University Ethics Policy

Ethics Policy Statement

The University of Southampton is committed to carrying out its research, teaching, enterprise and other activities within a comprehensive ethical framework.

This is reflected in the University’s value:

We value freedom to push the frontiers of knowledge forward, within an ethical framework, for the global good of humankind

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.

Activities which involve research/studies on human participants, their tissues or data and on animals will always require formal ethical consideration. However, the University believes ethical issues should be interpreted broadly and that review might also be needed for research, consultancy and enterprise where other factors could be present including:

• a risk of damage to the environment
• political or social sensitivity
• impact on culture and cultural heritage

It is the University’s expectation that staff, students and visitors should be aware of ethical considerations, ensure that they act in an ethical manner when engaged on University business and conduct their projects and studies to the highest ethical standards.

Overarching Ethics Policy Purpose

The purpose of this Policy is to:

1. Set out the principles applicable to all research, enterprise, consultancy projects and studies conducted at, by or in the name of the University of Southampton;

2. Provide members of the University with a clear understanding of the ethical review process operated by the University of Southampton; and

3. Support a culture of academic freedom and excellence by providing a framework for review which subjects research proposals and other studies to a level of scrutiny that is in proportion to the risk of harm or adverse effect to participants, researchers, the University and to society as a whole.

Scope

This Policy applies to all staff and students of the University engaged in studies or research as well as to visitors, individuals, collaborators, or agents conducting research or other studies in the name of or at the University and/or engaged to conduct research by the University. It extends to cover consultancy and enterprise activities, but is not intended to apply to operational decisions or actions taken by the University e.g. financial, estates and facilities, procurement or human resource matters as these are subject to different review procedures.

Principles of Ethical Research

1. Studies and research should be designed, reviewed and undertaken to ensure integrity, quality and transparency.

2. Participants must be fully informed about the research or study they are invited to participate in and their consent to take part must be made voluntarily, freely and without any coercion. Consents should be recorded, ideally in writing.

3. Risks should be managed so that harm and/or damage arising from the research is avoided or minimised wherever possible and measures should be taken to ensure that the benefits of research/study should outweigh any potential harm or damage caused.

4. The independence of the research/study must be clear, and any conflicts of interest or partiality must be explicit.

5. The same high ethical standards shall apply wherever in the world the study/research is undertaken.

The University meets these principles by communicating its standards and policies to staff through education and training, publication of this and related policies, and through this Ethics Policy and the process for the ethical review of research and studies.

Specific Policies and Guidance

This Ethics Policy is supplemented by specific ethics policies and guidance which are set out below:

• Policy on the Ethical Conduct of Research and Studies involving Human Participants (March 2012)
• Policy on use of Animals in Research

In light of the nature of the research and studies covered by these specific ethics policies, the standards set out therein are necessarily more stringent and it is intended for the higher standards described therein to apply.

The University Ethics Committee may decide to develop additional guidance or policies from time to time which it will make available through these pages and may provide more general guidance on the Research Governance Office’s web pages

Ethical Review Process

The University of Southampton is committed to providing a competent, rigorous and independent process of ethical review for the research and studies undertaken proportionate to the risk involved.

The University Ethics Committee has overall responsibility for the ethical review process here at the University, whilst the task of providing ethical review and granting approval for individual projects and studies falls to the Faculty Ethics Committees or the approved external body (e.g. National Research Ethics Service). It is anticipated that each of the University’s 8 Faculties will have its own Ethics Committee. However, the Faculty Ethics Committees (FECs) have the freedom to operate combined ethics committees where the workload merits it. Similarly each FEC may, if needed, operate one or more sub-committees. Each Faculty should ensure that their arrangements for ethical 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 UEC.

All Professional Services Departments in the University should have in place arrangements with an appropriate FEC to review any research or study they/their staff may undertake.

All studies involving human participants must be registered on the University’s electronic document management system, Ethics and Research Governance Online (ERGO), which is accessible at: https://www.ergo2.soton.ac.uk

It shall be the responsibility of the FEC for deciding the most appropriate method and system for the ethical review of non-human participant studies and research it is responsible for and the use of ERGO is permitted.[1]

Roles and Responsibilities

University Ethics Committee

The University Ethics Committee is chaired by the Pro Vice-Chancellor (Research), and is responsible for developing, keeping under review and monitoring the implementation of the University Ethics Policy, and for sustaining a University-wide awareness of research governance, ethical and related issues. UEC is also responsible for developing guidance in these areas, for receiving reports from the Faculty Ethics Committees and for ensuring that the members of Ethics Committees at the University receive appropriate training in ethical issues.

