Approval date: March 2018
Effective from: March 2018
Approved by: Senate
Table of Contents
This document sets out the University’s expectations regarding ethical review and approval. It is intended to facilitate the conduct of University activities in a manner that manages ethical risk appropriately, and which safeguards both participants and researchers.
The policy applies to all research, consultancy, impact/engagement, teaching, learning, fundraising and other projects that may raise ethical issues, whether undertaken by staff, students or other individuals acting on behalf of the University.
Within the broad scope above there are two domains:
a) All research projects (funded or unfunded), 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.
b) Although other activities, such as Teaching & Learning and fundraising, are not required to follow the research ethics process, they must be able to demonstrate that they are undertaken in full compliance with the University’s policies and codes of practice, that due consideration has been given to all ethical issues and that a robust (and equivalent) process for review and approval is in place.
The University expects the following factors to be considered in ethical assessment, and projects including these factors to undergo ethical review by the appropriate body:
i. NHS & Social Care: Any project involving the NHS or Social Care, its staff, patients, data or facilities; or individuals covered by the Mental Capacity Act 2005 or Adults with Incapacity (Scotland) Act 2000.
ii. Animals: Any project involving animals (as defined by the Animal Scientific Procedure Act).
iii. 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. 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) The collection or processing of sensitive personal data (including from secondary sources) without explicit consent;
j) Sensitive personal data transfer to partners outside the EEA;
k) Members of the public in a research capacity (‘participant research’);
l) Offering financial recompense to participants beyond reasonable expenses.
iv. Sensitive Materials: Any project involving:
a) data covered by statute such as the Official Secrets Act and Counter-Terrorism and Security Act 2013;
b) viewing or dissemination of illegal materials.
v. Environment: Any project posing a significant potential risk to a physical environment or material culture. This includes but is not limited to levels of pollution greater than that permitted under UK law.
vi. International: Any project involving:
a) travel to areas of acute political sensitivity;
b) cultural, governance or legal frameworks which are unfamiliar to the individual undertaking the work or not equivalent to those used in the UK;
c) requiring licences or permissions from international bodies.
vii. Safety of those involved: Any project posing a significant risk to the safety and well-being - whether physical, psychological, emotional or reputational - of those involved, including participants and/or the project team. ‘Significant risk’ is defined as outside that which a normal person would be exposed to in daily life.
viii. 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) funds or other project resources have been unethically obtained;
c) the funder or collaborator has a poor ethical track record;
d) the relationship could negatively affect the University’s reputation;
e) the terms of the funding are prohibitive (e.g. in restricting publication or influencing research design).
ix. Use of outputs: Any projects involving outputs which may be subject to export controls and which have the potential to:
a) contravene the UK’s international commitments (e.g. breach of applicable arms embargoes or other sanctions);
b) be used for internal repression or the abuse of human rights, provoke or prolong armed conflicts, or aggravate existing tensions in the destination country;
c) be used aggressively against another country;
d) adversely affect the national security of the UK or allies;
e) be to a destination where the behaviour of the buyer country raises concerns with regard to its attitude to terrorism or respect of international law;
f) be diverted or re-exported under undesirable conditions;
g) in the case of developing countries, seriously hamper the sustainable development of the recipient country.
The potential application of any outputs should be considered at the earliest possible opportunity.
x. Conflicts of Interest: Any project involving any actual, potential or perceived conflicts of interest. Approved projects require effective management of the interest to be put in place before work starts.
The University expects such projects to be reviewed by one of the following:
a) a NHS Research Ethics Committee (NHS REC) where this is required under the Governance Arrangements for Research Committees (GAfREC), including where projects involve NHS or Social Care;
b) the Animal Welfare Review Board (AWERB), where projects involve animals;
c) a Durham University departmental Ethics Committee, 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.
The University’s ethical approval will ordinarily only cover work undertaken by its staff and student body or subcontractors. Such approval will be contingent upon securing appropriate ethical approval, licenses and permissions from any other organisations involved in the research.
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.
Approval to accept another organisation’s review must be granted by the departmental ethics representative before commencing work. Copies of documentation should be made available to the department.
Council is responsible for the ethical governance of the University.
Ethics Advisory 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 Advisory Committee.
The Committee formally delegates to Faculty and departmental Ethics Sub-Committees the authority to assess and determine applications for projects within the scope of this policy.
Operational Guidelines, containing the roles and responsibilities of Faculty and departmental Ethics Sub-Committees, and Ethical Review Guidelines for Ethics Sub-Committees are set out in Appendices One and Two.
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 University Ethics Committees where there is uncertainty.
Roles and responsibilities of Researchers, Principal Investigators and Heads of Department are set out in the Research Integrity Policy and Code of Good Practice.
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.
Staff and students have a right of appeal against decisions made by an Ethics Sub-Committee. Appeals against a decision made by a departmental Ethics Sub-Committee will normally be heard by the relevant Faculty Ethics Sub-Committee. In exceptional cases an appeal may be referred to the Ethics Advisory 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 Advisory Committee.