Responsibilities of the data monitoring committee and motivating illustrations -- Composition of a data monitoring committee -- Independence of the data monitoring committee : avoiding conflicts of interest -- Confidentiality issues relating to the data monitoring committee -- Data monitoring committee meetings -- Data monitoring committee interactions with other trial components or related groups -- Statistical, philosophical and ethical issues in data monitoring -- Determining when a data monitoring committee is needed -- (...) Regulatory considerations for the operation of data monitoring committees -- Legal considerations for DMCs. (shrink)

This paper considers electronic monitoring (EM) a promising alternative to imprisonment as a criminal sanction for a series of criminal offenses. However, little has been said about EM from an ethical perspective. To evaluate EM from an ethical perspective, six initial ethical challenges are addressed and discussed. It is argued that since EM is developing as a technology and a punitive means, it is urgent to discuss its ethical implications and incorporate moral values into its design and development.

One of the central points of contention in the epistemology of testimony concerns the uniqueness (or not) of the justification of beliefs formed through testimony--whether such justification can be accounted for in terms of, or 'reduced to,' other familiar sort of justification, e.g. without relying on any epistemic principles unique to testimony. One influential argument for the reductionist position, found in the work of Elizabeth Fricker, argues by appeal to the need for the hearer to monitor the testimony for credibility. (...) Fricker (1994) argues, first, that some monitoring for trustworthiness is required if the hearer is to avoid being gullible, and second, that reductionism but not anti-reductionism is compatible with ascribing an important role to the process of monitoring in the course of justifiably accepting observed testimony. In this paper we argue that such an argument fails. (shrink)

It is often taken for granted that monitoring stands in some kind of tension with trusting (e.g., Hieronymi 2008; Wanderer and Townsend 2013; Nguyen forthcoming; McMyler 2011, Castelfranchi and Falcone 2000; Frey 1993; Dasgupta 1988, Litzky et al. 2006) — especially three-place trust (i.e., A trusts B to X), but sometimes also two-place trust (i.e., A trusts B, see, e.g., Baier 1986). Using a case study involving relationship breakdown, repair, and formation, I will argue there are some ways in (...) which monitoring can be conducive to two-place trust, and to instances of three-place trust that are likely to be repeated over time—especially when previously established two-place trust has broken down. The result, I hope, is not any kind of abandoning of the important idea that monitoring can undermine trust, but an appreciation of where the conflict between monitoring and trust doesn’t lie – one from which future work will hopefully be better positioned to illuminate where exactly the conflict is. (shrink)

One hypothesis concerning the human dorsal anterior cingulate cortex (ACC) is that it functions, in part, to signal the occurrence of conflicts in information processing, thereby triggering compensatory adjustments in cognitive control. Since this idea was first proposed, a great deal of relevant empirical evidence has accrued. This evidence has largely corroborated the conflict-monitoring hypothesis, and some very recent work has provided striking new support for the theory. At the same time, other findings have posed specific challenges, especially concerning (...) the way the theory addresses the processing of errors. Recent research has also begun to shed light on the larger function of the ACC, suggesting some new possibilities concerning how conflict monitoring might fit into the cingulate's overall role in cognition and action. (shrink)

Storchak, Ehlis, and Fallgatter provide an extensive literature review on electrophysiological measurements, which indicate that general predictive deficits in self‐monitoring are associated with various positive symptoms in patients with schizophrenia.

Monitoring ongoing clinical trials for early signs of effectiveness is an option for improving cost-effectiveness of trials that is becoming increasingly common. Alongside the obvious advantages made possible by monitoring, however, there are some downsides. In particular, there is growing concern in the medical community that trials stopped early for benefit tend to overestimate treatment effect. In this paper, I examine this problem from the point of view of statistical methodology, starting from the observation that the overestimation is (...) caused by the statistical method adopted. Consequently, I argue that some modifications can and should be made to the present statistical framework in order not to miss the advantages the possibility of monitoring can grant. (shrink)

