Decision-making by a Data and Safety Monitoring Board (DSMB) regarding clinical trial conduct and termination is intricate and largely limited by cases and rules. Decision-making by legal jury is also intricate and largely constrained by cases and rules. In this paper, I argue by analogy that legal decision-making, which strives for a balance between competing demands of conservatism and innovation, supplies a good basis to the logic behind DSMB decision-making. Using the doctrine of precedents in legal reasoning (...) as my central analog will lead us to a decision-theoretic analogy for much more systematic documentation of decisions in clinical trials. My conclusion is twofold: every DSMB decision should articulate a clear general principle (a ratio decidendi) that gives reason for the decision; and all such decisions should be made public. I use Bartha’s (2010) theory of analogical arguments to both frame and assess my argument by analogy. (shrink)

Data Safety and Monitoring Boards have been referred to as a “growth industry,” and this trend continues to be fueled by recent FDA guidance and the NIH's requirement that DSMBs be employed in virtually all phase III clinical trials. The widening role of DSMBs has been sporadically questioned on ethical grounds, but growth has continued, despite the fact that many of the questions endure, unanswered, save for repeated references to safeguarding the scientific integrity of trials. This (...) may be about to change. The recently appointed director of the Office for Human Research Protections , Jerry Menikoff, is on record as regarding current practices — where consent forms often promise what the DSMB has been assembled to specifically not provide — as constituting fraudulent behavior. That is, a subject may inherently rely on, to their detriment, information that has been misrepresented in the consent document. In this paper, we assemble some of the enduring questions and top them off with Menikoff's tour de force to present what we hope will be a compelling argument to require that consent forms fairly represent what the DSMB will do — and not do — with trial data as they accumulate. We argue that DSMBs should be used only in rare circumstances, and question the practice of precluding principal investigators from DSMB membership, but our main thrust is to ensure that DSMBs, when used at all, are properly described in trial consent forms. (shrink)

Data Safety and Monitoring Boards were introduced in the 1960s to monitor data in clinical trials to ensure subject safety. It was thought important that DSMB members be experts in the field of interest, but not otherwise involved in the study in order to maximize objectivity. Since then, the use of DSMBs has increased dramatically, and their scope has expanded to include scientific issues — in particular, to avoid bias that can result when trials (...) are stopped early because of evidence that one treatment has greater efficacy or causes greater harm than another; or that no treatment is likely to do better than any other. (shrink)

In this set of contributions to the Kennedy Institute of Ethics Journal celebrating the significant work and contributions of LeRoy Walters, we aim to bring new perspectives to topics that Dr. Walters helped to pioneer and continue his tradition of bringing moral insights and arguments to bear on the development of practical public and professional policies. Dr. Walters is well known for his invaluable service as member and chair of the Recombinant DNA Advisory Committee at the National Institutes of Health. (...) He also made major contributions to a variety of other committees responsible for the oversight of research and science, and to the development and implementation of influential... (shrink)

A discussion of lessons learned in the first months of the COVID-19 pandemic which allowed data safety monitoring boards (DSMBs) to continue their work protecting the interests of human research participants while preserving research studies.

If definitive evidence concerning treatment effectiveness becomes available from an ongoing randomized clinical trial, then the trial could be stopped early, with the public release of results benefiting current and future patients. However, stopping an ongoing trial based on accruing outcome data requires methodological rigor to preserve validity of the trial conclusions. This has led to the use of formal interim monitoring procedures, which include inefficacy monitoring that will stop a trial early when the experimental treatment appears (...) not to be working. For participants, inefficacy monitoring is especially important as it ensures that they are not being treated worse than if they had not enrolled on the trial. We discuss the importance of reporting with trial results the formal interim inefficacy monitoring guidelines that were utilized, and, if none were used, the reasons for their absence. A survey of two leading medical journals suggests that this is not current practice. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Update on Waiving Informed Consent in Emergency ResearchCharles R. McCarthyMadam: The closing statement of my article on Waiving Informed Consent in Emergency Research published in the June 1995 issue of the Kennedy Institute of Ethics Journal was: "No doubt we shall hear more of this issue."Indeed, we have heard much more on this issue. (1) In May 1995, after my article had already gone to press, the Food and (...) Drug Administration (FDA) and the National Institutes of Health (NIH) jointly published a report on the Public Forum on Informed Consent in Clinical Research Conducted in Emergency Circumstances. (2) On July 26, 1995, the Department of Health and Human Services (HHS) published in the Federal Register a Notice of Action Related to Emergency Research Activity (60 FR 38353-54). This action constituted a waiver of the requirement to obtain prior informed consent from subjects, as required by the Department's Regulations for the Protection of Human Subjects (45 CFR 46), for one specific NIH-funded project under strictly defined circumstances. (3) On September 21, 1995, FDA published a proposed rule to amend its current informed consent regulations (21 CFR 50) to permit harmonization of federal policies on emergency research and to reduce confusion as to when such research can proceed without obtaining prior informed consent from research subjects. The proposed regulation provides a narrow exception to the requirement for obtaining and documenting informed consent from each human research subject.The HHS waiver (a harbinger of a proposed amendment to its regulations) and the FDA proposed rule are intended to be harmonized so that an Institutional Review Board (IRB) in compliance with one set of regulations relative to the waiver of informed consent will be, ipso facto, in compliance with the other set of regulations.In brief: The FDA proposed amendments will allow an IRB to waive informed consent in emergency situations when:1. The human subjects are in a life threatening condition;2. Obtaining informed consent is not feasible because: (i) the subjects will not be able to provide consent because of their medical condition, (ii) the intervention must be administered before consent from legally authorized representatives is feasible, (iii) there is no reasonable way to identify prospectively the individuals likely to become eligible for the research because the emergence of the condition to be studied cannot be predicted reliably in particular individuals; [End Page 385]3. The opportunity to participate is in the interest of the subjects because: (i) a life threatening situation necessitates intervention, (ii) the risk of the intervention is reasonable in the light of what is known about the medical condition and the patient, the risks and benefits of current therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity;4. The research could not practicably be carried out without the waiver;5. Additional protection of the rights and welfare of the subjects will be provided including, at least: (i) consultation (which may include consultation carried out by the IRB itself) with representatives of the communities from which the subjects will be drawn, (ii) public disclosure prior to commencement of the study sufficient to describe the study and its risks and benefits, (iii) public disclosure of sufficient information following completion of the study to apprise the community and researchers of the study and its results, and (iv) the establishment of an independent data and safety monitoring board;6. The IRB has reviewed and approved an informed consent document for use with subjects or legal representatives in situations in which obtaining such consent may be feasible for some subjects.The preamble to the proposed amendments to the regulations and the amendments themselves contain much more information than is presented here. Readers are therefore encouraged to study the proposals carefully. The public comment period ended November 6, and the FDA is expected to issue a final rule in 1996.Charles R. McCarthyKennedy Institute of Ethics Georgetown University Washington, DCCopyright © 1995 The Johns Hopkins University Press... (shrink)

