The paper is intended to focus on peculiarities of nanomedicine and the importance of social concerns implicated, in order to understand if existing regulations are appropriate to maintain its safety or if a new ad hoc regulatory framework is needed. Consideration of social challenges will underline the crucial role of medical ethics in regulatory discussion.

The regulation of stem cell research is an issue that has drawn much comment, criticism and even judicial arbitration in recent years. An emerging issue, addressed in this article, is how the fruits of that research-stem cell medicine-are likely to be regulated en route from lab to market. Taking account of the ethical, legal, social and safety issues raised by stem cell medicine and the goals of governance, the article explains the relevant regulatory instruments (e.g. the draft UK (...) Stem Cell Bank Code, the EU Directive on Human Tissue, the EU Directives on medical products and devices, and the Human Tissue Act 2004) and critically examines the framework they provide. (shrink)

While acknowledging the potential benefits of pharmacogenomics as a methodology, a number of comprehensive reports in the past several years examine a multitude of ethical, legal, and social factors that may limit the extent to which these benefits are realized — and realized in ethically acceptable ways. This article aims to identify and explore the most basic ethical and regulatory issues that are likely to arise if pharmacogenomics becomes widely enough used to have a significant impact on research (...) and clinical practice. First, however, it addresses the question of whether pharmacogenomic tests are unique when compared to other genetic tests and thus deserving of more or less stringent ethical and regulatory requirements. (shrink)

Regulation must target the financial sector, which often funds and profits from environmentally unsustainable development. In an era of global financial markets, the financial sector has a crucial impact on the state of the environment. The long-standing movement for ethically and socially responsible investment (SRI) has recently begun to advocate environmental standards for financiers. While this movement is gaining more adherents, it has increasingly justified responsible financing as a path to be prosperous, rather than virtuous. This trend partly owes to (...) how financial institutions view their legal responsibilities. The business case motivations that now predominantly drive SRI are not sufficient to make the financial sector a means to sustainable development. Some modest legal reforms to improve the quality and extent of SRI have yet to make a tangible difference. A more ambitious strategy to promote SRI for environmental sustainability is possible, based on reforming the fiduciary duties of financial institutions. Such duties, tied to concrete performance standards, could make financiers invest in more ethically responsible ways. Other collateral reforms to financial markets, including improved corporate environmental reporting, are required to promote sustainability. (shrink)

ABSTRACTIt has been estimated that more than 80% of people in Africa use traditional medicine . With the HIV/AIDS epidemic claiming many lives in Africa, the majority of people affected rely on TM mainly because it is relatively affordable and available to the poor populations who cannot afford orthodox medicine. Whereas orthodox medicine is practiced under stringent regulations and ethical guidelines emanating from The Nuremburg Code,1 African TM seems to be exempt from such scrutiny. Although recently there have been calls (...) for TM to be incorporated into the health care system, less emphasis has been placed on ethical and regulatory issues.In this paper, an overview of the use of African TM in general, and for HIV/AIDS in particular, is given, followed by a look at: the relative laxity in the application of ethical standards and regulatory requirements with regards to TM; the importance of research on TM in order to improve and demystify its therapeutic qualities; the need to tailor‐make intellectual property laws to protect traditional knowledge and biodiversity. A framework of partnerships involving traditional healers’ associations, scientists, policy makers, patients, community leaders, members of the communities, and funding organizations is suggested as a possible method to tackle these issues. It is hoped that this paper will stimulate objective and constructive debate that could enhance the protection of patients’ welfare. (shrink)

The capacity to treat pain has never been greater; but, as you will read in the articles that follow, the problem of undertreated and neglected pain in the United States persists. Deep-seated perceptions and practices undergird this strong and well-documented pattern of neglect. Among the reasons frequently noted for the inadequacy of treatment for pain, however, is that the legal system actually penalizes effective interventions to relieve pain while it leaves neglect of pain unthreatened. It is the mission of the (...) American Society of Law, Medicine & Ethics to explore areas, such as this one, where developments in medicine directly encounter the law and, in turn, create ethical issues for clinicians, regulators, patients, and lawyers.This special issue of the Journal of Law, Medicine & Ethics is part of a multi-year project in which ASLME, with the wonderful support of the Mayday Fund, has worked to address legal and regulatory barriers to effective pain relief. (shrink)

