ABSTRACT This article aims to compare the national legal systems that regulate biomedical research in an industrialized country (United States) and a developing country (Venezuela). A new international order is emerging in which Europe, Japan and the United States (US) are revising common guidelines and harmonizing standards. In this article, we analyze – as an example – the US system. This system is controlled by a federal agency structured to regulate research funded by the federal government uniformly, either in the (...) US or abroad. In contrast, in Venezuela, a developing country, the creation of a centralized system is a slow process. Different types of ethical committees review research projects using non‐uniform criteria. Consequently, various parallel organizations that conduct biomedical research, such as universities, research institutes and private hospitals have diverse regulations operating at a local level. Thus, the most relevant difference between the Venezuelan and the US systems is the degree of standardization. In the US, the review process is performed by institutional review boards (IRBs), which have a similar organization and maintain relationships with a centralized agency, following standard regulations. Although new proposals for establishing national regulations are currently being considered in Venezuela, the success of these initiatives will depend on promoting governmental efforts to create a more structured centralized system supported by a national regulatory framework. This system will need governmental financial support at all levels. This article proposes an integrated system to regulate research with human participants in Venezuela and other developing countries. (shrink)

ABSTRACTGiven its intimate relationship with the human body and its environment, biotechnology innovation, and more particularly stem cell research innovations as a part thereof, implicate diverse social and moral/ethical issues. This paper explores some of the most important and controversial moral concerns raised by human embryonic stem cell research , focusing on concerns relating to the wellbeing of the embryo and the wellbeing of society . It then considers how and whether these concerns are dealt with in regulatory instruments in (...) Argentina, a southern developing country, examining in particular whether the values underlying these concerns have been translated into practical and effective rules reflective of the primary moral positions advanced. It concludes that Argentina's current state of stem cell research governance fails to consistently reflect the moral positions that have formed and is inadequate given Argentina's activity in this field. (shrink)

Background Biobanking and genomic research requires collection and storage of human tissue from study participants. From participants’ perspectives within the African context, this can be associated with fears and misgivings due to a myriad of factors including myths and mistrust of researchers. From the researchers angle ethical dilemmas may arise especially with consenting and sample reuse during storage. The aim of this paper was to explore these ethical considerations in the establishment and conduct of biobanking and genomic studies in Africa. (...) Methods We conducted a narrative synthesis following a comprehensive search of nine (9) databases and grey literature. All primary research study designs were eligible for inclusion as well as both quantitative and qualitative evidence from peer reviewed journals, spanning a maximum of 20 years (2000–2020). It focused on research work conducted in Africa, even if data was stored or analysed outside the region. Results Of 2,663 title and abstracts screened, 94 full texts were retrieved and reviewed for eligibility. We included 12 studies (7 qualitative; 4 quantitative and one mixed methods). Ethical issues described in these papers related to community knowledge and understanding of biobanking and genomic research, regulation, and governance of same by research ethics committees, enrolment of participants, types of informed consents, data collection, storage, usage and sharing as well as material transfer, returning results and benefit sharing. ca. Biospecimen collection and storage is given in trust and participants expect confidentially of data and results generated. Most participants are comfortable with broad consent due to trust in researchers, though a few would like to be contacted for reconsenting in future studies, and this would depend on whether the new research is for good cause. Sharing data with external partners is welcome in some contexts but some research participants did not trust foreign researchers. Conclusion Biobanking and genomic studies are a real need in Africa. Linked to this are ethical considerations related to setting up and participation in biobanks as well as data storage, export, use and sharing. There is emerging or pre-existing consensus around the acceptability of broad consent as a suitable model of consent, the need for Africans to take the lead in international collaborative studies, with deliberate efforts to build capacity in local storage and analysis of samples and employ processes of sample collection and use that build trust of communities and potential study participants. Research ethics committees, researchers and communities need to work together to work together to adapt and use clearly defined ethical frameworks, guidelines, and policy documents to harmonize the establishment and running of biobanking and genomic research in Africa. (shrink)

Vaccines are not the only public health tool, but they are critical in routine and emergency settings. Achieving optimal vaccination rates requires timely access to vaccines. However, we have persistently failed to secure, distribute, and administer vaccines in a timely, effective, and equitable manner despite an enduring rhetoric of global health equity.

Science matters. Science matters to the development of knowledge, to the sustainability of development, and to the shaping of social mores. Countries transitioning from developing to developed must be prepared to make science work for them and to forge a vision to become competitors in some aspects of science innovation. Drawing on data generated by the “Governing Emerging Technologies: Social Values and Stem Cell Regulation in Argentina” Project, this paper places the current Argentine bioscience setting in context by reviewing (...) the development of biosciences in Argentina, explores understandings of the social dimensions of bioscience innovation in Argentina and the possibilities of enhancing public support for science, and offers some preliminary thoughts on a model for socio-legal activity directed at encouraging social engagement with and the uptake of high technologies in Argentina. (shrink)

The recent outbreak of Ebola in West Africa has killed thousands of people, including healthcare workers. African responses have been varied and largely ineffective. The WHO and the international community’s belated responses have yet to quell the epidemic. The crisis is characteristic of a failure to properly comply with the International Health Regulations 2005. More generally, it stems from a failure of international health justice as articulated by a range of legal institutions and instruments, and it should prompt us to (...) question the state and direction of approaches to the governance of global public health. This paper queries what might be done to lift global public health as a policy arena to the place of prominence that it deserves. It argues that there are at least two critical reasons for the past, present and easily anticipated future failings of the global public health regime. After exploring those, it then articulates a new way forward, identifying three courses of action that might be adopted in realising better health outcomes and global health justice, namely value, institutional and legal reform. (shrink)

