scholarly journals Achieving Informed Consent for Cellular Therapies: A Preclinical Translational Research Perspective on Regulations versus a Dose of Reality

2016 ◽  
Vol 44 (3) ◽  
pp. 394-401 ◽  
Author(s):  
Aileen J. Anderson ◽  
Brian J. Cummings
Keyword(s):  
Informed Consent ◽  
Animal Studies ◽  
Research Participant ◽  
Research Subject ◽  
Cellular Therapies ◽  
Research Perspective ◽  
Pharmaceutical Agent ◽  
A Cell ◽  
The Subject ◽  
Novel Therapeutic Strategies

A central principle of bioethics is “subject autonomy,” the acknowledgement of the primacy of the informed consent of the subject of research. Autonomy requires informed consent — the assurance that the research participant is informed about the possible risks and benefits of the research. In fact, informed consent is difficult when a single drug is being tested, although subjects have a baseline understanding of the testing of a pharmacological agent and the understanding that they can stop taking the drug if there were an adverse event. However, informed consent is even less easily achieved in the modern arena of complex new molecular and cellular therapies. In this article, we argue that as science confronts new issues such as transplantation of stem cell products, which may live within the participant for the rest of their lives, researchers must carefully consider and constantly re-examine how they properly inform subjects considering participation trials of these novel therapeutic strategies.For example, the manufacture of a vial of a cell product that consists of a collection of growing cells is very different than the production of a vial of identical pills, which can be presumed to be identical. The scientific concepts on which these cellular approaches are based may seem alien and incomprehensible to a research subject, who thinks of a clinical trial as simply the selection and testing of the most efficacious pharmaceutical agent already proven to work in preclinical animal studies. The research subject would be wrong.

scholarly journals Engineering the Composition of Microfibers to Enhance the Remodeling of a Cell-Free Vascular Graft

Nanomaterials ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 1613
Author(s):  
Fang Huang ◽  
Yu-Fang Hsieh ◽  
Xuefeng Qiu ◽  
Shyam Patel ◽  
Song Li
Keyword(s):  
Vascular Graft ◽  
Animal Studies ◽  
Vascular Grafts ◽  
Cell Infiltration ◽  
Tubular Scaffold ◽  
Base Polymer ◽  
A Cell ◽  
Scaffold Materials ◽  
Stromal Cell Derived Factor ◽  
Technology Blending

The remodeling of vascular grafts is critical for blood vessel regeneration. However, most scaffold materials have limited cell infiltration. In this study, we designed and fabricated a scaffold that incorporates a fast-degrading polymer polydioxanone (PDO) into the microfibrous structure by means of electrospinning technology. Blending PDO with base polymer decreases the density of electrospun microfibers yet did not compromise the mechanical and structural properties of the scaffold, and effectively enhanced cell infiltration. We then used this technique to fabricate a tubular scaffold with heparin conjugated to the surface to suppress thrombosis, and the construct was implanted into the carotid artery as a vascular graft in animal studies. This graft significantly promoted cell infiltration, and the biochemical cues such as immobilized stromal cell-derived factor-1α further enhanced cell recruitment and the long-term patency of the grafts. This work provides an approach to optimize the microfeatures of vascular grafts, and will have broad applications in scaffold design and fabrication for regenerative engineering.

Commentary 1: Research with Persons Under Involuntary Commitment—Ethical Issues Surrounding Competence and Voluntariness

2019 ◽  
Vol 14 (5) ◽  
pp. 475-478
Author(s):  
Matthé Scholten ◽  
Jochen Vollmann
Keyword(s):  
Informed Consent ◽  
Ethical Issues ◽  
Research Participation ◽  
Research Participant ◽  
Involuntary Commitment ◽  
Proxy Consent ◽  
Undue Influence ◽  
Research Participants ◽  
Manic Symptoms ◽  
Prospective Research

In this case commentary, we analyze ethical concerns that were raised in response to an interview with a woman with bipolar disorder who was under involuntary commitment. We focus on competence and voluntariness as two prerequisites for valid informed consent. We recommend that judgments of competence be based on whether prospective research participants sufficiently possess certain decision-making abilities. Based on this functional approach, we argue that manic symptoms need not undermine competence and that, even if we were to assume that the research participant became incompetent during the interview, this would not invalidate her consent retroactively. It would, however, compromise her ability to revoke her consent. We furthermore show that obtaining additional proxy consent for research participation may compromise the autonomy of service users who are competent to consent. Then we turn to the issue of voluntariness. Arguing that neither the great strength nor the external etiology of a desire compromises voluntariness, we propose that the voluntariness of a decision instead depends on whether the decision-maker endorses it on reflection. The researchers disclosed that prospective research participants’ decision about study participation would have no influence on the duration of the commitment or the quality of care. We contend that because of this neither coercion nor undue influence was exerted in the informed consent process. Nevertheless, there is an increased likelihood of perceived coercion and undue influence under conditions of involuntary commitment, and we close by suggesting some safeguards to prevent this.

scholarly journals The research method of conceptual frameworks. The case of Pygmalion effect: A leadership style or self-fulfilling prophecy?

