Artículos de revistas: "E-consent"

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Mueller, Melissa J. y Jason Kadrmas. "2388". Journal of Clinical and Translational Science 1, S1 (septiembre de 2017): 41. http://dx.doi.org/10.1017/cts.2017.149.

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OBJECTIVES/SPECIFIC AIMS: The goal of the eResearch platform is to make consenting for clinical trials more convenient, accessible, and faster while retaining an ethical and informed consenting process. eResearch e-consent also allows for enhanced standardization and efficiency for research collaborations across academic research institutions, which, ultimately, helps drive discovery of better health care for our patients and communities. METHODS/STUDY POPULATION: The UMN’s CTSI and AHC Information Systems developed software, called eResearch Suite, for electronic consenting. The eResearch Suite includes viewing a consent, a “Check Your Understanding” quiz to assess comprehension of critical study details, and a signature block that captures the participant signature electronically and with an automatic date and time stamp. The eResearch Suite also has the capability to randomize participants, track participants via a master list, collect participant data, collect internal study data, and generate emails to participants. The eResearch Suite platform is written in Ruby on Rails. RESULTS/ANTICIPATED RESULTS: We have pilot tested the eResearch platform with one study thus far. Preliminary results of the study show that all participants consented via eResearch, with 64% of participants consenting remotely via eResearch before their first study visit. Participants e-consented using various devices including desktop computers, tablets, and smart phones. Participants also filled out surveys and questionnaires before their study visits, which saved the study team time and money. DISCUSSION/SIGNIFICANCE OF IMPACT: eResearch electronic consenting (e-consenting) changes the way potential participants consent for studies. e-Consenting is important because it allows individuals, or their Legally Authorized Representatives, to consent remotely. This may be faster, more convenient for people, reduce coercion, increase comprehension, and allow for consenting information or process to be shared with an individual’s family/friends. In acute and emergent settings we anticipate eResearch e-consenting will result in significant reduction of consent time by replacing faxed and paper consent with e-consent available via email and mobile devices. This allows legally authorized representatives to sign consent remotely, reduces the time physicians spend faxing consents, and allow them to avert more focus back on their patients. Time savings, whether for consent or study visits, may also result in a cost savings for studies.

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Recupero, Patricia R. y Samara E. Rainey. "Informed Consent to E-Therapy". American Journal of Psychotherapy 59, n.º 4 (octubre de 2005): 319–31. http://dx.doi.org/10.1176/appi.psychotherapy.2005.59.4.319.

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Wilbanks, John. "Design Issues in E-Consent". Journal of Law, Medicine & Ethics 46, n.º 1 (2018): 110–18. http://dx.doi.org/10.1177/1073110518766025.

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Electronic informed consent represents an opportunity to redesign the way that participants understand and elect to enroll in clinical research studies. However, electronic consent faces certain barriers common to all informed consent processes and other barriers specific to the technical environment. At Sage Bionetworks, we designed an electronic consent process as a software product and released it as an open source tool. We believe that using contemporary design processes to intentionally create cognitive friction, where potential study participants are confronted with interfaces that require them to slow down and contemplate study concepts, offers a significant opportunity for ethical design as research increasingly uses smartphones and digital methodologies.

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Wuyts, Kim, Riccardo Scandariato, Griet Verhenneman y Wouter Joosen. "Integrating Patient Consent in e-Health Access Control". International Journal of Secure Software Engineering 2, n.º 2 (abril de 2011): 1–24. http://dx.doi.org/10.4018/jsse.2011040101.

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Many initiatives exist that integrate e-health systems on a large scale. One of the main technical challenges is access control, although several frameworks and solutions, like XACML, are becoming standard practice. Data is no longer shared within one affinity domain but becomes ubiquitous, which results in a loss of control. As patients will be less willing to participate without additional control strategies, patient consents are introduced that allow the patients to determine precise access rules on their medical data. This paper explores the consequences of integrating consent in e-health access control. First, consent requirements are examined, after which an architecture is proposed which incorporates patient consent in the access control service of an e-health system. To validate the proposed concepts, a proof-of-concept implementation is built and evaluated.

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Galpottage, P. A. B. y A. C. Norris. "Patient consent principles and guidelines for e-consent: a New Zealand perspective". Health Informatics Journal 11, n.º 1 (marzo de 2005): 5–18. http://dx.doi.org/10.1177/1460458205050681.

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Chhin, Veng, Jerry Roussos, Terry Michaelson, Mazaheer Bana, Andrea Bezjak, Sophie Foxcroft, Jasmine L. Hamilton y Fei-Fei Liu. "Leveraging Mobile Technology to Improve Efficiency of the Consent-to-Treatment Process". JCO Clinical Cancer Informatics, n.º 1 (noviembre de 2017): 1–8. http://dx.doi.org/10.1200/cci.17.00041.

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Purpose This study reports on the implementation of an electronic consent-to-treatment system (e-Consent) in a busy radiation medicine program and compares it with the previous paper-based method of documenting patient consent. Methods A password-protected, electronic, e-Consent application was designed in-house and installed on iPad devices to document patient consent for radiation therapy treatments. A feasibility study, followed by a program-wide deployment of e-Consent, was executed. The effectiveness and impact of e-Consent on workflow were determined by comparing the number of problems arising from the paper-based consenting method with those from the e-Consent process. Staff satisfaction and perceived impact of e-Consent on workflow were determined by a program-wide survey of e-Consent users. Results The e-Consent completion rate was 94.2% (5,600 of 5,943 forms) 1 year after implementation, indicating successful uptake at the program level. Although the paper-based method of documenting patient consent was associated with an error rate of 7% (24 of 343 forms), e-Consent was associated with an error rate of 0.32% (18 of 5,600 forms) 1 year after deployment. Results of a 10-item e-Consent user survey indicated improvement in staff workflow and high overall satisfaction with e-Consent. Conclusion e-Consent is more efficient than paper-based methods for documenting patient consent. Moreover, replacing paper-based consent methods with an electronic version facilitated an improved workflow and staff satisfaction. Efforts aimed at implementing e-Consent throughout the entire cancer program are currently underway.

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Haussen, Diogo C., Leah Craft, Shannon Doppelheuer, Gabriel Martins Rodrigues, Alhamza R. Al-Bayati, Krishnan Ravindran, Meagan Schultz et al. "Legal authorized representative experience with smartphone-based electronic informed consent in an acute stroke trial". Journal of NeuroInterventional Surgery 12, n.º 5 (17 de septiembre de 2019): 483–85. http://dx.doi.org/10.1136/neurintsurg-2019-015283.

