Browsing by Author "Iltis, Ana S."

Now showing 1 - 12 of 12
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    Did Recent Efforts to Develop Policy for Genome Editing Have Adequate Public Engagement?
    (James A. Baker III Institute for Public Policy, 2022) Matthews, Kirstin R.W.; Iltis, Ana S.; James A. Baker III Institute for Public Policy
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    Ethical Considerations for the Creation of a National Neglected Tropical Disease Policy
    (James A. Baker III Institute for Public Policy, 2016) Iltis, Ana S.; Matthews, Kirstin R.W.; James A. Baker III Institute for Public Policy
    The term “neglected tropical diseases” (NTDs) refers to a group of parasitic, viral, and bacterial diseases that cause substantial and often debilitating illnesses, affecting more than one billion people globally. In the United States, addressing NTDs focuses largely on developing safe and effective mechanisms to prevent and treat NTDs. Furthermore, new or existing treatments must be made available to those in need—often people living in poverty or extreme poverty (less than $2 a day). But research, development, and delivery of these interventions is costly and relies mostly on funding from the federal government. With pressure to limit government expenditures, decisions regarding the allocation of limited resources entail balancing priorities, which involve many, often unarticulated or implicit, ethical judgments. This report highlights some of the central ethical issues pertaining to NTD policy development and argues that ethical considerations should be included in the policy development process. We conclude that the United States should develop an NTD policy to further reduce the prevalence and impact of NTDs both within and outside our borders.
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    Ethical, legal, regulatory, and policy issues concerning embryoids: a systematic review of the literature
    (2023) Iltis, Ana S.; Koster, Grace; Reeves, Emily; Matthews, Kirstin R. W.
    Recent advances in methods to culture pluripotent stem cells to model human development have resulted in entities that increasingly have recapitulated advanced stages of early embryo development. These entities, referred to by numerous terms such as embryoids, are becoming more sophisticated and could resemble human embryos ever more closely as research progresses. This paper reports a systematic review of the ethical, legal, regulatory, and policy questions and concerns found in the literature concerning human embryoid research published from 2016 to 2022. We identified 56 papers that use 53 distinct names or terms to refer to embryoids and four broad categories of ethical, legal, regulatory, or policy considerations in the literature: research justifications/benefits, ethical significance or moral status, permissible use, and regulatory and oversight challenges. Analyzing the full range of issues is a critical step toward fostering more robust ethical, legal, and social implications research in this emerging area and toward developing appropriate oversight.
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    Neglected Tropical Diseases and the United States South: Policy and Professional Responses to Improve Health in the South
    (James A. Baker III Institute for Public Policy, 2016) Iltis, Ana S.; Matthews, Kirstin R.W.; James A. Baker III Institute for Public Policy
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    NTD policy priorities: Science, values, and agenda setting
    (Public Library of Science, 2017) Iltis, Ana S.; Matthews, Kirstin R.W.; James A. Baker III Institute for Public Policy
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    Public and Stakeholder Engagement in Developing Human Heritable Genome Editing Policies: What Does it Mean and What Should it Mean?
    (2021) Iltis, Ana S.; Hoover, Sarah; Matthews, Kirstin R.W.; James A. Baker III Institute for Public Policy
    As scientific research pushes the boundaries of knowledge, new discoveries and technologies often raise ethical and social questions. Public responses vary from surprise, to unrealistic optimism about imminent new treatments, confusion, and absolute opposition. Regardless of the intent, the use of a precise gene editing tool on human embryos, such as CRISPR-Cas9, is an example of such a controversial emerging technology. Substantive disagreement about the appropriate research pathways and permissible clinical applications is to be expected. Many ethical concerns, especially related to genetic manipulation of human embryos, are rooted in deeply held moral, religious, or ideological beliefs that science alone cannot address. Today, more scientists and scientific societies as well as policy makers are calling for public and stakeholder engagement in developing guidelines and policies governing scientific practice. We conducted a critical interpretive review of the literature on public and stakeholder engagement in science policy development regarding emerging technologies to determine the ideals that should guide engagement efforts of entities developing recommendations or guidelines on policy for such technologies. We identify and describe five ideals. To illustrate possible applications of these ideals, we review the engagement efforts described in three reports on heritable human genome editing and assess those efforts in light of these ideals. Finally, we recommend possible avenues for engagement that would advance those goals.
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    Rethinking Human Embryo Research Policies
    (2021) Matthews, Kirstin R.W.; Iltis, Ana S.; Marquez, Nuria Gallego; Wagner, Daniel S.; Robert, Jason Scott; de Melo-Martín, Inmaculada; Bigg, Marieke; Franklin, Sarah; Holm, Soren; Metzler, Ingrid; Molè, Matteo A.; Taupitz, Jochen; Testa, Giuseppe; Sugarman, Jeremy; James A. Baker III Institute for Public Policy
    It now seems technically feasible to culture human embryos beyond the “fourteen-day limit,” which has the potential to increase scientific understanding of human development and perhaps improve infertility treatments. The fourteen-day limit was adopted as a compromise but subsequently has been considered an ethical line. Does it remain relevant in light of technological advances permitting embryo maturation beyond it? Should it be changed and, if so, how and why? What justifications would be necessary to expand the limit, particularly given that doing so would violate some people's moral commitments regarding human embryos? Robust stakeholder engagement preceded adoption of the fourteen-day limit and should arguably be part of efforts to reassess it. Such engagement could also consider the need for enhanced oversight of human embryo research. In the meantime, developing and implementing reliable oversight systems should help foster high-quality research and public confidence in it.