2019 ◽  
Vol 9 (3) ◽  
pp. 487-510
Author(s):  
Sejla Almadi
Keyword(s):  
Leadership Style ◽  
Meta Analysis ◽  
Educational Technology Research ◽  
Research Subject ◽  
Conceptual Frameworks ◽  
Pygmalion Effect ◽  
Less Is More ◽  
Database Research ◽  
The Subject

Conceptual frameworks are conjectural/hypothetical research tools that are particularly important and widely used in the disciplined inquiry, including educational (technology) research. However, there is a lack of guidance on how to construct them. Hence, the objective of the current research was to provide a methodological perspective through a case study on how to develop such a framework for deductive research with a complex research subject. To this end, a five-step technique was constructed and implemented: text database, research panorama, authors’ network and thread, location, and definition. The case of Pygmalion effect was actual and significant as a recent meta-analysis found it to have an outstanding impact, among other leadership interventions, and relevant to educational research as it was first experimented in educational context. The conclusion found the five steps to be intertwined as they were built upon each other, carried the thread forward and opened it up deeper and closer to the research subject by each section. The errors and limitations involved uniqueness, availability, less is more, meaningfulness, approach, and space. Hence, the recommendations were defined as the regard for the complexity of the research subject and the approach to which the defined steps were delegated, the preliminary search on the most up-to-date academic papers on the subject, the only necessary number of collected sources and classes, the sense-making in implementing the steps, and the adaptation to longer essays, theses, or to prepare the foundation of research proposals.

scholarly journals Analisis Penggunaan Cerita Rakyat Bengkulu Dalam pembelajaran Retorika/Komunikasi Massa

2018 ◽  
Vol 1 (1) ◽  
pp. 85
Author(s):  
Rio Kurniawan ◽  
Didi Yulistyo
Keyword(s):  
Teaching And Learning ◽  
Research Subject ◽  
Study Program ◽  
Positive Direction ◽  
Student Activities ◽  
Descriptive Research ◽  
Class A ◽  
Study Results ◽  
The Subject ◽  
Academic Year

The purpose of this study is to trace the extent of the use of Bengkulen folklore in the process of teaching and learning rhetorical subject. The study is a descriptive research which tries to portray the exercise of teaching rhetorical subject in which Bengkulen folklore is included. This study applies qualitative approach. The research subject deals with the fifth semester students of class A from the study program of Indonesian Language Teaching (FKIP) of Bengkulu University in the academic year of 2016-2017. The study results in that student activities change into positive direction in learning by folklore. The application of folklore to the students can improve their skill in rhetoric or public communication. It can be seen from the grades they achieve and the extent of their finishing the subject. Based on the data analyzed, the result shows that there 21 students who receive grade up 70 and their fulfillment in learning reaches 90, 84%.

scholarly journals Pemahaman Konsep Matematis Siswa Kelas VIII pada Materi Lingkaran

2019 ◽  
Vol 8 (2) ◽  
pp. 297-306
Author(s):  
Attin Warmi
Keyword(s):  
Data Collection ◽  
Daily Life ◽  
Concept Analysis ◽  
Research Subject ◽  
Mathematical Concepts ◽  
Average Value ◽  
Case Research ◽  
Class Viii ◽  
The Subject ◽  
Descriptive Method

