This article sets out the rationale for a United Nations Regulation for Artificial Intelligence, which is needed to set out the modes of engagement of the organisation when using artificial intelligence technologies in the attainment of its mission. It argues that given the increasing use of artificial intelligence by the United Nations, including in some activities considered high risk by the European Commission, a regulation is urgent. It also contends that rules of engagement for artificial intelligence at the (...) United Nations would support the development of ‘good artificial intelligence’, by giving developers clear pathways for authorisation that would build trust in these technologies. Finally, it argues that an internal regulation would build upon the work in artificial intelligence ethics and best practices already initiated in the organisation that could, like the Brussels Effect, set an important precedent for regulations in other countries. (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)

The debate over international trade has long pitted “free trade” advocates against those who argue that particular reasons support trade restraints. The newest argument is that open trade leads to a “race to the bottom” in the regulation of health, safety, welfare, and especially labor and environmental concerns, harming the nation’s citizens and undermining national sovereignty. One predicate for this argument – that trade increases competitive pressure on domestic industry – is accurate. That, in turn, will raise (...) the cost of some national policies that otherwise would win political approval. But the remainder of the race to the bottom argument rests on assumptions about regulation, the political process, and trade that do not stand up to examination. While responses to increased international competition will vary, the effects of such competition will generally be consistent with any meaningful notion of sovereignty and also will improve national welfare judged by common economic norms.Le débat sur le commerce international a longtemps opposé les défenseurs du libre échange à ceux qui soutiennent qu’il existe des raisons particulières en faveur de barrières à l’échange. L’argument le plus récent est que le libre échange conduit à une course au “nivellement par le bas” au niveau de la réglementation de la santé, de la sécurité, du bienêtre, et plus particulièrement dans les domaines du travail et de l’environnement. Selon ses tenants, elle aurait pour conséquence de léser les citoyens de la nation et d’affaiblir la souveraineté nationale.Un présupposé de cet argument – selon lequel le commerce accroît la pression concurrentielle subie par l’industrie nationale – est fondé. A son tour cela entraînera une augmentation du coût de certaines politiques nationales qui auraient par ailleurs obtenu un assentiment politique.Mais le reste de l’argumentation du nivellement par le bas repose sur des hypothèses à propos de la réglementation, du processus politique, et du commerce qui ne résistent pas à un examen critique.Bien que les réactions à une concurrence internationale accrue varient, les effets d’une telle concurrence seront généralement cohérents avec toute notion pertinente de souveraineté et amélioreront le bien-être national tel que jugé par les normes économiques standard. (shrink)

ABSTRACT In this paper I argue that liberal democratic communities are justified in regulating the activities of their members because of the inevitable existence of conflicting conceptions of what is considered as morally right. This will often lead to tension and disputes, and in such circumstances, reliance on peaceful or orderly co‐existence will not normally suffice. In such pluralistic societies, the boundary between permissible and impermissible activities will be unclear; and this becomes a particular concern in controversial issues which raise (...) specific anxieties and uncertainty. One context that has repeatedly raised issues in this regard is that of biotechnology and, in particular, the recent stem cell debate, on which this paper concentrates. While such developments have the potential to make significant improvements to therapeutic progress, we should also be sceptical because predicting the impact of these developments remains uncertain and complex. For the sake of socio‐political stability, it will therefore be necessary to enact and enforce rules which limit these competing claims in public policy but which may not be compatible with what individual moral commitments ideally permit. One way to achieve this is to establish procedural frameworks to resolve potential disputes in the public sphere about what is right, wrong, or permissible conduct. I argue that for one to commit to authoritative regulation, an idea of harm prevention through state intervention is necessary; and that this requires optimum mechanisms of procedure which allow the individual the opportunity to compromise and yet to continue to oppose or fight for changes as demanded by his or her moral position. (shrink)

ABSTRACTSome people might argue that there are already too many different documents, guidelines, and regulations in bioethics. Some overlap with one another, some are advisory and lack legal force, others are legally binding in countries, and still others are directed at narrow topics within bioethics, such as HIV/AIDS and human genetics. As the latest document to enter the fray, the UNESCO Declaration has the widest scope of any previous document. It embraces not only research involving human beings, but addresses broader (...) concerns in medicine and healthcare. The UNESCO draft declaration has some minor weaknesses, but on the whole, the strengths outweigh the weaknesses. One weakness is that some items in the draft are stated in a way that is too restrictive, thereby appearing to rule out legitimate activities. A strength of the Declaration is that it is relatively brief, yet at the same time contains sufficient detail to make it something more than a rehearsal of mere pieties. As the most recent of the numerous bioethics and human rights documents, the UNESCO draft draws on many of the earlier documents and also includes some of the most recent thinking about ethical norms and obligations. Perhaps its greatest strength lies not in details of the principles or their implementation, but rather in its stature as an international declaration issued by a United Nations organization. (shrink)

Background Research ethics guidelines are essential for conducting medical research. Recently, numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. This article analyzes these documents. Methods Thirteen Arab countries in the Middle East were explored for available national codes, regulations, and guidelines concerning research ethics, and 10 documents from eight countries were found. We studied these documents, considering the ethical principles stated in the Declaration of Helsinki, the Council for (...) International Organizations of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization - Guidelines for Good Clinical Practice (ICH-GCP). Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others. Results This study found different levels and kinds of research ethics regulations and guidelines in the countries examined. Two groups can be distinguished: the countries in the first group have one or more research ethics regulations or guidelines, while the countries in the second group have not yet established any. Most of the documents showed various degrees of deficiencies in regard to ethical protection. The majority of the documents that were examined refer to one or more international documents on biomedical research ethics. Conclusions Recently, a lot of efforts have been made in many countries in the Middle East. However, compared with international documents, most of the research ethics documents in use in this region demonstrate numerous deficiencies. As it relates to these documents, extensive differences could be observed in regard to development, structure, content, and reference to international guidelines. (shrink)