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BackgroundThe pilot use of a smartphone platform for electronic informed consent (e-Consent) in large vessel occlusion acute stroke (LVOS) trials has recently been reported. The degree of satisfaction from Legal Authorized Representatives (LARs) with regard to this process remains to be established.MethodsA single-center study evaluating the experience of LARs with the use of e-Consent in a LVOS randomized trial of an investigational drug administered within 12 hours of last known normal was carried out. A structured survey was used to evaluate the experience of the LARs with the e-consenting process.ResultsFrom February to November 2018, 60 consecutive patients were e-Consented. Of these, 53 LARs completed the survey. The median (IQR) age of the patients was 63 (53–70) years, baseline/discharge National Institutes of Health Stroke Scale score was 17 (12–20)/3(1–12), and 45% were independent at discharge. The survey was applied in person in 43% of cases and via telephone in 57%. Median LAR age was 48 (39–59) years, 64% were female, and a multi-ethnic composition was observed. Forty percent of LARs had less than tertiary level of education (high-school or less). Regarding the e-Consent, 98% of LARs reported to be ‘clear’ and 83% felt ‘very comfortable’ in signing. The overall experience was ‘excellent/good’ in 91%. Despite the positive general impression regarding the use of e-Consent, 12 LARs (22%) would have preferred paper consent. Multivariable regression indicated that lower educational status (tertiary education or less: OR 5.09, 95% CI 1.02 to 25.48; p=0.04) and lower baseline ASPECTS score (OR 0.63, 95% CI 0.41 to 0.96; p=0.03) were independently associated with preference for paper consent.Conclusionse-Consent was overall very well perceived by LARs in a randomized clinical trial of LVOS. A minority of proxies, who were more commonly less formally educated, would have preferred paper consenting.

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Coiera, E. "e-Consent: The Design and Implementation of Consumer Consent Mechanisms in an Electronic Environment". Journal of the American Medical Informatics Association 11, n.º 2 (21 de noviembre de 2003): 129–40. http://dx.doi.org/10.1197/jamia.m1480.

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Verreydt, Stef, Koen Yskout y Wouter Joosen. "Security and Privacy Requirements for Electronic Consent". ACM Transactions on Computing for Healthcare 2, n.º 2 (marzo de 2021): 1–24. http://dx.doi.org/10.1145/3433995.

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Electronic consent (e-consent) has the potential to solve many paper-based consent approaches. Existing approaches, however, face challenges regarding privacy and security. This literature review aims to provide an overview of privacy and security challenges and requirements proposed by papers discussing e-consent implementations, as well as the manner in which state-of-the-art solutions address them. We conducted a systematic literature search using ACM Digital Library, IEEE Xplore, and PubMed Central. We included papers providing comprehensive discussions of one or more technical aspects of e-consent systems. Thirty-one papers met our inclusion criteria. Two distinct topics were identified, the first being discussions of e-consent representations and the second being implementations of e-consent in data sharing systems. The main challenge for e-consent representations is gathering the requirements for a “valid” consent. For the implementation papers, many provided some requirements but none provided a comprehensive overview. Blockchain is identified as a solution to transparency and trust issues in traditional client-server systems, but several challenges hinder it from being applied in practice. E-consent has the potential to grant data subjects control over their data. However, there is no agreed-upon set of security and privacy requirements that must be addressed by an e-consent platform. Therefore, security- and privacy-by-design techniques should be an essential part of the development lifecycle for such a platform.

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Harle, Christopher A., Elizabeth H. Golembiewski, Kiarash P. Rahmanian, Babette Brumback, Janice L. Krieger, Kenneth W. Goodman, Arch G. Mainous y Ray E. Moseley. "Does an interactive trust-enhanced electronic consent improve patient experiences when asked to share their health records for research? A randomized trial". Journal of the American Medical Informatics Association 26, n.º 7 (2 de abril de 2019): 620–29. http://dx.doi.org/10.1093/jamia/ocz015.

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Abstract Objective In the context of patient broad consent for future research uses of their identifiable health record data, we compare the effectiveness of interactive trust-enhanced e-consent, interactive-only e-consent, and standard e-consent (no interactivity, no trust enhancement). Materials and Methods A randomized trial was conducted involving adult participants making a scheduled primary care visit. Participants were randomized into 1 of the 3 e-consent conditions. Primary outcomes were patient-reported satisfaction with and subjective understanding of the e-consent. Secondary outcomes were objective knowledge, perceived voluntariness, trust in medical researchers, consent decision, and time spent using the application. Outcomes were assessed immediately after use of the e-consent and at 1-week follow-up. Results Across all conditions, participants (N = 734) reported moderate-to-high satisfaction with consent (mean 4.3 of 5) and subjective understanding (79.1 of 100). Over 94% agreed to share their health record data. No statistically significant differences in outcomes were observed between conditions. Irrespective of condition, black participants and those with lower education reported lower satisfaction, subjective understanding, knowledge, perceived voluntariness, and trust in medical researchers, as well as spent more time consenting. Conclusions A large majority of patients were willing to share their identifiable health records for research, and they reported positive consent experiences. However, incorporating optional additional information and messages designed to enhance trust in the research process did not improve consent experiences. To improve poorer consent experiences of racial and ethnic minority participants and those with lower education, other novel consent technologies and processes may be valuable. (An Interactive Patient-Centered Consent for Research Using Medical Records; NCT03063268)

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Hinshelwood, Robert. "Natural ethics and informed consent Ética natural e consentimento livre e esclarecido". ETD - Educação Temática Digital 11 (1 de abril de 2010): 49. http://dx.doi.org/10.20396/etd.v11iesp..898.

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In this paper I examine one way in which psychoanalysis could contribute a natural ethics based on the inherent psychological development of a moral conscience. Psychoanalytic object-relations theories postulate the fundamental relational nature of human beings, and therefore the correlated concerns about the well-being of others. The notion of unconscious projective identification central to some theories provides an ethic of integration.

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Song, Hye Jin. "Consent order for consumer damage relief in e-commerce". LAW RESEARCH INSTITUTE CHUNGBUK NATIONAL UNIVERSITY 32, n.º 2 (31 de diciembre de 2021): 191–214. http://dx.doi.org/10.34267/cblj.2021.32.2.191.

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Leung, W. C. "Consent to treatment in the A&E department". Accident and Emergency Nursing 10, n.º 1 (enero de 2002): 17–25. http://dx.doi.org/10.1054/aaen.2001.0303.

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Harle, Christopher A., Elizabeth H. Golembiewski, Kiarash P. Rahmanian, Janice L. Krieger, Dorothy Hagmajer, Arch G. Mainous y Ray E. Moseley. "Patient preferences toward an interactive e-consent application for research using electronic health records". Journal of the American Medical Informatics Association 25, n.º 3 (19 de diciembre de 2017): 360–68. http://dx.doi.org/10.1093/jamia/ocx145.

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Abstract Objective The purpose of this study was to assess patient perceptions of using an interactive electronic consent (e-consent) application when deciding whether or not to grant broad consent for research use of their identifiable electronic health record (EHR) information. Materials and Methods For this qualitative study, we conducted a series of 42 think-aloud interviews with 32 adults. Interview transcripts were coded and analyzed using a modified grounded theory approach. Results We identified themes related to patient preferences, reservations, and mixed attitudes toward consenting electronically; low- and high-information-seeking behavior; and an emphasis on reassuring information, such as data protections and prohibitions against sharing data with pharmaceutical companies. Participants expressed interest in the types of information contained in their EHRs, safeguards protecting EHR data, and specifics on studies that might use their EHR data. Discussion This study supports the potential value of interactive e-consent applications that allow patients to customize their consent experience. This study also highlights that some people have concerns about e-consent platforms and desire more detailed information about administrative processes and safeguards that protect EHR data used in research. Conclusion This study contributes new insights on how e-consent applications could be designed to ensure that patients’ information needs are met when seeking consent for research use of health record information. Also, this study offers a potential electronic approach to meeting the new Common Rule requirement that consent documents contain a “concise and focused” presentation of key information followed by more details.

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Luttbeg, Norman R. "Without Consent: Mass-Elite Linkages in Presidential Politics.Warren E. Miller". Journal of Politics 52, n.º 1 (febrero de 1990): 280–82. http://dx.doi.org/10.2307/2131435.

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Grain, Heather. "E-Consent Design and Implementation Issues for Health Information Managers". Health Information Management 33, n.º 3 (octubre de 2004): 84–88. http://dx.doi.org/10.1177/183335830403300304.

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Seri, Marco, Claudio Graziano, Daniela Turchetti y Juri Monducci. "Test genetici e consenso informato". SALUTE E SOCIETÀ, n.º 3 (diciembre de 2012): 68–95. http://dx.doi.org/10.3280/ses2012-003005.

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The pace of discovery in the field of human genetics has increased exponentially in the last 30 years. We have witnessed the completion of the Human Genome Project, the identification of hundreds of disease-causing genes, and the dawn of genomic medicine (clinical care based on genomic information). Reduction of DNA sequencing costs, thanks to the so-called "next generation sequencing" technologies, is driving a shift towards the era of "personal genomes", but scientific as well as ethical challenges ahead are countless. We provide an overview on the classification of genetic tests, on informed consent procedures in the context of genetic counseling, and on specific ethical issues raised by the implementation of new DNA sequencing technologies.

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Marques Xavier, Glaucia y Tatiana Souza de Camargo. "LIMITES, NEGAÇÃO E CONTRATO:". Diversidade e Educação 9, n.º 2 (28 de enero de 2022): 488–518. http://dx.doi.org/10.14295/de.v9i2.13554.

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O consentimento é um conceito chave quando falamos em violência e em relações afetivo-sexuais. No entanto, pouco é discutido sobre o que exatamente ele significa, em que situações ele é utilizado e de que maneira. Este texto traz pistas sobre como es jovens entendem o consentimento e como a cultura escolar e os discursos que circulam sobre consentimento podem influenciar nesse entendimento. Um momento de observação participante e rodas de conversa com estudantes do oitavo ano de uma escola pública de Porto Alegre nos mostrou que o consentimento parece ser entendido a partir de três aspectos: limites, negação e contrato. O diálogo aparece neste texto como uma potente ferramenta para que es jovens revejam posições e mudem de opinião, demonstrando a importância de falar sobre esse tema que é tão pouco falado. PALAVRAS-CHAVE: consentimento. gênero e sexualidade. escola pública. violências. El consentimiento es un concepto clave cuando hablamos de violencia y relaciones afectivo-sexuales. Sin embargo, se discute poco sobre qué significa exactamente, en qué situaciones se usa y cómo. Este texto aporta pistas sobre cómo los/las/les jóvenes entienden el consentimiento y cómo la cultura escolar y los discursos que circulan sobre consentimiento pueden influir en este entendimiento. Un momento de observación participante y círculos de conversación con alumnos de octavo grado de una escuela pública de Porto Alegre nos mostraron que el consentimiento parece entenderse desde tres aspectos: límites, negación y contrato. El diálogo aparece en este texto como una poderosa herramienta para que los/las/les jóvenes revisen posiciones y cambien de opinión, demostrando la importancia de hablar sobre este tema del que tan poco se habla. PALABRAS-CLAVE: consentimiento. género y sexualidad. escuela pública. violencias. Consent is a key concept when it comes to violence and affective-sexual relationships. However, there are not many discussions about what exactly it means, in what situations it is used and in what way. This text provides clues about how young people understand consent and how school culture and discourses surrounding consent may influence this understanding. A moment of participant observation and conversation circles with eight grade students from a public school in Porto Alegre showed us that consent seems to be understood by young people from three aspects: boundaries, denial and contract. Dialogue appears in this text as a powerful tool in order for young people to review positions and change minds, highlighting the importance of talking about a topic that people rarely talk about. KEYWORDS: consent. gender and sexuality. public school. violence.

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Gesang, Bernward. "Über das Einstimmigkeitspostulat im Kontraktualismus1". Zeitschrift für philosophische Forschung 76, n.º 3 (15 de septiembre de 2022): 388–403. http://dx.doi.org/10.3196/004433022835885591.

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A legitimate moral justification has to be given by justifying a norm to everyone. Achieving unanimity about norms is a moral correctness criterion for certain contract theories. What exactly is meant by unanimity ? Most contract theorists quickly agree that unanimity, understood as the explicit factual agreement of everyone to a norm candidate, is de facto impossible to achieve. It is stated that the following types of consent can replace de facto unanimous consent: a) majority consent; b) rational consent, c) consent based on self-interest, d) consent based on transcendental interests and e) consent based on undisputed moral principles. I want to show that unanimous consent cannot be achieved in any of these ways, and if you claim that moral norms are based on unanimity or that there are no moral norms, then you have to dismiss morality.

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Muravyeva, Ekaterina, José Janssen, Marcus Specht y Bart Custers. "Exploring solutions to the privacy paradox in the context of e-assessment: informed consent revisited". Ethics and Information Technology 22, n.º 3 (24 de abril de 2020): 223–38. http://dx.doi.org/10.1007/s10676-020-09531-5.

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Abstract Personal data use is increasingly permeating our everyday life. Informed consent for personal data use is a central instrument for ensuring the protection of personal data. However, current informed consent practices often fail to actually inform data subjects about the use of personal data. This article presents the results of a requirements analysis for informed consent from both a legal and usability perspective, considering the application context of educational assessment. The requirements analysis is based on European Union (EU) law and a review of current practices. As the main outcome, the article presents a blueprint which will be the basis for the development of an informed consent template that supports data controllers in establishing an effective and efficient informed consent form. Because the blueprint, and subsequently, the template, distinguishes between legal and usability requirements, it also provides the basis for the mapping of legal requirements in other (non-European) contexts.

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Santosuosso, Amedeo y Valentina Sellaroli. "Consenso informato, autodeterminazione e libertÀ nella giurisprudenza". SALUTE E SOCIETÀ, n.º 3 (diciembre de 2012): 137–60. http://dx.doi.org/10.3280/ses2012-003009.

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In recent decades informed consent has become simply the expression of the fundamental rights of individuals despite the fact that some signs of its ambiguous nature still remain. This means that the idea of informed consent is very much influenced by external values, by the specific cultural context or by the laws in force in a certain historical period. The great amount of national and international legal references lead us to believe that, in this matter, there is a common constitutional sense, whose conceptual core is shared by the whole society and which consists of fundamental rights to self determination and to health as defined thanks to recent medical and scientific innovations. In this contribution, we shall address issues relating to individual liberty rights, examine a number of Italian and European judicial decisions concerning the right to life and self determination and consider the relationship between civil and criminal principles in matters of self determination in the light of constitutional principles deriving from the conclusion that the concept of individual from a legal perspective differs from the concept of individual from a biological perspective and that the biological boundary itself of any individual may be modified in several personal ways.

