With the growing amount of clinical research, regulations and research ethics are becoming more stringent. This trend introduces a need for quality assurance measures for ensuring adherence to research ethics and human research protection beyond Institutional Review Board approval. Audits, one of the most effective tools for assessing quality assurance, are measures used to evaluate Good Clinical Practice and protocol compliance in clinical research. However, they are laborious, time consuming, and require expertise. Therefore, we developed a simple auditing process and (...) evaluated its feasibility and effectiveness. The screening audit was developed using a routine audit checklist based on the Severance Hospital’s Human Research Protection Program policies and procedures. The measure includes 20 questions, and results are summarized in five categories of audit findings. We analyzed 462 studies that were reviewed by the Severance Hospital Human Research Protection Center between 2013 and 2017. We retrospectively analyzed research characteristics, reply rate, audit findings, associated factors and post-screening audit compliance, etc. Investigator reply rates gradually increased, except for the first year. The studies were graded as “critical,” “major,” “minor,” and “not a finding”, based on findings and number of deficiencies. The auditors’ decisions showed fair agreement with weighted kappa values of 0.316, 0.339, and 0.373. Low-risk level studies, single center studies, and non-phase clinical research showed more prevalent frequencies of being “major” or “critical”. Inappropriateness of documents, failure to obtain informed consent, inappropriateness of informed consent process, and failure to protect participants’ personal information were associated with higher audit grade. We were able to observe critical GCP violations in the routine internal audit results of post-screening audit compliance checks in “non-responding” and “critical” studies upon applying the screening audit. Our screening audit is a simple and effective way to assess overall GCP compliance by institutions and to ensure medical ethics. The tool also provides useful selection criteria for conducting routine audits. (shrink)

The expansion of the higher education system and the rationalization of universities in South Korea, while broadly following the global patterns, reflect the characteristics of the national political system. We show the rapid growth of universities and document core organizational changes among universities: the elaboration of faculty performance evaluation rules, the expansion and differentiation of central administrations, and the emergence of engagement in vision statements. These changes, constructing universities as organizational actors, parallel the changes in higher education systems elsewhere. However, (...) the uniqueness of the Korean experience lies with the role of the state as a catalyst guiding the overall direction and the structure and strategy of universities. We discuss the implications of our research for the rationalization of universities in a highly centralized system. (shrink)

The activities and consequences of workplace bullying and harassment have been widely explored in the literature but mainly studied within the scope of individuals or at the team level. Taking a holistic approach, we associate the concept of bullying with firm-level performance as well as stakeholders’ responses in the market. In this paper, we examine whether and how market investors react to the news of corporate harassment by top officials of publicly listed firms in Korea. Using a standard event study (...) methodology and multiple regression analysis with matched sample, we find significantly negative stock price reactions to news of corporate bullying. We also find that the impact is more salient if emotional bullying is involved and discuss both the theoretical and practical implications of these findings. (shrink)

What is the meaning of language expressions and how to compute or calculate it? In this paper, we give an answer to this question by analysing the meanings of aspects and tenses in natural languages inside the formal model of an grammar of applicative, cognitive and enunciative operations , using the applicative formalism, functional types of categorial grammars and combinatory logic . In the enunciative theory and following , an utterance can be decomposed into two components: a modus and a (...) dictum . In GRACE, the modus is a complex operator applied to a proposition and is generated from more elementary operators of the categories of tense, aspect, and modality. The dictum is a proposition generated by a predicative relation. In this way, we can attribute a semantic meaning to different grammatical aspecto-temporal operators. The applicative expressions of CL can be easily translated into a functional programming language such as HASKELL or CAML. (shrink)

Tumor‐infiltrating lymphocyte (TIL) therapy is a promising approach for treating refractory or advanced solid cancers by using autologous TILs harvested from cancer tissues. Despite the heterogeneity of cancer, TIL therapy can potentially produce a positive therapeutic response, including complete remission.After decades of research on lymphocyte functions, culture/expansion methods, therapeutic protocols, and multiple clinical trials, TIL therapy has finally reached a stage where it can be formally approved for clinical use.TIL therapy is expected to hold a unique position among anti‐cancer therapeutic (...) options as a standard intervention. To successfully introduce TIL therapy into clinical settings, there is a need to expand therapeutic indications and set up the best protocols for cancer tissue sampling and manufacturing, and related clinical trials. Moreover, studies on next‐generation TIL therapy have already begun, and post‐approval real‐world data will promote and support further research. (shrink)

From its inception, genomics has been a speculative endeavor, fixated on a far-off horizon that would deliver on the promise of targeted diagnostics and individualized therapeutics (Fortun 2008). M...