The capacity to treat pain has never been greater; but, as you will read in the articles that follow, the problem of undertreated and neglected pain in the United States persists. Deep-seated perceptions and practices undergird this strong and well-documented pattern of neglect. Among the reasons frequently noted for the inadequacy of treatment for pain, however, is that the legal system actually penalizes effective interventions to relieve pain while it leaves neglect of pain unthreatened. It is the mission of the (...) American Society of Law, Medicine & Ethics to explore areas, such as this one, where developments in medicine directly encounter the law and, in turn, create ethical issues for clinicians, regulators, patients, and lawyers.This special issue of the Journal of Law, Medicine & Ethics is part of a multi-year project in which ASLME, with the wonderful support of the Mayday Fund, has worked to address legal and regulatory barriers to effective pain relief. (shrink)

Human Biological Materials are an invaluable resource in biomedical research. Objective To determine if researchers and a Research Ethics Committee at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Study Design Ethically approved retrospective cross-sectional descriptive audit. Results Of the 1305 protocols audited, 151 fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors were from the USA . The principle investigators in all 151 protocols informed the (...) REC of their intent to store HBMs. Only 132 protocols informed research participants . In 148 protocols informed consent was obtained from research participants, 116 protocols solicited broad consent compared to specific consent [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC than the research participants that HBMs would be exported . Export permits and Material Transfer Agreements were not available in 109 and 143 protocols, respectively. Conclusions Researchers and the REC did not adequately address the inter-related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (shrink)

Human Biological Materials (HBMs) are an invaluable resource in biomedical research.ObjectiveTo determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries.Study DesignEthically approved retrospective cross‐sectional descriptive audit.ResultsOf the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 protocols informed (...) the REC of their intent to store HBMs. Only 132 protocols informed research participants (P < 0.0001). In 148 protocols informed consent (IC) was obtained from research participants, 116 protocols (76.8%) solicited broad consent compared to specific consent (32; 21.2%) [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC (90) than the research participants (67) that HBMs would be exported (p = 0.011). Export permits (EPs) and Material Transfer Agreements (MTAs) were not available in 109 and 143 protocols, respectively.ConclusionsResearchers and the REC did not adequately address the inter‐related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (shrink)

Recent developments of three-dimensional printing of biomaterials in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more particular (...) ethical issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article considers whether there is a limit as to what should be bioprinted in medicine; examines key risks of significant harm associated with testing 3D bioprinting for humans; investigates the clinical trial paradigm used to test 3D bioprinting; analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments. (shrink)

Several lines of evidence suggest that children born via Cesarean section are at greater risk for adverse health outcomes including allergies, asthma and obesity. Vaginal seeding is a medical procedure in which infants born by C-section are swabbed immediately after birth with vaginal secretions from the mother. This procedure has been proposed as a way to transfer the mother's vaginal microbiome to the child, thereby restoring the natural exposure that occurs during vaginal birth that is interrupted in the case of (...) babies born via C-section. Preliminary evidence indicates partial restoration of microbes. However, there is insufficient evidence to determine the health benefits of the procedure. Several studies, including trial, are currently underway. At the same time, in the clinic setting, doctors are increasingly being asked to by expectant mothers to have their babies seeded. This article reports on the current research on this procedure and the issues it raises for regulators, researchers, physicians, and patients. (shrink)

Researchers have used drones to track wildlife populations, monitor forest fires, map glaciers, and measure air pollution but have only begun to consider how to use these unmanned aerial vehicles to study human beings. The potential use of drones to study public gatherings or other human activities raises novel issues of privacy, confidentiality, and consent, which this article explores in depth. It argues that drone research could fall into several different categories: non-human subjects research, exempt HSR, or non-exempt HSR. (...) In the case of non-exempt HSR, it will be difficult for institutional review boards to approve studies unless they are designed so that informed consent can be waived. Whether drone research is non-HSR, exempt HSR, or non-exempt HSR, it is important for investigators to consult communities which could be affected by the research. (shrink)

