Only 19 new molecular entities and 3 biologics were approved by the Food and Drug Administration in 2007, the lowest rate in 24 years. This disappointing output occurred despite steady clinical trial and regulatory review times, the FDA maintaining high approval rates, and the pharmaceutical industry consistently reporting increasing revenues. A government report suggests that fewer new drug applications have been submitted to the FDA by the pharmaceutical industry in recent years. These data have rekindled the debate as to (...) the origins of pharmaceutical innovation and the comparative importance of public and private sources in contributing to drug discovery. The pharmaceutical industry contends that its research is responsible for most new medicines, and that the primary public institution supporting U.S. biomedical research, the National Institutes of Health, supports medical innovation “distinct from the process of drug development.”. (shrink)

This article investigates the role of Big Data in situations of psychological stress such as during the recent pandemic caused by the COVID-19 health crisis. Quarantine measures, which are necessary to mitigate pandemic risk, are causing severe stress symptoms to the human body including mental health. We highlight the most common impact factors and the uncertainty connected with COVID-19, quarantine measures, and the role of Big Data, namely, how Big Data can help alleviate or mitigate these effects (...) by comparing thestatus quoof current technology capabilities with the potential effects of an increase of digitalization on mental health. We find that, while Big Data helps in the pre-assessment of potentially endangered persons, it also proves to be an efficient tool in alleviating the negative psychological effects of quarantine. We find evidence of the positive effects of Big Data on human health conditions by assessing the effect of internet use on mental health in 173 countries. We found positive effects in 110 countries with 90 significant results. However, increased use of digital media and exclusive exposure to digital connectivity causes negative long-term effects such as a decline in social empathy, which creates a form of psychological isolation, causing symptoms of acute stress disorder. (shrink)

The evolution of wireless communications, from the first to the fifth generation, has driven Internet of Things (IoT) advancements. IoT is transforming sectors like agriculture, healthcare, and transportation, but also presents challenges like spectrum bandwidth demand, speed requirements, and security issues. IoT environments, with embedded sensors and actuators, connect to other devices to transmit and receive data over the internet. These data are processed locally or in the cloud, enabling decision-making and automation. Various wireless technologies, including Bluetooth, Zigbee, (...) LoRa, and WiFi, cater to specific IoT applications. 5G, with its high speeds, low latency, and efficient bandwidth sharing, is ideal for high-speed data transmission, and thus it provides robust infrastructure for low-latency and bandwidth-sensitive applications. This latest mobile network technology is being rapidly implemented worldwide, providing unprecedented throughput and low latency, which are crucial for the IoT. This paper presents a comprehensive systematic review on 5G security features, vulnerabilities, threats to mobile devices, security in IoT devices, common attacks to IoT devices and protection of data in this environment. Despite enhanced security, 5G faces challenges like Distributed Denial of Service (DDoS), Man In The Middle (MITM), cross-slice disruptions, and side-channel attacks. (shrink)

The framers of the U.S. Constitution believed that intellectual property rights were crucial to scientific advancement. Yet, the framers also recognized the need to balance innovation, privatization, and public use. The courts’ expansion of patent protection for biotechnology innovations in the last 30 years raises the question whether the patent system effectively balances these concerns. While the question is not new, only through a thorough and thoughtful examination of these issues can the current system be evaluated. It is (...) then a policy decision for Congress if any change is necessary. (shrink)

By focusing on patents for recent algorithms that incorporate publicly available data to yield automated racial and ethnic classification schemes, I provide a glimpse into how engineers and programmers understand and define racial and ethnic categories. Patents provide insights into how engineers and programmers encode assumptions about identity and behavior, due to disclosure provisions required by US patent law; similar requirements are present in patent laws throughout the world. Such disclosures provide insights that are otherwise unavailable for (...) most proprietary assets. I further discuss how such classification tools, especially when combined with advertisement-based platforms such as social media, can amplify systemic racism present in the underlying data sets. (shrink)

A patent is a property granted to any new shape, configuration or arrangement of elements, of any device, tool, instrument, mechanism or other object or part thereof, that allows for a better or different operation, use or manufacture of the object that incorporates it or that provides it with some utility, advantage or technical effect that it did not have before. As a document, a patent really is a title that recognizes the right to exploit the patented invention (...) exclusively, preventing others from making, selling or using it without the consent of the owner. The fact of making a patent is motivated by the fact of promoting creativity, hindering competition in the market as only one person holds the patent, thus protecting the initial investment and fighting against plagiarism. Patents are available to the public for dissemination and general knowledge. It is generally recognized in the specialized literature that patents can be used as an indicator to calculate the results generated by research and development activities, being a very useful indicator to measure various social, economic or technological aspects. For this reason, it is of relevant interest to have tools or systems that allow us to obtain the patents developed in a specific period of time and to carry out analyses of various economic and social factors. These analyses can serve to obtain a social perspective of society’s progress in the technological field, and this is why an analysis of patents is of our interest. This paper proposes a platform specifically designed to obtain knowledge about patents as an indicator of Spanish social, economic or technological aspects. For this purpose, the platform retrieves, analyses and visualizes functionalities that represent data on the landscape of patents obtained from the Spanish Patent and Trademark Office as a particular case of study. (shrink)

Patent landscaping is the process of finding patents related to a particular topic. It is important for companies, investors, governments, and academics seeking to gauge innovation and assess risk. However, there is no broadly recognized best approach to landscaping. Frequently, patent landscaping is a bespoke human-driven process that relies heavily on complex queries over bibliographic patent databases. In this paper, we present Automated Patent Landscaping, an approach that jointly leverages human domain expertise, heuristics based on (...) class='Hi'>patent metadata, and machine learning to generate high-quality patent landscapes with minimal effort. In particular, this paper describes a flexible automated methodology to construct a patent landscape for a topic based on an initial seed set of patents. This approach takes human-selected seed patents that are representative of a topic, such as operating systems, and uses structure inherent in patent data such as references and class codes to “expand” the seed set to a set of “probably-related” patents and anti-seed “probably-unrelated” patents. The expanded set of patents is then pruned with a semi-supervised machine learning model trained on seed and anti-seed patents. This removes patents from the expanded set that are unrelated to the topic and ensures a comprehensive and accurate landscape. (shrink)

Meeting 5G high bandwidth rates, ultra-low latencies, and high reliabilities requires of network infrastructures that automatically increase/decrease the resources based on their customers’ demand. An autonomous and dynamic management of a 5G network infrastructure represents a challenge, as any solution must account for the radio access network, data plane traffic, wavelength allocation, network slicing, and network functions’ orchestration. Furthermore, federation among administrative domains (ADs) must be considered in the network management. Given the increased dynamicity of 5G networks, artificial intelligence/machine (...) learning (AI/ML) solutions are strong candidates able to learn, and take quick provisioning decisions upon fast changes in network conditions. Therefore, this chapter presents an analysis of the state-of-the-art solutions for 5G networks’ management, where AI/ML solutions are discussed and compared with traditional methods. Additionally, the chapter provides a technology overview of both standards, and existing solutions regarding the 5G network management, and directions toward the integration of AI/ML in 5G networks. (shrink)

With the mobility and ease of connection, wireless sensor networks have played a significant role in communication over the last few years, making them a significant data carrier across networks. Additional security, lower latency, and dependable standards and communication capability are required for future-generation systems such as millimeter-wave LANs, broadband wireless access schemes, and 5G/6G networks, among other things. Effectual congestion control is regarded as of the essential aspects of 5G/6G technology. It permits operators to run many network illustrations (...) on a single organization while maintaining higher service quality. A sophisticated decision-making system for arriving network traffic is necessary to confirm load balancing, limit network slice letdown, and supply alternative slices in slice letdown or congestion. Because of the massive amount of data being generated, artificial intelligence and machine learning play a vital role in reconfiguring and improving a 5G/6G wireless network. In this research work, a hybrid deep learning method is being applied to forecast optimal congestion improvement in the wireless sensors of 5G/6G IoT networks. This proposed model is applied to a training dataset to govern the congestion in a 5G/6G network. The proposed approach provided promising results, with 0.933 accuracy, and 0.067 miss rate. (shrink)

Biobanks represent an invaluable research tool and, as a result of their intrinsic and extrinsic nature, may be looked upon as archives or repositories largely made up of libraries, or collections of content where the content is the biological material derived from different individuals or species, representing valuable tangible assets. Biobanks analyses aspects of the commons and common intellectual property relating to the concepts of private property, not only concerning data but biological materials as well, and the advantages and (...) disadvantages of patents in scientific research. Several recent initiatives in biomedical research have attempted to make their data freely available to others, so as to foster innovation. Many of these initiatives have adopted the open source model, which has gained widespread recognition in the computer industry. This title is structured into eight chapters and begins with an introduction, which is followed by chapters that discuss how the term 'biobank' came about in scientific literature; legal matters relating to biobanks; and intellectual and physical property. Later chapters comprehensively analyse the intellectual property of biobanks within the sphere of copyright; biotechnological inventions and research patentability; open data sharing in biobanks; and biobanks as commons or vault. Considers biobanks as both repositories and as collections of tangible assets Argues that the data in biobanks represents a high value intangible asset Explores regulatory gaps exploited by the private sector. (shrink)

This study analyses the patenting activities of university science and engineering professors in Canada between 1920 and 1975. Unlike most studies on commercial activities in academia, which typically focus on the post-1980 period and on university practices, we focus on the pre-1980 period and on the individual decisions of professors to patent their inventions. Based on quantitative patent data, we show that patenting, and thus professors’ interest in the possible commercial value of their scientific discoveries made in (...) university laboratories, was relatively common on an individual and informal basis well before the 1980s and the advent of what is now called “academic capitalism”. This contradicts the belief that before that period, universities were a kind of ivory towers in which professors isolated themselves from external influences and engaged only in pure and disinterested research. (shrink)

Data exclusivity is a temporary exclusive user right on the clinical data that need to be submitted to the regulatory authorities to prove that a new drug is safe and effective. For the pharmaceutical industry, data exclusivity is an important addition to the patent system, as data exclusivity will de facto delay the market entry of generic drugs until after the exclusive user rights on the clinical data have expired. In order to assess the (...) normative legitimacy of the industry’s demand to include minimum standards for data exclusivity in international agreements, this chapter evaluates the three justifications that have frequently been advanced, depicting data exclusivity as an essential policy tool to promote innovation, a mechanism to prevent the generic industry from ‘free-riding,’ and a legal instrument to protect the industry’s property rights in clinical data. (shrink)

In this research, patent prosecution is conceptualized as a system of reinforcement learning from human feedback. The objective of the system is to increase the likelihood for a language model to generate patent claims that have a higher chance of being granted. To showcase the controllability of the language model, the system learns from granted patents and pre-grant applications with different rewards. The status of “granted” and “pre-grant” are perceived as labeled human feedback implicitly. In addition, specific to (...) patent drafting, the experiments in this research demonstrate the model’s capability to learn from adjusting claim length and inclusion of limiting terms for narrowing claim scope. As proof of concept, the experiments focus on claim ones only and the training data originates from a patent dataset tailored specifically for artificial intelligence. Although the available human feedback in patent prosecution are limited and the quality of generated patent text requires improvement, the experiments following the 3-stage reinforcement learning from human feedback have demonstrated that generative language models are capable of reflecting the human feedback or intent in patent prosecution. To enhance the usability of language models, the implementation in this research utilizes modern techniques that enable execution on a single consumer-grade GPU. The demonstrated proof of concept, which reduces hardware requirements, will prove valuable in the future as more human feedback in patent prosecution become available for broader use, either within patent offices or in the public domain. (shrink)

The gradual increase in the density of highway vehicles and traffic flow makes the abnormal driving state of vehicles an indispensable tool for assisting traffic dispatch. Intelligent transportation systems can detect and track vehicles in real time, acquire characteristics such as vehicle traffic, vehicle speed, vehicle flow density, and vehicle trajectory, and further perform advanced tasks such as vehicle trajectory. The detection of abnormal vehicle trajectory is an important content of vehicle trajectory understanding. And the development of the Internet of (...) Things and 5G technology has led to a continuous increase in the rate of data information circulation. The “Internet of Vehicles” generated based on the practice of 5G communication technology constitutes a vehicle abnormal trajectory detection system, which has very high feasibility and safety and stability. Therefore, this research is aimed at the needs of preventing major accidents and forensic analysis during highway vehicles. Based on the integration of the Internet of Things 5G communication technology, a trajectorial anomaly detection of highway vehicle trajectory based on the integration of the Internet of Things 5G is proposed. By accurately sensing unsafe events at the perception layer, network layer, and application layer, the vehicle driving trajectory state is divided into several simple semantic representations. The semantic representation is analyzed, and then the moving target detection and moving target tracking algorithms needed to extract the vehicle trajectory are introduced. Through video detection and tracking of moving vehicle targets, the driving trajectory of the vehicle is obtained, and the movement characteristics of the vehicle in each frame of image are extracted. According to the relationship between the trajectory of the vehicle and the lane line, the vehicle trajectory analysis is realized, and then it is judged whether the vehicle has abnormal trajectory. Compared with the traditional method of manually detecting the driving condition of the vehicle, the abnormal trajectory detection of the vehicle based on the integration of the Internet of Things and 5G can quickly detect the abnormal trajectory of the vehicle in the traffic monitoring video. (shrink)

Patent strategy is increasingly recognized as a vital contributor in promoting core competitiveness of an enterprise. A top management team has been indicated as one of the key factors driving changes in patent strategy. Based on upper echelons theory, this study examines how TMT characteristics, including, team diversity, emotional intelligence, and safety climate, influence enterprise patent strategic change and, hence, the business outcome. The data from 930 top managers in 228 enterprises showed that the changes in (...) patent strategies are significantly influenced by the characteristics of top managers. These aforementioned internal TMT factors have diverse effects on the speed and scope of the enterprise patent strategic change, which in turn affects firm performance in a positive and negative way, respectively. (shrink)

Explanations of productivity differences between men and women in science tend to focus on the academic sector and the individual level. This article examines how variation in organizational logic affects sex differences in scientists' commercial productivity, as measured by patenting. Using detailed data from a sample of academic and industrial life scientists working in the United States, the authors present multivariate regression models of scientific patenting. The data show that controlling for education- and career-history variables, women are less (...) likely to patent than men. However, in biotechnology firms—industrial settings characterized by flatter, more flexible, network-based organizational structures— women scientists are more likely to become patent-holding inventors than in more hierarchically arranged organizational settings in industry or academia. The authors discuss how the organization of scientists'work settings may influence enduring disparities between men and women in science and the implications of these findings for future work. (shrink)

The literature on the natural-resource-based view of firms has mostly focused on the positive relationship between financial performance and environmental innovation. The present study extends this research by addressing recent calls to identify the specific managerial approaches that affect a firm’s ability to financially benefit from an innovative environmental strategy. In particular, the focus is on how the selected international scope of patented environmental innovations affects a firms’ financial performance. The sample used included a 5-year data panel of 3,087 (...) environmental patent applications by the 79 Information and Communication Technology firms in the Financial Times Global 500 firms list. The findings indicate that the geographical scope of the exploitation of environmental patents increases the positive relationship between patented environmental innovation and financial performance whereas the geographical scope of knowledge sourcing of environmental patents does reduce this performance. (shrink)

This work introduces the framework for selecting architecture in 5G networks, considering various technological, performance, economic, and operational factors. With the emergence of 5G technology, the architecture selection process has become pivotal in meeting diverse requirements for ultra-high-speed connectivity, low latency, scalability, and diverse service demands. The evaluation comprehensively analyses different architecture options, including centralized, distributed, cloud-based, and virtualized architectures. Factors such as network performance, scalability, cost-effectiveness, security, and compatibility are considered within a multi-criteria decision-making framework. Findings reveal each architecture (...) option's diverse strengths and limitations, emphasizing the importance of aligning architectural choices with specific use cases, deployment scenarios, and business objectives. We used the concept of multi-criteria decision-making (MCDM) methodology to control the various criteria. We used the single-valued neutrosophic set (SVNS) to deal with vague and inconsistent data. The SVNS is integrated with the hyperSoft set. The proposed methodology uses a single-valued neutrosophic hyperSoft set (SVNHSS) to select the best 5G architecture. We used the VIKOR method as an MCDM method to rank the alternatives. The proposed framework provides stakeholders with a structured methodology to evaluate and prioritize architecture options, facilitating informed decision-making in the complex landscape of 5G network deployments. (shrink)

Intellectual property can be an important asset for academic institutions. Good data management practices are important for capture, development and protection of intellectual property assets. Selected issues focused on the relationship between data management and intellectual property are reviewed and a thesis that academic institutions and scientists should honor their obligations to responsibly manage data.

Is the market civilizing or destructive? The increased salience of science commercialization is forcing scientists to address this question. Benefiting from the sociology of morality literature’s increased attention to specific kinds of morality and engaging with economic sociology’s moral markets literature, we generate competing hypotheses about scientists’ value-driven attitudes toward patenting. The Civilizing Market thesis suggests scientists who prioritize universalism will tend to support patenting. The Destructive Market thesis, by contrast, suggests universalism will be correlated with opposition to patenting. We (...) analyze survey data from biologists and physicists nested within academic organizations, which are nested within the following regions: France, Hong Kong, India, Italy, Taiwan, Turkey, UK, and the USA. Employing multilevel analysis, we find correlational evidence to support the Destructive Market thesis. Universalism is associated with anti-patenting attitudes, suggesting scientists expect patenting to have deleterious effects on science and society. We end with a discussion of this article’s implications for the moral markets literature, sociology of morality and business ethics. (shrink)

In patent prosecution, timely and effective responses to Office Actions (OAs) are crucial for securing patents. However, past automation and artificial intelligence research have largely overlooked this aspect. To bridge this gap, our study introduces the Patent Office Action Response Intelligence System (PARIS) and its advanced version, the Large Language Model (LLM) Enhanced PARIS (LE-PARIS). These systems are designed to enhance the efficiency of patent attorneys in handling OA responses through collaboration with AI. The systems’ key features (...) include the construction of an OA Topics Database, development of Response Templates, and implementation of Recommender Systems and LLM-based Response Generation. To validate the effectiveness of the systems, we have employed a multi-paradigm analysis using the USPTO Office Action database and longitudinal data based on attorney interactions with our systems over six years. Through five studies, we have examined the constructiveness of OA topics (studies 1 and 2) using topic modeling and our proposed Delphi process, the efficacy of our proposed hybrid LLM-based recommender system tailored for OA responses (study 3), the quality of generated responses (study 4), and the systems’ practical value in real-world scenarios through user studies (study 5). The results indicate that both PARIS and LE-PARIS significantly achieve key metrics and have a positive impact on attorney performance. (shrink)

The very expertise with which psychologists wield their tools for achieving laboratory control may have had the unwelcome effect of blinding psychologists to the possibilities of discovering principles of behavior without conducting experiments. When creatively interrogated, a diverse range of large, real-world data sets provides powerful diagnostic tools for revealing principles of human judgment, perception, categorization, decision-making, language use, inference, problem solving, and representation. Examples of these data sets include patterns of website links, dictionaries, logs of group interactions, (...) collections of images and image tags, text corpora, history of financial transactions, trends in twitter tag usage and propagation, patents, consumer product sales, performance in high-stakes sporting events, dialect maps, and scientific citations. The goal of this issue is to present some exemplary case studies of mining naturally existing data sets to reveal important principles and phenomena in cognitive science, and to discuss some of the underlying issues involved with conducting traditional experiments, analyses of naturally occurring data, computational modeling, and the synthesis of all three methods. (shrink)

Since the adoption of the WTO-TRIPS Agreement in 1994, there has been significant controversy over the impact of pharmaceutical patent protection on the access to medicines in the developing world. In addition to the market exclusivity provided by patents, the pharmaceutical industry has also sought to further extend their monopolies by advocating the need for additional ‘regulatory’ protection for new medicines, known as data exclusivity. Data exclusivity limits the use of clinical trial data that need to (...) be submitted to the regulatory authorities before a new drug can enter the market. For a specified period, generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originator's data. As a consequence, data exclusivity lengthens the monopoly for the original drug, impairing the availability of generic drugs. This article illustrates how the pharmaceutical industry has convinced the US and the EU to impose data exclusivity on their trade partners, many of them developing countries. The key arguments formulated by the pharmaceutical industry in favor of adopting data exclusivity and their underlying ethical assumptions are described in this article, analyzed, and found to be unconvincing. Contrary to industry's arguments, it is unlikely that data exclusivity will promote innovation, especially in developing countries. Moreover, the industry's appeal to a property rights claim over clinical test data and the idea that data exclusivity can prevent the generic competitors from ‘free-riding’ encounters some important problems: Neither legitimize excluding all others. (shrink)

The extension of intellectual property rights into the realm of biology has emerged as an increasing focus of controversy in relation to science,2 biodiversity,3 agriculture,4 health,5 development,6 human rights7 and trade.8 This paper presents the results of a review of international trends in activity for patent protection between 1990-2000 and provisional data to 2004 and 2005 from over 70 national patent offices, four regional patent offices and the World Intellectual Property Organisation using the European Patent (...) Office esp@cenet worldwide database.9 The review employed patent publication counts as an indicator of activity for traditional medicines, pharmaceuticals, agriculture, and biotechnology. The research provides insights into the internationalisation of patent activity in multiple areas of biology. The review emphasises the need to combine the further development of quantitative methods with qualitative analysis of the implications of international patent activity in relation to biological and genetic material for science, society and policy. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and (...) informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

This paper informally summarizes a two-day symposium held at the U.S. National Academy of Sciences in Washington, D.C., September 5–6, 2002. The issue was to what extent the progress of science and societal capacity for continued technological innovation are threatened by excessive protection of intellectual property. Excessive protection creates disadvantages not only for scientists and inventors but also for educators/students and for librarians/clientele. Speakers from a variety of disciplines and institutions agreed unanimously that scientific and technological progress is, indeed, under (...) serious threat. Various opinions were expressed about the degree of threat, currently and prospectively, as well as what counter-measures are best suited to resist undue restrictions on creative uses of scientific and technical data and information. This summary is based entirely on the author’s notes from the symposium, and the commentary offered is his alone. My apologies to the speakers if this paper does not accurately reflect the primary intent of their presentations. The “Suggested Readings” offered at the end are not specific to the speakers’ statements but rather are offered as a general resource to aid further research. The definitive record of the symposium is planned to be available from the National Academies Press as a Proceedings publication in the summer of 2003. (shrink)

The Bermuda Principles for DNA sequence data sharing are an enduring legacy of the Human Genome Project. They were adopted by the HGP at a strategy meeting in Bermuda in February of 1996 and implemented in formal policies by early 1998, mandating daily release of HGP-funded DNA sequences into the public domain. The idea of daily sharing, we argue, emanated directly from strategies for large, goal-directed molecular biology projects first tested within the “community” of C. elegans researchers, and were (...) introduced and defended for the HGP by the nematode biologists John Sulston and Robert Waterston. In the C. elegans community, and subsequently in the HGP, daily sharing served the pragmatic goals of quality control and project coordination. Yet in the HGP human genome, we also argue, the Bermuda Principles addressed concerns about gene patents impeding scientific advancement, and were aspirational and flexible in implementation and justification. They endured as an archetype for how rapid data sharing could be realized and rationalized, and permitted adaptation to the needs of various scientific communities. Yet in addition to the support of Sulston and Waterston, their adoption also depended on the clout of administrators at the US National Institutes of Health and the UK nonprofit charity the Wellcome Trust, which together funded 90% of the HGP human sequencing effort. The other nations wishing to remain in the HGP consortium had to accommodate to the Bermuda Principles, requiring exceptions from incompatible existing or pending data access policies for publicly funded research in Germany, Japan, and France. We begin this story in 1963, with the biologist Sydney Brenner’s proposal for a nematode research program at the Laboratory of Molecular Biology at the University of Cambridge. We continue through 2003, with the completion of the HGP human reference genome, and conclude with observations about policy and the historiography of molecular biology. (shrink)

Life on earth is bound together by a common heritage, centered around a molecule that is present in almost every living cell of every living creature. Deoxyribonucleic acid (DNA), composed of four base pairs, the nucleic acids thymine, adenine, cytosine, and guanine, encodes the data that directs, in conjunction with the environment, the development and metabolism of all nondependent living creatures. Except for some viruses that rely only on ribonucleic acid (RNA), all living things are built by the interaction (...) of DNA and RNA within cells and their environments. There is no worldwide consensus yet as to whether portions of the human genome should be granted intellectual property protection, as indeed they are in the United States and a number of other nations. DNA posed numerous challenges to the legal framework for patent protection and may suggest developing an entirely new social and legal category recognizing its uniqueness. (shrink)

This paper argues that regulatory agencies have a responsibility to further the public interest when they determine the conditions under which new technological products may be commercialized. As a case study, this paper analyzes the US 9th Circuit Court’s ruling on the efforts of the US Environmental Protection Agency to regulate an herbicide meant for use with seed that are genetically modified to be tolerant of the chemical. Using that case, it is argued that when regulatory agencies evaluate new technological (...) products, they have an obligation to draw on data, analyses, and evaluations from a variety of credible epistemic sources, and not rely solely or even primarily on the technology developer. Otherwise, they create conditions for their own domination and that of the polity by the technology developer. Moreover, in the interest of advancing the public interest, regulatory agencies must evaluate new technologies in a substantively and procedurally unbiased manner. (shrink)

Key activities in biomedicine and related research rely on collections of biological samples and related files. Access to such resources in industry and in academic contexts has become strategic and represents a central issue in the general framework of rising patenting practices and in debates about the knowledge economy. It raises important issues concerning the organisation of scientific and medical work, the outline of data-sharing guidelines, and science policy's contribution to the elaboration of an adapted framework. This paper presents (...) an ethnographic study of three French human biobanks. Building on field work (participant observation and in-depth interviews), the study focuses on data access in the concrete practices in biobanks. The paper develops a perspective based on an analysis of different exchange regimes. We argue that access practices are submitted to the different regimes that can coexist and be articulated within the daily activities of each biobank. We also discuss how this perspective can further our understanding of biomedical research, and how it might inform data access policy. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and (...) informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

This paper is the result of the research I undertook at Lancaster University with a Marie Curie Fellowship during the academic years 2000‐2002. The objective of this research was to study the limits and the challenges of the analogy between molecular geneticists’ work and hackers’ activities. By focusing on this analogy I aim to explore the different ethical and philosophical issues surrounding new genetics and its IPR regulations. The paper firstly will show the philosophical background lying behind the proposed analogy (...) and analyses the sense in which we can talk of geneticists as “hackers.” It will provide grounds for the analogy by exploring some of the techniques used by geneticists; in particular it will focus on the so‐called Shotgun method for genomic sequencing. After having provided reasons for the proposed analogy I will claim that the open source philosophy used in the computer field would be a good way to regulate research in the genetics and in pharmaceutical field too. The open source philosophy would provide fair distribution of research opportunities around the globe with the shift from patenting to copyright in sensitive fields such as genetics. (shrink)

The properties of DNA -- DNA as universal property -- DNA as intellectual property -- DNA as national property -- DNA as personal property -- DNA as academic property -- DNA as taxable propety.

The article is dedicated to the history of developing highly effective catalysts in the leading scientific institutions of Ukraine and explores the prerequisites for developing theories in physical chemistry, in particular those related to kinetics and catalysis. It highlights the significance of scientific discoveries at the turn of the 19th and 20th century and their application by native scientists to advance theoretical development in the field of chemistry. Special attention is paid to the works of Lev Pisarzhevskii, focusing on his (...) advancements in electronic chemistry and, in particular, the electronic theory of catalysis. The article also outlines current challenges in creating highly efficient catalysts for the chemical and light industry, emphasizing the importance of such indicators of catalysts as activity and selectivity. Drawing on historical, scientific and patent data, the study investigates the process of creating a highly efficient catalyst for obtaining acrylic acid from acrolein. This catalyst holds a great ractical importance for the production of various polymers in industrial conditions. It is shown that, as a result of research conducted by native scientists of the Institute of Physical Chemistry of the Academy of Sciences of the Ukrainian SSR and the Chemistry Department of Kyiv State University, the catalyst K-2-5 was developed. The catalyst has good indicators for the industrial production of acrylic acid from acrolein. The authors also highlight works studying the properties of the obtained catalyst, specifically its porous structure, which is an important factor in catalytic processes. They extensively focus on the kinetic indicators of catalytic reactions that occur when using this catalyst. The article also emphasizes the relevance of these developments for advancing research in catalysis and chemical industrial production. (shrink)

Science maps are visual representations of the structure and dynamics of scholarly knowl­edge. They aim to show how fields, disciplines, journals, scientists, publications, and scientific terms relate to each other. Science mapping is the body of methods and techniques that have been developed for generating science maps. This entry is an introduction to science maps and science mapping. It focuses on the conceptual, theoretical, and methodological issues of science mapping, rather than on the mathematical formulation of science mapping techniques. After (...) a brief history of science mapping, we describe the general procedure for building a science map, presenting the data sources and the methods to select, clean, and pre-process the data. Next, we examine in detail how the most common types of science maps, namely the citation-based and the term-based, are generated. Both are based on networks: the former on the network of publications connected by citations, the latter on the network of terms co-occurring in publications. We review the rationale behind these mapping approaches, as well as the techniques and methods to build the maps. We also present less-common types of science maps, including co-authorship networks, interlocking editorship networks, maps based on patents’ data, and geographic maps of science. Moreover, we consider how time can be represented in science maps to investigate the dynamics of science. We also discuss some epistemological and sociological topics that can help in the interpretation, contextualization, and assessment of science maps. Then, we present some possible applications of science maps in science policy. In the conclusion, we point out why science mapping may be interesting for all the branches of meta-science, from knowl­edge organization to epistemology. (shrink)

Les informaticiens, qui sont les premiers à avoir travaillé à la conception du libre accès, ne s’en sont pas nécessairement saisis pour leurs propres pratiques de publication scientifique, privilégiant longtemps les échanges interindividuels. La question de l’accès ouvert se pose pour leurs productions de manière différente selon qu’il s’agit de conception de logiciels ou de publication de texte, de recherche industrielle ou publique, de secteurs brevetables, de données ouvertes ou non.Computer scientists, who were the first to work on open access (...) design, have not necessarily been its most fervent users in their own scientific publication practice, since they have long given preference to interpersonal exchanges. Concerning their output, the question of open access arises in different terms, depending on whether the context is software design, text publishing, industrial public research, patentable sectors, or open or restricted access data. (shrink)

There are a number of ways one could criticize the practice of patenting genes. This chapter argues that computer‐mediated expressions have revealed the false dichotomy in the law of intellectual property and that as new technologies emerge they will continue to pose problems for courts and innovators alike. This is because the range and nature of our expressions is increased with new technologies like computers, nanotechnology, and biotech. Genetic engineering and nanotechnology undermine the distinction between “clearly” patentable inventions and copyrightable (...) works of authorship. Persons carry obligations, rights, moral duties, and are the objects of almost all our ethical and legal considerations. Health care in general has improved to enable us to make more careful predictions about risks and to make choices with greater information. Useful scientific data have emerged from the various “mapping” projects seeking to reveal the intricacies of genomes and phenotypes. (shrink)

Key ethical issues arise in association with the conduct of stem cell research by research institutions in the United States. These ethical issues, summarized in detail, receive no adequate translation into federal laws or regulations, also described in this article. U.S. Federal policy takes a passive approach to these ethical issues, translating them simply into limitations on taxpayer funding, and foregoes scientific and ethical leadership while protecting intellectual property interests through a laissez faire approach to stem cell patents and licenses. (...) Those patents and licenses, far from being scientifically and ethically neutral in effect, virtually prohibit commercially sponsored research that could otherwise be a realistic alternative to the federal funding gap. The lack of federal funding and related data-sharing principles, combined with the effect of U.S. patent policy, the lack of key agency guidance, and the proliferation of divergent state laws arising from the lack of Federal leadership, significantly impede ethical stem cell research in the United States, without coherently supporting any consensus ethical vision. Research institutions must themselves implement steps, described in the article, to integrate addressing ethical review with the many legal compliance issues U.S. federal and state laws create. (shrink)

There is growing interest for a communitarian approach to the governance of genomics, and for such governance to be grounded in principles of justice, equity and solidarity. However, there is a near absence of conceptual studies on how communitarian-based principles, or values, may inform, support or guide the governance of genomics research. Given that solidarity is a key principle in Ubuntu, an African communitarian ethic and theory of justice, there is emerging interest about the extent to which Ubuntu could offer (...) guidance for the governance of genomics research in Africa. To this effect, we undertook a conceptual analysis of Ubuntu with the goal of identifying principles that could inform equity-oriented governance of genomics research. Solidarity, reciprocity, open sharing, accountability, mutual trust, deliberative decision-making and inclusivity were identified as core principles that speak directly to the different macro-level ethical issues in genomics research in Africa such as: the exploitation of study populations and African researchers, equitable access and use of genomics data, benefit sharing, the possibility of genomics to widen global health inequities and the fair distribution of resources such as intellectual property and patents. We use the identified the principles to develop ethical guidance for genomics governance in Africa. (shrink)

In the Twentieth Century, Logic and Philosophy of Language are two of the few areas of philosophy in which philosophers made indisputable progress. For example, even now many of the foremost living ethicists present their theories as somewhat more explicit versions of the ideas of Kant, Mill, or Aristotle. In contrast, it would be patently absurd for a contemporary philosopher of language or logician to think of herself as working in the shadow of any figure who died before the Twentieth (...) Century began. Advances in these disciplines make even the most unaccomplished of its practitioners vastly more sophisticated than Kant. There were previous periods in which the problems of language and logic were studied extensively (e.g. the medieval period). But from the perspective of the progress made in the last 120 years, previous work is at most a source of interesting data or occasional insight. All systematic theorizing about content that meets contemporary standards of rigor has been done subsequently. (shrink)

This article identifies the dominant public narrative of AIDS in Malawi through an analysis of qualitative interview data and policy and intervention materials. The public narrative creates distinctions between “risky” and “healthy” sex that organize HIV prevention efforts around moral categories, rather than relative risk. These distinctions oppose images of backward, ignorant villagers to the protective power of “love matches”. The analysis demonstrates that the public narrative and corresponding prevention efforts only make sense in connection with the patently false (...) assumption that love, heterosexuality, and modernity effectively protect individuals from HIV. This research brings to light the unspoken assumptions of modernity in the “charmed circle” of heteronormativity, as well as the need to consider the workings of heteronormativity in studies of modernization and globalization. Furthermore, it highlights individualistic and oversimplified analytic models currently directing HIV prevention efforts and points to potentially more effective strategies. (shrink)

At first glance twentieth-century philosophy of science seems virtually to ignore chemistry. However this paper argues that a focus on chemistry helped shape the French philosophical reflections about the aims and foundations of scientific methods. Despite patent philosophical disagreements between Duhem, Meyerson, Metzger and Bachelard it is possible to identify the continuity of a tradition that is rooted in their common interest for chemistry. Two distinctive features of the French tradition originated in the attention to what was going on (...) in chemistry.French philosophers of science, in stark contrast with analytic philosophers, considered history of science as the necessary basis for understanding how the human intellect or the scientific spirit tries to grasp the world. This constant reference to historical data was prompted by a fierce controversy about the chemical revolution, which brought the issue of the nature of scientific changes centre stage.A second striking—albeit largely unnoticed—feature of the French tradition is that matter theories are a favourite subject with which to characterize the ways of science. Duhem, Meyerson, Metzger and Bachelard developed most of their views about the methods and aims of science through a discussion of matter theories. Just as the concern with history was prompted by a controversy between chemists, the focus on matter was triggered by a scientific controversy about atomism in the late nineteenth-century.Keywords: France; Epistemology; Chemistry; Revolution; Atomism; Realism. (shrink)

