The University is committed to maintaining the highest standards of rigour and integrity in its research. As a component of this commitment, the University requires that all research projects which involve human participants[1], human material[2], or personal data[3] should receive research ethics approval before they commence.
[1] ‘Participants’ includes owners of animals and their data - even if the owners of the animals, or their data, are not the subject of the research. Please see the ‘Procedure for the ethical review of research with the School of Veterinary Science’ for further guidance.
[2] ‘Material’ includes all material under the Human Tissue Act 2004, whether relevant or non-relevant – with the exception of cell lines; and the requirement for University ethical review extends to commercially purchased relevant material. The University Human Material team and the Research Ethics team reserve the right to request that a project undergo University ethical review, even if it does not fall within the definition listed above.
[3] For a definition of ‘personal data’, please see Article 4(1) of the General Data Protection Regulation.
Research ethics principles
This Policy aims to ensure that University research projects involving human participants, human material, or personal data are carried out safely, with informed and voluntary consent, and with due respect to confidentiality and privacy. Below are the guiding principles that the University expects its researchers to abide by:
- Except where the nature of the research makes this impossible, research staff and participants must be fully informed about the purpose, methods, and intended possible uses of the research. On the basis of this, information they must give their voluntary consent to take part in the project, free from coercion.
- Researchers must respect a participant’s right to withdraw from active participation in research, without adverse consequences to the participant.
- The confidentiality of the information supplied by research participants, and the anonymity of respondents, must be respected. Wherever possible, data should be anonymised and there should be full compliance with the principles within the Data Protection Act 2018. Personal data can only be disclosed when permission to disclose is part of the consent procedure.
- Risks to those involved in the research must be minimised, and harm to research participants and researchers must be avoided. Participants must be warned in advance about any potential risks of harm[1].
- The independence of the research must be clear, and any conflict of interest or partiality must be explicit.
- The research must conform to all relevant statutory requirements, and to the requirements of the institution in which the research is undertaken.
[1] ‘Risk’ and ‘harm’ should not be thought of solely in the context of medical research. All research involving human participants, personal data or human material contains some risk. Risks, harm, disadvantage, and burdens can be psychological, social, economic, cultural etc., as well as physical.
Responsibilities
The Committee on Research Ethics, and its subcommittees, are responsible to the University Council for seeking to ensure that research is conducted in accordance with these principles.
Those undertaking research falling within this Policy are responsible for:
- consideration of the ethical implications of any research project which involves human participants, human material, or personal data;
- obtaining formal ethical approval from the University before the research commences;
- and conducting the research in accordance with these principles.
In the case of research undertaken by undergraduate or postgraduate students, the Supervisor is primarily responsible for ensuring that the above responsibilities are met.
The University regards a failure to meet these responsibilities as a serious matter, which may constitute research misconduct.
Process and Procedure
The University is committed to providing a rigorous and independent process of ethical review that is proportionate to the potential risk. This process includes a range of procedures for specific application types. Further information on the processes for ethical review can be found on the research ethics webpages (requires a University of Liverpool log-in), or by contacting ethics@liverpool.ac.uk.
Training
All students and staff involved in research are required to undertake appropriate training before embarking on an evaluation of the ethical implications of their research. Details of available training can be found on the research ethics webpages.
Adverse events
Staff should ensure that they are familiar with the procedure for managing adverse events in research.
Quality assurance
The Central University Research Ethics Committees may periodically institute a selective audit of research projects. Where a Central University Committee considers that a study is being conducted in a way which is not in accord with the conditions of its original approval, it may consider withdrawal of its approval and require that the research be suspended or discontinued.
Recognition for contributions to research ethics
The University values the important contribution Research Ethics Committee members makes to University research, promoting ethical research practices and protecting the rights and interests of research participants. Contributions will be reflected through Professional Development Reviews, workload allocation models, and in progression processes.
Scope and exemptions
This Policy applies to staff, students, and anyone else conducting research under the auspices of the University. This includes research in wholly owned subsidiaries and the research undertaken or commissioned by University staff and students while working in a joint venture with a third party[2]. Research should be interpreted broadly to include all investigation undertaken in order to acquire knowledge and understanding, whether funded or unfunded.