AbstrakBanyak siswa yang kesulitan dalam memahami konsep matematika. Tujuan dari penelitian ini untuk mengetahui kemampuan pemahaman konsep siswa dalam menyelesaikan soal-soal pada pokok bahasan Lingkaran. Metode yang digunakan dalam penelitian ini  adalah metode deskriptif dengan penelitian kasus. Materi tentang Lingkaran merupakan materi yang terdapat di SMP kelas VIII pada semester genap dan materi ini merupakan salah satu materi yang berhubungan dengan kehidupan sehari hari. Kelas VIII F SMPN 3 Karawang Barat dipilih sebagai subjek penelitian. Pengumpulan data dilakukan dengan pemberian tes tertulis kemampuan pemahaman konsep. Soal berbentuk uraian yang sebelum digunakan sudah di uji validasi. Hasil penelitian ini menunjukan rata-rata nilai kemampuan pemahaman konsep matematis siswa adalah 10,06 termasuk dalam kriteria sedang.  Hasil analisis konsep per indikator, diketahui siswa sangat kurang pada indikator menerapkan hubungan antar konsep dan prosedur, kemudian dalam menerapkan konsep secara algoritma. Masih terdapat banyak siswa yang memiliki pemahaman konsep yang kurang.  Understanding of Mathematical Concepts Class VIII Students in Circle MaterialsAbstractMany students have difficulty understanding mathematical concepts. The purpose of this study is to determine the ability to understand students' concepts in solving questions on the subject of the Circle. The method used in this research is descriptive method with case research. The material about Circles is the material found in class VIII SMP in the even semester and this material is one of the materials related to daily life. Class VIII F of SMP 3 Karawang Barat was chosen as the research subject. Data collection is done by giving written tests the ability to understand concepts. Questions in the form of descriptions that have been validated before being used. The results of this study show the average value of the ability to understand students' mathematical concepts is 10.06 which is included in the criteria of being. The results of concept analysis per indicator, it is known that students are very lacking in indicators applying relationships between concepts and procedures, then in applying the concept algorithmically. There are still many students who lack an understanding of concepts.

scholarly journals Maladaptive oxidative stress cascade drives type I interferon hyperactivity in TNF activated macrophages promoting necrosis in murine tuberculosis granulomas

2020 ◽  
Author(s):  
Eric Brownhill ◽  
Shivraj M. Yabaji ◽  
Vadim Zhernovkov ◽  
Oleksii S. Rukhlenko ◽  
Kerstin Seidel ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Iron Chelator ◽  
Pathogen Transmission ◽  
Type I ◽  
Macrophage Response ◽  
Intrinsic Mechanism ◽  
A Cell ◽  
Novel Therapeutic Strategies ◽  
Jnk Activation ◽  
Inflammatory Milieu

ABSTRACTTuberculosis remains a critical infectious disease world-wide. The development of novel therapeutic strategies requires greater understanding of host factors that contribute to disease susceptibility. A major unknown in TB pathogenesis is the mechanism of necrosis in TB granulomas that leads to the massive lung tissue damage and cavity formation necessary for the pathogen transmission. In humans, TB progression has been linked to hyperactivity of type I IFN (IFN-I) pathway, the primary cause of which remains elusive.We studied the mechanistic drivers of pulmonary TB progression using a unique model B6J.C3-Sst1C3HeB/Fej Krmn mice that develop human-like necrotic TB granulomas and IFN-I hyperactivity. We established that IFNβ super-induction occurred in the susceptible macrophages in response to continuous TNF stimulation in the context of a dysregulated antioxidant defense. We observed that unresolving oxidative stress amplified the induction of IFNβ through JNK activation and induced the Integrated Stress Response via PKR activation as a compensatory pathway. Subsequently, PKR amplifies IFNβ upregulation, forming a positive feedback loop, maintaining the hyperinflammatory state in susceptible macrophages and leading to mitochondrial dysfunction. Thus, within the inflammatory milieu, a cell-intrinsic mechanism of chronic regulatory dysfunction and unresolved stress gradually weakens the macrophage and ultimately promotes the necrotization of TB granulomas. The aberrant macrophage response to TNF can be prevented by an iron chelator and inhibitor of lipid peroxidation, ferrostatin-1. Moreover, ferrostatin treatment increased macrophage survival and boosted bacterial control in the TNF-stimulated macrophages infected with virulent Mtb. These findings identify targets for host-directed therapeutics to interrupt necrotization in TB granulomas.

scholarly journals Intimacy and its violation: on the experience of illness in contemporary women's poetry

2021 ◽  
Author(s):  
Beata Morzyńska-Wrzosek
Keyword(s):  
Hospital Setting ◽  
The Body ◽  
Women's Poetry ◽  
Research Perspective ◽  
Artistic Representations ◽  
Body Boundary ◽  
New Type ◽  
The Subject ◽  
Experience Of Illness ◽  
Subjective Identity

This article discusses selected aspects of the problem of self-perception by a sick individual, specific to the poetry of Polish women of the last few decades. The aim of the analysis is to show that the body is central to the illness experience and that a new type of intimacy appears in connection with its ailment. This is a „clinical intimacy”, the specificity of which is defined by a confrontation with suffering, the proliferation of the feeling of isolation, the intensity of emotions related to making the body public, its discovery and exposure in a hospital setting. The issue of „gender expropriation” in a marginal situation is also important, as is the scar, wound, physical violation of the body boundary, read as the „punctum” of the patient's body. The interpretation emphasises the individualization of artistic representations of the aforementioned aspects of „clinical intimacy”. The anthropological research perspective adopted in the sketch allows for the diagnosis of the subject matter in the context of the process of shaping subjective identity.

