Ethical issues in translational research

The translation of biomedical research knowledge to effective clinical treatment is essential to the public good and is a main focus of current health policy. However, recent health policy initiatives intended to foster the translation of basic science into clinical and public health advances must also consider the unique bioethical issues raised by the increased focus on translational research. Safety of study participants and balancing of risk due to treatment with the potential benefits of the research is tantamount. This article synthesizes theory from clinical ethics, operational design, and philosophy to provide a bioethical framework for the health policy of translational research.     

Wetland mitigation and compensation: Canadian experience

Since Canada’s accession to the Ramsar Convention on Wetlands in 1981, the nation’s commitment to wetland conservation and management has increased significantly. This includes the adoption of one of the World’s first national wetland conservation policies by the Government of Canada, and the adoption of complementary policy and legislative initiatives by most of the 13 provincial and territorial jurisdictions. Numerous habitat ‘no net loss’ and environmental assessment policies, regulations and guidelines for incorporating mitigation processes into development decisions affecting wetland resources are used throughout Canada. The governments of Canada and six provinces have so far adopted wetland mitigation measures. These are in addition to comprehensive wetland fish and wildlife habitat initiatives, such as the species and habitat joint ventures delivered in Canada through the North American Waterfowl Management Plan by all jurisdictions and numerous non-government partners. This paper examines the current policies, regulations and programs, as well as past implementation experience with wetland mitigation and compensation in Canada.     

HUMAN DIGNITY IN INTERNATIONAL POLICY DOCUMENTS: A USEFUL CRITERION FOR PUBLIC POLICY?

Current developments in biomedicine are presenting us with difficult ethical decisions and raising complex policy questions about how to regulate these new developments. Particularly vexing for governments have been issues related to human embryo experimentation. Because some of the most promising biomedical developments, such as stem cell research and nuclear somatic transfer, involve such experimentation, several international bodies have drafted documents aimed to provide guidance to governments when developing biomedical science policy. Here I focus on two such documents: the Council of Europe's Convention for the Protection of Human Rights and Dignity of the Human Being and the Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being. I argue that by using human dignity as a criterion to determine the permissibility of particular human embryo research practices, these documents cannot aid in identifying research that would be contrary to human dignity. Thus, they fail to guide public policy on embryo experimentation. Their use of human dignity as a criterion makes their task of offering guidance unfeasible because the concept as used in these documents is too vague and is applied in contradictory ways. I discuss the main goals of these documents and their claims in relation to human embryo research. I then discuss how they have influenced public policy in several countries. Finally, I show that although these Council of Europe treaties attempt to serve as public policy guides in the area of embryo research, they fail to do so.     

Reflexive governance in biobanking: on the value of policy led approaches and the need to recognise the limits of law

Although a few jurisdictions around the world have legislated in response to the phenomenon of biobanking, the far more common response has been policy led with funders and other stakeholders initiating multi-level policy initiatives to guide biobanking practice. An example of this is UK Biobank which has developed and operates according to an Ethics and Governance Framework. Such an instrument has no basis in law and yet it has played a crucial role in the set up and ongoing management of the resource. It will continue to do so, as related policies emerge, such as access and intellectual property policies. Numerous biobanking initiatives have similar high-level policy documents that guide decisions and practice. These are often framed as a commitment to participants, researchers and society more broadly and invoke notions such as the public good and the public interest. As such, they serve as a benchmark against which to measure a biobank’s performance. Moreover, policies become an important means by which biobankers are held accountable. This article critically analyses this policy-driven phenomenon asking how effectively policy—often as an alternative to law—serves to police and to promote biobanking. It argues that a policy of reflexive governance—defined and developed herein—can best meet the challenges faced by many biobanks and without the need for recourse to law.     

Public consultation in ethics an experiment in representative ethics

Genome Canada has funded a research project to evaluate the usefulness of different forms of ethical analysis for assessing the moral weight of public opinion in the governance of genomics. This paper will describe a role of public consultation for ethical analysis and a contribution of ethical analysis to public consultation and the governance of genomics/biotechnology. Public consultation increases the robustness of ethical analysis with a more diverse set of moral experiences. Consultation must be carefully and respectfully designed to generate sufficiently diverse and rich accounts of moral experiences. Since dominant groups tend to define ethical or policy issues in a manner that excludes some interests or perspectives, it is important to identify the range of interests that diverse publics hold before defining the issue and scope of the discussion and the premature foreclosure of ethical dialogue. Consequently, a significant contribution of ethical dialogue strengthened by social analysis is to consider the context and non-policy use of power to govern genomics and to sustain social debate on enduring ethical issues.     

