skip to main content

Attention:

The NSF Public Access Repository (PAR) system and access will be unavailable from 8:00 PM ET on Friday, March 21 until 8:00 AM ET on Saturday, March 22 due to maintenance. We apologize for the inconvenience.


Title: Inherited regulation for advanced ARTs: comparing jurisdictions’ applications of existing governance regimes to emerging reproductive technologies
Abstract Over the past 5 years, advanced assisted reproductive technologies (ARTs), such as mitochondrial replacement therapies (MRTs) and heritable human genome editing (HHGE), have raised global policy concerns and fears of ‘unregulated’ proliferation. Yet, few innovations are ever truly unregulated and more often fall within the scope of one or more pre-existing regulatory regimes, a process referred to as ‘inherited regulation’. While the United Kingdom has enacted new legislation to specifically authorize and closely regulate MRTs, many jurisdictions will likely default to current oversight systems to manage advanced ARTs. This article evaluates and compares how several jurisdictions have already used four types of inherited regulatory regimes to manage MRTs and HHGE. Cases are drawn from jurisdictions where inherited regulatory interventions on advanced ARTs have taken place (USA, Greece, Ukraine, China, and Russia) and include jurisdictions closely connected with those cases (Mexico and Spain). When accounting for political, cultural, and religious contexts, many of these inherited regimes offer promise as starting points for governance of advanced ARTs, yet each will require further adjustments and tailoring to adequately manage the benefits and risks of these powerful innovations.  more » « less
Award ID(s):
1828010
PAR ID:
10344091
Author(s) / Creator(s):
;
Date Published:
Journal Name:
Journal of Law and the Biosciences
Volume:
9
Issue:
1
ISSN:
2053-9711
Format(s):
Medium: X
Sponsoring Org:
National Science Foundation
More Like this
  1. null (Ed.)
    The COVID-19 pandemic has caused more than 1,000,000 reported deaths globally, of which more than 200,000 have been reported in the United States as of October 1, 2020. Public health interventions have had significant impacts in reducing transmission and in averting even more deaths. Nonetheless, in many jurisdictions, the decline of cases and fatalities after apparent epidemic peaks has not been rapid. Instead, the asymmetric decline in cases appears, in most cases, to be consistent with plateau- or shoulder-like phenomena—a qualitative observation reinforced by a symmetry analysis of US state-level fatality data. Here we explore a model of fatality-driven awareness in which individual protective measures increase with death rates. In this model, fast increases to the peak are often followed by plateaus, shoulders, and lag-driven oscillations. The asymmetric shape of model-predicted incidence and fatality curves is consistent with observations from many jurisdictions. Yet, in contrast to model predictions, we find that population-level mobility metrics usually increased from low levels before fatalities reached an initial peak. We show that incorporating fatigue and long-term behavior change can reconcile the apparent premature relaxation of mobility reductions and help understand when post-peak dynamics are likely to lead to a resurgence of cases. 
    more » « less
  2. Abstract Regulatory agencies aim to protect the public by moderating risks associated with innovation, but a good regulatory regime should also promote justified public trust. After introducing the USDA 2020 SECURE Rule for regulation of biotech innovation as a case study, this essay develops a theory of justified public trust in regulation. On the theory advanced here, to be trustworthy, a regulatory regime must (1) fairly and effectively manage risk, must be (2) “science based” in the relevant sense, and must in addition be (3) truthful, (4) transparent, and (5) responsive to public input. Evaluated with these norms, the USDA SECURE Rule is shown to be deeply flawed, since it fails appropriately to manage risk, and similarly fails to satisfy other normative requirements for justified trust. The argument identifies ways in which the SECURE Rule itself might be improved, but more broadly provides a normative framework for the evaluation of trustworthy regulatory policy-making. 
    more » « less
  3. Abstract Background

    The development of public health policy is inextricably linked with governance structure. In our increasingly globalized world, human migration and infectious diseases often span multiple administrative jurisdictions that might have different systems of government and divergent management objectives. However, few studies have considered how the allocation of regulatory authority among jurisdictions can affect disease management outcomes.

