Jodi Halpern

Introduction: National Health Service (NHS) failures at Mid-Staffordshire, Shrewsbury and Telford, and East Kent reached the same conclusion: leaders who fail to listen and understand put patients at risk. The NHS response has been to promote compassionate leadership. Yet, compassion often entails emotional merging, which can blur boundaries and lead to fatigue. By contrast, empathic leadership and curiosity-driven perspectivetaking, rather than emotional merging, offers a promising new way forward. Yet no practical method exists to teach empathic leadership. To fill this gap, we aimed to develop heuristics ('rules of thumb') for empathic leadership and create a course to teach them. Methods: 21 healthcare leaders attended a structured workshop. Using established heuristic development and curriculum design methods, participants generated, refined and prioritised heuristics for empathic leadership, then co-designed a training course to teach them. Results: The group produced 35 heuristics and prioritised 12, including 'Listen first, speak last', 'Say sorry', and 'Walk the shop floor'. A one-day interprofessional empathic leadership course was then co-designed, featuring experiential learning, role play and implementation planning. Conclusion: We identified and prioritized heuristics for empathic leadership and produced a course to teach them. The short course may support healthcare leaders to strengthen empathic leadership in practice.

Recent critique of maternal-fetal therapy trial ethical guidance has highlighted the need to weigh maternal, fetal and societal interests, respectively, while deprioritizing psychosocial reasons for participation. Psychosocial reasons refer to the psychological and social influences on study participants' decisions, and they are often central to considerations about informed consent. However, psychosocial reasons are described as too indirect, subjective, and vague to incorporate into prenatal clinical and regulatory frameworks. This qualitative study examines the perspectives of 11 individuals (eight couples) enrolled in one of two maternal-fetal therapy phase I clinical trials for rare genetic conditions. Interviews revealed that motivations to participate were primarily psychosocial, including: existential concerns given prior bereavement and/or fear of loss; temporal control through taking action as opposed to feeling passive; hope and optimism; and intergenerational and social motivations given one's family experience with disease and desire for social connections. Psychosocial reasons for participating ought to be given more consideration in ethical frameworks for maternal-fetal therapy phase I clinical trials, as well as in the approach to informed consent. It is important for clinical research teams to be especially conscientious to ensure appreciation for participants' reasons for participating that extend beyond typical frameworks of clinical risk/benefit, and to support participants who might harbor optimistic expectations of medical procedures as they transition to postnatal realities.

Background: Blockchain technology has capabilities that can transform how sensitive personal health data are safeguarded, shared, and accessed in digital health research. Women’s health data are considered especially sensitive, given the privacy and safety risks associated with their unauthorized disclosure. These risks may affect research participation. Using a privacy-by-design approach, we developed 2 app-based women’s health research study prototypes for user evaluation and assessed how blockchain may impact participation. Objective: This study aims to seek the perspectives of women to understand whether applications of blockchain technology in app-based digital research would affect their decision to participate and contribute sensitive personal health data. Methods: A convergent, mixed methods, experimental design was used to evaluate participant perceptions and attitudes toward using 2 app-based women’s health research study prototypes with blockchain features. Prototype A was based on the status quo ResearchKit framework and had extensive electronic informed consent, while prototype B minimized study onboarding requirements and had no informed consent; the mechanisms of how the contributed data flowed and were made pseudonymous were the same. User evaluations were carried out in February and March 2021 and consisted of a think-aloud protocol, a perception survey, and a semistructured interview. Findings were mapped to the technology acceptance model to guide interpretation. Results: We recruited 16 representative female participants from 175 respondents. User evaluations revealed that while participants considered prototype B easier to use on intuitive navigation (theme 1) of specified tasks and comprehension (theme 2) of research procedures, prototype A trended toward being perceived more favorably than prototype B across most perception survey constructs, with an overall lower level of privacy concern (mean [SD]: 2.22 [1.10] vs 2.95 [1.29]) and perceived privacy risk (2.92 [1.46] vs 3.64 [1.73]) and higher level of perceived privacy (5.21 [1.26] vs 4.79 [1.47]), trust (5.46 [1.19] vs 4.76 [1.27]), and usability (67.81 [21.77] vs 64.84 [23.69]). Prototype B was perceived more favorably than prototype A with perceived control (4.92 [1.32] vs 4.89 [1.29]) and perceived ownership (5.18 [0.59] vs 5.01 [0.96]). These constructs, except for perceived ownership, were significantly correlated with behavioral intention to use the app (P<.05). Participants perceived the usefulness of these prototypes in relation to the value of research study to women’s health field (theme 3), the value of research study to self (theme 4), and the value of blockchain features for participation (theme 5). Conclusions: This study provides nuanced insights into how blockchain applications in app-based research remain secondary in value to participants’ expectations of health research, and hence their intention to participate and contribute data. However, with impending data privacy and security concerns, it remains prudent to understand how to best integrate blockchain technology in digital health research infrastructure.