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Cadigan, R. Jean, Rita Butterfield, Christine Rini, Margaret Waltz, Kristine J. Kuczynski, Kristin Muessig, Katrina A. B. Goddard y Gail E. Henderson. "Online Education and e-Consent for GeneScreen, a Preventive Genomic Screening Study". Public Health Genomics 20, n.º 4 (2017): 235–46. http://dx.doi.org/10.1159/000481359.

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Bergmann, Joachim, Oliver J. Bott, Dietrich P. Pretschner y Reinhold Haux. "An e-consent-based shared EHR system architecture for integrated healthcare networks". International Journal of Medical Informatics 76, n.º 2-3 (febrero de 2007): 130–36. http://dx.doi.org/10.1016/j.ijmedinf.2006.07.013.

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Murphy, Mark C. "Hobbes on Tacit Covenants". Hobbes Studies 7, n.º 1 (1994): 69–94. http://dx.doi.org/10.1163/187502594x00063.

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AbstractTacit consent theories of political obligation have fallen into disfavor. The difficulties that plague such accounts have been well-known since Hume's "Of the Original Contract"1 and have recently been forcefully reformulated by M. B. E. Smith, A. John Simmons, and Joseph Raz.2 In this article, though, I shall argue that Hobbes' version of the argument from tacit consent escapes the criticisms leveled by Hume, Smith, Simmons, and Raz against tacit consent theories as a class. Crucial to my defense of this claim will be a certain interpretation of Hobbes' account of covenants, an account quite different than that presupposed by the opponents of the argument from tacit consent.

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Maurer, Julia, Sonia Carboni y Cindy Roth. "Developing innovative procedures for obtaining informed consent: Three solutions underway". Regulatory Affairs Watch 2, n.º 3 (marzo de 2020): 19–22. http://dx.doi.org/10.54920/scto.2020.rawatch.3.19.

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The Swiss Personalized Health Network (SPHN), a national initiative funded by the State Secretariat for Education, Research and Innovation (SERI), was designed to promote the development of personalised medicine and personalised health in Switzerland. The SPHN aims to develop infrastructure projects that will make health-related data interoperable and shareable at the national level. Accordingly, certain projects related to informed consent (IC) were funded and are described in this article: the Electronic General Consent (e-GC), the Citizen Centered Consent: Shared, Transparent and Dynamic (the so-called C3-STuDY), and the proactive management tool of consent for research (in French so-called “Gestion Proactive des Consentements de Recherche”, GPCR).

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Wennberg, Mikko. "On Barnett's Theory of Default Rules". Canadian Journal of Law & Jurisprudence 16, n.º 1 (enero de 2003): 147–58. http://dx.doi.org/10.1017/s0841820900006664.

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This discussion is a critique of Professor Randy E. Barnett's solution to the problem of filling in gaps in incomplete contracts. The articles discussed are “The Sound of Silence: Default Rules and Contractual Consent” (1992) and “Rational Bargaining Theory and Contract: Default Rules, Hypothetical Consent, the Duty to Disclose, and Fraud” (1992).

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Kim, Hyeoneui, Elizabeth Bell, Jihoon Kim, Amy Sitapati, Joe Ramsdell, Claudiu Farcas, Dexter Friedman, Stephanie Feudjio Feupe y Lucila Ohno-Machado. "iCONCUR: informed consent for clinical data and bio-sample use for research". Journal of the American Medical Informatics Association 24, n.º 2 (2 de septiembre de 2016): 380–87. http://dx.doi.org/10.1093/jamia/ocw115.

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Background: Implementation of patient preferences for use of electronic health records for research has been traditionally limited to identifiable data. Tiered e-consent for use of de-identified data has traditionally been deemed unnecessary or impractical for implementation in clinical settings. Methods: We developed a web-based tiered informed consent tool called informed consent for clinical data and bio-sample use for research (iCONCUR) that honors granular patient preferences for use of electronic health record data in research. We piloted this tool in 4 outpatient clinics of an academic medical center. Results: Of patients offered access to iCONCUR, 394 agreed to participate in this study, among whom 126 patients accessed the website to modify their records according to data category and data recipient. The majority consented to share most of their data and specimens with researchers. Willingness to share was greater among participants from an Human Immunodeficiency Virus (HIV) clinic than those from internal medicine clinics. The number of items declined was higher for for-profit institution recipients. Overall, participants were most willing to share demographics and body measurements and least willing to share family history and financial data. Participants indicated that having granular choices for data sharing was appropriate, and that they liked being informed about who was using their data for what purposes, as well as about outcomes of the research. Conclusion: This study suggests that a tiered electronic informed consent system is a workable solution that respects patient preferences, increases satisfaction, and does not significantly affect participation in research.

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Chantler, Tracey, Ellen Pringle, Sadie Bell, Rosie Cooper, Emily Edmundson, Heidi Nielsen, Sheila Roberts, Michael Edelstein y Sandra Mounier-Jack. "Does electronic consent improve the logistics and uptake of HPV vaccination in adolescent girls? A mixed-methods theory informed evaluation of a pilot intervention". BMJ Open 10, n.º 11 (noviembre de 2020): e038963. http://dx.doi.org/10.1136/bmjopen-2020-038963.

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ObjectivesTo evaluate the usability and acceptability of an electronic consent pilot intervention for school-based immunisations and assess its impact on consent form returns and human papilloma virus (HPV) vaccine uptake.DesignMixed-methods theory-informed study applying qualitative methods to examine the usability and acceptability of the intervention and quantitative methods to assess its impact.Setting and participantsThe intervention was piloted in 14 secondary schools in seven London boroughs in 2018. Intervention schools were matched with schools using paper consent based on the proportion of students with English as a second language and students receiving free school meals. Participants included nurses, data managers, school-link staff, parents and adolescents.InterventionsAn electronic consent portal where parents could record whether they agreed to or declined vaccination, and nurses could access data to help them manage the immunisation programme.Primary and secondary outcome measuresComparison of consent form return rates and HPV vaccine uptake between intervention and matched schools.ResultsHPV vaccination uptake did not differ between intervention and matched schools, but timely consent form return was significantly lower in intervention schools (73.3% vs 91.6%, p=0.008). The transition to using electronic consent was not straightforward, while schools and staff understood the potential benefits, they found it difficult to adapt to new ways of working which removed some level of control from schools. Reasons for lower consent form return in e-consent schools included difficulties encountered by some parents in accessing and using the intervention. Adolescents highlighted the potential for electronic consent to by-pass their information needs.ConclusionsThe pilot intervention did not improve consent form return or vaccine uptake due to challenges encountered in transitioning to new working practice. New technologies require embedding before they become incorporated in everyday practice. A re-evaluation once stakeholders are accustomed with electronic consent may be required to understand its impact.

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Driscoll, Len. "Summary prospectus may cause many to re‐consider e‐delivery and consent strategies". Journal of Investment Compliance 10, n.º 1 (13 de marzo de 2009): 51–55. http://dx.doi.org/10.1108/15285810910948144.

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Pelotti, Susi. "Con e per il consenso informato alle cure". SALUTE E SOCIETÀ, n.º 3 (diciembre de 2012): 123–36. http://dx.doi.org/10.3280/ses2012-003008.

