On International Clinical Trials Day (20 May) Research Ethics Committee (REC) Chair Andy Hall talks about how RECs have adapted their ways of working to support research during the COVID-19 pandemic.
The UK reported its first case of COVID-19 in late January. Since that time, the lives of millions of people have been changed in ways which would have seemed incredible only six months ago. From the very beginning research was recognised as being central to containing, treating, and ultimately eliminating this terrible disease. Throughout the UK, research groups in many medical disciplines redirected their efforts towards these aims and applications for new studies or amendments to existing studies began to be submitted to the HRA for ethical review.
The quality of research included in this national effort has been hugely impressive and in addition to clinical trials of re-purposed drugs has covered subjects as diverse as the effects of viral infection on the cardiovascular system and clotting, the consequences of neonatal infection and the mental health consequences for staff dealing with large numbers of seriously ill patients. Ethical challenges have included the need to undertake research in emergency settings where it may be difficult to obtain consent or to obtain the advice from relatives to act as consultees. As always committees reviewing COVID-19 studies have benefited greatly from the insights of all members, including expert members whose clinical background can help to provide vital background information and the lived experience of treating patients with a serious illness.
By the middle of May 118 COVID-19 studies and 160 COVID-19 amendments have been processed, with turn-around times measured in days rather than weeks. The fact that this has been achieved at the same time as a wholesale change to remote working reflects the versatility, pragmatism and dedication of both the volunteers who sit on ethics committees and the staff of the HRA.
The highs and lows of remote working have been well documented in social media and the papers. We have had to learn a new etiquette for discussion and be prepared to allow our colleagues to peek inside our houses. Between 17 March and 15 May, there have been 157 virtual REC meetings - assessing the usual range of non-COVID-19 studies as well as those directly related to the pandemic. Inevitably, we have all begun to wonder if these remote meetings are the ’new normal’ for Research Ethics Committees - an idea which excites some and fills others with dread.
Chairing virtual ethics committee meetings has posed some new challenges - particularly if internet connections prove to be troublesome. On the plus side, meeting virtually prevents the need for travel - this can be a big advantage for applicants who for a traditional face to face meeting held in person may have spent several hours getting to the venue, especially for clinicians with only limited time to set aside for attending meetings. One the other hand, several committee members have mentioned that they miss the social contact of an in-person meeting - this is not merely a pleasant luxury - these conversations help to build trust and understanding in the group such that they work as an effective team.
‘Right touch’ regulation involves striking a balance between protecting participants and facilitating research. Preventing research without good reason is itself unethical and in a public health emergency such as the current pandemic delaying research to insist on minor improvements may delay the discovery of improvements in prevention, diagnosis, or treatment. Under these circumstances it is particularly important that the perfect does not become the enemy of the good. However, it is vital that our assessments continue to be robust and that we do not drop the high standards expected by the general public. For example, we must continue to ensure that potential participants are given sufficient information in a form which they can understand in order to decide whether to consent to take part. Studies need to be described in sufficient detail for committees to assess their validity and any additional burdens involved should be fully justified. By observing these principles, I am sure that committees are continuing to do their best to support research at a time when it is urgently needed, whilst protecting the participants they represent.
Being part of an NHS Research Ethics committee can be hard work, but it is extremely rewarding. You have the chance to learn about new areas of research, meet talented researchers at the forefront of their disciplines and discuss complex issues with people from a variety of backgrounds. The HRA is always looking to recruit new members, so if you are interested in taking part they will be very pleased to hear from you. You can find out more about becoming a REC member on the HRA website.
Emeritus Professor at Newcastle University
Chair of Newcastle and North Tyneside 2 Research Ethics Committee