Abstractabstract:Recent clinical trials of psychedelic drugs aim to treat a range of psychiatric conditions in adults. MDMA and psilocybin administered with psychotherapy have received FDA designation as "breakthrough therapies" for post-traumatic stress disorder (PTSD) and treatment-resistant depression (TRD) respectively. Given the potential benefit for minors burdened with many of the same disorders, calls to expand experimentation to minors are inevitable. This essay examines psychedelic research conducted on children from 1959 to 1974, highlighting methodological and ethical flaws. It provides ethics and (...) policy recommendations for psychedelics research involving children and adolescents, including recognizing that the psychedelic experience is an ineffable one that makes informed proxy consent for parents, guardians, and others especially challenging. Psychedelic experiences are associated with novel benefits and risks, such as significant personality changes, shifts in fundamental values, and possible re-exposure to traumatic memories. These effects may alter the process of personality development in minors. Recommendations for ethically sound psychedelics research in minors include strict adherence to eligibility criteria, including a comprehensive family and individual psychiatric, substance use, and trauma history. An age-appropriate assent process that includes considerations related to the use of therapeutic touch should be developed. In addition, oversight by data safety monitoring boards and patient and family advocates, coupled with the adoption of pharmacoequity best practices, will help to ensure safety and fairness of psychedelics research in children. (shrink)

The safety sign is important in our daily life and workplace to prevent potential safety issues. However, it remains undetermined whether the safety signs would influence the cognitive control ability of the people, which serves to guide the behaviors in a goal-directed manner. Therefore, this study aimed to examine the effect of safety signs on cognitive control by uncovering the behavioral performance and neural manifestations underlying the monitoring of conflict and error. The participants performed a (...) flanker task after watching low- and high-hazard safety signs with the electroencephalogram data recorded continually. The behavioral results indicated a classic congruency effect with higher accuracy rate and faster response time under a congruent condition compared to an incongruent condition. However, no hazard effect on behavioral performances was observed. The results of event-related potentials demonstrated a more negative N2 elicited by the incongruent trials and an increased ERN difference between the error and correct responses in the high-hazard condition compared to those in the low-hazard condition, implying that the monitoring of the conflict and error were both enhanced after watching the high-hazard safety signs. This study contributes to the understanding of the relationship between safety signs and cognitive control, and further expand the measurements that can be applied to assess the effectiveness of safety signs design. (shrink)

Research to improve the health of pregnant and fetal patients presents ethical challenges to clinical investigators, institutional review boards, funding agencies, and data safety and monitoring boards. The Common Rule sets out requirements that such research must satisfy but no ethical framework to guide their application. We provide such an ethical framework, based on the ethical concept of the fetus as a patient. We offer criteria for innovation and for Phase I and II and then (...) for Phase III clinical trials to improve the health of pregnant patients and of fetal patients and also criteria to responsibly manage the transition from investigation to clinical practice. Basing ethical criteria for research involving pregnant women on the ethical concept of the fetus as a patient insulates the proposed ethical framework and therefore research on pregnant women from the divisive and politicized concepts and discourses of personhood, fetal rights, and unborn child. (shrink)

BackgroundInternational guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned.MethodsIt was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon National Ethics Committee (...) for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety.ResultsIn total, 106 clinical trial protocols were identified from 2173 protocols seen in the archive and 104 included for review. Seventy six trials did not include the surveillance of adverse events as part of their objective. A total of 91 protocols did not budget for adverse event surveillance, 76 did not have a data safety management board, 11 included insurance for participants, 47 did not include a case definition for serious adverse events, 33 described procedures to detect adverse events, 33 described procedure for reporting and 22 described procedure for investigating adverse events.DiscussionsMost clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols.ConclusionClinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan to assess adverse events in clinical trial protocols. In order to improve on the safety of participants and marketed drug, there is a need to develop national guidelines for clinical trials by the government, and to improve evaluation procedures and monitoring of ongoing trials by the ethics committee. (shrink)

