Mental health-related data generated by app users during the routine use of Consumer Mental Health Apps (CMHAs) are being increasingly leveraged for research and product improvement studies. However, it remains unclear which ethical safeguards and practices should be implemented by researchers and app developers to protect users during these studies, and concerns have been raised over their current implementation in CMHAs. To better understand which ethical safeguards and practices are implemented, why and how, 17 app developers and researchers were interviewed (...) who had been involved in using CMHA data for studies. Interviewees discussed the impact on stakeholder interests, sufficiency thresholds and procedural alterations of informed consent, data protection, gathering app user perspectives and representing users in app design and study conduct, and ensuring adequate support. Although the reasoning behind how and why these ethical safeguards and practices should be implemented showed considerable variability and several gaps, interviewees converged on various general lines of reasoning. This allowed for the development of a coherent and nuanced account that could prove useful for future CMHA studies and which could stimulate further normative investigation of the role of ethical safeguards and practices in these studies. (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)

Definition of the problem The umbrella term “explicability” refers to the reduction of opacity of artificial intelligence (AI) systems. These efforts are challenging for medical AI applications because higher accuracy often comes at the cost of increased opacity. This entails ethical tensions because physicians and patients desire to trace how results are produced without compromising the performance of AI systems. The centrality of explicability within the informed consent process for medical AI systems compels an ethical reflection on the trade-offs. Which (...) levels of explicability are needed to obtain informed consent when utilizing medical AI? Arguments We proceed in five steps: First, we map the terms commonly associated with explicability as described in the ethics and computer science literature, i.e., disclosure, intelligibility, interpretability, and explainability. Second, we conduct a conceptual analysis of the ethical requirements for explicability when it comes to informed consent. Third, we distinguish hurdles for explicability in terms of epistemic and explanatory opacity. Fourth, this then allows to conclude the level of explicability physicians must reach and what patients can expect. In a final step, we show how the identified levels of explicability can technically be met from the perspective of computer science. Throughout our work, we take diagnostic AI systems in radiology as an example. Conclusion We determined four levels of explicability that need to be distinguished for ethically defensible informed consent processes and showed how developers of medical AI can technically meet these requirements. (shrink)

Millum and Bromwich’s excellent article provides both conceptual and practical rationale for reexamining the fundamentals of the informed consent process for research and clinical interventi...

In their latest contribution to a series of important joint papers on informed consent, Joseph Millum and Danielle Bromwich analyze and reject what they call the “standard view” on informed...

Valid Informed consent to medical treatment or research participation has traditionally been viewed as consisting of the following requirements: the person has t...

In their target article, Millum and Bromwich situate their article against a backdrop of well-documented empirical research demonstrating that many participants have variable and often poor...

Informed consent is at the core of the clinical relationship. With the introduction of machine learning in healthcare, the role of informed consent is challenged. This paper addresses the issue of whether patients must be informed about medical ML applications and asked for consent. It aims to expose the discrepancy between ethical and practical considerations, while arguing that this polarization is a false dichotomy: in reality, ethics is applied to specific contexts and situations. Bridging this gap and considering the whole (...) picture is essential for advancing the debate. In the light of the possible future developments of the situation and the technologies, as well as the benefits that informed consent for ML can bring to shared decision-making, the present analysis concludes that it is necessary to prepare the ground for a possible future requirement of informed consent for medical ML. (shrink)

Millum and Bromwich provide a thorough and thoughtful analysis of what is required for sufficient informed consent, offering distinct conceptualizations of the ethical requirements of disclo...

Although precision medicine cuts across a large spectrum of professions, interdisciplinary and cross-sectorial moral deliberation has yet to be widely enacted, let alone formalized in this field. In a recent research project on precision medicine, we designed a dialogical forum (i.e. ‘the Ethics Laboratory’) giving interdisciplinary and cross-sectorial stakeholders an opportunity to discuss their moral conundrums in concert. We organized and carried out four Ethics Laboratories. In this article, we use Simone de Beauvoir’s concept of moral ambiguity as a lens (...) to frame the participants’ experience with fluid moral boundaries. By framing our approach through this concept we are able to elucidate irremediable moral issues that are collectively underexplored in the practice of precision medicine. Moral ambiguity accentuates an open and free space where different types of perspectives converge and can inform each other. Based on our study, we identified two dilemmas, or thematic interfaces, in the interdisciplinary moral deliberations which unfolded in the Ethics Laboratories: (1) the dilemma between the individual and the collective good; and (2) the dilemma between care and choice. Through our investigation of these dilemmas, we show how Beauvoir’s concept of moral ambiquity not only serves as a fertile catalyst for greater moral awareness but, furthermore, how the concept can become an indispensable part of the practices of and the discourse about precision medicine. (shrink)

