To strengthen consensus, consult the stakeholders

CIOMS has been criticised for not adequately consulting stakeholders about its revised ethical guidelines regarding medical research. Political and logistical issues that arise in democratic processes and open exchange of information probably contributed to this exclusion. What might CIOMS have done to be more inclusive and attain broader consensus on its proposed revisions? Consensus is dynamic, and evolves as a community digests new information and perspectives. Engaging the public (and particularly the stakeholders) in discussion about the revisions would have generated broader consensus. It would have encouraged more stakeholders (i.e. researchers, potential research participants, research institutions, or governments) to buy in. CIOMS needs a process to encourage dialogue and stakeholder input. The CIOMS guidelines themselves promote stakeholder consultation and capacity building, but CIOMS has done relatively little to distribute or promote its own guidelines. CIOMS should do more to promote its revised guidelines, and engage stakeholders in dialogue. This paper explores the bioethics debate about universal and relative values to illustrate the value of consultation and consensus building. It concludes that like research sponsors, CIOMS and similar organisations have an ethical responsibility to facilitate capacity building in less developed areas, and to participate more actively in consensus building.     

An analytical approach to the implementation of genetically modified crops

Public scepticism towards genetically modified (GM) crops is increasing. To address this, the risks and benefits of GM crops must be examined across scientific disciplines, and be discussed with the authorities, the agricultural industry and the consumers. In a feasibility study we have systematically analysed the challenges of the development and marketing of GM crops in Europe. A life-cycle inventory was used together with established technology foresight techniques in an interdisciplinary and empirical framework. The approach taken in this study established a dialogue between stakeholders and provided a framework for discussions about the future direction of GM crops.     

Protected area stewardship in the Anthropocene: integrating science,law, and ethics to evaluate proposals for ecological restoration in wilderness

Every year, the four federal agencies that manage designated wilderness in the United States receive proposals to implement small‐ and large‐scale ecological restorations within the National Wilderness Preservation System. The combination of climate change with other landscape stressors is driving ecological restoration to be one of the single most important, challenging, and potentially litigious wilderness stewardship issues. In addition, different stakeholders may have strongly divergent views about what the right decision should be, and decisions need to go beyond routine technical and scientific analyses to incorporate a broader range of legal and ethical considerations. We present a framework based on a comprehensive, structured set of scientific, legal, and ethical questions to guide the evaluation of proposals for ecological restoration and other types of ecological intervention in wilderness. This framework of questions is a voluntary tool designed to increase communication and transparency among scientists, managers, and interested publics regarding the trade‐offs and uncertainties of ecological restoration, and promote informed public deliberation in managing the public resource of wilderness.     

Research Stakeholders’ Views on Benefits and Challenges for Public Health Research Data Sharing in Kenya: The Importance of Trust and Social Relations

Background

There is increasing recognition of the importance of sharing research data within the international scientific community, but also of the ethical and social challenges this presents, particularly in the context of structural inequities and varied capacity in international research. Public involvement is essential to building locally responsive research policies, including on data sharing, but little research has involved stakeholders from low-to-middle income countries.

Methods

Between January and June 2014, a qualitative study was conducted in Kenya involving sixty stakeholders with varying experiences of research in a deliberative process to explore views on benefits and challenges in research data sharing. In-depth interviews and extended small group discussions based on information sharing and facilitated debate were used to collect data. Data were analysed using Framework Analysis, and charting flow and dynamics in debates.

Findings

The findings highlight both the opportunities and challenges of communicating about this complex and relatively novel topic for many stakeholders. For more and less research-experienced stakeholders, ethical research data sharing is likely to rest on the development and implementation of appropriate trust-building processes, linked to local perceptions of benefits and challenges. The central nature of trust is underpinned by uncertainties around who might request what data, for what purpose and when. Key benefits perceived in this consultation were concerned with the promotion of public health through science, with legitimate beneficiaries defined differently by different groups. Important challenges were risks to the interests of study participants, communities and originating researchers through stigmatisation, loss of privacy, impacting autonomy and unfair competition, including through forms of intentional and unintentional ''misuse'' of data. Risks were also seen for science.