Different ethical principles conflict in research conducted in emergency research. Clinical care and its development should be based on research. Patients in critical clinical condition are in the greatest need of better medicines. The critical condition of the patient and the absence of a patient representative at the critical time period make it difficult and sometimes impossible to request an informed consent before the beginning of the trial. In an emergency, care decisions must be made in a short period of (...) time, and the more time is wasted, the more the risk of death or severe tissue damage and incapacity increases. Consent requests take time, and so the time period before treatment might put the patient’s life in jeopardy. Not requesting consent before a trial is also contradictory. A person should not be forced to participate in a trial against his or her will. Due to the dark history of medical research previously, international declarations and conventions have set up ethical principles for medical research. They emphasize the autonomy of the research participant—or his or her legal representative—to give a free and informed consent prior to the initiation of research. In the case of a critical emergency, the unconscious state of the patient, the emotional stress of family members or the lack of time to start life-sustaining measures may often restrict the possibilities of communicating with the patient or his/her representative. Therefore, written informed consent is difficult to achieve, and its voluntariness in emergency situations is, at best, open to question. The mortality of patients is high without clinical interventions in emergency research. Random selection of patients is difficult and requires extra work from personnel in the emergency rooms. Recruitment, information and asking for consent may also take time, postpone the initiation of treatment and increase the risk of death and irreversible tissue and organ damage, and therefore be risky for the patient. It is therefore essential that the health care professionals recruiting suitable research participants are well motivated and well trained. Medical research in an emergency setting should always be regarded as an exceptional situation requiring special provisions. Only such research should be done as cannot be done in other conditions. An independent body must approve the research protocol and the ways in which the consent of the participant or proxy are to be sought. In addition, the trial must be expected to result in direct and significant benefit for the research participants. If research without prior consent is not approved, the development of emergency care is threatened. On the other hand, if prior consent is not required, a person could be recruited into a clinical trial against his or her will. Doing good and avoiding harm, and respecting the autonomy of the patient are in conflict in the context of emergency medical research. To develop better medicines for patients experiencing acute medical emergencies, research into such conditions should be allowed. Research participants should have the possibility to participate or refuse to participate in research that may benefit them and other patients. The risk of irreversible damage occurring as the consequence of time delays for seeking consent is unacceptable. A prior wish about participation in clinical trials should be respected, if known. The conditions under which medical research in emergencies can be considered acceptable can be determined and agreed upon nationally and internationally. (shrink)

This is the account of an ongoing appeal initiated in 2009 by 725 doctors from 43 countries concerning medical complicity with torture in Israel. It has been underpinned by a voluminous and still accumulating evidence base from reputable international and regional human rights organisations, quoted below, and has spanned the terms of office of four World Medical Association presidencies and two UN special rapporteurs on torture. This campaign has been a litmus test of whether international medical codes regarding (...) doctors and torture actually matter, and are applied rigorously and even-handededly, particularly when compelling evidence incriminates a WMA member association. Our findings in the case of Israel suggest that this is not true, and that impunity largely operates. The WMA seems in partisan violation of its mandate to be the official international watchdog on the ethical behaviour of doctors. And as the IMA case demonstrates, by their inaction national medical associations or other regulatory bodies appear to function at base as buttresses and shields of the state. All data relevant to the study are included in the article. (shrink)

This article provides a critical review of new policies in China, the United States, and the European Union that characterize genomic data as a national strategic resource. Specifically, we review policies that regulate human genomic data for economic, national security, or other strategic purposes rather than ethical or individual rights purposes.

The issue of religious freedom while serving a sentence of imprisonment often occupies scientists from around the world. Basically, they agree that a prisoner, regardless of the act for which he or she has been convicted, has the right to religious freedom. Problems are posed, however, by the question of delimiting this freedom, especially at the level of the right to practise a chosen religion during prison isolation. The decisions of international tribunals and national courts are not uniform (...) owing to the generality of the rules governing this issue. The initial research question that we pose is this: how does society perceive the right to religious freedom in prisons? Does a convict have the right to demand respect for the rules of his or her religion regarding diet, clothes, appearance and participation in religious services? We look for answers to these questions in research conducted in Polish society, one that is confronted by international regulations. (shrink)

This essay combines information on the recent ISUD Sixth World Congress Humanity at the Turning Point: Rethinking Nature, Culture, and Freedom and some reflections inspired by presentations and discussions at the congress. It is focused on the presentation of one of the keynote speakers, Karl-Otto Apel, entitled “Discourse Ethics, Democracy, and International Law: Toward a Globalization of Practical Reason”. Apel argued that the transcendental-pragmatic foundation of morality serves as the ultimate basis for the universal conception of law, e.g., of (...) human rights. It establishes the transcendental basis of the idea of democracy, and at the same time establishes a regulative principle for a possible critique of the democratic states. Apel discussed the question of a political order of law able to represent the idea of human rights. In his approach to it, he referred to Kant’s idea of “a federation of free states” (as opposite to a “world state”) in the solution of the problem of a cosmopolitan system He noticed the tension between two orientations of international law: one towards “human rights” and hence a cosmopolitan law of single citizens and the other towards the sovereignty of single states. He asserted that the universal conception of law cannot be reduced to the legislative autonomy of any state. Consequently, the universal conception of human rights cannot be adequately realized either by particular democratic states or by a world state as a despotic superpower. Apel concluded that an adequate institution for the current debate regarding the issues of global peace and security can only be a federation of nations like the UN, the meta-institution of global discourse and the political representation of international law. At the heart of the essay is Kant’s cosmopolitan ideal and its relevance for today’s discussions about peace and security. Attention is paid to the attempts to rethink Kant by Karl-Otto Apel, Jürgen Habermas, Jaques Derrida, Martha Nussbaum, and David Held, among others. Some of the authors indicate the tension between the sovereignty ofstates and the universality of human rights. Other authors criticize cosmopolitanism as overly unifying in contrast to the socio-cultural diversity of societies. The essay draws a contrast between two tendencies concerning international relations. One is the current neoconservative course toward American domination throughout the world. An alternative to this is the philosophers’ call for “the cosmopolitan model of democracy” and strengthening the network of transnational grass-roots movements and international institutions, including the UN. (shrink)

