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.     

EMPIRICAL ETHICS AS DIALOGICAL PRACTICE

In this article, we present a dialogical approach to empirical ethics, based upon hermeneutic ethics and responsive evaluation. Hermeneutic ethics regards experience as the concrete source of moral wisdom. In order to gain a good understanding of moral issues, concrete detailed experiences and perspectives need to be exchanged. Within hermeneutic ethics dialogue is seen as a vehicle for moral learning and developing normative conclusions. Dialogue stands for a specific view on moral epistemology and methodological criteria for moral inquiry. Responsive evaluation involves a structured way of setting up dialogical learning processes, by eliciting stories of participants, exchanging experiences in (homogeneous and heterogeneous) groups and drawing normative conclusions for practice. By combining these traditions we develop both a theoretical and a practical approach to empirical ethics, in which ethical issues are addressed and shaped together with stakeholders in practice. Stakeholders' experiences are not only used as a source for reflection by the ethicist; stakeholders are involved in the process of reflection and analysis, which takes place in a dialogue between participants in practice, facilitated by the ethicist. This dialogical approach to empirical ethics may give rise to questions such as: What contribution does the ethicist make? What role does ethical theory play? What is the relationship between empirical research and ethical theory in the dialogical process? In this article, these questions will be addressed by reflecting upon a project in empirical ethics that was set up in a dialogical way. The aim of this project was to develop and implement normative guidelines with and within practice, in order to improve the practice concerning coercion and compulsion in psychiatry.     

Using the two-hybrid screen in the classroom laboratory

The National Science Foundation and others have made compelling arguments that research be incorporated into the learning of undergraduates. In response to these arguments, a two-hybrid research project was incorporated into a molecular biology course that contained both a lecture section and a laboratory section. The course was designed around specific goals for educational outcomes, including introducing research to a wide range of students, teaching students experimental design and data analysis, and enhancing understanding of course material. Additional goals included teaching students to search genomic databases, to access scientific articles, and to write a paper in scientific format. Graded events tested these goals, and a student evaluation indicated student perception of the project. According to our analysis of the data, the yeast two-hybrid screen was a success: several novel clones were identified; students met expectations on graded lab reports, the poster session, and the final paper; and evaluations indicated that students had achieved the outlined goals. Students indicated on the evaluations that the research project increased their interest in research and greatly improved understanding of the course material. Finally, several students in the course intend to submit the findings of the research project to an undergraduate research journal.     

Ordinary ethics: lay people's deliberations on social sex selection

Abstract

This article summarises the results of a research project that used a scenario about sex selection of embryos for social reasons as a basis for discussion groups with lay people. The aim of the research was to examine the processes by which non-professionals make ethical evaluations in relation to a contested area in medical genetics. We note in particular the role played in the discussions by expressions of instinct; making distinctions; rational argument; reference to principles; use of personal experience; analogies and examples; slippery slope arguments and meta-reflections. The implications for developing processes of public consultation and debate are also considered.     

Ethical, legal, and social aspects of farm animal cloning in the 6th Framework Programme for Research

Cloned livestock have potential importance in the provision of improved medicine as well as in the development of livestock production. The public is, however, increasingly concerned about the social and ethical consequences of these advances in knowledge and techniques. There is unevenness throughout Europe in different Member States' attitudes to research into livestock cloning. Although there is EU legislation controlling the use of animals for research purposes, there is no legislation specifically governing cloning in livestock production. The main EU reference is the 9th Opinion of the European Group on Ethics, which states "Cloning of farm animals may prove to be of medical and agricultural as well as economic benefit. It is acceptable only when the aims and methods are ethically justified and when carried out under ethical conditions." The ethical justification includes the avoidance of suffering, the use of the 3Rs principle and a lack of better alternatives. The Commission addresses these issues in the 6th Framework Programme by promoting the integration of ethical, legal and social aspects in all proposals where they are relevant, by fostering ethical awareness and foresight in the proposals, by encouraging public dialogue, and by supporting specific actions to promote the debate. Research must respect fundamental ethical principles, including animal welfare requirements.     

A priority paper for the societal and ethical aspects of synthetic biology

As synthetic biology develops into a promising science and engineering field, we need to have clear ideas and priorities regarding its safety, security, ethical and public dialogue implications. Based on an extensive literature search, interviews with scientists, social scientists, a 4 week long public e-forum, and consultation with several stakeholders from science, industry and civil society organisations, we compiled a list of priority topics regarding societal issues of synthetic biology for the years ahead. The points presented here are intended to encourage all stakeholders to engage in the prioritisation of these issues and to participate in a continuous dialogue, with the ultimate goal of providing a basis for a multi-stakeholder governance in synthetic biology. Here we show possible ways to solve the challenges to synthetic biology in the field of safety, security, ethics and the science–public interface.     