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The concept of informed consent is revisited in the light of the new development toward the model of "shared decision making". Consenting practice is not a defense against ligation or a formal procedural step, but it represents a process for helping patient to make a choice through a new relationship in which clinicians and patients work together using clinical evidence and patient's informed preference. Shared decision making is considered an ethical imperative, but is not yet the norm. Validated decision supports and training are needed for its implementation.

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Brunon-Ernst, Anne. "The Fallacy of Informed Consent: Linguistic Markers of Assent and Contractual Design in Some E-User Agreements". Revista Alicantina de Estudios Ingleses, n.º 28 (15 de noviembre de 2015): 37. http://dx.doi.org/10.14198/raei.2015.28.03.

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Orthodox contract law theory assumes that parties agree to the terms of a contract before entering into an agreement. However, recent factual evidence points towards the fact that consumers do not systematically read, and thus become informed of, the terms of a contract. Academics are asking for mandatory frameworks to ensure that informed consent is indeed sought and given by parties to a contract. The present study looks into the user agreements of four online companies that provide a marketplace for the sale of goods or free provision of services by other sellers and/or users (Ebay, Tripadvisor, YouTube and Amazon). The aim is firstly to identify the lexical/textual markers and peri-textual features of agreement in order to highlight the fallacy of informed consent. Secondly, the paper lists textual and peri-textual alternative contractual design (here called counter-design) in online user agreement. In so doing, contractual design features are distinguished from nudges. Suggested counter-design features help make informed consent effective.

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Simon, Christian M., Helen A. Schartz, Gary E. Rosenthal, Eric L. Eisenstein y David W. Klein. "Perspectives on Electronic Informed Consent From Patients Underrepresented in Research in the United States: A Focus Group Study". Journal of Empirical Research on Human Research Ethics 13, n.º 4 (23 de mayo de 2018): 338–48. http://dx.doi.org/10.1177/1556264618773883.

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Digital informed consent may better inform individuals about health research and increase participation. In the United States and elsewhere, minorities and rural populations are underrepresented in health research and may benefit from well-designed electronic informed consent (eIC). Seven focus groups were conducted with 50 Caucasian, African American, and rural patients in the United States. Participants were asked their preferences for a paper versus electronic informed consent document. Participants found the e-version easier to use, more interesting, and better for understanding. Minority participants emphasized limited access, computer literacy, and trust barriers to eIC. Rural participants were concerned about accessibility, connectivity, privacy, and confidentiality. People see value in electronic consenting. Researchers should consider barriers to eIC among underrepresented populations before recruitment.

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Brubaker, Linda, J. Eric Jelovsek, Emily S. Lukacz, Sunil Balgobin, Alicia Ballard, Alison C. Weidner, Marie G. Gantz, Ryan Whitworth y Donna Mazloomdoost. "Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study". Clinical Trials 16, n.º 5 (26 de julio de 2019): 481–89. http://dx.doi.org/10.1177/1740774519865541.

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Background/aims: In this study, we compared two research consent techniques: a standardized video plus usual consent and usual consent alone. Methods: Individuals who completed 24-month outcomes (completers) in the Operations and Pelvic Muscle Training in the Management of Apical Support Loss study were invited to participate in an extended, longitudinal follow-up study (extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss). Potential participants who were (1) able to provide consent and (2) not in long-term care facilities were randomized 1:1 to a standardized video detailing the importance of long-term follow-up studies of pelvic floor disorders followed by the usual institutional consent process versus the usual consent process alone. Randomization, stratified by site, used randomly permuted blocks. The primary outcome was the proportion of participants who enrolled in the extended study and completed data collection events 5 years after surgery. Secondary outcomes included the proportion enrolled in the extended study, completion of follow-up at each study year, completion of data collection points, completion of in-person visits, and completion of quality of life calls. Motivation and barriers to enrollment (study-level and personal-level) and satisfaction with the study consent process were measured by questionnaire prior to recruitment into extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss. Groups were compared using an intention-to-treat principle, using unadjusted Student’s t-test (continuous) and chi-square or Fisher’s exact (categorical) test. A sample size of 340 (170/group) was estimated to detect a 15% difference in enrollment and study completion between groups with p < 0.05. Results: Of the 327 Operations and Pelvic Muscle Training in the Management of Apical Support Loss completers, 305 were randomized to the consent process study (153 video vs 152 no video). Groups were similar in demographics, surgical treatment, and outcomes. The overall rate of extended study enrollment was high, without significant differences between groups (video 92.8% vs no video 94.1%, p = 0.65). There were no significant differences in the primary outcome (video 79.1% vs no video 75.7%, p = 0.47) or in any secondary outcomes. Being “very satisfied” overall with study information (97.7% vs 88.5%, p = 0.01); “strong agreement” for feeling informed about the study (81.3% vs 70.8%, p = 0.06), understanding the study purpose (83.6% vs 71.0%, p = 0.02), nature and extent (82.8% vs 70.2%, p = 0.02), and potential societal benefits (82.8% vs 67.9%, p = 0.01); and research coordinator/study nurse relationship being “very important” (72.7% vs 63.4%, p = 0.03) were better in the video compared to the no video consent group. Conclusion: The extended study had high enrollment; most participants completed most study tasks during the 3-year observational extension, regardless of the use of video to augment research consent. The video was associated with a higher proportion of participants reporting improved study understanding and relationship with study personnel.

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Brand, Laurie A. "Police, Protests, and State Power: Confronting Order and Disorder in Jordan (review article)". Middle East Journal 76, n.º 3 (1 de diciembre de 2022): 405–8. http://dx.doi.org/10.3751/76.3.30.

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Protesting Jordan: Geographies of Power and Dissent, by Jillian Schwedler. Stanford, CA: Stanford University Press, 2022. 372 pages. $90 cloth, $30 paper, e-book. Creating Consent in an Illiberal Order: Policing Disputes in Jordan, by Jessica Watkins. New York: Cambridge University Press, 2022. 230 pages. $99.99 cloth, $80 e-book.

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Liu, Fei Fei, Sarah Tosoni, Indu S. Voruganti, Rebecca Wong, Carl Virtanen, Donald Willison y Ann Heesters. "The use of patient health information outside the circle of care: Consent preferences of patients from a large academic cancer centre." Journal of Clinical Oncology 38, n.º 15_suppl (20 de mayo de 2020): e14122-e14122. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.e14122.