European and international regulation of human health research is typified by a morass of interconnecting laws, diverse and divergent ethical frameworks, and national and transnational standards. There is also a tendency for legislators to regulate in silos—that is, in discrete fields of scientific activity without due regard to the need to make new knowledge as generalisable as possible. There are myriad challenges for the stakeholders—researchers and regulators alike—who attempt to navigate these landscapes. This Delphi study was undertaken (...) in order to provide the first interdisciplinary and crosscutting analysis of health research regulation, as it is experienced by such stakeholders in the UK context. As well as reinforcing existing understandings of the regulatory environment, Delphi participants called for greater collaboration, and even co-production, of processes involved in health research regulation. On the basis of this research, we offer insights about how health research regulation can become a matter with which a wider range of stakeholders—including researchers, regulators, publics and research sponsors—can engage. The evidence supports the normative claim that health research regulation should continue to move away from strict, prescriptive rules-based approaches, and towards flexible principle-based regimes that allow researchers, regulators and publics to co-produce regulatory systems serving core principles. By unpacking thorny concepts and practices at the heart of health research regulation—including the public interest and public engagement—our results have the potential to situate and breathe life into them. The results also demonstrate that while proportionality is well-recognised as a crucial element of flexible regulatory systems, more must be done to operationalise this as an ethical assessment of the values and risks at stake at multiple junctures in the research trajectory. This is required if we are to move beyond proportionality as a mere risk-management tool. Compliance culture no longer accurately reflects the needs and expectations of researchers or regulators, nor does it necessarily produce the best research. Embracing uncertainty—both as a human practice and a regulatory objective—may represent the brighter future for health research. (shrink)

This chapter reviews Europe's contributions to basic assumptions made in international law and governance. It examines the internal legal models that Europe created and that became foundational blueprints for modern liberal democracies. The chapter also focuses on international legal structures that were designed to operate in a manner consistent with the domestic European model e.g., liberalization of trade, legal protections for foreign investors, or uniform codes of commercial law for international transactions. The post‐Second World War regulation (...) of commerce and livelihood in the European statecraft model came hand‐in‐hand with the protection of personal rights. The modern liberal democratic state derived its legitimacy from management of a social and political structure that bettered the material lot of its nationals. The historical process of formation of the European nation‐states’ geographical map created blocs that had clear boundaries associated with national identity. (shrink)

Background: The formulation and implementation of national ethical regulations to protect research participants is fundamental to ethical conduct of research. Ethics education and capacity are inadequate in developing African countries. This study was designed to develop a module for online training in research ethics based on the Nigerian National Code of Health Research Ethics and assess its ease of use and reliability among biomedical researchers in Nigeria.MethodologyThis was a three-phased evaluation study. Phase one involved development of an online (...) training module based on the Nigerian Code of Health Research Ethics (NCHRE) and uploading it to the Collaborative Institutional Training Initiative (CITI) website while the second phase entailed the evaluation of the module for comprehensibility, readability and ease of use by 45 Nigerian biomedical researchers. The third phase involved modification and re-evaluation of the module by 30 Nigerian biomedical researchers and determination of test-retest reliability of the module using Cronbach’s alpha. Results: The online module was easily accessible and comprehensible to 95% of study participants. There were significant differences in the pretest and posttest scores of study participants during the evaluation of the online module (p = 0.001) with correlation coefficients of 0.9 and 0.8 for the pretest and posttest scores respectively. The module also demonstrated excellent test-retest reliability and internal consistency as shown by Cronbach’s alpha coefficients of 0.92 and 0.84 for the pretest and posttest respectively. Conclusion: The module based on the Nigerian Code was developed, tested and made available online as a valuable tool for training in cultural and societal relevant ethical principles to orient national and international biomedical researchers working in Nigeria. It would complement other general research ethics and Good Clinical Practice modules. Participants suggested that awareness of the online module should be increased through seminars, advertisement on government websites and portals used by Nigerian biomedical researchers, and incorporation of the Code into the undergraduate medical training curriculum. (shrink)

The last half century has been characterized by a growth in the regulation of clinical research nationally and internationally. Each area of research on human subjects has been the subject of a vast academic literature and extensive public policy debate, from issues of informed consent to that of regulatory structures. Professor Bernard Dickens has provided an outstanding contribution to this debate internationally through his many innovative and incisive papers in this area. This paper provides an English lawyer’s perspective upon (...) the increasing regulation of clinical research practices and asks – does regulation equate with effective rights protection? From Nuremberg onwards, there has been concern to ensure that research practices are ethical and in accordance with legal principles. So, for example, there have been statements such as the Declaration of Helsinki, which was initially produced in 1964. In the European context in particular, notably influential statements have been the European Convention on Human Rights, which has been followed by the Council of Europe Convention on Human Rights and Biomedicine and, more recently, a Draft Additional Protocol on medical research. (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)

Biobank research and genomic information are changing the way we look at health and medicine. Genomics challenges our values and has always been controversial and difficult to regulate. In the future lies the promise of tailored medical treatments and pharmacogenomics but the borders between medical research and clinical practice are becoming blurred. We see sequencing platforms for research that can have diagnostic value for patients. Clinical applications and research have been kept separate, but the blurring lines challenges existing regulations and (...) ethical frameworks.Then how do we regulate it? This book contains an overview of the existing regulatory landscape for biobank research in the Western world and some critical chapters to show how regulations and ethical frameworks are developed and work. How should international sharing work? How design an ethical informed consent? An underlying critique: the regulatory systems are becoming increasingly complex and opaque. The international community is building systems that should respond to that. According to the authors in fact, it is time to turn the ship around. Biobank researchers have a moral responsibility to look at and assess their work in relation to the bigger picture: the shared norms and values of current society. Research ethics shouldn't only be a matter of bioethicists writing guidelines that professionals have to follow. Ethics should be practiced through discourse and regulatory frameworks need to be part of that public discourse. Ethics review should be then not merely application of bureaucracy and a burden for researchers but an arena where researchers discuss their projects, receive advice and practice their ethics skills. (shrink)