What Constitutes Adequate Public Consultation? Xenotransplantation Proceeds in Australia

The Australian moratorium on human clinical trials of xenotransplantation was lifted in December 2009. This decision follows public consultations on whether xenotransplantation should or should not proceed in Australia, which occurred in 2002 and 2004. However, the public consultation, in its design and process, did not facilitate meaningful public engagement and involvement, thus marginalising the public and devaluing their social experiences and diverse knowledges. This brief article questions what constitutes adequate public consultation, and suggests that consensus conferences or citizen juries should be explored as a mechanism for meaningful public engagement for future public consultation exercises in Australia.     

Regulation of hESC Research in Australia: Promises and Pitfalls for Deliberative Democratic Approaches

This paper considers the legislative debates in Australia that led to the passage of the Research Involving Human Embryos Act (Cth 2002) and the Prohibition of Human Cloning Act (Cth 2002). In the first part of the paper, we discuss the debate surrounding the legislation with particular emphasis on the ways in which demands for public consultation, public debate and the education of Australians about the potential ethical and scientific impact of human embryonic stem cells (hESC) research were deployed, and the explicit and implicit framing of the scope of public consultation. We then ask whether, given the calls for public consultations, debate and understanding, current work in democratic theory could be helpful in analysing the process of policy-making in these areas. In particular, we canvass the literature relating to aggregative and deliberative models of democracy for processes that support the legitimacy of policy. We identify features of the debate that reflect the appeal of deliberative approaches as well as some of the possible hurdles or limitations to developing deliberative democratic approaches to policy in ethically contentious areas.     

The ethics of risk displacement in research and public policy

We identify three distinct ethical problems that can arise with risk displacement. Risk displacement is the shifting of extant risk from one or more individuals to other individual(s) such that the reduction of risk to the first group is causally implicated in increasing risk to the second group. These problems are: concentration of risk in inequitable ways; transfer of risk to already vulnerable or disadvantaged populations; and exercise of undue influence over potential research participants. The first two arise in both public policy and research initiatives, whereas the third is a special concern that only applies to research initiatives. We argue that when one or more of these is of high magnitude, then the study or policy intervention may be ethically wrong. Finally, we conclude that although some risk displacement is ethically permissible, researchers and policymakers still have ethical reasons to reduce the magnitude of these problems.     

Everything and nothing: regulating embryo research in Canada

This article examines how medical and scientific professionals experience and engage with the governance of embryo research in Canada. Drawing on the history of embryo regulation in Canada and the findings of a survey conducted with lab directors in Canadian fertility clinics, we identify a disjuncture between the rules established by legislation, regulations, and research ethics guidelines and the real-life experiences of professionals in the field. This disjuncture, we argue, is the result of both the absence of implementation mechanisms that would give substance to the governing framework, as well as an inability on the part of medical and scientific professionals to engage in robust self-regulation. Overall, we demonstrate that in an ethically charged and highly technical area of policy-making like embryonic research, clarity about the roles and responsibilities of government and professionals in policy-making and implementation is critical to effective governance.     

The use of fresh embryos in stem cell research: ethical and policy issues

Fresh embryos resulting from in vitro fertilization, including many of poor quality, can provide sources of human embryonic stem cell lines. We consider why some donate such embryos for this research, address relevant ethical and policy issues, and present core guidelines for fresh embryo donation based on those of Canada.     

Expansion of gambling in Canada: implications for health and social policy

Canada experienced a dramatic increase in legalized gambling in the 1990s, primarily because of governments'' need to increase revenue without additional taxation. This article examines gambling from a public health perspective. The major public health issues include gambling addiction, family dysfunction and gambling by youth. Debates have emerged about the health, social and economic costs and benefits of gambling. Stakeholder and social policy groups have expressed concern about the impact of expanded gambling on the quality of life of individuals, families and communities. Epidemiological studies show that the prevalence of gambling in the general adult population is low but increasing. Of particular concern is the high though steady prevalence of gambling among youth. New technologies have been linked to gambling-related problems such as addiction to gambling by video lottery terminals. Gambling by means of the Internet represents another emerging issue. The article concludes with recommendations for health and social policy related to gambling. These recommendations incorporate a broad public health approach to create a strong research program and to balance risks and benefits.     

