Evolution of different dual-use concepts in international and national law and its implications on research ethics and governance.

This paper provides an overview of the various dual-use concepts applied in national and international non-proliferation and anti-terrorism legislation, such as the Biological and Toxin Weapons Convention, the Chemical Weapons Convention and United Nations Security Council Resolution 1540, and national export control legislation and in relevant codes of conduct. While there is a vast literature covering dual-use concepts in particular with regard to life sciences, this is the first paper that incorporates into such discussion the United Nations Security Council Resolution 1540. In addition, recent developments such as the extension of dual-use export control legislation in the area of human rights protection are also identified and reviewed. The discussion of dual-use concepts is hereby undertaken in the context of human- and/or national-security-based approaches to security. This paper discusses four main concepts of dual use as applied today in international and national law: civilian versus military, peaceful versus non-peaceful, legitimate versus illegitimate and benevolent versus malevolent. In addition, the usage of the term to describe positive technology spin-offs between civilian and military applications is also briefly addressed. Attention is also given to the roles civil society and research ethics may play in the governance of dual-use sciences and technologies.

The concept of governance in dual-use research.

The rapid advance of life science within the context of increased international concern over the potential misuse of findings has resulted in the lack of agreement on the issues of responsibility, control and collaboration. This progress of knowledge outpaces the efforts of creating moral and legal guidelines for the detection and minimization of the risks in the research process. There is a need to identify and address normative aspects of dual-use research. This paper focuses on the issues of safety and global collaboration in life science research by highlighting the importance of openness, enabling policies and cooperative governance. These safeguards are believed to reduce the risks related to the misuse of science while enabling the important research to move forward. The paper addresses the need for a better definition of dual use concept and, based on the historical precedents, explores the moral concerns and governmental strategies of dual-use research. The three necessary moves in addressing the issue of security in life sciences are suggested: the move from constraining to enabling types of policies, the move from secrecy to openness, and the move from segregation to integration of the public voice.

Dispatches from the evolution wars: shifting tactics and expanding battlefields.

Creationism continues to present a challenge to the teaching of evolution in the United States. With attempts to ban evolution education and to "balance" the teaching of evolution with creationism unavailing, creationists are increasingly favoring the approach of misrepresenting evolution as scientifically controversial. To understand the ongoing challenges facing evolution education in the United States, it is necessary to appreciate creationist actions at the different levels of educational governance--state legislatures, state boards of education, local boards of education, and finally the individual classroom--that serve as the battlegrounds for the evolution education wars. Scientists are in a unique position to defend the teaching of evolution, both by resisting creationist incursions as they occur and by helping to improve the teaching of evolution at both the precollege and college levels.

Data sharing and dual-use issues.

The concept of dual-use encapsulates the potential for well-intentioned, beneficial scientific research to also be misused by a third party for malicious ends. The concept of dual-use challenges scientists to look beyond the immediate outcomes of their research and to develop an awareness of possible future (mis)uses of scientific research. Since 2001 much attention has been paid to the possible need to regulate the dual-use potential of the life sciences. Regulation initiatives fall under two broad categories-those that develop the ethical education of scientists and foster an awareness and responsibility of dual-use issues, and those which assess the regulation of information being generated by current research. Both types of initiatives are premised on a cautious, risk-adverse philosophy which advocates careful examination of all future endpoints of research endeavors. This caution advocated within initiatives such as pre-publication review of journal articles contrasts to the obligation to share underpinning data sharing discussions. As the dual-use debate has yet to make a significant impact on data sharing discussions (and vice versa) it is possible that these two areas of knowledge control may present areas of ethical conflict for scientists, and thus need to be more closely examined. This paper examines the tension between the obligation to share exemplified by data sharing principles and the concerns raised by the risk-cautious culture of the dual-use debates. The paper concludes by reflecting on the issues of responsibility as raised by dual-use as relating to data sharing, such as the chain of custody for shared data.

Solving bottlenecks in data sharing in the life sciences.

The joint Open PHACTS/GEN2PHEN workshop on "Solving Bottlenecks in Data Sharing in the Life Sciences" was held in Volendam, the Netherlands, on September 19 and 20, 2011, and was attended by representatives from academia, industry, publishing, and funding agencies. The aim of the workshop was to explore the issues that influence the extent to which data in the life sciences are shared, and to explore sustainability scenarios that would enable and promote "open" data sharing. Several key challenges were identified and solutions to each of these were proposed.

