This book approaches the problems and circumstances confronting blacks in the context of black values, the black community, and the role of government. ^BContents:: The Black Community's Values as a Basis for Action; The Community as Agent of Change; and The Government's Role in Meeting New Challenges.

A central problem for the international governance of heritable germline gene editing is that there are important differences in attitudes and values as well as ethical and health care considerations around the world. These differences are reflected in a complicated and diverse regulatory landscape. Several publications have discussed whether reproductive uses would be legally permissible in individual countries and whether clinical applications could emerge in the context of regulatory gaps and gray areas. Systematic comparative studies that explore issues related to (...) the governance of this technology from different national and international perspectives are needed to address the lack of knowledge in this area. In this research report, we contribute to filling this gap by presenting views of stakeholders in the United Kingdom on challenges to the governance of heritable genome editing. We present findings from a multistakeholder study conducted in the United Kingdom between October 2016 and January 2018 and funded by the Wellcome Trust. This research included interviews, literature analysis, and a workshop. We involved leading U.K. scientists, in vitro fertilization clinicians, and representatives from regulatory bodies, patient organizations, and other civil societal organizations, as well as fertility companies. Part one of this article explores stakeholder perceptions of possible global developments in heritable genome editing and associated risks and governance challenges. Part two presents a range of policy options that were generated during the workshop in relation to the challenges discussed in part one. (shrink)

Background Studying global health problems requires international multidisciplinary teams. Such multidisciplinarity and multiculturalism create challenges in adhering to a set of ethical principles across different country contexts. Our group on health system responses to violence against women (VAW) included two universities in a European high-income country (HIC) and four universities in low-and middle-income countries (LMICs). This study aimed to investigate professional and policy perspectives on the types, causes of, and solutions to ethical challenges specific to the ethics (...) approval stage of the global research projects on health system responses to VAW. Methods We used the Network of Ethical Relationships model, framework method, and READ approach to analyse qualitative semi-structured interviews (n = 18) and policy documents (n = 27). In March-July 2021, we recruited a purposive sample of researchers and members of Research Ethics Committees (RECs) from the five partner countries. Interviewees signposted policies and guidelines on research ethics, including VAW. Results We developed three themes with eight subthemes summarising ethical challenges across three contextual factors. The global nature of the group contributed towards power and resource imbalance between HIC and LMICs and differing RECs’ rules. Location of the primary studies within health services highlighted differing rules between university RECs and health authorities. There were diverse conceptualisations of VAW and vulnerability of research participants between countries and limited methodological and topic expertise in some LMIC RECs. These factors threatened the timely delivery of studies and had a negative impact on researchers and their relationships with RECs and HIC funders. Most researchers felt frustrated and demotivated by the bureaucratised, uncoordinated, and lengthy approval process. Participants suggested redistributing power and resources between HICs and LMICs, involving LMIC representatives in developing funding agendas, better coordination between RECs and health authorities and capacity strengthening on ethics in VAW research. Conclusions The process of ethics approval for global research on health system responses to VAW should be more coordinated across partners, with equal power distribution between HICs and LMICs, researchers and RECs. While some of these objectives can be achieved through education for RECs and researchers, the power imbalance and differing rules should be addressed at the institutional, national, and international levels. Three of the authors were also research participants, which had potential to introduce bias into the findings. However, rigorous reflexivity practices mitigated against this. This insider perspective was also a strength, as it allowed us to access and contribute to more nuanced understandings to enhance the credibility of the findings. It also helped to mitigate against unequal power dynamics. (shrink)

Armed with expanded federal funding for human embryonic stem cell research and new methods for deriving pluripotent stem cells, stem cell researchers in the U.S. are poised to proceed with unprecedented speed toward the development of new clinical therapies. Staring into the new dawn of regenerative medicine, many observers may assume that the only responsible route to the clinic, both scientifically and ethically, is through FDA-approved clinical trials processes. Conventional wisdom dictates that, like pharmaceutical drugs and the use of biological (...) therapeutics, stem cell-based therapies will have to pass through a series of controlled studies — initially to assess safety and toxicity, then efficacy and comparative efficacy — before they can be justifiably administered to patients outside a clinical trials context. (shrink)

This paper discusses exceptional circumstances under which patients outside of clinical trials are likely to receive innovative stem cell-based interventions. These circumstances involve: (1) stem cell interventions not initially amenable to a clinical trials approach; (2) expanded access to investigational stem cell products (“compassionate use”); and (3) off-label uses of FDA approved stem cell products. This paper proposes a new approach to regulating these exceptional cases.