The Scope of Public Discourse Surrounding Proposition 71: Looking Beyond the Moral Status of the Embryo

Human embryonic stem cell research has generated considerable discussion and debate in bioethics. Bioethical discourse tends to focus on the moral status of the embryo as the central issue, however, and it is unclear how much this reflects broader community values and beliefs related to stem cell research. This paper presents the results of a study which aims to identify and classify the issues and arguments that have arisen in public discourse associated with one prominent policy episode in the United States: the 2004 Californian Stem Cell Research and Cures Initiative (also known as Proposition 71). The findings show that public discourse about Proposition 71 is characterised by a broader range of issues than those usually addressed in scholarly publications and public policy documents. While attention to the moral status of the embryo is an important issue in stem cell research, making it the main focus of public discourse has a polarising effect. This also limits opportunities to identify shared values, understand how political alliances are forged, and develop social consensus. Implications for future research and policy are discussed.     

Falling giants and the rise of gene editing: ethics,private interests and the public good

This paper considers the tensions created in genomic research by public and private for-profit ideals. Our intent is to strengthen the public good at a time when doing science is strongly motivated by market possibilities and opportunities. Focusing on the emergence of gene editing, and in particular CRISPR, we consider how commercialisation encourages hype and hope—a sense that only promise and idealism can achieve progress. At this rate, genomic research reinforces structures that promote, above all else, private interests, but that may attenuate conditions for the public good of science. In the first part, we situate genomics using the aphorism that ‘on the shoulders of giants we see farther’; these giants are infrastructures and research cultures rather than individual ‘heroes’ of science. In this respect, private initiatives are not the only pivot for successful discovery, and indeed, fascination in those could impinge upon the fundamental role of public-supported discovery. To redress these circumstances, we define the extent to which progress presupposes research strategies that are for the public good. In the second part, we use a ‘falling giant’ narrative to illustrate the risks of over-indulging for-profit initiatives. We therefore offer a counterpoint to commercialised science, using three identifiable ‘giants’—scientists, publics and cultures—to illustrate how the public good contributes to genomic discovery.     

The urgent need for human well-being elements in biodiversity research

Biodiversity research needs to broaden its scope by incorporating human well-being elements if it is to attract public attention and thus affect conservation policy. Emphasizing the invaluable link between biodiversity conservation and human well-being will likely change the current, apathetic public perceptions about biodiversity conservation—the results of which are evident in the lack of urgency in tackling the crisis of biodiversity loss.     

Building International Indigenous People’s Partnerships for Community-Driven Health Initiatives

In this article we present an international Indigenous people’s partnership project co-led by two Indigenous communities, Musqueam (Coast Salish, Canada) and Totoras (Quichua, Ecuador), as a community-driven health initiative. The Musqueam-Totoras partnership includes Indigenous organizations, universities, international agencies, government, and nongovernmental organizations to address Indigenous health concerns in both communities. Our collaborative approach provides a framework to (a) increase the development expertise of Indigenous people internationally, (b) increase skills among all participants, and (c) facilitate Indigenous knowledge mobilization and translation to promote cultural continuity. This international Indigenous people’s partnership between north and south reflects the diversity and commonalities of Indigenous knowledge, contributes to cultural revitalization, and minimizes the impact of assimilation, technology, and globalization. Indigenous people’s partnerships contribute to self-determination, which is a prerequisite to the building and maintenance of healthy communities and the promotion of social justice. The exchange of Indigenous knowledge upholds Indigenous values of respect, reciprocity, relevance, and responsibility. Given the history of colonization and the negligence of governments in the exercising of these values with respect to Indigenous communities, this contemporary exchange among Indigenous people in the Americas serves to reclaim these values and practices. International cooperation empowering Indigenous people and other marginalized groups has become fundamental for their advancement and participation in globalized economies. An international Indigenous people’s partnership provides opportunities for sharing cultural, historical, social, environmental, and economic factors impacting Indigenous health. These partnerships also create beneficial learning experiences in community-based participatory research and community-driven health initiatives, provide culturally sensitive research ethics frameworks, increase capacity building, and address basic human needs identified by participating communities.     

Using Win-Win Strategies to Implement Health in All Policies: A Cross-Case Analysis

Background

In spite of increasing research into intersections of public policy and health, little evidence shows how policy processes impact the implementation of Health in All Policies (HiAP) initiatives. Our research sought to understand how and why strategies for engaging partners from diverse policy sectors in the implementation of HiAP succeed or fail in order to uncover the underlying social mechanisms contributing to sustainable implementation of HiAP.

