Journal articles on the topic 'Consent search'
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McMullan, Sam. "Third Party Consent Searches Following the Search and Surveillance Act." Victoria University of Wellington Law Review 43, no. 3 (September 1, 2012): 447. http://dx.doi.org/10.26686/vuwlr.v43i3.5030.
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Many New Zealanders live in shared living arrangements. The result of this is that reasonable expectations of privacy are becoming more limited. State officials may conduct a lawful search where a person consents to such a search if that person has the authority to consent. Where people live in shared living arrangements, several people may have authority to consent to a search of the same property. This article explores the extent of a third party's power to consent to property searches where more than one person has authority to consent to a search under the Search and Surveillance Act 2012. It argues that the question of reasonable expectations of privacy should not be assessed by reference to property rights. It also considers the concept of "apparent" authority which has arisen in New Zealand from the Court of Appeal's decision in R v Bradley as well as the concept of a present and objecting occupant which has arisen in the United States in the Supreme Court decision of Georgia v Randolph.
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An, Seong-Su. "Consent search and seizure." Korean Journal of Comparative Criminal Law 10, no. 1 (July 2008): 301–36. http://dx.doi.org/10.23894/kjccl.2008.10.1.013.
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Kim, Gi Ho. "A study on consent search." Wonkwang University Legal Research Institute 40, no. 2 (June 30, 2024): 41–59. http://dx.doi.org/10.22397/wlri.2024.40.2.41.
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Searches are compulsory actions carried out on certain places, objects, or persons to discover specific objects or persons. The Constitution stipulates due process and warrant principles for searches related to compulsory dispositions. The Criminal Procedure Act also stipulates due process and warrant principles to ensure that searches are conducted in accordance with legal procedures and methods, and it also provides for exceptions to the warrant requirement. There are no explicit provisions allowing for consent searches. However, they are commonly conducted in investigative practice because they are more procedurally simple and efficient than searches conducted with warrants. There is a risk of abuse of consent searches as a means of circumventing or avoiding the warrant principle. The question is whether consent searches are permissible in light of the due process provisions, warrant principles, and exceptions to the warrant principle in the Constitution and Criminal Procedure Act. Consent searches are considered permissible as a voluntary investigative method as long as voluntary consent is guaranteed. Even if consent searches are generally permissible, legal requirements must be strictly established to prevent abuse. A search based on consent is lawful if a person capable of consent gives voluntary consent and the search is conducted within the scope of that consent. Whether the investigative agency must inform the person of their right to refuse consent is a matter of debate. While the notification of the right to refuse consent is not an absolute standard for determining voluntariness, it is an important factor to consider. If consent is given after being informed of the right to refuse, it is more likely to be considered voluntary. In criminal proceedings, the issue arises of how to determine the legality of a consent search. The burden of proving the legality of a consent search lies with the prosecutor, and any disadvantage in cases where the truth is unknown must fall on the prosecutor. The legality of a consent search can be proven through free proof as a legal fact, but the degree of proof must be sufficient to exclude reasonable doubt. When the legality of a consent search is contested, the decision should be based on whether the legality has been clearly proven by objective circumstances.
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Zuk, Peter, and Gabriel Lázaro-Muñoz. "Treatment Search Fatigue and Informed Consent." AJOB Neuroscience 12, no. 1 (January 2, 2021): 77–79. http://dx.doi.org/10.1080/21507740.2020.1866115.
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Kappeler, Victor E., and Joseph B. Vaughn. "The evolution of consent search law." American Journal of Criminal Justice 10, no. 2 (March 1986): 163–77. http://dx.doi.org/10.1007/bf02887468.
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Wulach, James S. "Psychological Evaluation of the Consent to Search." Journal of Psychiatry & Law 18, no. 3-4 (September 1990): 319–28. http://dx.doi.org/10.1177/0093185390018003-404.
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Lokshin, G. "Vietnam-China Relations: a Difficult Search for Consent." Problemy Dalnego Vostoka, no. 2 (April 2019): 126–35. http://dx.doi.org/10.31857/s013128120005187-6.
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Schellings, Ron, Alfons G. Kessels, Gerben ter Riet, J. André Knottnerus, and Ferd Sturmans. "Randomized consent designs in randomized controlled trials: Systematic literature search." Contemporary Clinical Trials 27, no. 4 (August 2006): 320–32. http://dx.doi.org/10.1016/j.cct.2005.11.009.
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Jafarbeiki, Sara, Amin Sakzad, Ron Steinfeld, Shabnam Kasra Kermanshahi, Chandra Thapa, and Yuki Kume. "ACE: A Consent-Embedded privacy-preserving search on genomic database." Heliyon 10, no. 8 (April 2024): e29399. http://dx.doi.org/10.1016/j.heliyon.2024.e29399.
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Lepola, Pirkko, Allison Needham, Jo Mendum, Peter Sallabank, David Neubauer, and Saskia de Wildt. "Informed consent for paediatric clinical trials in Europe." Archives of Disease in Childhood 101, no. 11 (May 25, 2016): 1017–25. http://dx.doi.org/10.1136/archdischild-2015-310001.
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ObjectivePaediatric clinical trials are often conducted as multinational trials. Informed consent or assent is part of the ethics committee approval for clinical trials. The consent requirements vary between countries due to national laws and regulations, which are not harmonised in Europe. These discrepancies can present challenges for paediatric clinical trials. The aim of this study was to assemble these consent and assent requirements across the European Economic Area. The collated national requirements have not been publicly available before, despite a real need for this data.MethodsNational consent and assent requirements for paediatric clinical trials were analysed and collated for 25 European Union Member States and 2 European Free Trade Association countries until the end of 2014. The data were retrieved from existing databases and through communication with the competent authorities and selected ethics committees. Results from a literature search for international or national guidelines, declarations and conventions and academic societies' publications served as comparison material.ResultsConsent and assent requirements are heterogeneous across these countries. We compiled our findings in ‘The Informed Consent and Assent Tool Kit’, a table including 27 national consent and assent requirements listed by individual country.ConclusionsWide variation in paediatric consents and assents presents challenges for multinational paediatric trials in Europe. The toolkit is available for all those involved in paediatric clinical trials and ethics committees, providing a new platform for proactive feedback on informed consent requirements, and may finally lead to a needed harmonisation process, including uniform standards accepted across Europe.
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Hettiarachchi, Radhika. "In search of consent: Agency, audience and identity in memory activism." Memory Studies 17, no. 3 (June 2024): 547–63. http://dx.doi.org/10.1177/17506980241243034.
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The article presents a public history practitioner’s perspective on memory activism, critically engaging with the experiences and lessons learned in the implementation of two public history projects in Sri Lanka – the Herstories Project and the Community Memorialisation Project. It draws on personal reflections and observations made while returning to some of the women participants to renew their consent for a new public iteration of their narratives, nearly a decade after first documenting their histories. It examines some of the conceptual and practical questions that emerged while implementing memory projects with the ‘public’ purposes of peacebuilding and transitional justice outcomes. Through six vignettes, it explores the complicated nature of ‘consent’ through the lens of agency, identity and the construction of victimhood. I argue that memory initiatives need to be cognisant of how power asymmetries and ‘macro-narratives’ frame how stories are told, to whom, and for what purpose, and that when consent is given, it is not given in perpetuity.