Discussion

Given background structural inequities in much international research, building trust in this low-to-middle income setting includes ensuring that the interests of study participants, primary communities and originating researchers will be promoted as far as possible, as well as protected. Important ways of building trust in data sharing include involving the public in policy development and implementation, promoting scientific collaborations around data sharing and building close partnerships between researchers and government health authorities to provide checks and balances on data sharing, and promote near and long-term translational benefits.     

The synthetic biology puzzle: a qualitative study on public reflections towards a governance framework

Synthetic biology is currently one of the most debated emerging biotechnologies. The societal assessment of this technology is primarily based on contributions by scientists and policy makers, who focus mainly on technical challenges and possible risks. While public dialogue is given, it is yet rather limited. This study explores public debates concerning synthetic biology based on a focus group study with citizens from Austria and Germany and contextualises the analysed public views with content from policy reports and previous empirical studies on public engagement. The findings suggest that discussants favoured a gradual implementation process of synthetic biology, which is receptive to questions about the distribution of possible benefits. The discussed topics correspond in many ways with content from policy reports and former investigations, yet the emphasis of the discussions was different for many aspects.     

Sharing Ecological Knowledge: Opportunities and Barriers to Uptake

Conserving tropical ecosystems is one of the foremost challenges of the 21st century. Lately, conservation efforts have focused on advancing conservation through dialogue and interaction with and among diverse stakeholders. Knowledge sharing, and specifically the transfer of scientific knowledge, can raise ecological awareness among stakeholders and is necessary to facilitate dialogue, yet the communication of tropical scientific research to local stakeholders is rarely effectively implemented. Such a communication gap potentially undermines the conservation and management of natural resources. The papers in this special section highlight the difficulties and benefits of sharing ecological knowledge, as well as the underlying reasons for why a research–implementation gap has arisen.     

Future societal issues in industrial biotechnology

Three international stakeholder meetings were organized by The Netherlands-based "Kluyver Center for Genomics of Industrial Fermentation" with the objective to identify the future societal issues in the field of industrial biotechnology and to develop a coordinated strategy for public dialogue. The meetings resulted in five unanimous recommendations: (i) that science, industry and the European Commission in conjunction with other stakeholders create a comprehensive roadmap towards a bio-based economy; (ii) that the European Commission initiate a series of round-table meetings to further articulate the views, interests and responsibilities of the relevant stakeholders and to define policy; (iii) that the development of new innovative communication activities is stimulated to increase public engagement and to discuss the ways that we do or do not want technologies to shape our common future; (iv) that further social studies are undertaken on public attitudes and behaviors to the bio-based economy and that novel methods are developed to assess public views of future technological developments; and (v) that the concept of sustainability is further operationalized and taken as a core value driving research and development and policy making.     

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.     

