Senate requires that all business and activity entered into by the University is undertaken in an appropriate manner within a proper ethical framework, and due ethical consideration is given to all undertakings, be they research, teaching, enterprise or other. This is reflected in the University's Values: "We value freedom to push the frontiers of knowledge forward, within an ethical framework, for the global good of humankind".
The Policy comprises three elements: this Policy Statement; a set of Guidelines to assist in implementation of the Policy and to inform staff in interpreting the ethical guidance within their local environment; and Regulations which set out the formal requirements of the Ethics Policy.
All staff and students are expected to act in accordance with University regulations which apply to their particular activity. In addition, staff and students should be aware of ethical considerations and ensure that they act in an ethical manner when engaged on University business. The view of the Research Councils in funding universities is that "Ethical issues should be interpreted broadly and may encompass, among other things, the involvement of human participants in research, the use of animals, research or other activity that may result in damage to the environment and the use of sensitive economic, social or personal data." A number of University policies and regulations are particularly applicable in this respect and include, in addition to the Ethics Policy, policies and regulations on Conflicts of Interest, Intellectual Property, Finance, use of computers, use of Information Systems Services, Safety, Freedom of Speech and Data Protection.
To support the implementation of this policy, the University has set up an ethical review system built on existing ethical review panels at School level. Each School is expected to have (or have arranged access to) an Ethics Committee to which questions may be put on ethical matters. In addition, the University has an Institutional Ethics Committee that has oversight of School level panels and sets the general framework within which the Ethics Policy is implemented.
Where staff or students are unsure how to proceed on an ethical issue, guidance may be sought from their School, the Research Support Office or depending on the context, other appropriate Professional Services such as Legal Services or Human Resources.
A glossary is included at the end of this section.
An important principle for any project or undertaking is that the lead individual (for example, the Principal Investigator in a research study) should consider if the activity raises any ethical issues. For the avoidance of doubt, ANY research involving human participants, human tissue or data on individuals will automatically require ethical consideration. The same can be said for experimental work involving animals. It is the responsibility of the lead individual to ensure that where appropriate the project is put to an appropriate committee for ethical review. The Research Councils' view is that "Ethical issues should be interpreted broadly and may encompass, among other things, the involvement of human participants in research, the use of animals, research that may result in damage to the environment and the use of sensitive economic, social or personal data.". The principles of the Helsinki Declaration should always be borne in mind.
2. Key Terms
2.1 ETHICS. General ethical principles adopt the values of 'doing positive good' and 'the avoidance of harm' and these should be at the heart of any ethical consideration.
2.2 HUMAN-RELATED RESEARCH. Research involving human participants must always be subjected to ethical scrutiny, to ensure it is carried out in a way that reduces the risk of harm to the participants and increases the potential for benefit. Such benefit may mean, for example, the advancement of knowledge, or the educational benefit of a student.
Research involving human participants is defined broadly to include research that:
(i) directly involves people in the research activities, through their physical
participation. Physical participation may include invasive (e.g. surgery) and / or non-invasive research (e.g. interviews, questionnaires, surveys, observational research)
and may mean the active or passive involvement of a person;
(ii) indirectly involves people in the research activities, through their provision of or
access to personal data and / or tissue;
(iii) involves people on behalf of others (e.g. parents / legal guardians of children and
the psychologically and / or physically impaired, and supervisors of people under
controlled environments (e.g. prisoners, pupils)).
2.3 DATA. Data are important in the context of ethical review. Data related to individuals needs to be handled carefully and in accordance with relevant legislation. The confidentiality of participants in research (or other activity as appropriate) should always be maintained and the privacy of participants should be protected in any publication arising from the research in line with current best practice.
The Ethics Policy uses as a guideline the Data Protection Act's (1998) definition of personal data:
"Data which relate to a living individual who can be identified from those data, or from those data and other information which is in the possession of, or is likely to come into the possession of, the data controller, and includes any expression of opinion about the individual and any indication of the intentions of the data controller or any other person in respect of the individual".
Particular care should be taken when collecting or storing sensitive personal data, which in the 1998 Act is defined as consisting of information as to:
(i) the racial or ethnic origin of the data subject;
(ii) his or her political opinions;
(iii) his or her religious beliefs or other beliefs of a similar nature;
(iv) whether he or she is a member of a trade union (within the meaning of the Trade
Union and Labour Relations (Consolidation) Act 1992);
(v) his or her physical or mental health or condition;
(vi) his or her sexual life;
(vii) the commission or alleged commission by him or her of any offence; and/or
(viii) any proceedings for any offence committed or alleged to have been committed by him or her, the disposal of such proceedings or the sentence of any court in such
proceedings'. (Source: Part I, Preliminary of the Data Protection Act 1998)
Care should also be taken when collecting and storing sensitive personal data in order that participants can not be identified indirectly - for example through the use of date of birth and postcode information.
