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Three decades of ethics review

Last updated on 30 Mar 2022

Ann Tunley, former Head of the Research Ethics Service and our current Head of Approvals Support, who retires this week, looks back on three decades in research ethics.

Ann Tunley...jpg

‘While there have been many changes to the way we do research ethics over the last 34 years, in some ways the purpose of an ethics committee and ethics hasn’t changed. It’s just the context. The way we do things is very different now. There are different frameworks, different principles, different legislation but ultimately, the essential aspects of ethical review remain the same. The emphasis is on protecting the rights, safety, dignity and wellbeing of research participants.

The research has moved on in terms of what can be done, the medicines that are available, and the technology, but the basis and the premise of the ethics committee remains the same.

Starting out

When I started my career in research ethics in January 1988 based at St James’s Hospital in Leeds, there were 200 Research Ethics Committees across the UK all based at individual institutions and all with different application forms. There were no computers, minutes would be written up on paper and then typed up. The volume of applications was greater but there tended to be lots of smaller research projects. Now applications tend to be on a more organised, multi-centre scale.

Previously if someone was running a national trial, they would have to go to a different ethics committee for each site where they wanted to run the study. Each ethics committee would undertake a separate ethical review for the same study. It was very different to the current integrated application process and single UK ethical opinion, now integrated with HRA Approval for research in the NHS and with the combined process with the MHRA.

The creation of a UK-wide system with a single ethical opinion made a huge difference to both the volume of applications and resources for researchers and ethics committees. It meant that ethics committees were not duplicating the work. It used to be very difficult for researchers with all the bureaucracy. It must have taken ages to get research up and running and the resources that must have been spent just completing all those application forms and sending them to the various committees.

The process is now considerably more streamlined.

Integrated working

While the ethical aspects are not all that different, the way RECs work has changed. It is an integrated process now. RECs work with an approvals specialist in the meeting. They are able to take assurance that things like indemnity and legal requirements have been looked at so that they can focus on the ethics.

The clinical trials legislation has been a big change and moving to a national database and national forms. Being a UK-wide service was a really big change and has helped us to develop much further as well as moving to a single employer with the HRA. It meant ethics staff could work together, collaborate and share knowledge and advice and improve processes further rather than sitting separately around the UK. It helped us to build consistency, share knowledge and good practice.

As well as the changes in technology another big change has been the timelines which certainly helped to speed up the start-up of research. The variation from area to area reduced and people know how to plan and when to expect to get an ethics opinion.

Public involvement

One of the biggest changes which has had a real impact on health and social care research is public involvement. When I first started my career researchers still referred to patients and public participants as ‘subjects’. Now public involvement plays an important role in health and social care research with public contributors helping to design studies and being encouraged to attend REC meetings.  

Key memories

One of the most significant parts of my career was co-ordinating research ethics committees to take on the urgent public health studies at the start of the COVID-19 pandemic. REC members joined ad hoc meetings around the country within 24 hours’ notice. The effects this work has had on had people’s lives has been amazing. It’s not just the clinical trials to develop the vaccines, but also the new treatments to help people with COVID. This research is now helping us to live with the virus. It was fantastic that we were able to act so quickly. The response was amazing from members and from staff. I was so proud of everyone.

The people

The thing I will miss most is the people. I’ve loved attending REC meetings because they were so interesting. I missed that part when I moved away from supporting the REC meetings myself and into senior management. People came from such varied backgrounds. They surprised each other with ideas and were able to bounce off each other and bring together a variety of views then factor that all into the applications. It is so important to have that mix of experts and lay people.

The next 10 years

In the future I’m sure we will continue to evolve and change. The opportunity to meet virtually has given rise to new opportunities to work in a different way. I hope it allows more people and people from more varied backgrounds to join as REC members.

But most of all I hope there will always be a need for research ethics. It is important to have independent ethical review to help ensure public trust in research. This hopefully means people will be willing to continue to take part in vital research.’

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