The importance of trust in clinical trial safety

Last updated on 1 May 2024

Clinical trials help test vital new treatments and medicines to see whether they are effective.

They are key to helping us improve care for illnesses and diseases that impact hundreds of thousands of people every year.

It is crucial that clinical trials are carried out ethically and safely so that people can be confident to take part and trust the findings.

UK Infected Blood Inquiry

The UK Infected Blood Inquiry is expected to be published next month.

The inquiry, first announced in 2017, is investigating the circumstances in which men, women and children treated by the NHS in the UK were given infected blood and infected blood products.

This includes the use of infected blood and infected blood products in clinical trials carried out in the 1970s and 1980s.

Concerns have been raised about whether these clinical trials were conducted ethically, including whether patients gave informed consent to take part.

The role of the Health Research Authority

Our role is to ensure that clinical trials carried out in the UK are safe, ethical and protect participants so that people who are invited to take part in a clinical trial can be confident to choose to do so.

We co-ordinate 64 Research Ethics Committees (REC) in England and work closely with those in Scotland, Northern Ireland and Wales to be consistent in the way that we work. These committees review all applications to do clinical trials in the UK, which cannot go ahead until they receive REC approval. NHS RECs were first formally established in the early 1990s.

The reviews carried out by our Research Ethics Committees ensure that the proposed research is ethical, that all the potential risks for participants are considered and that the information provided makes it clear what is involved in taking part so participants can make informed decisions about whether to take part – and give informed consent.

Our committees are made up of volunteers who come from many different walks of life. Some of them have previously been participants in clinical trials, some are health and care professionals. The one thing they all have in common is they ask the important questions that we would all want to see asked about research.

Is this research in the best interests of patients? Is it safe? What are the risks to participants?

Similarly, our Confidentiality Advisory Group (CAG) provides a safeguard around the use of confidential patient information for use in research.

Only once a study has received the appropriate approvals from the Health Research Authority and our partners can a clinical trial start recruiting participants.

Building trust in research

When it comes to taking part in research, we know that trust is key.

The findings of our recent survey carried out by YouGov made it clear that research being carried out transparently makes it more likely for people to take part in research.

Participants knowing what is involved in the research, how their data will be used, and being treated fairly are things that were all highlighted as being important.

Carrying out research in this way helps earn the trust of people thinking about taking part in research. It ensures that they have information that they can access and understand to make an informed decision about whether to take part, that they are treated well throughout the research and find out what happened as a result of their participation.

The response to the COVID-19 pandemic has shown us all how important clinical trials are and what difference they can make. The development of vaccines protected millions of lives.

The infected blood scandal risks undermining trust in clinical research. It is important that the HRA and the wider research community continues to earn and build trust so that people can be confident to take part in research and use its findings.

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