Journal Article

What features should an effective system for declaring and managing conflicts of interest in healthcare have? An adapted Delphi study of key stakeholders in the UK

Wilkes, Antony, Orr, Kevin, McCartney, Margaret, Metsis, Katrin, Sullivan, Frank, Millum, Joseph

2025

Overview

ObjectiveTo identify views and establish agreements of key stakeholders on the features of an effective system for declaring and managing conflicts of interest in healthcare.DesignA modified Delphi study consisting of two surveys and semi-structured interviews. Surveys included closed and free-text questions.Setting and participantsUK, purposefully and generally invited participants including academics, researchers, healthcare professionals, regulators, patients and citizens from 10 countries, during 25 August 2024 and 20 January 2025.Main outcome measuresQuantitative and qualitative analysis of two surveys and 21 interviews. Descriptive statistics were used to describe the sample and analyse closed survey questions. Thematic analysis was used to analyse free-text survey responses and interview data. Results were synthesised to describe the perceived importance and purposes of declaration of interest systems.ResultsIn the first survey round, 616 invitations were sent, along with social media advertisements. 237 questionnaires were returned and 200 full responses were analysable. 129 respondents consented to recontact on the online form. In the interview round, 37 invitations were sent and 21 interviews completed (response rate 59.5%). Invitations for the second survey were sent to all 129 participants who consented to recontact. 91 responses were received and 89 questionnaires were analysable (response rate 82%). Features of ideal systems to declare and manage the interests of healthcare professionals identified by participants were categorised under seven themes: regulatory issues, the healthcare environment, human vices, professional virtues, the use of judgement, features of a better system and patients and public. There was broad agreement on the need for transparency and clarity in declaration systems. The most agreed features were: clarity on what information was needed; it should be a centralised ‘deposit’ for all declarations; it should be publicly accessible, educating and informing people accessing and using the register. Having a lifelong personal identifier, some flexibility in declarations and some privacy features were also rated highly. Respondents were less concerned about scrutiny or a loss of trust. Small numbers of participants raised concerns about serious adverse effects, including loss of privacy, personal safety and the potential of information to contribute to conspiracy theories. There were also major disagreements between participants concerning whether or not healthcare professionals should work with industry, and whether conflicts of interest from working with industry can be safely managed. Individuals with each perspective felt they were acting ethically.ConclusionsWhile many agreements were identified, disagreements were also found. If improved declaration systems are to be accepted by professionals and useful to regulators, patients and citizens, the potential for benefit and harm from new declaration systems must be addressed.Registration detailsPrepublished, Open Science Framework https://osf.io/fbj5n.

• Publisher: British Medical Journal Publishing Group,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Change management / Conflict of Interest / Consent / Delivery of Health Care - ethics / Delphi method / Delphi Technique / Disclosure / ETHICS (see Medical Ethics) / Health Personnel / Health policy / Humans / Interviews / Medical device industry / Medical equipment / MEDICAL ETHICS / Medical personnel / Patients / Pharmaceutical industry / Professionals / Protocols & guidelines / Stakeholder Participation / Surgical mesh / Surveys and Questionnaires / United Kingdom