The Challenges of Research Informed Consent in Socio‐Economically Vulnerable Populations: A Viewpoint From the Democratic Republic of Congo

In medical research, the ethical principle of respect for persons is operationalized into the process of informed consent. The consent tools should be contextualized and adapted to the different socio‐cultural environment, especially when research crosses the traditional boundaries and reaches poor communities. We look at the challenges experienced in the malaria Quinact trial, conducted in the Democratic Republic of Congo, and describe some lessons learned, related to the definition of acceptable representative, the role of independent witness and the impact of socio‐economic vulnerability. To ensure children's protection, consent is required by the parents or, in their absence, by a legally mandated representative. In our setting, children's responsibility is often entrusted permanently or temporarily to relatives or friends without a tribunal mandate. Hence, a notion of ‘culturally acceptable representative’ under supervision of the local Ethics Committee may be more suitable. To ensure protection of illiterate subjects, an independent witness is required to confirm that the consent was freely given. However, in low‐literacy contexts, potential witnesses often don't have any previous relationship with patient and there may be power‐unbalance in their relationship, rather than genuine dialogue. In poor communities, trial participation may be seen as an opportunity to secure access to healthcare. Poverty may also lead to ‘competition’ to access the research‐related benefits, with a risk of disturbance at societal or household level. Adjusting consent procedures to sociocultural and socioeconomic realities is essential for fulfilling the underlying ethical principles. This requires a collaborative dialogue between researchers, regulators and ethics committees.     

Freedom and Responsibility in Synthetic Genomics: The Synthetic Yeast Project

First introduced in 2011, the Synthetic Yeast Genome (Sc2.0) Project is a large international synthetic genomics project that will culminate in the first eukaryotic cell (Saccharomyces cerevisiae) with a fully synthetic genome. With collaborators from across the globe and from a range of institutions spanning from do-it-yourself biology (DIYbio) to commercial enterprises, it is important that all scientists working on this project are cognizant of the ethical and policy issues associated with this field of research and operate under a common set of principles. In this commentary, we survey the current ethics and regulatory landscape of synthetic biology and present the Sc2.0 Statement of Ethics and Governance to which all members of the project adhere. This statement focuses on four aspects of the Sc2.0 Project: societal benefit, intellectual property, safety, and self-governance. We propose that such project-level agreements are an important, valuable, and flexible model of self-regulation for similar global, large-scale synthetic biology projects in order to maximize the benefits and minimize potential harms.     

Investigations of protein structure and function using the scientific literature: an assignment for an undergraduate cell physiology course

Undergraduate biology curricula are being modified to model and teach the activities of scientists better. The assignment described here, one that investigates protein structure and function, was designed for use in a sophomore-level cell physiology course at Earlham College. Students work in small groups to read and present in poster format on the content of a single research article reporting on the structure and/or function of a protein. Goals of the assignment include highlighting the interdependence of protein structure and function; asking students to review, integrate, and apply previously acquired knowledge; and helping students see protein structure/function in a context larger than cell physiology. The assignment also is designed to build skills in reading scientific literature, oral and written communication, and collaboration among peers. Assessment of student perceptions of the assignment in two separate offerings indicates that the project successfully achieves these goals. Data specifically show that students relied heavily on their peers to understand their article. The assignment was also shown to require students to read articles more carefully than previously. In addition, the data suggest that the assignment could be modified and used successfully in other courses and at other institutions.     

Preimplantational Ectogenesis: Science and Speculation Concerning In Vitro Fertilization and Related Procedures

In recent years, technical advances have made preimplantational ectogenesis (in vitro maturation, fertilization and early embryonic development) more than a theoretical concept. Such procedures hold great promise in medical research. However, despite our newly-acquired skills in tissue culture and microsurgical manipulation, and contrary to many sensational articles in the lay press, it is not likely that preimplantational ectogenesis will soon attain wide clinical use in humans. Adverse societal attitudes, based largely upon moral and ethical dilemmas, will probably combine with still-unresolved technical difficulties to restrict the clinical applications.     

Horizontal Hostility among Non-Meat Eaters

The present study examined intergroup judgments made between four groups of non-meat eaters: health vegetarians; ethical vegetarians; health vegans, and ethical vegans. Consistent with hypotheses based on horizontal hostility and the need to maintain ingroup distinctiveness, ethical vegetarians gave unfavorable evaluations to health vegetarians relative to vegans, especially when the mainstream omnivore group was made salient. Contrary to expectations, vegans gave relatively more favorable evaluations to ethical vegetarians than health vegetarians when mainstream salience was low. This was especially true for vegans who were motivated primarily by ethical concerns. When mainstream salience was high, vegans did not distinguish between the vegetarian subgroups. Results suggest that one’s motives for abstaining from meat often play a larger role in this type of intergroup perceptions than one’s dietary practices.     

