Ethics

I’ve heard people talk about ‘ethics’ a lot, what do they mean?

If people are talking about ‘ethics’ in the context of a clinical trial, they are usually referring to a process. This is usually one of two things:

  • a study protocol is submitted to the Research Ethics Committee
  • or a change to a study requires further permission from the Research Ethics Committee

Is this an important stage?

Absolutely. If a study that requires a ‘Favourable Opinion’ (approval) from a Research Ethics Committee and this is not done, the study must not go ahead.

For further information about whether your study requires a favourable opinion from an ethics committee, please click here.

What is a Research Ethics Committee and what does it do?

The NHS Health Research Authority (HRA) states that:

“The regulation of health research provides participants with assurance that the research that they take part in is of high quality, safe and ethical. It also ensures that the results of research can be relied on and used as evidence to inform future decisions about healthcare and treatment.

The UK has a range of bodies which have roles in regulating different aspects of health research in humans. The Health Research Authority provides Research Ethics Committees and the Confidentiality Advisory Group, which review applications to undertake certain types of research. We also work with other bodies to coordinate the overall system for regulation and governance of research.

Regulatory bodies have legal responsibilities to approve, licence or inspect particular research activities. In addition, research sites have responsibilities to manage research they host.”

Where can I get more information about what I need to do for my study?

Your first port of call should be the Research and Innovation team. You can also read about the ethics process on the HRA website.

The HRA website is a great source and details the “key stages in the research pathway”. To find out more, click here.

When can I apply for ethics?

You may only apply for ethics favourable opinion once your Sponsor has given you authorisation to do so.

Now I’ve got ethics, can I start my research?

No. Ethics is part of a process and an ethics favourable opinion is only valid where trust approval has been confirmed.

Is there anyone in Leicester’s Hospitals that I can talk to about this if I have any questions?

Certainly. Just complete the form below with your questions and a member of our team will get back to you.