scholarly journals DELAYED RISKS: HOW THE IDEA OF INFORMED CONSENT IS CHANGING UNDER THE INFLUENCE OF BIOBANKS

Author(s):  
Роман Рифатович Белялетдинов

С учетом позиций визуальной семиотики предложен концепт «отложенные риски». Концепт фиксирует основание, во-первых, для анализа ситуации, вызванной развитием новых форм биомедицинских исследований, прежде всего генетических, на платформе биобанков. Во-вторых, для поиска формы предупреждения участника эксперимента о рисках, в которых отсутствует очевидность непосредственной опасности для здоровья, но которые в отдаленном будущем потенциально могут входить в противоречия с личными представлениями участника о благе. Проблемную ситуацию образует специфика исследований в биобанках, технически не позволяющих запрашивать информированное согласие для каждого конкретного исследования. В статье представлен обзор возникающих способов решения проблемы. Эти способы связаны с новыми формами согласия на участие в биомедицинских исследованиях – расширенные формы, которые даются на проведение множественных исследований, без информирования донора биобанка о каждом конкретном биомедицинском исследовании, для которого используются его биообразцы. Однако релевантность таких форм согласий вызывает дискуссии, стимулируемые упоминаемыми в статье прецедентами, а также гипотетическими обстоятельствами. В статье приводятся аргументы в пользу переосмысления фактического риска для здоровья, связанного с формой обычного информированного согласия, как отложенного риска, соотносимого с социогуманитарными ценностными интенциями, ассоциирующимися с представлением о взаимосвязи автономии и блага. Переход от конкретного риска к ценностному риску, отложенному по своему эффекту во времени, может быть репрезентирован публичными механизмами. Действия этих механизмов контролируют институции социогуманитарных экспертиз и биоэтики, ответственных за легитимацию смены прагматики информированного согласия. Но в этой «буферной зоне» между интересами технонауки, в сферу которой входят биобанки, и участниками биомедицинских экспериментов остается место позициям патернализма. Сделать эти позиции различимыми (как в социальной оптике, так и в индивидуальной оптике) позволяют потенциалы визуальной семиотики. «Новая этика» служит пониманию направления разработки оптических инструментов своим установлением множественных ракурсов рассмотрения конфигурации отложенных рисков. Визуализация отложенных рисков достижима на основе семиотической диагностики ценностных интенций участников биомедицинских экспериментов, что даст возможность для доноров биобанков контролировать возникновение противоречий между их убеждением и использованием их биоматериалов, а в широкой перспективе это служит основанием доверия к институту биобанков. Необходимость в визуализации отложенных рисков определяет появление новых видов исследований с участием человека (переход от единичных биомедицинских исследований на человеке к множественным биомедицинским исследованиям на биоматериалах человека). И появление новых видов рисков: от конкретных рисков здоровью в рамках одного исследования к масштабным социогуманитарным последствиям возможных неэтичных исследований в рамках множественных исследований на основе биобанков. Taking into account standpoints of visual semiotics, the concept “delayed risks” is proposed. The concept fixes the basis (1) for analyzing the situation caused by the development of new forms of biomedical research, primarily genetic, on the platform of biobanks; and (2) for searching for a form of warning the participant of the experiment about risks with no evidence of an immediate danger to health, but in the distant future potentially conflicting with the participant’s personal ideas about the good. The problematic situation is formed by the specificity of studies in biobanks, which technically do not allow requesting informed consent for each specific study. The article provides an overview of the emerging solutions to the problem. These solutions are associated with new forms of consent for participation in biomedical research – extended forms that are given for multiple studies, without informing the biobank donor about each specific biomedical research for which his/her bio-samples are used. However, the relevance of such forms of consent is controversial, stimulated by the precedents mentioned in the article, as well as hypothetical circumstances. The article provides arguments in favor of rethinking the actual health risk connected with the form of conventional informed consent as a delayed risk correlated with sociohumanitarian value intentions that are associated with the idea of the relationship between autonomy and welfare. The transition from a specific risk to a value risk delayed in time by its effect can be represented by public mechanisms. The actions of these mechanisms are controlled by the institutions of sociohumanitarian expert examinations and bioethics, which are responsible for legitimizing the change in the pragmatics of informed consent. But in this “buffer zone” between the interests of technoscience, which includes biobanks, and participants in biomedical experiments, there remains a place for the positions of paternalism. The potentials of visual semiotics make it possible to distinguish these positions (both in social optics and in individual optics). The “new ethic” serves to understand the direction of optical instrument development by establishing multiple angles for considering the configuration of delayed risks. Visualization of delayed risks is achievable on the basis of semiotic diagnostics of the value intentions of participants in biomedical experiments, which will make it possible for biobank donors to control the occurrence of contradictions between their beliefs and the use of their biomaterials, and, in a broad perspective, this serves as the basis for trust in the institution of biobanks. The need for visualization of delayed risks determines the emergence of new types of research with human participation (the transition from single biomedical studies in humans to multiple biomedical studies on human biomaterials), as well as the emergence of new types of risks: from specific health risks in a single study to the large-scale socio-humanitarian consequences of possible unethical research in the framework of multiple studies based on biobanks.

Author(s):  
Helena Breuer ◽  
Jianhe Du ◽  
Hesham Rakha

Existing literature on the relationship between ride-hailing (RH) and transit services is limited to empirical studies that lack real-time spatial contexts. To fill this gap, we took a novel real-time geospatial analysis approach. With source data on ride-hailing trips in Chicago, Illinois, we computed real-time transit-equivalent trips for all 7,949,902 ride-hailing trips in June 2019; the sheer size of our sample is incomparable to the samples studied in existing literature. An existing Multinomial Nested Logit Model was used to determine the probability of a ride-hailer selecting a transit alternative to serve the specific O-D pair, P(Transit|CTA)[1]. We find that 31% of ride-hailing trips are replaceable, whereas 61% of trips are not replaceable. The remaining 8% lie within a buffer zone. We measured the robustness of this probability using a parametric sensitivity analysis and performed a two-tailed t-test. Our results indicate that of the four sensitivity parameters, the probability was most sensitive to the total travel time of a transit trip. The main contribution of our research is our thorough approach and fine-tuned series of real-time spatiotemporal analyses that investigate the replaceability of ride-hailing trips for public transit. The results and discussion intend to provide perspective derived from real trips and we anticipate that this paper will demonstrate the research benefits associated with the recording and release of ride-hailing data. [1] This value defines the replaceability of the trip, where a value ranging from 0 to 0.45 is considered not-replaceable (NR), and a value ranging from 0.55 to 1.0 is considered replaceable (R).


2021 ◽  
Author(s):  
KV Zorin ◽  
KG Gurevich

Not only quarantine measures should be the main strategy for preventing COVID-19, but also large-scale vaccination of the population. Therefore, there are many ethical questions associated with obtaining voluntary informed consent in biomedical research and clinical practice. An ethical review of vaccination against a new coronavirus infection can be carried out fully and adequately provided that the ethical aspects of voluntary informed consent are observed. Without this, it is impossible to control the quality, efficacy and safety of the vaccine, and, consequently, the vaccination of patients and its results.


Author(s):  
Miguel H. Kottow

Ever since medicine became a recognized profession, the relationship between patients and physicians was marked by authoritarian paternalism. With the advent of bioethics in the 1970s, patients' right to participate in decision making led to proclaim autonomy as the primary principle in clinical medicine and biomedical research, practically exercised as informed consent; yet, the issue remains contended and poorly regulated. Healthcare digitalization disassembles persons into clouds of data. Individual decision making is interfered with and replaced by dominant algorithms, supposedly delivering a P4 composite of precision medicine: personalized, preventive, predictive, participatory. Biomedicine develops into medicalization, marketization contractual client/provider relationship, and neglect of personal care for the ill and frail. These trends become dominant in digitalized healthcare as personal healthcare relationships, and ethically unsatisfactory medical services replace the psychosocial, existential elements of health/disease.


VASA ◽  
2020 ◽  
pp. 1-6
Author(s):  
Hanji Zhang ◽  
Dexin Yin ◽  
Yue Zhao ◽  
Yezhou Li ◽  
Dejiang Yao ◽  
...  

Summary: Our meta-analysis focused on the relationship between homocysteine (Hcy) level and the incidence of aneurysms and looked at the relationship between smoking, hypertension and aneurysms. A systematic literature search of Pubmed, Web of Science, and Embase databases (up to March 31, 2020) resulted in the identification of 19 studies, including 2,629 aneurysm patients and 6,497 healthy participants. Combined analysis of the included studies showed that number of smoking, hypertension and hyperhomocysteinemia (HHcy) in aneurysm patients was higher than that in the control groups, and the total plasma Hcy level in aneurysm patients was also higher. These findings suggest that smoking, hypertension and HHcy may be risk factors for the development and progression of aneurysms. Although the heterogeneity of meta-analysis was significant, it was found that the heterogeneity might come from the difference between race and disease species through subgroup analysis. Large-scale randomized controlled studies of single species and single disease species are needed in the future to supplement the accuracy of the results.


2020 ◽  
pp. 27-34
Author(s):  
Vladimir Batiuk

In this article, the ''Cold War'' is understood as a situation where the relationship between the leading States is determined by ideological confrontation and, at the same time, the presence of nuclear weapons precludes the development of this confrontation into a large-scale armed conflict. Such a situation has developed in the years 1945–1989, during the first Cold War. We see that something similar is repeated in our time-with all the new nuances in the ideological struggle and in the nuclear arms race.


