1. Purpose/Abstract
The Research Ethics Policy is intended to:
- Provide standards to safeguard the rights of individuals and groups, animals and the environment with whom and which researchers interact, including the University, its staff and students;
- Guide staff, students and any interested parties, including the public, in the ethical points of consideration that may arise from research activity associated with the University; Direct researchers to adhere to best practices relating to the ethical development, implementation and dissemination of research.
2. Introduction
Research at the University of Derby (hereby referred to as ‘The University’) is conducted according to the principles of integrity, academic excellence, accountability, inclusiveness and professionalism. The University promotes the general principles of honesty, academic rigour, transparency and open communication, and care and respect. All research must follow appropriate ethical, legal and professional frameworks, obligations, and standards. The general principles underpinning the University’s approach to research ethics are
- Beneficence: The research must be worthwhile in itself and ensure that any beneficial effects outweigh any possible risks. The methodology must be sound so that the results will be meaningful.
- Non-maleficence: This is the principle of ‘not doing harm’. Any possible harm must be avoided or mitigated by robust precautions. This is particularly important if the research involves participants who could be considered to be potentially vulnerable due to their location, economic, social or health status. Additionally, consideration of non-maleficence is important if the research involves animals. Consideration must be given to ensuring that the burden of taking part in the research does not fall disproportionately on those who are unlikely to benefit from the results.
- Confidentiality: Participants have the right to ensure their personal data are kept safe, stored securely for a defined period of time and destroyed appropriately (see the University Research Data Management Policy). Limits of anonymity and confidentiality, for example when disclosure of risk or harm is required, must be clear and transparent to everyone involved in the research.
- Integrity: The researcher must be transparent about any known conflicts of interest, for example personal, financial, institutional, or other gains they are due to make from the research. The methodology must be sound so that the results will be meaningful. They must acknowledge the relevant contributions of third parties involved in the project and ensure that research outcomes are disseminated appropriately. The University encourages anyone who witnesses research misconduct or poor research practice to report their concerns (see Research Governance, Ethics and integrity web site).
- Justice: All research participants must be fully aware of the purpose of the research, be recruited fairly, and not exploited.
The Research Ethics Policy conforms with the principles laid out in other relevant policies, guidelines and codes of conduct, including those of funding bodies such as the Research Councils and the UK Concordat to Support Research Integrity. The Research Ethics Policy provides the framework within which research ethics reviews will operate across the University.
The Research Ethics Policy describes the principles underpinning the ethical conduct of research and defines the principles for the objective and rigorous ethical review of research, which falls within its scope.
3. Scope
For the purpose of this policy, research is defined (based on the Research Excellence Framework definitions) as a process of investigation leading to new insights effectively shared.
This would include:
- the invention and generation of ideas, images, performances, artefacts including design, leading to new or substantially improved insights;
- work of direct relevance to the needs of commerce, industry, and to the public and voluntary sectors;
- scholarship such as the creation, development and maintenance of the intellectual infrastructure of subjects and disciplines (e.g., dictionaries, catalogues and research databases);
- the use of existing knowledge and experimentation to develop new or substantially improved materials, devices, products and processes, including design and construction.
- work of direct relevance to the needs of commerce, industry, culture, society, and to the public and voluntary sectors;
- the invention and generation of ideas, images, performances, artefacts including design, where these lead to new or substantially improved insights;
- the use of existing knowledge in experimental development to produce new or substantially improved materials, devices, products and processes, including design and construction. It excludes routine testing and routine analysis of materials, research that is published, disseminated or made publicly available in the form of assessable research outputs, and confidential reports
Research would not normally include:
- routine testing and routine analysis of materials, components and processes such as for the maintenance of national standards, as distinct from the development of new analytical techniques.
- the development of teaching materials that do not embody original research
If there is any doubt if a piece of research requires ethical approval ALWAYS consult the Chair of the appropriate College Research Ethics Committee (CREC).
The University Research Ethics Policy applies to all employees, students and visiting researchers of the University, including persons holding honorary, emeritus and visiting University appointments/conferments and students on placements who conduct research within, or on behalf of, the University.
4. Responsibilities
It is expected that all research undertaken at the University will be conducted in compliance with the University’s Research Misconduct Policy and Procedures and the UK Concordat to Support Research Integrity.
Researchers must adhere to any regulations laid down by their professional body and any legal requirements relating to their research, such as Acts of Parliament or statutory regulations.
Legislation or Government bodies may require ethical review to be conducted by a specific ethics committee. For example, the Human Tissue Act (2004), the Mental Capacity Act (2005), or the Medicines for Human Use (Clinical Trials) Regulations 2004 and Amended Regulations 2006) or the UK Policy Framework for Health and Social Care Research (2020). In these cases, ethics review by, for example, the NHS Research Ethics Committee takes precedence over the University ethics system. Researchers should avoid duplication of ethics review.
All research projects must have received research ethics approval BEFORE the research activity is initiated. This Policy is subject to the oversight of the University Research Ethics Committee (UREC), a subcommittee of the University Innovation Research Committee.
Research Ethics Applications are approved by CRECs, which are subcommittees of the College Research Committees. Research ethics applications are managed and monitored via Ethics Monitor.
The UREC ensures and monitors the integrity of research ethics at the University by coordinating activity of the URECs. It promotes the general principles of honesty, academic rigor, transparency, open communication, and care and respect. The UREC steers the development, review, implementation, monitoring and evaluation of policies, procedures and guidelines to facilitate the process of research ethics governance.