There is increasing consensus that the right to health can provide ethical, policy and practical groundings for health systems development. The goals of the right to health are congruent with those of health systems development, which are about strengthening health promotion organizations and actions so as to improve public health. The poor shape and performance of health systems in Chad question the extent of realization of the right to health. Due to its comprehensiveness and inclusiveness, the right to health (...) has the potential of being an organizational and a normative backbone for public health policy and practice. It can then be understood and studied as an integral component of health systems development. (shrink)

Direct-to-consumer advertising of healthcare products refers to a variety of marketing practices based on a combination of information and promotion strategies directed at consumers through different media such as radio and television broadcasts, newspaper and magazine ads, and, more recently, through the Internet. The principal form of marketing used by the pharmaceutical industry is the distribution of free samples to physicians but DTCA is an increasing part of global promotional spending for prescription drugs. Latest estimates suggest that DTCA now represents (...) an annual $3.2 billion enterprise for the U.S. pharmaceutical industry. Findings from the literature show that these substantial efforts are geared toward the newer pharmaceuticals for chronic conditions with huge market potentials. The lion's share is going to the 20 most prescribed pharmaceuticals. (shrink)

Heart disease is the leading cause of death amongst adult Americans and has recently become a top killer worldwide. The direct costs of cardiovascular disease are projected to triple in the next 20 years, from $272.5 billion to $818.1 billion (Heidenreich et al. 2011). Although there has been a decreased incidence and prevalence of ischemic heart disease over the past several decades in the United States, heart failure remains a major cause of morbidity and mortality. In the United States, approximately (...) 500,000 to 700,000 new cases are identified each year (Lloyd-Jones et al. 2009). Heart failure is now the number one diagnosis leading to hospitalization. As such, it is an increasingly heavy economic burden on .. (shrink)

Evidence-based policy has support in many areas of government and in public affairs more generally. In this paper we outline what evidence-based policy is, then we discuss its strengths and weaknesses. In particular, we argue that it faces a serious challenge to provide a plausible, over-arching account of evidence. We contrast evidence-based policy with evidence-based medicine, especially the role of evidence in assessing the effectiveness of medicines. The evidence required for policy decisions does not easily lend (...) itself to randomized controlled trials, nor, for that matter, being listed in a single all-purpose hierarchy. (shrink)

Transcranial direct current stimulation (tDCS), a simple means of brain stimulation, possesses a trifecta of appealing features: it is relatively safe, relatively inexpensive and relatively effective. It is also relatively easy to obtain a device and the do-it-yourself (DIY) community has become galvanised by reports that tDCS can be used as an all-purpose cognitive enhancer. We provide practical recommendations designed to guide balanced discourse, propagate norms of safe use and stimulate dialogue between the DIY community and regulatory authorities. We call (...) on all stakeholders—regulators, scientists and the DIY community—to share in crafting policy proposals that ensure public safety while supporting DIY innovation. (shrink)

Vaccination policy is an ethically challenging domain of public policy. It is a matter of collective importance that reaches into the most private sphere of citizens and unavoidably conflicts with individual-based ethics. Policy makers need to walk a tight rope in order to complement utilitarian public health values with individual autonomy rights, protection of privacy, non-discrimination and protection of the worst-off. Whether vaccination is voluntary or compulsory, universal or targeted, every option faces complex ethical hurdles because of (...) the interdependence of humans in infectious disease matters. In this article, we explore the following three policy questions. (i) Ethically, which policy measures should be addressed when vaccination coverage is insufficient in a population? Information campaigns, legal compulsion, or the use of financial incentives can all be effective, but also controversial policy options. (ii) Is it ethical to target vaccination programs at certain risk-groups? If such measures are necessary, we argue that policymakers will often have to decide which is more important to uphold: non-discrimination or the protection of privacy. And (iii), what is the ethical significance of adverse herd immunity effects? Some vaccination programs will improve average population health, but will at the same time increase the risk of severe morbidity and mortality for individuals in the worst-off groups of society. (shrink)