To state the obvious, “health matters”, but health (or its equitable enjoyment) is neither simple nor easy. Public health in particular, which encompasses a broad collection of complex and multidisciplinary activities which are critical to the wellbeing and security of individuals, populations and nations, is a difficult milieu to master effectively. In fact, despite the vital importance of public health, there is a relative dearth of ethico-legal norms tailored for, and directed at, the public health sector, particularly at the international (...) level. This is a state of affairs which is no longer tenable in the global environment. This article argues that public health promotion is a moral duty, and that international actors are key stakeholders upon whom this duty falls. In particular, the World Health Organization bears a heavy responsibility in this regard. The article claims that better health can and must be better promoted through a more robust interpretation of the WHO’s role, arguing that neither the WHO nor international law have yet played their necessary part in promoting health for all. (shrink)

In a world surrounded by smart objects from sensors to automated medical devices, the ubiquity of ‘smart’ seems matched only by its lack of clarity. In this article, we use our discussions with expert stakeholders working in areas of implantable medical devices such as cochlear implants, implantable cardiac defibrillators, deep brain stimulators and in vivo biosensors to interrogate the difference facets of smart in ‘implantable smart technologies’, considering also whether regulation needs to respond to the autonomy that such artefacts (...) carry within them. We discover that when smart technology is deconstructed it is a slippery and multi-layered concept. A device’s ability to sense and transmit data and automate medicine can be associated with the ‘sting’ of autonomy being disassociated from human control as well as affecting individual, group, and social environments. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:To Be or Not to Be:Waiving Informed Consent in Emergency ResearchCharles R. McCarthy (bio)The requirements for prior, legally authorized informed consent constitute a necessary condition for recruiting subjects into biomedical or behavioral research. However, informed consent requirements pose a serious problem for most research conducted in emergency care settings. For this reason, the Food and Drug Administration's (FDA) regulations governing investigational devices and the Department of Health and Human (...) Services' (HHS) regulations for the protection of human subjects allow narrow exceptions to the general requirements of informed consent. In a joint effort to clarify the applicability of the current FDA regulations and to better understand the intent of the HHS regulations as they apply to emergency research, the FDA and the National Institutes of Health (NIH) cosponsored a public forum on the ethical conduct of emergency research in January 1995.Although the forum was not designed as a consensus conference and participants vigorously disagreed on some of the details, a broad consensus emerged on several major points: (1) both HHS and FDA regulations should, in the immediate future, be interpreted to allow for randomized clinical trials in emergency situations so long as the subjects are carefully protected; and (2) consideration should be given to producing new, closely harmonized regulations from both agencies that will provide greater clarity concerning what kinds of emergency research may be allowed without obtaining prior informed consent.The FDA-NIH forum in January was occasioned primarily by controversy about the hypothermia research protocol described below, but it is obvious that many other kinds of emergency research also await the outcome of deliberations concerning waiver of informed consent in emergency situations. These include research into the care and treatment of: occlusive stroke; subarachnoid hemorrhage due to intracranial aneurysm; metabolic coma; status epilepticus; cardiac arrest; myocardial infarction; cardiac arrhythmia; hemorrhagic shock; pulmonary embolism; acute asthmatic attack; and poisoning. All of these conditions [End Page 155] are encountered in emergency settings where obtaining informed consent from the patient-subjects to participate in research is seldom possible, and obtaining consent from legally authorized representatives of the subjects is either not feasible, or, if obtained, is of doubtful validity.The Hypothermia Research Case and HHS RegulationsA $7.2 million grant for research on the use of hypothermia in the treatment of severe head trauma, the largest award ever made to the University of Texas Health Sciences Center at Houston, is in danger of expiring before the study is completed. The protocol, which involves the use of cooling blankets to induce hypothermia in patients suffering from severe head injuries, is designed to test the hypothesis that: "Early lowering of the body temperature of patients suffering from severe head trauma to approximately 91 degrees Fahrenheit will slow patients' metabolism and will/will not, as a consequence, reduce the rates of both morbidity and mortality in these patients." The protocol was approved by seven Institutional Review Boards (IRBs), each of which waived the requirement to obtain informed consent from research subjects in accordance with Sec. 46. 116(d) of the HHS Regulations for the Protection of Human Subjects.1However, NIH's Office for Protection from Research Risks (OPRR), which is responsible for assuring compliance with the HHS regulations, has taken a controversial regulatory position by requiring informed consent from a legally authorized representative of each subject to be entered in the hypothermia trial. Because the obtaining of surrogate consent has proved to be very difficult, OPRR's position has slowed the research to a point where it may have to be terminated.At issue in the controversy is a fundamental question of ethics and public policy. Is it ever permissible to involve incompetent subjects in research without either their consent, or the consent of their legally authorized representatives? Pertinent HHS regulations for the protection of human subjects seem to answer the question affirmatively by allowing local IRBs to waive some or all of the elements of informed consent under carefully limited circumstances (45 CFR 46 116(d)). Nevertheless, OPRR has signalled the research community that use of the informed consent waiver provision for the Houston hypothermia study is not permitted under the regulations. OPRR judged that the risks... (shrink)

