Modeling policy development: examining national governance of stem cell-based embryo models.

Researchers can now coax human pluripotent stem cells to imitate the structure and spontaneous self-organization of the developing human embryo. Although these stem cell-based embryo models present an advantageous alternative to embryo research, they also raise ethical and policy challenges. In 2021, the International Society for Stem Cell Research revised its Guidelines for Stem Cell Research and Clinical Translation, providing contemporaneous best practices for ethical conduct in the field. The Guidelines complement national governance frameworks; however, they also contain contentious and aspirational norms that might catalyze change in research practice and in the enactment of national policies. Using a sample of 11 research-intensive countries, the authors compare research policy frameworks against the International Society for Stem Cell Research Guidelines to showcase how developments in global and national policies might affect stem cell-based embryo model research governance and illustrate fertile areas for ethical reflection and policy development.

Following scientific advances, researchers can induce stem cells to model the development of the human embryo with increasing accuracy. The International Society for Stem Cell Research Guidelines for Stem Cell Research and Clinical Translation provide contemporary standards for research on so-called stem cell-based embryo models (SCB-EMs). However, because SCB-EMs are not mentioned in national policies and do not fit neatly into existing regulatory categories, it is unclear how countries intend to regulate them. In this article, the authors compare policy frameworks in 11 research-intensive countries to analyze how the influential Guidelines both complement and catalyze change in national policies. The Guidelines provide specific instructions for assessing and monitoring different kinds of SCB-EM research proposals, serving as a useful reference to bolster open-ended national policy requirements. However, in some areas the Guidelines appear to conflict with national policies governing stem cell and embryo research, reflecting divergent priorities and ethical assessments. Without policy review to address regulatory and ethical uncertainty, researchers may default to adherence to the Guidelines, a global standard that does not necessarily reflect local historic, legal and cultural influences. Evidence from France and Israel indicates that comprehensive legislative review is both useful and can proceed without eroding compromises designed to uphold plural beliefs regarding the moral status of the human embryo. As exemplified in countries such France and Israel, mandated legislative review processes are useful tools that can be deployed in manner that upholds pluralistic beliefs regarding the human embryo's moral status. They can serve as a pathway to re-engage the public and ensure diverse viewpoints are reflected in governance of SCB-EM research, ultimately facilitating public trust in science.

Mending the gaps: ethically sensitive cells and the evolution of European stem cell policy.

The past decades witnessed the slow evolution of Europe's heterogeneous stem cell (SC) policy and substantial scientific advances in the field. Parallel to these developments, professional organizations have grown in influence. With the recently revised International Society for Stem Cell Research's Guidelines as a backdrop, we address the evolution of SC policies in 46 European countries and discuss how they fare against evolving ethical standards, societal views, and scientific advances. We identify areas of convergence, divergence, and the suitability of extant governance mechanisms to meet their stewardship roles. Europe represents a rich case study as it encompasses a wide range of policy approaches present worldwide. Comparative studies provide an opportunity to promote insight into national frameworks and to foster international harmonization.

European countries have adopted different types of rules or policies, including laws and professional standards, to regulate stem cell research. These differences are because each country has different history and cultures. Also, individuals and institutions (e.g., religious leaders, politicians and advocacy organizations) have different degrees of power to influence the type of policies that are adopted in each country. Over the past decades, stem cell policies have evolved slowly even with significant scientific advances. Yet, during this time, professional organizations have grown in influence, for example, the prominent International Society for Stem Cell Research, whose guidelines (or rules) are considered 'best practices' in the field. In this article, we identify and analyze stem cell policies in 46 European countries, comparing them against the International Society for Stem Cell Research's new Guidelines. In addition, we show the similarities and differences amongst these policies. Europe presents an interesting case study because the region includes a wide typology of policies like those adopted in the rest of the world, making this comparison useful for other countries as they consider the suitability of their own policies.

Acceptability, feasibility, and pilot results of the tele-harm reduction intervention for rapid initiation of antiretrovirals among people who inject drugs.

