Consenting to Adverse Events

2020 ◽  
pp. 179-205
Author(s):  
Jill A. Fisher

Chapter 7 draws on secondary data about the safety of Phase I trials to discuss how research staff and healthy volunteers alike struggle to make sense of the omnipresent hypothetical risks of studies, outlined in informed consent forms, in the face of tangible evidence of the trials’ relative safety. Serial participation fundamentally shapes healthy volunteers’ view of trial risks. This is because repeated enrollment diminishes the importance of the formal consent process as healthy volunteers’ own experiences take priority. As long as participants are unharmed in the studies they complete, they become desensitized to the risks and place trust in the research process, believing that the clinics will keep them safe. At the same time, as model organisms, healthy volunteers are often regarded as being indifferent to risks. They are even stigmatized as desperate people too focused on the money that they will earn from a study to assess appropriately the harms that might occur. From this vantage point, study participation is viewed contradictorily as safe unless someone is not taking the consent process seriously.

2002 ◽  
Vol 69 ◽  
pp. 117-134 ◽  
Author(s):  
Stuart M. Haslam ◽  
David Gems ◽  
Howard R. Morris ◽  
Anne Dell

There is no doubt that the immense amount of information that is being generated by the initial sequencing and secondary interrogation of various genomes will change the face of glycobiological research. However, a major area of concern is that detailed structural knowledge of the ultimate products of genes that are identified as being involved in glycoconjugate biosynthesis is still limited. This is illustrated clearly by the nematode worm Caenorhabditis elegans, which was the first multicellular organism to have its entire genome sequenced. To date, only limited structural data on the glycosylated molecules of this organism have been reported. Our laboratory is addressing this problem by performing detailed MS structural characterization of the N-linked glycans of C. elegans; high-mannose structures dominate, with only minor amounts of complex-type structures. Novel, highly fucosylated truncated structures are also present which are difucosylated on the proximal N-acetylglucosamine of the chitobiose core as well as containing unusual Fucα1–2Gal1–2Man as peripheral structures. The implications of these results in terms of the identification of ligands for genomically predicted lectins and potential glycosyltransferases are discussed in this chapter. Current knowledge on the glycomes of other model organisms such as Dictyostelium discoideum, Saccharomyces cerevisiae and Drosophila melanogaster is also discussed briefly.


Author(s):  
Miraida Morales ◽  
Sarah Barriage

This poster presents a pilot study that analyzed a small corpus of informed consent forms used in research with children, adolescents, and adult early readers using Coh-Metrix, a readability measurement tool. Recommendations for increasing readability of consent forms in order to improve the informed consent process are also provided. Cette affiche présente une étude pilote qui a analysé un corpus restreint de formulaires de consentement éclairé utilisés dans la recherche avec les enfants, les adolescents et les lecteurs précoces adultes,  utilisant Coh-Metrix, un outil de mesure de la lisibilité. Nous fournissons également des recommandations pour augmenter la lisibilité des formulaires de consentement afin d'améliorer le processus de consentement éclairé.


2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 733-734
Author(s):  
Lindsay Peterson ◽  
David Dosa ◽  
Patricia D’Antonio

Abstract Preparedness of residents in long-term care (LTC) in the face of hurricane emergencies is a contested and largely unanswered question. Our prior work involving the U.S. Gulf Coast hurricanes of 2005-08 showed that exposure to various storms on nursing home (NH) residents resulted in significantly more deaths than reported by health care officials. This work also highlighted that evacuation of NH residents, compared to sheltering in place, was independently associated with morbidity and mortality. Hurricane Irma struck Florida on Sept. 10, 2017, prompting the evacuation of thousands of NH and assisted living community (ALC) residents. This symposium will discuss the effects of Hurricane Irma on vulnerable older adults residing in NHs and ALCs using mixed quantitative and qualitative methodologies. The first presentation will discuss morbidity and mortality of NH residents exposed to Hurricane Irma and will stratify by long stay/short stay status and hospice enrollment. The second presentation will discuss improvements and continued barriers to NH preparedness based on interviews with 30 administrators following Hurricane Irma. Using a novel methodology to identify residents of ALCs using secondary data sources, the third presentation will document AL resident morbidity and mortality risk following Hurricane Irma. The final presentation will highlight results of interviews with 70 stakeholders from small and large ALCs concerning the hurricane experiences of residents, including those with dementia. This symposium offers a multi-faceted view of a disaster’s effects on LTC residents across Florida, including novel data from the NH environment and lesser-examined ALCs.


Author(s):  
Caitlin Geier ◽  
Robyn B. Adams ◽  
Katharine M. Mitchell ◽  
Bree E. Holtz

Informed consent is an important part of the research process; however, some participants either do not read or skim the consent form. When participants do not read or comprehend informed consent, then they may not understand the potential benefits, risks, or details of the study before participating. This study used previous research to develop experimentally manipulated online consent forms utilizing various presentations of the consent form and interactive elements. Participants ( n = 576) were randomly exposed to one of six form variations. Results found that the highly interactive condition was significantly better for comprehension than any of the other conditions. The highly interactive condition also performed better for readability, though not significantly. Further research should explore the effects of interactive elements to combat habituation and to engage participants with the parts of the consent form unique to the study.