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    Unproven Stem Cell Interventions and Encouraging Collaboration Between Regulators and Desperate Patients
    (James A. Baker III Institute for Public Policy, 2016) Matthews, Kirstin R.W.; Iltis, Ana S.; James A. Baker III Institute for Public Policy
    Stem cells have been touted by scientists as the new future for medicine, but with limited therapies currently available, clinics around the world are marketing unproven inventions using stem cells to allegedly "cure" diseases ranging from Autism to Multiple Sclerosis. This poster documents the analysis of several national and local policy initiatives that aim to provide expanded access to patients.ﾠ
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    Unproven Stem Cell Treatments and Re-evaluating the Role of the US FDA: Bringing the Lost and Desperate Back Home
    (James A. Baker III Institute for Public Policy, 2015) Matthews, Kirstin R.W.; Iltis, Ana S.; James A. Baker III Institute for Public Policy
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    Unproven stem cell-based interventions and achieving a compromise policy among the multiple stakeholders
    (BioMed Central Ltd, 2015) Matthews, Kirstin R.W.; Iltis, Ana S.; James A. Baker III Institute for Public Policy
    Background: In 2004, patient advocate groups were major players in helping pass and implement significant public policy and funding initiatives in stem cells and regenerative medicine. In the following years, advocates were also actively engaged in Washington DC, encouraging policy makers to broaden embryonic stem cell research funding, which was ultimately passed after President Barack Obama came into office. Many advocates did this because they were told stem cell research would lead to cures. After waiting more than 10 years, many of these same patients are now approaching clinics around the world offering experimental stem cell-based interventions instead of waiting for scientists in the US to complete clinical trials. How did the same groups who were once (and often still are) the strongest supporters of stem cell research become stem cell tourists? And how can scientists, clinicians, and regulators work to bring stem cell patients back home to the US and into the clinical trial process? Discussion: In this paper, we argue that the continued marketing and use of experimental stem cell-based interventions is problematic and unsustainable. Central problems include the lack of patient protection, US liability standards, regulation of clinical sites, and clinician licensing. These interventions have insufficient evidence of safety and efficacy; patients may be wasting money and time, and they may be forgoing other opportunities for an intervention that has not been shown to be safe and effective. Current practices do not contribute to scientific progress because the data from the procedures are unsuitable for follow-up research to measure outcomes. In addition, there is no assurance for patients that they are receiving the interventions promised or of what dosage they are receiving. Furthermore, there is inconsistent or non-existent follow-up care. Public policy should be developed to correct the current situation. Conclusion: The current landscape of stem cell tourism should prompt a re-evaluation of current approaches to study cell-based interventions with respect to the design, initiation, and conduct of US clinical trials. Stakeholders, including scientists, clinicians, regulators and patient advocates, need to work together to find a compromise to keep patients in the US and within the clinical trial process. Using HIV/AIDS and breast cancer advocate cases as examples, we identify key priorities and goals for this policy effort.
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    Unproven Stem Cell-Based Interventions: Advancing Policy through Stakeholder Collaboration
    (2017) Matthews, Kirstin R.W.; Iltis, Ana S.; James A. Baker III Institute for Public Policy
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    Unproven stem cell–based interventions and achieving a compromise policy among the multiple stakeholders
    (BioMed Central, 2015) Matthews, Kirstin R.W.; Iltis, Ana S.
    Background: In 2004, patient advocate groups were major players in helping pass and implement significant public policy and funding initiatives in stem cells and regenerative medicine. In the following years, advocates were also actively engaged in Washington DC, encouraging policy makers to broaden embryonic stem cell research funding, which was ultimately passed after President Barack Obama came into office. Many advocates did this because they were told stem cell research would lead to cures. After waiting more than 10 years, many of these same patients are now approaching clinics around the world offering experimental stem cell-based interventions instead of waiting for scientists in the US to complete clinical trials. How did the same groups who were once (and often still are) the strongest supporters of stem cell research become stem cell tourists? And how can scientists, clinicians, and regulators work to bring stem cell patients back home to the US and into the clinical trial process? Discussion: In this paper, we argue that the continued marketing and use of experimental stem cell-based interventions is problematic and unsustainable. Central problems include the lack of patient protection, US liability standards, regulation of clinical sites, and clinician licensing. These interventions have insufficient evidence of safety and efficacy; patients may be wasting money and time, and they may be forgoing other opportunities for an intervention that has not been shown to be safe and effective. Current practices do not contribute to scientific progress because the data from the procedures are unsuitable for follow-up research to measure outcomes. In addition, there is no assurance for patients that they are receiving the interventions promised or of what dosage they are receiving. Furthermore, there is inconsistent or non-existent follow-up care. Public policy should be developed to correct the current situation. Conclusion: The current landscape of stem cell tourism should prompt a re-evaluation of current approaches to study cell-based interventions with respect to the design, initiation, and conduct of US clinical trials. Stakeholders, including scientists, clinicians, regulators and patient advocates, need to work together to find a compromise to keep patients in the US and within the clinical trial process. Using HIV/AIDS and breast cancer advocate cases as examples, we identify key priorities and goals for this policy effort.