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Correa-Morris, Jyrko. "Reduction of Search Space for the Mean Partition Problem." WSEAS TRANSACTIONS ON MATHEMATICS 22 (October 20, 2023): 736–45. http://dx.doi.org/10.37394/23206.2023.22.81.
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The contributions of this paper are threefold. First, it conducts a formal comparison of the primary approaches to consensus clustering, using the concepts of agreement and consent. Secondly, it presents theoretical evidence justifying the preference for mean-based methods, which rely on consent, over other agreement-based procedural methods like the q-rule, which are now mostly used as quality evaluators in practice. Thirdly, the paper computes the exact reduction achieved by criteria available in existing literature to assess the quality of mean-based consensus solutions and reduce the search space’s size. Finally, it compiles the regions where consensus functions associated with well-known dissimilarity measures, such as the Mirkin metric and Variation of Information, accumulate their consensus solutions.
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Song, Jin-Kyung. "A Brief Study on Consent Search in view of the Constitution." DONG-A LAW REVIEW 91 (May 31, 2021): 137–68. http://dx.doi.org/10.31839/dalr.2021.05.91.137.
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Prozorov, Valery Vladimirovich. "Two strategies of verbal behavior: debate and joint search for consent." International Journal “Speech Genres” 11, no. 1 (2015): 57–67. http://dx.doi.org/10.18500/2311-0740-2015-1-11-57-67.
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Lichtenberg, Illya. "The impact of a verbal warning on police consent search practices." Journal of Criminal Justice 32, no. 1 (January 2004): 85–87. http://dx.doi.org/10.1016/j.jcrimjus.2003.10.008.
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Edwards, Sarah J. L., Richard J. Lilford, Jim Thornton, and Jenny Hewison. "Informed consent for clinical trials: in search of the “best” method." Social Science & Medicine 47, no. 11 (December 1998): 1825–40. http://dx.doi.org/10.1016/s0277-9536(98)00235-4.
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Rosenfeld, Richard, and Scott H. Decker. "Consent to Search and Seize: Evaluating an Innovative Youth Firearm Suppression Program." Law and Contemporary Problems 59, no. 1 (1996): 197. http://dx.doi.org/10.2307/1192214.
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Feijó, Camila de Aquino, Valeria Maria de Souza Framil, and Daniele Muñoz Gianvecchio. "Disclosure of information in medicine: analysis of judicial cases." Revista Bioética 30, no. 4 (December 2022): 780–90. http://dx.doi.org/10.1590/1983-80422022304569en.
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Abstract Consent expresses a voluntary decision, taken after disclosure of information, to accept treatment considering risks, benefits, and possible consequences. This study analyzed the role of consent forms in decisions by the São Paulo State Court of Justice. Bibliographic search was conducted using the keywords “consent form” and “medical error.” The 65 rulings identified were analyzed using Excel. Of the 15 cases in which patients were not presented with a consent form, 12 showed lack of information disclosure. In 31% of the cases, the defendant was found guilty, and most of the plaintiffs who received financial compensation were awarded moral damages. Plastic surgery, gynecology and obstetrics were the branches that most often featured as defendants. The findings attest the relevant role played by the consent form and the medical expert.
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Okpala, Nnaemeka, Amala Okpala, Gareth John, and Hugh Cox. "Effectiveness of consenting in Otorhinolaryngology." Open Medicine 7, no. 2 (April 1, 2012): 198–202. http://dx.doi.org/10.2478/s11536-011-0131-0.
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AbstractInformed consent in today’s medical practice has become a cornerstone and a routine ethical component playing a major role in forming a therapeutic alliance with the patient. The present study sought to analyse the effectiveness of the consent forms and the consenting process in Otorhinolaryngology. This three month questionnaire-based study covered varying operations which ranged from tonsillectomies, grommet insertions to pharyngeal pouch stapling. Twenty-nine percent of consent forms were signed on the day of the operation. Of the patients who received leaflets (51%) during the process of informed consent, a majority (88%) found it useful. The respondents were satisfied with the explanation of the procedure, benefits and complications (70–74%). Majority kept their consent forms at home (60%) and did not bother engaging in further search with regards to the information in the consent form (81%). Majority of the patients agreed that they had enough time to make an informed consent. Patients were satisfied with the consent process but more can be done to improve the consenting process.
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O'Connor, Carolyn, and Stephanie Begun. "Understanding Sexual Consent Among Adolescents." Social Science Protocols 5, no. 1 (February 27, 2022): 1–7. http://dx.doi.org/10.7565/ssp.v5.6738.
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Background: Sexual consent remains one of the most important tools in the prevention of sexual violence, for which adolescents are an especially vulnerable group. However, it is unclear how sexual consent processes are defined and used by this population. To bridge this gap in knowledge, we present a protocol for a forthcoming scoping review that will identify and synthesize the available empirical research findings on sexual consent conceptualizations and processes among adolescents.
Methods/Design: Using the framework by Arksey and O’Malley (2005), a systematic search of six academic databases (Education Source, ERIC, Gender Studies Database, PsycINFO, Social Services Abstracts, and Sociological Abstracts) will be conducted; this range has been selected due to the multi-disciplinary nature of sexual consent research. Following two levels of screening, data from the full-text articles will be charted and subjected to qualitative thematic analysis.
Discussion: These collated results will provide a map of key concepts and establish gaps in the extant literature in order to guide future research on this topic. The findings will advance our knowledge of sexual consent as it is understood by the adolescent population; they may also inform the content and delivery of sexual education programs to ensure that they are relevant to their target audience and assist in the prevention of sexual violence.
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O'Connor, Carolyn, and Stephanie Begun. "Understanding Sexual Consent Among Adolescents." Social Science Protocols 5, no. 1 (February 27, 2022): 1–7. http://dx.doi.org/10.7565/ssp.v5.6738.
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Background: Sexual consent remains one of the most important tools in the prevention of sexual violence, for which adolescents are an especially vulnerable group. However, it is unclear how sexual consent processes are defined and used by this population. To bridge this gap in knowledge, we present a protocol for a forthcoming scoping review that will identify and synthesize the available empirical research findings on sexual consent conceptualizations and processes among adolescents.
Methods/Design: Using the framework by Arksey and O’Malley (2005), a systematic search of six academic databases (Education Source, ERIC, Gender Studies Database, PsycINFO, Social Services Abstracts, and Sociological Abstracts) will be conducted; this range has been selected due to the multi-disciplinary nature of sexual consent research. Following two levels of screening, data from the full-text articles will be charted and subjected to qualitative thematic analysis.
