Covid-19: the ethics of clinical research in quarantineBMJ 2020; 369 doi: https://doi.org/10.1136/bmj.m2060 (Published 29 May 2020) Cite this as: BMJ 2020;369:m2060
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PPI during lockdown.
I serve on a Research Ethics Committee. The weakest part of many applications is the Patient and Public Involvement (PPI) section. Often the REC is the only “PPI” a study gets. RECs are now seeing 1 or 2 fast tracked COVID-19 applications each meeting. The PPI is weaker than ever – how can you access patients and public in a time of lockdown? In fact PPI is needed more than ever. A pandemic changes how a REC looks at research applications; for example, risk and benefit balances are different, individual and population needs have to be balanced. In this epidemic many seriously ill patients will lose capacity during the illness – losing their data will impact on the validity of the results of the research.
During lockdown I have been involved in a group building a modern negative pressure ventilator. A clinical trial was needed and I volunteered to organise the PPI for the patient facing literature and to explore the general public’s views on offering a new device to treat COVID-19 patients.
I decided to approach my U3A Book Group. We have been meeting for about 3y and are used to reading and then analysing and discussing. We often disagree. After lockdown we started to meet by Zoom. I emailed them asking if they would give me feedback on the trial. They were very happy to help. Although they were all female and over 60y, they have families and friends from whom they also gathered views.
I sent them the patient literature by email, asking them to phone me or email me with their comments about it. I then set up a Zoom meeting, and invited them to that. The purpose of the Zoom meeting was to discuss the ethical issues around taking consent from patients who were anxious and unwell, separated from their families, on oxygen, possibly about to lose capacity, being offered an unproven treatment, whether that treatment should be removed from them if the patient liked it, how relatives would react etc. In fact although I had a list of the issues I wanted opinions on, the group generated the opinions without any prompting from me.
With their permission I recorded the Zoom conference, and afterwards I worked through the recording to extract their opinions, and sent it to the doctors organising the clinical trial.
Their feedback has helped to improve the patient facing literature, strongly supported our plan for a short video clip, and gave us very useful insights into how patients and the public might view our research.
I think groups like this might be useful to other research groups – especially for research where there is no patient support group already in existence.
Dr Diane Ackerley
Competing interests: No competing interests