If you plan to apply for ethical approval for research involving human participants or personal data from one of the University’s research ethics committees their applications forms and local guidance will help you to understand what to include in your application and what issues need to be addressed.
The information requested by your local committee will depend on your discipline and the type of research that you intend to undertake.
There are, however, some core issues that ethics committees will normally expect you to have addressed as part of your application:
Wherever possible, ethics committees will expect you to demonstrate that you intend to respect the autonomy of individuals involved in your research. Normally this will include:
- Providing research participants with sufficient information to make an informed decision as to whether to take part in research (informed consent);
- Ensuring that participants are not subject to coercion to take part or penalty for not taking part;
- Ensuring that participants are, and are aware that they are, free to withdraw from the research at any time without giving a reason and without a prejudice;
- Protecting and respecting personal data provided by participants through rigorous and appropriate procedures for confidentiality and anonymisation.
Ethics committees will expect you to show that your research is worthwhile and will have beneficial effects that outweigh the risks posed by the project (see below). The recipient of the benefit will vary from project to project, but may include, among others, society, science, scholarship, health, and/or the participant themselves. The potential benefits of research should be presented realistically and not be exaggerated.
Ensuring that you maximise the benefits of your work is part of your obligation to research participants and scholarship and ethics committees will normally expect you to have taken efforts to do so. This would normally include:
- Designing, reviewing and conducting research in a manner that ensures quality and integrity and maximises the chance of obtaining useful results;
- Ensuring that research is effectively and appropriately disseminated;
- Ensuring that the aims of the research are transparent and that the methodology used is appropriate to addressing them.
Ethics committees will expect you to have thoroughly considered the potential (and potential severity) for harm to come to research participants or others as part of your research.
You will be expected to consider all possible risks of harm that might be posed by your research, keeping in mind that certain harms, such as distress, embarrassment or anxiety, can be subjective and difficult to predict.
Harm (where identified) should normally be avoided and you will be expected to show how you will do so. Where the risk of harm cannot be avoided, an ethics committee will expect to see that you have taken robust precautions to mitigate the potential for harm and deal with harm should it occur.
It will normally be expected that the degree of risk (and potential severity) of harm should be proportionate to the potential benefits of the research. Research posing a high risk of harm or a risk of severe harm will require careful consideration by the researcher and ethics committee before being approved.
Research ethics committees will also expect research to be, where possible, fair to those participating in research.
The nature of your research will not always allow the benefits, risks and costs of the research to be distributed in a strictly fair manner, but ethics committees will normally expect you to show that you have made efforts to do so wherever possible and that your research does not unfairly discriminate against certain individuals or groups.
Behaving with integrity
Researchers have an obligation to conduct their research with integrity and transparency. Research ethics committees will expect you to declare any actual or potential conflicts of interest that affect your research and to be honest and transparent throughout the ethical approval process and the research process. Any plans to withhold information from research participants should be explained and justified in your application for ethical approval.
Applicants for ethical approval should consider the core principles above and address any that apply to their work as part of their application. Failure to address the aspects above may lead to delays to your application for ethical approval.
In particular, researchers should ensure that their applications address both the risks posed by their research and the potential benefits offered. Research ethics committees will normally look for the benefits of your research to outweigh the risk of harm and will assess your application to ensure that this is the case. It is therefore important that you address both in a manner appropriate to your research.
Sources and further reading
The Research Ethics Guidebook, http://www.ethicsguidebook.ac.uk/
Association of Research Ethics Committees, A Framework of Policies and Procedures for University Research Ethics Committee (2013), http://arec.org.uk/wp-content/uploads/Framework-of-policies-and-procedures.pdf
The British Psychological Society, Code of Human Research Ethics (2010), http://www.bps.org.uk/sites/default/files/documents/code_of_human_research_ethics.pdf
ESRC, Framework for Research Ethics (2016), http://www.esrc.ac.uk/funding/guidance-for-applicants/research-ethics/
UK Clinical Ethics Network, Ethical Issues, http://www.ukcen.net/index.php/ethical_issues