Search

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., Competing Interests: The authors have declared that no competing interests exist.

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?, (Copyright © 2017. Published by Elsevier Ltd.)

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.

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., (© The Author(s) 2016. Published by Oxford University Press.)

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., (Copyright © 2015 Cold Spring Harbor Laboratory Press; all rights reserved.)

Trade secret protection arises under state common law and state statutes. In general, a trade secret is information that is not generally known to the public and is maintained as a secret, and it provides a competitive advantage or economic benefit to the trade secret holder. Trade secrets can be worth tens or hundreds of millions of dollars, and damage awards in trade secret litigation have been high; often, there is a lot at stake. Obtaining a trade secret through "improper means" is misappropriation. If the alleged trade secret, however, was developed independently, known publicly, or not maintained as a secret, then those defenses may successfully overcome a claim for trade secret misappropriation. With today's interconnectedness in the biotechnology and pharmaceutical fields, more collaborations, joint ventures, and outsourcing arrangements among firms, and increased mobility of employees' careers, life science companies need to not only understand how to protect their trade secrets, but also know how to defend against a claim for trade secret theft., (Copyright © 2015 Cold Spring Harbor Laboratory Press; all rights reserved.)

The European patent system is very much like those of the United States and other major countries. Patent applications can be filed as a first filing, as a priority application, or as a national phase of a Patent Cooperation Treaty application. The applications are searched, rigorously examined, and ultimately granted, with the time periods varying somewhat depending on the application type. The object of this article is to highlight some of the differences between the U.S. and European systems, particularly as they relate to life sciences., (Copyright © 2014 Cold Spring Harbor Laboratory Press; all rights reserved.)

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 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.

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.

The dual-use dilemma in the life sciences-that illicit applications draw on the same science and technology base as legitimate applications-makes it inherently difficult to control one without inhibiting the other. Since before the September 11 attacks, the science and security communities in the United States have struggled to develop governance processes that can simultaneously minimize the risk of misuse of the life sciences, promote their beneficial applications, and protect the public trust. What has become clear over that time is that while procedural steps can be specified for assessing and managing dual-use risks in the review of research proposals, oversight of ongoing research, and communication of research results, the actions or decisions to be taken at each of these steps to mitigate dual-use risk defy codification. Yet the stakes are too high to do nothing, or to be seen as doing nothing. The U.S. government should therefore adopt an oversight framework largely along the lines recommended by the National Science Advisory Board for Biosecurity almost 5 years ago-one that builds on existing processes, can gain buy-in from the scientific community, and can be implemented at modest cost (both direct and opportunity), while providing assurance that a considered and independent examination of dual-use risks is being applied. Without extraordinary visibility into the actions of those who would misuse biology, it may be impossible to know how well such an oversight system will actually succeed at mitigating misuse. But maintaining the public trust will require a system to be established in which reasonably foreseeable dual-use consequences of life science research are anticipated, evaluated, and addressed.

Recent developments in our ability to capture, curate, and analyze data, the field of data-intensive science (DIS), have indeed made these interesting and challenging times for scientific practice as well as policy making in real time. We are confronted with immense datasets that challenge our ability to pool, transfer, analyze, or interpret scientific observations. We have more data available than ever before, yet more questions to be answered as well, and no clear path to answer them. We are excited by the potential for science-based solutions to humankind's problems, yet stymied by the limitations of our current cyberinfrastructure and existing public policies. Importantly, DIS signals a transformation of the hypothesis-driven tradition of science ("first hypothesize, then experiment") to one that is typified by "first experiment, then hypothesize" mode of discovery. Another hallmark of DIS is that it amasses data that are public goods (i.e., creates a "commons") that can further be creatively mined for various applications in different sectors. As such, this calls for a science policy vision that is long term. We herein reflect on how best to approach to policy making at this critical inflection point when DIS applications are being diversified in agriculture, ecology, marine biology, and environmental research internationally. This article outlines the key policy issues and gaps that emerged from the multidisciplinary discussions at the NSF-funded DIS workshop held at the Seattle Children's Research Institute in Seattle, on September 19-20, 2010., (© Mary Ann Liebert, Inc.)

This paper focuses on the issue of what to do if a couple who generates embryos chooses to lawfully, and in their (and my) view, ethnically discard those embryos. Specifically, is it appropriate to use the cells that come from "excess" embryos in medical research instead of discarding them when a couple has ceased trying to have any additional children?

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.

A 6-week series of seminars addressing replacement of harmful animal use in education and training was held across Latin America in March-April 2008. Organised by InterNICHE and partner organisations in Bolivia, Peru, Brazil, Argentina and Mexico, the events built on the experience of previous major outreach in Russia and India. Up to 6 full-day seminars were held at universities and independent venues in each country. Smaller meetings with campaigners, teachers and professional bodies complemented the large presentations. All events included spoken presentations, demonstrations and free trials of a wide range of alternatives. Speakers included InterNICHE experts and those from the host countries who are involved in replacement work. Partner organisations were empowered through the process of planning and execution of the seminars, and the tour helped to identify and provide support to others who are progressing humane education initiatives. Further collaboration is now planned. Information on the current situation concerning animal use and alternatives, including laws and regulations, was also gathered from each country. The tour succeeded in raising awareness and generating interest in replacement alternatives, also by national-level interviews and media coverage. Information and freeware alternatives were widely distributed, and further translations of material into Spanish and Portuguese are in progress. To continue the hands-on access to alternatives provided at the seminars, a Mexican / Central American Alternatives Loan System has been established, and others are being built in Peru and Brasil. The donation of computers and alternatives to selected universities is also being planned in order to establish multimedia laboratories that will promote alternatives through example.

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.

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.

Policy regarding academically generated biomedical intellectual property (IP) has been shaped by two important events: the Vannevar Bush report to then President Roosevelt in 1945 and the Bayh-Dole Act of 1980. This policy, which vests the intellectual property produced from federally funded biomedical research from the government to the academic institution, was designed to promote technology transfer and thus promote the health of the U.S. economy. However, the policy has led to significant challenges, particularly in implementation. Here it is argued that the difficulties are due to differences in the structure of motivations between biomedical scientists, institutional officials, and private sector entrepreneurs. Understanding these differences may lead to a review of policy with the goal of enhancing technology transfer for the future., (Copyright 2004 Wiley-Liss, Inc.)

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.

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.