In biomedical research lack of trust is seen as a great threat that can severely jeopardise the whole biomedical research enterprise. Practices, such as informed consent, and also the administrative and regulatory oversight of research in the form of research ethics committees and Institutional Review Boards, are established to ensure the protection of future research subjects and, at the same time, restore public trust in biomedical research. Empirical research also testifies to the role of trust as one of the decisive (...) factors in research participation and lack of trust as a barrier for consenting to research. However, what is often missing is a clear definition of trust. This paper seeks to address this gap. It starts with a conceptual analysis of the term trust. It compares trust with two other related terms, those of reliance and trustworthiness, and offers a defence of Baier’s attribute of ‘good will’ a basic characteristic of trust. It, then, proceeds to consider trust in the context of biomedical research by examining two questions: First, is trust necessary in biomedical research?; and second, do increases in regulatory oversight of biomedical research also increase trust in the field? This paper argues that regulatory oversight is important for increasing reliance in biomedical research, but it does not improve trust, which remains important for biomedical research. It finishes by pointing at professional integrity as a way of promoting trust and trustworthiness in this field. (shrink)

Background In the UK, the solidaristic character of the NHS makes it one of the most trusted public institutions. In recent years, the introduction of data-driven technologies in healthcare has opened up the space for collaborations with private digital companies seeking access to patient data. However, these collaborations appear to challenge the public’s trust in the. Main text In this paper we explore how the opening of the healthcare sector to private digital companies challenges the existing social contract and the (...) NHS’s solidaristic character, and impacts on public trust. We start by critically discussing different examples of partnerships between the NHS and private companies that collect and use data. We then analyse the relationship between trust and solidarity, and investigate how this relationship changes in the context of digital companies entering the healthcare system. Finally, we show ways for the NHS to maintain public trust by putting in place a solidarity grounded partnership model with companies seeking to access patient data. Such a model would need to serve collective interests through, for example, securing preferential access to goods and services, providing health benefits, and monitoring data access. Conclusion A solidarity grounded partnership model will help establish a social contract or licence that responds to the public’s expectations and to principles of a solidaristic healthcare system. (shrink)

Artificial intelligence is changing healthcare and the practice of medicine as data-driven science and machine-learning technologies, in particular, are contributing to a variety of medical and clinical tasks. Such advancements have also raised many questions, especially about public trust. As a response to these concerns there has been a concentrated effort from public bodies, policy-makers and technology companies leading the way in AI to address what is identified as a "public trust deficit". This paper argues that a focus on trust (...) as the basis upon which a relationship between this new technology and the public is built is, at best, ineffective, at worst, inappropriate or even dangerous, as it diverts attention from what is actually needed to actively warrant trust. Instead of agonising about how to facilitate trust, a type of relationship which can leave those trusting vulnerable and exposed, we argue that efforts should be focused on the difficult and dynamic process of ensuring reliance underwritten by strong legal and regulatory frameworks. From there, trust could emerge but not merely as a means to an end. Instead, as something to work in practice towards; that is, the deserved result of an ongoing ethical relationship where there is the appropriate, enforceable and reliable regulatory infrastructure in place for problems, challenges and power asymmetries to be continuously accounted for and appropriately redressed. Data sharing not applicable as no datasets generated and/or analysed for this study. (shrink)

BackgroundThe academic and medical literature highlights the positive effects of empathy for patient care. Yet, very little attention has been given to the impact of the requirement for empathy on the physicians themselves and on their emotional wellbeing.DiscussionThe medical profession requires doctors to be both clinically competent and empathetic towards the patients. In practice, accommodating both requirements can be difficult for physicians. The image of the technically skilful, rational, and emotionally detached doctor dominates the profession, and inhibits physicians from engaging (...) emotionally with their patients and their own feelings, which forms the basis for empathy. This inhibition has a negative impact not only on the patients but also on the physicians. The expression of emotions in medical practice is perceived as unprofessional and many doctors learn to supress and ignore their feelings. When facing stressful situations, these physicians are more likely to suffer from depression and burnout than those who engage with and reflect on their feelings. Physicians should be supported in their emotional work, which will help them develop empathy. Methods could include questionnaires that aid self-reflection, and discussion groups with peers and supervisors on emotional experiences. Yet, in order for these methods to work, the negative image associated with the expression of emotions should be questioned. Also, the work conditions of physicians should improve to allow them to make use of these tools.SummaryEmpathy should not only be expected from doctors but should be actively promoted, assisted and cultivated in the medical profession. (shrink)