The standard account of informed consent has recently met serious criticism, focused on the mismatch between its implications and widespread intuitions about the permissibility of conducting research and providing treatment under conditions of partial knowledge. Unlike other critics of the standard account, we suggest an account of the relations between autonomy, ignorance, and valid consent that avoids these implausible implications while maintaining the standard core idea, namely, that the primary purpose of the disclosure requirement of informed consent is to prevent (...) autonomy-undermining ignorance. The problem with the standard account, we argue, is that it fails to distinguish between different forms of ignorance–in particular, error and suspending ignorance–that have very different effects on individuals’ ability to provide valid consent. While error often undermines our ability to provide valid consent, suspending ignorance, we argue, does not. Once the moral weight of this distinction is appreciated, it becomes apparent that valid informed consent requires far less knowledge than suggested by the standard account. (shrink)

One of the ethical principles of medical research involving human subjects is obtaining proper informed consent (IC). However, if the participants’ actual awareness of medical research terminology is lower than the researchers’ prediction of that awareness, it may cause difficulty obtaining proper IC. Therefore, this study aims to clarify the presence of “perception gaps” and then discuss IC-related issues and measures based on the insights obtained. We conducted two online surveys: a “public survey” to understand the Japanese public’s awareness of (...) 11 medical research terms and a “physicians’ survey” to investigate physicians’ predictions regarding public awareness. In the “public survey,” for each term, respondents were instructed to select their situation from “understand,” “have heard,” or “have never heard.” In the “physicians’ survey,” respondents were asked to estimate the proportions of the general public who would “have understood,” “have heard,” or “have never heard” by using an 11-step scale. We analyzed separately in two age groups to understand the age-related difference. We received 1002 valid responses for the “public survey” and 275 for the “physicians’ survey.” Of the public respondents, more than 80% had never heard of terms such as interventional study, prospective clinical study, cohort study, Phase I clinical trial, or double-blind study. Concurrently, physicians overestimated general public awareness of the terms placebo, cohort study, double-blind study, and randomized clinical trial (in the group of people under 60). The results revealed the perception gap between the general public and physicians which raise serious concerns about obtaining proper IC from clinical research participants. (shrink)

Informed Consent: What Must Be Disclosed and What Must Be Understood seeks to challenge the “standard view” of consent. It seeks to do so by segregating the “disclosure function” from the “understa...

Moral agential neuroenhancement can transform us into better people. However, critics of MB raise four central objections to MANEs use: It destroys moral freedom; it kills one moral agent and replaces them with another, better agent; it carries significant risk of infection and illness; it benefits society but not the enhanced person; and it’s wrong to experiment on nonconsenting persons. Herein, I defend MANE’s use for prisoners of war fighting unjustly. First, the permissibility of killing unjust combatants entails that, in (...) cases where MANE is equally or more likely as termination to reduce moral recidivism in unjust combatants, then MANE is morally justified. Second, the relevant infections and illnesses caused by MANE are less bad than death, so MANE leaves unjust POWs better off than the alternative. Third, just as incarceration is often permissible despite benefitting society but not the incarcerated, the same holds for unjust POWs. Fourth, we should accept a broader construal of “benefit” that includes moral benefits. Thus, 3 and 4 are false when applied to unjust POWs. Fifth, medical experimentation likely to help nonconsenting persons is sometimes permissible. Because MANE is likely to help unjust POWs irrespective of their consent or lack thereof, its use is permissible. Sixth, basic principles of proper medical care support the use of MANE on unjust POWs as pro tanto morally obligatory. I conclude that militaries should therefore begin to employ MANE for unjust POWs. (shrink)

In their important and insightful article, Joseph Millum and Danielle Bromwich distinguish two informational requirements for valid consent—the disclosure requirement and the understanding requirem...

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 “Informed Consent: What Must be Disclosed and What Must be Understood?”, we reject a dogma at the heart of research ethics. We demonstrate that the constitutive claim...

In the article “Informed Consent: What Must be Disclosed and What Must be Understood?” Joseph Millum and Danielle Bromwich argue that informed consent requires satisfaction of certain disclosure an...