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A team-taught interdisciplinary approach to engineering ethics.

This paper outlines the development and implementation of a new course in Engineering Ethics at the University of Tennessee. This is a three-semester-hour course and is jointly taught by an engineering professor and a philosophy professor. While traditional pedagogical techniques such as case studies, position papers, and classroom discussions are used, additional activities such as developing a code of ethics and student-developed scenarios are employed to encourage critical thinking. Among the topics addressed in the course are engineering as a profession and its role in society; ethical successes and failures; risk, safety, and the environment; professional responsibilities; credit and intellectual property; and international concerns. The most significant aspect of the course is that it brings both engineering and non-engineering points of view to the topics at hand. This is accomplished in two ways. First, as mentioned previously, it is team-taught by engineering faculty with an interest in ethical and societal issues, and by philosophy faculty with expertise in the field of professional ethics and an interest in science and technology. Second, the course is offered to both engineers and non-engineers. This mix of students requires that all students must be able to explain their technical and ethical decisions in a non-technical manner. Work teams are structured to maximize interdisciplinary interaction and to foster insights by each student into the professional commitments and attitudes of others.

Curriculum↗

Teaching engineering ethics using role-playing in a culturally diverse student group.

The use of role-playing ("active learning") as a teaching tool has been reported in areas as diverse as social psychology, history and analytical chemistry. Its use as a tool in the teaching of engineering ethics and professionalism is also not new, but the approach develops new perspectives when used in a college class of exceptionally wide cultural diversity. York University is a large urban university (40,000 undergraduates) that draws its enrolment primarily from the Greater Toronto Area, arguably one of the most culturally diverse cities in the world, embracing the largest percentage of Canada's immigration. Among the area's five million inhabitants, 50% identify themselves as a visible minority born outside Canada, while over 100 languages and dialects are spoken daily. Although students admitted from this international pool have usually been exposed to western attitudes during secondary education and are rapidly assimilated into Canadian culture, responses to specific ethical issues are strongly influenced by their prior culture. Two and three-part scripts for case studies based on NSF or original scenarios were written to illustrate issues such as gifts, attitudes towards women and ethnic minorities, conflict of interest, whistle-blowing, sexual harassment, individual rights, privacy, environment, intellectual property, and others. Following the presentation, the actors lead group discussion based on previously specified questions. Once the initial shyness and reluctance of some cultures has been overcome through the building of rapport, students have written original scripts based on hypothetical or prior personal situations. The method is now being adopted in a short course format to assist the professional integration of foreign trained engineers.

Canada↗

International Federation of Clinical Chemistry. Use of artificial intelligence in analytical systems for the clinical laboratory. IFCC Committee on Analytical Systems.

The incorporation of information-processing technology into analytical systems in the form of standard computing software has recently been advanced by the introduction of artificial intelligence (AI) both as expert systems and as neural networks. This paper considers the role of software in system operation, control and automation and attempts to define intelligence. AI is characterized by its ability to deal with incomplete and imprecise information and to accumulate knowledge. Expert systems, building on standard computing techniques, depend heavily on the domain experts and knowledge engineers that have programmed them to represent the real world. Neural networks are intended to emulate the pattern-recognition and parallel-processing capabilities of the human brain and are taught rather than programmed. The future may lie in a combination of the recognition ability of the neural network and the rationalization capability of the expert system. In the second part of this paper, examples are given of applications of AI in stand-alone systems for knowledge engineering and medical diagnosis and in embedded systems for failure detection, image analysis, user interfacing, natural language processing, robotics and machine learning, as related to clinical laboratories. It is concluded that AI constitutes a collective form of intellectual property and that there is a need for better documentation, evaluation and regulation of the systems already being used widely in clinical laboratories.

Artificial Intelligence↗

Use of artificial intelligence in analytical systems for the clinical laboratory.

OBJECTIVE: To consider the role of software in system operation, control and automation, and attempts to define intelligence. METHODS AND RESULTS: Artificial intelligence (Al) is characterized by its ability to deal with incomplete and imprecise information and to accumulate knowledge. Expert systems, building on standard computing techniques, depend heavily on the domain experts and knowledge engineers that have programmed them to represent the real world. Neural networks are intended to emulate the pattern-recognition and parallel processing capabilities of the human brain and are taught rather than programmed. The future may lie in a combination of the recognition ability of the neural network and the rationalization capability of the expert system. In the second part of this paper, examples are given of applications of Al in stand-alone systems for knowledge engineering and medical diagnosis and in embedded systems for failure detection, image analysis, user interfacing, natural language processing, robotics and machine learning, as related to clinical laboratories. CONCLUSION: Al constitutes a collective form of intellectual property, and that there is a need for better documentation, evaluation and regulation of the systems already being used widely in clinical laboratories.