Patients who search for a better treatment, an increased quality of life, or even a chance to preserve life itself may claim to have an interest in accessing investigational medicinal products (IMP), particularly when no validated treatment for their disease or condition exists. For many, awaiting the uncertain and time-consuming process of converting an IMP into an approved drug may not appear a realistic option, as prognoses may be grim and a dramatic outcome may seem hard to avert. Gaining access (...) to an IMP, however, often proves to be a difficult enterprise with a highly uncertain outcome. In addition, the process of seeking access to IMP is surrounded by various ethical issues that will be explored in this article. This paper explores the ethical concerns in two potential tracks of seeking access to IMP for minors: on an individual basis, or collectively, as a patient organisation. In this discourse, several unique ethical and regulatory concerns related to the direct negotiation of access to IMP for minor patients are identified, with a focus on product safety, the recruitment of research subjects, the unnoticed entry of market mechanisms in the recruitment of research subjects, and the sidelining of third parties in the recruitment process. The paper concludes with a concise reflection on the way forward. The quest for access to investigational drugs is particularly relevant to paediatric practice, in which a significant share of the drugs prescribed has never been tested in children or labelled for use in the paediatric population. (shrink)

Regulating technologies, innovations and risks is an activity that, as much as scientific research needs proofs and evidence. It is the site of development of a distinct kind of science, regulatory science. This special issue addresses the question of the standards of knowledge governing how we test, assess and monitor technologies and their effects. This topic is relevant and timely in the light of problematics of regulation of innovation, regulatory failure and capture. Given the enormous decisions and stakes (...) regulatory science commends, it becomes crucial to ask where its standards come from and gain credibility, but also what valuations of technology and appreciations of their risks or benefits do they embed, and who controls them? This paper introduces the four contributions comprising the special issue, and outlines a perspective from which to question the construction of regulatory science or, in the terminology adopted here, the authorization and standardization of regulatory knowledge, particularly the role of networks of scientific experts therein. (shrink)

BackgroundThis paper highlights the issues that one of the 90 Italian Research Ethics Committees (RECs) might encounter during the approval phase of a clinical trial to identify corrective and preventive actions for promoting a more efficient review process and ensuring review quality. Publications on the subject from Italy and the rest of Europe are limited; encouraging constructive debate can improve RECs’ service to the subject of the clinical trial.MethodsWe retrospectively reviewed a cohort of 822 clinical trial protocols, initially reviewed (...) by REC, from June 2014 to December 2018. Data collected for each protocol were type of trial, sample size, use of placebo, number and kind of revisions requested by the REC before approval, and time taken for approval. Data for each protocol were collected by a trained clinical research assistant using the REC’s files and electronic archives.ResultsAlmost 45% of the reviewed studies (374/822) required clarifications, significant changes to the documentation, or minor changes before final approval.ConclusionsPreventive measures are needed to reduce the number of requested corrections and thus also the time required for approval, while maintaining review quality. All critical points and proposals presented in this paper require harmonization through updates to European regulations, as regulatory harmonization produces better compliance with rules and reduces the number of changes required before the trials’ final approval. Such updates include the development of standardized formats for informed consent, the verification of any evidence in favor of using off-label treatments over placebo as comparators, using multidisciplinary staff in clinical trials with children and adolescents, improving the legal definition of RECs to assign responsibilities and ensure independence, and providing guidance for RECs to engage clinical research assistants in internal audits. (shrink)

In the biomedical field, calls for the generation of new regulations or for the amendment of existing regulations often follow the emergence of apparently new research practices (such as embryonic stem cell research), clinical practices (such as facial transplantation) and entities (such as Avian Influenza/’Bird Flu’). Calls for regulatory responses also arise as a result of controversies which bring to light longstanding practices, such as the call for increased regulation of human tissue collections that followed the discovery of unauthorised (...) post-mortem organ retention. Whilst it seems obvious that new regulations should only be generated if existing regulations are inadequate (a practice referred to in this paper as ‘regulatory syncretism’), this does not always occur in practice. This paper examines the conceptual steps involved in generating regulatory responses to emerging phenomena. Two decision points are identified. First, a stance is taken as to whether the emerging phenomenon raises unique ethical or legal issues (exceptionalism versus non-exceptionalism). Second, the decision is made as to whether new regulation should be generated only for truly unique phenomena (syncretism versus asyncretism). It is argued here that it is important to make a careful assessment of novelty, followed by a reflective and deliberate choice of regulatory syncretism or asyncretism, since each type of regulatory response has advantages which need to be harnessed and disadvantages which need to be managed—something that can only occur if regulators are attentive to the choices they are making. (shrink)