Collaborations in global health research are on the rise because they enhance productivity, facilitate capacity building, accelerate output and make tackling big, multifactorial research questions possible. In this paper, I examine the concepts of trust and reliance in scientific collaborations in general, but also in the particular context of collaborations in global health research between high‐income countries and low‐and‐middle income countries (LMIC). I propose and defend the argument that given the particular characteristics of collaborations and demands of trust relationships, reliance (...) is a better relational mode for successful collaborations. Although reliance can be difficult to establish in situations where asymmetry of power exists, trust should not be the only relational mode available to LMIC researchers because of the type of vulnerability it introduces to the relationship. I conclude that the promotion of good collaborations requires addressing the power imbalances between partners, and establishing an even playing field in global health research. (shrink)

In their proof-of-concept study, Meier et al. built an algorithm to aid ethical decision making. In the limitations section of their paper, the authors state a frequently cited ax...

Medicine is not merely a job that requires technical expertise, but a profession concerned with making the best decisions and recommendations with reference to, and in consultation with, the patient. This means that the skill set required for healthcare professionals in order to provide good care is a combination of scientific knowledge, technical aptitude, and affective qualities or virtues such as compassion and empathy.

An increasing number of European research projects return, or plan to return, individual genomic research results (IRR) to participants. While data access is a data subject’s right under the General Data Protection Regulation (GDPR), and many legal and ethical guidelines allow or require participants to receive personal data generated in research, the practice of returning results is not straightforward and raises several practical and ethical issues. Existing guidelines focusing on return of IRR are mostly project-specific, only discuss which results to (...) return, or were developed outside Europe. To address this gap, we analysed existing normative documents identified online using inductive content analysis. We used this analysis to develop a checklist of steps to assist European researchers considering whether to return IRR to participants. We then sought feedback on the checklist from an interdisciplinary panel of European experts (clinicians, clinical researchers, population-based researchers, biobank managers, ethicists, lawyers and policy makers) to refine the checklist. The checklist outlines seven major components researchers should consider when determining whether, and how, to return results to adult research participants: 1) Decide which results to return; 2) Develop a plan for return of results; 3) Obtain participant informed consent; 4) Collect and analyse data; 5) Confirm results; 6) Disclose research results; 7) Follow-up and monitor. Our checklist provides a clear outline of the steps European researchers can follow to develop ethical and sustainable result return pathways within their own research projects. Further legal analysis is required to ensure this checklist complies with relevant domestic laws. (shrink)

The academic and medical literature highlights the positive effects of empathy for patient care. Yet, very little attention has been given to the impact of the requirement for empathy on the physicians themsel..

Biomedical research is an increasingly multidisciplinary activity bringing together a range of different academic fields and forms of expertise to investigate diseases that are increasingly understood to be complex and multifactorial. Recently the discipline of ethics has been starting to find a place in large-scale biomedical collaborations. In this article we draw from our experience of working with the Malaria Genomic Epidemiology Network and other research projects to reflect upon the integration of ethics into biomedical research. We examine the way (...) in which ethics input may be valuable to research, the forms it tends to take, and also the problems and limitations of such collaborations. (shrink)

Returning research results to participants is recognised as an obligation that researchers should always try to fulfil. But can we ascribe the same obligation to researchers who conduct genomics research producing only aggregated findings? And what about genomics research conducted in developing countries? This paper considers Beskow's et al. argument that aggregated findings should also be returned to research participants. This recommendation is examined in the context of genomics research conducted in developing countries. The risks and benefits of attempting such (...) an exercise are identified, and suggestions on ways to avoid some of the challenges are proposed. I argue that disseminating the findings of genomic research to participating communities should be seen as sharing knowledge rather than returning results. Calling the dissemination of aggregate, population level information returning results can be confusing and misleading as participants might expect to receive individual level information. Talking about sharing knowledge is a more appropriate way of expressing and communicating the outcome of population genomic research. Considering the knowledge produced by genomics research a worthwhile output that should be shared with the participants and approaching the exercise as a ‘sharing of knowledge’, could help mitigate the risks of unrealistic expectations and misunderstanding of findings, whilst promoting trusting and long lasting relationships with the participating communities. (shrink)

Char et al. describe an interesting and useful approach in their paper, “Identifying ethical considerations for machine learning healthcare applications.” Their proposed framework, which see...

