activities will require formal ethical review, but researchers should consider the ethical implications throughout the whole research process. Public and Patient involvement (PPI), and Public Engagement (PE) are two areas which require ethical consideration, but which would not usually require a formal ethical review in their delivery.

‘Service Evaluation’ – or anonymous data capture used to improve a methodology for engagement usually does not need formal ethical review, however, should be carried out adhering to ethical principles. Publication of methodologies is becoming increasingly common and so researchers/practitioners need to be sensitive and frequently assess whether a conversation about ethical review is required.

Researchers should consider whether any aspect of the PPI or public engagement activities could be considered research. For example, if PPI contributors are also research participants or if public engagement activities generate research data, then an ethical review would be required. Researchers should also consider whether there are likely to be any outputs which they would wish to publish. This may also necessitate a formal ethical review to meet publisher requirements. While researchers should always think ethically, formal ethics review is only required for the parts of a project that generates research data.

However, other types of Participatory Research such as Crowdsourcing, Citizen Science and Collaborative Research need formal ethics review and approval. Co-production as a methodology is likely to require formal ethical review if leading to research data, however since the principles and values of the approach itself should be co-produced, ethical considerations are an important early conversation to have with partners and researchers may want to seek advice from their local Research Ethics Committee to open a dialogue as to when formal ethics reviews may be needed.

11. Investigator’s self experimentation

Investigator’s self-experimentation may not raise conventional ethical concerns, but researchers should be aware of the risks of such research.  Self-experimentation refers to investigator conducting research on themselves, and there have been some publicised cases of self-experimentation, such as the Helicobacter pylori study by Barry Marshall, and memory studies by Hermann Ebbinghaus.

The University is committed to ensure the safety, rights, and well-being of all human participants and thus ethical considerations of self-experimentation are reviewed via the same process as any other research. Such research should be submitted on ERGO II to undergo ethics review and approval, ahead of conducting the research, to ensure the safety of researcher involved and the integrity of the research conducted at or by the University. 

12. Ethics review by Institutional Review Board (IRB)

The Research Ethics Committee (REC) of the Faculty of Environmental and Life Sciences (FELS) is registered with the Office for Human Research Protections (OHRP) at the US Department of Health and Human Services (HHS), to act as the University of Southampton Institutional Review Board (IRB reference number: IRB00013925).  In addition, the University has a valid and active Federal wide Assurance (FWA) in place (reference: FWA00033443), which enables the University to conduct human subject research projects that receive funding or any other support from a US federal agency.

Research projects that require IRB approval should contact REGO for advice. 

13. Use of animals in research

As part of facilitating advances in science and medical knowledge, the University involves animals in some of its activities, including research at the forefront of prevention and treatment of disease, international conservation, and climate change, as well as in the education of future scientists. All such activity is scrutinised using the 3Rs ethical framework: Replacement, Reduction and Refinement. This involves a commitment to only using animals when there is no alternative option, minimising their use by adopting and developing alternative techniques, and fostering a culture of care to ensure any suffering is minimised and the highest possible standards of animal welfare are maintained.

The University’s AWERB ensures that animal related activity is carried out with scientific rigour and according to ethical principles, including weighing the potential benefits of the activity against the likely harm to the animals concerned.

For further guidance, please see The University of Southampton Policy for involving animals in research and education.

14. Research involving cultural heritage

In many areas the University’s research activities are greatly dependent on a wide range of resources that make up the cultural heritage of varied communities. As some of these resources are finite, irreplaceable, and non-renewable, they should be safeguarded and treated with great respect. Special care along with following high standards of ethical behaviour should be taken into consideration to ensure that such research does not cause any unintended loss or damage to tangible or intangible cultural heritage, or the unnecessary or harmful loss of any information relevant to the understanding of cultural heritage.

For further information, please see the  Ethics Policy on Cultural Heritage.

15. Dissemination of research findings

The University expects all research findings should be appropriately disseminated. Researchers should provide study participants with information on how and when research findings will be made available.

The dissemination of research should be carefully considered, especially if any information gathered during the research activity can be classified as sensitive or has the potential to cause upset or harm to either individuals, communities or groups involved in the research, or living descendants or relatives (including when research included any documents of the deceased). All sources of information must be adequately acknowledged and referenced.  Full anonymity is expected as standard in dissemination, but it is acknowledged that there are some disciplines where full anonymity is not applicable due to the nature of the research, in which case, justification will be required.

16. Appeals

Where a researcher has a concern about the decision of a FREC to withhold, suspend or withdraw approval, they should attempt to resolve the matter with their FREC. In the first instance they should contact the Chair who may decide to convene a different panel from its FREC members to review the application, seek guidance from another FREC, invite the researcher to resubmit their application or confirm the original decision.

If their concerns cannot be resolved at FREC level, researchers may appeal the decision of the FREC to the University Research Ethics Committee by contacting the Head of the Research Ethics and Governance Office at risethic@soton.ac.uk.

Appeals will only be permitted on one of two grounds:

  1. That the researcher possesses new evidence that was not available at the time the FREC made its decision, and it has subsequently refused to consider such evidence.
  2. That there had been a significant failure in the application of procedures which had affected the decision of the FREC.

17. Related policies and guidance

As the ethics landscape continues to evolve, UREC may develop additional policies and guidance in line with any new regulatory and legislative requirements. It is the responsibility of the individual researchers to check for the latest versions and any new University policies and guidance to ensure that they comply with all requirements relevant to their study.

Linked policies and guidance documents:

18. Advice

For ethics queries and advice please email: risethic@soton.ac.uk
For clinical governance queries and advice please email: rgoinfo@soton.ac.uk

19. Version control

Approval date for first policy: March 2012

Author: Research Ethics and Governance Team (REGO)

VersionRevision dateRevised by:Section AmendmentAuthorised by:
V22024REGO (Sri Tanquturi)      -Full redraftSenate

References: