Without trust there is no credible human health research (HHR). This article accepts this truism and addresses a crucial question that arises: how can trust continually be promoted in an ever-changing and uncertain HHR environment? The article analyses long-standing mechanisms that are designed to elicit trust—such as consent, anonymization, and transparency—and argues that these are best understood as trust represented by proxies of trustworthiness, i.e., regulatory attempts to convey the trustworthiness of the HHR system and/or its actors. Often, such proxies (...) are assumed to operate as markers that trust exists or, at least, has not been lost. But, since trust can neither be “built” nor “secured,” this is a precarious assumption. Worryingly, there is no existing theoretical account of how to understand and evaluate these proxies of trustworthiness as part of a trusted HHR ecosystem. To remedy this, the paper argues for a radical reimagining of trust and trustworthiness as performative acts that ought to be understood in relation to each other and by reference to the common values at stake. It is shown that proxies of trustworthiness are the operational tools used to perform trustworthiness. It advocates for a values-based approach to understanding the relationship between trust and trustworthiness. This establishes a strong basis for an evaluative framework for proxies of trustworthiness, i.e., to determine how to perform trustworthiness well. Five common proxies in HHR are scrutinized from a values perspective. The contribution is to provide a far-reaching normative and practical framework by which existing and future proxies of trustworthiness can be identified, assessed, maintained, or replaced in rapidly changing HHR regulatory ecosystems where trust itself is crucial to the success of the entire HHR enterprise. (shrink)

BackgroundThe informed consent process in clinical trials has been extensively studied to inform the development processes which protect research participants and encourage their autonomy. However, ensuring a meaningful informed consent process is still of great concern in many research settings due to its complexity in practice and interwined socio-cultural factors.ObjectivesThis study explored the practices and meaning of the informed consent process in two clinial trials conducted by Oxford University Clinical Research Unit in collaboration with the Hospital for Tropical Diseases in (...) Ho Chi Minh City, Vietnam.MethodsWe used multiple data collection methods including direct observervations, in-depth interviews with study physicians and trial participants, review of informed consent documents from 2009 to 2018, and participant observation with patients’ family members. We recruited seven physicians and twenty-five trial participants into the study, of whom five physicians and thirteen trial participants completed in-depth interviews, and we held twenty-two direct observation sessions.ResultsWe use the concept “fragmented understanding” to describe the nuances of understanding about the consent process and unpack underlying reasons for differing understandings.ConclusionsOur findings show how practices of informed consent and different understanding of the trial information are shaped by trial participants’ characteristics and the socio-cultural context in which the trials take place. (shrink)

The development of novel neurotechnologies, such as brain-computer interface (BCI) and deep-brain stimulation (DBS), are very promising in improving the welfare and life prospects many people. These include life-changing therapies for medical conditions and enhancements of cognitive, emotional, and moral capacities. Yet there are also numerous moral risks and uncertainties involved in developing novel neurotechnologies. For this reason, the progress of novel neurotechnology research requires that diverse publics place trust in researchers to develop neural interfaces in ways that are overall (...) beneficial to society and responsive to ethical values and concerns. In this article, we argue that researchers and research institutions have a moral responsibility to foster and demonstrate trustworthiness with respect to broader publics whose lives will be affected by their research. Using Annette Baier’s conceptual analysis of trust, which takes competence and good will to be its central components, we propose that practices of ethical reflexivity could play a valuable role in fostering the trustworthiness of individual researchers and research institutions through building and exhibiting their moral competence and good will. By ethical reflexivity, we mean the reflective and discursive activity of articulating, analyzing, and assessing the assumptions and values that might be underlying their ethical actions and projects. Here, we share an ethics dialog tool—called the Scientific Perspectives and Ethics Commitments Survey (or SPECS)—developed by the University of Washington’s Center of Neurotechnology (CNT) Neuroethics Thrust. Ultimately, the aim is to show the promise of ethical reflexivity practices, like SPECS, as a method of enhancing trustworthiness in researchers and their institutions that seek to develop novel neurotechnologies for the overall benefit of society. (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)

