Code of practice and principles for good ethical governance

1. Purpose of the code of practice

1.1. The purpose of this procedural guidance is to support staff in their consideration of ethical issues arising from academic activity, in accordance with certain general principles and standards approved by the University Senate and Council in July 2005. Although the decision to undertake an academic activity such as research rests with the individual member of staff, such decisions must be taken within the broader ethical framework of the University, and it is the responsibility of the individual to seek guidance on and, if necessary, approval for activities which might be ethically sensitive.

2. Ethical standards

2.1. The University exists to advance and disseminate knowledge and learning while maintaining proper ethical standards.

2.2. The ethical standards which apply to academic activities (including research, teaching, consultancy and outreach work) arise from the basic principle that such activities should neither include practices which directly impose a risk of serious harm nor be indirectly dependent upon such practices. Serious harms include, for example, failure to respect the interests of human beings and damage to items of cultural value or the natural environment. Ethical practice also requires that the use of animals in academic work is fully justified and that statutory controls and codes of practice are observed at all times.

2.3. All activities undertaken by staff and students as members of the University must comply with the University’s ethical standards. A flow diagram of the ethical approval process is attached and staff and students should familiarise themselves with this process.

3. Funding, conduct and dissemination of academic activities

3.1. The question as to whether there is an involvement in unethical practice can arise in the context of the acceptance of external funding of any variety, whether for research, teaching projects or general departmental/University development (e.g. in the form of benefactions. If funding is offered in the form of a gift, advice should be sought from the Director of Development as a matter of course ). It is the responsibility of the individual to identify whether there are any ethical issues and then to consult further with appropriate colleagues, such as Head of Department, line manager or departmental/subject-level ethics committee.

3.2. When faced with a decision about whether to accept funding from a particular source, the following questions are paramount:

3.2.1. Might acceptance of this funding potentially bring my department, and by extension the University, into disrepute?

3.2.2. Might acceptance of this funding detrimentally affect other existing relationships within the University?

3.2.3. In the case of funding for research, consultancy or other such work, might the outputs or results be:

used by the funder to enhance unethical practices?
subject to limitations on dissemination or approval by the funder?

3.3. If the answer to any of these three questions is ‘yes’, the matter should be discussed further with the Head of Department or his/her nominee (e.g. Chair of Departmental Research Committee). If no decision can be reached in discussion with these colleagues, the issue should be referred in the first instance to the departmental/subject-level ethics committee. Likewise, if the departmental/subject-level ethics committee is unable to resolve the matter, there is prima facie evidence that a substantial ethical issue is involved, and the departmental/subject-level ethics committee should refer the case in question to the University Ethics Committee which will make a ruling and, if appropriate, recommendations to the University Council.

3.4. If it is agreed in further discussion that the organisation or individual offering funding is involved in activities that include unethical practices, the University’s approved principles for good ethical governance and practice apply, namely that there is a presumption against accepting the funding where the results of the research could be used to enhance unethical practices. In some cases this presumption may be over-ridden, for example where the organisation has acknowledged the problem and is already attempting to eliminate it. In all such cases, however, the matter must be referred to the University Ethics Committee.

3.5. Individuals should bear in mind that the cornerstones for the management of ethical issues in the University are explicit discussion, institutional accountability, and proportionality (that is, some regard should be taken of the degree and risk (including the impact and/or likelihood) of the potential ethical harm when considering the level of ethical consideration and approval required). Please refer to the ethical decision flow diagram for further guidance on when decisions require formal ethical approval.

3.6. Research involving human subjects usually requires the acquisition of informed consent from participants and/or their representatives. It is essential that the confidentiality of information gained in the course of research is respected; and the anonymity of participants is preserved, where stipulated.

3.7. Where research involves the participation of vulnerable groups (e.g. children), appropriate provision should be made to gain informed consent and additional safeguards (e.g. Criminal Records Bureau checks) implemented.

3.8. Where research involves the use of animals, statutory controls and codes of practice must be observed, especially with regard to minimising the number of animals used and having regard for their welfare. Formal procedures exist for ensuring this observation. The University supports the principle of the three R’s – that those involved in animal research should aim at Replacing, Refining and Reducing the use of animals for research purposes.

3.9. It is fundamental to academic research that researchers should be able to publish their results freely, without needing to obtain permission from funding organisations. Funding bodies may wish to impose restrictive clauses that allow delays in publication, for example to allow protection of intellectual property. Where such clauses do not infringe the fundamental freedom of the researcher to publish their findings, they can be accepted.

3.10. When results are published, proper credit must be given to all the researchers involved. Individuals should refer to the University Code of Good Practice for Research, for further guidance on undertaking and publishing research.

4. Ethical management

4.1. The University must maintain effective management systems for ensuring compliance with its ethical standards. This will be achieved by establishing a system of properly devolved ethics committees under the oversight of the University Ethics Committee.

4.2. Where a member of staff or student, acting as members of the University, proposes to undertake a research project which gives rise to possible ethical concerns they must obtain approval from the appropriate ethics committee.

4.3. Any external organisation involving or using University staff or students, premises or facilities must comply with the procedures established by the University for achieving compliance with the University’s ethical standards.

4.4. The cornerstones for the management of ethical issues in the University are explicit discussion, institutional accountability, and proportionality.

