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Ethical approval

Researchers need to consider the ethical implications of the research they are planning to carry out prior to finalising a research plan. Making sure that your research is ethical focuses primarily on two areas.

The first concerns the rights of patients, staff and learners to be treated as openly and fairly as possible within the research, and to consent fully to taking part.

The second focuses on making sure that appropriate scientific principles are applied so that those who rely on research findings to make their clinical, educational or other decisions are receiving results that are accurate and the result of sound research design.

Organisations are increasingly aware that staff, students and patients can no longer be seen as fodder for research and if you want to publish your research findings, then you will need to state how and by whom your study was approved. This ethical stance is located within a legal framework that includes the Human Rights Act and Data Protection Act. High-profile events, such as the retention of organs at Alder Hey Hospital in Liverpool, highlighted the importance of taking an ethical approach to all aspects of patient participation in research. Any research that involves NHS patients, potential patients or staff (this may also include students or professionals in training) needs to have been granted appropriate ethics approvals and NHS permissions.

In the UK, a national body, the Health Research Authority (HRA), promotes and protects the interests of patients and the public in health research (see www.hra.nhs.uk). The HRA makes sure that health research is ethically reviewed and approved, and that anyone considering participating in health research is provided with information to help them decide whether they wish to take part. The HRA is a non-departmental public body of the Department of Health and hosts the Integrated Research Application System (IRAS) on behalf of partners, including the devolved administrations of Scotland, Wales and Northern Ireland (see https://www.myresearchproject.org.uk/signin.aspx).

The Integrated Research Application System (IRAS):

  • is a single system for applying for the permissions and approvals for health and social care / community care research in the UK
  • enables you to enter the information about your project once instead of duplicating information in separate application forms
  • uses filters to ensure that the data collected and collated is appropriate to the type of study, and consequently the permissions and approvals required
  • helps you to meet regulatory and governance requirements.

 

The National Research Ethics Service (NRES) is responsible for 70 Research Ethics Committees (RECs). RECs meet regularly to consider around 6,000 applications for new research projects each year. NRES is also responsible for specialist RECs, such as the Gene Therapy Advisory Committee (GTAC), which reviews gene and stem cell therapy clinical trial applications from an ethical perspective.

Research governance frameworks and NHS permission processes are also devolved (see http://www.hra.nhs.uk/resources/research-legislation-and-governance/research-governance-frameworks/).

Of course, educational research is also carried out in universities and here, similar processes apply, though usually at local level in the form of a university, faculty or departmental ethics committee. The process of applying for ethical approval is useful in pushing you to clarify the aims, process and outputs of the research. Ethical considerations may lead to modification of your planned research: you may decide that the time frame, scale or scope of the research is unrealistic.

Depending on who has commissioned the research (for example, external funding body, government department, charity or an internal department), there will be issues that have to be addressed around who owns the data that are produced through the research. We have mentioned ensuring compliance with legislative requirements around data protection above; this involves obtaining consent from those involved in the study, ensuring anonymity of participants, and ensuring that data are stored appropriately and securely. The data and outputs from externally commissioned research will normally belong to the funding body, not to the researcher or the organisation carrying out the research. It is important that measures are put in place to ensure that all involved are aware of how data and other research outputs are to be managed.

A final issue that you will need to consider as you plan and carry out educational research is that of your own position as researcher. This is particularly relevant if you are researching your own organisation or have a position of influence over research ‘subjects’ (e.g. students or teachers). In educational research, which often involves qualitative methodologies, this issue is typically brought to the fore as part of the methods selected, and in the analysis and discussion.

The reading list includes texts and articles on carrying out research in educational, clinical and training settings which provide more information.

Thinking point
Find out how ethics approval is obtained in your own organisation and look at the approval forms for guidance as to the sorts of issues you will have to consider in planning and designing your research study.

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