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

Regulatory authorities have advised smokers who would not or could not quit smoking to switch to lower tar cigarettes. Smoking such cigarettes was seen as a means of reducing the harm caused by smoking, but not as offering a ‘safe’ smoking option. Correspondingly manufacturers have been required to place tar and nicotine information on packet labels and/or advertisements. This paper explores the possibility that the conventional format for conveying tar and nicotine information could be responsible for the belief, held (...) by a significant proportion of smokers, that some brands of lower tar cigarettes are absolutely ‘safe’. To deal with this situation it is suggested that changes should be made to health warnings, and tar and nicotine communications. Proposed changes to the latter are evaluated in terms of their ethical and public health implications. The authors conclude that brand specific warnings and a classification of cigarettes as either ‘Very Dangerous’ or ‘Dangerous’, is best suited to reconciling consumer needs for information with the public health objectives of reducing the harm caused by smoking. (shrink)

As social media becomes increasingly popular, human subjects researchers are able to use these platforms to locate, track, and communicate with study participants, thereby increasing participant retention and the generalizability and validity of research. The use of social media; however, raises novel ethical and regulatory issues that have received limited attention in the literature and federal regulations. We review research ethics and regulations and outline the implications for maintaining participant privacy, respecting participant autonomy, and promoting researcher transparency when (...) using social media to locate and track participants. We offer a rubric that can be used in future studies to determine ethical and regulation-consistent use of social media platforms and illustrate the rubric using our study team’s experience with Facebook. We also offer recommendations for both researchers and institutional review boards that emphasize the importance of well-described procedures for social media use as... (shrink)

The revised Common Rule includes a new option for the conduct of secondary research with identifiable data and biospecimens: regulatory broad consent. Motivated by concerns regarding autonomy and trust in the research enterprise, regulators had initially proposed broad consent in a manner that would have rendered it the exclusive approach to secondary research with all biospecimens, regardless of identifiability. Based on public comments from both researchers and patients concerned that this approach would hinder important medical advances, however, regulators decided (...) to largely preserve the status quo approach to secondary research with biospecimens and data. The Final Rule therefore allows such research to proceed without specific informed consent in a number of circumstances, but it also offers regulatory broad consent as a new, optional pathway for secondary research with identifiable data and biospecimens. In this article, we describe the parameters of regulatory broad consent under the new rule, explain why researchers and research institutions are unlikely to utilize it, outline recommendations for regulatory broad consent issued by the Secretary's Advisory Committee on Human Research Protections, and sketch an empirical research agenda for the sorts of questions about regulatory broad consent that remain to be answered as the research community embarks on Final Rule implementation. (shrink)

The presented paper focuses on the analysis of strategic documents at the level of the European Union concerning the regulation of artificial intelligence as one of the so-called disruptive technologies. In the first part of the article, we outline the basic terminology. Subsequently, we focus on the summarizing and systemizing of the key documents adopted at the EU level in terms of artificial intelligence regulation. The focus of the paper is devoted to issues of personal data protection and cyber (...) security included in these strategic documents. The final part contains recommendations for future research and evaluation of its key features. (shrink)

Medicines regulators have generally adopted a scientistic view of medicines evaluation, which they present as an exercise that should—and indeed can—be purely “objective,” based only on knowledge produced through validated research protocols. The growing body of social science literature analyzing the regulation of medicines has questioned this pretense of objectivity and underlined the socio-political construction of evidence on the risks and benefits of medicines. But while the European Medicines Agency has become the dominant regulatory body in Europe and a (...) key player at world level, very few studies have investigated its actual practices. Based on interviews with European regulators, but also on direct observations of several meetings of the European Medicines Agency’s main expert committee, this article aims to analyze how regulatory knowledge is defined and then transformed into regulatory decisions. First, it describes the main characteristics of European medicines regulation and the historical definition of what can count as “objective” evidence on the safety and efficacy of medicines. Second, it demonstrates that experts use many different types of knowledge in building their opinions: the results of studies, but also knowledge about firms’ past and present strategies, about patients’ needs and future behavior, about the state of research and clinical practices, and about legal and policy-making issues. Third, it explains why, in spite of the various forms of knowledge involved, experts manage to produce consensual opinions on medicines and why these opinions are considered genuine decisions in the sector. (shrink)