5. Framework for ethical decision making

5.1. The University has a devolved model for the scrutiny of research proposals, comprising an overarching University Ethics Committee and a number of Departmental/Subject-level Ethics Committees. Whilst certain departments are linked to particular subject level research committees, that there may be occasions when the specialist knowledge of a particular committee would make it more appropriate for the review to be undertaken by a different committee. Where this occurs, approval from the Chairs of the appropriate committees should sought in advance. The current Departmental/Subject-level Ethics Committees comprise the following:

Biology Department Ethics Committee
Health Sciences Ethics Committee
Psychology Department Ethics Committee
Physical Sciences Ethics Committee (Chemistry, Computer Science, Electronics, Environment, Mathematics, Physics)
Humanities and Social Sciences Ethics Committee (Archaeology, Economics, English, History, History of Art, Language and Linguistics, Management, Music, Philosophy, Politics, Sociology, SPSW)
Educational Studies Ethics Committee
HYMS Education Ethics Committee
Centre for Housing Policy Ethics Committee
York Neuro-imaging Centre (YNiC) Research Ethics Committee

5.2. Departmental/Subject-level ethics committee should have at least 6 members, of whom one should be a lay member. Exceptionally, where a committee deals with a small community or a focussed area of activity, a smaller committee may be appropriate. A quorum of 4 members is required. Additional members may be co-opted, particularly where specialist expertise in a given area is required or where there is potential for conflict of interest on the committee.

5.3. The model terms of reference for Departmental/Subject-level ethics committees are as follows:

To ensure that the ethical standards of the University are met, in both teaching and research
To consider cases where there might be potential involvement in unethical practice arising in the context of teaching, consultancy, outreach or research (e.g. in relation to the funding, conduct, dissemination, collaboration or application of these activities), to offer guidance and advice to Heads of Department and individual members of staff on these cases, and to refer cases that raise substantive issues to the University Ethics Committee, as appropriate
To approve any projects involving human participants (who may be adults or children), human material (e.g. tissue or fluid samples), human data (e.g. surveys and questionnaires on issues such as lifestyle, housing and working environments, attitudes and preferences), animals or other organisms, following statutory procedures where these apply, and to refer complex or difficult cases to the University Ethics Committee, as appropriate.
To report annually to the University Ethics Committee on the business undertaken by the committee, providing a statistical overview of the work of the committee and drawing attention to any general issues.

5.4. Departmental/Subject-level Ethics Committees may agree to undertake expedited reviews where, for example, the ethical issues of the activity carry only a minimal risk or the work has similarity to projects previously approved. Departmental/Subject-level Ethics Committees should draw up clear procedures as to when such reviews would be permitted.

5.5. Departmental/Subject-level Ethics Committees will submit to the University Ethics Committee an Annual Report of their activities.

5.6. Particularly difficult ethical issues must be submitted from Departmental/Subject-level Ethics Committees to the University Ethics Committee for guidance, and in exceptional cases, the University Ethics Committee may make recommendations to the University Council on cases referred to it.

5.7. The standards and policies of the University in respect of Research Ethics should be reviewed every 3 years.

6. Framework for the consideration of ethical decisions

6.1. When an ethical issue arises during the course of academic activity, the following procedure, agreed by the University Research and Ethics Committees, should be followed by all staff and students. It should be noted that:

‘academic activity’ encompasses teaching, research (both funded and unfunded), consultancy and outreach;
ethical issues might arise from the source of funding, the partners or collaborators involved, the methodology used, the subjects used, potential restrictions on dissemination and the potential application of the project findings;
it is the responsibility of the member of the University (staff or student) leading the activity to consider the possible ethical implications in the first instance. The University Senate has agreed that it is important not to take such responsibility from individuals who need to be proactively engaged with any potential ethical issues in their own work.

6.2. Ethical issues will arise if the activity in question involves any of the following:

human participants in research (adults or children)
human material (e.g. tissue or fluid samples)
human data (e.g. surveys and questionnaires on issues such lifestyle, housing, working environment, attitudes and preferences)
vertebrates, especially mammals and birds

If any of the above are involved in the activity, the issue must be referred for discussion and decision to a departmental/subject-level ethics committee. Research on organisms other than vertebrates may raise ethical concerns if unusual procedures or particularly large numbers are involved, or if the organism is endangered in the wild.

6.3. In addition, if after due consideration there is evidence of the potential for involvement in unethical practice (that is practice which falls outside the ethical standards of the University), the issue must be referred for discussion and decision to the relevant departmental/subject-level ethics committee. If there is any uncertainty, staff should consult with the relevant contact for the committee (e.g. Secretary or Chair).

6.4. A number of activities require ethical scrutiny/approval by an outside body (eg the NHS). Even where such external scrutiny is undertaken, the matter should still be referred to the relevant departmental/subject-level ethics committee so that it can consider the project from a departmental/University perspective. Whilst it is acknowledged that there are risks and workload implications associated with multiple reviewing, and that departmental/ subject-level ethics committee might not be qualified to deal with the particular ethical issues of concern to outside bodies, it is however vital that departments, and by extension the University, are aware of all projects with ethical implications being undertaken by its staff and students. Brief pre-review by the departmental/subject-level ethics committee seeks to establish a practice whereby the department/University is informed of projects being submitted for external review and therefore able to identify any issues of specific concern for the department and/or University. The final outcome of ethical scrutiny by any outside body should always be reported back to the relevant departmental/subject-level ethics committee for information, allowing it to submit a comprehensive annual report to the University Ethics Committee as now required each Autumn Term.

6.5. Where there are significant changes to the approved protocol for a project which required ethical approval these must be reported to the body which originally granted the ethical approval. There should be a clear well documented audit trail, including the original protocol, ethics approvals, and any subsequent modifications, must be kept throughout in an appropriate and easily accessible format.

6.6. In all of the above, the cornerstones of the University’s Code of Practice and Principles for Good Ethical Governance are explicit discussion, institutional accountability and proportionality.

6.7. In the event of a complaint relating to unethical practice, the complaint should be referred to the University Ethics Committee which will investigate it in collaboration with the department concerned.

6.8. The above procedure is illustrated in the attached flowchart diagram.

Information for staff