This collection explores the subject of conflicts of interest. It investigates how to manage conflicts of interest, how they can affect well-meaning professionals, and how they can limit the effectiveness of corporate boards, undermine professional ethics, and corrupt expert opinion. Legal and policy responses are considered, some of which (e.g., disclosure) are shown to backfire and even fail. The results offer a sobering prognosis for professional ethics and for anyone who relies on professionals who have conflicts of interest. The (...) contributors are leading authorities on the subject in the fields of law, medicine, management, public policy, and psychology. The nuances of the problems posedby conflicts of interest will be highlighted for readers in an effort to demonstrate the manyways that structuring incentives can affect decision making and organizations' financial well-being. (shrink)

© JNCCN-Journal of the National Comprehensive Cancer Network.Background: Next-generation tumor sequencing panels, which include multiple established and novel targets across cancers, are emerging in oncology practice, but lack formal positive coverage by US payers. Lack of coverage may impact access and adoption. This study identified challenges of NGTS coverage by private payers.Methods: We conducted semi-structured interviews with 14 NGTS experts on potential NGTS benefits, and with 10 major payers, representing more than 125,000,000 enrollees, on NGTS coverage considerations. We used (...) the framework approach of qualitative research for study design and thematic analyses and simple frequencies to further describe findings.Results: All interviewed payers see potential NGTS benefits, but all noted challenges to formal coverage: 80% state that inherent features of NGTS do not fit the medical necessity definition required for coverage, 70% view NGTS as a bundle of targets versus comprehensive tumor characterization and may evaluate each target individually, and 70% express skepticism regarding new evidence methods proposed for NGTS. Fifty percent of payers expressed sufficient concerns about NGTS adoption and implementation that will preclude their ability to issue positive coverage policies.Conclusions: Payers perceive that NGTS holds significant promise but, in its current form, poses disruptive challenges to coverage policy frameworks. Proactive multidisciplinary efforts to define the direction for NGTS development, evidence generation, and incorporation into coverage policy are necessary to realize its promise and provide patient access. This study contributes to current literature, as possibly the first study to directly interview US payers on NGTS coverage and reimbursement. (shrink)

The increased use of human biological material for cell-based research and clinical interventions poses risks to the privacy of patients and donors, including the possibility of re-identification of individuals from anonymized cell lines and associated genetic data. These risks will increase as technologies and databases used for re-identification become affordable and more sophisticated. Policies that require ongoing linkage of cell lines to donors’ clinical information for research and regulatory purposes, and existing practices that limit research participants’ ability to control what (...) is done with their genetic data, amplify the privacy concerns. (shrink)

Understanding the clinical significance of variants associated with hereditary cancer risk requires access to a pooled data resource or network of resources—a “cancer gene variant commons”—incorporating representative, well-characterized genetic data, metadata, and, for some purposes, pathways to case-level data. Several initiatives have invested significant resources into collecting and sharing cancer gene variant data, but further progress hinges on identifying and addressing unresolved policy issues. This commentary provides insights from a modified policy Delphi process involving experts from a range (...) of stakeholder groups involved in the data-sharing ecosystem. In particular, we describe policy issues and options generated by Delphi participants in five domains critical to the development of an effective cancer gene variant commons: incentives, financial sustainability, privacy and security, equity, and data quality. Our intention is to stimulate wider discussion and lay a foundation for further work evaluating policy options more in-depth and mapping them to those who have the power to bring about change. Addressing issues in these five domains will contribute to a cancer gene variant commons that supports better care for at-risk and affected patients, empowers patient communities, and advances research on hereditary cancers. (shrink)

This book examines the threat that climate change poses to the projects of poverty eradication, sustainable development, and biodiversity preservation. It offers a careful discussion of the values that support these projects and a critical evaluation of the normative bases of climate change policy. This book regards climate change policy as a public problem that normative philosophy can shed light on. It assumes that the development of policy should be based on values regarding what is important to (...) respect, preserve, and protect. What sort of climate change policy do we owe the poor of the world who are particularly vulnerable to climate change? Why should our generation take on the burden of mitigating climate change that is caused, in no small part, by emissions from people now dead? What value is lost when natural species go extinct, as they may well do en masse because of climate change? This book presents a broad and inclusive discussion of climate change policy, relevant to those with interests in public policy, development studies, environmental studies, political theory, and moral and political philosophy. (shrink)