ABSTRACTThe general assumption that people fail to notice discrepancy between their answer and the normative answer in the conjunction fallacy task has been challenged by the theory of Logical Intuition. This theory suggests that people can detect the conflict between the heuristic and normative answers even if they do not always manage to inhibit their intuitive choice. This theory gained support from the finding that people report lower levels of confidence in their choice after they commit the conjunction fallacy compared (...) to when their answer is not in conflict with logic. In four experiments we asked the participants to give probability estimations to the options of the conflict and no-conflict versions of the tasks in the original set-up of the experiment or in a three-option design. We found that participants perceive probabilities for the options of the conflict version less similar than for the no-conflict version. As people are less confident when choosing between more similar options, this simil.. (shrink)

There is sufficient evidence to believe that variations in the error-related negativity (ERN) are linked to dispositional characteristics in individuals. However, explanations of individual differences in the amplitude of the ERN cannot be derived from functional theories of the ERN. The ERN has a counterpart that occurs after correct responses (correct-response negativity, CRN). Based on the assumption that ERN and CRN reflect an identical cognitive process, variations in CRN might be associated with dispositional characteristics as well. Higher CRN amplitudes have (...) been found to reflect task engagement. In the present study, a simple-choice-reaction task was used to investigate ERN and CRN amplitudes in relation to their score on a conscientiousness scale. The task consisted of a simple rule that required pressing the left or right key when a circle or square appeared, respectively. During alternative conditions that occur infrequently, participants were instructed to violate or reverse the previously established response rules. Smaller ΔERN amplitudes (manifested in almost equal CRN and ERN amplitudes) and a tendency of better task performance from participants scoring high on the conscientiousness scale might indicate a greater focus on the task and higher motivation of responding correctly. In addition, higher Pc amplitudes directly following the CRN indicated that the response monitoring system of less conscientious participants showed a higher disengagement. The role of individual differences in CRN amplitude should be studied in future experiments on performance monitoring. (shrink)

The proportion of elderly in society is growing rapidly, leading to increasing health care costs. New remote monitoring technologies are expected to lower these costs by reducing the number of close encounters with health care professionals, for example the number of visits to health care centres. In this paper, I discuss issues of priority setting raised by this expectation. As a starting-point, I analyse the recent debate on principles for priority setting in Sweden. The Swedish debate illustrates that developing (...) an approach to priority setting is an ongoing process. On the basis of this analysis, I conclude that several different ethical principles, and specifications of these principles, can be appealed to for giving priority—over close encounters—to a large-scale introduction of remote monitoring technologies in health care services to elderly people, but also that many specifications can be appealed to against giving such priority. I propose that given the different views on principles, it is necessary to develop fair procedures of deliberation on these principles and their application, in particular in order to reach agreement on exactly how much resources should be allocated to remote monitoring and how much to close encounters. I also present a few points to consider in a large-scale introduction of remote monitoring. (shrink)

The eye may be window to the soul, but neuroscientists aim to get inside and measure the interior directly. There's also talk about moving some walls.

The jurisprudence under international human rights treaties has had a considerable impact across countries. Known for addressing complex agendas, the work of expert bodies under the treaties has been credited and relied upon for filling the gaps in the realization of several objectives, including the peace and security agenda. -/- In 1982, the Human Rights Committee (ICCPR), in a General Comment observed that “states have the supreme duty to prevent wars, acts of genocide and other acts of mass violence ... (...) Every effort … to avert the danger of war, especially thermonuclear war, and to strengthen international peace and security would constitute the most important condition and guarantee for the safeguarding of the right to life.” Over the years, all treaty bodies have contributed in this direction, endorsing peace and security so as “to protect people against direct and structural violence … as systemic problems and not merely as isolated incidents …”. A closer look at the jurisprudence on peace and security, emanating from treaty monitoring mechanisms including state periodic reports, interpretive statements, the individual communications procedure, and others, reveals its distinctive nature. (shrink)