Background Traditional top-down national regulation of internationally mobile doctors and nurses is fast being rendered obsolete by the speed of globalisation and digitisation. Here we propose a bottom-up system in which responsibility for hiring and accrediting overseas staff begins to be shared by medical employers, managers, and insurers. Discussion In this model, professional Boards would retain authority for disciplinary proceedings in response to local complaints, but would lose their present power of veto over foreign practitioners recruited by employers (...) who have independently evaluated and approved such candidates' ability. Evaluations of this kind could be facilitated by globally accessible National Registers of professional work and conduct. A decentralised system of this kind could also dispense with time-consuming national oversight of continuing professional education and license revalidation, which tasks could be replaced over time by tighter institutional audit supported by stronger powers to terminate underperforming employees. Summary Market forces based on the reputation (and, hence, financial and political viability) of employers and institutions could continue to ensure patient safety in the future, while at the same time improving both national system efficiency and international professional mobility. (shrink)

Purpose This paper reviews the origins of the Ethics Council of the Federation of Social Communication Media of Chile and looks into the historical circumstances surrounding its creation, the concept of self-regulation as understood by its founders, and the criteria that initially ruled its operation. Design/methodology/approach A qualitative survey of nine contemporary witnesses and the confrontation with the scientific literature. Findings The results reveal a significant coincidence with the academic literature both in the description of the concept of self- (...) class='Hi'>regulation and in the origin of the ethics councils and of the system under which they operate. However, a series of nuances not usually considered in the concept of self-regulation are described. Originality/value This study will help assess the national and international possibilities of self-regulation and the significance of the Chilean ethics council. (shrink)

Today, a rights-based approach to technology regulation is central to national and international law-making. A human-rights-based approach would involve viewing technology from the prism of human rights objectives and principles. A more specific turn would be to evaluate their impact on specific rights, namely the right to life, right to peaceful assembly, right to development, right to redressal, rights against discrimination, right to education, etc. Normative frameworks have emerged to further protect human rights from technology-based harms. This (...) paper covers a few conceptual and institutional considerations highlighted in seminal works from scholars and international human rights institutions. To name a few; (1) technology and discriminatory challenges (2) design and use of technology (3) digital divide amongst countries (4) duty of actors, (5) neoliberal technologies, (6) the use of prohibitions and remedies, and (7) the emergence of new human rights. Much of the advocacy and rights-based interventions around the globe are attentive to technology’s challenges to human rights. The abovementioned considerations define the core of the international normative framework, which is often advanced to protect human rights from technology-based harms. (shrink)

Stem cell research is a newly emerging technology that promises a wide variety of benefits for humanity. It has, however, also caused much ethical, legal, and theological debate. While some forms of its application were prohibited in the beginning, they have now started to be used in many countries. This fact obliges us to discuss the regulation of stem cell research at national and international level. It is obvious that in order to make regulations and to draw (...) up legislation at national or international levels it helps to know the perspectives of different cultures and faith traditions. In this article the issue is explored from an Islamic perspective. Firstly, some basic information is given about Islam to explain how laws are drawn up and regulations made in this tradition. Secondly, the principles on which the laws and regulations are based are applied to stem cell research, and finally the permitted and prohibited methods of stem cell research are described. The discussions throughout the paper demonstrate that while some ethicists argue that stem cell research is unethical in the Islamic tradition, tradition permits it as long as such research is aimed at improving human health. (shrink)

While National Human Rights Institutions are widely regarded as particularly promising tools in the emerging transnational regime for the regulation of business and human rights, we still know little about their potential and actual contribution to this field. This article bridges the gap between business and human rights research and NHRI scholarship, proceeding in three steps: Firstly, I analyze the structural conditions for NHRIs to tackle business-related human rights abuses effectively, focusing on the key conditions of legitimacy and (...) competences. Secondly, I examine the envisaged role and functions of NHRIs in business and human rights regulation according to the Paris Principles and the UN Guiding Principles. Thirdly, I reconstruct and critically assess NHRIs’ mandates and powers to address corporate human rights abuse, based on the analysis of surveys and reports. I argue that there is a significant mismatch between the essential structural conditions for effective NHRI engagement with business and human rights, the expected contribution of NHRIs to the prevention and remedy of corporate human rights abuses, and the limitations of their mandates and powers in practice. To overcome that misalignment and unlock NHRIs’ full potential, this article proposes a reform of the Paris Principles which would provide these institutions with a robust source of international legitimacy and increase the pressure on state governments to extend their powers. (shrink)

The paper examines the issue of corporate social responsibility against the backdrop of its self-regulatory posture. Using the African experience as a case study, the paper observes that the activities of multinationals show very clearly that they are grossly irresponsible despite their professed self-regulation. Instead, the multinationals have created an image of terror due to their deep-rooted involvements in human rights abuses, environmental degradation, tax evasion, bribery, market manipulation, and other forms of unethical practices, notwithstanding their so-called self-regulation. (...) The paper concludes by advocating the establishment of a broad-based United Nations Global Business Regulatory Agency to fully take charge of corporate regulation in the global business terrain. (shrink)

The use of private military force by states has been a long-standing phenomena in the history of warfare. Armies of mercenaries, privateering and recruitment of foreign nationals into armed forces have been common during the Middle Ages and later on. However, with the invention of effective firearms and artillery, standing regular armies, conscription and other developments that resulted in the essential rise of costs of war, the role of private military entrepreneurs diminished. By the end of XIXth century the state (...) became almost the only subject that was able to wage a full-scale war. Nevertheless, already in the middle of the XXth century mercenarism has been reborn in Africa’s colonial and post-colonial wars. The end of the XXth century and the beginning of the XXI century witnesses an enormous rise of private security and military companies (PSMC) that are hired to perform different functions related to use of force not only by states, but also by other clients such as international organisations, transnational corporations, etc. A PSMC may be defined as a profit-seeking private enterprise, which is established according to the national law of the state and which is providing, on the basis of a contract, services directly or indirectly connected with the use of military force or its institutions whether in time of armed conflict or peace, notwithstanding how such company describes itself. International humanitarian law has no specific regulation of PSMC. Nevertheless, it would be erroneous to state that the activity of PSMC is not regulated, because international humanitarian law in any case, in one or another way, is applicable to the personnel of PSMC if it is engaged in armed conflict of either international or non-international character. (shrink)