The state members of the European Union have witnessed the emergence of equality policies which target discrimination on the grounds of sexual orientation and gender identity. These are usually based on the single issue model focusing exclusively on discrimination suffered by LGBT people, however there are other approaches to this issue which take into account the interaction of different axes of inequality, namely, the multiple and intersectional discrimination models. This article analyses the implications of these three models from a theoretical (...) and empirical perspective, pointing out their respective advantages and disadvantages. (shrink)

This volume was initiated to meet the challenges of the increasing contemporary trend to "treat" substance users (in the broadest sense of this concept), whether in institutional settings, ambulatory programs, or even controlled environments such as prisons. Although several essays concentrate more particularly on some of the ethico-moral problems encountered by juridico-moral interventions--problems relating to criminalization, decriminalization, legalization, and interdiction--the main focus is on broadly medical or therapeutic responses to drug use, and in particular on problems encountered within the (...) domain of drug user counseling. Codes of ethics for drug user counselors can be found as an appendix. (shrink)

The article explores some of the issues that have arisen in the discourse on pharmaceutical cognitive enhancement (PCE), that is, the use of stimulant drugs such as methylphenidate, amphetamine and modafinil by healthy individuals of various populations with the aim of improving cognitive performance. Specifically, we explore the presumed sizes of existing PCE user populations and the policy actions that have been proposed regarding the trend of PCE. We begin with an introductory examination of the academic stances and philosophical (...) issues involved in defining PCE. We then focus on an examination of the population sizes of presumed current PCE users that have been listed in the academic literature on PCE, on presuppositions, which have been problematized by some authors as based on anecdotal or misinterpreted survey data. We follow this with an empirical examination of a potential PCE user population in a national context (students at the University of Ljubljana in Slovenia). We then proceed to examine the regulatory options proposed in the academic literature to address PCE, finally comparing them with an empirical overview of the policy recommendations on PCE produced in the multinational context of several national ethics advisory bodies (EABs) in Europe. Our main conclusion is that there is still little debate among the national EABs on what type of public policy responses, if any, are needed to address PCE in European countries, and that the issues they do address are similar to those discussed and proposed in the academic articles on PCE. (shrink)

Human infection challenge studies provide illuminating case studies for several ongoing debates in research ethics, including those related to research risks and payment of participants. Grimwade et al 1 add to previous public engagement, qualitative evidence and philosophical literature on these topics.1–8 The authors advocate revision of research payment policy and practice based on their main finding that members of the public endorse ex ante payment of participants proportional to research-related risk exposure, in addition to post hoc compensation for (...) any lasting harms that occur.1 Although ‘payment for risk’ would diverge from most current research ethics guidelines, it is noteworthy that the difference in payment to participants that their framework would allow might only be small, at least in the case of currently accepted studies. The absolute difference would likely be small because the risk of currently accepted HCS participation is usually very low.9 10 On a ‘value of statistical life’ approach, mirroring actuarial accounting for fatal risks, a 1 in 100 000 risk of death might attract an extra payment of only US$96.1 Most HCS do not involve fatality risks this high, although, on pessimistic estimates, the risk of COVID-19 HCS in young healthy adults might involve similar levels of risk.11 Such risks might arguably be justified by large expected public health benefits,12,9 11 13 but it remains controversial whether higher levels of payment could …. (shrink)

Drawing on Sir Ian Kennedy's extensive experience in healthcare law, ethics and public policy-making, this book explores vital issues in the law surrounding healthcare and regulation. The book contains a range of published and unpublished essays and speeches with the addition of notes and commentaries by the author that bring the pieces up to the present day. Those who want to understand developments, from transplants to confidentiality, from COVID-19 to public inquiries to regulation will find a rich seam of (...) rigorous, informed analysis. The author's unique range of experience allows him to share insights on a variety of issues; from the conduct of the disgraced breast surgeon, Ian Paterson, to research at Porton Down, to the economics of innovation in drug development at NICE. His abiding interest in the welfare of children informs his trenchant forensic examination of how children fare in the NHS. Those involved in or with an interest in law, moral philosophy, and public policy will find much food for thought. (shrink)

