Trusting relationships between patients with non-curative cancer and healthcare professionals create ethical obstacles for informed consent in clinical trials: a grounded theory study.

Mary Murphy, Eilis McCaughan, Gareth Thompson, Matthew Carson, Jeff Hanna, Monica Donovan, Richard Wilson, Donna Fitzsimons

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Clinical trial participation for patients with non-curative cancer is unlikely to present personal clinical benefit, which raises the bar for informed consent. Previous work demonstrates that decisions by patients in this setting are made within a ‘trusting relationship’ with healthcare professionals. The current study aimed to further illuminate the nuances of this relationship from both the patients’ and healthcare professionals’ perspectives.

Face-to-face interviews using a grounded theory approach were conducted at a regional Cancer Centre in the United Kingdom. Interviews were performed with 34 participants (patients with non-curative cancer, number (n) = 16; healthcare professionals involved in the consent process, n = 18). Data analysis was performed after each interview using open, selective, and theoretical coding.

The ‘Trusting relationship’ with healthcare professionals underpinned patient motivation to participate, with many patients ‘feeling lucky’ and articulating an unrealistic hope that a clinical trial could provide a cure. Patients adopted the attitude of ‘What the doctor thinks is best’ and placed significant trust in healthcare professionals, focusing on mainly positive aspects of the information provided. Healthcare professionals recognised that trial information was not received neutrally by patients, with some expressing concerns that patients would consent to ‘please’ them. This raises the question: Within the trusting relationship between patients and healthcare professionals, ‘Is it possible to provide balanced information?’. The theoretical model identified in this study is central to understanding how the trusting professional-patient relationship influences the decision-making process.

The significant trust placed on healthcare professionals by patients presented an obstacle to delivering balanced trial information, with patients sometimes participating to please the ‘experts’. In this high-stakes scenario, it may be pertinent to consider strategies, such as separation of the clinician-researcher roles and enabling patients to articulate their care priorities and preferences within the informed consent process. Further research is needed to expand on these ethical conundrums and ensure patient choice and autonomy in trial participation are prioritised, particularly when the patient’s life is limited.
Original languageEnglish
Article number85 (2023)
Pages (from-to)1-8
Number of pages8
JournalBMC Palliative Care
Issue number1
Early online date1 Jul 2023
Publication statusPublished online - 1 Jul 2023

Bibliographical note

Funding Information:
The authors disclosed receipt of the following financial support for the research, authorship, and publication of this article: this work was supported by the Research and Development Division of the Northern Ireland Health and Social Care Service. The funding body played no role in the design of the study; data collection, analysis, and interpretation; and in writing the manuscript.

Publisher Copyright:
© 2023, The Author(s).


  • Clinical trial participation
  • Patients with non-curative cancer
  • Healthcare professionals
  • Decision-making
  • Consent process
  • Qualitative study
  • Grounded theory
  • Interviews


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