Business ethics is one of the most significant demands made by institutional and individual investors, who usually require the participation of the board of directors in the planning and implementation of ethical behaviour in corporations. This is done by drawing up an ethics code and then monitoring its fulfilment. This study has a dual objective: first, to analyse the role played by the composition of the board of directors, and by that we mean its independence and the diversity of (...) its members, on the implementation and scope of an EC, and, second, to detect whether the corporate governance system moderates the level of involvement of the board in ethical issues. The findings obtained from a data panel sample made up of 760 listed companies from 12 countries for the years 2003–2009 show that the largest companies with large-sized and diverse boards implement the most developed ECs. Nevertheless, the extent of involvement of the independent directors is conditioned by the level of shareholder orientation characteristic of the system of CG in the corporation’s country of origin. (shrink)

Research to improve the health of pregnant and fetal patients presents ethical challenges to clinical investigators, institutional review boards, funding agencies, and data safety and monitoring boards. The Common Rule sets out requirements that such research must satisfy but no ethical framework to guide their application. We provide such an ethical framework, based on the ethical concept of the fetus as a patient. We offer criteria for innovation and for Phase I and II and then (...) for Phase III clinical trials to improve the health of pregnant patients and of fetal patients and also criteria to responsibly manage the transition from investigation to clinical practice. Basing ethical criteria for research involving pregnant women on the ethical concept of the fetus as a patient insulates the proposed ethical framework and therefore research on pregnant women from the divisive and politicized concepts and discourses of personhood, fetal rights, and unborn child. (shrink)

The effect of arousal safety has been analyzed on purchase intention, then attitude towards the advertisement and attitude towards the brand have been incorporated as intervening variables between the relationships. The interaction effect of self-monitoring and message arguments have also been taken in to consideration for better understanding of the consumer’s response. The data has been gathered from 206 respondents by using purposive sampling method. The research instrument was comprised of summated rating/additive scale and semantic differential scaling. (...) Confirmatory Factor Analysis has been applied after the application of preliminary tests on the data. Structure Equation Modeling and moderation and mediation analysis have also been applied to test the hypotheses. Arousal safety in the advertisements shape consumers response and it proved to be a fully mediated model. Self-monitoring also probes the relationship. Message arguments haven’t had any affect as moderator, hence can be used as a focal predictor. The study is a starting point for future research to provide a coherent methodology for capturing the necessary data, processing the underlying information and evaluating the effects of arousal safety in advertisements. The study extends the field of advertising in the direction of arousal safety effects. In comparison to previous research, empirical evidence on the arousal safety in television advertising and purchase intention in relation with moderating and mediating variables is provided. (shrink)

The COVID-19 pandemic and its related policies (e.g., stay at home and social distancing orders) have increased people’s use of digital technology, such as social media. Researchers have, in turn, utilized artificial intelligence to analyze social media data for public health surveillance. For example, through machine learning and natural language processing, they have monitored social media data to examine public knowledge and behavior. This paper explores the ethical considerations of using artificial intelligence to monitor social media to understand (...) the public’s perspectives and behaviors surrounding COVID-19, including potential risks and benefits of an AI-driven approach. Importantly, investigators and ethics committees have a role in ensuring that researchers adhere to ethical principles of respect for persons, beneficence, and justice in a way that moves science forward while ensuring public safety and confidence in the process. (shrink)

High degrees of uncertainty and a lack of effective therapeutic treatments have characterized the COVID-19 pandemic and the provision of drug products outside research settings has been controversial. International guidelines for providing patients with experimental interventions to treat infectious diseases outside of clinical trials exist but it is unclear if or how they should apply in settings where clinical trials and research are strongly regulated. We propose the Professional Oversight of Emergency-Use Interventions and Monitoring System as an alternative pathway (...) based on guidance developed for the ethical provision of experimental interventions to treat COVID-19 in Singapore. We support our proposal with justifications that establish moral duties for physicians to record outcomes data and for institutions to establish monitoring systems for reporting information on safety and effectiveness to the relevant authorities. Institutions also have a duty to support generation of evidence for what constitutes good clinical practice and so should ensure the unproven intervention is made the subject of research studies that can contribute to generalizable knowledge as soon as practical and that physicians remain committed to supporting learning health systems. We outline key differences between POEIMS and other pathways for the provision of experimental interventions in public health emergencies. (shrink)

This paper explores an increasingly prevalent element of board-level commitment to sustainability. We propose a theoretical framework under which the existence and associated actions of board-level sustainability committees are motivated by shared value creation, where the interests of a diverse group of stakeholders are satisfied and sufficient profit is achieved. Using hand-collected data, we find that sustainability committees are heterogeneous in focus and vary in their effectiveness. Specifically, we disaggregate the sustainability committee construct based on stakeholder group focus and (...) find that associations between sustainability committees and performance outcomes are stronger when committees focused on a specific stakeholder group are paired with relevant performance outcomes. We generally find that sustainability committees are effective at impacting relevant strengths, but do not mitigate relevant concerns. These results are consistent with the shared value framework, where committees both generate value by pursuing sustainability-related opportunities and protect value by monitoring, but not necessarily mitigating sustainability-related risks. Univariate tests suggest that effective committees are also larger, more independent, and meet more frequently. Finally, we propose a new method to classify industries based on their sensitivity to certain stakeholder groups and find that the effectiveness of committees focused on specific stakeholders is more pronounced in industries that are sensitive to these stakeholders. (shrink)

A recent advent has been seen in the usage of Internet of things (IoT) for autonomous devices for exchange of data. A large number of transformers are required to distribute the power over a wide area. To ensure the normal operation of transformer, live detection and fault diagnosis methods of power transformers are studied. This article presents an IoT-based approach for condition monitoring and controlling a large number of distribution transformers utilized in a power distribution network. In this (...) article, the vibration analysis method is used to carry out the research. The results show that the accuracy of the improved diagnosis algorithm is 99.01, 100, and 100% for normal, aging, and fault transformers. The system designed in this article can effectively monitor the healthy operation of power transformers in remote and real-time. The safety, stability, and reliability of transformer operation are improved. (shrink)

Many preventive intervention studies with adolescents address high-risk behaviors such as drug and alcohol use, and unprotected sex. Randomized controlled trials (RCT) are the gold standard methodology used to test the effectiveness of these behavioral interventions. Interventions outside the rigidly described protocol are prohibited. However, there are ethical challenges to implementing inflexible intervention protocols, especially when the target population is young, experiences many stressful events, and lives in a resource-poor environment. Teens who are at high risk for substance use or (...) sexual risk behaviors tend to be at risk for other problems such as exposure to violence, sexual and physical abuse, depression, and homelessness. How should investigators deal with the psychological and social needs of teenagers in prevention programs in an ethically appropriate way and at the same time preserve the validity of RCT results? We have identified program characteristics, participant characteristics, interaction with parents, and problems with adolescents not in the study as sources of ethical dilemmas in RCT with at-risk adolescents. As a result of our experience, we recommend that every behavioral intervention study develop an ethics protocol, which should include rules for providing help to participants, has contact information for experts to provide guidance, and an emergency procedure for dealing with life threatening situations. In addition, studies should have a resource manual, train research staff in these ethical issues, and work with a data safety and monitoring board or ethics committee. (shrink)

Fraudulent analysis and reporting of psychological data have the potential to contaminate the scientific knowledge base and eventuate in the unjustified expenditure of public money and scientific effort (Koocher & Keith-Spiegel, 1998). Traditionally, the field has relied on quantitative methodologists to educate researchers in proper analysis and reporting practices, and to examine these via peer review. The field has also relied on psychologists with training or board service in ethics to establish standards and implement strategies to discourage misconduct. However, (...) this division of responsibility for examination, standard setting, and deterrence is shown to compromise the effectiveness of methodologists' and ethicists' respective gatekeeping efforts. Methodologically and ethically trained specialists instead need to coordinate efforts to safeguard analysis and reporting procedures. Researchers also need to increase self-monitoring. Potential obstacles to achieving these ends are considered, and three tactics are proposed to overcome them. (shrink)

In this commentary, I reflect on the differences between two independent citizen approaches to monitoring radiological contamination, one in Belarus after the 1986 Chernobyl nuclear accident and the other in Japan following the 2011 Fukushima Daiichi accident. I examine these approaches from the perspective of their contribution to making radiological contamination more publicly visible. The analysis is grounded in my earlier work, where I examined how we have come to know what we know about post–Chernobyl contamination and its effects (...) in Belarus, a former Soviet republic most heavily affected by the fallout. As I described in this study, much of what we know about the consequences of Chernobyl is based on the work of the Belarusian nonprofit Institute of Radiation Safety, “Belrad.” I compare Belrad’s approach to radiological monitoring with the work of the volunteer network Safecast, arguably one of the best-known citizen science projects in the world, which is working to monitor the scope of the post–Fukushima contamination. Through this comparison of approaches, I raise broader questions about a form of sensing practices—data-related practices of citizen science that make environmental hazards publicly in/visible. (shrink)

Personal Health Monitoring (PHM) uses electronic devices which monitor and record health-related data outside a hospital, usually within the home. This paper examines the ethical issues raised by PHM. Eight themes describing the ethical implications of PHM are identified through a review of 68 academic articles concerning PHM. The identified themes include privacy, autonomy, obtrusiveness and visibility, stigma and identity, medicalisation, social isolation, delivery of care, and safety and technological need. The issues around each of these are (...) discussed. The system / lifeworld perspective of Habermas is applied to develop an understanding of the role of PHMs as mediators of communication between the institutional and the domestic environment. Furthermore, links are established between the ethical issues to demonstrate that the ethics of PHM involves a complex network of ethical interactions. The paper extends the discussion of the critical effect PHMs have on the patient’s identity and concludes that a holistic understanding of the ethical issues surrounding PHMs will help both researchers and practitioners in developing effective PHM implementations. (shrink)