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e14122 Background: Massive volumes of patient health information (PHI) are required to realize the anticipated benefits of artificial intelligence in future clinical medicine. To maintain public trust in medical research however, consent policies must evolve to reflect contemporary patient preferences. Methods: From January-December 2019, patients attending clinics at a large academic cancer centre were invited to complete a 27-item iPad survey on consent preferences. Survey items focused on: (a) broad vs. specific consent; (b) opt-in vs. opt-out approaches for research contact; (c) comfort sharing with different recipients; (d) perceptions on commercialization; and (e) options to track information use and study results. Demographic questions addressed cancer type, treatment stage, age, gender, ethnicity, education level, and household income. Results: A total of 222 participants were included in the analysis (112 males, 108 females; 2 rather not say); 83% were comfortable sharing PHI with researchers at their own hospital. While 56% of patients preferred broad consent, 38% preferred to be contacted with study details and asked to consent every time (specific consent); 6% prefer not to share at all. Younger patients ( < 49 years) most often chose specific consent (50%); significantly more than those 75+ years (24%; p < .05). Younger patients ( < 49 years) were also significantly more uncomfortable than older patients (50+ years) sharing even within their own hospital (13% uncomfortable vs. 1% uncomfortable; p < .05). A significant majority of patients (63%, p = .0001) preferred to be asked for permission before being entered into a contact pool vs. automatic entry with opportunity to opt-out. The majority of patients were uncomfortable sharing PHI with commercial enterprises (51% uncomfortable, 27% comfortable, 22% neutral). A significant majority expressed the desire to track who is using their PHI (61%, p < .0001), and be notified regarding study results (70%, p < .0001). Conclusions: While most patients were willing to share their PHI with researchers at their own hospital, many preferred a transparent and reciprocal consent process. These data also suggest a generational shift, wherein younger patients preferred more informed consent options. Modernizing consent policies to reflect increased patient interest in the exercise of their autonomy is crucial in fostering sustained public engagement in medical research.

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Borgesius, Frederik Zuiderveen. "CONSENTIMENTO INFORMADO. PODEMOS FAZER MELHOR EM DEFESA DA PRIVACIDADE". Logeion: Filosofia da Informação 2, n.º 2 (6 de abril de 2016): 80–90. http://dx.doi.org/10.21728/logeion.2016v2n2.p80-90.

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Precisamos repensar a nossa abordagem quanto à proteção da privacidade na internet. Atualmente, os formuladores de políticas vêm se aprofundando na ideia de consentimento informado como um meio para proteger a privacidade. Por exemplo, em diversos países, as empresas são obrigadas por lei a obter o consentimento de um indivíduo antes de fazer uso dos seus dados; com base nessas requisitos de consentimento informado, a lei tem por objetivo empoderar as pessoas a fazerem escolhas de privacidade tendo em vista os seus melhores interesses. No entanto, estudos comportamentais colocam em cheque a eficácia desta abordagem de empoderamento como um meio para proteger a privacidade. Este artigo defende uma abordagem conjunta de proteção e empoderamento dos indivíduos para aprimorar a proteção da privacidade. Este artigo aborda problemas práticos do consentimento informado como um meio para proteger a privacidade, e ilustra problemas com os atuais regulamentos de proteção à privacidade dos dados, concernentes à segmentação comportamental. Primeiramente, discutem-se os problemas de privacidade relativos à segmentação comportamental, e o papel central do consentimento informado ao abrigo da lei de proteção à privacidade. Em seguida, enfatizam-se os problemas práticos referentes ao consentimento informado. Por fim, o artigo argumenta que os formuladores de políticas devem dar mais atenção aos regulamentos que protegem as pessoas, e menos aos que as empoderam. INFORMED CONSENT: WE CAN DO BETTER TO DEFEND PRIVACYAbstractWe need to rethink our approach to defend privacy on the internet. Currently, policymakers focus heavily on the idea of informed consent as a means to defend privacy. For instance, in many countries the law requires firms to obtain an individual’s consent before they use data about her. With such informed consent requirements, the law aims to empower people to make privacy choices in their best interests. But behavioural studies cast doubt on this approach’s effectiveness, as people tend to click OK to almost any request they see on their screens. To improve privacy protection, this article argues for a combined approach of protecting and empowering the individual.

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Candelier, Gilles, Thomas Apard y Jean Pierre Lemerle. "Benefits of the “e-Informed Consent” in Hand Surgery for the Surgeon and the Patient". HAND 11, n.º 1_suppl (septiembre de 2016): 95S. http://dx.doi.org/10.1177/1558944716660555ga.

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C., Rose Davy y Koushiki Mani. "E-learning in COVID 19 period: first year students’ perspective: a web-based Google form descriptive study". International Journal Of Community Medicine And Public Health 8, n.º 2 (27 de enero de 2021): 743. http://dx.doi.org/10.18203/2394-6040.ijcmph20210232.

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Background: The current COVID-19 pandemic has drastically changed the paradigm of medical education. Face-to-face mode of teaching was the basis of traditional medical education. In this crisis situation, e-learning has become the only method of education for continuous learning. In this study, we attempt to find out the students’ perspective of various aspects of e-learning.Methods: For the purpose of the study, a questionnaire was prepared to understand student’s attitude towards e-learning, their likes and dislikes about e-learning and also suggestions from their end to improve the existing modes of e-learning. The set of questionnaire (Google forms) along with informed consent was shared via whatsapp group at the end of physiology theory teaching session.Results: 175 first year MBBS students gave their consent and participated in this study. The most preferred method of e-learning was power-point with recorded narration and the least preferred method was live classes. Poor connectivity issue is the major challenge faced by the students in our study.Conclusions: In this COVID-19 era, the future of medical education has changed forever. E-learning is the new normal method of teaching. In order to be effective, students require support from Government, faculties and parents.

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Alanezi, M. A. y A. Sellami. "An Unified Framework for Measuring E-Service Quality". Engineering, Technology & Applied Science Research 9, n.º 3 (8 de junio de 2019): 4249–54. http://dx.doi.org/10.48084/etasr.2694.

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Companies continually seek efficiency by utilizing the rapid advances in technology to improve their electronic services (e-services). A perusal of the literature shows varying approaches for measuring e-service quality; these approaches have found little consent among reviewers. Therefore, this study attempts to provide a new framework, a roadmap, as a useful model for researchers to measure user perception of e-service quality. For this model, an extensive study is carried and these study findings indicate that system functionality, procedure, content, user support, and manageability should be included in an empirical research model for measuring e-service quality.

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Bardach, Naomi S., Regina Lam y Carolyn B. Jasik. "Assessment of automated clinical trial recruitment and enrolment using patient-facing technology". BMJ Health & Care Informatics 28, n.º 1 (enero de 2021): e100076. http://dx.doi.org/10.1136/bmjhci-2019-100076.

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ObjectiveInteractive patient care systems (IPCS) at the bedside are becoming increasingly common, but evidence is limited as to their potential for innovative clinical trial implementation. The objective of this study was to test the hypothesis that the IPCS could feasibly be used to automate recruitment and enrolment for a clinical trial.MethodsIn medical-surgical units, we used the IPCS to randomise, recruit and consent eligible subjects. For participants not interacting with IPCS study materials within 48 hours, study staff-initiated recruitment in-person. Eligible study population included all caregivers and any patients >6 years old admitted to medical-surgical units and oncology units September 2015 to January 2016. Outcomes: randomisation assessed using between-group comparisons of patient characteristics; recruitment success assessed by rates of consent; paperless implementation using successful acquisition of electronic signature and email address. We used χ2 analysis to assess success of randomisation and recruitment.ResultsRandomisation was successful (n=1012 randomised, p>0.05 for all between-group comparisons). For the subset of eligible, randomised patients who were recruited, IPCS-only recruitment (consented: 2.4% of n=213) was less successful than in-person recruitment (61.4% of n=87 eligible recruited, p<0.001). For those consenting (n=61), 96.7% provided an electronic signature and 68.9% provided email addresses.ConclusionsOur results suggest that as a tool at the bedside, the IPCS offers key efficiencies for study implementation, including randomisation and collecting e-consent and contact information, but does not offer recruitment efficiencies. Further research could assess the value that interactive technologies bring to recruitment when paired with in-person efforts, potentially focusing on more intensive user-interface testing for recruitment materials.Trial registration numberNCT02491190.