There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences, the International Conference on Harmonization's standards for industry, and the CONSORT group's reporting norms, in addition to the influential U.S. Federal Common Rule, Food and Drug Administration's body of regulations, and information sheets by the Department (...) of Health and Human Services. There are also many norms published at more local levels by official agencies and professional groups.Any account of international standards should cover both scientific and ethical norms at once – the two are conceptually intertwined. Recent sources recognize that “[s]cientifically unsound research on human subjects is unethical in that it exposes research subjects to risks without possible benefit.”. (shrink)

The evidence linking tobacco product advertising to adolescent smoking initiation and resulting long-term addiction, premature death, and disability is well established. Each link in the causal chain has been substantiated: children and adolescents are especially vulnerable to advertising; point-of-sale advertising comprises 92.1% of cigarette advertising and marketing expenditures by manufacturers and 71.3% of smokeless tobacco advertising; tobacco companies have targeted youth through advertising; advertising exposure causes adolescents to start and to continue smoking; among adults who become daily smokers, nearly all (...) first use of cigarettes occurs by 18 years of age; adolescents who smoke are at high risk for long-term addiction because their brains are still developing; and long-term addiction results in the tremendous personal, social and financial costs of tobacco-related illnesses. (shrink)

The study contributes to building an understanding of the impact of political forces on the information environment of listed firms in a developing economy. Specifically, it investigates the tensions between politico-institutional factors and accounting regulation on the prolonged and incomplete implementation of the International Financial Reporting Standards in Bangladesh from 1998 to 2010. Two phases of interviews were conducted in 2010–2011 and IFRS-related enforcement documents from 1998 to 2010 were evaluated. The study contributes that IFRSs are being diffused to (...) developing countries like Bangladesh, but they invariably interact with local institutions, with variable outcomes. Coercive, normative and mimetic isomorphisms are low in Bangladesh. Notably, political forces have been undermining mimetic isomorphism because of the high level of government intervention and the high level of political lobbying. Political institutional pressures stand in the way of mimetic isomorphism and constitute negative forces that add further tension to accounting regulation in Bangladesh. Regarding the low level of normative isomorphism, there is evidence of a ‘blame culture’, with state institutions and professional accountancy institutions in the country blaming each other for the poor progress in IFRS implementation. Although the study focuses on Bangladesh, its results have implications for international policy makers, as well as the governments and regulators of other developing economies facing similar challenges in implementing IFRS. (shrink)

Every day, television news operations have available dozens of video news releases (VNRs), public relations handout videos designed to mimic news formats. Electronic tracking indicates some of these VNRs are used. Critics typically assail VNRs on ethical grounds, that VNRs deceive audience members into thinking they are watching news gathered by reporters, rather than a promotional pitch. Using a snowball technique, the researchers presented survey respondents with authentic-looking local television news stories; 157 respondents evaluated three stories (out of nine). (...) Some stories used station-generated footage, some network, and some VNRs. Respondents were asked their best estimation of the source. The data indicated a real likelihood VNR deception is occurring. Two of the three VNRs deceived at least half the respondents. Respondents were incorrect an average of 46% of the time when attempting to identifying VNRs, compared to 29% incorrectly identifying network video and 20% incorrectly identifying locally shot video. (shrink)

Interest in purchasing local food from suppliers who follow sustainable practices is growing in Canada. Such suppliers wish to have their products recognized in the market so that price premiums might be received, and new markets developed. In response, the organization Local Food Plus (LFP) developed standards and a certification process to authenticate local and sustainable claims. LFP provides certification seals, and labeling provisions for qualifying producers and processors. However, given pre-existing national food labeling rules, it is (...) not evident that existing regulations permit such claims. Using LFP as a case, this study examined whether current federal labeling rules might impede the marketing of local and sustainable claims. Key findings include that the use of the terms natural, sustainable, and local in panel language and on shelf-talkers could be contested; and that the absence of specific regulation of numerous pertinent terms means they can only be assessed against general fraud prevention regulations, resulting in case-by-case determinations of compliance. Sustainability food label approvals in Canada, based on these general provisions, have not always been favorable to sustainable producers and firms. Existing regulation of these potentially contested terms appears to be out of step with other policy-related developments at the federal level and / or conceptual developments in the field. Proposals are made for amending existing rules to better support local and sustainable claims. (shrink)

This collection is drawn from a recent Global Political conference held to mark the centenary of the birth of Harold Innis, Canada's most important political economist. Throughout his life, Innis was concerned with topics which remain central to political ecology today, such as the link between culture and nature, the impact of humanity on the environment and the role of technology and communications. In this volume, the contributors address environmental issues which Innes was concerened with, from a contemporary, political economy (...) perspective. They explore a wide range of themes and issues including: sustainability; risk and regulation; population growth; and planetary management. Case studies provide further insight into issues such as industrial racism, women and development and collective action. (shrink)

This study examines the botanical and chymical investigations Nehemiah Grew conducted for his magnum opus, The Anatomy of Plants (1682), and explores how they informed his political economic theory, as documented in the unpublished manuscript The Means of a Most Ample Increase of the Wealth and Strength of England (1707). While several scholars have argued that Grew's political economy is best described as mercantilist, this article argues for a much more multifaceted and idiosyncratic reading of Grew's political economy, which aligned (...) with or prefigured not only mercantilism, but also aspects of cameralism, physiocracy, Colbertism, and some of the utopian ideologies of Samuel Hartlib and his circle. By focusing on his knowledge of plant anatomy and plant chymistry, this paper shows that Grew developed a sophisticated understanding of local English ecologies and the natural resource management necessary to maintain a financially strong state. It also reveals an economic thinker deeply skeptical of empire, who was, instead, in favor of national economic self-sufficiency through domestic mineral extraction, agrarian improvement, and a highly regulated market. This article focuses on Grew's development of saline chymistry, his geometric approach to both plant anatomy and geography, his investigations of mineral soils, and his research into tree growth and timber management to demonstrate the deep connections between his botany and his economics. (shrink)