Science, biomedical technology and biolaw.

Starting from legislative recognition of the grounding principles of human rights, the authors describe and comment upon the Council of Europe's Convention on human rights and human dignity confronted with scientific discoveries and also upon the Oviedo Convention of 1997 for the protection of Human Rights and dignity of the human being with regard to the application of biology and medicine. The authors specify that, given the promise made by Romania to observe international obligations, the Romanian law no. 2/1998 on organ and tissue transplantation abrogates the stipulations of the law 3-1978 and also includes 9 appendices which, being part of the law, guarantee in addition the observance of its provisions. All these regulations on the relationship between science and human rights have determined an evolution from the fatality of natural risks to current compensations, as an expression of human solidarity. They have determined the transition from social and vocational paternalism to personal autonomy and personal guarantees of independence and freedom. All these developments are faithfully reflected by comparative legislation on the use of life science outcomes on persons as they presently are. This is also reflected in Romanian legislation concerning tissue and organ transplantation and in mental health legislation.

Empowering the inventor--the case of monoclonal antibodies.

Academic ownership of intellectual property facilitated wide dissemination and commercialization of antibody technology. Moves at the University of Cambridge to reclaim institutional IP rights should thus be treated with caution.

Beyond financial conflicts of interest: Institutional oversight of faculty consulting agreements at schools of medicine and public health.

IMPORTANCE: Approximately one-third of U.S. life sciences faculty engage in industry consulting. Despite reports that consulting contracts often impinge on faculty and university interests, institutional approaches to regulating consulting agreements are largely unknown. OBJECTIVE: To investigate the nature of institutional oversight of faculty consulting contracts at U.S. schools of medicine and public health. DESIGN: Structured telephone interviews with institutional administrators. Questions included the nature of oversight for faculty consulting agreements, if any, and views about consulting as a private versus institutional matter. Interviews were analyzed using a structured coding scheme. SETTING: All accredited schools of medicine and public health in the U.S. PARTICIPANTS: Administrators responsible for faculty affairs were identified via internet searches and telephone and email follow-up. The 118 administrators interviewed represented 73% of U.S. schools of medicine and public health, and 75% of those invited to participate. INTERVENTION: Structured, 15-30 minute telephone interviews. MAIN OUTCOMES AND MEASURES: Prevalence and type of institutional oversight; responses to concerning provisions in consulting agreements; perceptions of institutional oversight. RESULTS: One third of institutions (36%) required faculty to submit at least some agreements for institutional review and 36% reviewed contracts upon request, while 35% refused to review contracts. Among institutions with review, there was wide variation the issues covered. The most common topic was intellectual property rights (64%), while only 23% looked at publication rights and 19% for inappropriately broad confidentiality provisions. Six in ten administrators reported they had no power to prevent faculty from signing consulting agreements. Although most respondents identified institutional risks from consulting relationships, many maintained that consulting agreements are "private." CONCLUSIONS AND RELEVANCE: Oversight of faculty consulting agreements at U.S. schools of medicine and public health is inconsistent across institutions and usually not robust. The interests at stake suggest the need for stronger oversight.

Product Development and Commercialization of Diagnostic or Life Science Products for Scientists and Researchers.

Commercializing a diagnostic or life science product often encompasses different goals than that of research and grant funding. There are several necessary steps, and a strategy needs to be well defined in order to be successful. Product development requires input from and between various groups within a company and, for academia, outside entities. The product development stakeholder groups/entities are research, marketing, development, regulatory, manufacturing, clinical, safety/efficacy, and quality. After initial research and development, much of the work in product development can be outsourced or jointly created using public-private partnerships. This chapter serves as an overview of the product development process and provides a guide to best define a product strategy.

Dual use issues in research - A subject of increasing concern?