Research ethics: the case with the tule (kuna), Urabbá, Colombia

An ethical analysis was performed during the development of a research project titled "Culture, nourishment and malaria in the Kuna aboriginals of Urabá, Colombia." This project had 2 objectives; (1) to investigate the prevalence of malaria and its relationship with hypovitaminosis A and nutritional status, and (2) to understand the community's conceptions and practices towards malaria. The current paper summarizes reflections concerning the application of ethical principles and moral values during the course of the malaria research project. Two intercultural relationships were clearly defined: the culture of the Tule (Kuna) Indians, with a traditional medical system, and the culture of the research group, focused on the biomedical model. The rationale and the discussion proposed during the writing of the project proposal was presented as well as the dilemmas that developed during the project within the communities. These problems required rapid decision-making in situations for which the scientists had not been adequately prepared. A need was indicated for application of ethical principles to permeate the analysis throughout the research process in a horizontal manner, such that the human dignity of the participants and the ethnicity of the community are preserved above the purposes of the project. In the research process, mediation between the ethics of conviction and the ethics of consequences must take precedence, with both outcomes tied to an informed consent in place during the process. The establishment of national and local research ethics committees was indicated as necessary to preserve the lifestyle and culture of the ethnic groups. These values were seen as endangered given the trading pressures and health policies in a globalized world.     

The prospect for international regulatory interventions in embryo transfer and reproductive technologies in the next century

Historically, international regulatory interventions in the area of animal reproductive technologies have focused on the need for mitigation against the dissemination of diseases with the movement of genetics and germplasm across international borders. The continued globalization of agriculture under the Sanitary/Phytosanitary (SPS) Agreement of the World Trade Organization (WTO) ensures that disease considerations arising from third and fourth generation reproductive technologies such as in vitro fertilized embryos, transgenics and xenotransplantation will continue to give rise to animal health regulatory measures. Furthermore, in the aftermath of the raising of the public consciousness and the ensuing consumer confidence crisis concerning animal husbandry and livestock production practices following the Bovine Spongiform Encephalopathy outbreak, evolving societal values are expected to expand regulatory considerations to address veterinary public health and ethical concerns. Consequently, it is expected that the role of the International Embryo Transfer Society in fostering meaningful dialogue and profiling of the research necessary to provide for appropriate science based regulation development will increase in importance.     

Ethical issues in medical research in the developing world: a report on a meeting organised by Fondation Mérieux

This paper reports on a multidisciplinary meeting held to discuss ethical issues in medical research in the developing world. Many studies, including clinical trials, are conducted in developing countries with a high burden of disease. Conditions under which this research is conducted vary because of differences in culture, public health, political, legal and social contexts specific to these countries. Research practices, including standards of care for participants, may vary as a result. It is therefore not surprising that ethical issues emerge. This meeting sought to identify and discuss these issues from the perspectives of the many actors in such research, including community representatives, with a view to finding ethical and pragmatic solutions to these issues. Dialogue between these actors was also promoted, with a view to identifying the need to develop such dialogue in future.
Drawing from the experiences of the speakers, the colloquium attempted to outline some answers to several key questions characterising the field today. Experiences related to epidemiologic research, vaccine trials, drug trials, diagnostic tests and to some fundamental ethical issues in health research. Speakers were from different countries, disciplines and professions. The meeting provided a forum for consultation and debate between different ethics actors. Both encouraging findings and challenges emerged.     

Leidraad voor medisch wetenschappelijk onderzoek bij ouderen

This paper describes the development of a guideline on medical research with older subjects. Although our society is aging, evidence on health care for older persons is lacking on many topics, because these subjects are underrepresented in most drug and non-drug trials, while these services are used many older persons, and result in many adverse reactions and unplanned hospitalisation. Part of the reasons for this underrepresentation is the multimorbidity, often leading to exclusion, but also the lack of appropriate research methods plays a major role. Therefore, this paper describes the methods and results of the development of a multidisciplinary, evidence based guideline on how to conduct medical research in older persons. The recent changes in European and Dutch legislation on medical research were another reason to start this guideline project. We conducted two systematic reviews (on informed consent and recruitment) and conducted surveys and focus groups on the other four topics covered by the paper: proportionality, resistance, drop out, and societal relevance. In total we formulated 45 recommendations, all agreed on in consensus meetings, in which older persons’ representatives played a major role. This Guideline on medical research in older persons, will be implemented via the ethical review boards, the medical scientific committees, and the Ministry of Health in the Netherlands, who commissioned the guideline work. We hope the guideline stimulates quality and quantity of research on older adults to answer the increasing number of societal and scientific questions with regard to this populations.     