Targeted transitions in chromatin states at thousands of genes are essential drivers of eukaryotic development. Therefore, understanding the in vivo dynamics of epigenetic regulators is crucial for deciphering the mechanisms underpinning cell fate decisions. This review illustrates how, in addition to its cell memory function, the Polycomb group of transcriptional regulators orchestrates temporal, cell and tissue‐specific expression of master genes during development. These highly sophisticated developmental transitions are dependent on the context‐ and tissue‐specific assembly of the different types of Polycomb (...) Group (PcG) complexes, which regulates their targeting and/or activities on chromatin. Here, an overview is provided of how PcG complexes function at multiple scales to regulate transcription, local chromatin environment, and higher order structures that support normal differentiation and are perturbed in tumorigenesis. (shrink)

In 2007 new meat inspection regulations standardizing meat production throughout the Province of British Columbia (BC), Canada came into effect moving food for local consumption closer to continentally harmonized production standards. Critics argue that the economic viability of small-scale livestock farmers is threatened. Small-scale women farmers are central to the creation of alternative local agri-food networks in BC. Using gender as an analytically enabling tool this paper argues that public food-safety regulation can create the conditions for the (...) dominance of private agri-food governance. The discursive creation of a feminized privileged consumer legitimates much non-democratic agri-food governance. The paper argues that more just and ecologically sustainable futures require a ‘gender troubling’ of agri-food governance in which the privileged identity of the food consumer is reconstructed as global citizen in the context of the food sovereignty of the farmers who produce their food. (shrink)

The history and context of the public policy regarding stem cell research in the European Union are complex. The regulations respond to and aim to realize political and economic goals across a large region that is culturally diverse, as well as addressing moral judgments on a contested emerging area of research. This history and context are relevant for the arguments developed here in relation to autologous stem cell research and how it is affected by those regulations.The EU is currently an (...) open market across 28 countries with different languages as well as varied cultural, religious, and political histories. Bridging the diverse traditions and their corresponding local policies and regulations is often a... (shrink)

It is unclear what proper remuneration for surrogacy is, since countries disagree and both commercial and altruistic surrogacy have ethical drawbacks. In the presence of cross-border surrogacy, these ethical drawbacks are exacerbated. In this article, we explore what would be ethical remuneration for surrogacy, and suggest regulations for how to ensure this in the international context. A normative ethical analysis of commercial surrogacy is conducted. Various arguments against commercial surrogacy are explored, such as exploitation and commodification of surrogates, reproductive capacities, (...) and the child. We argue that, although commodification and exploitation can occur, these problems are not specific to surrogacy but should be understood in the broader context of an unequal world. Moreover, at least some of these arguments are based on symbolic rhetoric or they lack knowledge of real-world experiences. In line with this critique we argue that commercial surrogacy can be justified, but how and under what circumstances depends on the context. Surrogates should be paid a sufficient amount and regulations should be in order. In this article, the Netherlands and India are case examples of contexts that differ in many respects. In both contexts, surrogacy can be seen as a legitimate form of work, which requires the same wage and safety standards as other forms of labor. Payments for surrogacy need to be high enough to avoid exploitation by underpayment, which can be established by the mechanisms of either minimum wage, or Fair-Trade guidelines. An international treaty governing commercial surrogacy should be in place, and local professional bodies to protect the interests of surrogates should be required. Commercial surrogacy should be permitted across the globe, which would also reduce the need for intended parents to seek surrogacy services abroad. (shrink)

A 78-year-old Chinese woman joined a clinical trial sponsored by a Pharmaceutical companies. Unfortunately a serious Serious Adverse Event occurred. The sponsor paid for the cost of the medical care arising from the SAE, but refused the family’s request for compensation. The family then sued the company and the hospital in Beijing. Although the SAE was related to a complication of lower extremity angiography and not the drug itself, it was a direct consequence of participating in the trial. According Good (...) Clinical Practice, a set of regulations promulgated under Chinese law, “the sponsor should provide Insurance to those human subjects who participate in clinical trials, cover the cost of Treatment and the corresponding economic compensation for the occurrence of the harm or death associated with the trial”. The court ordered the trial sponsor to provide a translation of the company’s insurance policy, so that the court could understand the amount of compensation available to the Patient under the policy, but the sponsor never surrendered either the documentation or a translation. Consensus was never reached about the amount of compensation due to the patient through negotiation with the hospital, the company and the family. The Litigation ended after nine hearings and five long years. This chapter provides an ethical analysis of the case relative to at least three areas of Risks of Exploitation when a major, international Pharmaceutical companies sponsors clinical research in a country with an immature legal system and where Research participants have limited resources. (shrink)