This article addresses issues of regulatory convergence and Europeanization as they have developed within the agrochemicals sector. Taking the United Kingdom as a case study, the article considers the continuing importance of local and national factors within systems that are ostensibly international and standardized. In particular, the article shows how the embedded social relations of regulatory science in the United Kingdom, including institutional practices, judgments of expertise, and established relationships of trust, result in a “nation centeredness” and (...) divergence of regulatory cultures despite the putative development of a harmonized European framework. It is argued that, as a consequence, the claimed universalism of scientific culture in this area is in tension with the local conditions of its practice and enactment. (shrink)

This paper addresses recent calls to study the role of the state in private regulation. Integrating current scholarship on the state as a catalyst of private regulatory regimes with prior literature on regulatory failure and self-regulation, it identifies and problematizes unsettled assumptions used as a starting point by this growing body of research. The case study traces the evolution of public debates and the interaction of different regulatory initiatives dealing with corporate social responsibility issues in Canada’s (...) mining industry. Findings reveal the conditions under which the state is more likely to encourage firm-level, fragmented initiatives than facilitate and promote industry-wide regulatory strengthening and consolidation. I discuss the need for greater analytical precision regarding the variation in regulatory policy preferences across time and branches of government and the interaction between public and private regulatory initiatives. The conclusion outlines suggested areas for future research as well as the likely outcome of Canada’s current CSR policy framework. (shrink)

Placebo-controlled trials are held by many, including regulators at agencies like the United States Food and Drug Administration, to be the gold standard in the assessment of new medical interventions. Yet the use of placebo controls in clinical trials has been the focus of considerable controversy. In this two-part article, we challenge a number of common beliefs concerning the value of placebo controls. Part I critiques statistical and other scientific justifications for the use of placebo controls in clinical research. The (...) continued use of placebo controls in clinical trials on diseases for which accepted treatment exists raises equally important ethical, legal, and regulatory issues for which various justifications have been given. Defense of this practice relies on normative as well as empirical myths.In their attack on the prevailing use of placebo controls, Kenneth Rothman and Karin Michels emphasize that this practice stands in violation of the World Medical Association's guidelines on the ethics of human experimentation, most commonly known as the Helsinki Declaration. (shrink)

This special issue gathers together a selection of papers presented by international experts during a workshop entitled ‘Ethics of Cyber-Conflicts’, which was devoted to fostering interdisciplinary debate on the ethical and legal problems and the regulatory gap concerning cyber conflicts. The workshop was held in 2013 at the Centro Alti Studi Difesa in Rome under the auspices of the NATO Cooperative Cyber Defence Centre of Excellence . This NATO-accredited international military organisation that has always placed a high value on (...) an interdisciplinary approach to cyber defence, uniting as it does perspectives from technical, policy, legal, and strategic domains. The Centre’s mission is to enhance capability, cooperation, and information-sharing between NATO, its member states, and partner countries in the area of cyber defence by virtue of research, education, and consultation. The workshop was one of the projects supported by the Centre to achieve this mission.Readers may .. (shrink)

Means–ends decoupling has recently been suggested as one consequence of the problems organizations face in trying to comply with institutional rules in contexts of institutional complexity. Such decoupling is characterized by the adoption, implementation, and scrutiny of particular codes of practice, which tend not to deliver the outcomes they were developed to produce. Recent scholarship focusing on this issue has suggested that such decoupling is a consequence of the trade-off organizations need to make between compliance and goal achievement, most especially (...) when the latter is difficult to evaluate. Although recent scholarship has suggested that this tension might be mitigated by the activities of developers of compliance rules, in this article, we explore how actors internal to organizations, in this case, two charitable organizations, mitigate this tension via nonconformance with particular codes. We focus on how the process of accounting for nonconformance results in the discursive coupling of means and ends as actors creatively develop vocabularies of motive, which respond to anticipated social criticism. (shrink)