The revelation that data obtained for the US-based National Surgical Adjuvant Breast and Bowel Project (NSABP) from subjects enrolled at Hôpital Saint-Luc in Montreal was falsified has eroded public trust in research. Institutions can educate researchers and help prevent unethical research practices by establishing procedures to monitor research involving human subjects. Research monitoring encompasses four categories of activity: annual reviews of continuing research, monitoring of informed consent, monitoring of adherence to approved protocols and monitoring of the (...) integrity of data. The authors describe characteristics of research projects that may call for monitoring procedures in each category. The form taken by such monitoring depends on the nature of the protocol. Although appropriate research monitoring requires substantial investment of personnel and financial resources, it is required under guidelines regulating research involving human subjects in Canada. Research monitoring is a step forward in re-establishing public confidence in medical research. (shrink)

Performing two cognitively demanding tasks at the same time is known to decrease performance. The current study investigates the underlying executive functions of a dual-tasking situation involving the simultaneous performance of decision making under explicit risk and a working memory task. It is suggested that making a decision and performing a working memory task at the same time should particularly require monitoring—an executive control process supervising behavior and the state of processing on two tasks. To test the role of (...) a supervisory/monitoring function in such a dual-tasking situation we investigated 122 participants with the Game of Dice Task plus 2-back task (GDT plus 2-back task). This dual task requires participants to make decisions under risk and to perform a 2-back working memory task at the same time. Furthermore, a task measuring a set of several executive functions gathered in the term concept formation (Modified Card Sorting Test, MCST) and the newly developed Balanced Switching Task (BST), measuring monitoring in particular, were used. The results demonstrate that concept formation and monitoring are involved in the simultaneous performance of decision making under risk and a working memory task. In particular, the mediation analysis revealed that BST performance partially mediates the influence of MCST performance on the GDT plus 2-back task. These findings suggest that monitoring is one important subfunction for superior performance in a dual-tasking situation including decision making under risk and a working memory task. (shrink)

Monitoring and evaluation (M&E) is an essential part of public health programmes. Since M&E is the backbone of public health programmes, ethical considerations are important in their conduct. Some of the key ethical considerations are avoiding conflicts of interest, maintaining independence of judgement, maintaining fairness, transparency, full disclosure, privacy and confidentiality, respect, responsibility, accountability, empowerment and sustainability. There are several ethical frameworks in public health, but none focusing on the monitoring and evaluation process. There is a need to (...) institutionalise the ethical review of M&E proposals. A theoretical framework for ethical considerations is proposed in this paper. This proposed theoretical framework can act as the blueprint for building the capacity of ethics committees to review M&E proposals. A case study is discussed in this context. After thorough field testing, this practical and field-based ethical framework can be widely used by donor agencies, M&E teams, institutional review boards and ethics committees. (shrink)

Monitoring and evaluation is an essential part of public health programmes. Since M&E is the backbone of public health programmes, ethical considerations are important in their conduct. Some of the key ethical considerations are avoiding conflicts of interest, maintaining independence of judgement, maintaining fairness, transparency, full disclosure, privacy and confidentiality, respect, responsibility, accountability, empowerment and sustainability. There are several ethical frameworks in public health, but none focusing on the monitoring and evaluation process. There is a need to institutionalise (...) the ethical review of M&E proposals. A theoretical framework for ethical considerations is proposed in this paper. This proposed theoretical framework can act as the blueprint for building the capacity of ethics committees to review M&E proposals. A case study is discussed in this context. After thorough field testing, this practical and field-based ethical framework can be widely used by donor agencies, M&E teams, institutional review boards and ethics committees. (shrink)

Design of clinical trials for germline gene editing stretches current accepted standards for human subjects research. Among the challenges involved is a set of issues concerningintergenerational monitoring—long-term follow-up study of subjects and their descendants. Because changes made at the germline would be heritable, germline gene editing could have adverse effects on individuals’ health that can be passed on to future generations. Determining whether germline gene editing is safe and effective for clinical use thus may require intergenerational monitoring. The (...) aim of this paper is to identify and argue for the significance of a set of ethical issues raised by intergenerational monitoring in future clinical trials of germline gene editing. Though long-term, multigenerational follow-up study of this kind is not without precedent, intergenerational monitoring in this context raises unique ethical challenges, challenges that go beyond existing protocols and standards for human subjects research. These challenges will need to be addressed if clinical trials of germline gene editing are ever pursued. (shrink)

The neural basis of progress monitoring has received relatively little attention compared to other sub-processes that are involved in goal directed behavior such as motor control and response inhibition. Studies of error-monitoring have identified the dorsal anterior cingulate cortex (dACC) as a structure that is sensitive to conflict detection, and triggers corrective action. However, monitoring goal progress involves monitoring correct as well as erroneous events over a period of time. In the present research, 20 healthy participants (...) underwent fMRI while playing a game that involved monitoring progress towards either a numerical or a visuo-spatial target. The findings confirmed the role of the dACC in detecting situations in which the current state may conflict with the desired state, but also revealed activations in the frontal and parietal regions, pointing to the involvement of processes such as attention and working memory in monitoring progress over time. In addition, activation of the cuneus was associated with monitoring progress towards a specific target presented in the visual modality. This is the first time that activation in this region has been linked to higher-order processing of goal-relevant information, rather than low-level anticipation of visual stimuli. Taken together, these findings identify the neural substrates involved in monitoring progress over time, and how these extend beyond activations observed in conflict and error monitoring. (shrink)

It is often taken for granted that monitoring stands in some kind of tension with trusting (e.g., Hieronymi 2008; Wanderer and Townsend 2013; Nguyen forthcoming; McMyler 2011, Castelfranchi and Falcone 2000; Frey 1993; Dasgupta 1988, Litzky et al. 2006) — especially three-place trust (i.e., A trusts B to X), but sometimes also two-place trust (i.e., A trusts B, see, e.g., Baier 1986). Using a case study involving relationship breakdown, repair, and formation, I will argue there are some ways in (...) which monitoring can be conducive to two-place trust, and to instances of three-place trust that are likely to be repeated over time—especially when previously established two-place trust has broken down. The result, I hope, is not any kind of abandoning of the important idea that monitoring can undermine trust, but an appreciation of where the conflict between monitoring and trust doesn’t lie – one from which future work will hopefully be better positioned to illuminate where exactly the conflict is. (shrink)

Active monitoring of research with human subjects is no longer reserved for especially complex research or investigating research alleged to be problematic. Rather, many human research subjects’ protection programmes now engage in routine monitoring. Although limited data concerning such monitoring are available, the Association for the Accreditation of Human Research Protection Programs , reports that in 2011 its accredited organisations conducted many routine audits .1 While accredited organisations currently represent a small subset of human subjects’ research programmes, (...) these data are consistent with AAHRP's standard : ‘The Organization measures and improves, when necessary, compliance with organizational policies and procedures and applicable laws, regulations, codes, and guidance. The Organization also measures and improves, when necessary, the quality, effectiveness, and efficiency of the Human Research Protection Program.’2In this issue of Journal of Medical Ethics …. (shrink)

This article discloses topical issues of the need for constant monitoring of changes in the business activity in enterprise structures. The main purpose of the study is to monitor the business activity of industrial enterprise structures of Ukraine to predict their development under martial law. A critical analysis of the content of scientific publications to solve the problem of improving the management of business activity of business structures revealed the lack of attention of scientists to the problems under study. (...) The relevance of its solution is due to the scale of the impact of military conflicts on the business activity in enterprise structures, which requires its monitoring to further establish the state and ensure compliance of the business with the norms that are considered necessary to maintain a certain level of stability of development or to survive, to determine areas where the business can improve its activities and become more profitable. The methodological basis is the system of methods used to obtain the final results of the study: theoretical generalization – to deepen the essence of the concept of «monitoring business activity»; analysis, synthesis and logical generalization – to obtain conclusions during monitoring of business confidence and business climate in industry; prognostic – to predict the development of industrial business structures of Ukraine under martial law. The object of research in the work is the business activity of business structures. The article presents the results of monitoring business confidence and business climate in the industry of Ukraine under martial law. Analysis, synthesis and logical generalization of monitoring results became the basis for further forecasting the development of business structures. The results of the study can be useful for business structures that seek to maintain a certain level of stability of development and identify areas of improvement. (shrink)