2020 ◽  
Author(s):  
Amir Karami ◽  
Brandon Bookstaver ◽  
Melissa Nolan

BACKGROUND The COVID-19 pandemic has impacted nearly all aspects of life and has posed significant threats to international health and the economy. Given the rapidly unfolding nature of the current pandemic, there is an urgent need to streamline literature synthesis of the growing scientific research to elucidate targeted solutions. While traditional systematic literature review studies provide valuable insights, these studies have restrictions, including analyzing a limited number of papers, having various biases, being time-consuming and labor-intensive, focusing on a few topics, incapable of trend analysis, and lack of data-driven tools. OBJECTIVE This study fills the mentioned restrictions in the literature and practice by analyzing two biomedical concepts, clinical manifestations of disease and therapeutic chemical compounds, with text mining methods in a corpus containing COVID-19 research papers and find associations between the two biomedical concepts. METHODS This research has collected papers representing COVID-19 pre-prints and peer-reviewed research published in 2020. We used frequency analysis to find highly frequent manifestations and therapeutic chemicals, representing the importance of the two biomedical concepts. This study also applied topic modeling to find the relationship between the two biomedical concepts. RESULTS We analyzed 9,298 research papers published through May 5, 2020 and found 3,645 disease-related and 2,434 chemical-related articles. The most frequent clinical manifestations of disease terminology included COVID-19, SARS, cancer, pneumonia, fever, and cough. The most frequent chemical-related terminology included Lopinavir, Ritonavir, Oxygen, Chloroquine, Remdesivir, and water. Topic modeling provided 25 categories showing relationships between our two overarching categories. These categories represent statistically significant associations between multiple aspects of each category, some connections of which were novel and not previously identified by the scientific community. CONCLUSIONS Appreciation of this context is vital due to the lack of a systematic large-scale literature review survey and the importance of fast literature review during the current COVID-19 pandemic for developing treatments. This study is beneficial to researchers for obtaining a macro-level picture of literature, to educators for knowing the scope of literature, to journals for exploring most discussed disease symptoms and pharmaceutical targets, and to policymakers and funding agencies for creating scientific strategic plans regarding COVID-19.


2020 ◽  
Vol 3 (1) ◽  
pp. 8-13
Author(s):  
Moch. Munir ◽  
Amiruddin Kade ◽  
Muslimin Muslimin

This study aims to determine the relations between metacognitive to science process skills on grade VIII students MTs Negeri 3 Parigi. This research is descriptive, the approach used is a quantitative approach, manifested in the form of numbers analyzed by statistics and the results are described. The population is students of MTs Negeri 3 Parigi Academic Year 2017-2018 with a population of three classes, with a sample of 30 students. The instrument used is a metacognitive questionnaire consisting of 50 questions and an essay about science process skills 6 questions test. The result of the prerequisite test of the research result is all metacognitive indicators of normal and linear distributed and based on the regression feasibility test show that all data is feasible for regression test. The result of the regression test and test of determination to obtain a value which is not significant. Based on the results of the research analysis it can be concluded that the relationship of each metacognitive indicator to science process skills was not significant even there were metacognitive indicators that reverse direction significantly. The magnitude of the relationship of each metacognitive indicator with science process skills maximum 15.3%.  


2019 ◽  
Vol 22 (3) ◽  
pp. 365-380 ◽  
Author(s):  
Matthias Olthaar ◽  
Wilfred Dolfsma ◽  
Clemens Lutz ◽  
Florian Noseleit

In a competitive business environment at the Bottom of the Pyramid smallholders supplying global value chains may be thought to be at the whims of downstream large-scale players and local market forces, leaving no room for strategic entrepreneurial behavior. In such a context we test the relationship between the use of strategic resources and firm performance. We adopt the Resource Based Theory and show that seemingly homogenous smallholders deploy resources differently and, consequently, some do outperform others. We argue that the ‘resource-based theory’ results in a more fine-grained understanding of smallholder performance than approaches generally applied in agricultural economics. We develop a mixed-method approach that allows one to pinpoint relevant, industry-specific resources, and allows for empirical identification of the relative contribution of each resource to competitive advantage. The results show that proper use of quality labor, storage facilities, time of selling, and availability of animals are key capabilities.


Author(s):  
Richard Culliford ◽  
Alex J. Cornish ◽  
Philip J. Law ◽  
Susan M. Farrington ◽  
Kimmo Palin ◽  
...  

Abstract Background Epidemiological studies of the relationship between gallstone disease and circulating levels of bilirubin with risk of developing colorectal cancer (CRC) have been inconsistent. To address possible confounding and reverse causation, we examine the relationship between these potential risk factors and CRC using Mendelian randomisation (MR). Methods We used two-sample MR to examine the relationship between genetic liability to gallstone disease and circulating levels of bilirubin with CRC in 26,397 patients and 41,481 controls. We calculated the odds ratio per genetically predicted SD unit increase in log bilirubin levels (ORSD) for CRC and tested for a non-zero causal effect of gallstones on CRC. Sensitivity analysis was applied to identify violations of estimator assumptions. Results No association between either gallstone disease (P value = 0.60) or circulating levels of bilirubin (ORSD = 1.00, 95% confidence interval (CI) = 0.96–1.03, P value = 0.90) with CRC was shown. Conclusions Despite the large scale of this study, we found no evidence for a causal relationship between either circulating levels of bilirubin or gallstone disease with risk of developing CRC. While the magnitude of effect suggested by some observational studies can confidently be excluded, we cannot exclude the possibility of smaller effect sizes and non-linear relationships.


Sign in / Sign up

Export Citation Format

Share Document