This article analyzes the concept of “grand challenges” as part of a shift in how scientists and policymakers frame and communicate their respective agendas. The history of the grand challenges discourse helps to understand how identity work in science and science policy has been transformed in recent decades. Furthermore, the question is raised whether this discourse is only an indicator, or also a factor in this transformation. Building on conceptual history and historical semantics, the two parts of (...) the article reconstruct two discursive shifts. First, the observation that in scientific communication references to “problems” are increasingly substituted by references to “challenges” indicates a broader cultural trend of how attitudes towards what is problematic have shifted in the last decades. Second, as the grand challenges discourse is rooted in the sphere of sports and competition, it introduces a specific new set of societal values and practices into the spheres of science and technology. The article concludes that this process can be characterized as the sportification of science, which contributes to self-mobilization and, ultimately, to self-optimization of the participating scientists, engineers, and policymakers. (shrink)

As an approach to public engagement, deliberation has the potential to pursue a range of goals identified by public participation theorists including the opportunity to substantively inform policy processes, increase the public’s knowledge and understanding of public issues and create or restore loss of public trust and confidence in public institutions. Baum and colleagues (2009) offer several important take-home messages for policy makers and public health leaders about the value of engaging with the public about ethically challenging, value-laden (...) and resource intensive policy issues such as pandemic response planning. (shrink)

This chapter focuses on the aims and challenges of the creative ageing policy. It tries to provide an integrated summary of discussions undertaken in the field of the arts and ageing. The chapter also underlines associations of this discourse with health care, social services, and other topics such as social and technological innovations for ageing societies.

Evidence-based policy is gaining support in many areas of government and in public affairs more generally. In this paper we outline what evidence—based policy is then discuss its strengths and weaknesses. In particular, we argue that it faces a serious challenge to provide a plausible account of evidence. This account needs to be at least in the spirit of the hierarchy of evidence subscribed to by evidence-based medicine (from which evidence—based policy derives its name and inspiration). Yet (...) evidence-based policy’s hierarchy needs to be tailored to the kinds of evidence relevant and available to the policy arena. The evidence required for policy decisions does not easily lend itself to randomised controlled trials (the "gold standard" in evidence-based medicine), nor, for that matter, being listed in a single all—purpose hierarchy. (shrink)

Inducement prizes have been long used to stimulate individuals and groups to accomplish diverse goals. Lately, governments have become more and more interested in these prizes and sought to include this kind of incentives within the set of policy tools available to promote science, technology, and innovation. To date, however, there has been little empirically-based scientific knowledge on how to design, manage, and evaluate innovation prizes. This note discusses aspects of the prize phenomenon and the opportunities and challenges (...) related with the use of innovation prizes as a government policy instrument. Compared to other incentive mechanisms, prizes are likely to present advantages to, for example, accelerate the development and commercialization of technologies that are held back for diverse reasons and help to leverage public money with external ideas, collaborative efforts, and the participation of diverse individuals and organizations. Still, despite these advantages and other interesting features of prizes, there are key questions that policy-makers and scholars must address to better understand this kind of incentives and further improve prize designs and implementations before governments move forward to a more widespread use of innovation prizes in science and technology policies. (shrink)

Overby and colleagues (2015) draw our critical attention to a variety of ethical challenges associated with the practice of controlled donation after circulatory determination of death (cDCDD). Alt...

This volume-"Selected Contemporary Challenges of Aging Policy"-is the most international of all published monographs from the series "Czech-Polish-Slovak Studies in Andragogy and Social Gerontology." Among the scholars trying to grasp the nuances and trends of social policy, there are diverse perspectives, resulting not only from the extensive knowledge of the authors on the systematic approach to the issue of supporting older people but also from the grounds of the represented social gerontology schools. In the texts of Volume (...) VII interesting are both distinct and coherent elements presenting the role of local, regional and global policies in the prism of the countries from which the authors originate: the Czech Republic, Slovenia, Lithuania, Latvia, Poland, Slovakia, Italy, Turkey, and the United States. The chapters show a wealth of methodological approaches to the perception of social policy and its tools. In the texts there are issues related to the idea of active ageing, discrimination against older people in the workplace, comparability of solutions friendly to employment of older adults in the Czech Republic, Poland, and Slovakia as well as focused on the importance of educational forms determining an active life in old age. This monograph also attempted to answer the question regarding how to transfer the idea of intergenerational learning into the realm of practice. This issue complements the chapter on the implementation of intergenerational programs in institutions providing long-term care support. The book also outlines a public policy on ageing in the perspective of the changes over the last few decades and the case demonstrating solutions to accelerate self-reliance as a key to active ageing. We hope that seventh volume of our series will be an intellectual stimulus for further international research on change in social policy and will contribute to the dissemination of best practices as well as contribute to positive social change. (shrink)