Artificial Intelligence↗

Pharmaceuticals and public policy: learning from the New Zealand experience.

Pharmaceuticals provide a useful analytical prism through which to view a wider range of policy issues in the health arena. The fundamental characteristics of pharmaceuticals are shared by many other health care items and raise important policy questions in five key institutional areas: the market, science, the State, the professions, and the public. In one way or another the key policy issues raised in each one of these areas concern fundamental questions of restraint and regulation: the ability of the market to exert the normal disciplines of price competition on pharmaceuticals; the extent to which the claims of intellectual property conflict with the norms of scientific advance; the reconciliation of the different functions of the State, particularly in the management of risk; the efficacy of traditional mechanisms of self-regulation and peer review in the health professions; and the implications of pharmaceuticals for broader questions of social control. These issues are illustrated from the recent experience of a country, New Zealand, that has undergone major deregulation and restructuring of State activities. Conclusions are drawn for policy development in the pharmaceuticals area.

Drug Approval↗

Technology transfer to the developing world: does new technology have any relevance for developing countries?

Technology is not limited to equipment and commodities but includes know-how, understanding and the ability to control and exploit underlying principles and processes. Diverse technologies, not only those termed 'biomedical', affect the incidence and control of all diseases including tuberculosis. 'New technology' implies something recently developed, but any technology is new to those without prior experience. For developing countries, technologic novelty is far less important than relevance, which encompasses, among other things: direct application to reducing risk of infection and disease; affordability and cost-effectiveness; saving foreign exchange; satisfying public demand with political benefit to the government; and promotion of social equity. The value of health gained by the new technology should exceed its cost, but this is difficult to measure. It is usually presumed that industrial countries are eager to export technologies, but intellectual property and patient regulations of the importing country may inhibit such transfers. Similarly, ethical issues involving protection of human subjects and informed consent may complicate clinical trials and technology assessment in the developing country environment.

Cost-Benefit Analysis↗

Challenges and opportunities for enhancing biotechnology and technology transfer in developing countries.

Biotechnological innovation is gaining increased recognition as an important tool for improving global health. The challenge, however, lies in defining the role of technology transfer to develop therapies for diseases prevalent in developing countries. During the past decade, a large disparity emerged between the developed and developing world in accessing affordable medicines because of the pharmaceutical industry's focus on health areas bearing greatest profits. Discussed herein are several mechanisms that provide partial solutions to this challenge. The Office of Technology Transfer of the US National Institutes of Health has increased its technology licensing pertaining to neglected diseases to partners in developing regions. Establishing partnerships through the transfer of technologies and assisting indigenous institutions build R and D capacity may positively impact policies on protection of intellectual property rights and increase multinational company investments in lesser-developed countries. This will most probably result in the development of more accessible therapies for those in need.

Biotechnology↗

Economic impact of transgenic crops in developing countries.

Transgenic crops are being adopted rapidly at the global level, but only a few developing countries are growing them in significant quantities. Why are these crops so successful in some countries but not in others? Farm level profitability ultimately determines whether farmers adopt and retain a new technology, but this depends on much more than technical performance. Recent economic studies in developing countries find positive, but highly variable, economic returns to adopting transgenic crops. These studies confirm that institutional factors such as national agricultural research capacity, environmental and food safety regulations, intellectual property rights and agricultural input markets matter at least as much as the technology itself in determining the level and distribution of economic benefits.

Crops, Agricultural↗

Rational and efficient geometric definition of pharmacophores is essential for the patent process.

The geometric description of pharmacophores suffers from approximations. No consensus has been clearly established, despite the increasing interest in using pharmacophores in drug design and in patent applications. We therefore propose an original definition of a pharmacophore using spherical coordinates. These coordinates give a precise description of each point using three parameters: distance to a geometric origin and two angles. If necessary, these parameters can be easily and rapidly converted to cartesian coordinates. Our method can guarantee, to the patent applicant, the safe protection of his intellectual property by both improving markedly the readability of a pharmacophore definition and bringing, to the person who is skilled in the art, enough information to understand easily the essence of the invention.