Improving the science-policy dialogue to meet the challenges of biodiversity conservation: having conversations rather than talking at one-another

A better, more effective dialogue is needed between biodiversity science and policy to underpin the sustainable use and conservation of biodiversity. Many initiatives exist to improve communication, but these largely conform to a ‘linear’ or technocratic model of communication in which scientific “facts” are transmitted directly to policy advisers to “solve problems”. While this model can help start a dialogue, it is, on its own, insufficient, as decision taking is complex, iterative and often selective in the information used. Here, we draw on the literature, interviews and a workshop with individuals working at the interface between biodiversity science and government policy development to present practical recommendations aimed at individuals, teams, organisations and funders. Building on these recommendations, we stress the need to: (a) frame research and policy jointly; (b) promote inter- and trans-disciplinary research and “multi-domain” working groups that include both scientists and policy makers from various fields and sectors; (c) put in place structures and incentive schemes that support interactive dialogue in the long-term. These are changes that are needed in light of continuing loss of biodiversity and its consequences for societal dependence on and benefits from nature.     

Direct-to-consumer genetic testing through Internet: marketing, ethical and social issues

We probably did not anticipate all the consequences of the direct to consumer genetic tests on Internet, resulting from the combined skills of communication and genomic advances. What are the commercial strategies used by the companies offering direct-to-consumer genetic tests on Internet and what are the different social expectations on which they focus? Through a quantitative and qualitative analysis of the web sites offering such tests, it seems that these companies target a triple market based on: the "healthism" which raises health and hygiene to the top of the social values; the contemporary demands of the users to become actual actors of health decisions; and finally on the need for bio-social relationships. These three commercial strategies underlie various ethical and societal issues justifying a general analysis.     

Ethical,Legal, and Clinical Considerations when Disclosing a High‐Risk Syndrome for Psychosis

There are complex considerations when planning to disclose an attenuated psychosis syndrome (APS) diagnosis. In this review, we evaluate ethical, legal, and clinical perspectives as well as caveats related to full, non‐ and partial disclosure strategies, discuss societal implications, and provide clinical suggestions. Each of the disclosure strategies is associated with benefits as well as costs/considerations. Full disclosure promotes autonomy, allows for the clearest psychoeducation about additional risk factors, helps to clarify and/or correct previous diagnoses/treatments, facilitates early intervention and bolsters communication between providers but there are important considerations involving heritability, comorbidity, culture, and stigma. Non‐disclosure advances nonmaleficence by limiting stigma and stress (which may inadvertently exacerbate the condition), and confusion (related to the rapidly evolving diagnosis) in a sensitive developmental period but is complicated by varying patient preferences and the possibility that, as new treatments without adverse effects become available, the risk with false positives no longer justifies the accompanying loss of autonomy. Partial disclosure balances ethical considerations by focusing on symptoms instead of labels, but evidence that laypersons may interpret this information as a pseudo‐diagnosis and that symptoms alone also contribute to stigma limits the efficacy of this approach. In addition, there are notable societal considerations relating to disclosure involving conservatorship, the reach of insurance companies, and discrimination. We advocate a hybrid approach to disclosure and recommend future research aimed at understanding the effects of stigma on clinical course and a renewed focus on those help‐seeking cases that do not transition but remain clinically relevant.     

Harnessing synthetic biology for kelp forest conservation1

Environmental and climatic change is outpacing the ability of organisms to adapt, at an unprecedented level, resulting in range contractions and global ecosystem shifts to novel states. At the same time, scientific advances continue to accelerate, providing never‐before imagined solutions to current and emerging environmental problems. Synthetic biology, the creation of novel and engineered genetic variation, is perhaps the fastest developing and transformative scientific field. Its application to solve extant and emerging environmental problems is vast, at times controversial, and technological advances have outpaced the social, ethical, and practical considerations of its use. Here, we discuss the potential direct and indirect applications of synthetic biology to kelp forest conservation. Rather than advocate or oppose its use, we identify where and when it may play a role in halting or reversing global kelp loss and discuss challenges and identify pathways of research needed to bridge the gap between technological advances and organismal biology and ecology. There is a pressing need for prompt collaboration and dialogue among synthetic biologists, ecologists, and conservationists to identify opportunities for use and ensure that extant research directions are set on trajectories to allow these currently disparate fields to converge toward practical environmental solutions.