While substantial evidence is emerging internationally of positive increases in the participation of women on company boards, there is less evidence of any significant change in the proportion of women in senior executive ranks. This paper describes evidence of positive changes in the number of women on boards in Australia. Unfortunately these changes are not mirrored in the senior executive ranks where the proportion of women remains consistently low. We explore some of the reasons for these disproportionate changes and examine (...) the likely effect of the recent amendments to the Australian stock exchange’s corporate governance code designed to improve gender diversity both on boards and throughout organisations. Based on the early corporate response to these regulatory changes, it is interesting to consider whether Australia’s approach in promoting voluntary self-regulation at the corporate level may be as effective in the long run as the emerging trend in Europe to apply legislated quotas for female corporate board representation. Interview evidence is presented suggesting that the primary reasons for the lack of women in leadership are not simply lack of opportunity at the apex of the corporation, but issues at mid-management level that are unlikely to be resolved by mandatory board quotas. In some circumstances carefully monitored voluntary targets may be more effective at promoting cultural and strategic change at the heart of the corporation. In summary, mandatory quotas may achieve early and significant results in terms of female board representation. However, voluntary targets for women’s participation on boards and in executive ranks may promote more effective cultural and practical change in support of greater representation of women in leadership. (shrink)

Controlled human infection challenge studies (CHIs) involve intentionally exposing research participants to, and/or thereby infecting them with, micro‐organisms. There have been increased calls for more CHIs to be conducted in low‐ and middle‐income countries (LMICs) where many relevant diseases are endemic. This article is based on a research project that identified and analyzed ethical and regulatory issues related to endemic LMIC CHIs via (a) a review of relevant literature and (b) qualitative interviews involving 45 scientists and ethicists with (...) relevant expertise. In this article we argue that though there is an especially strong case for conducting CHIs in endemic (LMIC) settings, certain ethical issues related to the design and conduct of such studies (in such settings) nonetheless warrant particularly careful attention. We focus on ethical implications of endemic LMIC CHIs regarding (a) potential direct benefits for participants, (b) risks to participants, (c) third‐party risks, (d) informed consent, (e) payment of participants, and (f) community engagement. We conclude that there is a strong ethical rationale to conduct (well‐designed) CHIs in endemic LMICs, that certain ethical issues warrant particularly careful consideration, and that ethical analyses of endemic LMIC CHIs can inform current debates in research ethics more broadly. (shrink)

The prevalence of technology-embedded products, services, and cities, described colloquially as ‘smart’ technologies and ‘smart’ cities, has seen a spate of unprecedented growth in recent years. South Africa (SA) has not been left behind, with smartphones, smart watches, and smart voice-controlled virtual personal assistants such as Amazon’s Alexa now frequently used. But while these technologies hold great promise to revolutionise homes, offices and cities, their adoption poses challenges to individual and collective interests and wellbeing. After demonstrating the legal and ethical (...) difficulties brought about by the introduction of these technologies, this article explores whether SA legislation is sufficiently robust to address these challenges. While the current legislative landscape addresses certain crucial difficulties – such as the safeguarding of personal data by the Protection of Personal Information Act No. 4 of 2013 (‘POPIA’) – it is suggested that the position regulating other aspects of smart technology adoption is, in large part, fragmented and ill-equipped to deal with some of the more pressing legal and ethical questions. Our contention is that, not dissimilar to the issues arising from artificial intelligence-based technological adoption, the extant legislative and regulatory frameworks do not go far enough in addressing the many concerns emerging from recent novel technological design, development, and deployment. Not only do smart technologies give rise to unique challenges, so does their deployment within the Global South and in South Africa, in particular. We suggest that appropriate and effective regulatory reform measures be undertaken in SA to provide better ethical guidance and policy prescriptions buttressed by rigorous regulatory oversight. (shrink)

This paper examines the transformation of environmental regulatory system in Poland during the 1990s. It is a case of institutional transplantation from the past into the present: the place remained constant but the economic and political context rapidly changed over time. Drawing on five case studies of privatized firms, a mailed questionnaire, and policy and institutional analysis, it investigates how Poland developed an effective system for managing industrial pollution while also achieving considerable socioeconomic progress. One key lesson is that (...) considerable and effective evolution of policies can take place during radical shifts in the political-economic context, as long as certain conditions are fulfilled. These include a good “fit” between the approaches taken and the existing modes of conducting societal transactions; wide sharing of certain values among the key societal actors; and continuity in policies and institutions. It also appears that a broad support for the rule of law and due process are crucial. The case of Poland also suggests that, while the developing countries do not necessarily need to reenact the evolution that has taken place among the developed countries during the past three decades, neither can they expect to leapfrog from a highly polluting “dirty” economy to a sustainable economy. The study also suggests that success in the first phase of regulatory system’s transformation—centered around reducing pollution from the energy and manufacturing sectors—is not a predictor of its success in next phase, centered around sustainability issues. The types of institutions, political circumstances, and national capabilities are different for each phase. (shrink)