The current SARS-CoV-2 crisis raises questions about the challenges faced by nation states and international organisations in offering a coordinated international response to the pandemic, and reveals the great vulnerability of European countries, which are implementing lockdown measures and imposing restrictions on international travel, for the most part on a unilateral basis. Such measures run counter to the prevailing approach of the previous two centuries that developed an international public health space. This article examines the measures adopted by European states (...) in order to contain 19th-century cholera pandemics, which took shape through the development of an international maritime quarantine system, based primarily on the implementation of national regulations and local decision-making. This regime was quickly viewed as ineffective and out of step with liberal ideas that urged a “laissez-faire” approach to public health matters. In its stead, a long-term trend developed towards easing quarantine measures. Nation states supported the internationalisation of the fight against pandemics, which chiefly consisted of externalising quarantine measures to the East in order to eliminate them in Europe. This process was based on a subtle dialectical relationship between the construction of an international public health space and the affirmation of state sovereignty, and continued into the 20th century with the progressive creation of international institutions responsible for advancing global health. (shrink)

It is now typical for human subjects research to be regulated by review by an independent research ethics committee in most jurisdictions. However it is common for countries to opt to only compulsorily regulate medical research while leaving some or all non-medical research either unregulated or only regulated on a voluntary basis. In this paper I will argue, using regulation in the UK as an example, that it is difficult to justify this sharp distinction in practices. While I won’t (...) come to any definitive conclusions in this paper as to whether research ought to be regulated compulsorily I will suggest that we would be better to regulate all research, albeit perhaps with a lighter touch than the present UK system if we want to prevent some highly risky research avoiding appropriate regulation. I will examine several arguments to defend making such a distinction; that medical professionals have special moral duties, that medical research has a higher magnitude/frequency of risks and that regulating non-medical research constitutes the inappropriate imposition of the medical model onto non-medical research. Having critiqued these objections I will then discuss the advantages of harmonizing the regulation of research and conclude that there is not a good reason to treat medical and non-medical research as fundamentally different in kind. (shrink)

Purpose: Despite various comparative studies in the field of cultural heritage protection in the world, there is still a significant lack of comparative research on policies related to the legal system of countries' governance. The purpose of this study is to address the comparative policies in Iran and Italy, with a particular focus on the results of the executive experiences of two different types of policies in the cities of Oroumieh (North-West of Iran) and Turin (in North-West of Italy). Design/methodology/approach: (...) Utilising the comparative, analytical, bibliographic and descriptive historical research methodology, which is based on the study of the local, national and international comprehensive review of regulations and policy-making of cultural heritage preservation policies in Iran and Italy. In this research, the related documents in three languages (Persian, Italian and English) have been examined to compare profoundly and comprehensively the policies and regulations adopted in these two countries to be able to analyze the national and transnational regulations and local policies in the cultural heritage sector. Findings: In addition to many cultural similarities and numerous commonalities, especially in the multiplicity of urban cultural heritage in historical centers, the results suggest that the legislation structure in Iran is much more centralized than in Italy. Also, the findings suggest that Italy focuses on aligning its previously centralized national legislative system in line with contemporary European heritage and preservation policies. Originality/value: The paper outlines how to use historical and cultural similarities through comparative study to benefit the experiences of two historical countries in urban heritage conservation and policy-making part despite their differences. (shrink)

The availability of new genetic testing technologies to identify individuals as at risk for a particular disease has inspired tremendous concern that individuals with gene mutations will soon be universally identified, for both insurance and employment purposes, as a genetic underclass. Scholarship in science and technology studies, however, suggests that understandings of genetic knowledge might be locally contingent, while research in comparative politics helps us understand how national context might play an important role in framing approaches to the regulation (...) of genetic information. What role does national context play in defining genetic risk and shaping approaches to the privacy of genetic information? Using data from interviews, document analysis, and ethnographic observation, the author follows debates among advocacy groups, insurers, and governments in the United States and Britain about the appropriate use of genetic information in insurance underwriting to understand how national context frames the definition of genetic risk as well as its regulation. (shrink)

The theme of the 10th Annual Research Ethics Conference organized by the Uganda National Council for Science and Technology (2018) was “Evolution of Research Ethics in Uganda and the Region: Past, Present and Future”. We were asked to address the topic: “The History of CIOMS and the recent changes in the international ethics guidelines: implications for local research”. The thrust of the conference was to track progress in ensuring ethical conduct of research, highlight challenges encountered, and to propose strategies (...) for effective and meaningful implementation of international ethical guidelines in local contexts. Consequently, the purpose of this paper is to comment on the implications of the history of CIOMS ethical guidelines and suggest strategies for their effective and meaningful implementation in the East African region, and perhaps the whole of Sub‐Saharan Africa. Inferring from the ‘evolutionary’, ‘flexible’, and ‘general’ nature of the CIOMS guidelines, we proposed a six‐point strategy for ensuring their effective and meaningful implementation in local contexts. This strategy is in the form of obligations for local research regulators and researchers, the fulfillment of which will go a long way towards their smooth and meaningful implementation in local contexts. These obligations are: ensuring evidence‐based adaptation of each individual guideline; ensuring sufficiently judicious and motivated RECs membership; acting proactively to ensure harmony between bioethics and local legal regimes; cultivating a ‘bioethics culture’ among the public; moving towards regional bioethics governance; and playing an active and meaningful role in future revisions of these guidelines. (shrink)