[2] This Policy only applies to University spin out companies if the University retains a controlling interest. Individual members of the University staff may be directly involved in spin-out companies that are not owned by the University. In these cases, they should ensure that their involvement in the work of the company will not compromise the reputation of the University. If in doubt, researchers should seek guidance from the Committee on Research Ethics (ethics@liverpool.ac.uk).
Where research has received ethical approval from an external institution – other than an NHS Research Ethics Committee – then University research ethics approval should be sought in addition to the approval in place from the external institution.
Research requiring review by an NHS Research Ethics Committee
Research which requires review by an NHS Research Ethics Committee under the Department of Health Framework must seek approval through the Health Research Authority process. Please use the NHS Health Research Authority ‘Do I need NHS REC review?’ decision tool to determine whether review by an NHS Research Ethics Committee is needed.
Studies which require review by an NHS Research Ethics Committee do not need University Research Ethics review.
Student research undertaken with a third-party organisation
In some cases, as part of their assessed degree course, students are seconded to a third-party organisation. During this secondment, they may work on research projects in which the research is directed by that organisation, and not the University. In such circumstances, if there is no involvement in the study from the University of Liverpool Supervisor, then the ethical assessment of this research is not covered by this Policy. However, the relevant Faculty, School or Department of the University who are sponsoring the secondment should obtain formal written reassurance from the organisation hosting the student that it has procedures to ensure that the research will be undertaken in an ethically responsible way.
Studies involving, or funded by, the Ministry of Defence
Studies involving, or funded by, the Ministry of Defence require review by the Ministry of Defence Research Ethics Committee, and do not require review by a University Research Ethics Committee.
Doctorate in Clinical Psychology ‘Clinical Service Research Investigation’ projects
Doctorate in Clinical Psychology trainees are not expected to seek University research ethics review for their Clinical Service Research Investigation projects. Please see the Clinical Service Research Investigation (CSRI) – ‘Programme Methodology Framework’ for further guidance.
Clinical audits which have approval from an NHS Trust
Clinical audits which have obtained approval or permission from the relevant body within the Department of Health framework (for example, the local clinical governance team, or research and development office, or the Confidentiality Advisory Group) - do not require review by a University research ethics committee. Please see the procedure for the ethical approval of health-related research projects classed as service evaluation or audit for further guidance.
Evaluation activities
Research should be interpreted broadly to include all investigation undertaken in order to acquire knowledge and understanding, whether funded or unfunded. This includes health-related projects classed as service evaluation – please see the procedure for the ethical approval of health-related research projects classed as service evaluation or audit for further guidance.
For other types of evaluation, the distinction between data collection activities which are clearly research, and data collection activities for the purposes of evaluation or audit can be difficult to define. A significant determinant of whether research ethics approval is needed relates to the plans for the use of the data.
In circumstances whereby, as an example, a questionnaire is used to evaluate your own professional practice in order to improve your own practice, then research ethics approval is not normally needed, as long as the responses are anonymous and the data are not written up.
However, if there are aspects of the data collection and use which are akin to research, for example: plans to write up and present or publish the data; or if the responses are identifiable, then research ethics approval is required.
Secondary analysis of fully anonymised data
University Research Ethics Committee review is not normally required for the secondary analysis of data which have: been anonymised by an external party, and will be provided to the research team in a fully anonymised format.
However, if there is any possibility of the research team rendering the data identifiable - either through linking back to the identifiable information; or through linking the data with other data sets in a way which would compromise the anonymity of the data, then University Research Ethics Committee review will be required.
Data gathered through the internet
University Research Ethics Committee review is not normally required for publicly available data such as published biographies, interviews broadcast on radio or television, newspapers etc. However, the use of publicly available information - especially data gathered through the internet or through social media - should always be critically examined, and the identity of individuals protected wherever possible.
If there are any potential considerations over:
- the identifiability of online data sources;
- the potential sensitivity of the use of the data;
- the potential vulnerability of the participants;
- how privacy is constituted in digital contexts; etc.
Then University Research Ethics Committee approval should be sought.
Scientific research involving animals
This Policy does not apply to research and testing using animals where a Home Office Licence is required under the Animals (Scientific Procedures) Act 1986. Such studies require review by the University’s Animal Welfare and Ethical Review Body (awcom@liverpool.ac.uk).
Contacts
This Policy will be regularly reviewed in the light of experience and revisions to codes of practice laid down by any relevant professional or learned society. Any comments should be sent to ethics@liverpool.ac.uk.
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