scholarly journals Minimal Risk in Research Involving Pregnant Women and Fetuses

2011 ◽  
Vol 39 (3) ◽  
pp. 529-538 ◽  
Author(s):  
Carson Strong

How should the definition of “minimal risk” in the federal research regulations be interpreted in regard to pregnant women and fetuses? Surprisingly, there has been little discussion of this question. There is, after all, a substantial amount of published work addressing the question of how “minimal risk” should be interpreted. Similarly, there is a large body of literature on the ethics of research involving pregnant women and fetuses, particularly maternal-fetal surgery. However, in neither of these bodies of work can one find an analysis of minimal risk in regard to fetuses or pregnant women.The concept of minimal risk is defined in the regulations as follows:Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Juliette Servante ◽  
Gill Swallow ◽  
Jim G. Thornton ◽  
Bethan Myers ◽  
Sandhya Munireddy ◽  
...  

Abstract Background As pregnancy is a physiological prothrombotic state, pregnant women may be at increased risk of developing coagulopathic and/or thromboembolic complications associated with COVID-19. Methods Two biomedical databases were searched between September 2019 and June 2020 for case reports and series of pregnant women with a diagnosis of COVID-19 based either on a positive swab or high clinical suspicion where no swab had been performed. Additional registry cases known to the authors were included. Steps were taken to minimise duplicate patients. Information on coagulopathy based on abnormal coagulation test results or clinical evidence of disseminated intravascular coagulation (DIC), and on arterial or venous thrombosis, were extracted using a standard form. If available, detailed laboratory results and information on maternal outcomes were analysed. Results One thousand sixty-three women met the inclusion criteria, of which three (0.28, 95% CI 0.0 to 0.6) had arterial and/or venous thrombosis, seven (0.66, 95% CI 0.17 to 1.1) had DIC, and a further three (0.28, 95% CI 0.0 to 0.6) had coagulopathy without meeting the definition of DIC. Five hundred and thirty-seven women (56%) had been reported as having given birth and 426 (40%) as having an ongoing pregnancy. There were 17 (1.6, 95% CI 0.85 to 2.3) maternal deaths in which DIC was reported as a factor in two. Conclusions Our data suggests that coagulopathy and thromboembolism are both increased in pregnancies affected by COVID-19. Detection of the former may be useful in the identification of women at risk of deterioration.


2016 ◽  
Vol 44 (2) ◽  
pp. 352-358 ◽  
Author(s):  
Mark A. Rothstein

The HIPAA Privacy Rule is notoriously weak because of its incomplete coverage, numerous exclusions and exemptions, and limited rights for individuals. The three areas in which it provides the most protection are fundraising, marketing, and research. Provisions of the 21st Century Cures Act, pending in Congress, and the Notice of Proposed Rulemaking to amend the federal research regulations (Common Rule), awaiting final regulatory action, would weaken the privacy protections for research. If these measures are adopted, the HIPAA Privacy Rule would have so little value that it might not be worth the aggravation and burden.


2021 ◽  
pp. 1-22
Author(s):  
Meg Rithmire ◽  
Hao Chen

Abstract A large body of literature on state–business relations in China has examined the political role of capitalists and collusion between the state and the private sector. This paper contributes to that literature and understanding of the internal differentiation among China's business elites by documenting the emergence of a particular kind of large, non-state business group that we argue is more akin to a mafia system than any standard definition of a firm. Drawing on large-N descriptive data as well as deep ethnographic and documentary research, we argue that mafia-like business systems share organizational principles (plunder and obfuscation) and means of growth and survival (relations of mutual endangerment and manipulation of the financial system). Understanding the particular moral economy that underlies mafia-like business systems and their interactions with the state challenges methodological foundations of research on China's political economy and helps to explain recent conflict between high-profile business people and the state.


2021 ◽  
pp. 2-3
Author(s):  
Ana Tostões

Devoted to the theme of single-family houses, given the key role they played in the ideal definition of the Modern Movement architecture, as a symbolic and functional affirmation of the utopian turning of dreams into reality, the aim of this issue is to consider the transformation of daily life, and to address the architectural challenges that arose from the joy contained in what we might call the “architecture of happiness.” As we continue to endure a pandemic that has now lasted for more than a year, docomomo wishes to declare that “till the moment, the best vaccine to prevent contagion was invented by architects: the house”. Thus, in response to the question “How should we live?”, it is intended to debate the house and the home agenda as an important topic at the core of Modern Movement architecture. Nowadays, the growing emphasis on wellbeing goes beyond the seminal ideas that modern houses were “machines à habiter” and is closer to an idealistic vision of a stimulating shell for humans, which is shaped by imagination, experimentation, efficiency, and knowledge.