Discussion: These collated results will provide a map of key concepts and establish gaps in the extant literature in order to guide future research on this topic. The findings will advance our knowledge of sexual consent as it is understood by the adolescent population; they may also inform the content and delivery of sexual education programs to ensure that they are relevant to their target audience and assist in the prevention of sexual violence.
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Çakir, Asu. "Readability Assessment of Consent Forms Concerning Pediatric Dentistry Found on Turkish Websites." Middle East Research Journal of Dentistry 3, no. 01 (January 22, 2022): 1–5. http://dx.doi.org/10.36348/merjd.2023.v03i01.001.
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Aim: Informed consent of the patient must be obtained for any procedure to be performed on the patient. Consent forms should ensure that patients are adequately informed about the procedure to be applied to them. In the meantime, patients need to understand the consent form they have read. Therefore, this study aims to assess the readability of consent forms concerning pediatric dentistry in Turkey. Methodology: Using the keywords pediatric dentistry, consent form, general anesthesia, and sedation, 100 consent forms first encountered in Google search were examined. These consent forms were evaluated using the Ateşman readability index. Results: In this study, 100 websites were examined, and 62% of the consent forms were rated as medium difficulty. In terms of readability level, the text with the lowest readability level is at the fifth and sixth-grade levels, the text with the highest level is at the undergraduate level, and the text with the average level is at the ninth and tenth-grade levels. Conclusion: Considering that the rate of high school and above literacy in our country is 37%, it seems reasonable that health institutions should regulate the readability level of consent forms.
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Esler, Annemarie, Aimee C. H. Goodman, and Alexander J. Wood. "Water Rescue within UKSAR: consent, capacity and necessity." Journal of Search and Rescue 3, no. 2 (November 1, 2019): 19–43. http://dx.doi.org/10.61618/hilg1366.
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For Search & Rescue Operators providing pre-hospital care and rescue within an aquatic environment, difficulties arise not only from the logistics of performing these interventions, but also obtaining consent from casualties. A great proportion of UKSAR operatives are volunteers, nevertheless, the law expects them to provide the same standard of care as a professional. Consequently, this high standard, combined with the proliferation of operations concerning mental health and the supposed “litigation culture”, leaves these volunteers in a uniquely difficult position. This paper aims to provide a guide, for those operating in and around water, on law regarding consent, capacity and necessity in England & Wales.
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Verreydt, Stef, Koen Yskout, and Wouter Joosen. "Security and Privacy Requirements for Electronic Consent." ACM Transactions on Computing for Healthcare 2, no. 2 (March 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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Belyaletdinov, Roman. "In Search of Socio-humanitarian Trajectories for the Development of Biobanks: Science and Social Trust." Chelovek 33, no. 5 (2022): 63. http://dx.doi.org/10.31857/s023620070022792-8.
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Social trust is the basis for the development of biomedical technologies that affect the value and moral spheres of modern society. Axiological factors, external to science, are decisive in the formation of the legitimation of scientific research. Bioethics allows for the “acclimatization” of rather controversial scientific developments, achieving through a deliberative social process the recognition of new scientific methods that directly affect human life. The need to obtain informed consent from donors of biobanks is associated with the generally accepted procedure for conducting clinical trials. In a broader sense, biomaterials in the context of research are considered as the inalienable property of patients, which implies their right to control what happens to samples of biomaterials. However, given the workload of biobanks, which can host dozens of studies, the process of informing all donors about each individual study is an extremely difficult task, requiring both technical and time resources. Today, the form of extended informed consent is considered as the most appropriate model for the interaction of donors and depositories of biomaterials. Thus, the legal approach to the problem of informed consent for biobanks would seem to be more functional, while the need to take into account the moral principles of biobank donors remains relevant as a condition for trust in science.
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Schroeter, Kathryn. "In Search of the Abominable Consent Form: The Impact of Readability and Personalization." AORN Journal 69, no. 4 (April 1999): 869–72. http://dx.doi.org/10.1016/s0001-2092(06)62365-x.
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Wagner, Laura, Shanna Davis, and Mitchell M. Handelsman. "In search of the abominable consent form: The impact of readability and personalization." Journal of Clinical Psychology 54, no. 1 (January 1998): 115–20. http://dx.doi.org/10.1002/(sici)1097-4679(199801)54:1<115::aid-jclp13>3.0.co;2-n.
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Alahmad, Ghiath. "Informed Consent in Pediatric Oncology." Cancer Control 25, no. 1 (January 1, 2018): 107327481877372. http://dx.doi.org/10.1177/1073274818773720.
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Objective: Obtaining informed consent in pediatric cancer research can be subject to important ethical challenges because of the difficulty in distinguishing between care and research, which are interrelated. Pediatric oncologists also often conduct research, such as clinical trials, on their own patients, which may influence voluntary informed consent. This review aims to determine the ethical issues encountered in obtaining informed consent in pediatric oncology by identifying and summarizing the findings of existing qualitative studies on this topic. Methods: A systematic review of qualitative studies was conducted. Medline, Embase, CINAHL, and PubMed were searched using the following terms: (oncolog* or cancer or hematol* or haematol* or leuk* or malign* or neoplasm*) and (child* or adolescent* or minor* or young people or pediatr* or paediatr*) and ethic* or moral*) and (qualitative or interview). Other sources were also mined to identify all relevant studies. The data analysis method used was thematic analysis. Results: At the end of the search process, 2361 studies were identified. Duplicates were removed and irrelevant studies were excluded. After screening the full text of the remaining studies against our inclusion and exclusion criteria, 13 studies were included in the qualitative analysis. All studies were qualitative studies using semistructured and structured interviews, qualitative analysis of open-ended questions, and observation of informed consent conferences. Four themes were identified: parental comprehension of the trial and medical terms, influence of parental distress on decision-making, no offer of an alternative treatment, and influence of the doctor–parent relationship. Conclusion: Many ethical challenges affect the informed consent process. These challenges may include a lack of parental understanding, the potential influence of treating doctors, and vulnerability because of psychological status. All of these result in parents being unable to give well-informed and voluntary consent. Researchers are encouraged to adopt a stepwise approach during the informed consent process.
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Hribov, M. L., and O. I. Kozachenko. "LEGAL REGULATION OF USING SECRET COOPERATION FOR THE PURPOSE OF INVESTIGATING CRIMINAL OFFENSES." Herald of criminal justice, no. 1-2 (2023): 26–41. http://dx.doi.org/10.17721/2413-5372.2023.1-2/26-41.