Consequences of world-scale anti-terrorism campaign (which included pre-emptive and coercive regime changes in Afghanistan and Iraq) equaled to or even exceeded consequences of the terrorist challenge itself, and must be analyzed as dialectically interfaced dual factor influencing international politics and law. This dual factor changes basic rules of international relations through wider employment of the principle of pre-emption (retaliation against perceived intentions, rather than against actions), and further blurring of national sovereignty resulting from more coercive interference of (...) the international community into domestic affairs of certain states and societies. Counter-terrorism is philosophically interpreted internationally as reestablishment and strengthening of the monopoly of a state onto use of force, while terrorism is accused for illegal use of force “for private political purposes”. Counter-terrorist practices return previously missing severe coercive sanctions in the international law, and are implemented on behalf of the international community. The problem is to assure both legality and legitimacy of applied measures, especially in situation when major world powers’ interests are split in elaboration of the UN SC decisions authorizing the internationalinterference into sovereign affairs of states. In fact, the very field of counter-terrorism becomes a field for projection and juxtaposing pragmatic interests of world powers. Classical contradiction between international law based on values and principles and pragmatic politics based on interests re-emerges in the area of terrorist challenges/antiterrorist responses. Counter-terrorist practices require as much legal regulation as do terrorist challenges themselves. (shrink)

Environmental Ethics and Behavioural Change takes a practical approach to environmental ethics with a focus on its transformative potential for students, professionals, policy makers, activists, and concerned citizens. Proposed solutions to issues such as climate change, resource depletion and accelerating extinctions have included technological fixes, national and international regulation and social marketing. This volume examines the ethical features of a range of communication strategies and technological, political and economic methods for promoting ecologically responsible practice in the face (...) of these crises. The central concern of the book is environmental behaviour change: inspiring, informing and catalysing reflective change in the reader, and in their ability to influence others. By making clear the forms of environmental ethics that exist, and what each implies in terms of individual and social change, the reader will be better able to formulate, commit to, articulate and promote a coherent position on how to understand and engage with environmental issues. (shrink)

This thesis demonstrates that by redefining the notion of nationhood and by treating nations and national minorities equally with respect to self-determination, it is possible to formulate basic principles of the international legal system, which would promote territorial integrity and stability of multinational states better than the existing system. I demonstrate that theories dealing with self-determination based solely on human rights or cases of secession address the problem with inadequate tools. I also show that minority-rights approaches do not (...) accommodate self-determination claims of national groups properly. ;I offer a new idea of nationhood as a political culture of self-determination with which people self-identify. It includes beliefs about co-nationals' mutual membership in a political community, which is perceived by them as having a self-determining power. Definitions of nationhood which use the notion of culture, but not political culture, are both too inclusive---they fail to distinguish between national and ethnic groups, and too exclusive---they overlook multicultural nations. ;Contested secession has received much attention in recent scholarship. Since, however, contested secession is based upon the disagreement of two or more national groups concerning their self-determination within particular boundaries, I consider secession within the scope of a systematic approach to the regulation of relations among national groups. I propose that international legal principles should be based upon the recognition of states and national groups as the two basic elements of the international system, and the equal recognition of nations as political cultures of self-determination. I interpret self-determination as a claim to equality within the boundaries a multinational state, and formulate a criterion of minimal justice for states. It requires that states respect equality of self-determination of national groups on their territory. National groups can secede from multinational states either by mutual agreement, or if their they are persistently denied a status with respect to self-determination equal to that of other national groups. (shrink)

Despite their growing usage in commercial and industrial applications, nanomaterials have yet to be been thoroughly researched as to their potential health, safety, and environmental risk to human life after incorporation into new product improvement, development, design, and manufacturing processes. Identifying the appropriate governance framework for effective risk assessment analysis of toxicological risk to human beings—specifically manufacturing employees and consumers—and other living organisms, resulting from the development and application of these nanotechnology-based products, has yet to be scientifically determined. With major (...) regulatory gaps in the public regulation framework at national and international levels of governance, a proposed private governance framework is needed to assist the existing public regulatory framework with the proliferation of products and manufacturing processes utilizing nanomaterials. There are three distinct (yet complimentary) approaches available to develop a private governance framework to complement existing national public regulatory frameworks: responsible innovation, risk management, and voluntary guidelines/industry standards. The case for supporting a hybrid governance framework, combining public and private governance mechanisms, for nanotechnology is reflective of the current public policy environment that has emerged to best address health, safety, and environmental risk assessment issues concerning nanotechnology and nanomaterials. (shrink)

BackgroundEthical and regulatory guidance on the collection and use of human biospecimens for research forms an essential component of national health systems in Sub-Saharan Africa, where rapid advances in genetic- and genomic-based technologies are fueling clinical trials involving HBS and the establishment of large-scale biobanks.MethodsAn extensive multi-level search for publicly available ethics regulatory guidance was conducted for each SSA country. A second review documented active trials listed in the WHO International Clinical Trials Registry Platform as of January 2015 (...) in which HBS collection was specified in the protocol. Findings were combined to determine the extent to which countries that are study sites for HBS-related research are supported by regulatory guidance language on the collection, use, ownership and storage of biospecimens.ResultsOf the 49 SSA countries, 29 had some form of national ethics guidance, yet only 17 provided language relating to HBS-related research, with specific guidance on consent, ownership, reuse, storage, and export/import/transfer. Ten countries accounted for 84 % of the active clinical trials involving the collection of HBS in SSA. All except one of these countries were found to have some national guidance in the form of regulations, codes of ethics, and/or standard operating procedures; however, only seven of the ten offered any language specific to HBS.ConclusionsDespite the fact that the bulk of registered clinical trials in SSA involving HBS, as well as existing and proposed sites for biorepositories under the H3Africa Initiative, are currently situated in countries with the most complete ethics and regulatory guidance, variability in the regulations themselves may create challenges for planned and future pan-African collaborations and may require legislative action at the national level to revise. Countries in SSA that still lack regulatory guidance on HBS will require extensive health system strengthening in ethics governance before they can be full participants in the modern research enterprise. (shrink)