Lost in translation

Some view social constructivism as a threat to the unique objectivity of science in describing the world. But social constructivism merely observes the process of science and can offer ways for science to regain public esteem.Political groups, civil organizations, the media and private citizens increasingly question the validity of scientific findings about challenging issues such as global climate change, and actively resist the application of new technologies, such as GM crops. By using new communication technologies, these actors can reach out to many people in real time, which gives them a huge advantage over the traditional, specialist and slow communication of scientific research through peer-reviewed publications. They use emotive stories with a narrow focus, facts and accessible language, making them often, at least in the eyes of the public, more credible than scientific experts. The resulting strength of public opinion means that scientific expertise and validated facts are not always the primary basis for decision-making by policy-makers about issues that affect society and the environment.The scientific community has decried this situation not only as a crisis of public trust in experts but more so as a loss of trust in scientific objectivity. The reason for this development, some claim, is a postmodernist perception of science as a social construction [1]. This view claims that context—in other words society—determines the acceptance of a scientific theory and the reliability of scientific facts. This is in conflict with the more traditional view held by most scientists, that experimental evidence, analysis and validation by scientific means are the instruments to determine truth. ‘Social constructivism'', as this postmodernist view on science has been called, challenges the ‘traditional'' view of science: that it is an objective, experiment-based approach to collect evidence that results in a linear accumulation of knowledge, leading to reliable, scientifically proven facts and trust in the role of experts.However, constructivists maintain that society and science have always influenced one another, thereby challenging the notion that science is objective and only interested in uncovering the truth. Moderate social constructivism merely acknowledges a controversy and attempts to provide answers. The extreme interpretation of this approach sustains that all facts and all parties—no matter how absurd or unproven their ‘facts'' and claims—should be treated equally, without any consideration for their interests [2].…scientific expertise and validated facts are not always the primary basis for decision-making by policy-makers about issues that affect society and the environmentThe truth might actually be somewhere in the middle, between taking scientific results as absolute truths at one extreme, and requiring that all facts and all actors should be given equal attention and consideration at the other. What is needed, however, is a closer connection and mutual appreciation between science and society, especially when it comes to science policy and making decisions that require scientific expertise. To claim that all perspectives are equally important when there is a lack of absolute facts—leading to an ‘all truths are equal'' approach to decision-making—is surely ridiculous. Nonetheless, societies are highly complex and sufficient facts are often not available when policy-makers and regulatory bodies have to make a decision. The aim of this essay is to argue that social construction and scientific objectivity can coexist and even benefit from one another.The question is whether social constructivism really caused a crisis of objectivity and a change in the traditional view of science? A main characteristic of the traditional view is that science progresses in isolation from any societal influences. However, there are historical and contemporary examples of how social mores influence the acceptability of certain areas of research, the direction of scientific research and even the formation of a scientific consensus—or in the words of Thomas Kuhn, of a scientific paradigm.Arrival at a scientific consensus driven by non-scientific factors will probably happen in a new research field when there is insufficient scientific information or knowledge to make precise claims. As such, societal factors can become determinants in settling disputes, at least until more information emerges. Religious and ethical beliefs have had such an impact on science throughout history. One could argue, for example, that the focus on research into induced pluripotent stem cells and the potency of adult stem cells is driven, at least in part, by religious and ethical objections to using human embryonic stem cells. Similarly, the near universal consensus that scientists should not clone humans is not based on scientific reason, but on social, religious and ethical arguments.Another example of the influence of non-scientific values on the establishment of a scientific consensus comes from the field of artificial intelligence. In the 1960s, a controversy erupted between the proponents of symbolic processing—led by Marvin Minsky—and the proponents of neural nets—who had been led by the charismatic Frank Rosenblatt. The publication of a book by Minsky and Seymour Papert, which concluded that progress in neural networks faced insurmountable limitations, coincided with the unfortunate death of Rosenblatt and massive funding from the US Department of Defense through the Defense Advanced Research Projects Agency (DARPA) for projects on symbolic processing. DARPA''s decision to ignore neural networks—because they could not foresee any immediate military applications—convinced other funding agencies to avoid the field and blocked research on neural nets for a decade. This has become known as the first artificial intelligence winter [3]. The military, in particular, has often had a major influence on setting the direction of scientific research. The atomic bomb, radar and the first computers are just some examples of how military interests drove scientific progress and its application.The traditional perception of science also supposes a gradual and linear accumulation of scientific knowledge. Whilst the gradual part remains undisputed, scientific progress is not linear. Theories are proposed, discussed, rejected, accepted, sometimes forgotten, rediscovered and reborn with modifications as part of an ever-changing network of scientific facts and knowledge. Gregor Mendel discovered the laws of inheritance in 1865, but his finding received scant attention until their rediscovery in the early 1900s by Carl Correns and Erich von Tschermak. Ignaz Semmelweis, a Hungarian obstetrician, developed the theory that puerperal fever or childbed fever is mainly transmitted by the poor hygiene of doctors before assisting in births. He observed that when doctors washed their hands with a chlorine solution before obstetric consultations, deaths in obstetrics wards were drastically reduced. The medical community ridiculed Semmelweis at the time, but the development of Louis Pasteur''s germ theory of disease eventually vindicated him [4].Another challenge to the traditional view of science is the claim that scientific facts are constructed. This does not necessarily imply that they are false: it acknowledges the process of independently conducted experiments, ‘trial and error'' approaches, collaborations and discussions, to establish a final consensus that then becomes scientific fact. Critics of constructivism claim that viewing scientific discovery this way opens the gate to non-scientific influences and arguments, thereby undermining factuality. However, without consensus on the importance of a discovery, no fact is sufficient to change or establish a scientific theory. In fact, classical peer review treats scientific discoveries as constructions essentially by taking apart the proposed fact, analysing the process of its determination and, based on the evidence, accepting or rejecting it.‘Social constructivism'' […] challenges the ‘traditional'' view of science: that it is an objective, experiment-based approach to collect evidence…Ultimately, then, it seems that social constructivism itself is not the sole or most important factor for changing the traditional view of science. Social, religious and ethical values have always influenced human endeavours, and science is no exception. Yet, there is one aspect of traditional science for which constructivism only has the role of an observer: public trust in scientific experts. Societies can resist the introduction of new technologies owing to their potential risks. Traditionally, the potential victims of such hazards—consumers, affected communities and the environment—had no input into either the risk-assessment process, or the decisions that were made on the basis of the assessment.The difficulty is that postmodern societies tend to perceive certain risks as greater compared with how they were viewed by modern or premodern societies, ostensibly and partly because of globalization and better communication [5]. As a result, the evaluation of risk increasingly takes into account political considerations. Each stakeholder inevitably defines risks and their acceptability according to their own agenda, and brings their own cadre of experts and evidence to support their claims. As such, the role of unbiased experts is undermined not only because they are similarly accused of having their own agenda, but also because the line between experts and non-experts is redrawn [5]. In addition, the internet and other communication technologies have unprecedentedly empowered non-expert users to broadcast their opinions. The emergence of so-called ‘pseudo-experts'', enabled by “the cult of the amateur” [6], further challenges the position of scientific experts. Trust is no longer a given for anyone, and even when people trust science, it is not lasting, and has to be earned for new information. This erosion of trust cannot be blamed entirely on the “cult of the amateur”. The German sociologist Ulrich Beck argued that when scientists make recommendations to society on how to deal with risks, they inevitably make assumptions that are embedded in cultural values, moving into a social and cultural sphere without assessing the public view of those values. Scientists thus presuppose a certain set of social and cultural values and judge everything that comes against that set as irrational [5].…without consensus on the importance of a discovery, no fact is sufficient to change or establish a scientific theoryRegardless of how trust in expertise was eroded, and how pseudo-experts have filled the gap, the main issue is how to assess the implications of scientific results and new technologies, and how to manage any risks that they entail. To gain and maintain trust, decision-making must consider stakeholder involvement and public opinion. However, when public participation attempts to accommodate an increasing number of stakeholders, it raises the difficult issue of who should be involved, either as part of the administrative process or as producers of knowledge [7,8]. An increasing number of participants in decision-making and an increasing amount of information can result in conflicting perspectives, different perceptions of facts and even half-truths or half-lies when information is not available, missing or not properly explained. There is no dominant perspective and all evidence seems subjective. This seems to be the nightmare scenario when ‘all truths are equal''.It is important to point out that the constructivist perspective of looking at the interactions between science and society is not an attempt to impose a particular world-view; it is merely an attempt to understand the mechanisms of these interactions. It attempts to explain why, for example, anti-GMO activists destroy experimental field trials without any scientific proof regarding the harm of such experiments. In