Methods

In this explanatory multiple case study, we analyzed grey and peer-review literature and key informant interviews to identify mechanisms leading to implementation successes and failures in relation to different strategies for engagement across three case studies (Sweden, Quebec and South Australia), after accounting for the role of different contextual conditions.

Findings

Our results yielded no support for the use of awareness-raising or directive strategies as standalone approaches for engaging partners to implement HiAP. However, we found strong evidence that mechanisms related to “win-win” strategies facilitated implementation by increasing perceived acceptability (or buy-in) and feasibility of HiAP implementation across sectors. Win-win strategies were facilitated by mechanisms related to several activities, including: the development of a shared language to facilitate communication between actors from different sectors; integrating health into other policy agendas (eg., sustainability) and use of dual outcomes to appeal to the interests of diverse policy sectors; use of scientific evidence to demonstrate the effectiveness of HiAP; and using health impact assessment to make policy coordination for public health outcomes more feasible and to give credibility to policies being developed by diverse policy sectors.

Conclusion

Our findings enrich theoretical understanding in an under-unexplored area of intersectoral action. They also provide policy makers with examples of HiAP across wealthy welfare regimes, and improve understanding of successful HiAP implementation practices, including the win-win approach.     

Guidelines for Community-based Ethics Review of Children’s Science Fair Projects

Low-level community based ethics committees staffed by teachers, parents and community representatives can readily review children’s science fair projects subject to the revision of two core assumptions currently governing children’s Science Fairs. The first part of the paper recasts the New Zealand Royal Society guidelines from its primary emphasis on risk to a new assumption, without benefit there can be no risk. Equally, this revision gives more prominence to the participant information sheet, allowing it to act as a quasi application form which provides ethical transparency between student researchers, participants and a community based ethics committee. A second core assumption, more accurately labeled a cult of originality, produces a random, open-ended array of student topics taking ethics review beyond the confidence level of most community based ethics review committees. This paper reins in Science Fair coordinators recommending they make community level ethics review more manageable by providing a list of preapproved topics for those students wanting to conduct research involving human participants. These revised assumptions create a workable division of labour. Teachers’ preapproved topics involving human participants are more likely to be low risk, permitting community level ethics review to focus primarily on two aspects of the minimization of harm: first, for all participants, especially those with diminished autonomy, and second, for the child researchers themselves, as some participants may be unknown to the student. These revised assumptions make science and ethics more accessible to public education thus demonstrating how Science Fairs can lead students and the community into better understanding the role and function that ethics has in all scientific research human participants. Martin Tolich chaired New Zealand’s National Health Ethics committee, the multi-region ethics committee.     

Dance education in Singapore: Policy,discourse, and practice

This article provides an overview of dance education in schools in Singapore with regard to physical education, co-curricular activity, initiatives by the National Arts Council's Arts Education unit, and pre-tertiary and tertiary dance programs. In an effort to gain a better understanding of how well the official discourse and the reality of schooling in dance interconnect, a meta-analysis of published articles, conference papers, committee reports, and curricula was conducted. Situated within the larger sociocultural, political, and historical contexts, Singapore presents a curious case for probing the merits and limitations of research, policy initiatives, and policy implementation. In the conclusion, the author argues that the development of a coherent dance education in Singapore requires “fixing” three dilemmas—meritocratic schooling in dance, the ill-defined and exhaustive use of the term “talent,” and the uneven research that has not kept pace with the policy initiatives.     

The World Maritime University—Sasakawa Global Ocean Institute: A New Institute in a Unique University

Abstract

Building capacity in ocean affairs, the law of the sea, and marine scientific research in relation to the needs of developing countries is an integral part of the U. Convention on the Law of the Sea and associated instruments, including the International Maritime Organization (IMO) treaty regime. This article traces the development of capacity-building initiatives at the World Maritime University (WMU) over the past three decades, including the establishment of the WMU–Sasakawa Global Ocean Institute in 2018. The establishment of the new institute should be viewed within the wider context of the extraordinary philanthropy of the Sasakawa Peace Foundation and the Nippon Foundation in building human resource capacity and in supporting advanced academic research on complicated and contentious ocean issues. The article describes the extensive consultation process that informs the research, education, and capacity development agenda of the new institute, including work on the ocean-related goals of the 2030 Agenda for Sustainable Development.