Author(s):  
Ismail Ismail ◽  
Abdulloh Hamid

This research is an attempt to know the courtesy reading the Quran in the book of At-Tibyan fi Adabi Hamalatil Quran by Imam Nawawi. The question that is to be answered through this study is (1) how the courtesy to read Al-Quran in the book At-Tibyan, (2) How does the relevance of courtesy to read the Qur'an in the book of At-Tibyan in contemporary times? The research methods use library research. This study is conducted using data collection techniques by conducting observations on certain sources, seeking, studying books, articles, journals, theses or others related to this study. Data collection is divided into two sources, namely primary and secondary data. Then the data are analyzed using descriptive and contextual methods. The results show that courtesy reading the Quran in the book of At-Tibyan fi Adabi Hamalatil Quran includes: Solemn, sincere, ethical, clean and holy State, facing the Qibla, start with Ta'awudz. While the relevance of courtesy reading the Quran in the book of At-Tibyan fi Adabi Hamalatil Quran with the context of contemporary can be a solution in improving the manners of interacting with the Quran, especially in the face of today's characteristics or contemporary.


2020 ◽  
Vol 4 (2) ◽  
pp. 165-173
Author(s):  
Deni Saadah Purba ◽  
Dwi Lindarto Hadinugroho

The Shophouse is a multi-story building that has multiple functions. The 1st floor is used as a commercial area, and the 2nd floor above is used as a residential place. Revitalization is an effort to revive an urban area through improving the quality of the environment, taking into accounts the socio- cultural aspects and characteristics of the region. The facade is the identity of the building itself by retaining elements and elements on the building façade. This research purposes of finding the dominant appearance of the elements of finding in the shophouse façade in the city of Medan, which is useful for the design revitalizing model of the face of the city as the image of the identity city. The method used in this study is qualitative descriptive, with a variable observation phase with the collection of primary and secondary data through direct observation in the field, then analyzed the shop facade elements that have been Grouped and found the most dominant element. The result of the analysis of the dominant facade element found in the shop façade of Medan is China, Malay, and India. The findings of the dominant facade element can be the identity identifier of the region and city of Medan today.


2013 ◽  
Vol 4 (10) ◽  
pp. 311-316
Author(s):  
Kutsanedzie F. ◽  
Mensah E. .

The Polytechnics in Ghana were established and given the mandate enshrined in the Constitution of Ghana under the Act of Parliament of the Republic of Ghana (Act 745) to train students in the fields of Science, Technology, Applied Social Science and Applied Art to serve the middle-manpower management needs of the country. In addition, the polytechnics are to provide skills development, conduct and publish industry driven research findings. Polytechnic graduate are expected by employers and captains of industry to be more practical-skilled and biased by virtue of their training. However, over the years, it appears the polytechnic graduate training is becoming more of theoretical rather than what was initially intended. Commentaries of stakeholders reveal that the polytechnics are gradually losing their focus vis-à-vis the practical training of students as they are fast comparing themselves to the universities. This paper uses observation of the polytechnics educational system, interviews with stakeholders and other secondary data as the bases to critically examine and identify the conditions that hamper the practical training of the polytechnic students – practical content of syllabi; teacher – student ratio in the face of high student intake; qualification of lecturers in terms of practical training. It thus recommends ways by which the polytechnics can improve upon the practical training of its student via mobilizing and utilizing its resources to create industries to facilitate the training of its students as well as reducing graduate unemployment. This thus will serve as lynch-pin to drive the country’s industrialization process.


Author(s):  
Huong Le ◽  
Hoang Phi ◽  
Luu Dao ◽  
Yen Nguyen ◽  
Lien Le ◽  
...  

Population arrangement to islands for settlement is one of the important policies in many ways of each nation. This study was conducted to provide an understanding of the current situation and impacts of the migration to Tho Chu Island, Phu Quoc District, Kien Giang Province, Vietnam. In-depth interviews and survey questions were used to collect preliminary data on displaced people, insular living conditions, positive and negative impacts of the migration process on the socio-economic development on the island. They are also supplemented by secondary data which were collected from various sources in research process. The study shows that the migration to the island not only helps to supplement the labor force for the island, contributes to economic and labor structure restructuring on the island but also contributes to diversifying island economic activities and expand the space, enrich the cultural life of the island. However, the process of migration to the island also poses a number of problems for the people and the government on the island.


2021 ◽  
pp. 7-21
Author(s):  
Aleksandra Anna Kargol

This paper considers the idea of an underground man. It attempts to answer why writers reach for such a type of heroes and their position in the face of contemporary novel solutions. Maria Komornicka and Fyodor Dostoyevsky see in fallen individuals a source of creative inspiration. The confessional prose of these writers is an attempt to talk about the nihilist heroes who have chosen to live in a place of the metaphorical underground. The underground space becomes a construct of these works, and it is also a symbolic place where individuals desire chaos and darkness. The heroes of Demons and Notes from the Underground escape from where “everyone” lives and go underground, devoting themselves to underground mysticism because only such space protects them against the total collapse of the universe. Underground imagery governs the research process and shows how it determines the structure of a work and influences the methodology and ways of reading these works


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