1.1 This document sets out the University’s expectations regarding ethical review and approval for research, scholarship and related activities. It is intended to facilitate the conduct of University activities in a manner that manages ethical risk appropriately, safeguards both participants and researchers and supports best practice in the ethical conduct of these activities.
1.2 In addition to the ethics process, researchers are responsible for complying with other relevant governance considerations, and should refer to the Research Integrity Policy and Code of Good Practice (particularly section 7) for an outline of key responsibilities in this area.
2.1 The policy applies to all research and research-related, scholarship and taught programme activities that may raise ethical issues, whether undertaken by staff, students or other individuals acting on behalf of the University.
3.1 All research and scholarship projects (funded or unfunded), including student projects, and all projects in scope of the Work with Outside Bodies Policy, must identify relevant ethical considerations and, where appropriate, undergo full ethical review (and secure approval) before any work starts. Those undertaking the work should remain alert to emerging ethical issues throughout the life of the project; where issues are identified after project start, or where there are significant amendments to the design or execution of the project, re-approval may be required.
3.2 Where alternative processes are in place for taught programme activities which take account of all relevant ethical considerations, such as module or programme approvals, these may be understood as equivalent, and further review via the ethics processes outlined below would not be required.
3.3 Staff and students are expected to adhere to any external requirements for ethical review which apply to their project, for example
a) Heath Research Authority Research Ethics Committee (NHS REC) review for health and social care research where this is required under the Governance Arrangements for Research Committees (GAfREC).
b) Ministry of Defence Research Ethics Committee (MODREC) for research funded or sponsored by the Ministry of Defence which involves human participants.
4.1 The University expects the following factors to be considered in ethics assessment, and projects including these factors to undergo ethics review by the appropriate body:
4.2 Humans & Personal Data: Any projects involving people, their data or tissues, particularly those which are high risk either due to their participant profile, design or methodology. This may include projects which involve
a) human participants or subjects;
b) lay input to project design or delivery (e.g., participatory research) or use of lay volunteers to undertake research;
c) use of data from social media: social media users are defined as human participants where projects involve observing online behaviour or using their data for research purposes.
d) secondary data including personal data that is not in the public domain, or use of which raises other ethical considerations;
e) human tissues.
4.2.1 Significant risks include:
a) Potentially vulnerable groups, e.g. children / minors, prisoners, those with cognitive impairment or those in unequal relationships;
b) Requirement for co-operation of a gatekeeper for initial access (e.g. students at school, members of a self-help group, nursing home residents);
c) Requirement for participants to take part without full knowledge and consent (e.g. involving covert observation or deception of participants);
d) Sensitive topics (e.g. sexual activity, drug use, politics, illegal activities);
e) Administering drugs, food or other substances to participants;
f) Obtaining tissue samples (including blood) from participants;
g) Any invasive, intrusive or potentially harmful procedure;
h) Prolonged or repetitive testing;
i) Any significant risk to the safety or well-being - whether physical, psychological, emotional or reputational - of participants. ‘Significant risk’ is defined as outside that which a normal person would be exposed to in daily life.
j) Members of the public who are acting as researchers or as co-producers in the design or delivery of the research
k) Offering financial recompense to participants beyond reasonable expenses.
l) Conflicts of interest in the relationship between the researcher and participants, or for participants in relation to participation in the research.
4.2. Ethical approval is not normally required for activities involving humans or personal data if any of the following exemptions apply:
a) The activity is not classed as research, and does not involve vulnerable groups, sensitive topics or risk to safety or wellbeing of those involved; e.g. internal programme or module reviews; collecting feedback on a service or event, where this information will be used solely for evaluation purposes. If it is anticipated that the data could be used for research, then ethics review should be undertaken.
b) Activities where personal data collection is limited to interaction with individuals who are providing expert advice in a professional capacity.
c) Use of secondary data involving only information freely available in the public domain (this does not include data gathered from social media, which will always require ethics review). For example, published biographies, newspaper accounts of an individual's activities and published minutes of a meeting, whilst they may contain personal data, would not require ethics review. Exceptions apply where the published outputs will identify individuals and where there is a risk of reputational or other harm.
d) Use of secondary data involving only anonymised records and data sets that exist in the public domain, where there is no risk that analysis may lead to re-identification of data. For example, datasets available through the Office for National Statistics or the UK Data Archive where appropriate permissions have already been obtained and it is not possible to identify individuals from the information provided, and where there is no (very low) risk or intention that analysis will re-create identifiable data e.g. through the combination of multiple datasets relating to the same cohort.
e) Where exemptions are applied to student projects this should always be confirmed by the supervisor.
4.3 Animals: Any project involving animals (as defined by the Animal Scientific Procedure Act). This includes any projects using animal tissues that raise ethical concerns.
4.4 Data, Materials & Resources: Any project involving:
a) viewing or dissemination of materials subject to the Counter Terrorism and Security Act 2013, or that are otherwise illegal.
b) data, materials or resources that may have involved the exploitation or harm of individuals in its production, or otherwise have been unethically obtained.