2.4 RESEARCH GOVERNANCE. The University has a Research Governance Office which is responsible for ensuring studies involving human participants comply with relevant legislation and guidance. A key part of the Office's duties is ensuring studies have appropriate clearance before commencing - such as in terms of ethical review, insurance cover and data protection. Please email email@example.com or telephone +44 (0) 2380 595058 for more information.
3. Studies involving animals
Studies falling within the scope of the Animals (Scientific Procedures) Act 1986 should be undertaken in compliance with the University's general policy on the use of animals in research and teaching, which complies fully with the Act.
4. Ethics Review Panels
4.1 Generally speaking, it is up to a School Ethics Committee to determine if it should review all research or other proposals, regardless of whether an external review will also be expected or required, or simply review only those proposals involving human participants where no external review will take place.
4.2 For any research involving NHS patients, staff or resources, submission of the project to the appropriate REC is mandatory. Details of the various REC's and their operation may be obtained from COREC. Special panels exist for projects involving the Prison Service or human DNA.
4.3 Other studies may be required to comply with externally developed guidelines, such as in the case of psychological studies, guidance issued by the British Psychological Society. In any event, if a study or project involving human participants does not qualify to go to an LREC or similar body, then it will be required to seek approval from a School Ethics Committee.
4.4 Some studies, if they are seeking funding from a particular source (e.g. ESRC, BBSRC, FSA, Nuffield, Wellcome), will be required to adhere to certain guidelines or grant/contract conditions. RSO maintains a list of funding bodies and can highlight any particular conditions which attach to grants: if necessary, such conditions should be taken into account as part of the ethical consideration of a project.
4.5 Studies involving human participants should be undertaken in compliance with the current procedures for research governance, available from the Research Governance Office: see 2.4 above.
4.6 Studies undertaken or commissioned by Professional Services, which will involve human participants (for example, a questionnaire-based study of vulnerable students) should be discussed with the Research Governance Office and where appropriate an ethical review undertaken. Such studies may be routed via a relevant School Ethics Committee or an external committee as applicable.
5. School Ethics Committees
5.1 Terms of Reference
(i) The School Ethics Committee (SEC) should determine its own detailed terms of reference, adhering to the general principles herein, and should decide if it wishes to review all projects a School enters into or just those which are not eligible to be reviewed externally. Sample School codes of practice and guidelines are available from RSO. If a project requires, for example, LREC approval, then a School may decide that no internal School review is required in addition.
(ii) For the avoidance of doubt, ALL studies involving human participants, and not subject to other external ethical review, MUST BE REVIEWED BY A SEC.
(iii) The SEC should arrange to meet at regular intervals and in addition have a mechanism for review of urgent or short-notice cases.
(iv) Smaller Schools, or those with very low volumes of projects for which ethical review is deemed necessary, may by agreement establish a joint SEC. Alternatively, such Schools may agree with another School that projects may be submitted to that School's SEC.
(v) The SEC should as a minimum consider the principles of:
- 'doing good'
- 'doing no harm'
- risk management, which encompasses the assessment of hazards (i.e. source of potential harm) and an analysis of risk (i.e. the probability of such harm occurring)
- data protection
(vi) The SEC should report, via the Chair, to a higher level School-based Committee, for example the Research Committee, Planning and Resource Committee or the School Board.
(vii) The SEC should report via the Chair at least annually to the University Ethics Committee with confirmation of its current terms of reference and constitution, and should consider any feedback or advice the Chair receives from the University Ethics Committee.
(viii) Where a SEC is unable to resolve a particular issue, including any concerns of an ethical or related nature raised by participants in a study, the Chair will relay all relevant details to the UEC which will consider such matters and adjudicate on them.
(i) The SEC should be chaired by a senior member of the School's management team, or appropriate nominee
(ii) The SEC should agree a constitution. It is recognised that the terms of such constitution may vary from School to School depending on the particular local circumstances
(iii) In general, the SEC should have a minimum of six members, and a quorum of four members
(iv) The constitution must allow for at least one independent member, to provide assurance that good practice is followed in the SEC's business and deliberations. The role and responsibility of the independent member should be stated.
(v) The constitution should also allow for at least one member to be from the School's student body. The role and responsibility of the student member should be stated.
6. University Ethics Committee
6.1 Senate and Council have established the University Ethics Committee (UEC) to assure itself, and the University’s stakeholders, that the University as an institution is involved in properly conducted and high quality research, education and related activities, through a focus on the proper ethical treatment of all participants in the research or other activities of the University. UEC will meet at least once per term.
6.2 Terms of Reference
(i) To be responsible for keeping under review and monitoring the implementation of the University’s Ethics Policy, and for sustaining a University-wide awareness of ethical issues.
(ii) To develop policy and guidelines with and for the Schools in relation to ethical and related issues.