addition, constructivism does not attempt to destroy the credibility of science, nor to overemphasize alternative knowledge, but to offer possibilities for wider participation in policy-making, especially in contentious cases when the lines between the public and experts are no longer clear [8]. In this situation, expert knowledge is not meant to be replaced by non-expert knowledge, but to be enriched by it.Nonetheless, the main question is whether scientific objectivity can prevail when science meets society. The answer should be yes. Even when several seemingly valid perspectives persist, objective facts are and should be the foundation of decisions taken. Scientific facts do matter and there are objective frameworks in place to prove or disprove the validity of information. Yet, in settling disputes, the decision must also be accountable to prevent loss of trust. By establishing frameworks for inclusive discussions and acknowledging the role of non-expert knowledge, either by indicating areas of public concern or by improving the communication of scientific facts, consent and thus support for the decision can be achieved.Moreover, scientific facts are important, but they are only part of an informational package. In particular, the choice of words and the style of writing can become more important than the factual content of a message. Scientists cannot communicate to the wider public using scientific jargon and then expect unconditional trust. People tend to mistrust things they cannot understand. To be part of a decision-making process, members of the public need access to scientific information presented in an understandable manner. The core issue is communication, or more specifically, translation: explaining facts and findings by considering the receiver and context, and adapting the message and language accordingly. Scientists must therefore translate their work. Equally important, they must do this proactively to take advantage of social constructivism and its view of science. By understanding how controversies around new scientific discoveries and scientific expertise arise, they can devise better communication strategies.…the internet and other communication technologies have unprecedentedly empowered non-expert users to broadcast their opinionsSome examples show how better interaction between science and society—such as the involvement of more stakeholders and the use of appropriate language in communication—can raise awareness and acceptability of previously contentious technologies. In Burkina Faso in 1999, Monsanto partnered with Africare to provide farmers with GM cotton to address pest resistance to pesticides and to increase yields. The plan was originally met with suspicion from the public and public research institutes, but the partners managed to build trust among the different stakeholders by providing transparent and correct information. The project started with a public–private partnership. By being open about their motives, including profit-making, and acknowledging and discussing any potential risks, the project gradually achieved the full support of the main partners [9]. Another challenge was the relationship between scientists and journalists. By using scientific communicators that were both open to dialogue and careful to maintain the discussion within scientific boundaries, the relationship with the press improved [10]. In this case, efforts to translate scientific knowledge included transparency of information and contextualizing its delivery, as well as an increasingly wider participation of stakeholders in the development and commercialization of GM cotton.…scientists[…]should consider proactively translating their research for a wider audience […] in an inclusive and contextualized mannerWhen the Philippines, the first Asian country to adopt a GM food, approved Bt maize, environmental NGOs and the Catholic Church opposed the crop with regular protests. These slowly dissipated as farmers gradually adopted Bt maize [11] and the reporting media focused less on sensationalist stories [12]. Between 2000 and 2009, media coverage contributed substantially to a mostly positive (41%) or neutral (38%) public perception of biotechnology in the Philippines [12]. Most newspaper reports focused on the public accountability of biotechnology governance and analysed the validity of scientific information, together with the way in which conflicts in biotechnology research were managed. Science writers translated scientific facts into language that the wider public could understand. In addition, sources in which the public placed trust—either scientists or environmentalists—were cited in the media, which helped to facilitate public discussion [12]. In this case, the efforts of science writers to provide balanced, well-informed coverage, as well as a platform for public discussions, effectively translated the scientific facts and improved public opinion of Bt maize.Constructivism is not a threat to science. It is a concept that looks at the components and the processes through which a scientific theory or fact emerges; it is not an alternative to these processes. In fact, scientists should consider embracing constructivism, not only to understand what happens with the products of their labour beyond the laboratory, but also to understand the forces that determine the fate of scientific developments. We live in a complex world in which individual actors are empowered through modern communication tools. This might make it more challenging to prove and maintain scientific objectivity, but it does not make it unnecessary. Public decision-making requires an objective fact base for all decisions concerning the use of scientific discoveries in society. If scientists want to prevent their messages from being misunderstood or hijacked for political purposes, they should consider proactively translating their research for a wider audience themselves, in an inclusive and contextualized manner.? Open in a separate windowMonica Racovita     