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The use of secret cooperation for the purpose of investigating criminal offenses is an established and effective practice that ensures timely identification and prevention of crimes, allows to prevent the commission of crimes. However, today this activity is actually outside the law, as it is not regulated by legislation and is not properly regulated at the level of subordinate acts. The purpose of the article is to refine the problem of legislative regulation of using secret cooperation for the purpose of investigating criminal offenses. The main results of the study are the justification that the use of secret cooperation for the purpose of investigating criminal offenses should be based on the norms of the law, which would establish the activity, which in theory and in practice is called «operative search». At the same time, proposals on determining the content of operative search and the list and content of specific measures that are tools for its implementation are given. Those of these tools, the conspiratorial use of which can be entrusted to undercover employees, are identified, namely: interviewing people with their voluntary consent; inspection of publicly accessible objects; inspection of publicly inaccessible objects with the voluntary consent of the persons under whose control they are; receiving confidential information with the consent of persons who have access to it; search surveillance. The research made it possible to come to the conclusion that in order to legally regulate the use of secret cooperation for the purpose of investigating criminal offenses, the Law of Ukraine «On operative-search activity» requires: first, to regulate operative search as the initial stage of operative-search activity, at which operative units, on their own initiative, take measures to find and record information on: preparation of a crime; attempts to commit crimes; committing a completed (but undetected) crime; secondly, to the grounds of operative-search activity (Article 6 of the Law of Ukraine «On operative-search activity»), include the item: «prevention, early detection and suppression of crimes and expose the causes and conditions conducive to the crime»; thirdly, submit a comprehensive list of operational-search measures; fourthly, to provide for the possibility of conspiratorial implementation of specific operational-search measures by an undercover employee; fifth, separately and in detail regulate the most important issues of secret cooperation, namely: its content and forms, the mechanism of attracting people to cooperation, the powers of secret employees, the issue of ensuring their conspiracy, security and social protection, etc.
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Lamont, Scott, Yun-Hee Jeon, and Mary Chiarella. "Health-care professionals’ knowledge, attitudes and behaviours relating to patient capacity to consent to treatment." Nursing Ethics 20, no. 6 (March 20, 2013): 684–707. http://dx.doi.org/10.1177/0969733012473011.
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This integrative review aims to provide a synthesis of research findings of health-care professionals’ knowledge, attitudes and behaviours relating to patient capacity to consent to or refuse treatment within the general hospital setting. Search strategies included relevant health databases, hand searching of key journals, ‘snowballing’ and expert recommendations. The review identified various knowledge gaps and attitudinal dispositions of health-care professionals, which influence their behaviours and decision-making in relation to capacity to consent processes. The findings suggest that there is tension between legal, ethical and professional standards relating to the assessment of capacity and consent within health care. Legislation and policy guidance concerning capacity assessment processes are lacking, and this may contribute to inconsistencies in practice.
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Kurek, Justyna. "Legal Security Aspects of Online Search. Postulates de lege ferenda." Internal Security 11, no. 2 (February 17, 2020): 129–40. http://dx.doi.org/10.5604/01.3001.0013.8212.
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Classified online search of telecommunication systems with the use of spyware tools requires comprehensive regulation. On the one hand, it should ensure the balance between an effective legal framework for guaranteeing public security in the online environment and legal regulation, on the other hand — it should respect constitutional norms, in particular the right of the individual to protect privacy, the inviolability of the home and the protection of correspondence. Legal and political consent for such activities requires, however, the creation of institutional, material, legal and procedural guarantees.
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Vito, Anthony G., and George E. Higgins. "Understanding the role of race, gender and age in request to consent search drivers." Journal of Ethnicity in Criminal Justice 19, no. 3-4 (October 2, 2021): 223–43. http://dx.doi.org/10.1080/15377938.2021.1985029.
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Shaw, David. "The Consent Form in the Chinese CRISPR Study: In Search of Ethical Gene Editing." Journal of Bioethical Inquiry 17, no. 1 (January 3, 2020): 5–10. http://dx.doi.org/10.1007/s11673-019-09953-x.
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Niznick, Naomi, Ronda Lun, Brian Dewar, Dar Dowlatshahi, and Michel Shamy. "Advanced consent for participation in acute care randomised control trials: protocol for a scoping review." BMJ Open 10, no. 10 (October 2020): e039172. http://dx.doi.org/10.1136/bmjopen-2020-039172.
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IntroductionInformed consent is essential to clinical research, though obtaining informed consent for participation in research for emergency conditions is challenging. Adapted consent methods include consent from a substitute-decision maker, deferral of consent and waiver of consent. A novel approach is to use advanced consent, where a potential participant provides consent in the present in the event that they become eligible for enrolment into a future study. This scoping review will map and synthesise the literature on the use of advanced consent for participation and enrolment in randomised control trials for emergency conditions.Methods and analysisGuided by Arksey and O'Malley’s scoping review methodology framework, we will search electronic databases (Medline, Embase, Web of Science and the Cochrane Register of Clinical Trials), the grey literature sources and reference lists of relevant studies. Eligible studies will include English language articles that discuss, examine or employ the use of advanced consent for enrolment in randomised control trials, specifically related to emergency conditions or emergency treatment. Diverse types of articles will be eligible for inclusion, including peer-reviewed qualitative and quantitative studies such as randomised control trials, observational studies, surveys, systematic reviews, as well as narrative reviews and ethics papers. Studies will be screened by two independent reviewers to determine eligibility for inclusion. Data on bibliographic information, study characteristics and methodology, and reported results, specifically author disposition, will be extracted and described using qualitative analysis.Ethics and disseminationFormal ethics review is not required as primary data will not be collected. The findings of this study will be disseminated through a peer-reviewed publication. The findings of this study will help identify knowledge gaps that may guide areas for future research and may aid in the design of future clinical trials using advanced consent.
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Wilmes, Nick, Charlotte W. E. Hendriks, Caspar T. A. Viets, Simon J. W. M. Cornelissen, Walther N. K. A. van Mook, Josanne Cox-Brinkman, Leo A. Celi, et al. "Structural under-reporting of informed consent, data handling and sharing, ethical approval, and application of Open Science principles as proxies for study quality conduct in COVID-19 research: a systematic scoping review." BMJ Global Health 8, no. 5 (May 2023): e012007. http://dx.doi.org/10.1136/bmjgh-2023-012007.
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BackgroundThe COVID-19 pandemic required science to provide answers rapidly to combat the outbreak. Hence, the reproducibility and quality of conducting research may have been threatened, particularly regarding privacy and data protection, in varying ways around the globe. The objective was to investigate aspects of reporting informed consent and data handling as proxies for study quality conduct.MethodsA systematic scoping review was performed by searching PubMed and Embase. The search was performed on November 8th, 2020. Studies with hospitalised patients diagnosed with COVID-19 over 18 years old were eligible for inclusion. With a focus on informed consent, data were extracted on the study design, prestudy protocol registration, ethical approval, data anonymisation, data sharing and data transfer as proxies for study quality. For reasons of comparison, data regarding country income level, study location and journal impact factor were also collected.Results972 studies were included. 21.3% of studies reported informed consent, 42.6% reported waivers of consent, 31.4% did not report consent information and 4.7% mentioned other types of consent. Informed consent reporting was highest in clinical trials (94.6%) and lowest in retrospective cohort studies (15.0%). The reporting of consent versus no consent did not differ significantly by journal impact factor (p=0.159). 16.8% of studies reported a prestudy protocol registration or design. Ethical approval was described in 90.9% of studies. Information on anonymisation was provided in 17.0% of studies. In 257 multicentre studies, 1.2% reported on data sharing agreements, and none reported on Findable, Accessible, Interoperable and Reusable data principles. 1.2% reported on open data. Consent was most often reported in the Middle East (42.4%) and least often in North America (4.7%). Only one report originated from a low-income country.DiscussionInformed consent and aspects of data handling and sharing were under-reported in publications concerning COVID-19 and differed between countries, which strains study quality conduct when in dire need of answers.