A learning health system (LHS) seeks to establish a closer connection between clinical care and research and establishes new responsibilities for healthcare providers as well as patients. A new set of technological approaches in medication adherence monitoring can potentially yield valuable data within an LHS, and raises the question of the scope and limitations of patients’ responsibilities to use them. We argue here that, in principle, it is plausible to suggest that patients have a prima facie obligation to use (...) novel adherence monitors. However, the strength of the obligations depends considerably on the extent to which data that adherence monitors generate are, in fact, used to further the goals of LHSs. The way in which data ownership is structured in the USA poses a considerable challenge here, while the European Union framework offers a more promising alternative. (shrink)

The aim of the paper is to investigate the effects of the corporate governance model on social and environmental disclosure (SED). We analyze the disclosures of the 100 U.S. Best Corporate Citizens in the period 2005–2007, and we posit a series of simultaneous relationships between different attributes of the governance system and a multidimensional construct of corporate social performance (CSP). We consider both the extent and the quality of SED, with the purpose of identifying increasing levels of corporate commitment to (...) stakeholders and shedding some light on whether SED is used as a signal or rather as a legitimacy tool. Our empirical evidence shows that the stakeholders’ orientation of corporate governance is positively associated with CSP and SED. On the other hand, we do not find support for the monitoring intensity of corporate governance being negatively associated with social performance. We also find that CSP in the “product” dimension is positively associated with the extent and quality of SED whilst CSP in the “people” dimension is negatively associated with the extent and quality of SED. At a time when shareholders and stakeholders share more common aspects in their relationships with firms, this is a significant area to explore and this research fills an important lacuna in this respect. (shrink)

James Russell claims that executive difficulties in both autism and schizophrenia are likely to be due to impairments of action monitoring at "a fairly high level". I argue that there is room for some 'intermediate' level of action-monitoring in between the higher and lower levels he distinguishes and that impairments at this intermediate level may play an important role in explaining some of the difficulties encountered by both schizophrenic patients and subjects with autism.

As computers became multi-component systems in the 1950s, handling the speed differentials efficiently was identified as a major challenge. The desire for better understanding and control of ‘concurrency’ spread into hardware, software, and formalism. This paper examines the way in which the problem emerged and was handled across various computing cultures from 1955 to 1985. In the machinic culture of the late 1950s, system programs called ‘monitors’ were used for directly managing synchronisation. Attempts to reframe synchronisation in the subsequent algorithmic (...) culture pushed the problem to a higher level of abstraction; Dijkstra’s semaphores were a reaction to the algorithms’ complexity. Towards the end of the 1960s, the culture of ‘structured programming’ created a milieu in which Dijkstra, Hoare, and Brinch Hansen (among others) aimed for a concurrency primitive which embodied the new view of programming. Via conditional critical regions and Dijkstra’s ‘secretaries’, the co-produced ‘monitor’ appeared to provide the desired encapsulation. The construct received embodiment in a few programming languages; this paper ends by considering Modula and Concurrent Pascal. (shrink)

The ethical monitoring of brain-machine interfaces (BMIs) is discussed in connection with the potential impact of BMIs on distinguishing traits of persons, changes of personal identity, and threats to personal autonomy. It is pointed out that philosophical analyses of personhood are conducive to isolating an initial thematic framework for this ethical monitoring problem, but a contextual refinement of this initial framework depends on applied ethics analyses of current BMI models and empirical case-studies. The personal autonomy-monitoring problem is (...) approached by identifying various ways in which the inclusion of a robotic controller in the motor pathway of an output BMI may limit or jeopardize personal autonomy. (shrink)