The expansion of the corpus of international human rights to include the right to water and sanitation has implications both for the process of recognizing human rights and for future developments in the relationships between technology, engineering and human rights. Concerns with threats to human rights resulting from developments in science and technology were expressed in the early days of the United Nations (UN), along with the recognition of the ambitious human right of everyone “to enjoy the benefits of scientific (...) progress and its applications.” This comment explores the hypothesis that the emerging concepts most likely to follow recognition of the human right to water primarily involve issues of science and technology, such as access to medicines or clean and healthy environment. Many threats to human rights from advances in science, which were identified in the past as potential, have become real today, such as invasion of privacy from electronic recording, deprivation of health and livelihood as a result of climate change, or control over individual autonomy through advances in genetics and neuroscience. This comment concludes by urging greater engagement of scientists and engineers, in partnership with human rights specialists, in translating normative pronouncements into defining policy and planning interventions. (shrink)

Farm animal welfare in livestock production is a topical and important issue attracting growing interest of policy makers, consumers, stakeholders in the supply chain and others. While there is much public interest in the issue this is not reflected in the supply and market shares of animal food products that are produced under welfare standards that exceed legislative requirements. Given the obstacles to devising stricter legislative standards, higher welfare animal food products are mostly made available through market-based approaches. This (...) paper discusses different challenges and opportunities for a range of public and consumer policies and makes recommendations on how these might be strengthened. The paper does not report primary empirical findings but assembles available knowledge on citizen and consumer attitudes and perceptions towards animal welfare from various research disciplines. We argue that in order for public and consumer policies to be (more) efficient and effective, it is important to develop a segmented and targeted strategy. This paper will thus elaborate on what information could and should be provided to whom. This implies the need for a good understanding of how people conceptualize farm animal welfare. Further, information provisioning should address the needs and expectations of those specific consumer segments most likely to be motivated to purchase higher welfare products. Based on the assembled information, opportunities and challenges for information provisioning and communication to the public and consumers are identified. The merits and limitations of different forms of information provisioning and animal welfare labelling are discussed and recommendations are set forth for future research. (shrink)

Malaysia is a multi-ethnic religious country with a population of 28.5 million, it is characterised by mainly three ethnic groups-Malay and indigenous people, Chinese, and Indians. Ever since independence in 1957, Malaysia has successfully transformed itself from a poor country into a middle-income nation. The Malaysian economy has seen a periodic growth despite challenging external factors. It can also definitely claim its success of combat against poverty. Despite its poverty reduction success, there still remains a vulnerable group of people in (...) the country experiencing poverty for some geographical and societal reasons. This concept paper has several objectives: A brief description of the country’s nature of poverty, poverty reduction policies and programs, and an analysis facing the challenges and recommendations for a sustainable poverty reduction in Malaysia. (shrink)

Listening to other cultures offers challenges to our fundamental assumptions and world views. In New Zealand public policy on Assisted Reproductive Technology is being worked out in a society committed to the development of bicultural partnership honouring the Treaty of Waitangi, a treaty with the indigenous people.Strong claims to the cultural significance of genetic heritage by Maori have made apparent to non-Maori their own assumptions. These claims also resist reductive understandings of genetics.In this paper I review, as a (...) Pakeha ethicist, initiatives taken in New Zealand, and the impact of bicultural development on public policy on ART. I also discuss some of the issues this raises for western bioethics as it relates to non-western approaches and include reference to the significance of genetic heritage as it is affecting guidelines for donor insemination and surrogacy. (shrink)