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Vito, Anthony, George Higgins, and Gennaro Vito. "Police Stop and Frisk and the Impact of Race: A Focal Concerns Theory Approach." Social Sciences 10, no. 6 (June 16, 2021): 230. http://dx.doi.org/10.3390/socsci10060230.
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The findings of this study outline the racial differences in stop and frisk decisions by Illinois officers in consent searches and those based upon reasonable suspicion within the context of the elements of focal concerns theory. The analysis for this study was performed using propensity score matching (PSM) and allowed the researchers to create a quasi-experimental design to examine the race of the citizen and police decision making. According to our analysis of official Illinois law enforcement data, Black citizens, particularly males, were less likely to give their consent to a stop and frisk search. Black male citizens were also more likely to be stopped and searched due to an assessment of reasonable suspicion by the officer. Elements of focal concerns theory were also factors in pedestrian stops under conditions of consent and reasonable suspicion. Citizens judged as blameworthy were more likely to be stopped and frisked under conditions of consent and reasonable suspicion. The effect of a verbal threat and the officer’s prior knowledge about the citizen had even more significant impacts.
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Raja, Haseem, and Rishi Talwar. "Consent for septoplasty: Are we meeting patients’ expectations?" Medico-Legal Journal 89, no. 4 (October 4, 2021): 237–40. http://dx.doi.org/10.1177/00258172211042699.
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The requirements for informed consent were modified in 2015 following the UK Supreme Court judgment of Montgomery v Lanarkshire Health Board. This marked a decisive shift from the traditional paternalistic ‘doctor knows best' model towards a more patient-centred approach. This study examines the current standard of consent for septoplasty and whether it complies with the law. We also report whether the ‘reasonable patient’ and surgeon agree about which risks should be discussed during the consent process. Ten complications were identified as common or serious via a literature search. Using questionnaires, 21 Ears, Nose and Throat surgeons were asked which of these they routinely discussed, and 103 patients were asked how seriously they regarded those complications. Results were compared using the Test of Proportions. Most surgeons routinely discuss all risks except negative change in sense of smell and numbness of upper incisors. The ‘reasonable patient’ regarded these two complications as serious or very serious. However, less than 70% of surgeons mentioned them. A significant proportion of Ears, Nose and Throat surgeons do not routinely mention all the risks that the ‘reasonable patient' would want to know about before undergoing a septoplasty. This may result in more clinical negligence claims, as managing a patient's reasonable expectations is an important factor.
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Raja, Haseem, and Rishi Talwar. "Consent for septoplasty: Are we meeting patients’ expectations?" Medico-Legal Journal 89, no. 4 (October 4, 2021): 237–40. http://dx.doi.org/10.1177/00258172211042699.
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The requirements for informed consent were modified in 2015 following the UK Supreme Court judgment of Montgomery v Lanarkshire Health Board. This marked a decisive shift from the traditional paternalistic ‘doctor knows best' model towards a more patient-centred approach. This study examines the current standard of consent for septoplasty and whether it complies with the law. We also report whether the ‘reasonable patient’ and surgeon agree about which risks should be discussed during the consent process. Ten complications were identified as common or serious via a literature search. Using questionnaires, 21 Ears, Nose and Throat surgeons were asked which of these they routinely discussed, and 103 patients were asked how seriously they regarded those complications. Results were compared using the Test of Proportions. Most surgeons routinely discuss all risks except negative change in sense of smell and numbness of upper incisors. The ‘reasonable patient’ regarded these two complications as serious or very serious. However, less than 70% of surgeons mentioned them. A significant proportion of Ears, Nose and Throat surgeons do not routinely mention all the risks that the ‘reasonable patient' would want to know about before undergoing a septoplasty. This may result in more clinical negligence claims, as managing a patient's reasonable expectations is an important factor.
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Vito, Anthony G., Elizabeth L. Grossi, Vanessa Woodward Griffin, and George E. Higgins. "Consent searches: understanding the role of race and what occurs during the traffic stop." Policing: An International Journal 42, no. 4 (August 12, 2019): 611–23. http://dx.doi.org/10.1108/pijpsm-11-2018-0162.
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Purpose The purpose of this paper is to apply focal concerns theory as a theoretical explanation for police officer decision making during a traffic stop that results in a consent search. The study uses coefficients testing to better examine the issue of racial profiling through the use of a race-specific model. Design/methodology/approach The data for this study come from traffic stops conducted by the Louisville Police Department between January 1 and December 31, 2002. Findings The results show that the three components of focal concerns theory can explain police officer decision making for consent searches. Yet, the components of focal concerns theory play a greater role in stops of Caucasian male drivers. Research limitations/implications The data for this study are cross-sectional and self-reported from police officers. Practical implications This paper shows the utility of applying focal concerns theory as a theoretical explanation for police officer decision making on consent searches and how the effects of focal concerns vary depending on driver race. Social implications The findings based on focal concerns theory can provide an opportunity for police officers or departments to explain what factors impact the decision making during consent searches. Originality/value This is the first study (to the researchers’ knowledge) that examines the racial effects of focal concerns on traffic stop consent searchers using coefficients testing.
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Niznick, Naomi, Ronda Lun, Brian Dewar, Jeffrey Perry, Dar Dowlatshahi, and Michel Shamy. "Advance consent for participation in randomised controlled trials for emergency conditions: a scoping review." BMJ Open 13, no. 2 (February 2023): e066742. http://dx.doi.org/10.1136/bmjopen-2022-066742.
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ObjectiveAdvance consent is a recognised method of obtaining informed consent for participation in research, whereby a potential participant provides consent for future involvement in a study contingent on qualifying for the study’s inclusion criteria on a later date. The goal of this study is to map the existing literature on the use of advance consent for enrolment in randomised controlled trials (RCTs) for emergency conditions.DesignScoping review designed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses–Extension for Scoping Reviews guidelines.Data sourcesWe searched electronic databases including MEDLINE, Embase, Web of Science and the Cochrane Register of Clinical Trials from inception to 10 February 2020.Eligibility criteriaEligible studies included articles that discussed or employed the use of advance consent for enrolment in RCTs related to emergency conditions. There were no restrictions on the type of eligible study. Data were extracted directly from included papers using a standardised data charting form. We produced a narrative review including article type and authors’ dispositions towards advance consent.ResultsOur search yielded 1039 titles with duplicates removed. Six articles met inclusion criteria. Three articles discussed the theoretical use of research advance directives in emergency conditions; one article evaluated stakeholders’ perceptions of advance consent; and one article described a method for patients to document their preferences for participation in future research. Only one study employed advance consent to enrol participants into a clinical trial for an emergency condition.ConclusionOur review demonstrates that there has been minimal exploration of advance consent for enrolment in RCTs for emergency conditions. Future studies could aim to assess the acceptability of advance consent to participants, along with the feasibility of enrolling research participants using this method of consent.ProtocolThe protocol for this scoping review was published a priori.
