The nature of research into healthcare technologies means that it is frequently the case that research will necessitate the use of human and animal subjects, including their data or tissues.
While these studies will often be vital, either to enhance the understanding of biological systems or undertake an initial validation of your technology, the potential for harm to the subjects of those experiments necessitates a rigorous approach to the ethical oversight of the research.
Various levels of ethical approval are required depending on the type of study and you should familiarise yourself with your institution’s guidance on the process for gaining the relevant approvals.
Ethics and animal studies
There is an expectation that projects involving animal studies should be conducted in accordance with the guidelines produced by the National Centre for Replacement, Reduction & Refinement of Animals in Research (NC3Rs).
We expect all research to implement the principles in the guidance and it is a condition of funding from EPSRC.
As part of this responsibility researchers should always consider the 3Rs when designing experiments involving animals.The 3Rs are:
- replacement – using alternative models which do not involve animals where they are available and appropriate
- reduction – using the minimum number of animals which allows you to generate statistically meaningful results
- refinement – minimising the suffering and improving animal welfare
They are there to guide thinking not only for the humane use of animals in research, but also to ensure experiments are well-designed to generate meaningful results and no animal lives are wasted.
There are different levels of protection applicable to different animal species at different stages of their development. In many cases there will be additional Home Office licensing requirements as described in the Animal (Scientific Procedures) Act 1986.
Acquiring these approvals can take further time on top of any local approvals and will prevent any work taking place until they are granted.
This is an active area of legislation and requirements may change as time goes on. We advise you to check the NC3Rs website for the latest developments.
We would also encourage researchers to familiarise themselves with the Animal Research: Reporting of In Vivo Experiments (ARRIVE) guidelines produced by NC3Rs. These guidelines are intended to improve standards of reporting and ensure that the data from animal experiments can be fully evaluated and utilised by other researchers and reduce the need for repeat animal experiments.
Ethics and human studies
Where you intend to use human participants you will need to demonstrate that it is ethically justifiable to involve them in your project. This will require a consideration of the potential benefits to the individual or society offset against any risks.
As early proof of concept studies should not alter the patients normal care pathway, the level of potential benefit to the patient will normally be minimal, the level of acceptable risk will therefore be proportionately low.
Your project may not involve people directly but may involve the use of data. You should consider carefully how their data will be stored and protected. If the data is anonymised consider whether your analyses may lead to re-identification of an individual.
For any studies involving human participants that take place within the NHS, further approval will be required from the Health Research Authority (HRA), which in turn requires a further application process to a relevant Research Ethics Committee (REC).
Your clinical collaborators should be well placed to advise on this process, but you will need to consider how this will fit into your project’s timeline, particularly as you are unlikely to be in a position to apply at the outset of your research.
Justifying your proposal
As part of your proposal you will be asked to answer questions covering issues such as:
- would the project involve the use of human subjects
- will personal information be used
- would the project involve the use of vertebrate animals or other organisms covered by the Animals (Scientific Procedures) Act
- will human tissue be used.
Wherever the answer is yes, the information you will be asked to provide is important as it forms part of the case and justification for your project, which reviewers will be asked to comment on.
Lack of detail or clarity will lead reviewers to conclude that these aspects have not been considered carefully and they will not recommend the project for funding.
Where we believe there is insufficient information in your application’s ethical sections for the relevant science to be reviewed fully, we will be unable to accept your proposal.
While there are many statutory requirements for approval and licensing when including humans or animals in your research, remember to consider all potential ethical implications of your work. Doing so will not only help you carry out good science but will also help you consider the kind of topics that may come up when discussing your project with the public or other stakeholders.
Where the ethical implications are controversial you should also consider how you will embed a responsible research and innovation approach in your project.
What to consider to make sure your research is ethical
You should consider:
- if your project will involve human participants, their data or tissues
- if your project will involve the use of animals
- how you’ll ensure that any animal experiments are appropriate
- if you know what aspects of your proposed work require approvals and which do not
- if you know how the ethical approvals system works within your institution
- what are the typical time frames needed for getting ethical approvals or licences
- the impact of these timescales on your project work plan
- if you need to ensure a responsible innovation approach.
Resources that can be requested
As part of your proposal you should consider requesting resources to:
- undertake training in relevant ethical topics
- undertake training in the use of animals in research
- admin support for completion of relevant approvals
- cover the cost of human participation or animal research.
EPSRC policy on the use of animals in research – guidance on preparing EPSRC proposals for projects undertaking animal research.
NC3Rs responsibility in the use of animals in bioscience research guidelines – full guidance on using animals in research.
NC3Rs Experimental Design Assistant – interactive tool for optimising and validating proposed animal experiments.
Animals (Scientific Procedures) Act 1986 – the legislation governing the use of animals in research.
NC3Rs ARRIVE guidelines – guidance on best practice in publishing the results of animal studies.
Health Research Authority – guidance and information on undertaking research in the NHS.
National Institute for Health Research clinical trials toolkit – resources and guidance on best practice for researchers planning human trials.