An introduction to research ethics

What do we mean by ‘research ethics’?

Research ethics is a key part of research governance. Good research is ethical research, and vice versa. This aspect of research governance is concerned with maintaining high ethical standards in research by applying a set of ethical guidelines or principles that govern the actions and expectations of researchers in the design, conduct and dissemination of research.

In the NHS, Research Ethics Committees exist to uphold the rights, safety, dignity and wellbeing of research participants (NHS patients and staff). There are over 80 NHS Research Ethics Committees across the UK. Each committee comprises approximately 15 members, a third of which are lay-members (i.e. members of the public). These committees will review around 6,000 research ethics applications per year.

The Health Research Authority (HRA) have produced a useful decision aid to help researchers decide whether or not their research study requires ethical approval from an NHS committee (‘Do I need NHS Ethics approval?’).

Do I need NHS Ethics approval?

http://www.hra-decisiontools.org.uk/

Explore the questions in the decision aid and familiarise yourself with the different options and outcomes.

To apply for ethical approval via the NHS, you will need to complete an application in IRAS. To do this you will need to request an IRAS account, which can be done from the landing page on the IRAS website: https://www.myresearchproject.org.uk/

After submission, your application will be assessed according to the risk the proposed research poses to members of the public (in terms of potential for harm). Research that carries low risk may be eligible for a proportionate review, which is usually quicker than a full review. For research that requires a full review, the researcher will likely need to attend a Research Ethics Committee panel discussion to respond directly to any ethical concerns raised by members of the committee.

Some types of research carry higher risks than others. For example, clinical trials of new medicinal products or interventions will usually carry greater risks (e.g. potential for adverse reactions to new treatments) compared to interview studies, where no change in treatment is involved. However, this is not always straightforward, as some interview studies may cover sensitive topics, such as mental health, which could be potentially distressing for participants to talk about.

How do Research Ethics Committees assess the ethics of a research project?

A committee will apply a set of ethical principles when reviewing an application. Ethical principles commonly include:

1. Respect for participants
2. Beneficence (to do social good) and non-maleficence (to do no harm)
3. Justice
4. Informed consent
5. Confidentiality and data protection
6. Integrity
7. Conflict of interest

You will notice that some of these principles overlap with principles listed in the UK Policy Framework for Health and Social Care Research.

After review, the Research Ethics Committee will notify the applicants of the outcome. This usually takes one of the following forms:

1. Favourable opinion
2. Favourable opinion with conditions (the committee stipulate certain conditions or caveats)
3. Provisional opinion (the committee may request further information before they can arrive at a final outcome)
4. Unfavourable opinion (applicants will need to resubmit their application due to a lack of clarity or significant ethical challenges).

The role of the Research Ethics Committee does not stop here. The researcher(s) will have certain reporting requirements to abide by. The Research Ethics Committee will need to be contacted if any amendments (i.e. changes) are needed to the original design or conduct of the study, if protocol breaches occur (i.e. the researchers behave in a way that was not originally described in the application), adverse events (i.e. something happens to the research participants as a consequence of taking part in the research), the research comes to an end.

The overarching role of research governance is to review and oversee the approval and delivery of research, ensuring it adheres to these principles.

The central principle of the NIHR Good Clinical Practice (a training requirement for anyone undertaking research in the NHS) is patient safety and high-quality data – the research ethics approval process provides a framework to review and oversee research projects to this end.

There are often many elements to consider when designing and planning your project and many regulations and legal frameworks which your research must adhere to. The ethics process will look at:

• whether the design of the protocol will produce the data required;
• whether the number, length and timing of any visits are appropriate and do not place undue burden on the participants;
• if the number of participants required will provide results of statistical significance;
• if the acquisition of and access to personal identifiable data (PID – including medical records) is appropriate and secure;
• if patients or participants have been consulted in the design and oversight of the study;
• and information about data security, insurance, oversight and which NHS sites are involved.

They will also closely review:

• if the language used in the participant information sheet and consent form is clear and adequately describes what will happen to the participant and their data;
• that the consent process is open and transparent;
• the process for withdrawing or complaining;
• and any recompense they will receive and how.

Do all research studies require ethical approval?

Not all health and social care research will need approval from an NHS Research Ethics Committee. You may be able to obtain suitable approvals from a University Research Ethics Committee, particularly if your research does not take place in NHS settings or with patients.

If you intend on including human subjects as your participants then it is likely you will need ethical approval. However, some types of research involving human subjects may not require REC approval at all. For example, a workforce survey study in which individually identifiable information is not shared may not need REC approval; though this largely depends on the nature of the survey topic (i.e. whether it includes questions about sensitive information).

As a general rule, it is advisable to liaise with your research and development office and/or sponsor during the design process as they will be able to inform decisions about approval requirements. You may use the decision aids to help guide these conversations.

Summary

The HRA website has a wealth of information, guidance and advice to help with the application and approval process. The IRAS website also offers online training and a step-by-step guide to support you to complete an application. Local NHS R&I offices, University Research Offices, Clinical Research Network and Early Engagement/Study Support teams are all available to help guide you through the processes you will need to obtain your approvals and beyond.

Links referred to in this article

Do I need NHS Ethics Review? http://www.hra-decisiontools.org.uk/ethics/

IRAS applications https://www.myresearchproject.org.uk/

CRN Study Support: https://www.nihr.ac.uk/explore-nihr/support/study-support-service.htm/