Background: Over the last several decades, scientists and social groups have frequently raised concerns about politicization or political interference in regulatory science. Public actors (environmentalists and industry advocates, politically aligned public figures, scientists and political commentators, in the United States as well as in other countries) across major political-regulatory controversies have expressed concerns about the inappropriate politicization of science. Although we share concerns about the politicization of science, they are frequently framed in terms of an ideal of value-free (...) science, according to which political and economic values have no legitimate role to play in science. For several decades, work in philosophy of science has identified serious conceptual and practical problems with the value-free ideal. -/- Objectives: Our objectives are to discuss the literature regarding the conceptual and practical problems with the value-free ideal and offer a constructive alternative to the value-free ideal. -/- Discussion: We first discuss the prevalence of the value-free ideal in regulatory science, then argue that this ideal is self-undermining and has been exploited to delay protective regulation. To offer a constructive alternative, we analyze the relationship between the goals of regulatory science and the standards of good scientific activity. This analysis raises questions about the relationship between methodological and practical standards for good science, tensions among various important social goods, and tensions among various social interests. We argue that the aims of regulatory science help to legitimize value-laden choices regarding research methods and study designs. Finally, we discuss how public deliberation, adaptive management, and community-based participatory research can be used to improve the legitimacy of scientists as representatives of the general public on issues of environmental knowledge. -/- Conclusions: Reflecting on the aims of regulatory science—such as protecting human health and the environment, informing democratic deliberation, and promoting the capacities of environmental justice and Indigenous communities—can clarify when values have legitimate roles in regulatory science. (shrink)

Cognitive enhancement takes many and diverse forms. Various methods of cognitive enhancement have implications for the near future. At the same time, these technologies raise a range of ethical issues. For example, they interact with notions of authenticity, the good life, and the role of medicine in our lives. Present and anticipated methods for cognitive enhancement also create challenges for public policy and regulation.

We discuss how the approach taken by regulators to address financial reporting issues has a significant influence on tone at the top. While tone must ultimately be established internally, regulators are more likely to have a positive impact on the quality of financial reporting by addressing organizational tone. A strong tone at the top should ensure that the financial reports are characterized by greater transparency and complete disclosures, and a regulator’s response will depend upon their perspective as to what (...) motivates management. A compliance-based approach, rooted in agency theory’s assumption that managers act in their own best interests, seeks to mandate desirable behavior through elevated monitoring and reduced managerial discretion. Alternatively, an empowerment-based approach rooted in stewardship theory views managers as trustworthy guardians and grants them greater discretion without burdensome external monitoring. In practice, regulations fall on a continuum between these two approaches. To illustrate the continuum between compliance and empowerment, we present three cases in financial and tax reporting and examine the outcomes of these recent regulatory responses. We then provide conclusions regarding the effectiveness of each regulation by considering how tone was influenced within organizations. (shrink)

In bioethics and health policy, we often discuss the appropriate boundaries of public funding; how the interface of public and private purchasers and providers should be organized and regulated receives less attention. In this paper, I discuss ethical and regulatory issues raised at this interface by three medical practice models in which physicians provide insured services while requiring or requesting that patients pay for services or for the non-insured services of the physicians themselves or their associates. This choice (...) for such practice models is different from the decision to design an insurance plan to include or exclude user fees, co-payments and deductibles. I analyze the issues raised with regards to familiar health care values of equity and efficiency, while highlighting additional concerns about fair terms of access, provider integrity, and fair competition. I then analyze the common Canadian regulatory response to block fee models, considering their extension to wellness clinics, with regards to fiduciary standards governing the physician–patient relationship and the role of informed consent. I close by highlighting briefly issues that are of common concern across different fundamental normative frameworks for health policy. (shrink)