CRECs will submit their annual reports to the June/July to the UREC. The UREC will provide an Annual Report which gives an overview of the operation of the Research Ethics Approval Process, compliance and any breaches of research ethics and/or integrity across the University. The UREC’s Annual Report will inform the Annual Research Integrity Statement considered/approved by the September/October Meeting of the University Innovation Research Committee. This statement is part of the compliance requirements of the UK Concordat to Support Research Integrity.
5. Policy Statement
5.1 General principles underpinning the ethical conduct of research
Researchers must abide by the following principles at all stages of the research lifecycle. This includes the planning stage, applying for funding, and the conduct and later stages of the project, such as dissemination and impact activities.
- The researcher must conduct their research with honesty and integrity, with minimal risk to participants and to themselves. Researchers must respect the rights, values, culture, interests and dignity of participants and related persons in research.
- Research must be undertaken in accordance with all appropriate University Policies and relevant common law or legislation.
- Full informed consent should normally be obtained from participants or appropriate legal guardian to enable participants to take part voluntarily. Consent should be given freely without force or coercion.
- Wherever possible, researchers have an obligation to protect research participants from significant harm as a result of their participation in the research
- The confidentiality of information supplied by research participants and any agreement to grant anonymity must be respected.
- Care must be taken with collecting, handling, and storing sensitive, classified and/or personal data. Such data should be kept securely and protected from unauthorised access. Particular care should be taken to ensure that human data cannot be linked back to individuals unless by authorised persons, who are explicitly identified in the Research Ethics Application. It is essential that all sensitive, classified and /or personal data are retained for defined periods and disposed of appropriately in line with legal and funder requirements (see the University Research Data Management Policy).
- Both the design of research and its conduct should ensure integrity and quality, and provide benefits that outweigh potential risk or harm.
- Research shall be undertaken subject to the principle of academic independence. Where any conflicts of interest or partiality arise, these must be clearly stated prior to ethical approval being obtained.
- The same high ethical standards shall apply wherever in the world the research is being undertaken and to any modality in which the research is carried out.
- The principal investigator and the research team shall be responsible for determining what ethical issues emerge from the proposed project and for obtaining ethical approval of the project.
- Researchers are responsible for ensuring the project is undertaken as approved by the University research ethics approval process and in compliance with any legal or organisational requirements.
- Researchers are responsible for confirming with the CREC Chair the significance of any divergence from the approved research and the potential need to acquire further ethics approval before continuing with the research.
5.2 Collaborative Research
The University Research Ethics Policy and its principles should be highlighted to all proposed collaborators (e.g. academic, business, third and public sector) or project partners providing co-funding or in-kind contribution, prior to a submission for funding. Where a joint research project with another institution is proposed, the lead principal investigator at the University shall submit an application to the University to seek ethical approval. In cases where the co-applicant is at the University of Derby (and the lead/principal investigator is at another institution), the University of Derby co-applicant shall submit an application to evidence ethical approval, ensuring that the ethics approval from the other institution is attached with the ethics application (if it is made available). In addition, it should be noted that compliance with ethical principles which may be regarded as appropriate in the jurisdiction where the research is being undertaken is not a substitute for ethical approval from the University of Derby.
Where research is to be conducted outside the UK or involves international partners, University representatives or partners should establish whether ethics review is required by the non-UK partners, and how the principles of the University’s Research Ethics Policy may be followed in developing and undertaking the research. Legal and ethical requirements for all overseas countries must also be followed, including determining whether an overseas country has a requirement for an ethics review process to be conducted by a research ethics committee based within the country in question. When planning international collaborative work associated security issues should be considered (see Security Related Issues in International Research Collaboration: A Guide).
6. Sanctions
Failure of staff or students to comply with this policy should be addressed in the context of the University’s Research Misconduct Policy and Procedures. Research Misconduct Policy and Procedures and the UK Concordat to Support Research Integrity.
7. Related Documentation
All these documents are available on Policy Hub
7.1 University Research Ethics Procedures
This document defines the processes associated with applying for research ethics review at the University and provides guidance on specific issues to consider when making an application, including for research carried out under the auspices of the NHS and HM Prison and Probation Service.
7.2 Research Data Management Policy
This Policy provides a standard to safeguard the data arising from research associated with the University. It provides the principles to support researchers to adhere to best practice relating to the management and open access of research data and ensure compliance with the needs of external funding agencies.
7.3 Research Data Management Policy: Procedures
This document defines the procedures to support University staff and students to safeguard the data arising from research associated with the University.
7.4 Publication and Open access Policy
This Policy provides the principles the University will adhere to in the support and operation of fair, inclusive, consistent and transparent research publication and Open Access.
7.5 Publication and Open Access Procedures
This document describes the procedures to support implementation of the Publication and Open Access Policy.
7.6 Security Related Issues in International Research Collaboration: A Guide
This Guide, based on information from Universities UK, the UK Government, the Centre for the Protection of National Infrastructure (CPNI) and the National Security Centre, provides details about what should be considered before proceeding with international research collaborations in the context of security related issues.
8. References
9. Equality Analysis
Research Ethics applications made under this Policy will be monitored to ensure fairness and consistency in the application of this Policy. This will be undertaken annually and reported to UIRC and will inform the compliance requirements of the UK Concordat to Support Research Integrity.