BackgroundDespite the recognition that developing artificial intelligence (AI) that is trustworthy is necessary for public acceptability and the successful implementation of AI in healthcare contexts, perspectives from key stakeholders are often absent from discourse on the ethical design, development, and deployment of AI. This study explores the perspectives of birth parents and mothers on the introduction of AI-based cardiotocography (CTG) in the context of intrapartum care, focusing on issues pertaining to trust and trustworthiness.MethodsSeventeen semi-structured interviews were conducted with birth parents (...) and mothers based on a speculative case study. Interviewees were based in England and were pregnant and/or had given birth in the last two years. Thematic analysis was used to analyze transcribed interviews with the use of NVivo. Major recurring themes acted as the basis for identifying the values most important to this population group for evaluating the trustworthiness of AI.ResultsThree themes pertaining to the perceived trustworthiness of AI emerged from interviews: (1) trustworthy AI-developing institutions, (2) trustworthy data from which AI is built, and (3) trustworthy decisions made with the assistance of AI. We found that birth parents and mothers trusted public institutions over private companies to develop AI, that they evaluated the trustworthiness of data by how representative it is of all population groups, and that they perceived trustworthy decisions as being mediated by humans even when supported by AI.ConclusionsThe ethical values that underscore birth parents and mothers’ perceptions of trustworthy AI include fairness and reliability, as well as practices like patient-centered care, the promotion of publicly funded healthcare, holistic care, and personalized medicine. Ultimately, these are also the ethical values that people want to protect in the healthcare system. Therefore, trustworthy AI is best understood not as a list of design features but in relation to how it undermines or promotes the ethical values that matter most to its end users. An ethical commitment to these values when creating AI in healthcare contexts opens up new challenges and possibilities for the design and deployment of AI. (shrink)

BackgroundResearch proactively and deliberately aims to bring about specific changes to how societies function and individual lives fare. However, in the ever-expanding field of ethical regulations and guidance for researchers, one ethical consideration seems to have passed under the radar: How should researchers act when pursuing actual, societal changes based on their academic work?Main textWhen researchers engage in the process of bringing about societal impact to tackle local or global challenges important concerns arise: cultural, social and political values and institutions (...) can be put at risk, transformed or even hampered if researchers lack awareness of how their ‘acting to impact’ influences the social world. With today’s strong focus on research impacts, addressing such ethical challenges has become urgent within in all fields of research involved in finding solutions to the challenges societies are facing. Due to the overall goal of doing something good that is often inherent in ethical approaches, boundaries to researchers’ impact of something good is neither obvious, nor easy to detect. We suggest that it is time for the field of bioethics to explore normative boundaries for researchers’ pursuit of impact and to consider, in detail, the ethical obligations that ought to shape this process, and we provide a four-step framework of fair conditions for such an approach. Our suggested approach within this field can be useful for other fields of research as well.ConclusionWith this paper, we draw attention to how the transition from pursuing impact within the Academy to trying to initiate and achieve impact beyond the Academy ought to be configured, and the ethical challenges inherent in this transition. We suggest a stepwise strategy to identify, discuss and constitute consensus-based boundaries to this academic activity. This strategy calls for efforts from a multi-disciplinary team of researchers, advisors from the humanities and social sciences, as well as discussants from funding institutions, ethical committees, politics and the society in general. Such efforts should be able to offer new and useful assistance to researchers, as well as research funding agencies, in choosing ethically acceptable, impact-pursuing projects. (shrink)

Efficiency is an important value for all publicly funded healthcare systems. Limited resources need to be used prudently and wisely in order to ensure best possible outcomes and waste avoidance. Since 2010, the drive for efficiency, in the UK, has acquired a new impetus, as the country embarked on an ‘age of austerity’ purportedly to balance its books and reduce national deficit. Although the NHS did not suffer any direct budget cuts, the austerity policies imposed on the welfare system, including (...) social and mental healthcare, have had a direct and detrimental impact on the healthcare service. This paper draws from a qualitative study conducted in three A&E Departments in England to explore the effects of austerity policies on the everyday experiences of doctors and nurses working in Emergency Departments. It discusses the operationalisation of efficiency in A&E, in a climate of austerity, and its effects on the experiences and practices of healthcare professionals. It uses the empirical data as a springboard to highlight the role of structures and regulations, in this case targets and protocols, in how core healthcare ethical values, such as empathy, are exercised in practice. It provides an analysis of the normative role structures and regulations can play on the perception and practice of professional duties and obligations in healthcare. (shrink)

