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In this paper we report findings from a commissioned report to the COVID-19 Clinical Research Coalition on approaches to streamline multinational REC review/approval during public health emergencies. As currently envisioned in the literature, a system of REC mutual recognition is theoretically possible based on shared procedural REC standards, but raises numerous concerns about perceived inequities and mistrust. [ABSTRACT FROM AUTHOR]

This paper provides an overview of the societal impact of a rising dementia population and examines the legal and ethical implications posed by voluntary registries as a community-oriented solution to improve interactions between law enforcement and individuals with dementia. It provides a survey of active voluntary registries across the United States, with a focus on Arizona, which has the highest projected growth for individuals living with dementia in the country. [ABSTRACT FROM AUTHOR]

Capitalizing on the hype surrounding stem cell research, numerous clinics around the world offer 'stem cell therapies' for a variety of medical conditions. Despite questions about the safety and efficacy of these interventions, anecdotal evidence suggests a relatively large number of patients are traveling to receive these unproven treatments - a practice called 'stem cell tourism.' Because these unproven treatments pose risks to individual patients and to legitimate translational stem cell research, stem cell tourism has generated substantial policy concern and inspired attempts to reduce these risks through the development of guidelines for patients and medical practitioners. This paper examines the roles and responsibilities of physicians in patients' home countries with respect to patients' decisions to try unproven stem cell therapies abroad. Specifically, it examines professional guidance from two organizations - the American Medical Association and the International Society for Stem Cell Research - and assesses physicians' professional and legal obligations to patients considering unproven stem cell therapies. Then, drawing on qualitative interviews conducted with patients who traveled abroad for unproven stem cell treatments, it explores the roles that physicians actually play in patients' decisions and compares these actual roles with their professional and legal responsibilities. The paper concludes with a discussion of strategies to help improve the guidance physicians provide to patients considering unproven treatments. [ABSTRACT FROM AUTHOR]

A bottom-up approach grounded in micro-level understanding of the thinking, feeling, behavioral, and social aspects of living with low income and associated low literacy can lead to greater understanding and improvement of interactions in the health arena. This paper draws on what we have learned about marketplace interactions in subsistence economies to inform innovations in medical education, design and delivery of healthcare for lowincome patients, outreach education, and future micro-level research at the human-healthcare interface. [ABSTRACT FROM AUTHOR]

Returning genomic research results to family members raises complex questions. Genomic research on life-limiting conditions such as cancer, and research involving storage and reanalysis of data and specimens long into the future, makes these questions pressing. This author group, funded by an NIH grant, published consensus recommendations presenting a framework. This follow-up paper offers concrete guidance and tools for implementation. The group collected and analyzed relevant documents and guidance, including tools from the Clinical Sequencing Exploratory Research (CSER) Consortium. The authors then negotiated a consensus toolkit of processes and documents. That toolkit offers sample consent and notification documents plus decision flow-charts to address return of results to family of living and deceased participants, in adult and pediatric research. Core concerns are eliciting participant preferences on sharing results with family and on choice of a representative to make decisions about sharing after participant death. [ABSTRACT FROM AUTHOR]

There has been considerable debate on which genomic research results to return to participants and when those results should be returned, but little attention to how those results should be returned, especially to minority and culturally diverse participants. This paper explores the cultural and ethical considerations around returning research results to participants and families of culturally diverse backgrounds, with a special focus on considerations when the research participant is deceased, and raises points for further discussion. [ABSTRACT FROM AUTHOR]

The successes of the Human Genome Project have ushered in a new era of genomic science. To effectively translate these discoveries, it will be critical to improve the communication of genetic risk within families. This will require a systematic approach that accounts for the nature of family relationships and sociocultural beliefs. This paper proposes the application of the Family Systems Illness Model, used in the setting of cancer care, to the evolving field of genomics. [ABSTRACT FROM AUTHOR]

Genomic research results and incidental findings with health implications for a research participant are of potential interest not only to the participant, but also to the participant's family. Yet investigators lack guidance on return of results to relatives, including after the participant's death. In this paper, a national working group offers consensus analysis and recommendations, including an ethical framework to guide investigators in managing this challenging issue, before and after the participant's death. [ABSTRACT FROM AUTHOR]

As global health curricula and competencies are defined, the instructional foundation of practice-based learning and soft skills training requires reexamination. This paper explores the integration of social-emotional instruction into global health education, specifically highlighting its role in interprofessional learning environments. One method to teach the core competencies in the higher education context is through restorative practices. Restorative practices is a 'social science that integrates developments from a variety of disciplines and fields in order to build healthy communities, increase social capital, decrease crime and antisocial behavior, repair harm and restore relationships.' The restorative philosophy incorporates the core competencies of socio-emotional learning and views conflict as an opportunity for learning. The first part discusses the foundations of social-emotional learning (SEL). It then explores the applicability of SEL in interprofessional and global health education. [ABSTRACT FROM AUTHOR]

Five years ago, an article co-written by two of us (Joly and Simard) presented an emerging trend to disclose certain individual genetic results to research participants. Since then, both technologies and research practices have evolved significantly. Given this rapid evolution, our goal is to provide updated and thorough guidance on this issue. Our paper begins by identifying the ethical principles that support the return of results: justice, beneficence, and respect for persons. Then, it presents the results of an analysis of international norms on the return of results, covering both general and individual research results. It reveals existing divergence and consensus on these topics within the international community. With the goal of promoting greater harmonization, we conclude by proposing a flexible framework for the return of individual research results. [ABSTRACT FROM AUTHOR]