The development of the CRISPR/Cas9 gene editing system has generated new possibilities for the use of gene drive constructs to reduce or suppress mosquito populations to levels that do not support disease transmission. Despite this prospect, social resistance to genetically modified organisms remains high. Gene drive open field research thus raises important questions regarding what is owed to those who may not consent to such research, or those could be affected by the proposed research, but whose consent is not solicited. (...) The precise circumstances under which informed consent must be obtained, and from whom, requires careful consideration. Furthermore, appropriate engagement processes should be central to any introduction of genetically modified mosquitos in proposed target settings. In this work, international guidance documents on informed consent and engagement are reviewed and applied to the genetically modified mosquito research context. Five analogous research endeavours that involve area-wide / open field experiments are reviewed. The approach of each in respect to the solicitation of individual informed consent and community engagement are highlighted. While the solicitation of individual informed consent in host settings of gene drive field trials may not be possible or feasible in some instances, local community and stakeholder engagement will be key to building trust towards the proposed conduct of such research. In this regard, the approaches taken by investigators and sponsors of political science field research and weather modification field research should be avoided. Rather, proponents of gene drive field research should look to the Eliminate Dengue field trials, cluster randomised trials, and pragmatic clinical trials for guidance regarding how the solicitation of individual informed consent of host communities ought to be managed, and how these communities ought to be engaged. (shrink)

The development of the CRISPR/Cas9 gene editing system has generated new possibilities for the use of gene drive constructs to reduce or suppress mosquito populations to levels that do not support disease transmission. Despite this prospect, social resistance to genetically modified organisms remains high. Gene drive open field research thus raises important questions regarding what is owed to those who may not consent to such research, or those could be affected by the proposed research, but whose consent is not solicited. (...) The precise circumstances under which informed consent must be obtained, and from whom, requires careful consideration. Furthermore, appropriate engagement processes should be central to any introduction of genetically modified mosquitos in proposed target settings. In this work, international guidance documents on informed consent and engagement are reviewed and applied to the genetically modified mosquito research context. Five analogous research endeavours that involve area-wide / open field experiments are reviewed. The approach of each in respect to the solicitation of individual informed consent and community engagement are highlighted. While the solicitation of individual informed consent in host settings of gene drive field trials may not be possible or feasible in some instances, local community and stakeholder engagement will be key to building trust towards the proposed conduct of such research. In this regard, the approaches taken by investigators and sponsors of political science field research and weather modification field research should be avoided. Rather, proponents of gene drive field research should look to the Eliminate Dengue field trials, cluster randomised trials, and pragmatic clinical trials for guidance regarding how the solicitation of individual informed consent of host communities ought to be managed, and how these communities ought to be engaged. (shrink)

When it comes to using patient data from the National Health Service for research, we are often told that it is a matter of trust: we need to trust, we need to build trust, we need to restore trust. Various policy papers and reports articulate and develop these ideas and make very important contributions to public dialogue on the trustworthiness of our research institutions. But these documents and policies are apparently constructed with little sustained reflection on the nature of trust (...) and trustworthiness, and therefore are missing important features that matter for how we manage concerns related to trust. We suggest that what we mean by ‘trust’ and ‘trustworthiness’ matters and should affect the policies and guidance that govern data sharing in the NHS. We offer a number of initial, general reflections on the way in which some of these features might affect our approach to principles, policies and strategies that are related to sharing patient data for research. This paper is the outcome of a ‘public ethics’ coproduction activity which involved members of the public and two academic ethicists. Our task was to consider collectively the accounts of trust developed by philosophers as they applied in the context of the NHS and to coproduce an argumentative position relevant to this context. (shrink)

Research involving adults who lack capacity to consent relies on proxy (or surrogate) decision making. Proxy decisions about participation are ethically complex, with a disparity between normative accounts and empirical evidence. Concerns about the accuracy of proxies’ decisions arise, in part, from the lack of an ethical framework which takes account of the complex and morally pluralistic world in which proxy decisions are situated. This qualitative study explored the experiences of family members who have acted as a research proxy in (...) order to develop an understanding of the ethical concepts involved, and the interactions between those concepts. Proxies described a complex process of respecting the wishes and preferences of the person they represented, whist integrating preferences with what they viewed as being in the interests of the person. They aimed to make a decision that was ‘best’ for the person and protected them from harm; they also aimed to make the ‘right’ decision, viewed as being authentic to the person’s values and life. Decisions were underpinned by the relationship between the person and their proxy, in which both trust and trustworthiness were key. Proxies’ decisions, based both on respect for the person and the need to protect their interests, arose out of their dual role as both proxy and carer. The findings raise questions about accounts which rely on existing normative assumptions with a focus on accuracy and discrepancy, and which fail to take account of the requirement for proxies to make authentic decisions that arise out of their caring obligations. (shrink)