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Blockchain technology has capabilities that can transform how sensitive personal health data are safeguarded, shared, and accessed in digital health research. Women’s health data are considered especially sensitive, given the privacy and safety risks associated with their unauthorized disclosure. These risks may affect research participation. Using a privacy-by-design approach, we developed 2 app-based women’s health research study prototypes for user evaluation and assessed how blockchain may impact participation. Objective: This study aims to seek the perspectives of women to understand whether applications of blockchain technology in app-based digital research would affect their decision to participate and contribute sensitive personal health data. Methods: A convergent, mixed methods, experimental design was used to evaluate participant perceptions and attitudes toward using 2 app-based women’s health research study prototypes with blockchain features. Prototype A was based on the status quo ResearchKit framework and had extensive electronic informed consent, while prototype B minimized study onboarding requirements and had no informed consent; the mechanisms of how the contributed data flowed and were made pseudonymous were the same. User evaluations were carried out in February and March 2021 and consisted of a think-aloud protocol, a perception survey, and a semistructured interview. Findings were mapped to the technology acceptance model to guide interpretation. Results: We recruited 16 representative female participants from 175 respondents. User evaluations revealed that while participants considered prototype B easier to use on intuitive navigation (theme 1) of specified tasks and comprehension (theme 2) of research procedures, prototype A trended toward being perceived more favorably than prototype B across most perception survey constructs, with an overall lower level of privacy concern (mean [SD]: 2.22 [1.10] vs 2.95 [1.29]) and perceived privacy risk (2.92 [1.46] vs 3.64 [1.73]) and higher level of perceived privacy (5.21 [1.26] vs 4.79 [1.47]), trust (5.46 [1.19] vs 4.76 [1.27]), and usability (67.81 [21.77] vs 64.84 [23.69]). Prototype B was perceived more favorably than prototype A with perceived control (4.92 [1.32] vs 4.89 [1.29]) and perceived ownership (5.18 [0.59] vs 5.01 [0.96]). These constructs, except for perceived ownership, were significantly correlated with behavioral intention to use the app (P<.05). Participants perceived the usefulness of these prototypes in relation to the value of research study to women’s health field (theme 3), the value of research study to self (theme 4), and the value of blockchain features for participation (theme 5). Conclusions: This study provides nuanced insights into how blockchain applications in app-based research remain secondary in value to participants’ expectations of health research, and hence their intention to participate and contribute data. However, with impending data privacy and security concerns, it remains prudent to understand how to best integrate blockchain technology in digital health research infrastructure.

Fear and anxiety can interfere profoundly with a person's ability to deliberate. Patients sometimes face critical medical decisions while subject to intense emotions which involve catastrophic (or wishful) convictions about the future. Medical teams, and even psychiatrists and bioethicists, lack a model for what to do in such cases. Philosophical accounts of autonomy and the clinical criteria for decision‐making capacity derived from them fail to address cases in which emotions do not merely skew judgment but rather block decision‐making capacity itself. This paper provides an account of when emotions undermine a person's freedom to deliberate, which is the basis of the capacity for autonomy. People subject to what I call ‘concretized emotions’ meet the cognitive criteria for decision‐making capacity. Yet their emotions dictate their views of reality and prevent them from meeting the basic conditions for deliberation. To deliberate one needs to be able to think through alternatives, and this thinking through alternatives needs to be responsive to evidence. With concretized fear, both the ability to think through alternatives and the ability to respond cognitively to evidence is undermined. The person can engage in apparent deliberation, but her thought processes regarding the feared matter are characterized by the rigid view that things are just as they seem from her emotional view. This paper develops a theoretical and clinical model for a more appropriate and nuanced approach to acting responsibly toward patients subject to intense fear and related emotional states that block their decision‐making capacity.

(2020). Upstream Ethical Mapping of Germline Genome Editing. The American Journal of Bioethics: Vol. 20, No. 8, pp. 1-4.

The late 2018 announcement of the claimed births of CRISPR-edited babies has stimulated widespread condemnation and calls by some leading scientists for a moratorium on any further germline genome editing (GGE) for reproductive purposes. Concurrently, national and international bodies are calling for the development of robust guidelines and regulations that will identify permissible conditions under which such GGE efforts might eventually proceed. Crucially, these conditions go beyond rigorous safety standards to address some of the social and ethical concerns that arise with germline interventions. As these bodies convene to navigate this unique terrain, we suggest an important standard for generating ethically robust guidelines. Our approach builds from concerns about social exclusion and social justice with a focus on fundamental human rights. We believe that a deontological or rights-based approach, rather than a utilitarian approach, is needed to ensure that this socially disruptive technology minimizes further marginalization of people with disabilities and does not create a new form of social injustice. In pursuit of a deontological framework, we propose the implementation of an objective assessment tool: the Human Rights Impact Assessment (HRIA). Use of the HRIA establishes necessary constraints on applications of GGE in order to safeguard the most vulnerable members of society. [End Page 44]

Genome editing has opened up the possibility of heritable alteration of the human germline. The potential of this powerful tool has spurred a call for establishing robust regulatory frameworks to outline permissible uses of genome editing and to map a rational and ethical course. In response, major national scientific bodies and international organizations have convened and released comprehensive reports outlining recommendations for ethical regulatory frameworks. Significantly, these include an emphasis on public participation and the development of principles to guide future applications of genome editing. While essential, public input and principles are not sufficient to ensure ethical uses of this technology. We propose an approach that relies not only on agreed-upon principles and a democratic process but requires a Human Rights Impact Assessment to evaluate the potential burdens that such biomedical interventions may place on human rights.