Dual use is defined as the application of materials, knowledge or technologies for military or terrorist purposes, as well as for good. In biological science, it is considered to be a growing threat as the genetics of pathogenicity traits and toxins are becoming on one hand elucidated in a detail that was not anticipated 20years ago and on the other hand technological advances in genetic engineering and synthetic biology are continually enabling easier access to these technologies. On a theoretical and policy level, much has happened over the past decade, but translating these policies and concepts to operational level awareness and robust processes requires more attention. Where the research is conducted, scientists have to make ethical judgements and account for their data sharing and publication policies. How can we ensure the requirement for dual use review is taken on board, but is not skewing research detrimentally and imposing a disproportionate burden?

BioSharing: curated and crowd-sourced metadata standards, databases and data policies in the life sciences.

BioSharing (http://www.biosharing.org) is a manually curated, searchable portal of three linked registries. These resources cover standards (terminologies, formats and models, and reporting guidelines), databases, and data policies in the life sciences, broadly encompassing the biological, environmental and biomedical sciences. Launched in 2011 and built by the same core team as the successful MIBBI portal, BioSharing harnesses community curation to collate and cross-reference resources across the life sciences from around the world. BioSharing makes these resources findable and accessible (the core of the FAIR principle). Every record is designed to be interlinked, providing a detailed description not only on the resource itself, but also on its relations with other life science infrastructures. Serving a variety of stakeholders, BioSharing cultivates a growing community, to which it offers diverse benefits. It is a resource for funding bodies and journal publishers to navigate the metadata landscape of the biological sciences; an educational resource for librarians and information advisors; a publicising platform for standard and database developers/curators; and a research tool for bench and computer scientists to plan their work. BioSharing is working with an increasing number of journals and other registries, for example linking standards and databases to training material and tools. Driven by an international Advisory Board, the BioSharing user-base has grown by over 40% (by unique IP address), in the last year thanks to successful engagement with researchers, publishers, librarians, developers and other stakeholders via several routes, including a joint RDA/Force11 working group and a collaboration with the International Society for Biocuration. In this article, we describe BioSharing, with a particular focus on community-led curation.Database URL: https://www.biosharing.org.

Protecting Trade Secrets in Canada.

Patents in the life sciences industries are a key form of intellectual property (IP), particularly for products such as brand-name drugs and medical devices. However, trade secrets can also be a useful tool for many types of innovations. In appropriate cases, trade secrets can offer long-term protection of IP for a lower financial cost than patenting. This type of protection must be approached with caution as there is little room for error when protecting a trade secret. Strong agreements and scrupulous security can help to protect the secret. Once a trade secret is disclosed to the public, it cannot be restored as the owner's property; however, if the information is kept from the public domain, the owner can have a property right of unlimited duration in the information. In some situations patents and trade secrets may be used cooperatively to protect innovation, particularly for manufacturing processes.

Advanced science education in the regulatory arena: the Center for Drug Evaluation and Research Experience at the Food and Drug Administration.

A challenge faced by the Center for Drug Evaluation and Research (CDER) in effectively carrying out its mission requires it to integrate the disciplines of science, medicine, law, and public policy. One way to do that is by ensuring a highly trained multidisciplinary staff. The CDER has been able to meet this requirement by identifying the core competencies needed to accomplish its mission. The use of a competency-based training model in the planning, development, and delivery of its advanced scientific education program allows CDER staff to maintain current knowledge as well as prepare for future scientific education needs. The CDER educational model could be readily adapted to meet the educational needs of other organizations.

Ethical issues for bioscientists in the new millennium.

The scientific understanding of biological processes is developing extremely fast, providing opportunities for changing people's lives in many ways-through health care, food and the environment. The speed with which these changes are occurring means that even bioscientists can only keep up with their own narrow field of science. It is not surprising that members of the public are frightened about the rapidity and impact of the changes arising from the biological revolution. These concerns are often expressed in ethical terms. Decision making about the direction of research and its application is becoming more transparent. This means that bioscientists will have to engage in the debate about their work with members of the public, including those who are opposed to it, in order to create acceptance of their work and its products. At the moment, bioscientists are often ill equipped to enter this debate because of their lack of training in ethics and lack of understanding of the impact of ethics on their work. A better understanding of bioethics will be necessary for entering this debate with vigour. A comprehensive ethical analysis is outside the scope of this text. Some of the principal arguments about the ethics of two aspects of bioscience research-genetically modified crops and the use of experimental animals-will be discussed to illustrate a few of the issues that derive from ethical analyses. I hope that this will encourage toxicologists to take a greater interest in bioethics.