Weaponizing Principles: Clinical Ethics Consultations & the Plight of the Morally Vulnerable

Internationally, there is an on‐going dialogue about how to professionalize ethics consultation services (ECSs). Despite these efforts, one aspect of ECS‐competence that has received scant attention is the liability of failing to adequately capture all of the relevant moral considerations in an ethics conflict. This failure carries a high price for the least powerful stakeholders in the dispute. When an ECS does not possess a sophisticated dexterity at translating what stakeholders say in a conflict into ethical concepts or principles, it runs the risk of naming one side's claims as morally legitimate and decrying the other's as merely self‐serving. The result of this failure is that one side in a dispute is granted significantly more moral weight and authority than the other. The remedy to this problem is that ECSs learn how to expand the diagnostic moral lens they employ in clinical ethics conflicts.     

Defining the spectrum of genome policy

Many achievements in the genome sciences have been facilitated by policies that have prioritized genome research, secured funding and raised public and health-professional awareness. Such policies should address ethical, legal and social concerns, and are as important to the scientific and commercial development of the field as the science itself. On occasion, policy issues take precedence over science, particularly when impasses are encountered or when public health or money is at stake. Here we discuss the spectrum of current issues and debates in genome policy, and how to actively engage all affected stakeholders to promote effective policy making.     

Environmental and Health Implications of Nanotechnology—Have Innovators Learned the Lessons from Past Experiences?

Nanotechnology (NT) is expected to bring about novel technological designs and materials resulting in a wide spectrum of applications. Experience gained from past innovations shows that new technologies are often accompanied by undesired side-effects. If such side-effects are neglected or underestimated, they may result in damage. In this article we examine whether innovators, the pioneers of technological advance in nanotechnology, are aware of the lessons that can be learned from adverse effects that have occurred in connection with several past innovations. Based on the results of a survey taken among innovators we discuss what consequences the innovators draw for the present innovation process and which priorities they set when dealing with environmental and health risks of nanotechnology. Results suggest that innovators may be not very sensitive to early scientific warnings regarding risks of nanotechnology. The innovators are confident that risks are assessable and manageable on a “business as usual” basis. They consider lacking public acceptance as a potential hurdle for innovation and many innovators are afraid of a backlash. Nevertheless, they seldom engage in risk communication or stakeholder dialogue. Picking up recommendations voiced by the innovators interviewed, we sketch some possible approaches as to how innovators could tackle the potential risks of nanotechnology in a proactive manner.     

Consistency and use of information about threats in the participatory process for identification of priority conservation areas in the Brazilian Amazon

Despite the increasing number of scientific papers on the subject, conservation planning has failed to actively prioritise the creation of new protected areas. Strategies proposed to increase the creation of new protected areas based on conservation plans include broad stakeholder participation in decision-making processes in order to include their concerns and facilitate social acceptance of proposed actions. However, there are controversial views about the effectiveness of stakeholder participation. The quality of the decision depends both on the information used by stakeholders and on how it is used, so it is necessary to evaluate both these aspects of a decision-making process. Threats are intrinsically related to conservation decisions because they are more easily understood by people than biodiversity values, and they can affect both decisions and outcomes of conservation actions. This article analyses how information about threats was used in the decision-making process conducted by the Brazilian Government in 2006 to indicate priority areas for the conservation of the Amazon biome. We first verified the consistency of the information on threats attributed by stakeholders to these new priority areas, and then assessed whether the existence, levels and types of threats influenced the choice of areas for conservation. The results showed that there were some successes in recognising threats, but also many inconsistencies, especially in assigning levels of intensity for some types of threats such as fishing. The decision-making process also did not fully use available information to indicate areas for conservation. The lack of understanding on the motivation behind these inconsistencies could suggest the presence of political opportunism. A more quantitative approach to assigning priorities is needed: one that is less dependent on the individual input of stakeholders and more accurately reflects the actual emergency status of proposed areas. This indicates that greater effort should be allocated to combining a participatory approach with a robust decision support system.     