Background: The school meals program has multiple objectives of education, nutrition, and value transfer. To ensure achieving the goal, total quality management (TQM) is implemented in the school meals program. Supply chain issues pose significant challenges to TQM implementation in the program execution. Aim: This study aims to examine national and international capacities in supply chain management by analyzing the variety of food items delivered through the school meals program. Methods: The Bayesian Mindsponge Framework, combining the reasoning strengths (...) of Mindsponge Theory and inference advantages of Bayesian analysis, was employed on a dataset of 126 government representatives who manage large-scale school meal programs in 126 different countries. Results: Findings showed that the method of obtaining supplies, whether through in-kind donations from local, regional, national sources, or national food reserves and purchasing from neighboring or distant countries, had a significant positive association with the variety of food items included in school meals or snacks. Conversely, obtaining supplies in-kind from neighboring or distant countries had a significant negative association with the food variety. Additionally, purchasing supplies from local, regional, or national food reserves had an unclear association with the food variety. Conclusions: Findings underscore the importance of supporting the World Bank and World Food Programme’s recommendation to rely more on local resources and capacities. Enhancing supply chain management at the national level is crucial for developing a long-term and sustainable school meals program. (shrink)

Informed consent is recognized as a primary ethical requirement to conduct research involving humans. In the investigations with the use of human biological material, informed consent (IC) assumes a differentiated condition on account of the many future possibilities. This work presents suitable alternatives for IC regarding the storage and use of human biological material in research, according to new Brazilian regulations. Both norms – Resolution 441/11 of the National Health Council, approved on 12 May 2011, and Ordinance 2.201 ( (...) class='Hi'>NATIONAL GUIDELINES FOR BIOREPOSITORIES AND BIOBANKS OF HUMAN BIOLOGICAL MATERIAL FOR RESEARCH PURPOSE) of the Brazil Ministry of Health, approved on 14 September 2011 – state that the consent of subjects for the collection, storage and use of samples stored in Biobanks is necessarily established by means of a Free and Informed Consent Form (ICF). In order to obtain individual and formal statements, this form should contain the following two mutually exclusive options: an explanation about the use of the stored material in each research study, and the need for new consent or the waiver thereof when the material is used for a new study. On the other hand, ICF suitable for Biorepositories must be exclusive and related to specific research. Although Brazilian and international regulations identify the main aspects to be included in the IC, efforts are still necessary to improve the consent process, so that the document will become a bond of trust between subject and researcher. (shrink)

The historical background of the discovery of adverse health effects of medicines, food additives, pesticides, and other chemicals is reviewed, and the development of national and international regulations and testing procedures to protect the public against the toxic effects of these drugs and chemicals is outlined. Ethical considerations of the safety evaluation of drugs and chemicals by human experimentation and animal toxicity studies, ethical problems associated with clinical trials, with the falsification of clinical and toxicological data, and with (...) inadequate experimental methodology, are reviewed, and the ethics of the marketing of drugs and their post-marketing surveillance, are similarly considered. These ethical problems are illustrated with many specific examples, including the drugs neoarsphenamine, chloramphenicol, thalidomide, diethyl stilboestrol and benoxaprofen. (shrink)

The historical background of the discovery of adverse health effects of medicines, food additives, pesticides, and other chemicals is reviewed, and the development of national and international regulations and testing procedures to protect the public against the toxic effects of these drugs and chemicals is outlined. Ethical considerations of the safety evaluation of drugs and chemicals by human experimentation and animal toxicity studies, ethical problems associated with clinical trials, with the falsification of clinical and toxicological data, and with (...) inadequate experimental methodology, are reviewed, and the ethics of the marketing of drugs and their post-marketing surveillance, are similarly considered. These ethical problems are illustrated with many specific examples, including the drugs neoarsphenamine, chloramphenicol, thalidomide, diethyl stilboestrol and benoxaprofen. (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)

Since the founding of the UN, the protection of human rights has been a national and international challenge. In international human rights covenants, State Parties firstly commit themselves to respecting human rights in their respective constitutional area and to protecting and possibly incorporating them into the relevant constitution, but, secondly, they also submit to an international control. National protection is usually organized by different institutions, but also accompanied by critical NGOs and the national civil (...) public. International protection is on the one hand implemented by a number of international organizations and institutions, but on the other hand is accompanied by a critical, now regionally and internationally operating public. This includes a number of permanent NGOs, but also ad hoc groups, tribunals and the various media and anonymous campaigns on the Internet and the social networks. This paper examines the functions and tasks of such concomitant national and international public spheres and tries to assess their importance for the protection of human rights. (shrink)

One of the most complex and uncertain areas of international legal doctrine concerns how to deal with the aspiration of a people to achieve self-determination through the establishment of a new state and the related claim to a specific territory over which statehood is to be exercised. Recently, when the General Assembly of the United Nations referred to the International Court of Justice the question of the legality of the declaration of independence by Kosovar Albanians, the Court was (...) given an opportunity to clarify and develop the law on external self-determination. Instead, the Court answered extremely narrowly, confining its analysis to the legality of the act of declaration without determining any consideration of international legal norms applicable to the act of secession that was being proposed. This article intends to fill the gap left by the ICJ’s decision: first by critiquing the inadequacy and tensions visible in the existing doctrine and second by examining how recent developments in international law may allow for a more normatively coherent approach to the problem. (shrink)

The enrolment of children and adolescents in health research requires that attention to be paid to specific assent and consent requirements such as the age range for seeking assent; conditions for parental consent (and waivers); the age group required to provide written assent; content of assent forms; if separate assent and parental consent forms should be used, consent from emancipated young adults; reconsent at the age of adulthood when a waiver of assent requirements may be appropriate and the conditions for (...) waiving assent requirements. There is however very little available information for researchers and ethics committees on how to navigate these different issues. To provide guidance to research initiatives, the SickleInAfrica consortium conducted a thematic analysis of a sample of research ethics guidelines and procedures in African countries, to identify guidance for assent requirements in health research. The thematic analysis revealed that 12 of 24 African countries specified the age group for which assent is required. The minimum age for written assent varied across the countries. Five countries, Algeria, Botswana, Cameroon, Nigeria and The Democratic Republic of Congo require consent from both parents/family council in certain circumstances. Botswana, Nigeria, South Africa and Uganda have specific assent/consent requirements for research with emancipated minors. South Africa and Algeria requires re-consent at onset of adulthood. Five countries (Botswana, Cameroon, Nigeria, South Africa and Tanzania) specified conditions for waiving assent requirements. The CIOMS and the ICH-GCP guidelines had the most comprehensive information on assent requirements compared to other international guidelines. An interactive map with assent requirements for different African countries is provided. The results show a major gap in national regulations for the inclusion of minors in health research. The SickleInAfrica experience in setting up a multi-country SCD registry in Africa highlights the need for developing and harmonising national and international guidelines on assent and consent requirements for research involving minors. Harmonisation of assent requirements will help facilitate collaborative research across countries. (shrink)