Patient safety has only recently been subjected to wide-spread systematic study. Healthcare differs from other high risk industries in being more diverse and multi-contextual, and less certain and regulated. Also many patient safety problems are low-frequency events associated with many, varied contributing factors. The subject of this paper is the epistemology of patient safety (the science of the method of finding out about patient safety). Patient safety research is considered here on the background of a (...) risk management framework which requires researchers to: • Understand the context - as a subset of healthcare quality, services and systems research, with technical and human behavioural (cultural) components and a range of external and internal organisational influences, a wide range of research disciplines is necessary • Identify the risks - identify the things that go wrong and the frequency and nature of different types of incidents from sources such as medical record review, observational studies, audit, incident and medico-legal reports • Analyse the risks - deconstruct the things that go wrong, identifying contributing factors and trying to detect trends and patterns in contributing factors, detection, mitigation factors, ameliorating factors and actions taken to reduce risk • Evaluate the risks - decide on priorities, identifying preventive and corrective strategies and judging the risk- and cost-benefit of potential corrective strategies such as standardisation or simplification of a process or device • Manage the risk - evaluate and scope preventive and/or corrective strategies and then implement these, or place the problem on a risk register pending solution, or accept that what is needed is unaffordable • Communicate and consult - use interactive sessions, audit, on-going feedback, reminders and patient mediated prompts • Monitor and review the state of the problem - get baseline trends and patterns so that changes can be tracked and properly attributed to an intervention A hierarchy of levels of evidence has been proposed for clinical research and we argue that insufficient weighting has been given to lower ranked levels of research and to qualitative research, although critical interpretive synthesis is now gaining acceptance in mainstream thinking (e.g. by the Cochrane Collaboration). Fundamental challenges remain including how to grasp the elusive concept of patient safety, how to quantify, characterise and cost the problems, how to judge the extent to which harm can be attributed to errors, violations or system failures, how to identify contributing factors and the extent to which they can be implicated, how to judge whether incidents or their precursors are preventable, how to generate strong evidence to make healthcare safer and how to translate research into practice. Future directions include addressing the mundane as well as rare, dramatic events, and developing further research in non-hospital settings and in developing countries. In summary, a mixture of qualitative and quantitative methods, using information from all available data sources and combining retrospective, real time and prospective study designs, is necessary to address some of the more difficult patient safety problems. (shrink)

In recent years, universities have been urged to restructure and re-evaluate their ability to trace and monitor their students as the “smart campus” is being built upon datafication, while networked apps and sensors serve as the means through which its constituents are connected and governed. This paper advances a dialectical and communication-centered approach to the Internet of Things campus ecosystem and provides an empirical investigation into the tensions experienced by students and the ways that these students envision alternative practices that (...) support their digital engagement. Drawing upon student focus group interviews in a large American research and innovation intensive university, dialectical tensions identified include convenience–annoyance, integration–independence, and safety–insecurity, brought upon by students’ ongoing and prospective negotiations with Internet of Things. Furthermore, in a bid to understand students’ alternative data imaginaries, this project examined students’ preferred Internet of Things-related communication practices with campus digital application platforms, analog and older forms of digital media, as well as in-person interactions with traditional authorities within classroom and group settings. Finally, this contribution presents a discussion of the findings for theory and praxis, particularly for smart campus innovation and social data governance, in terms of potential growing challenges involving complexifying student privacy concerns, data normalization and coercion, and tertiary digital divides and inequalities. (shrink)

The 2018 Varsity Medical Ethics debate convened upon the motion: “This house believes that the constant monitoring of our health does more harm than good”. This annual debate between students from the Universities of Oxford and Cambridge is now in its tenth year. This year’s debate was hosted at the Oxford Union on 8th of February 2018, with Oxford winning for the Opposition, and was the catalyst for the collation and expansion of ideas in this paper.New technological devices have (...) the potential to enhance patient autonomy, improve patient safety, simplify the management of chronic diseases, increase connectivity between patients and healthcare professionals and assist individuals to make lifestyle changes to improve their health. However, these are pitted against an encroachment of technology medicalising the individual and home, an exacerbation of health inequalities, a risk to the security of patient data, an alteration of the doctor-patient relationship dynamic and an infringement on individual self-identity. This paper will draw upon and develop these concepts, while contending arguments for and against constant health monitoring. This is not a review of medical devices and health monitoring, but a reflective development and more detailed elaboration of the main points highlighted in the 2018 Varsity Medical Ethics debate. (shrink)

The 2018 Varsity Medical Ethics debate convened upon the motion: “This house believes that the constant monitoring of our health does more harm than good”. This annual debate between students from the Universities of Oxford and Cambridge is now in its tenth year. This year’s debate was hosted at the Oxford Union on 8th of February 2018, with Oxford winning for the Opposition, and was the catalyst for the collation and expansion of ideas in this paper.New technological devices have (...) the potential to enhance patient autonomy, improve patient safety, simplify the management of chronic diseases, increase connectivity between patients and healthcare professionals and assist individuals to make lifestyle changes to improve their health. However, these are pitted against an encroachment of technology medicalising the individual and home, an exacerbation of health inequalities, a risk to the security of patient data, an alteration of the doctor-patient relationship dynamic and an infringement on individual self-identity. This paper will draw upon and develop these concepts, while contending arguments for and against constant health monitoring. This is not a review of medical devices and health monitoring, but a reflective development and more detailed elaboration of the main points highlighted in the 2018 Varsity Medical Ethics debate. (shrink)

Visual inspections have been typically used in condition assessment of infrastructure. However, they are based on human judgment and their interpretation of data can differ from acquired results. In psychology, this difference is called cognitive bias which directly affects Structural Health Monitoring -based decision making. Besides, the confusion between condition state and safety of a bridge is another example of cognitive bias in bridge monitoring. Therefore, integrated computer-based approaches as powerful tools can be significantly applied in (...) SHM systems. This paper explores the relationship between the use of advanced computational intelligence and the development of SHM solutions through conducting an infrastructure monitoring methodology. Artificial Intelligence -based algorithms, i.e., Artificial Neural Network, hybrid ANN-based Imperial Competitive Algorithm, and hybrid ANN-based Genetic Algorithm, are developed for damage assessment using a lab-scale composite bridge deck structure. Based on the comparison of the results, the employed evolutionary algorithms could improve the prediction error of the pre-developed network by enhancing the learning procedure of the ANN. (shrink)

On March 12, 2009, a Sikorsky S-92A helicopter travelling to two offshore oil installations crashed into the sea about 55 km away from the coastal city of St. John’s in Newfoundland and Labrador, Canada. It sank quickly with the loss of 17 lives. There was one survivor. The article examines the circumstances of the crash to assess the effectiveness of an instrumental, business case for safety and, by extension, for corporate social responsibility. The article fills a gap in the (...) business and the management literature by adopting a qualitative, case study methodology to complement earlier, predominantly quantitative research. The study analyzes a comprehensive set of documentary data available from the offshore regulator’s public inquiry website, including many days of verbatim testimony from the industry, the union, regulators, investigators, the lone survivor and families of the deceased, in addition to written submissions and expert reports. Investigatory reports from the Transportation Safety Board of Canada and the NL Inquiry were analyzed, as were regulatory documents and media coverage. Although offshore safety has improved since the Ocean Ranger disaster in 1982, the empirical evidence in this case study adds to our understanding of how reliance on a voluntary, instrumental business case for CSR in the absence of a normative concept of CSR is likely to fail, largely because of the existence of a powerful tension between oil exploration and production and investment in safety. (shrink)

An interlocking-directorates monitoring system The subject of the study was interlocking directorates in Polish joint stock companies. In order to explore this area a monitoring system has been developed which consists of a database and query system. Data is automatically introduced from printed announcements into the MySQL database using PHP scripts.The phenomenon of interlocking directorates in Polish joint stock companies is comparable with other countries. Board members in Poland are significantly younger than, for example, in the USA. (...) Women constitute an important group of board members. Insurance companies and investment funds are closely connected with other companies, but banks are not.The monitoring system developed enables us to identify who is, and who was, a board member of every joint stock company. It also enables us to identify, for every person, which board he or she now serves on, and has served on, in the past. The system also enables us to produce different reports concerning, for example, changes in certain indexes in subsequent years. The system is also accessible via the Internet. (shrink)

Big data and Machine learning Techniques are reshaping the way in which food safety risk assessment is conducted. The ongoing ‘datafication’ of food safety risk assessment activities and the progressive deployment of probabilistic models in their practices requires a discussion on the advantages and disadvantages of these advances. In particular, the low level of trust in EU food safety risk assessment framework highlighted in 2019 by an EU-funded survey could be exacerbated by novel methods of analysis. (...) The variety of processed data raises unique questions regarding the interplay of multiple regulatory systems alongside food safety legislation. Provisions aiming to preserve the confidentiality of data and protect personal information are juxtaposed to norms prescribing the public disclosure of scientific information. This research is intended to provide guidance for data governance and data ownership issues that unfold from the ongoing transformation of the technical and legal domains of food safety risk assessment. Following the reconstruction of technological advances in data collection and analysis and the description of recent amendments to food safety legislation, emerging concerns are discussed in light of the individual, collective and social implications of the deployment of cutting-edge Big Data collection and analysis techniques. Then, a set of principle-based recommendations is proposed by adapting high-level principles enshrined in institutional documents about Artificial Intelligence to the realm of food safety risk assessment. The proposed set of recommendations adopts Safety, Accountability, Fairness, Explainability, Transparency as core principles (SAFETY), whereas Privacy and data protection are used as a meta-principle. (shrink)

Health regulators must carefully monitor the real-world safety and effectiveness of marketed vaccines through post-market monitoring in order to protect the public’s health and promote those vaccines that best achieve public health goals. Yet, despite the fact that vaccines used in collective immunization programmes should be assessed in the context of a public health response, post-market effectiveness monitoring is often limited to assessing immunogenicity or limited programmatic features, rather than assessing effectiveness across populations. We argue that post-market (...) monitoring ought to be expanded in two ways to reflect a ‘public health notion of post-market effectiveness’, which incorporates normative public health considerations: effectiveness monitoring should yield higher quality data and grant special attention to underrepresented and vulnerable populations; and the scope of effectiveness should be expanded to include a consideration of the various social factors that maximize a vaccine’s effectiveness at the population level, paying particular attention to how immunization programmes impact related health gradients. We use the case of the human papillomavirus vaccine in Canada to elucidate how expanding post-market effectiveness monitoring is necessary to close the gap between clinical practice and public health, and to ensure that vaccines are effective in a morally relevant sense. (shrink)

Contributing to a rising number of Critical Data Studies which seek to understand and critically reflect on the increasing datafication and digitalisation of governance, this paper focuses on the field of school monitoring, in particular on digital data infrastructures, flows and practices in state education agencies. Our goal is to examine selected features of the enactment of datafication and, hence, to open up what has widely remained a black box for most education researchers. Our findings are based (...) on interviews conducted in three state education agencies in two different national contexts, thus addressing the question of how the datafication and digitalisation of school governance has not only manifested within but also across educational contexts and systems. As our findings illustrate, the implementation of data-based school monitoring and leadership in state education agencies appears as a complex entanglement of very different logics, practices and problems, producing both new capabilities and powers. Nonetheless, by identifying different types of ‘doing data discrepancies’ reported by our interviewees, we suggest an analytical heuristic to better understand at least some features of the multifaceted enactment of data-based, increasingly digitalised governance, within and beyond the field of education. (shrink)