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Tudor, Keith y Charles Grinter. "Informing Consent for the Publication of Case Material". Ata: Journal of Psychotherapy Aotearoa New Zealand 18, n.º 1 (1 de octubre de 2014): 51–65. http://dx.doi.org/10.9791/ajpanz.2014.05.

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In this article, the authors examine the ethical issues involved in the use of case studies by health professionals when presenting research, specifically focusing on how informed consent is obtained from or, rather, negotiated with the client. It is argued that collecting personal information for the purposes of healing is not the same as collecting it for the purposes of research and, therefore, that informed and voluntary consent for this use is essential. The theoretical principles covering ethics in research are discussed in relation to the use of case studies in publications, based on international codes and declarations, on Te Tiriti o Waitangi, and framed in a relational paradigm. Practical considerations and recommendations for those writing for journals and, specifically, this journal, are presented and promoted. Waitara I tēnei tuhinga ka arotakehia e ngā kaituhi ngā take matatika o te whakamahi a ngā ngaio hauora i ngā tauria whaiaro i roto i ā rātou mahi rangahau. Ko te kīi, he rerekā anō te kaupapa kohi korero whaiaro hai whai oranga ki tērā o te kohikohi korero hai mahi rangahau. Nā tēnei, me mātua whakatau korero mātau, whai whakaaetanga hoki ēnei momo mahi. Ka matapakihia nga mātāpono haukoti i te matatika rangahau ki te whakaurunga o ngā tauira whaiaro ki ngā tuhinga whakaputa, e ai ki ngā tohu me ngā whakahau o te ao me tā Te Tiriti o Waitangi: ka horaina, ka tautokohia ngā whakatauhanga whakaaro me ngā whakaritenga mā te hunga e tuhi ana mō ngā huataka, tohutika ki tēnei huataka.

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Posteraro, Nicola. "Il “problema” del consenso informato: dai diritti del malato alla spersonalizzazione del rapporto medicopaziente / The “problem” of the informed consent: from the rights of the patient to the depersonalization of his relationship with the doctor". Medicina e Morale 66, n.º 3 (3 de julio de 2017): 371–87. http://dx.doi.org/10.4081/mem.2017.497.

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Il lavoro analizza il tema del diritto al consenso informato. Si parte con un’analisi generale del “nuovo” concetto di salute, per poi passare a trattare più dettagliatamente del diritto de quo. Ci si sofferma in particolare sulla informazione quale requisito atto a renderlo valido e si affronta il tema del nuovo rapporto medico-paziente; infine, si svolgono delle considerazioni critiche rispetto alla cd. spersonalizzazione di tale relazione medicale. ---------- The work deals with the process of the informed consent. It analyzes the “new” right to health; then, it focalizes its attention on the right to be informed before conducting a healthcare. At the end, it considers the theme of the relationship between the doctor and the patient and investigates the problem of its depersonalization.

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Camasmie, Paula Miranda y Beatriz Gaydeczka. "Adaptação cultural do instrumento The Process and Quality of Informed Consent para o português brasileiro". Revista Família, Ciclos de Vida e Saúde no Contexto Social 10, n.º 4 (15 de diciembre de 2022): 759–76. http://dx.doi.org/10.18554/refacs.v10i4.5436.

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Objetivo: apresentar resultados da adaptação cultural do The Process and Quality of Informed Consent para o português brasileiro. Método: pesquisa descritiva, quali-quantitativa e transversal, desenvolvida em 2019, cujos procedimentos foram de traduções, análises consensuais e avaliação de equivalência por um comitê de juízes, retrotradução e avaliação semântica. Resultados: participaram 6 juízes, com título de doutor, domínio sobre a temática e conhecimento do idioma inglês e 12 pacientes de estudos clínicos, maiores de 18 anos. Obteve-se o instrumento O Processo e a Qualidade do Consentimento Informado adaptado transculturalmente, que originalmente tinha e, após adaptação para o português, manteve 20 itens. Conclusão: o instrumento adaptado demonstrou poder avaliar o processo de consentimento informado em Pesquisas Clínicas e as intervenções destinadas a melhorá-lo.

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De Angelis, Fernando. "Consenso libero ed informato: la Convenzione di Oviedo nell'articolato contesto storico e giuridico delle fonti / Free and informed consent: the Oviedo Convention in the articulated historical and legal context of the sources". Medicina e Morale 65, n.º 1 (21 de septiembre de 2016): 57–67. http://dx.doi.org/10.4081/mem.2016.428.

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La Convenzione di Oviedo del 1997 ha creato regole basilari ed uniformi in tema di consenso libero ed informato. Nonostante siano passati vent’anni, pochi Stati hanno firmato e ratificato la Convenzione. Oggi però la Carta dei diritti fondamentali di Nizza del 2000 ed il Trattato di Lisbona del 2007, riformando profondamente l’Unione Europea, possono dare finalmente alla Convenzione di Oviedo l’auspicata attuazione interna, seppur in modo indiretto. Il contributo affronta il tema dell’articolato contesto storico e giuridico delle fonti di questa Convenzione. ---------- The Oviedo Convention of 1997 has established fundamental and uniform rules in reference to free and informed consent. Even though twenty years have passed, few States have signed and ratified the Convention. Anyway, today’s the Charter of Fundamental Rights of 2000 and the Treaty of Lisbon of 2007, reforming deeply the European Union, can finally give the hoped implementation to the Convention of Oviedo, at least indirectly. The contribution deals with the articulated historical and juridical context of the sources related to the Convention.

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Zhao, Ying-Qi, Suresh T. Chari, Anirban Maitra, Lynn M. Matrisian, Eva E. Shrader, Bechien U. Wu, Avinash Kambadakone et al. "Abstract A028: The Early Detection Initiative trial version 2: A platform trial to test novel approaches to pancreatic cancer screening in patients with new onset hyperglycemia and diabetes". Cancer Research 82, n.º 22_Supplement (15 de noviembre de 2022): A028. http://dx.doi.org/10.1158/1538-7445.panca22-a028.