Building on an illustrative case of a systemic environmental threat and its multi‐stakeholder response, this paper draws attention to the changing political impacts of corporations in the digital age. Political Corporate Social Responsibility (PCSR) theory suggests an expanded sense of politics and corporations, including impacts that may range from voluntary initiatives to overcome governance gaps, to avoiding state regulation via corporate political activity. Considering digitalization as a stimulus, we explore potential responsibilities of corporations toward public goods in contexts with (...) functioning governments. We show that digitalization—in the form of transparency, surveillance, and data‐sharing—offers corporations’ scope for deliberative public participation. The starry sky beetle infestation endangering public and private goods is thereby used to illustrate the possibility of expanding the political role of corporations in the digital sphere. We offer a contribution by conceptualizing data‐deliberation as a Habermasian variation of PCSR, defined as the (a) voluntary disclosure of corporate data and its transparent, open sharing with the public sector (b) along with the cooperation with governmental institutions on data analytics methods for examining large‐scale datasets (c) thereby complying with existing national and international regulations on data protection, in particular with respect to privacy and personal data. (shrink)

National Action Plans on business and human rights are a growing phenomenon. Since 2011, 42 such plans have been adopted or are in-development worldwide. By comparison, only 39 general human rights action plans were published between 1993 and 2021. In parallel, NAPs have attracted growing scholarly interest. While some studies highlight their potential to advance national compliance with international norms, others criticise NAPs as cosmetic devices that states use to deflect attention from persisting abuses and needed (...) class='Hi'>regulation. In response to wider critiques of international human rights norms, and their failure to exact universal state compliance, experimentalist governance theory highlights the dynamic, dialogic and iterative character of human rights implementation as well as the role of stakeholders. In this article, we apply experimentalist governance theory to evaluate the role and character of business and human rights NAPs. Rather than attempting to evaluate NAPs’ ultimate consequences for rights-holders, which appears premature, we focus on NAPs processes. Specifically, we analyse NAPs processes in twenty-five states against five experimentalist governance criteria relating to stakeholder participation; agreement on a broad problem definition; local contextualisation; monitoring and peer review and periodic revision and learning. According to our findings, NAPs on business and human rights in most states demonstrate resemblance to the traits of experimentalist governance. In particular, our analysis points to the emergence of relatively sophisticated and demanding institutional governance mechanisms within NAPs — including the institutionalisation of complex deliberative processes. Nevertheless, our paper also identifies some significant shortcomings in NAPs, related to the lack of inclusion of vulnerable groups and the lack of explicit indicators and targets. (shrink)

Farming of fish and other aquatic species has increased in recent decades and never before have there been more controversial debates on animal welfare in fish husbandry. The practices used and associated welfare issues are becoming increasingly focused on by scientists, consumers and policy makers. International and national organisations have issued recommendations and guidelines concerning fish welfare but there is still a lot of information lacking. Due to § 2 of the German animal protection law, animals must be (...) adequately nourished, cared for and behaved in a proper manner, and pain or avoidable suffering or damage must be avoided. Keeping fish in accordance with the animal protection laws should be part of a good professional aquaculture practice and is indispensable for ethical, legal and economic reasons. As other vertebrates fish have the right of a healthy life with physical and mental integrity, under which they can perform adequately.The paper provides and discusses legal aspects of animal protection applied to fish taking the German welfare act and EU regulations as example. First possible indicators for the assessment of well-being will be mentioned. The assessment of fish welfare indicators should be carried out within the frame of daily and regular working routines, e. g. feeding, harvesting, grading or slaughtering. Further customer’s perception and human interpretation of welfare in fish are discussed and set into the context of human sentiments, projected on fish and the debate on consciousness in fish. (shrink)