As an EU state, Lithuania has become an active member of the eEurope 2005 initiative, implementing the goals set forth in the strategic plan for the development of information society in Lithuania. Information technologies introduced into various areas of life open up new, more convenient opportunities to receive services and information. The modernization of state management becomes an integral factor for ensuring continuous social development. The objective of this paper is to study practical aspects of the application of specialized knowledge (...) in the investigation of crimes on electronic data and information systems security and to offer some recommendations for the investigation and prevention of such crimes. This article is the first of a two part study. In the next article, the authors intend to present aspects of prevention in crimes against electronic data and information systems security. The authors used statistical data, results of a survey of experts—investigators of crimes on electronic data and information system security, experts of information technology (IT) forensics. (shrink)

We present results from a study about women and employee-elected board members, and fill some of the gaps in the literature about their contribution to board effectiveness. The empirical data are from a unique data set of Norwegian firms. Board effectiveness is evaluated in relation to board control tasks, including board corporate social responsibility (CSR) involvement. We found that the contributions of women and employee-elected board members varied depending on the board tasks studied. In the article we also (...) explored the effects of the esteem of the women and employee-elected board members, and we used creative discussions in the boardroom as a mediating variable. Previous board research, including research about women and employee-elected directors, questions if the board members contribute to board effectiveness. The main message from this study is that it may be more important to ask how, rather than if, women and employee-elected board members contribute, and we need to open the black box of actual board behavior to explore how they may contribute. (shrink)

A growing number of consumer technology companies are aiming to convince older people that humanoid robots make helpful tools to support aging-in-place. As hybrid devices, socially assistive robots (SARs) are situated between health monitoring tools, familiar digital assistants, security aids, and more advanced AI-powered devices. Consequently, they implicate older people’s privacy in complex ways. Such devices are marketed to perform functions common to smart speakers (e.g., Amazon Echo) and smart home platforms (e.g., Google Home), while other functions are more (...) specific to older people, including health and safety monitoring and serving as companions to mitigate loneliness. Privacy is a key value central to debates about the ethics of using SARs in aged care, yet there has been very little interchange between these debates and the robust theoretical discussion in the legal literature about the future of privacy and AI governance. Drawing on two qualitative studies of older people’s views on consumer SARs, the paper contributes novel findings about older people’s thinking on privacy and data governance at the intersection of their experiences with present day digital technologies and projections for future AI systems, and places their views in dialogue with debates about the future of privacy protection and AI governance. (shrink)

In the near future, vehicles will gradually gain more autonomous functionalities. Drivers’ activity will be less about driving than about monitoring intelligent systems to which driving action will be delegated. Road safety, therefore, remains dependent on the human factor and we should identify the limits beyond which driver’s functional state (DFS) may no longer be able to ensure safety. Depending on the level of automation, estimating the DFS may have different targets, e.g. assessing driver’s situation awareness in (...) lower levels of automation and his ability to respond to emerging hazard or assessing driver’s ability to monitor the vehicle performing operational tasks in higher levels of automation. Unfitted DFS (e.g., drowsiness) may impact the driver ability respond to taking over abilities. This paper reviews the most appropriate psychophysiological indices in naturalistic driving while considering the DFS through exogenous sensors, providing the more efficient trade-off between reliability and intrusiveness. The DFS also originates from kinematic data of the vehicle, thus providing information that indirectly relates to drivers behaviour. The whole data should be synchronously processed, providing a diagnosis on the DFS, and bringing it to the attention of the decision maker in real time. Next, making the information available can be permanent or intermittent (or even undelivered), and may also depend on the automation level. Such interface can include recommendations for decision support or simply give neutral instruction. Mapping of relevant psychophysiological and behavioural indicators for DFS will enable practitioners and researchers provide reliable estimates, fitted to the level of automation. (shrink)

Surveys and routine clinical procedures applied in research protocols are typically considered only minimally risky to participants. The apparent benign nature of "minimal risk" tasks increases the chance that investigators and Institutional Review Boards (IRBs) will overlook the probability that clinical tools will identify signs, symptoms, or definitive test results that are clinically-relevant to subjects' welfare. "Minimal risk" procedures may also pose a particular hazard to participants in clinical research by increasing the therapeutic misconception because the tasks mimic clinical (...) care and are often conducted in clinical settings. Investigators should anticipate which measures could yield clinically-important findings and should describe explicit plans for data monitoring, disclosure, and follow-up. Protocols that include reliable and valid clinical measures should prompt a more detailed risk assessment by the IRB, even when the tasks meet the regulatory criteria for minimal physical, psychological, or emotional risk. (shrink)

Pragmatic trials aim to directly inform health care decision-making through the collection of so-called ‘real world data’ from observations of comparative treatment effects in clinical practice. In order to ensure the applicability and feasibility of a pragmatic trial, design features may be necessary that deviate from standard research ethics requirements. Examples are traditional requirements to seek written informed consent and to perform extensive data and safety monitoring. Proposals for deviations from standard research ethics practice have resulted (...) in controversy about their ethical acceptability. One of the justifications for altered procedures is the allegedly high social value of pragmatic trials. In order to properly operationalize the concept in the ethical assessment of pragmatic trial designs, specification is warranted. We identified three determinants from common claims about a pragmatic trial's social value: the extent to which the research question has real world relevance, the trial design's ability to generate a real world answer and the probability of direct uptake of the results by decision-makers in practice. Subsequently, we discuss how these determinants should be applied to the practice of pragmatic trials, and to what extent they might be applicable to explanatory trials. (shrink)