Faculty Ethics Committees

Each Faculty will normally be expected to have an Ethics Committee but, with the agreement of the Chair of UEC, Deans may agree to establish joint Ethics Committees across Faculties, or to operate one or more sub-committees to a FEC.

The role of the FECs is to ensure the research and studies undertaken in their Faculty obtain the appropriate ethical review in accordance with this Overarching Ethics Policy Framework. Further to ensure through its review process that all such projects adhere to applicable Faculty and University policies, legislation, professional guidelines and best practice.

FECs must include a minimum of 6 academic staff members and one student representative from the relevant Faculty (with one senior member of the Faculty management committee or appropriate nominee to act as Chair), and one independent or “lay” member from outside the University. Ethics Committees should meet face to face at least once in every semester but otherwise may conduct meetings and discussions via email or other electronic media (including ERGO as applicable).

In order to manage workloads and ensure the timely ethical review of studies FECs may also develop delegation strategies for the appropriate review of studies including by sub-committee(s), a subset of FEC members, and single sign off in the case of low risk work (e.g. Category C studies for Human Participant Research) and/or for an expedited review. Any matter delegated may be elevated for full FEC review should any of the reviewers consider it appropriate. UEC expects all FECs to report annually on any strategies and processes adopted and to regularly monitor approvals given to ensure the quality of the ethical review undertaken. Issues with/arising from reviews (including any from external reviews such as NRES) should be discussed at FEC so that training needs can be identified and recommended.

Research Governance Office

The primary function of the Research Governance Office (RGO) is to review all the applicable elements of good research governance for higher risk studies involving human participants; and to arrange University sponsorship and insurance for eligible research studies. All researchers conducting Category A studies must insure that they have both “sponsorship” and insurance in place prior to starting their research or any study, (in addition to any external approvals that may be required), and this is applied for by submitting details of the proposed research/study to the RGO through the ERGO system before the research or study is commenced.

The RGO is also responsible for monitoring the University’s Ethical review system on behalf of UEC and ensuring that high ethical standards are maintained across the University. In the event that the RGO discovers any failure to comply with this policy or to attain the high ethical standards required by the University in the course of its monitoring, it will refer its concerns to the appropriate FEC, and report on the action it has taken to UEC. The RGO will only directly intervene on a project that has already commenced where it is a Category A study that has not received approval or in any cases where it perceives an immediate risk to the health or well-being of researchers or participants, or to the integrity of the University.

In addition to its regulatory and monitoring role, the RGO provides guidance and training to FECs as well as researchers, and provides researchers with a source of support and advice when they are submitting research for external ethical review.

Researchers

The University expects all researchers (whether staff, visitors or students) to take personal responsibility for familiarising themselves with this Ethics Policy, specific policies and guidance and with the procedures they need to follow for the research or studies they undertake.

It is the responsibility of the Chief or Principal Investigator for any research/study to ensure that all their colleagues involved in that research/study are aware of and comply with the policies of the University and with the contents of the approved ethics application for the research/study.

Notwithstanding any ethical approval that may be obtained, researchers are still required to ensure that their research or other studies are conducted in accordance with the ethical requirements of their funding body and/or any professional bodies or associations relevant to their discipline as well as comply with health and safety requirements.

Professional Service Departments

The University expects all Professional Service Department to have arrangements with an appropriate FEC to ensure any research/study they or their staff undertake involving human participants receives ethical review. All such research/study shall be registered on and administered through ERGO.

Research & Innovation Services

The RSO Teams based in the Faculties shall have responsibility for supporting FECs and administer the use of ERGO. Find your R&IS Contact

Appeals

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

In the event that their concerns cannot be resolved at FEC level, researchers may appeal the decision of the FEC to the University Ethics Committee by contacting the Head of the Research Governance Office at [email protected]. Appeals will only permitted on one of 2 grounds:

1. That the researcher possesses new evidence that was not available at the time the FEC made its decision and it has subsequently refused to consider such evidence; or

2. That there had been a significant failure in the application of procedures which had affected the decision of the FEC.

Researchers may not question the judgement of the FEC. Upon receiving an appeal the Head of the RGO will refer the appeal to the Chair of UEC, who may remit the appeal to a differently constituted FEC or reserve it for the decision of UEC.

Sanctions

Any breach of this Ethics Policy will be taken extremely seriously, and may result in disciplinary action including proceedings for gross misconduct where the breach is committed by a member of staff, or formal disciplinary proceedings under the relevant University procedures where it is committed by a student. Visitors breaching this policy may have their visitor status reviewed or withdrawn.