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Maxwell, Lauren, Regina Gilyan, Sayali Arvind Chavan, Laura Merson, Abha Saxena, and Rob Terry. "Guidance for ensuring fair and ethical broad consent for future use. A scoping review protocol." F1000Research 10 (February 11, 2021): 102. http://dx.doi.org/10.12688/f1000research.51312.1.
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Introduction: Broad consent for future use is the reuse of data and/or samples collected by a study by researchers who may not be affiliated with the original study team for purposes that may differ from the objectives of the original study. Sharing participant-level data and samples collected from research participants facilitates reuse and transparency and can accelerate drug or vaccine development, research findings, and translation. Data reuse and synthesis help prevent unnecessary research, thereby respecting research participants time and efforts and building their trust in the research process. Despite these myriad benefits, data and sample sharing represent a significant investment of time for the team that collected the data or samples, and may present additional risks for research participants, including that of re-identifiability and incidental findings, or for the source community. This scoping review will summarize existing guidance on broad consent for future use and highlight evidence gaps related to the ethical, equitable implementation of broad consent for future use. Methods and analysis: We will apply the Arskey and O’Malley scoping review methodology and best practice as outlined in the Joanna Briggs scoping review guidelines. The research questions have been identified through a literature review and consultation with subject-matter experts. The systematic search will be conducted in three databases using a tailored search strategy. We will search the reference lists of included articles or related systematic reviews for additional citations. The title-abstract and full text screening and charting the data will be conducted independently by two reviewers. Discrepancies will be resolved by a third reviewer. Results will be summarized in narrative form. Ethics and dissemination: This scoping review summarizes findings from existing publications and grey literature rather than primary data and, as such, does not require ethics review. Findings will be disseminated through an open access publication and webinar.
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Shlobin, Nathan A., Mark Sheldon, and Sandi Lam. "Informed consent in neurosurgery: a systematic review." Neurosurgical Focus 49, no. 5 (November 2020): E6. http://dx.doi.org/10.3171/2020.8.focus20611.
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OBJECTIVEInformed consent has served as a main principle of medical ethics and laws in the United States. The 1986 American Association of Neurological Surgeons Code of Ethics implied medicolegal liability for the failure to obtain informed consent without providing practical guidance regarding the application of informed consent to individual patient encounters in a medicolegal environment. Here, the authors aimed to identify baseline patient recall after discussions with neurosurgeons and their capacity to provide informed consent, describe the effects of interventions to improve patient comprehension, and elucidate the role of informed consent in malpractice litigation in neurosurgery. Their findings may guide neurosurgeons in discussions to properly inform patients and reduce the risk of litigation.METHODSA systematic review was conducted to explore informed consent within neurosurgery and its application to medicolegal liability using the PubMed, Embase, and Scopus databases. Titles and abstracts from articles identified in the search were read and selected for full-text review. Studies meeting prespecified inclusion criteria were reviewed in full and analyzed for study design, aim, population, interventions, and outcomes.RESULTSOf 1428 resultant articles, 21 were included in the review. Baseline patient recall was low, particularly for risks and alternatives of treatments, and even decreased over time. Cognitive impairment was noted as a factor limiting the ability to provide informed consent. Interventions incorporating a combination of modalities in informed consent discussions, a specialized consent form with points for neurosurgeons to check off upon discussion, interactive websites, question prompt lists, and illustrations were found to be effective in improving patient knowledge. Lack of informed consent was a common factor for malpractice litigation. Spine surgery was particularly prone to costly lawsuits. Payments were generally greater for plaintiff verdicts than for settlements.CONCLUSIONSThe application of informed consent to patient encounters is an important facet of clinical practice. Neurosurgeons have a duty to provide patients with all pertinent information to allow them to make decisions about their care. The authors examined baseline patient comprehension and capacity, interventions to improve informed consent, and malpractice litigation; it appears that determining the proper capacity to provide informed consent and considering informed consent as a process that depends on the setting are important. There is room to improve the informed consent process centered on baseline patient health literacy and understanding as well as clear communication using multiple modalities.
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O'Sullivan, Jane, Cathleen McCarrick, Paul Tierney, Donal B. O'Connor, Jack Collins, and Robert Franklin. "Identification of Informed Consent in Patient Videos on Social Media: Prospective Study." JMIR Medical Education 6, no. 2 (October 13, 2020): e14081. http://dx.doi.org/10.2196/14081.
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Background The American Medical Association Code of Medical Ethics states that any clinical image taken for public education forms part of the patient’s records. Hence, a patient’s informed consent is required to collect, share, and distribute their image. Patients must be informed of the intended use of the clinical image and the intended audience as part of the informed consent. Objective This paper aimed to determine whether a random selection of instructional videos containing footage of central venous catheter insertion on real patients on YouTube (Google LLC) would mention the presence of informed consent to post the video on social media. Methods We performed a prospective evaluation by 2 separate researchers of the first 125 videos on YouTube with the search term “central line insertion.” After duplicates were deleted and exclusion criteria applied, 41 videos of patients undergoing central line insertion were searched for reference to patient consent. In the case of videos of indeterminate consent status, the posters were contacted privately through YouTube to clarify the status of consent to both film and disseminate the video on social media. A period of 2 months was provided to respond to initial contact. Furthermore, YouTube was contacted to clarify company policy. The primary outcome was to determine if videos on YouTube were amended to include details of consent at 2 months postcontact. The secondary outcome was a response to the initial email at 2 months. Results The researchers compiled 143 videos. Of 41 videos that contained footage of patient procedures, 41 were of indeterminate consent status and 23 contained identifiable patient footage. From the 41 posters that were contacted, 3 responded to initial contact and none amended the video to document consent status. Response from YouTube is pending. Conclusions There are instructional videos for clinicians on social media that contain footage of patients undergoing medical procedures and do not have any verification of informed consent. While this study investigated a small sample of available videos, the problem appears ubiquitous and should be studied more extensively.
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Akbar, Freade, and Ray Wagiu Basrowi. "Issues About Digital Informed Consent in Clinical Research." Indonesian Journal of Community and Occupational Medicine 2, no. 1 (July 29, 2022): 40–7. http://dx.doi.org/10.53773/ijcom.v2i1.46.40-7.