In April 2020, close to the start of the first U.K. COVID-19 lockdown, the U.K. government announced the development of a COVID-19 contact tracing app, which was later trialled on the U.K. island, the Isle of Wight, in May/June 2020. United Kingdom surveys found general support for the development of such an app, which seemed strongly influenced by public trust. Institutions developing the app were called upon to fulfil the commitment to public trust by acting with trustworthiness. Such calls presuppose (...) that public trust associated with the app can emerge if the conditions for trustworthiness are met and that public trust is simplistic, i.e., linearly the sum of each member of the publics’ individual – U.K. government trust relationship. Drawing on a synthesis of the trust literature and fifteen interviews with members of the public trialling the app on the Isle of Wight, this paper aims to explore what trust mechanisms and relationships are at play when thinking about public trust in the context of the U.K. COVID-19 app. We argue that public trust is a complex social phenomenon and not linearly correlated with institutional trustworthiness. As such, attention needs to widen from calls for trustworthy infrastructures as a way to build public trust, to a deeper understanding of those doing the trusting; in particular, what or whom do people place their trust in when considering whether using the app and why. An understanding of this will help when trying to secure public trust during the implementation of necessary public health measures. (shrink)

Members of research ethics committees (RECs) face a number of ethical challenges when reviewing genomic research. These include issues regarding the content and type of consent, the return of individual research results, mechanisms of sharing specimens and health data, and appropriate community engagement efforts. This article presents the findings from a survey that sought to investigate the opinions and attitudes of REC members from four Arab countries in the Middle East and North Africa (Egypt, Morocco, Sudan, and Jordan) toward these (...) ethical issues. Our findings suggest that efforts are required to better familiarize REC members with the requirements for ethical biobank research. Additionally, we recommend that further research is undertaken with REC members regarding the main items that should be present in the Material Transfer Agreements /Data Transfer Agreements in their corresponding countries and the type of consent that should be used in genomic research. (shrink)

With the growth of precision medicine research on health data and biospecimens, research institutions will need to build and maintain long-term, trusting relationships with patient-participants. While trust is important for all research relationships, the longitudinal nature of precision medicine research raises particular challenges for facilitating trust when the specifics of future studies are unknown. Based on focus groups with racially and ethnically diverse patients, we describe several factors that influence patient trust and potential institutional approaches to building trustworthiness. Drawing on (...) these findings, we suggest several considerations for research institutions seeking to cultivate long-term, trusting relationships with patients: Address the role of history and experience on trust, engage concerns about potential group harm, address cultural values and communication barriers, and integrate patient values and expectations into oversight and governance structures. (shrink)

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)

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)

BackgroundIt has been argued that ethics review committees—e.g., Research Ethics Committees, Institutional Review Boards, etc.— have weaknesses in reviewing big data and artificial intelligence research. For instance, they may, due to the novelty of the area, lack the relevant expertise for judging collective risks and benefits of such research, or they may exempt it from review in instances involving de-identified data.Main bodyFocusing on the example of medical research databases we highlight here ethical issues around de-identified data sharing which motivate the (...) need for review where oversight by ethics committees is weak. Though some argue for ethics committee reform to overcome these weaknesses, it is unclear whether or when that will happen. Hence, we argue that ethical review can be done by data access committees, since they have de facto purview of big data and artificial intelligence projects, relevant technical expertise and governance knowledge, and already take on some functions of ethical review. That said, like ethics committees, they may have functional weaknesses in their review capabilities. To strengthen that function, data access committees must think clearly about the kinds of ethical expertise, both professional and lay, that they draw upon to support their work.ConclusionData access committees can undertake ethical review of medical research databases provided they enhance that review function through professional and lay ethical expertise. (shrink)