BACKGROUND: People who inject drugs (PWID) have been a marginalized and a stigmatized population since the beginning of the AIDS epidemic and have not experienced the same life-changing benefits of antiretroviral therapy as others. Tele-Harm Reduction (THR) is a telehealth-enhanced, harm reduction intervention, delivered within a trusted SSP venue. It aims to facilitate initiation of care and achieve rapid HIV viral suppression among PWID living with HIV. METHODS: In this mixed-methods study, we employed the Practical, Robust, Implementation and Sustainability Model (PRISM) implementation science framework to identify multilevel barriers and facilitators to implementing the THR intervention. Focus groups (n = 2, 16 participants), stakeholder interviews (n = 7) and in-depth interviews were conducted with PWID living with HIV (n = 25). In addition, to assess feasibility and acceptability, we pilot tested the THR intervention and reported viral suppression at 6 months. RESULTS: Focus groups and stakeholder interviews revealed system and organizational level barriers to implementation including requirements for identification and in person visits, waiting times, stigma, case management inexperience, multiple electronic health records, and billing. A potential facilitator was using telehealth for case management and initial provider visit. In the in depth interviews conducted with PWID living with HIV, participants expressed that the SSP creates a convenient, comfortable, confidential environment for delivering multiple, non-stigmatizing PWID-specific services. 35 PWID living with HIV were enrolled in the pilot study, 35 initiated antiretroviral therapy, and 25 (78.1%) were virally suppressed at six months. CONCLUSION: Rooted in harm reduction, the THR intervention shows promise in being an acceptable and feasible intervention that may facilitate engagement in HIV care and viral suppression among PWID.

When is an abscess more than an abscess? Syringe services programs and the harm reduction safety-net: a case report.

BACKGROUND: Syringe services programs (SSPs) are able to offer wrap-around services for people who inject drugs (PWID) and improve health outcomes. CASE PRESENTATION: A 47-year-old man screened positive for a skin and soft tissue infection (SSTI) at an SSP and was referred to a weekly on-site student-run wound care clinic. He was evaluated by first- and third-year medical students, and volunteer attending physicians determined that the infection was too severe to be managed on site. Students escorted the patient to the emergency department, where he was diagnosed with a methicillin-resistant Staphylococcus aureus arm abscess as well as acute HIV infection. CONCLUSION: Student-run wound care clinics at SSPs, in conjunction with ongoing harm reduction measures, screenings, and treatment services, provide a safety-net of care for PWID and help mitigate the harms of injection drug use.

Correction to: When is an abscess more than an abscess? Syringe services programs and the harm reduction safety-net: a case report.

An amendment to this paper has been published and can be accessed via the original article.

Regulating Preimplantation Genetic Testing across the World: A Comparison of International Policy and Ethical Perspectives.

Preimplantation genetic testing (PGT) is a reproductive technology that, in the course of in vitro fertilization (IVF), allows prospective parents to select their future offspring based on genetic characteristics. PGT could be seen as an exercise of reproductive liberty, thus potentially raising significant socioethical and legal controversy. In this review, we examine-from a comparative perspective-variations in policy approaches to the regulation of PGT. We draw on a sample of 19 countries (Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India, Israel, Italy, Japan, Mexico, Netherlands, Singapore, South Korea, Switzerland, United Kingdom, and the United States) to provide a global landscape of the spectrum of policy and legislative approaches (e.g., restrictive to permissive, public vs. private models). We also explore central socioethical and policy issues and contentious applications, including permissibility criteria (e.g., medical necessity), nonmedical sex selection, and reproductive tourism. Finally, we further outline genetic counseling requirements across policy approaches.

Prioritizing diversity in human genomics research.

Recent studies have highlighted the imperatives of including diverse and under-represented individuals in human genomics research and the striking gaps in attaining that inclusion. With its multidecade experience in supporting research and policy efforts in human genomics, the National Human Genome Research Institute is committed to establishing foundational approaches to study the role of genomic variation in health and disease that include diverse populations. Large-scale efforts to understand biology and health have yielded key scientific findings, lessons and recommendations on how to increase diversity in genomic research studies and the genomic research workforce. Increased attention to diversity will increase the accuracy, utility and acceptability of using genomic information for clinical care.