BackgroundAs the use of AI becomes more pervasive, and computerised systems are used in clinical decision-making, the role of trust in, and the trustworthiness of, AI tools will need to be addressed. Using the case of computational phenotyping to support the diagnosis of rare disease in dysmorphology, this paper explores under what conditions we could place trust in medical AI tools, which employ machine learning.MethodsSemi-structured qualitative interviews with stakeholders who design and/or work with computational phenotyping systems. The method of constant (...) comparison was used to analyse the interview data.ResultsInterviewees emphasized the importance of establishing trust in the use of CP technology in identifying rare diseases. Trust was formulated in two interrelated ways in these data. First, interviewees talked about the importance of using CP tools within the context of a trust relationship; arguing that patients will need to trust clinicians who use AI tools and that clinicians will need to trust AI developers, if they are to adopt this technology. Second, they described a need to establish trust in the technology itself, or in the knowledge it provides—epistemic trust. Interviewees suggested CP tools used for the diagnosis of rare diseases might be perceived as more trustworthy if the user is able to vouchsafe for the technology’s reliability and accuracy and the person using/developing them is trusted.ConclusionThis study suggests we need to take deliberate and meticulous steps to design reliable or confidence-worthy AI systems for use in healthcare. In addition, we need to devise reliable or confidence-worthy processes that would give rise to reliable systems; these could take the form of RCTs and/or systems of accountability transparency and responsibility that would signify the epistemic trustworthiness of these tools. words 294. (shrink)

It is widely acknowledged that trust plays an important role for the acceptability of data sharing practices in research and healthcare, and for the adoption of new health technologies such as AI. Yet there is reported distrust in this domain. Although in the UK, the NHS is one of the most trusted public institutions, public trust does not appear to accompany its data sharing practices for research and innovation, specifically with the private sector, that have been introduced in recent years. (...) In this paper, we examine the question of, what is it about sharing NHS data for research and innovation with for-profit companies that challenges public trust? To address this question, we draw from political theory to provide an account of public trust that helps better understand the relationship between the public and the NHS within a democratic context, as well as, the kind of obligations and expectations that govern this relationship. Then we examine whether the way in which the NHS is managing patient data and its collaboration with the private sector fit under this trust-based relationship. We argue that the datafication of healthcare and the broader ‘health and wealth’ agenda adopted by consecutive UK governments represent a major shift in the institutional character of the NHS, which brings into question the meaning of public good the NHS is expected to provide, challenging public trust. We conclude by suggesting that to address the problem of public trust, a theoretical and empirical examination of the benefits but also the costs associated with this shift needs to take place, as well as an open conversation at public level to determine what values should be promoted by a public institution like the NHS. (shrink)

A rapidly growing proportion of health research uses ‘secondary data’: data used for purposes other than those for which it was originally collected. Do researchers using secondary data have an obligation to disclose individual research findings to participants? While the importance of this question has been duly recognised in the context of primary research, it remains largely unexamined in the context of research using secondary data. In this paper, we critically examine the arguments for a moral obligation to disclose individual (...) research findings in the context of primary research, to determine if they can be applied to secondary research. We conclude that they cannot. We then propose that the nature of the relationship between researchers and participants is what gives rise to particular moral obligations, including the obligation to disclose individual results. We argue that the relationship between researchers and participants in secondary research does not generate an obligation to disclose. However, we also argue that the biobanks or data archives which collect and provide access to secondary data may have such an obligation, depending on the nature of the relationship they establish with participants. (shrink)

The role of ethics committees is to protect and safeguard the rights and welfare of participants, and promote good research by providing ethical guidance to researchers. In order for ethics committees to fulfil their role and obligations, they need to have adequate understanding of the science and scientific methods used in research. Genomics is a novel and rapidly evolving research field, and identifying the ethical issues raised by it is not straightforward. Limited understanding of, and expertise in, reviewing genomic research (...) may lead ethics committees to either hamper novel research, or overlook important ethical problems. Researchers are in the best position to assist ethics committees in their efforts to remain informed about scientific advancements. (shrink)