1 Shearman K, et al. BMJ Open 2022;12:e055208. doi:10.1136/bmjopen-2021-055208 Open access Acceptability of donor funding for clinical trials in the UK: a qualitative empirical ethics study using focus groups to elicit the views of research patient public involvement group members, research ethics committee chairs and clinical researchers Kirstie Shearman , 1 Alexander Masters , 2 Dominic Nutt , 2 Simon Bowman , 3 Heather Draper 1 To cite: Shearman K, Masters A, Nutt D, et al. Acceptability of donor funding for clinical trials in the UK: a qualitative empirical ethics study using focus groups to elicit the views of research patient public involvement group members, research ethics committee chairs and clinical researchers. BMJ Open 2022;12:e055208. doi:10.1136/ bmjopen-2021-055208 ► Prepublication history and additional supplemental material for this paper are available online. To view these fles, please visit the journal online (http://dx.doi.org/10.1136/ bmjopen-2021-055208). Received 05 July 2021 Accepted 25 May 2022 For numbered affliations see end of article. Correspondence to Professor Heather Draper; h.draper@warwick.ac.uk Original research © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. ABSTRACT Objectives The Plutocratic Proposal is a novel method of funding early phase clinical trials where a single donor funds the entire trial and in so doing secures a place on it. The aim of this study was to identify and explore concerns that may be raised by UK research ethics committees (RECs) when reviewing clinical trials funded in this way. Design Empirical ethics combining ethical analysis and qualitative data from three focus groups held online using Frith’s symbiotic approach. Data were analysed using inductive thematic approach informed by the study aims and ethical analysis. Participants 22 participants were recruited: 8 research patient public involvement group members, 7 REC chairs and 7 clinical researchers. All were based in the UK. Results With one exception, participants thought the Plutocratic Proposal may be ‘all things considered’ acceptable, providing their concerns were met, primary of which was upholding scientifc integrity. Other concerns discussed related to the acceptability of the donor securing a place on the trial including: whether this was an unfair distribution of benefts, disclosing the identity of the donor as the funder, protecting the donor from exploitation and funding a single study with multiple donors on the same terms. Some misgivings fell outside the usual REC purview: detrimental impact of donors of bad character, establishing the trustworthiness of the matching agency and its processes and optimising research funding and resources. Despite their concerns, participants recognised that because the donor funds the whole trial, others would also potentially beneft from participating. Conclusions We identifed concerns about the Plutocratic Proposal. UK RECs may be open to approving studies if these can be addressed. Existing governance processes will do some of this work, but additional REC guidance, particularly in relation to donors securing a place on the trial, may be necessary to help RECs navigate ethical concerns consistently. INTRODUCTION Many promising clinical interventions do not progress to early clinical trials due to a lack of funding, and some that do may fail for commercial reasons. 1 2 The ‘valley of death’, in which promising therapies may flounder, is a persisting, multifaceted and international problem. 3 4 One solution to this funding shortfall in the initial stages of development proposed by two patient advo- cates, Masters and Nutt, 5 is that a single, very wealthy individual commits to funding an entire single-arm phase I or phase IIa clinical trial in exchange for the guarantee of a place on the trial. Importantly, this guarantee is subject to the inclusion and exclusion criteria being met at the point of recruitment. Their STRENGTHS AND LIMITATIONS OF THIS STUDY ⇒ The Plutocratic Proposal has received a cautiously favourable reception in the literature, but this is the frst study to explore whether studies funded using this model may be deemed acceptable by UK re- search ethics committees. ⇒ Empirical ethics, which combines philosophical analysis and empirically obtained insights, is a rec- ognised methodology for understanding and evalu- ating ethical issues that affect policy in healthcare services and research. ⇒ Focus groups are a useful qualitative tool for explor- ing potentially controversial topics, as they permit participants to engage with each other’s views but we cannot be confdent that we reached data satu- ration in this study. ⇒ Qualitative fndings are not generalisable beyond the study sample. on April 18, 2023 by guest. Protected by copyright. http://bmjopen.bmj.com/ BMJ Open: first published as 10.1136/bmjopen-2021-055208 on 17 June 2022. Downloaded from