Anosognosia for hemiplegia is a lack of awareness about paralysis following stroke. Recent explanations use a ‘forward model’ of movement to suggest that AHP patients fail to register discrepancies between internally- and externally-generated sensory information. We predicted that this failure would impair the ability to recall from memory whether information is internally- or externally-generated . Two experiments examined this prediction. Experiment 1 demonstrated that AHP patients exhibit a reality monitoring deficit for non-motor information , whilst hemiplegic controls without anosognosia (...) perform like age-matched healthy volunteers . Experiment 2 explored if this deficit occurs when AHP patients discriminate performed, imagined, or observed movement. Results showed impaired reality monitoring for movements in AHP and nonAHP patients relative to HVs. Findings suggest that reality monitoring processes not directly related to movement, together with a failure to reality monitor movements, contribute to the pathogenesis of AHP. (shrink)

Futsal is a sport that presents alternation of high- and low-intensity moments, which lacks investigations regarding the effects of the organization of the training load on biomotor skills. In this sense, this study aims to verify the monitoring of the training load throughout the season and the behavior of biomotor skills in futsal athletes. Twelve futsal athletes from the adult category, who competed in the first division of the Paulista championship, participated in the study. Throughout the season, the internal (...) training load was calculated, through the relationship between volume and the rate of perceived exertion, monotony, and training strain. The training periods were divided into preparatory, competitive, and competitive II for a total of four moments of evaluation: M1: at the beginning of the preparatory period; M2: 50 week, at the end of the preparatory period; M3: 13th week, in the middle of the competitive period; and M4: at the start of the competitive period II. The tests used were: Power of lower limbs: countermovement jump ; Displacement speed, over the 10-meter distance, and Aerobic power by the Carminatti test. The variables analyzed were compared at different moments of evaluation using the two-way ANOVA completed by the Bonferroni test. For monotony, training strain, and ILT, the ANOVA ONE-WAY test was used between the evaluation periods completed by the Bonferroni test. The significance value adopted was p < 0.05. A significant improvement was observed in the power of lower limbs from M1 to M3, from M2 to M3, and from M1 to M4. Aerobic power showed a significant increase from M1 to M3 and from M1 to M4. The ITL showed a difference between competitive I and II in relation to the preparatory period. In conclusion, the proposed training organization was sufficient to improve the power of the lower limbs and the aerobic power. (shrink)

Monitoring of MAIDMonitoring of MAID was recognised as an essential component of the MAID program. However, monitoring started late in the rollout of the program, and even at present is missing some essential elements that would be important for effective oversight and public accountability. Health CanadaCanada is using some of the data obtained from practitioners and pharmacists to produce Annual Reports on MAID, but these reports aim at providing only a “societal perspective,” rather than an in-depth assessment of (...) the program’s performance. A major deficit is lack of monitoring and reporting on the compliance with eligibility criteria and procedural safeguards that should be coming from territorial and provincial governments, and that would provide assurance that MAID delivery complies with the Criminal CodeCriminal Code of Canada. Monitoring is based entirely on self reporting and therefore it is recommended that Health Canada obtain supportive data by initiation of on-site retrospective reviews of randomly selected MAID deliveries across the country. In addition, it would be useful to enhance the quantity and quality of data collected from MAID assessors and providers. Organizations involved in MAID provisions (hospitals, regional health authorities and so on) should also report annually on MAID activities to their respective communities. Improvement of monitoring and reporting would address serious concerns among professionals, people with disabilities and advocates for vulnerable populations while providing for a higher level of transparency and accountability. (shrink)

ArgumentThis paper examines the earthquake monitoring and prediction program, called “collective monitoring, collective defense,” in communist China during the Cultural Revolution, a period of political upheavals and natural disasters. Guided by their scientific and political ideas, the Chinese developed approaches to earthquake monitoring and prediction that emphasized mass participation, everyday knowledge, and observations of macro-seismic phenomena. The paper explains the ideas, practices, and epistemology of the program within the political context of the Cultural Revolution. It also suggests (...) possibilities for comparative analysis of science, state, and natural disasters. The paper redefines the concept of “citizen science” and argues that the concept provides a useful comparative perspective on the intimate relationship between science and the macropolitics of modern state and society. (shrink)