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Introduction: Informed consent is a concrete form of moral and ethical values that urgently needs to be emphasized, especially in research that requires the role of humans as subjects and is commonly associated with experimental research. Informed consent itself consists of two forms of print and digital, along with the times many parties began to examine how the role of informed consent, the advantages and disadvantages between print and digital, the application of good digital informed consent, and how information about research should be conveyed to the research subject so that it is easy to understand and in accordance with moral and ethical standards. The purpose of this article is to address issues related to digital informed consent in clinical research.Methods: We conducted a search on the SpingerLink database in March 2022 to see various publications in the last 2 years related to electronic informed consent using keywords: digital, informed consent, research. Results: Total 4 articles as source of literature review. Recent research shows the tendency of research subjects to choose digital informed consent because content is easier to personalize, makes it easier to understand content that is only needed by the subject, and the ease of adding digital content in certain forms of media such as audio, and video into digital formats. From the researcher’s side will increase the active participation and number of study subjects, making it easier for long-term interaction, especially follow-up research. There are 4 types of informed consent based on utilization for research and 5 informed consent processes that must be carried out in clinical research, which is attempted using language that is easily understood by the research subject and dynamic for further research.Conclusions: Informed consent in any form constitutes the autonomy right of the subject. Digital formats provide better prospects in facilitating communication to research subjects. But this ease must be accompanied by the consistency of the application of the standard informed consent process, even in intervention studies with biological samples this is more stringent. Informed consent given to the subject must use language that is easy to understand, and transparent. The subject of the study is given the right at any time to exit the research. In the future, the issue of morals and ethics of research will grow, and more dynamic informed consent is needed, especially for interventional clinical research.
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De Sutter, Evelien, Drieda Zaçe, Stefania Boccia, Maria Luisa Di Pietro, David Geerts, Pascal Borry, and Isabelle Huys. "Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review." Journal of Medical Internet Research 22, no. 10 (October 8, 2020): e19129. http://dx.doi.org/10.2196/19129.
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Background Informed consent is one of the key elements in biomedical research. The introduction of electronic informed consent can be a way to overcome many challenges related to paper-based informed consent; however, its novel opportunities remain largely unfulfilled due to several barriers. Objective We aimed to provide an overview of the ethical, legal, regulatory, and user interface perspectives of multiple stakeholder groups in order to assist responsible implementation of electronic informed consent in biomedical research. Methods We conducted a systematic literature search using Web of Science (Core collection), PubMed, EMBASE, ACM Digital Library, and PsycARTICLES. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used for reporting this work. We included empirical full-text studies focusing on the concept of electronic informed consent in biomedical research covering the ethical, legal, regulatory, and user interface domains. Studies written in English and published from January 2010 onward were selected. We explored perspectives of different stakeholder groups, in particular researchers, research participants, health authorities, and ethics committees. We critically appraised literature included in the systematic review using the Newcastle-Ottawa scale for cohort and cross-sectional studies, Critical Appraisal Skills Programme for qualitative studies, Mixed Methods Appraisal Tool for mixed methods studies, and Jadad tool for randomized controlled trials. Results A total of 40 studies met our inclusion criteria. Overall, the studies were heterogeneous in the type of study design, population, intervention, research context, and the tools used. Most of the studies’ populations were research participants (ie, patients and healthy volunteers). The majority of studies addressed barriers to achieving adequate understanding when using electronic informed consent. Concerns shared by multiple stakeholder groups were related to the security and legal validity of an electronic informed consent platform and usability for specific groups of research participants. Conclusions Electronic informed consent has the potential to improve the informed consent process in biomedical research compared to the current paper-based consent. The ethical, legal, regulatory, and user interface perspectives outlined in this review might serve to enhance the future implementation of electronic informed consent. Trial Registration PROSPERO International Prospective Register of Systematic Reviews CRD42020158979; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=158979
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Klein, Harry, Tali Mazor, Priti Kumari, Andrea Ovalle, Pavel Trukhanov, Jason Hansel, Joyce Yu, James Lindsay, Michael Hassett, and Ethan Cerami. "Abstract 4091: Design and adoption of MatchMiner at Dana-Farber Cancer Institute." Cancer Research 82, no. 12_Supplement (June 15, 2022): 4091. http://dx.doi.org/10.1158/1538-7445.am2022-4091.
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Abstract Precision medicine (PM) drugs targeting alterations such as EGFR mutations and BCR-ABL fusions have provided great clinical benefit to patients. However, with an abundance of tumor sequencing data and trial eligibility criteria available, it can be challenging for clinicians to identify PM trial options for patients. To address this challenge at Dana-Farber Cancer Institute (DFCI), we developed MatchMiner, an open-source platform for computationally matching patients to PM trials. MatchMiner has three modes of use: (1) patient-centric, where clinicians can view all available trial matches for a patient, (2) trial-centric, where clinical trial teams identify patients for their trials based on genomic and clinical criteria, and (3) trial search, where clinicians search for available trials based on clinical and genomic eligibility. Trial matching is performed via the MatchEngine, which computes trial matches based on patient genomic and clinical data and PM trial eligibility criteria. To encode trial eligibility criteria, we developed a structured format called clinical trial markup language (CTML), which uses Boolean logic to encode inclusion and exclusion criteria. Here, we describe our implementation of MatchMiner at DFCI including strategies that were successful and MatchMiner’s impact on trial consent. Since MatchMiner first went live in March 2017, a number of strategies have helped facilitate utilization of MatchMiner. The biggest impact has come from targeted departmental collaborations (Gastrointestinal, Breast, and Center for Cancer Therapeutic Innovation or CCTI), where the MatchMiner team worked directly with key departmental stakeholders to develop customized workflows. To facilitate access to MatchMiner among individual clinicians, we integrated the patient-centric and trial search modes into the Epic electronic health record. Other implementation strategies were piloted, such as weekly emails to clinicians alerting them to potential trial matches, but were less impactful. Overall, departmental collaborations have resulted in several ongoing MatchMiner initiatives. Thus far at DFCI, we have curated 354 PM trials into MatchMiner and facilitated 220 patient consents. For PM trials, 222 genes, 7 mutational signatures and nearly all cancer types were represented, demonstrating that there is a wide range of PM trial options available to patients. We also examined the distribution of trial phases and disease centers running each trial. The majority were Phase I and Phase II trials run out of the CCTI, consistent with the frequency with which novel drugs do not progress to later phase trials. Lastly, we have identified 220 trial consents that benefitted from MatchMiner. Retrospective analysis of a subset of these trial consents (n=166) revealed a significant 22% decrease in time to consent relative to other consents to the same trials, demonstrating the clinical impact of MatchMiner. Citation Format: Harry Klein, Tali Mazor, Priti Kumari, Andrea Ovalle, Pavel Trukhanov, Jason Hansel, Joyce Yu, James Lindsay, Michael Hassett, Ethan Cerami. Design and adoption of MatchMiner at Dana-Farber Cancer Institute [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 4091.