The rapid spread of SARS‐CoV‐2 worldwide has triggered intense activity in the field of biotechnology, leading to the development and regulatory approval of multiple COVID‐19 vaccines in less than 1 year while raising sustained scrutiny as to the ethical issues associated with this process. This article pursues a twofold objective. First, it reconstructs and provides a thorough overview of the different steps, from clinical trial design to regulatory procedures, underpinning the “fast‐tracking” of COVID‐19 vaccine R&D and approval. (...) Second, drawing on a review of published literature, the article identifies, outlines, and analyzes the most ethically challenging aspects related to such process, including concerns around vaccine safety, issues in study design, the enrollment of study participants, and the challenges in obtaining valid informed consent. By scrutinizing relevant aspects of COVID‐19 vaccine development and regulatory processes leading to market authorization, this article ultimately aims to provide a comprehensive overview of the regulatory and ethical issues underpinning the roll‐out of this key pandemic‐containment technology worldwide. (shrink)

This article describes the use of a Policy Delphi to explore the options for restructuring the regulatory body for nursing in South Africa. Two rounds using postal questionnaires were used, the second of which also included group interviews. Aspects such as the statutory home of the body, its structure, who should appoint or elect members, and its composition, were explored. To a large extent, there was agreement on many issues. It would seem that this approach to consulting the (...) profession is a profitable one, which informs while it consults. (shrink)

Biomedical research has a strong impact on a country’s scientific-technological and socioeconomic development. It can make a significant contribution at three different levels: promotion of public health; the exchange of knowledge within the scientific community; and economic/ financial profitability. Africa only attracts ~3.3% of the world’s clinical research. This small proportion is due to, among several factors, the absence of two fundamental aspects: specific robust legislation and capacity for regulatory and ethical evaluation. There are five Portuguese- speaking African countries (...) – Angola, Cabo Verde, Guinea-Bissau, Mozambique and São Tomé and Príncipe. Despite presenting different degrees of clinical research development, these countries show a common serious insufficiency in the minimum conditions necessary for hosting, collaborating or leading biomedical research projects. These countries are also excluded from the support of international organisations for capacity building because of the language barrier. The Biomedical Ethics and Regulatory Capacity Building Partnership for Portuguese-Speaking African Countries project has developed methods to build capacity and partnership through research on national law, comparisons with international standards and by issuing recommendations at a national level. Through collaborative intensive training, trainees are taught to become educators at a national level. This, in turn, creates a sustainable impact at country level. BERC-Luso is a pioneering project, owing to a combination of innovative features. The partnership project: was developed exclusively in Portuguese; involves a large number of African countries, and national and international institutions; has been further enhanced by the diversity and complementarity of its action plans; and has also benefited from a broad participatory methodology based on resolution of recipients’ problems by the recipients themselves. It thus stands out as a model for similar future projects. (shrink)

The objective of this paper is to present a legal theory of agency selection. The theory posits why certain legal forms of agency are chosen when agencies are created by the executive branch of government. At the core of the theory is the idea that the executive branch chooses agency forms that strike a politically optimal balance between maximising its control while minimising its legal and political accountability for agency activities. This optimal balance is determined on an issue by issue (...) basis. As such, the rise of the regulatory state has provided a means by which the executive branch of government has been able to strategically choose to divest itself of and minimise its legal accountability for the administration of government while, at the same time, maintaining effective political control of the administrative arm of government. (shrink)

The advent of sales over the Internet has led to interesting developments in sales tax policy as states attempt to monitor, control, and collect revenue from illusive Internet tobacco vendors. Tobacco sales have been successfully monitored and regulated, to some extent, in convenience stores, grocery stores, and smoke shops, and in most cases sales taxes are collected. The Internet, however, is extremely difficult to regulate. States could use their regulatory powers to ban the sale of products such as tobacco (...) and alcohol over the Internet, but enforcement would be nearly impossible.The issue of enforcement of Internet sales is extremely difficult. Keeping the products out of the wrong hands, under aged children for example, is difficult. Also, it is difficult in terms of tax policy. (shrink)

The advent of sales over the Internet has led to interesting developments in sales tax policy as states attempt to monitor, control, and collect revenue from illusive Internet tobacco vendors. Tobacco sales have been successfully monitored and regulated, to some extent, in convenience stores, grocery stores, and smoke shops, and in most cases sales taxes are collected. The Internet, however, is extremely difficult to regulate. States could use their regulatory powers to ban the sale of products such as tobacco (...) and alcohol over the Internet, but enforcement would be nearly impossible.The issue of enforcement of Internet sales is extremely difficult. Keeping the products out of the wrong hands, under aged children for example, is difficult. Also, it is difficult in terms of tax policy. (shrink)