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Abstract The Early Detection Initiative (EDI) is an innovative study designed to build a platform that will evaluate novel approaches to early detection of resectable pancreatic ductal adenocarcinoma (PDAC) in patients over age 50 with new onset hyperglycemia and diabetes (NOD). This randomized controlled trial (RCT) of algorithm-based screening for PDAC uses a modified Zelen’s design with post-randomization consent. Eligible subjects are identified through electronic medical record (EMR) surveillance and randomized 1:1 to the Observation or Intervention Arm. The Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score, an algorithm that further risk stratifies NOD based on age and changes in weight and glycemic parameters, is calculated in the Intervention Arm. Consenting subjects with ENDPAC >0 have Computerized Tomography (CT) scan imaging for PDAC detection; potential harm, including over-diagnosis, is also estimated. At the time of abstract submission >2000 individuals have been randomized and >50 subjects consented for CT imaging. EDI version 2 adds several innovations in response to challenges encountered and experience gained so far. Most significantly, EDI v2 has a platform design with a common control arm and allows for multiple intervention arms. This opens the door for evaluating future new biomarkers for PDAC early detection in a high–risk NOD population, including new blood-based biomarkers for the early detection of cancer that are now commercially available. EDI v2 focuses primarily on co-efficacy endpoints (PDAC stage shift in ENDPAC >0 group, and in all patients, excluding non-consented patients); effectiveness evaluation becomes a secondary objective. This addresses the challenges of low consent rate (~25%) due to lack of awareness of connection between NOD and PDAC and low acceptance for a novel research screening modality. The analyses of primary endpoints were adjusted to accommodate potential over-diagnosis due to screening and imbalance between ENDPAC >0 and ENDPAC ≤0 groups due to low consent rate and likely imperfect enrichment by ENDPAC, when evaluating all patients. Electronic eligibility checks and consent shorten the recruitment time, a critical factor for stage shift due to rapid progression of PDAC. A pre-randomization screening pilot study is planned to enhance the post-randomization consent rate. Intervention to Control randomization ratio is changed to 2:1, allowing more rapid recruitment and, when factoring the consent rate, doubling the sample size of the observation arm. Through these innovations, EDI v2 maintains the full advantage of Zelen’s design that made the trial feasible in sample size and cost. Simulation studies demonstrate that our approach correctly controls the type-1 error and the trial has adequate statistical power. The EDI trial represents an innovative and contemporary approach to developing and refining an early detection strategy for pancreatic cancer. Citation Format: Ying-Qi Zhao, Suresh T. Chari, Anirban Maitra, Lynn M. Matrisian, Eva E. Shrader, Bechien U. Wu, Avinash Kambadakone, Barbara Kenner, Jo Ann S. Rinaudo, Sudhir Srivastava, Ying Huang, Ziding Feng. The Early Detection Initiative trial version 2: A platform trial to test novel approaches to pancreatic cancer screening in patients with new onset hyperglycemia and diabetes [abstract]. In: Proceedings of the AACR Special Conference on Pancreatic Cancer; 2022 Sep 13-16; Boston, MA. Philadelphia (PA): AACR; Cancer Res 2022;82(22 Suppl):Abstract nr A028.

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Pistorius, Tania. "Monitoring, interception and Big Boss in the workplace: is the devil in the details?" Potchefstroom Electronic Law Journal/Potchefstroomse Elektroniese Regsblad 12, n.º 1 (26 de junio de 2017): 1. http://dx.doi.org/10.17159/1727-3781/2009/v12i1a2718.

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This article discusses the opposing dynamics in the modern workplace environment, specifically employees’ expectations of e-privacy and employers’ interception and monitoring of electronic communications. In terms of the Regulation of Interception of Communications and Provision of Communication-Related Information Act 70 of 2002 employees must take prior notice of or consent to the interception and monitoring of their e-communications. The article focuses on the extent to which click-wrap agreements and hypertext or XML links to e-workplace policies could meet these requirements.

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Tambunan, Santonius. "MEKANISME DAN KEABSAHAN TRANSAKSI JUAL BELI E-COMMERCEMENURUT KITAB UNDANG-UNDANG HUKUM PERDATA". Badamai Law Journal 1, n.º 1 (1 de marzo de 2016): 180. http://dx.doi.org/10.32801/damai.v1i1.257.

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The title ofthis studyis themechanismand thevalidity of thetransactione-commerce in terms ofArticle1320Indonesian Civil Law. The research method usedin this studyis the kind ofnormativeresearchthatexaminesthe norms, principles and legaldoctrinesrelating tothe issues raised. Thetype ofresearchthat researchers usein this studyare the type ofresearch on thelevel ofhorizontalsyncisthe norminterms of theInformation and Electronic Transaction Act withthe provisionsof Article1320Indonesian Civil Law.Offer and acceptance are the stages of pre online buying and selling contracts in e-commerce. In this process the good faith of the parties shall take precedence in the transaction. The momentum of the sales contract e-commerce can not be separated from the pre-contract stage. Although the mechanism is different transactions, but in general the contract e-commerce trading has occurred since the purchaser or consumer to send a message of acceptance of the products on offer to the seller (merchant). This suggests that the momentum of buying and selling contracts e-commerce more closely at the theory of acceptance (ontvangstheorie).Subjective terms in the transaction e-commerce are consent of the individuals who are bound thereby and capacity to conclude an agreement. While the objective terms are a specific subject and an admissible cause. Information and Electronic Transaction Act is a lexspecialis provisions of Article1320Indonesian Civil Law. However, in this Act only regulates consent of the individuals who are bound thereby and a specific subject, while capacity to conclude an agreement and an admissible cause has not been accommodated. Therefore, capacity to conclude an agreement and an admissible cause, can refer to the Civil Code as its lexgeneralis. Keywords: E-commerce, Sale and PurchaseTransaction, Mechanism, Validity

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Almeida-Magana, R., J. Grierson, H. Maroof, R. Clow, E. Dineen, T. Al-Hammouri, N. Muirhead, C. Brew-Graves, J. Kelly y G. Shaw. "E-Consent – an innovative solution to maintain recruitment momentum in clinical trials during the COVID-19 pandemic". European Urology 81 (febrero de 2022): S503—S504. http://dx.doi.org/10.1016/s0302-2838(22)00411-0.

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Chudacoff, Howard P. "The Crucible of Consent: American Child Rearing and the Forging of Liberal Society by James E. Block". American Studies 53, n.º 2 (2014): 175. http://dx.doi.org/10.1353/ams.2014.0074.

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Morse, Robert J. y Robin Fretwell Wilson. "Realizing Informed Consent in Times of Controversy: Lessons from the SUPPORT Study". Journal of Law, Medicine & Ethics 44, n.º 3 (2016): 402–18. http://dx.doi.org/10.1177/1073110516667938.

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This Essay examines the elegantly simple idea that consent to medical treatment or participation in human research must be “informed” to be valid. It does so by using as a case study the controversial clinical research trial known as the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (“SUPPORT”). The Essay begins by charting, through case law and the adoption of the common rule, the evolution of duties to secure fully informed consent in both research and treatment. The Essay then utilizes the SUPPORT study, which sought to pinpoint the level of saturated oxygen that should be provided to extremely low birth weight infants to demonstrate modern complexities and shortcomings of the duty to secure informed consent. This Essay shows how the duty is measured by foreseeability of risks and benefits in human research and why federal regulators believed the tradeoffs in risk and benefits from differing oxygen levels administered in the support study were foreseeable. It then explores the contours of the duty to secure informed consent when applied to researchers who also serve as treating physicians, highlighting how common law duties differ in jurisdictions that apply the professional standard and those that apply the patient-centered material risk standard. This Essay provides new insight into what the law must do to make real the notion that [e]very human being of adult years and sound mind has a right to determine what shall be done with his body.”

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