2016 ◽  
Vol 18 (1) ◽  
Author(s):  
Adeniji K. Adesemowo ◽  
Rossouw Von Solms ◽  
Reinhard A. Botha

Background: With the evolution of data, via information into knowledge and beyond, intangible information assets (seen as an integral part of IT assets in this article) increasingly come to fore. A contemporary issue facing organisations in the knowledge economy and beyond is how best to safeguard and derive optimum value from their evolving information assets. A well-known fact is that risk exists because there is the possibility of threats to an asset. Likewise, no assets equals no risk. Although a large body of work is addressing threat models, the nature of the assets of the knowledge economy and beyond has not been well researched.Objectives: To investigate the definition of information assets across a number of financial, risk and information technology standards, frameworks and regulations, in order to ascertain whether a coherent definition exists across the board. If there is none (or limited), then propose a workable definition that is apt for the knowledge economy and beyond.Method: Qualitative thematic content analysis and a comparative study based on four main themes (Assets, Types of Asset, Information, and Information Assets). This then serves as a basis for argumentation schemes that lead to a proposed re-definition. The qualitative research approach assists us to address the concern of the incoherent definition of information and information assets across the board.Results: Contrary to expectations, the research study found the current definition to be incoherent. When the asset to be controlled is not properly defined and understood, it stands the risk of not being identified properly. This implies that the effectiveness, efficiency, reliability of internal control, and compliance with the applicable legislation and regulations would not be appropriate. This article highlights the need for a fundamental shift in how information assets (valuable, but unvalued organisational intangible assets) are being viewed and treated, especially with regard to information risk and internal controls.Conclusion: This article has identified a major defect in most standards, frameworks, and regulations dealing with regard to the safeguarding and management of information assets (and IT assets). It has established from the review carried out that information assets have not been properly defined across the board. Beyond this significant finding, it was further shown that the principle of risk (assessment) across the board requires the identification of the asset that needs to be controlled. A starting point, then, is a coherent definition (as proposed) for the information asset in itself. Therefore, proper definition across the board might assists in proper identification that could result in appropriate control and graceful handling of the end-of-life disposal.Keywords: infonomics; information asset; information risk; internal control; reputation loss


Author(s):  
Yasmin Coelho de Freitas ◽  
Francisco De Assis Ferreira ◽  
Carlos Eduardo Batista Groner ◽  
Igor Tristão Azevedo ◽  
Jacqueline Rogéria Bringhenti ◽  
...  

 The social isolation promoted by COVID-19 impacts the routine and habits of families with a reflection on the characteristics and generation of solid waste and consumption of natural resources. This situation has been identified as an opportunity for educational institutions to promote awareness actions with their internal and external community as a contribution to reduce such effects. In order to disseminate sustainable practices related to the daily life of the pandemic and to evaluate responses, the group of teachers and students developed activities which contributed to minimize the effects of the pandemic. The ease and speed of social media was used as a tool for actions. The methodological steps were: survey of the existing contents in the official networks of the Federal Institute of Espírito Santo related to the topic of interest, the definition of the InstagramTM social network, profile creation for the Ifes Biotechnology and Sustainability Laboratory (Labiotecs), increase of followers, creation and dissemination of content and publications analysis. The work is based on the Deming Cycle methodology in order to optimize its planning and execution. Among the results, 179 followers on the profile were reached, 10 posts were shared in the feed, 4 questionnaires and 5 polls applied until 06/17/2020. The effectiveness of the work was shown through the reach of publications and public acceptance. Also, the Deming cycle proved to be adequate and capable of being replicated.


2021 ◽  
Vol 6 (2) ◽  
pp. 19-25
Author(s):  
Murod Turgunov ◽  

Thecurrent article discusses the issues of ensuring the rights of the child in the Avesta, the sacred book of the Zoroastrians, analyzes the problems of modern family law, implementation of theprovisions of international legal instruments into national legislation regulating family relations in the historical and legal values.Furthermore, the author examines issues related to the definition of pregnancy, its termination, and the legal status of pregnant women based on the analysis of the relevant parts of the Avesta.On the basis of the study of the provisions of this holy book, the author compares the provisions of the modern criminal legislation of Uzbekistan with the provisions of this historical book on marriages, the definition of kinship, the legalstatus of children and adolescents


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