Exploiting the regulatory change in China’s Environmental Protection Law in 2015 as a plausibly exogenous shock to the stringency of pollution control, we evaluate the joint role of state ownership and environmental regulation in shaping firms’ environment-friendly (green) investments. Using a difference-in-differences methodology, we find that state-owned enterprises (SOEs) make significantly more green investments than non-SOEs in response to the regulatory change. We propose and empirically analyze four potential mechanisms that may drive this result: (i) environment-related government subsidies granted (...) to SOEs, (ii) political promotion incentives of SOEs’ top management, (iii) government administrative intervention, and (iv) SOEs’ concern for social welfare. We find strong support for the last mechanism whereby SOEs undertake greater green investments due to their greater concern for social welfare, as evidenced by the fact that SOEs making greater charitable donations and those controlled by local governments (and thus more bonded with local communities) make greater green investments. Consistent with this interpretation, we show that regions where SOEs have a greater economic influence improved their air quality to a greater extent after 2015 than regions where non-SOEs are more dominant. In sum, we demonstrate that state ownership and environmental regulation complement one another in motivating corporate green investment. Our results highlight the important implications for the effectiveness and interplay of different government tools in addressing environmental issues. (shrink)

The Food and Drug Administration and the European Medicines Agency have launched a recent initiative to enhance collaboration in research, with the intent to “ensure that clinical trials submitted in drug marketing applications in the United States and European Union are conducted uniformly, appropriately, and ethically.” This initiative recalls efforts from two decades ago when the United States, the European Union and Japan formed the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use as (...) a mechanism for harmonizing clinical research regulations. The intent of harmonization was to improve patients’ “access to new drugs, to prevent unnecessary global development delays and to avoid animal and human study duplications” through policy reconciliation.FDA/EMA efforts at collaboration call for a reassessment of past harmonization efforts: to what extent are ICH member policies already synchronized and to what extent can they be harmonized in the future? This paper will focus on these questions through the lens of pediatric investigation. (shrink)

To understand how regulation influences competitiveness and upgrading processes, this article focuses on the organizational changes involved in “rewarding regulation.” Through a qualitative study of two clusters in the agrifood industry in Nicaragua, it analyzes two types of regulation and their interaction with small producers’ production organizations: food safety and environmental sustainability. The analysis shows that regulation plays a crucial role in fostering changes in organizational practices and routines. This occurs when local organizations build new (...) knowledge and skills to upgrade products and production processes, while developing new connections among producers and between them to other private and public actors that support economic development. “Rewarding regulation” is part of a process of learning and creating networks that help build local know-how and generate supportive collective resources. (shrink)

In the current efforts of harmonizing the standards and enforcement of IPRs protection worldwide, this paper explores software piracy trajectories and dynamics in Africa. Using a battery of estimation techniques that ignore as well as integrate short-run disturbances in time-dynamic fashion, we answer the big questions policy makers are most likely to ask before harmonizing IPRs regimes in the battle against software piracy. Three main findings are established. (1) African countries with low software piracy rates are catching-up their counterparts with (...) higher rates; implying despite existing divergent IPRs systems, convergence in piracy rate could be a genuine standard-setting platform. (2) Legal origins do not play a very significant role in the convergence process. (3) A genuine timeframe for standardizing IPRs laws in the fight against piracy is most likely between a horizon of 4–8 years. In other words, full (100 %) convergence within the specified horizon will mean the enforcements of IPRs regimes without distinction of nationality and locality. Policy implications and caveats are discussed. (shrink)

Fire safety expertise was in great demand following the Grenfell Tower fire in London in June 2017. The government established a review of building regulations and an expert panel to inform its responses to Grenfell, and many other relevant organisations also formed their own expert panels. However, expert knowledge in fire safety is a highly contested domain, with knowledge claims based on differing sources. Fire fighters can claim expertise based on their experience of fighting fires, scientists and science-based engineers can (...) claim expertise from experimentation, and those who create and enact regulations can claim expertise in what can termed ’codespeak’—the language of regulation. Although distanced from fundamental empirical experience of fire, codespeak is powerful because of its relative clarity and certainty, and legal status. Building users also bring their own form of ‘local’ expertise—they have first-hand experience of the practicalities of the solutions wrought by the other experts. Policy-makers thus face many competing forms of expert advice on fire safety, and their ability to judge what is most relevant in any particular case rests on the existence of a sufficient range and depth of in-house government expertise. (shrink)

The article is devoted to the study of the development patterns of the local government system in the Russian Federation. The submission to the State Duma of the Russian Federation of the draft Federal Law «On the general principles of the organization of local self-government in the unified system of public authority» in December 2021 means the preparation of a new stage of municipal reform and makes it relevant to study long-term changes in the institutional organization of (...) class='Hi'>local self-government. The purpose of the study is to analyze changes in the structure of local self-government bodies and the rules of their formation at each stage of the development of this institution, as well as to identify the main patterns of this process. The analysis of the legislative base regulating the structure and rules of formation of local self-government bodies has been carried out. The data related to the development of the local government system provided by the Ministry of Justice of the Russian Federation were analyzed. It is shown that the structure of local self-government bodies has not undergone significant changes. However, there have been changes in the ways of forming local self-government bodies, which reflect the trend towards their loss of institutional independence and integration into a single system of public power. This trend appeared at the stage of implementation of the Federal Law on Local Self-Government in 2003 and was consolidated in the new Draft law on Local self-government submitted to the State Duma of the Russian Federation in 2021. It is concluded that there is a tendency to increase the dependence on federal and regional legislators of local self-government bodies. For the institute of heads of municipalities, the loss of institutional independence was clearly manifested by the introduction of the procedure for electing heads by competition, displacing both election at municipal elections and election from the Council of Deputies. The formation of representative bodies, having passed the stage of delegating deputies to higher levels, returns to the model of direct elections. However, this happens in the context of the rejection of a two-tier system of local self-government. (shrink)

