Does my project need ethical approval?
Ethical review is not about preventing or making it difficult to carry out research, but about helping the researcher think through the ethical issues and how to deal with them. The risks and benefits for participants and also the researchers are considered. The principles of good research practice encourage those involved in research to consider the wider consequences of their research and engage with practical, ethical and intellectual challenges inherent in high quality research.
While the NHS draws distinctions between research, service evaluation, clinical audit, surveillance and usual practice in public health, the University of Leeds requires that the collection of any human data should, potentially, be subject to ethics review, unless it is exempted as described in the Research Ethics Policy.
Research at the University of Leeds is conducted according to the principles of academic excellence, community, integrity, inclusiveness and professionalism. All research must be conducted according to appropriate ethical, legal and professional frameworks, obligations and standards.
In addition, the following research must be subject to review through the appropriate research ethics committee and formally approved before it is undertaken:
- research involving living human participants or the personal data of living human participants;
- research involving human tissue;
- research with the potential for adverse environmental impact;
- research involving NHS patients, staff or resources; and
- scientific and medical research involving animals.
Research that may raise other significant ethical issues or pose a reputational risk to researchers or the institution should also be referred for advice and/ or review.
As a general principle, review or validation is more likely to be required if
- It is possible to identify individual participants from the data
- Data collected for one purpose is to be used for another
- The work conducted is not within the parameters of normal planning, analysis and evaluation within the procedural frameworks agreed by the University.
However, if in any doubt, researchers should contact the Senior Research Ethics Administrator for advice.
Broadly defined, research includes all investigation undertaken in order to acquire knowledge and understanding including:
- work of educational value undertaken to improve the understanding of the research process
- scholarship such as contributions to research databases, catalogues and dictionaries
- the generation of designs, concepts, artefacts and performances that lead to new intellectual understanding
- the experimental use of existing knowledge to develop new materials, products and processes.
This definition of research would not normally include:
- routine audit and evaluation, such as the routine evaluation of teaching
- the development of teaching materials that do not involve original research
- routine testing and analysis of materials and processes.
This applies to all staff and students of the University who carry out or contribute to research (including those with visiting or honorary contracts), whether or not their current place of work or study is within University premises or not. Third parties (for example staff of other institutions undertaking research with Leeds students) are also expected to adhere to the University's ethical standards of research conduct.
The ethical review processes flowchart is designed to help you decide which is the most appropriate route of review for your project.
Research reviewed through other frameworks
Research involving animals
Research involving animals is reviewed through a discrete University framework. Further information can be obtained by contacting the University's Home Office Liaison Officer at firstname.lastname@example.org.
The University's framework of ethical review has been designed to complement that provided by the NHS and, in the case of research involving genetically modified organisms, DEFRA. Research reviewed through these frameworks will not require internal review, although proof of NHS or DEFRA review must be provided.
Research subject to NHS ethical review
Research reviewed by the NHS includes:
- research involving NHS patients, personal data or tissue
- research involving adults lacking the capacity to consent
- research classified as a Clinical Trial
- research involving human tissue.
Research subject to DEFRA review
Research reviewed by the DEFRA includes projects involving the release of genetically modified organisms into the environment.
Research which has already obtained ethical approval from another UK HEI
The University will normally accept evidence of approval by another UK institution in lieu of internal review, provided that similar standards have been applied (evidence of which will be required). However, care should be taken with international research legislative and cultural imperatives vary widely. Research taking place outside the UK will normally require review within the University of Leeds, as well as being compliant with relevant legal and ethical requirements in the host country.