4.5 Impact of the research process or outputs: Any project involving:
a) a significant potential risk to a physical environment or material culture (including artifacts).
b) potential adverse impact on a community which is not directly involved in the research;
c) cultural, governance or legal frameworks which are unfamiliar to the individual undertaking the work, such that there is a potential risk to the conduct of the project or the viability of future research
d) an ethical framework different to that in the UK;
e) other significant issues relating to local practice or political sensitivities;
f) development of products/technologies relating to arms manufacture, fossil fuel extraction, alcohol, tobacco, gambling, or pornography;
g) other significant issues relating to the potential use (or misuse) of outputs, i.e. where this could cause harm.
4.6 Safety of the research team: Any project posing a significant risk to the safety and well-being - whether physical, psychological, emotional or reputational - of the project team. This includes travel to areas considered to be of acute political sensitivity, or otherwise deemed to be high risk.
4.7 Collaborator or Funding Source: Any project where any of the following may apply:
a) the funder or collaborator’s ethos and values are at odds with the University’s;
b) the funder or collaborator has a poor ethical track record;
c) the terms of the funding are prohibitive (e.g. in restricting publication or influencing research design);
d) the funding has been obtained in an unethical way.
5.1 The University expects projects involving ethical considerations listed in section 4, or other ethical issues identified by the researcher, to be reviewed by one of the following:
a) the Animal Welfare Review Board (AWERB), where projects involve animals;
b) a Durham University departmental Ethics Sub-Committee (or equivalent departmental ethics process), in the case of all other projects. Projects involving the above considerations which are deemed to be low risk may be subject to a light-touch process, e.g. projects which involve human participants but do not involve any significant risk factors. This may include supervisors acting as approver for student projects.
5.2 Scope of University ethics process
5.2.1 The University’s ethical review will ordinarily only cover work undertaken by its staff and student body or subcontractors, though it may cover work undertaken by partner institutions in collaborative projects where Durham is the lead institution. Approval will be contingent upon securing appropriate ethical approval, licenses and permissions from any other organisations involved in the research.
5.3 Accepting approvals from other organisations
5.3.1 The University operates a principle of single review. Where appropriate, the University will accept ethical review from other organisations without requiring review by a University ethics committee where:
a) their review covers the work being undertaken by the University’s researchers; and
b) the University can satisfy itself that the standard of review and the governance / legal framework is equivalent to its own; and
c) there is a valid reason for the University not undertaking its own review, for example where there is a statutory requirement for review by an external body (for example the NHS Research Ethics Committee); where a researcher joins the University bringing a pre-approved body of research; or where the design of a collaborative project means that a single review by one institution is more pragmatic.
5.3.2 Review by an NHS REC, MODREC, or other UK HEI (where they are the lead institution) is automatically accepted where this covers the full scope of the work. Approval to accept another organisation’s review is not automatic and must be granted by the departmental ethics representative before commencing work. In all cases, copies of documentation should be made available to the department.
6.1 Institutional responsibility
6.1.1 Council is responsible for the ethical governance of the University.
6.2 Ethics Committee
6.2.1 Ethics Committee oversees the operation of the University’s Ethics Framework on behalf of Council. Its terms of reference are set out in the Standing Orders for Ethics Committee.
6.3 Ethics Sub-Committees
6.3.1 The Committee formally delegates to Faculty Ethics Sub-Committees and to departments the authority to assess and determine applications for projects within the scope of this policy. Departmental review should be undertaken by a process approved by the Faculty Ethics Sub-Committee.
6.3.2 Operational Guidelines, containing the roles and responsibilities of Faculty Ethics Sub-Committees and departmental ethics processes, and Ethical Review Guidelines are set out in Appendices One and Two.
6.4 Individuals
6.4.1 Individuals are responsible for reviewing whether the nature, design and conduct of their work is ethically robust, and in cases of concern for acting quickly and decisively to protect all those involved and the integrity of their work. Advice can and should be sought from the appropriate ethics committee where there is uncertainty.
6.4.2 Roles and responsibilities of Researchers, Principal Investigators and Heads of Department are set out in the Research Integrity Policy and Code of Good Practice.
6.5 Research and Innovation Services
6.5.1 Research and Innovation Services are responsible for
a) Providing guidance and resources to support the implementation of this policy.
b) Checking that proposals/applications for funded work have followed appropriate processes for ethical review, and that approval has been granted (where required) before work begins.
7.1 Staff and students have a right of appeal against decisions made by a Faculty Ethics Sub-Committee or departmental ethics process. Appeals against a decision made by a departmental ethics review process will normally be heard by the relevant Faculty Ethics Sub-Committee. In exceptional cases an appeal may be referred to the Ethics Committee. An appeal against a decision made by a Faculty Ethics Sub-Committee will normally be heard by another Faculty Ethics Sub-Committee, as determined by the Chair of Ethics Committee.
8.1 Appendices:
a) Operational Guidelines for Ethics Sub-Committees
b) Ethical Review Guidelines
Related Documents:
Research Integrity Policy and Code of Good Practice
/prod01/prodbucket01/media/durham-university/research-/73895.webp)