In recent years, global corporations and national governments have been enacting a growing number of codes of conduct and public regulations to combat dangerous and degrading work conditions in global supply chains. At the receiving end of this activity, local producers must contend with multiple regulatory regimes, but it is unclear how these regimes interact and what results, if any, they produce. This article examines this dynamic in the sugar sector in Brazil. It finds that although private and public (...) agents rarely communicate, let alone coordinate with one another, they nevertheless reinforce each other’s actions. Public regulators use their legal powers to outlaw extreme forms of outsourcing. Private auditors use the trust they command as company insiders to instigate a process of workplace transformation that facilitates compliance. Together, their parallel actions block the low road and guide targeted firms to a higher road in which improved labor standards are not only possible but even desirable. (shrink)

Pressure from the public and non-governmental organisations is pushing lead companies in the cocoa and chocolate sectors towards becoming more environmentally sustainable and socially just. Because of this, several sustainability programmes, certification schemes and delivery initiatives have been introduced. These have changed the relationship between chocolate companies, cocoa exporters, and small-scale farmers. This paper observes how large companies in the cocoa export and consumer markets are shifting away from their traditionally remote position in the cocoa sector. The pressure to ensure (...) sustainability and justice has provoked more mutually dependent relationships with cocoa producers. Our analysis outlines the implications this emerging reconfiguration of global-local relationships has for procedural justice principles of interdependence and refutability, and the distributive justice principles of need and equity. These principles are important because they enable the different dimensions of inclusion: ownership, voice, risk, and reward. This paper highlights and qualifies arrangements surrounding these justice principles that manifest in the way five service delivery initiatives - associated with sustainability programmes and led by major buying companies in Ghana’s cocoa sector – are implemented. We show inclusiveness as an outcome of dynamic global-local relationships that are constantly reworked in response to smallholder farmers’ agency and state regulations. Portraying inclusiveness as an outcome of interactions changes its conceptualisation from a predefined ethical standpoint included in the design of standards to a result of unfolding mutual dependencies, which refashion how inclusive agriculture value chains work. (shrink)

Proteolytic cleavage of extracellular matrix (ECM) is a critical regulator of many physiological and pathological events. It affects fundamental processes such as cell growth, differentiation, apoptosis and migration. Most proteases are produced as inactive proenzymes that undergo proteolytic cleavage for activation. Proteolytic activity is additionally modified by endogenous inhibitors. Mechanisms that localize and concentrate protease activity in the pericellular microenvironment of cells are prerequisites for processes like angiogenesis, bone development, inflammation and tumor cell invasion. Methods that enable real‐time, high‐resolution imaging (...) and precise quantification of local proteolytic activity in vitro and in vivo remain major challenges. These methods will play an important role in the understanding of basic principles e.g. in cancer cell invasion, the identification of new therapeutical targets and hence drug design. This review highlights mechanisms and functions of local proteolytic activity with special emphasis on tumor cell invasion and metastasis, and focuses on techniques for the investigation of this process. BioEssays 27:1181–1191, 2005. © 2005 Wiley Periodicals, Inc. (shrink)

Uncoupling proteins (UCPs) regulate mitochondrial function, and thus cellular metabolism. Angiotensin‐converting enzyme (ACE) is the central component of endocrine and local tissue renin–angiotensin systems (RAS), which also regulate diverse aspects of whole‐body metabolism and mitochondrial function (partly through altering mitochondrial UCP expression). We show that ACE expression also appears to be regulated by mitochondrial UCPs. In genetic analysis of two unrelated populations (healthy young UK men and Scandinavian diabetic patients) serum ACE (sACE) activity was significantly higher amongst UCP3‐55C (rather (...) than T) and UCP2 I (rather than D) allele carriers. RNA interference against UCP2 in human umbilical vein endothelial cells reduced UCP2 mRNA sixfold (P < 0·01) whilst increasing ACE expression within a physiological range (<1·8‐fold at 48 h; P < 0·01). Our findings suggest novel hypotheses. Firstly, cellular feedback regulation may occur between UCPs and ACE. Secondly, cellular UCP regulation of sACE suggests a novel means of crosstalk between (and mutual regulation of) cellular and endocrine metabolism. This might partly explain the reduced risk of developing diabetes and metabolic syndrome with RAS antagonists and offer insight into the origins of cardiovascular disease in which UCPs and ACE both play a role. (shrink)

The United Kingdom is a leader in genomics research, and the presence of numerous types of biobanks and the linking of health data and research within the UK evidences the importance of biobank-based research in the UK. There is no biobank-specific law in the UK and research on biobank materials is governed by a confusing set of statutory law, common law, regulations, and guidance documents. Several layers of applicable law, from European to local, further complicate an understanding of privacy (...) protections. Finally, biobanks frequently contain data in addition to the samples; the legal framework in the UK generally differentiates between data and samples and the form of the data affects the applicability of legal provisions. Biobanks must be licensed by the Human Tissue Authority; certain projects must be reviewed by Research Ethics Committees, and all projects are encouraged to be reviewed by them. Data Access Committees in biobanks are also common in the UK. While this confusing array of legal provisions leaves privacy protections in biobanking somewhat unclear, changes at the EU level may contribute to harmonization of approaches to privacy. (shrink)