As donor trust legitimises research, trust is vital for research in the fields of biomedicine, genetics, translational medicine and personalised medicine. For parts of the donor community, the consent signature is a sign of trust in research. Many consent processes in biomedical research ask donors to provide their data for an unspecified future use, which introduces uncertainty of the unknown. This uncertainty can jeopardise donor trust or demand blind trust. But which donor wants to trust blindly? To reduce this uncertainty, (...) we explore first, which future-proof actors donors could trust when signing a consent form. Second, we discuss the question Can we know if donor trust expires? and what prevents donor trust from expiring. Finally, we present possible measures that can help to nurture trust in the far future. In this article, we draw on our previous research on trust in biomedical research, on trust in the broader healthcare system and Niklas Luhmann’s and Anthony Giddens’ trust theories. Our findings suggest that, in the far future, researchers will need to consider donor autonomy, as well as societal norms and values of the time period in which the data were donated. They will need to find mechanisms where possible to publicly announce the use of old data sets. However, foremost researchers will need to treat the data respectfully. It remains vital that professionals and the society continue to elaborate on the norms and values that shape the common understanding of what is morally right and wrong when researching data. (shrink)

_341_ _Objectives: _In patients with multivessel disease both the detection of the culprit lesion and the exact allocation are important preconditions for sufficient treatment and improved outcome. In a vessel based approach the combination of quantitative coronary angiography and fractional flow reserve measured by a pressure wire should be advantageous compared to myocardial SPECT, as morphological and functional information is delivered simultaneously. Therefore our aim was to evaluate MS in the detection and allocation of hemodynamically significant stenoses obtained by the (...) combined gold standard QCA plus FFR in patients with multivessel disease. _Methods: _FFR and QCA of 95 vessels in 80 patients have been evaluated. Hemodynamically significant target lesions were defined as intermediate stenoses between 50 and 75% with an FFR. (shrink)

Harms and risks to groups and third-parties can be significant in the context of research, particularly in data-centric studies involving genomic, artificial intelligence, and/or machine learning technologies. This article explores whether and how United States federal regulations should be adapted to better align with current ethical thinking and protect group interests. Three aspects of the Common Rule deserve attention and reconsideration with respect to group interests: institutional review board (IRB) assessment of the risks/benefits of research; disclosure requirements in the informed (...) consent process; and criteria for waivers of informed consent. In accordance with respect for persons and communities, investigators and IRBs should systematically consider potential group harm when designing and reviewing protocols, respectively. Research participants should be informed about any potential group harm in the consent process. We call for additional public discussion, empirical research, and normative analysis on these issues to determine the right regulatory and policy path forward. (shrink)

In Jordan, research ethics committees exist in most health settings. However, little is known about Jordanian public views regarding the ethics of clinical research. This study aimed to evaluate Jordanian public understanding and attitudes about ethics in clinical research. A questionnaire was used to collect information that included demographics, public knowledge, and attitudes towards ethics in clinical research. It was administered via face-to-face interviews in two major cities in Jordan from 1st June to 15th August 2017. Of the 2315 respondents, (...) 2.33% were found to have poor knowledge, 22.16% had fair knowledge, and 75.51% had good knowledge of ethics in clinical research. Furthermore, 75.81% of respondents had positive attitudes towards ethics in research. However, only 45.23% reported that they trust clinical researchers in Jordan. Even though a large majority of respondents were aware of key features of research ethics, efforts are needed to address negative perceptions and knowledge deficits. (shrink)

Experimental design is one aspect of a scientific method. A well-designed, properly conducted experiment aims to control variables in order to isolate and manipulate causal effects and thereby maximize internal validity, support causal inferences, and guarantee reliable results. Traditionally employed in the natural sciences, experimental design has become an important part of research in the social and behavioral sciences. Experimental methods are also endorsed as the most reliable guides to policy effectiveness. Through a discussion of some of the central concepts (...) associated with experimental design, including controlled variation and randomization, this chapter will provide a summary of key ethical issues that tend to arise in experimental contexts. In addition, by exploring assumptions about the nature of causation and by analyzing features of causal relationships, systems, and inferences in social contexts, this chapter will summarize the ways in which experimental design can undermine the integrity of not only social and behavioral research but policies implemented on the basis of such research. (shrink)