Scholars have emphasized the potential of self-regulation, realized through ‘codes of good governance’, to improve gender diversity on boards. Yet, unconvinced of the effectiveness of this self-regulation, many regulators have implemented mandatory quota laws. Our study sheds light on this dilemma. Seeking to broaden our conceptual knowledge of how such ‘codes’ work in the specific case of gender diversity on boards, we ask: Under which conditions is self-regulation via voluntary principles of good governance effective? Expanding recent institutional-theory perspectives (...) from the literature of women on boards, we show that, in the case of Austria, self-regulation via code recommendations is ineffective unless supported by additional forces. The primary reason for this, we argue, is that nominators do not expect benefits from gender-diverse boards. Furthermore, non-compliant companies face little pressure to change due to the small number of companies that have already adopted respective code recommendations. We identify two potential alternatives to boost the effectiveness of voluntary self-regulation for gender-diverse boards: First, the introduction of concrete targets for female representation and the public monitoring of fulfillment; and, second, the establishment of a credible threat that mandatory quotas will be imposed if diversity goals are not achieved. Drawing on longitudinal data from 2006 to 2016 on listed and state-owned companies in Austria, we give an empirical account of the conditions that assure effective self-regulation. Arguing that codes suffer from what we call ‘opportunity bias’, we conclude that political goals based on ethical rather than instrumental considerations are unlikely to be effectively implemented solely by codes of good governance. (shrink)

In 1927, Walter Lippmann published The Phantom Public, denouncing the ‘mystical fallacy of democracy.’ Decrying romantic democratic models that privilege self-governance, he writes: “I have not happened to meet anybody, from a President of the United States to a professor of political science, who came anywhere near to embodying the accepted ideal of the sovereign and omnicompetent citizen.” Almost 90 years later, Lippmann’s pragmatism is as relevant as ever, and should be applied in new contexts where similar self-governance concerns persist. (...) This paper does just that, repurposing Lippmann’s argument in the context of the ongoing debate over the role of the digital citizen in Big Data management. It is argued that proposals by the Federal Trade Commission, the White House and the US Congress, championing failed notice and choice privacy policy, perpetuate a self-governance fallacy comparable to Lippmann’s, referred to here as the fallacy of data privacy self-management. Even if the digital citizen had the faculties and the system for data privacy self-management, the digital citizen has little time for data governance. We desire the freedom to pursue the ends of digital production, without being inhibited by the means. We want privacy, and safety, but cannot complete all that is required for its protection. If it is true that the fallacy of democracy is similar to the fallacy of data privacy self-management, then perhaps the pragmatic solution is representative data management: a combination of non/for-profit digital dossier management via infomediaries that can ensure the protection of personal data, while freeing individuals from what Lippmann referred to as an ‘unattainable ideal.’. (shrink)

The Internet of Things is an emerging information industry. Applying the information collection, transmission, and processing technologies in the Internet of Things technology to environmental monitoring, environmental emergency, and other environmental protection supervision fields will greatly improve the speed and accuracy of environmental supervision and facilitate the scientific development of environmental protection. Through the Internet of Things, people can obtain a large amount of reliable real-time information, and it is not easy to be affected by time, place, and environment, (...) while the wireless sensor network has the advantages of easy installation and low cost, so environmental monitoring through the Internet of Things is the future development trend. In this paper, in view of the current situation of water scarcity and serious water pollution in China, combined with the development trend and advantages of the Internet of Things, and based on the inadequacy of the existing microbial sensor data collection equipment, we propose a design scheme of microbial concentration monitoring system for waters based on IoT. The system is based on Zig Bee wireless sensor network to build a common data acquisition platform and design special hardware to carry out high-precision microbial sensor data acquisition in water and through the PC to complete the real-time measurement data storage, waveform display, and data processing. In this paper, the schematic diagram and PCB board design of the system hardware module NUC120 main control board, CC2530 RF board, Wi-Fi wireless communication module, and high-precision ADC acquisition module are completed and fabricated. Then, the four modules are combined to realize the development of the data aggregation node and data acquisition node of the dedicated Zig Bee wireless network hardware device. (shrink)

The general perception of how innovative assisted reproductive technologies are introduced is through a carefully controlled series of experiments in an animal model, such as the mouse. Only after the technique has been proven can one consider confirmatory studies on mammals closely related to humans, such as rhesus monkeys or other nonhuman primates. With this background of a peer-reviewed body of well-established published data, there is sufficient foundation and rationale to propose a clinical investigation to a responsible human subjects (...) institutional review board. IRBs weigh the benefits and risks of the new methods to human subjects, and then consider the appropriate informed consent procedures for the particular case. Only after a large number of clinical studies are performed at multiple sites and are peer reviewed can the efficacy and safety of the innovative approach be clearly evaluated. At that time, the potential therapy can be responsibly offered to suitable beneficiaries. (shrink)

The general perception of how innovative assisted reproductive technologies are introduced is through a carefully controlled series of experiments in an animal model, such as the mouse. Only after the technique has been proven can one consider confirmatory studies on mammals closely related to humans, such as rhesus monkeys or other nonhuman primates. With this background of a peer-reviewed body of well-established published data, there is sufficient foundation and rationale to propose a clinical investigation to a responsible human subjects (...) institutional review board. IRBs weigh the benefits and risks of the new methods to human subjects, and then consider the appropriate informed consent procedures for the particular case. Only after a large number of clinical studies are performed at multiple sites and are peer reviewed can the efficacy and safety of the innovative approach be clearly evaluated. At that time, the potential therapy can be responsibly offered to suitable beneficiaries. (shrink)