Among the data clustering algorithms, the k-means (KM) algorithm is one of the most popular clustering techniques because of its simplicity and efficiency. However, KM is sensitive to initial centers and it has a local optima problem. The k-harmonic means (KHM) clustering algorithm solves the initialization problem of the KM algorithm, but it also has a local optima problem. In this paper, we develop a new algorithm for solving this problem based on a modified version of particle swarm (...) optimization (MPSO) algorithm and KHM clustering. In the proposed algorithm, MPSO is equipped with the cuckoo search algorithm and two new concepts used in PSO in order to improve the efficiency, fast convergence, and escape from local optima. MPSO updates the positions of particles based on a combination of global worst, global best with personal worst, and personal best to dynamically be used in each iteration of the MPSO. The experimental result on eight real-world data sets and two artificial data sets confirms that this modified version is superior to KHM and the regular PSO algorithm. The results of the simulation show that the new algorithm is able to create promising solutions with fast convergence, high accuracy, and correctness while markedly improving the processing time. (shrink)

The article analyses the legal regulation of electronic marketing in the European context. The historical and teleological perspective on past and present regulations of electronic marketing is provided. Emphasis is given on the ability of the legal rules to preserve the balance of private and entrepreneurial interests, and the desirable principles of the regulation of the socially beneficial electronic marketing. The paper concludes that the harmonization of legal regulation of electronic marketing at the European Union level (...) is limited, which causes numerous negative consequences, such as jurisdiction shopping. Some countries (e.g. Finland) follow opt-out regimes for at least some types of electronic marketing, while other countries (including Lithuania) prohibit most forms of electronic marketing without the prior consent of the customer (opt-in). Thus, further regulation and harmonization of the electronic marketing law is suggested at the regional (the EU) and national level, along with more self-regulation and a balanced approach towards future regulation. (shrink)

Background The European Union aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury, aiming to inform and stimulate initiatives to improve efficiency. Methods We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury. (...) Documents included detailed information on IRB procedures and the duration from IRB submission until approval. They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. Results From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally or locally and primary IRB approval was obtained after one, two or three review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days and appeared to be shorter after submission to local IRBs compared to central IRBs. Conclusion We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries. (shrink)

A step towards constructing an ethics of international activism is proposed by formulating a series of constraints on what would constitute morally permissible agency in the context that involves delivering services abroad, directly or indirectly. Perhaps surprisingly, in this effort the author makes use of the concept of ‘force multiplier’. This idea and its official applications have explanatory importance in considering the correlation between the post-Cold War phenomenal growth in the number of international non-governmental organizations and the emergence of the (...) US as the sole, unchallenged superpower. Four moral constraints useful for morally assessing international activism are formulated and defended. The final outcome is an argument in favor of an overarching duty for any activist-minded Westerner to go local, while developing nations are urged to closely regulate, even criminalize, activities by international activists and ‘human rights organizations’ on their territory when not in solidarity or in support of local movements. The position defended, urging the normative primacy of local over international activism, also finds support in Immanuel Kant’s Third Definitive Article for A Perpetual Peace. (shrink)

Purpose The purpose of this paper is to describe and explore the current state of internet regulation through content filters in Swedish public libraries. Design/methodology/approach Data was collected through an electronic survey directed to library managers of Sweden’s 290 main municipal libraries. 164 answers were returned, yielding a 57% response rate. The analysis comprises descriptive statistics for quantitative data and an activity theory approach with focus on contradictions for qualitative counterparts. Findings In total, 33% of the responding libraries report (...) having content filters; 50% have not; and a surprising 18% do not know. There is a strong correlation between internet misuse and positive attitudes towards filters, and, reversely, between lack of misuse and lack of active stances concerning filters. Rather than seeing this as weakness, the authors suggest that there is strength in a context-bound flexibility open to practical experience and weighting of values, ethics, legislation and local circumstances. More troublesome indications concern the high deferral of decision-making to local authorities (municipalities) whereby libraries are left with limited insight and influence. Research limitations/implications The situation calls for professional organisations to address political mandate questions, and educational programs to strengthen future information professionals’ knowledge of IT in general; filter issues in specific; and local authority decision-making. The study highlights the need of adequate information professional competences and mandates to decide on and oversee internet regulation. Originality/value To the best of the authors’ knowledge, this is the first internationally published study on content filters in Swedish public libraries. (shrink)

Large-scale, interoperable biobanks are an increasingly important asset in today's life science research and, as a result, multiple types of biobanks are being established around the globe with very different financial, organizational and legal set-ups. With interdisciplinary chapters written by lawyers, sociologists, doctors and biobank practitioners, Global Genes, Local Concerns identifies and discusses the most pressing issues in contemporary biobanking.This timely book addresses pressing questions such as: how do national biobanks best contribute to translational research?; What are the opportunities (...) and challenges that current regulations present for translational use of biobanks?; How does inter-biobank coordination and collaboration occur on various levels?; and how could academic and industrial exploitation, ownership and IPR issues be addressed and facilitated? Identifying that biobanks' foundational and operational set-ups should be legally and ethically sound, while at the same time reflecting the hopes and concerns of all the involved stakeholders, this book contributes to the continued development of international biobanking by highlighting and analysing the complexities in this important area of research.Academics in the fields of law and ethics, health law and biomedical law, as well as biobank managers and policymakers will find this insightful book a stimulating and engaging read. (shrink)