    Methods

    Here we evaluate the relative merits of decentralized and centralized management by developing and numerically analyzing a two-jurisdictionSIRSmodel that explicitly incorporates migration. In our model, managers choose between vaccination, isolation, medication, border closure, and a travel ban on infected individuals while aiming to minimize either the number of cases or the number of deaths.

    Results

    We consider a variety of scenarios and show how optimal strategies differ for decentralized and centralized management levels. We demonstrate that policies formed in the best interest of individual jurisdictions may not achieve global objectives, and identify situations where locally applied interventions can lead to an overall increase in the numbers of cases and deaths.

    Conclusions

    Our approach underscores the importance of tailoring disease management plans to existing regulatory structures as part of an evidence-based decision framework. Most importantly, we demonstrate that there needs to be a greater consideration of the degree to which governance structure impacts disease outcomes.

     
    more » « less
  4. Oligodendrocytes are multifunctional central nervous system (CNS) glia that are essential for neural function in gnathostomes. The evolutionary origins and specializations of the oligodendrocyte cell type are among the many remaining mysteries in glial biology and neuroscience. The role of oligodendrocytes as CNS myelinating glia is well established, but recent studies demonstrate that oligodendrocytes also participate in several myelin-independent aspects of CNS development, function, and maintenance. Furthermore, many recent studies have collectively advanced our understanding of myelin plasticity, and it is now clear that experience-dependent adaptations to myelination are an additional form of neural plasticity. These observations beg the questions of when and for which functions the ancestral oligodendrocyte cell type emerged, when primitive oligodendrocytes evolved new functionalities, and the genetic changes responsible for these evolutionary innovations. Here, I review recent findings and propose working models addressing the origins and evolution of the oligodendrocyte cell type and adaptive myelination. The core gene regulatory network (GRN) specifying the oligodendrocyte cell type is also reviewed as a means to probe the existence of oligodendrocytes in basal vertebrates and chordate invertebrates. 
    more » « less
  5. Patient-generated health data (PGHD), created and captured from patients via wearable devices and mobile apps, are proliferating outside of clinical settings. Examples include sleep tracking, fitness trackers, continuous glucose monitors, and RFID-enabled implants, with many additional biometric or health surveillance applications in development or envisioned. These data are included in growing stockpiles of personal health data being mined for insight via big data analytics and artificial intelligence/deep learning technologies. Governing these data resources to facilitate patient care and health research while preserving individual privacy and autonomy will be challenging, as PGHD are the least regulated domains of digitalized personal health data (U.S. Department of Health and Human Services, 2018). When patients themselves collect digitalized PGHD using “apps” provided by technology firms, these data fall outside of conventional health data regulation, such as HIPAA. Instead, PGHD are maintained primarily on the information technology infrastructure of vendors, and data are governed under the IT firm’s own privacy policies and within the firm’s intellectual property rights. Dominant narratives position these highly personal data as valuable resources to transform healthcare, stimulate innovation in medical research, and engage individuals in their health and healthcare. However, ensuring privacy, security, and equity of benefits from PGHD will be challenging. PGHD can be aggregated and, despite putative “deidentification,” be linked with other health, economic, and social data for predictive analytics. As large tech companies enter the healthcare sector (e.g., Google Health is partnering with Ascension Health to analyze the PHI of millions of people across 21 U.S. states), the lack of harmonization between regulatory regimes may render existing safeguards to preserve patient privacy and control over their PHI ineffective. While healthcare providers are bound to adhere to health privacy laws, Big Tech comes under more relaxed regulatory regimes that will facilitate monetizing PGHD. We explore three existing data protection regimes relevant to PGHD in the United States that are currently in tension with one another: federal and state health-sector laws, data use and reuse for research and innovation, and industry self-regulation by large tech companies We then identify three types of structures (organizational, regulatory, technological/algorithmic), which synergistically could help enact needed regulatory oversight while limiting the friction and economic costs of regulation. This analysis provides a starting point for further discussions and negotiations among stakeholders and regulators to do so. 
    more » « less