The PAL+ program, an incentive concerted action about malaria and associated infectious diseases, for developing countries

The French Ministry in charge of Research has launched a multi-institutional incentive concerted action to assist Southern countries on malaria: the PAL+ program. PAL+ aims at bringing out: 1) conditions to promote novel preventive and therapeutic tools adapted to existing situations in the countries concerned; 2) a contribution to help research teams in Southern countries become competitive. PAL+ plans to strengthen cooperative relationships with developing countries (subsaharian Africa, South East Asia and South American countries). Research programs were oriented towards public health needs in malaria-endemic countries and thus mainly focused on: i) development of new antimalarial drugs and new therapeutical strategies: new targets and new leads for drugs, clinical assays for recognition of malaria and optimization of effective treatment or prophylactic drug dosage; ii) pathophysiology of severe malaria: mechanisms of immunity, biology and genome of host and parasite and research leading to vaccine trials; iii) basic and field research on mosquito genetics and biology which may lead to new prevention and control opportunities; iv) social studies on behaviours and habits around prevention and medication of malaria. The objective is to help Southern countries increase their capacity in clinical research, epidemiology, therapeutics, public health and social science (e.g. behaviours and habits accompanying medicine-taking). This means a true partnership and training adapted to specific needs and based on sound science. Research was therefore largely pursued in the laboratories of Southern countries and PAL+ supported the initiative in different ways by: i) providing easier opportunities for scientists from the North to collaborate with scientists from the South; ii) supporting networks of scientist collaborations. This was achieved by setting up a new type of relationships between scientists, based on a continuous dialogue and on bringing them together in small meetings on thematic discussions, the so-called Ateliers de PAL+. The Ateliers should play a major role in increasing the scientific capacity in developing countries. PAL+ program is a commitment to speed up better understanding of the disease by helping endemic countries contribute to research for their own benefit.     

Health and environment

The impact of the environment (air, water, food pollution) on health is a major concern in contemporary society. Unfortunately, there are relatively few objective epidemiological data on this subject and their accuracy is limited. Risks are often not quantified, whereas in public health the quantitative assessment of the various risks and benefits must provide the bases for a global strategy. Actual risks should be distinguished from putative risks and, when the risks are putative, an effort should be made to ascertain the upper and lower limits of the risk. The validity of a linear no threshold relationship for assessing putative risks should be discussed and, whenever appropriate, other relationships should be considered. Since emotional reactions often pervade environmental issues, which in turn are exploited for political or commercial reasons, it is not surprising that any statement or action may provoke violent debate. It is serious to underestimate the importance of a risk, since appropriate measures may not be put in place. However, it is equally serious to overestimate it because this can provoke unjustified fears, a pervasive unease, and a rejection of certain technologies, even to the point of discrediting science. It can lead therefore to a questioning of progress by instilling fears about any innovation, as well as facilitating the manipulation of public opinion for financial or ideological reasons, and finally to distortions in budget allocations and public health actions. Confronted with this situation, the Academy's role should be threefold. a) Whenever necessary, point out the need for an increase in appropriate fundamental research. When epidemiological data are uncertain, analyse the cause of these uncertainties and advocate appropriate development in statistical methodologies and epidemiological research, which could ascertain the upper limit of the putative risk. The lack of knowledge often results in public anxiety; this reaction should be investigated and psychosociological research must be encouraged and supported. b) Inform the scientific community and the public; fight against misinformation and sensationalism in the news, and take advantage of the Internet to this end. Encourage openness and transparency in the preparation of scientific reports and dialogue with the stakeholders. c) Better define the role and the place of experts, ensure their independence, monitor their competence and make sure they represent the various fields involved. When reports are conflicting, the Academy should be ready to organize a forum for analysing the roots of these disagreements and to delineate the limits of the uncertainties.     