The World Health Assembly adopted the new International Health Regulations on May 23, 2005. The new IHR represent the culmination of a decade-long revision process and an historic development for international law and public health. The new IHR appear at a moment when public health, security, and democracy have become intertwined, addressed at the highest levels of government. The United Nations Secretary-General Kofi Annan, for example, identified IHR revision as a priority for moving humanity toward “larger freedom.” This (...) article analyzes the new IHR and their implications for global health and security in the 21st century.The WHA instructed the WHO Director-General to revise the IHR in 1995 because the Regulations did not provide an effective framework for addressing the international spread of disease. Doubts about the IHR's effectiveness had, however, been present long before 1995. The critiques identified the narrow scope of the regulations, the lack of compliance by states, and the absence of a strategy for responding to rapid changes in public health's global economic and technological environments. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 12.1 (2002) 103-113 [Access article in PDF] Scope Note Update Searching Across Boundaries: National Information Resource on Ethics and Human Genetics* While indeed an historical moment, the announcement of the mapping of the human genome has been treated in the literature as a beginning—a new way to think about biology and the ways in which biological concepts are applied to medicine. Issues of (...) both Science and Nature magazines celebrated the event by establishing interdisciplinary websites where readers can access essays on aspects of genome mapping and directly link to databases to search for more information on the topics (IV. Genome Gateway 2001; The Human Genome 2001). Since 1994, the National Information Resource on Ethics and Human Genetics (NIREHG), a special project of the National Reference Center for Bioethics Literature (NRC), has been providing such an integrated information service on ethics and genetics. Designed to enable a wide range of users to go from annotated bibliographies (Scope Notes) and brief essays (called "enotes") to database searching, NIREHG fosters an interdisciplinary approach to research on ethics and genetics. Links are provided between and among Scope Notes and enotes to information maintained on the NIREHG site as well as to sources found throughout the Internet. In providing the following annotations added to NIREHG materials since 1997, the Kennedy Institute of Ethics Journal (in its online presence through Project Muse) becomes an additional forum for NIREHG links. "It is a rare and wonderful moment when success teaches us humility, and this, I argue, is precisely the moment at which we find ourselves at the end of the twentieth century" (IV. Keller 2000, p. 7). It is with both joy and humility that we celebrate the mapping of the human genome. [End Page 103] I. Genetic Testing Andrews, Lori B. Future Perfect: Confronting Decisions About Genetics. New York: Columbia University Press, 2001. 264 p.Noting the wide impact of genetic testing, Andrews discusses patient self concept, reproduction decisions, confidentiality, discriminations in health insurance and employment, the need for competent counseling, and the legal, ethical, and social regulations she deems important to help solve dilemmas arising from the tests and their ensuing ramifications. She describes three models, pointing out both advantages and problems: a medical model with physician gatekeepers, a public health model that could provide education as well some testing for those unable to afford tests, and a fundamental rights model that could give greater weight to individuals decisions about the use of health care services. The book has 85 pages of footnotes.American Society of Human Genetics. Social Issues Subcommittee on Familial Disclosure. Professional Disclosure of Familial Genetic Information. American Journal of Human Genetics 62 (2): 474-83, February 1998.The ASHG statement outlines points to consider: the general rule of confidentiality, exceptional circumstances that permit disclosure, and the ethical duty to inform patients about familial implications. Background discussion includes: ethical frameworks for disclosure of otherwise confidential information, the duty to warn under law, and international trends and positions.Boetzkes, Elisabeth. Genetic Knowledge and Third-Party Interests. Cambridge Quarterly of Healthcare Ethics 8 (4): 386-92, Summer 1999.Protection from the interests of insurers or prospective employers are discussed from the point of view of the ethical basis of the professional obligation to confidentiality as well as the right to privacy of those tested. However, the author supports family members, saying that "first-party resistance to disclosure may be overcome by weighty third-party claims."Chadwick, Ruth; Shickle, Darren; ten Have, Henk; and Wiesing, Urban, eds. The Ethics of Genetic Screening. Dordrecht, The Netherlands: Kluwer Academic Publishers, 1999. 255 p.Twenty-one chapters and 23 authors provide views of genetic testing/screening in different European countries and offer brief discussions of sociological perspectives, moral and philosophical issues, privacy, reconciling liberty and the common good, and questions raised in genetic testing of children.Clayton, Ellen Wright. Genetic Testing in Children. Journal of Medicine and Philosophy 22 (3): 233-51, June 1997.Clayton argues that there is room for... (shrink)

This paper examines the implications of the General Agreement on Trade in Services (GATS), the World Trade Organization’s agreement governing trade in health-related services, for health policy and healthcare reform in the United States. The paper describes the nature and scope of US obligations under the GATS, the ways in which the trade agreement intersects with domestic health policy, and the institutional factors that mediate trade-offs between health and trade policy. The analysis suggests that the GATS provisions on market access, (...) national treatment and domestic regulation, which are designed to eliminate ‘regulatory barriers’ to global trade in health services, limit the range of options that state and federal regulators and legislative bodies can employ to regulate the health sector and implement healthcare reforms. As such, the paper identifies the broader social and ethical implications of free trade policy. (shrink)

The recent upsurge of national sentiments in the former socialist countries has also brought about the desire to create “national”philosophies. Such attempts are bound to be unsuccessful, partly because of the increasingly internationalized contexts of philosphical inquiry. What is possible instead and is actually taking place in many countries, cultures, and even cities are philosophical “schools” In smaller countries frequently the most productive position for philosophy is to be simultaneously national and international, facilitating in this way (...) a critical discussion within the limited national cultural space and simultaneously pursuing universal philosophical problems. (shrink)

the recent announcement of the claimed births of CRISPR-edited babies has prompted both widespread condemnation and calls by leading scientists for a moratorium on any further germline genome editing for reproductive purposes. Concurrently, national and international bodies are calling for the development of robust guidelines and requirements that will identify permissible conditions under which such GGE efforts may proceed. As detailed recommendations to navigate this unique terrain are under development, we suggest an approach that begins with identifying serious (...) concerns about social exclusion and social justice that arise... (shrink)

Earth’s life-support system is facing megaproblems of sustainability. One important way of how these problems can be addressed is through innovation. This paper argues that responsible innovation that contributes to sustainable development consists of three dimensions: innovations avoid harming people and the planet, innovations ‘do good’ by offering new products, services, or technologies that foster SD, and global governance schemes are in place that facilitate innovations that avoid harm and ‘do good.’ The paper discusses global governance schemes based on deliberation (...) as a means to foster such responsible innovation. These schemes can provide voluntary soft-law regulations that complement and extend national and international hard-law regulations and facilitate collective innovation that contributes to SD goals. The article addresses the facilitative role of governments and international organizations in overcoming problems of deliberation and offers illustrative examples of such governance schemes. (shrink)

ABSTRACT Various mechanisms to ensure the protection of subjects in human research have been suggested, including the presence of witnesses during the informed consent process. For our commentary on the use of witnesses and their potential role and responsibility during the consent process, we start by addressing current guidelines for human subjects research in four Latin American countries. By using examples from public health research, we highlight some of the practical difficulties of using witnessed consent, from becoming a meaningless ritual (...) at one end of the spectrum to the research subject feeling intimidated or coerced to participate at the other. Apart from these practical difficulties, it is unclear what responsibility the witness could and should have. We argue that there are important ethical questions about the role of witnesses that have not been adequately addressed in national and international regulations. This work addresses these gaps and argues that more debate is required to define the role and responsibilities of witnesses in the consent process, their training requirements and whether a universal legal requirement for witnessed consent, regardless of the type of research, is desirable. (shrink)

In the space of two decades, social rights have emerged from the shadows and margins of human rights jurisprudence. The authors in this book provide a critical analysis of almost two thousand judgments and decisions from twenty-nine national and international jurisdictions. The breadth of the decisions is vast, from the resettlement of evictees to the regulation of private medical plans to the development of state programs to address poverty and illiteracy. The jurisprudence not only implicates our understanding (...) of economic, social, and cultural rights, but also challenges the philosophical debates that question whether these rights can and should be justiciable. (shrink)