A Technological Perspective of Mobile and Electronic Commerce Systems

2012 ◽  
pp. 485-504
Author(s):  
Wen-Chen Hu ◽  
Yanjun Zuo ◽  
Naima Kaabouch ◽  
Lei Chen
Keyword(s):  
Electronic Commerce ◽  
Mobile Networks ◽  
Mobile Commerce ◽  
Mobile Internet ◽  
Research Subject ◽  
Wired Networks ◽  
Mobile Middleware ◽  
Phone Calls ◽  
The Subject ◽  
Technological Perspective

The emergence of wireless and mobile networks has made possible the introduction of electronic commerce to a new application and research subject: mobile commerce. Mobile commerce is a promising trend of commerce because Internet-enabled smartphones such as iPhones are becoming very popular these days. People use smartphones to perform daily tasks like browsing the mobile Internet and making phone calls anytime and anywhere. However, understanding or constructing a mobile or an electronic commerce system is not easy because the system involves a wide variety of disciplines and technologies and the technologies are constantly changed. To facilitate understanding and constructing such a system, this chapter divides the system into six components: (i) applications, (ii) client devices or computers, (iii) mobile middleware, (iv) wireless networks, (v) wired networks, and (vi) host computers. Elements in these components specifically related to the subject are described in detail and lists of current technologies for component construction are discussed.

Szasz, suicide, and medical ethics

Thomas Szasz ◽  
2019 ◽  
pp. 55-64
Author(s):  
George J. Annas
Keyword(s):  
Mental Illness ◽  
Informed Consent ◽  
Suicide Prevention ◽  
Assisted Suicide ◽  
Physician Assisted Suicide ◽  
The Subject ◽  
The Right ◽  
Suicidal Patients ◽  
Commit Suicide

Szasz objected to the medicalization of suicide, the legalization of suicide prevention, and especially the coercive role of psychiatry in this realm. He declared that, by medicalizing suicide, we banish the subject from discussion. What is meant by acceptable and unacceptable “suicide”? Who has a right to commit suicide? How does suicide implicate freedom? Does it reflect abortion jurisprudence? How do psychiatrists become suicide’s gatekeepers? Current phenomena (e.g., new physician-assisted suicide legislation) illuminate these and other issues (e.g., euthanasia, informed consent, informed refusal, the “right to die,”), all suggesting how Szasz would react to each. Suicide is legal, but is almost always considered a result of mental illness. Courts approve psychiatrists who want to commit “suicidal” patients involuntarily. Granting physicians prospective legal immunity for prescribing lethal drugs is, at best, a strange and tangential reaction to our inability to discuss suicide (and dying) rationally. Szasz got it right.

Mobile and Electronic Commerce Systems and Technologies

2009 ◽  
pp. 1204-1225
Author(s):  
Wen-Chen Hu ◽  
Chyuan-Huei Thomas Yang ◽  
Jyh-haw Yeh ◽  
Weihong Hu
Keyword(s):  
Electronic Commerce ◽  
Mobile Networks ◽  
Research Subject ◽  
Server Side ◽  
Wired Networks ◽  
Mobile Middleware ◽  
Arduous Task ◽  
Application Programming ◽  
The Subject ◽  
Client Side

The emergence of wireless and mobile networks has made possible the introduction of electronic commerce to a new application and research subject: mobile commerce. Understanding or constructing a mobile or an electronic commerce system is an arduous task because the system involves a wide variety of disciplines and technologies and the technologies are constantly changing. To facilitate understanding and constructing such a system, this article divides the system into six components: (i) applications, (ii) client computers or devices, (iii) mobile middleware, (iv) wireless networks, (v) wired networks, and (vi) host computers. Elements in these components specifi- cally related to the subject are described in detail and lists of current technologies for component construction are discussed. Another important and complicated issue related to the subject is the mobile or electronic commerce application programming. It includes two types of programming: client-side and server-side programming, which will be introduced too.

Sign in / Sign up

Export Citation Format

Share Document