(iii) To advise School Ethics Committees regarding procedures, or where a particular issue is unresolved, including where concerns are raised by participants in a particular study; and where necessary to adjudicate upon such matters.
(iv) With the consent of the Head of School involved, to designate particular School Ethics Committees as being responsible institutionally for developing best practice and acting as the lead committee for certain categories of project.
(v) To receive at least an annual report from each School Ethics Committee.
(vi) To ensure that members of UEC and of School Ethics Committees have received, or will receive, appropriate training in ethical matters.
(vii) To report to the appropriate bodies within the University.
Chair: The Deputy Vice-Chancellor with the research portfolio (or other senior officer to be appointed on the recommendation of the Vice-Chancellor)
The Deputy Vice-Chancellor with the research portfolio (if not Chair)
The Deputy Vice-Chancellor with the education portfolio
The Secretary and Registrar (or nominee)
The Director of the Research Support Office
The University Safety Advisor (or nominee)
Two members from each Faculty (appointed by the Dean concerned)
A senior academic with relevant experience (e.g. in ethics or as member of an LREC) (appointed by the Chair of UEC)
Two Chairs of School Ethics Committees from Faculties other than that of the senior academic (appointed by the Chair of UEC after consultation with the Deans)
A person not employed by the University (appointed by the Chair of UEC)
The Secretary will be designated by the Secretary and Registrar.
BBSRC - the Biotechnology and Biological Sciences Research Council
COREC - The Central Office for Research Ethics Committees, which operates on behalf of the Department of Health in England to co-ordinate the development of operational systems for local and multi-centre Research Ethics Committees (LRECs and MRECs), on behalf of the National Health Service in England
ESRC - the Economic and Social Research Council
FSA - the Food Standards Agency
LREC - a Local Research Ethics Committee, such as the Southampton and South West Hampshire Research Ethics Committee (see COREC site for further information)
MREC - a Multi-Centre Research Ethics Committee, such as South East Multi-Centre Research Ethics Committee (see COREC site for further information)
REC - a Research Ethics Committee, under the COREC structure e.g. an LREC, MREC or other committee (see COREC site for further information)
RSO - the Research Support Office at the University of Southampton
SEC - a School Ethics Committee, as described above (see 5)
UEC - the University Ethics Committee, as described above (see 6)
1 The University fully endorses and requires compliance with the Research Council guidelines on research governance and related matters - (refer to RG2 for ethical matters). In addition, for those individuals working with the NHS, the University requires that the Department of Health's Framework for Research Governance (2001) is followed.
2. Attention is also drawn to the following policies or guidelines of the University, which have particular relevance to the Ethics Policy:
- Research Integrity and Academic Conduct
- Research involving animals
- Research Governance
- Acceptance of sensitive or classified research contracts
- Conflicts of Interest Policy
- Data Protection
- Health and Safety - See HR website in SUSSED
- Freedom of Information
3. All research involving human participants must undergo ethical review. If a project is not eligible for review by an LREC or similar external review body, then it must be submitted to a School Ethics Committee (SEC) for review. If a project requires, for example, LREC approval, then a School may decide that no internal School review is required in addition. However, it is for each SEC to determine which projects it should otherwise review and it may decide to review all projects. The SEC will determine whether any project needs to be referred to the University Ethics Committee.
4. Subject to (5) below, each School is required to have an Ethics Committee, chaired by a senior member of the School's management team, or appropriate nominee, and with a membership which complies with the Guidelines attached. The Committee's terms of reference should take into account the outline terms of reference also contained in the Guidelines. The Committee must maintain a written record of its meetings and any decisions reached.
5. Smaller Schools, or those with very low volumes of projects for which ethical review is deemed necessary, may by agreement establish a joint School Ethics Committee. Alternatively, such Schools may agree with another School that projects may be submitted to that School's Ethics Committee. The Research Governance Office will hold a list of the chairs of School Ethics Committees and can provide advice if necessary on where it may be appropriate to submit projects.
6. Similarly, if a project is felt to be outside the expertise of a School's Ethics Committee, but within the expertise of another School's Ethics Committee, it may be submitted to the other Committee with that Committee's permission.
7. Projects arising within Professional Services and requiring an ethical review may be submitted to a relevant external body or to a relevant School Ethics Committee with the agreement of that Committee.
8. The University Ethics Committee will be chaired by the DVC Research (or other officer of the University as agreed by Senate) with a membership and terms of reference as set out in the attached Guidelines. The Committee must maintain a written record of its meetings and any decisions reached.
9. The University Ethics Committee will adjudicate on any matters a School feels unable to deal with or on which it requires further advice.
10. Members of ethics committees should receive appropriate training, the training requirement and delivery to be agreed between the University Ethics Committee and the Chair of each School Ethics Committee.
- Please see the following page for breach of this code by staff:
- Disciplinary Procedure - See HR website in SUSSED
- Please see the following pages for breach of this code by students: