The development of an information society and information technologies does not result in positive consequences only. Individuals with criminal intent also find their niche. Information security includes the creation of the input, processing and output processes of protection. The objective of information security is to protect the system of values, to protect and ensure accuracy and integrity and to minimize losses that may be incurred if the information is modified or destroyed. In the development of an information society, the new (...) visible changes in the legislation for the classification of crimes–crimes against computers–altered the concept of electronic crime data and information system security concepts. This article presents a brief analysis on the concept of the change of crimes against security of electronic data and information systems, the legislation analysis, the crimes against security of electronic data systems and information dynamics and its relationship with business factors. (shrink)

BackgroundUse of routinely collected patient data for research and service planning is an explicit policy of the UK National Health Service and UK government. Much clinical information is recorded in free-text letters, reports and notes. These text data are generally lost to research, due to the increased privacy risk compared with structured data. We conducted a citizens’ jury which asked members of the public whether their medical free-text data should be shared for research for public benefit, (...) to inform an ethical policy.MethodsEighteen citizens took part over 3 days. Jurors heard a range of expert presentations as well as arguments for and against sharing free text, and then questioned presenters and deliberated together. They answered a questionnaire on whether and how free text should be shared for research, gave reasons for and against sharing and suggestions for alleviating their concerns.ResultsJurors were in favour of sharing medical data and agreed this would benefit health research, but were more cautious about sharing free-text than structured data. They preferred processing of free text where a computer extracted information at scale. Their concerns were lack of transparency in uses of data, and privacy risks. They suggested keeping patients informed about uses of their data, and giving clear pathways to opt out of data sharing.ConclusionsInformed citizens suggested a transparent culture of research for the public benefit, and continuous improvement of technology to protect patient privacy, to mitigate their concerns regarding privacy risks of using patient text data. (shrink)

BackgroundElectronic cigarettes as substitute devices for regular tobacco cigarettes have been increasing in recent times. We investigated neuronal substrates of vaping e-cigs and smoking r-cigs from r-cig smokers.MethodsTwenty-two r-cig smokers made two visits following overnight smoking cessation. Functional magnetic resonance imaging data were acquired while participants watched smoking images. Participants were then allowed to smoke either an e-cig or r-cig until satiated and fMRI data were acquired. Their craving levels and performance on the Montreal Imaging Stress Task and (...) a 3-back alphabet/digit recognition task were obtained and analyzed using two-way repeated-measures analysis of variance. Regions-of-interest were identified by comparing the abstained and satiated conditions. Neuronal activation within ROIs was regressed on the craving and behavioral data separately.ResultsCraving was more substantially reduced by smoking r-cigs than by vaping e-cigs. The response time for the 3-back task was significantly shorter following smoking r-cigs than following vaping e-cigs = 5.3, p = 0.035). Neuronal activations of the right vermis, right caudate, and right superior frontal gyrus were significantly correlated with the RT for the 3-back task only for smoking r-cigs.ConclusionOur findings suggest that insufficient satiety from vaping e-cigs for r-cigs smokers may be insignificant effect on working memory function. (shrink)

This chapter addresses the morality of two types of national security electronic surveillance (SIGINT) programs: the analysis of communication “metadata” and dragnet searches for keywords in electronic communication. The chapter develops a standard for assessing coercive government action based on respect for the autonomy of inhabitants of liberal states and argues that both types of SIGINT can potentially meet this standard. That said, the collection of metadata creates opportunities for abuse of power, and so judgments about the trustworthiness (...) and competence of the government engaging in the collection must be made in order to decide whether metadata collection is justified in a particular state. Further, the moral standard proposed has a reflexive element justifying adversary states’ intelligence collection against one another. Therefore, high-tech forms of SIGINT can only be justified at the cost of justifying cruder versions of signals intelligence collection practiced by a state’s less-advanced adversaries. (shrink)

Big data, big impact -- Values and actions -- Current practices -- Aligning values and actions.

Electronic machinic phenomena yield fascinating links with biological processes. Either in the macro-micro-structure of binary encoded information ‐ bytes on media ‐ to the processual flow programs execute on hardware while operating it. Observing micro-electronic worlds akin to living entities: electronic voltages running throughout electronic architectures pipelining data to memory registers; operating systems executing programs on electronic substrates; data flows taking place in machines and in communications protocols within networks. Static art-sci constructs explore (...) and visualize these observations as 2D drawings (Neon Paleolitikos Drawings, 2017‐present) or 3D sculptures (Binary and Biological Sculpture Series, 2018‐present), creatively exposing their inherent rhythmic organization of information, while dynamic installations (Phoenix.Wolfanddotcom.info, Wolfanddotcom, Half-Plant, 2017, Ant Ennae Labyrinths, 2019‐present) propose immersive interference mechanisms that attempt user entanglement in non-human environments. Seven aesthetic case examples are introduced and explored, observing and seeking resonances between micro-granular electronic, biological and hybrid data as source synthesis. This research proposes a look at bio-electronic aggregates on Neon Paleolitikos strata. After the Anthropocene, Neon Paleolitikos is an imaginary epoch dating since the decline of mankind until the zenith of bio-electronic life forms: operational symbioses combined among ruins of silica, transistors, algorithms, cells, plants, animals and electricity. (shrink)

Privacy, Due process and the Computational Turn: The Philosophy of Law Meets the Philosophy of Technology engages with the rapidly developing computational aspects of our world including data mining, behavioural advertising, iGovernment, profiling for intelligence, customer relationship management, smart search engines, personalized news feeds, and so on in order to consider their implications for the assumptions on which our legal framework has been built. The contributions to this volume focus on the issue of privacy, which is often equated with (...) data privacy and data security, location privacy, anonymity, pseudonymity, unobservability, and unlinkability. Here, however, the extent to which predictive and other types of data analytics operate in ways that may or may not violate privacy is rigorously taken up, both technologically and legally, in order to open up new possibilities for considering, and contesting, how we are increasingly being correlated and categorizedin relationship with due process – the right to contest how the profiling systems are categorizing and deciding about us. (shrink)

BackgroundThe research shows a growing trend in using an electronic platform to supplement or replace traditional paper-based informed consent processes. Instead of the traditionally written informed consent document, electronic informed consent may be used to assess the research subject’s comprehension of the information presented. By doing so, respect for persons as one of the research ethical principles can be upheld. Furthermore, these electronic methods may reduce potential airborne infection exposures, particularly during the pandemic, thereby adhering to the (...) beneficence and nonmaleficence principle. This scoping review aims to identify the ethics related criteria that have been included in electronic informed consent processes and to synthesize and map these criteria to research ethics principles, in order to identify the gaps, if any, in current electronic informed consent processes.MethodsThe search was performed based on internet search and three main databases: PubMed, SCOPUS and EBSCO. PRISMA Extension for Scoping Reviews : Checklist and Explanation guideline was used to report this work.ResultsOf 34 studies that met the inclusion criteria, 242 essential original constructs were collated, and 7 concepts were derived. Digital content showed the highest percentage of collated original constructs followed by accessibility, comprehension engagement, autonomy, confidentiality, language, and parental consent. Twenty-five new items were synthesized for eConsent criteria which may provide guidance for ethical review of research involving eConsent.ConclusionThe current study adds significant value to the corpus of knowledge in research ethics by providing ethical criteria on electronic informed consent based on evidence-based data. The new synthesized items in the criteria can be readily used as an initial guide by the IRB/rec members during a review process on electronic informed consent and useful to the future preparation of a checklist. (shrink)

Increasing adoption of electronic health records in hospitals provides new opportunities for patient data to support public health advances. Such learning healthcare models have generated ethical debate in high-income countries, including on the role of patient and public consent and engagement. Increasing use of electronic health records in low-middle income countries offers important potential to fast-track healthcare improvements in these settings, where a disproportionate burden of global morbidity occurs. Core ethical issues have been raised around the role (...) and form of information sharing processes for learning healthcare systems, including individual consent and individual and public general notification processes, but little research has focused on this perspective in low-middle income countries. We conducted a qualitative study on the role of information sharing and governance processes for inpatient data re-use, using in-depth interviews with 34 health stakeholders at two public hospitals on the Kenyan coast, including health managers, providers and researchers. Data were collected between March and July 2016 and analysed using a framework approach, with Nvivo 10 software to support data management. Most forms of clinical data re-use were seen as an important public health good. Individual consent and general notification processes were often argued as important, but contingent on interrelated influences of the type of data, use and secondary user. Underlying concerns were linked to issues of patient privacy and autonomy; perceived risks to trust in health systems; and fairness in how data would be used, particularly for non-public sector re-users. Support for engagement often turned on the anticipated outcomes of information-sharing processes, as building or undermining trust in healthcare systems. As reported in high income countries, learning healthcare systems in low-middle counties may generate a core ethical tension between supporting a public good and respecting patient autonomy and privacy, with the maintenance of public trust acting as a core requirement. While more evidence is needed on patient and public perspectives on learning healthcare activities, greater collaboration between public health and research governance systems is likely to support the development of efficient and locally responsive learning healthcare activities in LMICs. (shrink)

PurposeWithin a larger mandate of reviewing the key global trends concerning consumer protection in the electronic commerce (e-commerce) literature, this study aims to study the legal framework concerning e-commerce and consumer protection in the Sultanate of Oman and to analyse the current regulations concerning e-commerce and consumer protection.Design/methodology/approachThis study followed the normative legal research approach and resorted to the desk research process to facilitate content analysis of literature containing consumer protection legislation and regulatory provisions in Oman in particular and (...) the rest of the world in general.FindingsThe study reveals that consumer protection initiatives in Oman are well entrenched for offline transactions, but are relatively new and limited for e-commerce. In spite of the promulgation of consumer protection laws, electronic transaction law and cybercrime law, consumer protection measures for e-commerce in Oman do not address a large number of the global concerns necessary to build consumer confidence and trust in the online environment.Research limitations/implicationsThere is a dearth of information concerning Oman on this topic in the extant literature. The research also witnessed the lack of empirical data on the issue of consumer protection and e-commerce in Oman that offer a detailed database of consumer complaints and associated outcomes.Practical implicationsThe mechanism of consumer protection in electronic transactions is not robust in many countries. Because of the lack of comprehensive and robust legislation, consumers remain vulnerable in the online contractual purchase process. Moving beyond the fragmented legislation, many countries are currently mulling an all-comprehensive e-commerce law, implications of this paper will help the policymakers in identifying the focus areas.Social implicationsConsumer protection is a burning global issue in this era of consumerism. It is important to build consumer trust, transparency and integrity of transactions to reduce the risk and uncertainties of purchase.Originality/valueConsumer protection studies conducted in the context of Oman, hitherto, deal more with data protection and dispute resolution mechanisms, and less with legal provisions, regulations and consumer confidence. The study shares newer insights based on a systematic review of legal and business databases. It is the first study of its kind in the context of Oman and the Middle East in general. (shrink)

Proliferation of data processing and data storage devices in the Internet of Things poses significant privacy risks. At the same time, faster and faster use-cycles and obsolescence of devices with electronic components causes environmental problems. Some of the solutions to the environmental challenges of e-waste include mandatory recycling schemes as well as informal second hand markets. However, the data security and privacy implications of these green policies are as yet badly understood. This paper argues that based (...) on the experience with second hand markets in desktop computers, it is very likely that data that was legitimately collected under the household exception of the Data Protection Directive will “leak” into public spheres. Operators of large recycling schemes may find themselves inadvertently and unknowingly to be data controller for the purpose of Data Protection law, private resale of electronic devices can expose the prior owner to significant privacy risks. (shrink)

Ethics should guide the design of electronic health records (EHR), and recognized principles of bioethics can play an important role. This approach was adopted recently by a team of informaticists designing and testing a system where patients exert granular control over who views their personal health information. While this method of building ethics in from the start of the design process has significant benefits, questions remain about how useful the application of bioethics principles can be in this process, especially (...) when principles conflict. For instance, while the ethical principle of respect for autonomy supports a robust system of granular control, the principles of beneficence and non-maleficence counsel restraint due to the danger of patients being harmed by restrictions on provider access to data. Conflict between principles has long been recognized by ethicists and has even motivated attacks on approaches that state and apply principles. In this paper we show how using ethical principles can help in the design of EHRs by first, explaining how ethical principles can and should be used generally, and then by, discuss how attention to details in specific cases can show that the tension between principles is not as bad as it initially appeared. We conclude by suggesting further ways in which the application of these (and other) principles can add value to the ongoing discussion of patient involvement in their health care. This is a new approach to linking principles to informatics design that we expect will stimulate further interest. (shrink)

The analysis of data from electronic health records aspires to facilitate healthcare efficiencies and biomedical innovation. There are also ethical, legal and social implications from the handling of sensitive patient information. The paper explores the concerns, expectations and implications of the National Health Service England care.data programme: a national data sharing initiative of linked electronic health records for healthcare and other research purposes. Using Nissenbaum’s contextual integrity of privacy framework through a critical Science and Technology (...) Studies lens, it examines the way technologies and policies are developed to promote sustainability, governance and economic growth as the de facto social values, while reducing privacy to an individualistic preference. The state, acting as a new, central data broker reappropriates public ownership rights and establishes those information flows and transmission principles that facilitate the assetisation of NHS datasets for the knowledge economy. Various actors and processes from other contexts attempt to erode the public healthcare sector and privilege new information recipients. However, such data sharing initiatives in healthcare will be resisted if we continue to focus only on the monetary and scientific values of these datasets and keep ignoring their equally important social and ethical values. (shrink)

Currently, most studies are moving towards Big Data Analytics because they are important in research, and this is becoming increasingly important as Internet and Web 2.0 technologies become increasingly popular and how to handle this massive data. Moreover, this proliferation of the Internet and social media has revolutionized the search process. With this Big Data of data generated by users using social media or electronic platforms, the use of these details and daily activities is integrated (...) with tools designed for analysis. The topic of analyzing big social media will be discussed and an intensive explanation will be given to the topic of Big Data. This paper compares Big Data analysis techniques using several methods of analysis, the first technique using neural networks and the second technique using data clustering. The purpose of this study is to infer the ages that use social media and what are their interests in writing and in the end, who are the most widely used social media males or females. (shrink)

Because of difficulty processing the electronic medical record data of patients with cerebrovascular disease, there is little mature recognition technology capable of identifying the named entity of cerebrovascular disease. Excellent research results have been achieved in the field of named entity recognition, but there are several problems in the pre processing of Chinese named entities that have multiple meanings, of which neglecting the combination of contextual information is one. Therefore, to extract five categories of key entity information for (...) diseases, symptoms, body parts, medical examinations, and treatment in electronic medical records, this paper proposes the use of a BERT-BiGRU-CRF named entity recognition method, which is applied to the field of cerebrovascular diseases. The BERT layer first converts the electronic medical record text into a low-dimensional vector, then uses this vector as the input to the BiGRU layer to capture contextual features, and finally uses conditional random fields to capture the dependency between adjacent tags. The experimental results show that the F1 score of the model reaches 90.38%. (shrink)

This chapter provides an analysis of the long process of introducing an electronic identity for online authentication in Germany. This process is described as a multi-facet innovation, involving actors from different policy fields shifting over time. The eID process started in the late ‘90s in the context of eGovernment and eCommerce with the legislation on e-signatures, which were supposed to allow for online authentication of citizens. When after 5 years it was recognized that this was not the case, a (...) new digital ID card, which had meanwhile been announced, was chosen as token for the eID. This process was dominated by the concerns for visual inspection and border control, including the storage of digital fingerprints. Under the leadership of the Ministry of the Interior (BMI) and technical guidance of the Federal Agency for Information Security (BSI), technical specifications have to a large extent been adopted from the electronic passport, which had been smoothly introduced 2 years before. However, in the legislative process some concern regarding digital fingerprints on the eID card was raised and led to an opt-in solution. In 2009, a bill on the new ID card was passed which regulates the eID function for online authentication as well. This is characterized as a radical innovation by introducing a double-sided, mutual authentication of the citizen and the service provider and implementing the principle of proportionality regarding the access of service providers to data on the chip. At the time of writing, field tests are conducted. Roll-out of the new eID card is to start in November 2010. Therefore no figures about adoption can be provided here. (shrink)

Purpose Advances in electronic performance monitoring have raised employees’ concerns regarding the invasion of privacy and erosion of trust. On the other hand, EPM promises to improve performance and processes. This paper aims to focus on how the alignment of EPM design and organizational culture through effective organizational mechanisms can address privacy concerns, and, hence, positively affect employees’ perception toward technology. Design/methodology/approach Based on a theoretical lens extending two conceptual frameworks, a qualitative approach was used to analyze interview (...) class='Hi'>data collected from a comparative case study of two organizations in the USA and Qatar within the oil and gas sector. These two contexts were selected to emphasize the cross-cultural and organizational differences in employees’ acceptance of EPM. Findings The study revealed that national and corporate cultures affected employees’ perception and acceptance of monitoring in both countries. Because of diversity, though EPM was better accepted in Qatar, as they are an easy way to enforce standardization and to push employees to adapt to a dominating corporate culture. Conversely, in the USA where culture is more innovation-oriented, organizational mechanisms shifted the perceptions of EPM to being mean to obtain feedback rather than to impose standards. Research limitations/implications This qualitative study is based on a descriptive comparative case study of two organizations with two cultural contexts. The limited sample size and cross-sectional nature of data may need to be extended to a larger cultural scope that is observed over a longer period to safely generalize the findings. Practical implications Decision-makers in multinational corporations with different cultural backgrounds may benefit of this study’s outcomes, as it emphasizes the importance of the fit between EPM designs and the cultural settings. Furthermore, organizations aiming to conduct analytics on EPM data have to justify and prove its benefits to employees to facilitate acceptance. Social implications The study shows that employees in Qatar have a different cultural frame of reference in their perception of fairness and ethics than their counterparts in the USA because of changes in the meaning of social relations, personal goals and behavioral norms. Originality/value The originality of this study lays in its empirical validation of a composite framework examining both national and corporate cultures on employees’ reactions to EPM systems. It also proves the critical importance of organizational mechanisms to align the EPM design with the organization cultural settings. (shrink)

Whether due to simplicity or hypocrisy, the question of access to patient data for biomedical research is widely seen in the public discourse only from the angle of patient privacy. At the same time, the desire to live and to live without disability is of much higher value to the patients. This goal can only be achieved by extracting research insight from patient data in addition to working on model organisms, something that is well understood by many patients. (...) Yet, most biomedical researchers working outside of clinics and hospitals are denied access to patient records when, at the same time, clinicians who guard the patient data are not optimally prepared for the data’s analysis. Medical data collection is a time- and cost-intensive process that is most of all tedious, with few elements of intellectual and emotional satisfaction on its own. In this process, clinicians and bioinformaticians, each group with their own interests, have to join forces with the goal to generate medical data sets both from clinical trials and from routinely collected electronic health records that are, as much as possible, free from errors and obvious inconsistencies. The data cleansing effort as we have learned during curation of Singaporean clinical trial data is not a trivial task. The introduction of omics and sophisticated imaging modalities into clinical practice that are only partially interpreted in terms of diagnosis and therapy with today’s level of knowledge warrant the creation of clinical databases with full patient history. This opens up opportunities for re-analyses and cross-trial studies at future time points with more sophisticated analyses of the same data, the collection of which is very expensive. (shrink)

In the past few years, the ethical ramifications of AI technologies have been at the center of intense debates. Considerable attention has been devoted to understanding how a morally responsible practice of data science can be promoted and which values have to shape it. In this context, ethics and moral responsibility have been mainly conceptualized as compliance to widely shared principles. However, several scholars have highlighted the limitations of such a principled approach. Drawing from microethics and the virtue theory (...) tradition, in this paper, we formulate a different approach to ethics in data science which is based on a different conception of “being ethical” and, ultimately, of what it means to promote a morally responsible data science. First, we develop the idea that, rather than only compliance, ethical decision-making consists in using certain moral abilities, which are cultivated by practicing and exercising them in the data science process. An aspect of virtue development that we discuss here is moral attention, which is the ability of data scientists to identify the ethical relevance of their own technical decisions in data science activities. Next, by elaborating on the capability approach, we define a technical act as ethically relevant when it impacts one or more of the basic human capabilities of data subjects. Therefore, rather than “applying ethics”, data scientists should cultivate ethics as a form of reflection on how technical choices and ethical impacts shape one another. Finally, we show how this microethical framework concretely works, by dissecting the ethical dimension of the technical procedures involved in data understanding and preparation of electronic health records. (shrink)

Drawing on Burawoy's framework of “factory regimes” and concepts of power and practice from Foucault and de Certeau, this article depicts a production regime of “familial hegemony” found in a Hong Kong electronics factory. It suggests that the social construction of gender has to be inserted into a theory of production politics if the specific forms and processes of this hegemonic regime are to be explained. In this particular case, ethnographic data capture how an everyday culture of familialism, built (...) around notions of gender norms and behavior, is actively constructed by management and workers to serve their respective interests on the shopfloor. (shrink)

With the rapid development of sensor technology for automated driving applications, the fusion, analysis, and application of multimodal data have become the main focus of different scenarios, especially in the development of mobile edge computing technology that provides more efficient algorithms for realizing the various application scenarios. In the present paper, the vehicle status and operation data were acquired by vehicle-borne and roadside units of electronic registration identification of motor vehicles. In addition, a motion model and an (...) identification system for the single-vehicle lane-change process were established by mobile edge computing and self-organizing feature mapping. Two scenarios were modeled and tested: lane change with no vehicles in the target lane and lane change with vehicles in the target lane. It was found that the proposed method successfully identified the stochastic parameters in the process of driving trajectory simulation, and the standard deviation between simulation and the measured results obeyed a normal distribution. The proposed methods can provide significant practical information for improving the data processing efficiency in automated driving applications, for solving single-vehicle lane-change applications, and for promoting the formation of a closed loop from sensing to service. (shrink)

We hypothesize that recent uses of the Internet as a public-participation mechanism in the United States fail to overcome the adversarial culture that characterizes the American regulatory process. Although the Internet has the potential to facilitate deliberative processes that could result in more widespread public involvement, greater transparency in government processes, and a more satisfied citizenry, we argue that efforts to implement Internet-based public participation have overlaid existing problematic government processes without fully harnessing the transformative power of information technologies. Public (...) comments submitted in two United States Department of Agriculture rulemaking processes—the National Organic Program’s organic standard and the Forest Service’s Roadless Area Conservation Rule—compose our data. We conclude that the Internet provides an arena for playing out three types of conflicts that have long plagued environmental decision-making processes: conflicts over trust of federal agencies, the use of science, and the role of public values. (shrink)

Discussions about biotechnology tend to assume that it is something to do with genetics or manipulating biological processes in some way. However, the field of biometrics––the measurement of physical characteristics––is also biotechnology and is likely to affect the lives of more people more quickly than any other form. The possibility of social exclusion resulting from the use of biometrics data for such uses as identity cards has not yet been fully explored. Social exclusion is unethical, as it unfairly discriminates (...) against individuals or classes of people. Social exclusion is unethical, as it unfairly discriminates against individuals or classes of people. This article looks at some of the ways in which social exclusion might arise from the use of biometric data, and introduces a model of balancing individual interests with which to analyse whether it is justified to run the risk of excluding some members of society for the benefit of others. (shrink)

This article reviews the debate over electronic data bases and privacy, with an emphasis on the United States since the Privacy Act of 1974. Proposals that have value for the 1990s, both nationally and internationally, are synthesized. Some current controversies are discussed, including some of the reasons for the failure of previous privacy legislation. The way social values affect both statistical and intelligence systems is reviewed, and the debate over organizational necessity and computerization is examined. Some controversial systems (...) and programs are described, along with suggestions designed to move closer to state-of-the-art privacy oversight. (shrink)

Public trust is paramount for the well functioning of data driven healthcare activities such as digital health interventions, contact tracing or the build-up of electronic health records. As the use of personal data is the common denominator for these healthcare activities, healthcare actors have an interest to ensure privacy and anonymity of the personal data they depend on. Maintaining privacy and anonymity of personal data contribute to the trustworthiness of these healthcare activities and are associated (...) with the public willingness to trust these activities with their personal data. An analysis of online news readership comments about the failed care.data programme in England revealed that parts of the public have a false understanding of anonymity in the context of privacy protection of personal data as used for healthcare management and medical research. Some of those commenting demanded complete anonymity of their data to be willing to trust the process of data collection and analysis. As this demand is impossible to fulfil and trust is built on a false understanding of anonymity, the inability to meet this demand risks undermining public trust. Since public concerns about anonymity and privacy of personal data appear to be increasing, a large-scale information campaign about the limits and possibilities of anonymity with respect to the various uses of personal health data is urgently needed to help the public to make better informed choices about providing personal data. (shrink)

Mendelian Inheritance in Man, a computerized catalogue of human genetic disorders authored and maintained by cardiologist and medical genetics pioneer Victor A. McKusick, played a major part in demarcating between a novel biomedical science and the eugenic projects of racial betterment which existed prior to its emergence. Nonetheless, it built upon prior efforts to systematize genetic knowledge tied to individuals and institutions invested in eugenics. By unpacking the process of digitizing a homespun cataloguing project and charting its development into an (...) online database, this article aims to illuminate how the institution-building efforts of one individual created an ‘information order’ for accessing genetic information that tacitly shaped the norms and priorities of the field toward the pursuit of specific genes associated with discernible genetic disorders. This was not by design, but rather arose through negotiation with the catalogue's users; it accommodated further changes as biomedical research displaced the Mendelian paradigm. While great effort was expended toward making sequence data available to investigators during the Human Genome Project, MIM was largely taken for granted as a ‘legacy system’, McKusick's own labour of love. Drawing on recent histories of biomedical data, the article suggests that the bibliographical work of curation and translation is a central feature of value production in the life sciences meriting attention in its own right. (shrink)

Background We aimed to examine the ethical concerns Singaporeans have about sharing health-data for precision medicine and identify suggestions for governance strategies. Just as Asian genomes are under-represented in PM, the views of Asian populations about the risks and benefits of data sharing are under-represented in prior attitudinal research. Methods We conducted seven focus groups with 62 participants in Singapore from May to July 2019. They were conducted in three languages and analysed with qualitative content and thematic analysis. (...) Results Four key themes emerged: nuanced understandings of data security and data sensitivity; trade-offs between data protection and research benefits; trust in the public and private sectors; and governance and control options. Participants were aware of the inherent risks associated with data sharing for research. Participants expressed conditional support for data sharing, including genomic sequence data and information contained within electronic medical records. This support included sharing data with researchers from universities and healthcare institutions, both in Singapore and overseas. Support was conditional on the perceived social value of the research and appropriate de-identification and data security processes. Participants suggested that a data sharing oversight body would help strengthen public trust and comfort in data research for PM in Singapore. Conclusion Maintenance of public trust in data security systems and governance regimes can enhance participation in PM and data sharing for research. Contrary to themes in much prior research, participants demonstrated a sophisticated understanding of the inherent risks of data sharing, analysed trade-offs between risks and potential benefits of PM, and often adopted an international perspective. (shrink)

Recently, big data analytics have gained significant attention in healthcare industry due to generation of massive quantities of data in various forms such as electronic health records, sensors, medical imaging, and pharmaceutical details. However, the data gathered from various sources are intrinsically uncertain owing to noise, incompleteness, and inconsistency. The analysis of such huge data necessitates advanced analytical techniques using machine learning and computational intelligence for effective decision making. To handle data uncertainty in healthcare (...) sector, this article presents a novel metaheuristic rough set-based feature selection with rule-based medical data classification technique on MapReduce framework. The proposed MRSFS-RMDC technique designs a butterfly optimization algorithm for minimal rough set selection. In addition, Hadoop MapReduce is applied to process massive quantity of data. Moreover, a rule-based classification approach named Repeated Incremental Pruning for Error Reduction is used with the inclusion of a set of conditional rules. The RIPPER will scale in a linear way with the number of training records utilized and is suitable to build models with data uncertainty. The proposed MRSFS-RMDC technique is validated using benchmark dataset and the results are inspected under varying aspects. The experimental results highlighted the supremacy of the MRSFS-RMDC technique over the recent state of art methods in terms of different performance measures. The proposed methodology has achieved a higher F-score of 96.49%. (shrink)

Decisions are taken by humans very often during professional as well as leisure activities. It is particularly evident during surfing the Internet: selecting web sites to explore, choosing needed information in search engine results or deciding which product to buy in an on-line store. Recommender systems are electronic applications, the aim of which is to support humans in this decision making process. They are widely used in many applications: adaptive WWW servers, e-learning, music and video preferences, internet stores etc. (...) In on-line solutions, such as e-shops or libraries, the aim of recommendations is to show customers the products which they are probably interested in. As input data the following are taken: shopping basket archives, ratings of the products or servers log files.The article presents a solution of recommender system which helps users to select an interesting product. The system analyses data from other customers' ratings of the products. It uses clustering methods to find similarities among the users and proposed techniques to identify users' profiles. The system was implemented in Apache Mahout environment and tested on a movie database. Selected similarity measures are based on: Euclidean distance, cosine as well as correlation coefficient and loglikehood function. (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 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 collection serves as a catalyst for new interdisciplinary developments in language, logic and computation.

This article starts with the analysis of the existing electronic commerce system, summarizes its characteristics, and analyzes and solves its existing problems. Firstly, the characteristics of the relational database My Structured Query Language and the distributed database HBase are analyzed, their respective advantages and disadvantages are summarized, and the advantages and disadvantages of each are taken into account when storing data. My SQL is used to store structured business data in the system, while HBase is used to (...) store unstructured data such as pictures. These two storage mechanisms together constitute a data storage subsystem. Secondly, considering the large amount of data in the e-commerce system and the complex calculation of the data mining algorithm, this paper uses MapReduce to realize the parallelization of the data mining algorithm and builds a Hadoop-based commodity recommendation subsystem on this basis. We use JavaEE technology to design a full-featured web mall system. Finally, based on the impact of cloud computing, mobile e-commerce is analyzed, including relevant theories, service mode, architecture, core technology, and the application in e-commerce, which can realize e-commerce precision marketing, find the optimal path of logistics, and take effective security measures to avoid transaction risks. This method can avoid the disadvantages of the traditional e-commerce, where large-scale data cannot be processed in a timely manner, realize the value of mining data behind, and realize the precision marketing of e-commerce enterprises. (shrink)

BackgroundLiterature on issues relating to comprehension during the process of obtaining informed consent (IC) has largely focused on the challenges potential participants can face in understanding the IC documents, and the strategies used to enhance comprehension of those documents. In this review, we set out to describe the factors that have an impact on comprehension and the strategies used to enhance the IC process in sub-Saharan African countries.MethodsFrom November 2021 to January 2022, we conducted a literature search using a PRISMA (...) tool. We searched electronic databases (PubMed, EMBASE, EBSCOHOST) to identify relevant peer reviewed studies. We then reviewed the references of these articles to find additional literature that might have been missed through the initial search. We were particularly interested in full text articles in English that focused on the IC process in SSA published between 2006 and 2020. We included systematic reviews, and studies from Western and Asian countries that included data about SSA. We excluded articles that focused on medical interventions and studies that did not require IC.ResultsOut of the 50 studies included most were multi-country (n = 13) followed by single country studies in South Africa (n = 12); Kenya, Tanzania, Uganda (n = 5) each; Gambia, Ghana and Nigeria (n = 2)each ; and one each for Botswana, Malawi, Mali, Mozambique. We identified three areas of focus: (1) socio-cultural factors affecting IC; (2) gaps in the ethical and legal frameworks guiding the IC process; and (3) strategies used to improve participants’ understanding of IC.ConclusionOur review showed wide recognition that the process of achieving IC in SSA is inherently challenging, and there are limitations in the strategies aimed at improving comprehension in IC. We suggest that there is a need for greater flexibility and negotiation with communities to ensure that the approach to IC is suited to the diverse socio-cultural contexts. We propose moving beyond the literal translations and technical language to understanding IC comprehension from the participants’ perspectives and the researchers’ views, while examining contextual factors that impact the IC process. (shrink)

Human brain is a highly evolved coordinating mechanism in the species Homo sapiens. It is only in the last 100 years that extensive knowledge of the intricate structure and complex functioning of the human brain has been acquired, though a lot is yet to be known. However, from the beginning of civilisation, people have been conscious of a 'mind' which has been considered the origin of all scientific and cultural development. Philosophers have discussed at length the various attributes of consciousness. (...) At the same time, most of the philosophical or scientific frameworks have directly or indirectly implied mind-body duality. It is now imperative that we develop an integrated approach to understand the interconnection between mind and consciousness on one hand and brain on the other. This paper begins with the proposition that the structure of the brain is analogous, at least to certain extent, to that of the computer system. Of course, it is much more sophisticated and complex. The second proposition is that the Chomskyean concept of 'mental organs' is a good working hypothesis that tries to characterise this complexity in terms of an innate cognitive framework. By following this dual approach, brain as a data processing system and brain as a superstructure of intricately linked mental organs, we can move toward a better understanding of 'mind' within the framework of empirical science. The one 'mental organ' studied extensively in Chomskyean terms is 'language faculty' which is unique in its relation to brain, mind and consciousness. (shrink)

BackgroundIn the context of translational research, researchers have increasingly been using biological samples and data in fundamental research phases. To explore informed consent practices, we conducted a retrospective study on informed consent documents that were used for CARPEM’s translational research programs. This review focused on detailing their form, their informational content, and the adequacy of these documents with the international ethical principles and participants’ rights.MethodsInformed consent forms (ICFs) were collected from CARPEM investigators. A content analysis focused on information related (...) to biological samples and data treatment (context of sampling and collect, aims, reuse, consent renewal), including the type of consent. An automatic assessment of the readability of the ICFs were performed with the IT program “Flesch Score”.Results29 ICFs from 25 of 49 studies were analyzed after selection criteria were applied. Three types of consent were identified: 11 broad consents, six specific consents, and two opt-out consents. The Flesch Scores showed that most of the documents were too complex to be fully understood by most of the potential research participants. Most of the biological samples were collected during the healthcare routine, but the information content about secondary use of biological samples varied between ICFs. All documents mentioned personal data treatment but information about their reuse was not standardized in the ICFs.ConclusionsOur review of current IC procedures of CARPEM showed that practices could be improved considering new translational research methods. “Old fashion written ICFs” should be adapted to the translational research approach, to better respect individual rights and international research ethics principles. In this context, theoretically, a digital tool allowing dynamic information and consent of participants, through an electronic interactive platform may be a good way to promote more active participation in research. Nevertheless, its feasibility in the complex environment of biological samples and data research remains to prove. The way of a combination of a broad consent followed by dynamic information may be alternatively tested. (shrink)

From a speech given at a conference sponsored by the Electronic Funds Transfer Association (EFTA) on "The Puzzle of Data Security and Consumer Privacy," Washington, DC, 16 November 1992. At that time, Dr. Perry was a Consultant in Advisory Services for the Ethics Resource Center.

Social Networking Services provide services in return for rights to commercialize users’ personal data. We argue that what makes this transaction permissible is not users’ autonomous consent but the provision of sufficiently valuable opportunities to exchange data for services. We argue that the value of these opportunities should be assessed for both (a) a range of users with different decision-making abilities and (b) third parties. We conclude that regulation should shift from aiming to ensure autonomous consent towards ensuring (...) that users face options that they will use to advance individual and common interests. (shrink)

The exponential digitization of medical data has led to a transformation of the practice of medicine. This change notably raises a new complexity of issues surrounding health IT. The proper use of these communication tools, such as telemedicine, e-health, m-health the big medical data, should improve the quality of monitoring and care of patients for an information system to "human face". Faced with these challenges, the author analyses in an ethical angle the patient-physician relationship, sharing, transmission and storage (...) of medical information, setting pins to an ethic for the digitization of medical information. Drawing on good practice recommendations closely associated with values, this model is developing tools for reflection and present the keys to understanding the decision-making issues that reflect both the technological constraints and the complex nature of human reality in medicine. (shrink)

Emergent technologies are undermining both decisional privacy (intimacy) and informational privacy. Regarding the former consider, e.g., technical intrusions on burglar alarms and telephone calls. Regarding the latter consider how routinely technologies enable intrusion into electronic data processing (EDP) in spite of government efforts to maintain control. These efforts are uneven among nations thus inviting selective choice of a data storage country. Deregulation of telecommunications and assigning operators First Amendment rights invites multiple efforts to profit from preferential treatment (...) of multiple competitors. (shrink)

Many experiments have been conducted over the past eight decades to explore whether the ostensible psychic ability of psychokinesis (PK, or "mind over matter") might be a genuine human potential, and the most extensive of these have involved attempts to mentally influence the output of electronic, binary-bit random number generators (RNGs). Research of this type can generally be divided into two lines: proof-oriented (concerned with the accumulation and statistical evaluation of data from controlled experiments designed specifically to test (...) for the presence of PK effects on the microscopic scale) and process-oriented (concerned with conducting exploratory experiments designed to systematically vary certain test conditions in order to search for and identify any physical, biological, and psychological factors which might have a role in improving or moderating PK effects). To help orient novice investigators and cross-disciplinary researchers who may be considering work along these lines (as well as offer some initial guiding insight on possible directions for future research), this paper provides a general review of some of the notable proof- and process-oriented findings that have been obtained to date in experimental microscopic PK research using RNGs. The review generally indicates that although a considerable amount of proof-oriented data for micro-PK has accumulated over the years, the relatively sparse amount of process-oriented data available at present leaves a lot of open questions regarding the underlying factors involved, providing ample opportunity for novice investigators and cross-disciplinary researchers to make valuable research contributions in the future. (shrink)

Frameworks for responsible data stewardship, such as that proposed by McCoy et al. (2023), are intended to encourage and provide guidelines for data processors to engage in responsible data process...