Timely effective regulation of genetic advances presents a challenge for justice systems. We used a 51-item battery to examine views on major genetics-related issues of those at the forefront of regulating this area – Supreme Court judges (N = 73). We also compared their views with those of other justice stakeholders (N = 210) from the same country (Romania). Judges showed greater endorsement and less variability in views on the use of genetic data and technologies than the other groups. (...) The agreement among the judges was strikingly strong for some controversial issues, including gene editing; patenting of genetic findings; and the State using genetic information for crime prevention. Judges and other lawyers recognized the need for amending the relevant laws. Without appropriate regulation, genetic science has a risk of propelling inequality rather than fulfilling its promise to improve people’s lives. (shrink)

As new energy vehicle is the future of automobile development, it is of great significance to dig deeper into the technical topics and development trends of new energy vehicles for accurately understanding the technical trends of the new energy vehicle industry, grasping development opportunities, and scientifically formulating strategic plans. This paper takes the patent texts in the field of new energy vehicles from 2000 to 2020 in the patent database of CNKI as the data source, identifies 25 (...) technical topics implied in the patent texts by using the LDA topic model, analyzes the evolution trend of the 25 technical topics in terms of importance and popularity, and predicts the popularity and development trend of each technical topic in new energy vehicles from 2021 to 2025 by constructing the ARIMA model. The popularity and development trend of each technology topic of new energy vehicles in China from 2021 to 2025 are predicted by constructing ARIMA model. Drawing on quantitative evidence, the study found that there are top five technical topics in terms of importance in this field, namely, Topic 8, Topic 5, Topic 14, Topic 9, and Topic 15. From 2014 to 2020, the importances of Topic 5, Topic 8, Topic 6, Topic 9, and Topic 15 are gradually rising. In terms of popularity of technical topics, from 2014 to 2020, the first to fifth topics are Topic 20, Topic 8, Topic 3, Topic 15, and Topic 10. Based on the prediction of ARIMA model, it is found that the popularity of these five technical topics is steadily increasing from 2021 to 2025, among which the popularity of Topic 20 will increase from 63.58 to 113.07, the largest increase in popularity among all technical topics. The paper provides implications for countries dedicated to developing the new energy vehicle industry. (shrink)

Applying the Roman Catholic Church's set of moral principles on social concerns called Catholic social teaching (CST) on charity, distributive justice, private property and the common good, and utilising some secondary data and scientific literature, this article argues that establishing distributive justice for the global distribution of the COVID-19 vaccines must be a priority than donating millions of doses in the name of charity to address vaccine scarcity. Catholic social teaching teaches that the right to private property is a (...) basic right but has moral limits and is subordinated to the moral principles on the universal destination of earth's goods and the common good. CONTRIBUTION: The current COVID-19 vaccines are developed by people and organisations outside the pharmaceutical companies and largely funded using taxpayers' money. Thus, by virtue of justice, these vaccines must belong to all nations as global public health goods. Patents are to be suspended to allow poor countries to reproduce the popular vaccines and address the current vaccine shortage. (shrink)

Iot is a system of interconnected devices which are able to transfer data to and fro without the human-to-human interaction but over through other devices. IoT is now used for various purposes ranging from smart homes for controlling smart devices within the home, smart cities in which all the network devices operate synchronously, autonomous vehicles which is still a work in progress. With the advent of 5g comes the improvement in transmission rate, the number of devices available in square (...) kilometer and the elimination of congestion. The topic in discussion is reducing the food wastage in Australia by leveraging IoT. A large number of techniques are used to accomplish the said task such as qualitative analysis, inductive design and production data. The challenge is to maintain the freshness of the food by detecting the decay early on and warning the supplier when the food must be replaced thereby decreasing the wastage of food. The IoT devices requires to monitor the food, detect and alert the supplier when the food must be replaced. In this way the quality of the food can be supervised and reduce the wastage of the food. (shrink)

In a Special Issue of Discourse Studies titled ‘The Epistemics of Epistemics’, contributing authors criticize Heritage’s research on participants’ orientations to, and management of, the distribution of knowledge in conversation. These authors claim that the analytic framework Heritage developed for analyzing epistemic phenomena privileges the analysts’ over the participants’ point of view, and rejects standard methods of conversation analysis ; that and are adopted in developing and defending the use of abstract analytic schemata that offer little purchase on either the (...) specific actions speakers accomplish or the understanding others display of them; and that, by virtue of these deficiencies, claims about the systematic relevance of epistemic phenomena for talk-in-interaction breach long-standing norms regarding the relationship between data analysis and generalizing claims. Using a collection of excerpts bearing on the import of epistemics for action formation and action sequencing, I demonstrate that these claims are patently false and suggest that they reflect the authors’ effort to recast CA as a kind of fundamentalist enterprise. I then consider excerpts from a second collection to illustrate how the form of social organization described by Heritage can be used to explicate other phenomena that depend on systematic alterations to its basic features. In conclusion, I suggest that CA’s success in enhancing our grasp of the organization of talk-in-interaction derives from its unique commitment to both generalization and context specificity, collections and single cases, findings plus a continual openness to the ‘something more’ that each particular case can provide. (shrink)