Computer-Aided Design↗

Artificial intelligence-driven advancements in agricultural biotechnology.

The need for faster and more informative data processing for better decision-making is driving the adoption of artificial intelligence (AI) in the agricultural sector. Thanks to recent advancements in computer science and the increase in computational powers of modern computers, AI is not only augmenting traditional solutions, but also helping in developing novel solutions to existing challenging matters. AI-driven models have an exceptional ability to identify patterns and combine a diverse collection of data together and make inference. The increasing pressure on farmlands posed by the growing global population and climate change is lessening growth, yield, and productivity ultimately posing risk to food security worldwide. Incorporation of AI in agriculture has the potential to drive farming efficiency to new heights. This comprehensive review critically evaluates the evolution of AI in agricultural biotechnology from a theoretical concept to a global phenomenon. A comprehensive literature search was performed using major scientific databases, including PubMed, Web of Science, Embase, Scopus, Lens and the Cochrane Library. In this review, we empirically demonstrate the fields advancement toward more capable AI systems and discuss the current applications of AI across crop improvement and precision agriculture such as crop improvement and genetic engineering, genomic selection and plant breeding, pest and disease detection, precision agriculture and smart farming, soil health and nutrient management, climate resilient crop development, livestock biotechnology, challenges and ethical considerations in AI based agricultural biotechnology. Furthermore, this review addresses the exponential growth of commercial intellectual property in the field and contrast it with academic publication outputs. Finally, we critically assess the ethical challenges impeding equitable adoption of AI including data sovereignty and digital divide, while projecting future frontiers involving quantum computing. This review will help build sustainable agricultural systems capable of adapting to climate change, contribute to the development of climate-resilient and high-yielding crops, and address global food security challenges.

Agriculture↗

Improving research supervision in nursing.

In this paper, four experienced researchers from the UK, China and Australia offer guidance in research supervision based on their experiences and the recent document, Improving standards in postgraduate research degree programmes [Higher Education Funding Council for England, 2003. Improving standards in postgraduate research degree programmes. Formal consultation. Department for Employment and Learning, Northern Ireland, Higher Education Funding Council for England, Higher Education Funding Council for Wales, Scottish Higher Education Funding Council, HEFCE, London]. Supervision is an important aspect of not only the development of the neophyte researcher, but of academic staff and research activity in general. With increased academic accountability, good supervision should be an integral component of a quality research governance framework and resourced as such. Recommendations include: adoption of these standards; rigorous selection of research students and supervisors and development of projects; development of departmental procedures for monitoring, feedback and intellectual property; and transparency, rigour and fairness in examination procedures.

Attitude of Health Personnel↗

What determines the acceptability of genetically modified food that can improve human nutrition?

It has been predicted that by 2025 there will be an annual shortfall of cereals for feeding the human population of 68.5 million tones. One possible solution is the use of genetically modified (GM) crops, which are already grown extensively (59 million ha of GM crops were planted in 2002) in the USA, South America, Africa and China. Nevertheless, there is considerable disagreement about the advisability of using such crops, particularly in Europe. Obviously, the safety of the food derived from the GM crops is a primary consideration. Safety assessment relies on establishing that the food is substantially equivalent to its non-GM counterpart and specific testing for allergenicity of proteins and toxicity of metabolites and the whole food. There appears to be international agreement on the principles of safety assessment. Safety to the environment is equally important, but will not be covered in this presentation. The public's perception of the risk of new technology is critical to its acceptance. Perception of risk, in turn, depends on the credibility of the source of the information and trust in the regulatory process. In many countries, the public appears to have lost its trust in the scientists and government dealing with GM food, making the acceptability of GM crops uncertain. Of equal importance are the socio-economic factors that impinge on the viability of GM produce. These include intellectual property protection, trade liberalization (through subsidy and tariff barriers in developed countries) and the intensity of bio safety regulations. The socio-economic interests of developed and developing countries may diverge and may even be contradictory in any one country. Acceptance of GM crops will thus depend on detailed issues surrounding particular crops and economies.

Commerce↗

Plant-derived pharmaceuticals--the road forward.