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Dhamanaskar, Roma, and Jon F. Merz. "High-impact RCTs without prospective informed consent: a systematic review." Journal of Investigative Medicine 68, no. 8 (October 1, 2020): 1341–48. http://dx.doi.org/10.1136/jim-2020-001481.
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The prevalence of randomized controlled trials (RCTs) performed without fully informed prospective consent from subjects is unknown. We performed this study to estimate the prevalence of high-impact RCTs performed without informed consent from all subjects and examine whether such trials are becoming more prevalent. We performed a systematic review of English-language RCTs published from 2014 through 2018 identified in Scopus and sorted to identify the top 100 most highly cited RCTs each year. Text search of title and abstract included terms randomized controlled or clinical trial and spelling variants thereof, and excluded metaanalyses and systematic reviews. We independently identified the most highly cited RCTs based on predefined criteria and negotiated to agreement, then independently performed keyword searches, read, abstracted and coded information regarding informed consent from each paper and again negotiated to agreement. No quality indicators were assessed. We planned descriptive qualitative analysis and appropriate quantitative analysis to examine the prevalence and characteristics of trials enrolling subjects with other than fully informed prospective consent. We find that 44 (8.8%, binomial exact 95% CI 6.5% to 11.6%) of 500 high-impact RCTs did not secure informed consent from at least some subjects. The prevalence of such trials did not change over the 5 years (OR=1.09, z=0.78, p=0.44). A majority (66%) of the trials involved emergency situations, and 40 of 44 (90.9%) of the trials involved emergency interventions, pragmatic designs, were cluster randomized, or a combination of these factors. A qualitative analysis explores the methods of and justifications for waiving informed consent in our sample of RCTs.
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Walsh, Kieran. "Case reports on dangerous infectious diseases: a review of patient consent." BMJ Military Health 166, no. 3 (June 29, 2018): 179–80. http://dx.doi.org/10.1136/jramc-2018-000949.
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Case reports are commonly used to describe new infectious diseases. In the past 20 years, there have been an increasing number of emerging infectious diseases that could constitute a major threat to global health security (through naturally occurring pandemics or deliberate release of infectious agents). It is vitally important that case reports related to infectious diseases are written up according to the highest possible standards and that guidelines regarding patient consent to publish are followed. So, do case reports that relate to dangerous infectious diseases follow guidance related to patient consent? To help find the answer to this question, I looked at a sample of case reports published on PubMed between 1 January 2014 and 31 December 2016. I searched for freely available full-text reports of infections that affected humans. The search was conducted for case reports on infectious diseases that pose the greatest risk to global health—infections that have been classified as Tier 1 agents by the Centers for Disease Control and Prevention. An assessment was carried out as to whether the identified case reports satisfied the criteria related to consent as outlined in the CARE guidelines. In total, 71 case reports were found. These were related to Ebola, Botulism, Yersinia and Tularaemia. The authors stated that they had obtained consent to publish in 17 of these case reports. Only a minority of published case reports on extremely dangerous pathogens contain documented evidence that consent was obtained from the patient in question. In this sample, 24% of case reports contained such evidence regarding consent.
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Malenko, Oleksandr. "TOPICAL ISSUES OF PROTECTING THE RIGHTS AND LEGITIMATE INTERESTS OF THE ACCUSED IN CORRUPTION CRIMINAL PROCEEDINGS INVOLVING CONFIDANTS (REGARDING THE PROCEDURE FOR ATTRACTING A CONFIDANT BY AN AUTHORIZED ENTITY)." Criminalistics and Forensics, no. 68 (July 3, 2023): 253–67. http://dx.doi.org/10.33994/kndise.2023.68.25.
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In the scientific article, the author examines the theoretical and practical problems of the procedure for the investigator’s involvement of a person in confidential cooperation and conducting covert investigative (search) actions during the pre-trial investigation of corruption criminal proceedings. It also reveals the issue of the use by the defence side of the established violations in the algorithm of involving the relevant person in criminal proceedings in order to justify the inadmissibility of evidence obtained as a result of covert investigative (search) actions with the participation of the confidant. Based on the analysis of the judicial practice of the High Anti-Corruption Court and the Appeals Chamber of the High Anti-Corruption Court, the author concluded that there is no uniform application of Article 275 of the Criminal Procedure Code of Ukraine in the activities of law enforcement agencies. Most often, investigators attract confidants by selecting an application for voluntary consent to confidential cooperation and participation in covert investigative (search) actions and the adoption of a corresponding resolution. There are cases of a decision on the participation of a confidant in criminal proceedings by the prosecutor when adopting a resolution on the conduct of covert investigative (search) actions – control over the commission of a crime (with the written consent of the person). The author has researched judicial practice in cases where the materials of criminal proceedings do not contain any procedural documents regarding the involvement of a confidant in covert investigative (search) actions and confidential cooperation. The article stated the fact that the High Anti-Corruption Court and the Appels Chamber of the High Anti-Corruption Court ignored all violations of the prosecution regarding the implementation of Article 275 of the Criminal Procedure Code of Ukraine.
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Lablans, M., D. Kadioglu, M. Muscholl, and F. Ückert. "Exploiting Distributed, Heterogeneous and Sensitive Data Stocks while Maintaining the Owner’s Data Sovereignty." Methods of Information in Medicine 54, no. 04 (2015): 346–52. http://dx.doi.org/10.3414/me14-01-0137.
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SummaryBackground: To achieve statistical significance in medical research, biological or data samples from several bio- or databanks often need to be complemented by those of other institutions. For that purpose, IT-based search services have been established to locate datasets matching a given set of criteria in databases distributed across several institutions. However, previous approaches require data owners to disclose information about their samples, raising a barrier for their participation in the network.Objective: To devise a method to search distributed databases for datasets matching a given set of criteria while fully maintaining their owner’s data sovereignty.Methods: As a modification to traditional federated search services, we propose the decentral search, which allows the data owner a high degree of control. Relevant data are loaded into local bridgeheads, each under their owner’s sovereignty. Researchers can formulate criteria sets along with a project proposal using a central search broker, which then notifies the bridgeheads. The criteria are, however, treated as an inquiry rather than a query: Instead of responding with results, bridgeheads notify their owner and wait for his/her decision regarding whether and what to answer based on the criteria set, the matching datasets and the specific project proposal. Without the owner’s explicit consent, no data leaves his/ her institution.Results: The decentral search has been deployed in one of the six German Centers for Health Research, comprised of eleven university hospitals. In the process, compliance with German data protection regulations has been confirmed. The decentral search also marks the centerpiece of an open source registry software toolbox aiming to build a national registry of rare diseases in Germany.Conclusions: While the sacrifice of real-time answers impairs some use-cases, it leads to several beneficial side effects: improved data protection due to data parsimony, tolerance for incomplete data schema mappings and flexibility with regard to patient consent. Most importantly, as no datasets ever leave their institution, owners can reject projects without facing potential peer pressure. By its lower barrier for participation, a decentral search service is likely to attract a larger number of partners and to bring a researcher into contact with the right potential partners.