Public perspectives on genetic biocontrol technologies for controlling invasive fish

Understanding people’s knowledge, attitudes, and concerns about genetic biocontrol can help researchers understand the challenges and opportunities that may be encountered during development of these technologies. This study conducted eight focus groups in the United States Great Lakes and Lake Champlain region to assess different stakeholders’ views about genetic biocontrol technology, factors affecting whether or not they support its use, and recommendations on how to proceed with its development. Stakeholders were excited about having a new invasive species control tool, but they were deeply concerned about potential unintended consequences. The primary concerns relate to ecological impacts, along with the cost of development and the possibility that such efforts will distract from other, ongoing control work. Participants made a number of recommendations to genetic biocontrol developers, including setting up regulatory systems, conducting independent cost benefit analyses and risk assessments, and engaging stakeholders throughout the development process.     

Making Science Accessible: A Semiotics of Scientific Communication

This article serves as a demonstration of how certain models of literary analysis, used to theorize and analyze fiction and narrative, can also be applied to scientific communication in such a manner as to promote the accessibility of science to the general public and a greater awareness of the methodology used in making scientific discovery. The approach of this article is based on the assumption that the principles of structuralism and semiotics can provide plausible explanations for the divide between the reception of science and literature. We provide a semiotic analysis of a scientific article that has had significant impact in the field of molecular biology with profound medical implications. Furthermore, we show how the structural and semiotic characteristics of literary texts are also evident in the scientific papers, and we address how these characteristics can be applied to scientific prose in order to propose a model of scientific communication that reaches the public. By applying this theoretical framework to the analysis of both scientific and literary communication, we establish parallels between primary scientific texts and literary prose.     

Diagnostic testing for vaccinomics: is the regulatory approval framework adequate? A comparison of Canada, the United States, and Europe

Vaccinomics aims to integrate variability information from multiple levels of the biological hierarchy from genome to proteome to metabolome, and ways in which these biological parts interact with each other and the environment. Vaccinomics holds significant promise as a new public health tool in designing safer and more effective vaccines for both developed and developing countries. Vaccinomics tests that are envisioned to be used in tandem with vaccine-based health interventions could permit an informed forecast of individual and subpopulation variations in immune responses to vaccines, reduce adverse effects, and contribute to a foundation for rational and directed use of vaccines. A proactive, multidisciplinary engagement with vaccinomics is now timely and much needed in order to develop regulations that best ensure the protection of the public and promote the transition of vaccinomics innovations from discovery to real-life public health applications. This article examines and compares the regulatory oversight of vaccinomics tests in Canada, the United States, and Europe. Recent trends in these jurisdictions suggest that regulatory agencies view personalized genomics/omics medicine, such as vaccinomics, as a desirable goal. At the same time, proposals to increase oversight could impact progress in the field and affect the availability of vaccinomics tests in public health practice and the diagnostic test market. The comparative analysis of vaccinomics in three jurisdictions presented in this article highlights both the convergence and divergence of regulatory oversight. In a rapidly emerging field such as vaccinomics that is pivotal for global public health, achieving better harmonization of policies may be an advantageous target, while ensuring that symmetry exists between the goals of public safety and promoting public health innovation. We suggest it is now timely to proactively initiate a constructive dialogue among all stakeholders (publics, policymakers, researchers, private sector, governments) to foster the development of appropriately targeted regulatory policies in this field.