Plant-derived pharmaceuticals are poised to become the next major commercial development in biotechnology. The advantages they offer in terms of production scale and economy, product safety, ease of storage and distribution cannot be matched by any current commercial system; they also provide the most promising opportunity to supply low-cost drugs and vaccines to the developing world. However, despite the promised benefits, the commercialization of plant-derived pharmaceutical products is overshadowed by the uncertain regulatory terrain, particularly with regard to the adaptation of good manufacturing practice regulations to field-grown plants. The success of such products also depends on careful negotiation of the intellectual property landscape, particularly the achievement of freedom-to-operate licenses for use in developing countries.

Biotechnology↗

Drug repurposing in status epilepticus.

The treatment of status epilepticus (SE) has changed little in the last 20 years, largely because of the high risks and costs of new drug development for SE. Moreover, SE poses specific challenges to drug development, such as patient diversity, logistical hurdles, and the need for acute treatment strategies that differ from chronic seizure prevention. This has reduced the appetite of industry to develop new drugs in this area. Drug repurposing is an attractive approach to address this unmet need. It offers significant advantages, including reduced development time, lower costs, and higher success rates, compared to novel drug development. Here I demonstrate how novel methods integrating biological knowledge and computational methods can be applied to drug repurposing in status epilepticus. Biological approaches focus on addressing mechanisms underlying drug resistance in SE (using for example ketamine, tacrolimus and safinamide) and longer-term consequences (using for example omaveloxolone, celecoxib and losartan). Additionally, artificial intelligence platforms, such as ChatGPT, can rapidly generate promising drug lists, while in silico methods can analyze gene expression changes to predict molecular targets. Combining AI and in silico approaches has identified several candidate drugs, including metformin, sirolimus and riluzole, for SE treatment. Despite the promise of repurposing, challenges remain, such as intellectual property issues and regulatory barriers. Nonetheless, drug repurposing presents a viable solution to the high costs and slow progress of traditional drug development for SE. This paper is based on a presentation made at the 9th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures, in April 2024.

Animals↗

Translation of an experimental oral vaccine formulation into a commercial product.

An effective experimental vaccine may fail to become a therapeutic reality for a number of scientific, regulatory or commercial reasons. In this review, we share some of our personal experiences as University-based researchers and provide an account of some of the problems that we have encountered during preliminary scale-up and assessment of an oral influenza vaccine formulation. Many of the problems we have faced have been non-scientific and related to identifying project-funding sources, finding suitable contract manufacturing companies that are GMP compliant, and protecting intellectual property generated from the scientific studies. The review is intended as a practical guide that will allow other researchers to adopt effective strategies to permit the translation of an effective experimental formulation to a viable commercial product.

Administration, Oral↗

The essential drugs concept is needed now more than ever.

The debate on access to essential medicines, which was live in the late 1970s and 1980s when strong pressure from public health advocates led the pharmaceutical industry to accept the concept, is now back on the international health policy agenda. Currently, the Essential Drugs List (EDL) forms an integral part of national drug policies in 146 countries, guiding the selection of drugs on the basis of public health relevance, efficacy, safety and cost. The essential medicines debate is back on the agenda as part of the access to medicines debate. The Trade Related Aspects on Intellectual Property Rights agreement has caused concern among public health advocates in terms of its impact on access to essential medicines. This article reviews the concept of essential medicines in the light of the changing political context and recommends that the EDL is supported as a crucial public policy tool in all countries.

Advertising↗

Patents and access to essential drugs.

This paper provides a brief overview of historical developments in patent law including its recent incorporation into world trade law. The impact of patents on access to essential drugs will be discussed. The relationship between intellectual property rights and the right to health will be considered.

Commerce↗

The evolution of gene patents viewed from the United States Patent Office.

In my remarks here, I have necessarily limited myself to general principles of patent law that are applicable to a consideration of gene-related inventions. Were I still Commissioner of Patents and Trademarks, I would not let electrical engineers anywhere near the examination of applications for patents for gene-related inventions, just as I would not let the USPTO's many Ph.D.s in microbiology or genetics near the examination of complex applications on computer architecture or programming. The same should hold true for attorneys who prosecute patent applications. That is why the U.S. patent system works so well. There can be no discrimination in the system by the field of technology--a principle enshrined in Article 27 of the World Trade Organization's Trade-Related Aspects of Intellectual Property. But we quite properly depend upon specialists to apply across-the-board general principles to very specialized technological fields of endeavor. This works very well in a system in which in the U.S., "everything under the sun made by humans" is patentable.

Creativity↗