Background:Academic ethical awareness is an important aspect especially for nursing students who will provide ethical nursing care to patients in future or try to tread the path of learning toward professional acknowledgement in nursing scholarship.Purpose:The purpose of this study was to explore academic ethical awareness and its related characteristics among undergraduate nursing students.Methods:This study commenced the survey with cross-sectional, descriptive questions and enrolled convenient samples of 581 undergraduate nursing students from three universities in South Korea. It was investigated with structured (...) questionnaires including general characteristics and academic ethical awareness related.Ethical considerations:This study was reviewed and approved by the Institutional Review Board at National University.Findings:Academic ethical awareness was the highest regarding behaviors violating the respect or confidentiality of patients and cheating on exams, while it was the lowest for inappropriate behaviors in class. From the result of general characteristics difference, male students showed higher score than female students in relative; first-year students showed higher score than other year students; the higher score was rated from students who were highly satisfied with their major than the other not satisfied with their major; and students with low academic stress showed higher ethical awareness score than persons with higher stress.Conclusion:Personal behaviors were rated with low ethical awareness in relative, but items related to public rules and actual effects on patients or others were rated with higher score. Nursing satisfaction and academic stress are main factors on ethical awareness. To improve overall ethical awareness level of nursing students, it is required to provide more education about the importance of personal behaviors in class and need to improve the understanding of how it will be connected with future situation and effect. (shrink)

Based on real-life intergroup animosities originating from a historical conflict, the current study examined how the perceived stance of the outgroup about the conflict affects the dehumanization of the outgroup. In Study 1, Korean undergraduates attributed more human nature to the Japanese after reading an article that the Japanese government did issue an official apology for a historical wrong. In turn, the more human nature assigned to the Japanese predicted higher expectations about positive mutual relations in the future. Similarly, in (...) Study 2, Japanese undergraduates attributed more human uniqueness to Koreans after reading an article that an official apology for a historical wrong from Japan was accepted by Koreans. The higher the perceived human uniqueness of Koreans was, the higher were the willingness to help and the expectations of a positive relationship in the future. The findings demonstrate how mutual dehumanization can be reduced as a result of the other side’s reconciliatory stances and can further contribute to improving intergroup relations. (shrink)

Background Nurses providing care to patients with end-of-life or terminal illnesses often encounter ethically challenging situations leading to moral distress. However, existing quantitative studies have examined moral distress using instruments that address general clinical situations rather than those specific to end-of-life care. Furthermore, qualitative studies have often been limited to participants from a single unit or those experiencing moral distress-induced circumstances. A comprehensive and integrated understanding of the overarching process of moral distress is vital to discern the unique circumstances surrounding (...) end-of-life care and its consequential impacts. Research objectives To explore the moral distress experiences of nurses who are frequently involved in caring for patients with end-of-life or terminal illnesses and apply it to two existing theories: the model of moral distress and the ecological model. Research design A qualitative descriptive approach was employed. Participants and research context Seven focus group interviews involving 30 nurses were performed. The subsequent transcriptions underwent rigorous content analysis. Ethical considerations We obtained Institutional Review Board approval from a university. Focus group interviews were conducted with nurses who agreed to participate and signed the consent form. Findings The moral distress-inducing factors and nurses’ perceived impact of moral distress were identified and categorized based on moral distress theories and ecological models. A total of 15 categories and 30 subcategories across the following 4 domains were derived: (1) intrapersonal, (2) interpersonal, (3) organizational, and (4) structural factors. Conclusions End-of-life-specific circumstances induced moral distress among nurses, with both negative and positive impacts identified. Effective organizational and policy support is essential to manage conflicts, form a healthy organizational culture, provide training, and prevent unnecessary expenses due to the negative consequences of moral distress. (shrink)

Public investments in genomic and precision medicine have begun to yield clinically useful interventions, most recently, for example, two new, FDA-approved gene therapies for sickle cell disease (F...

With the growth of precision medicine research on health data and biospecimens, research institutions will need to build and maintain long-term, trusting relationships with patient-participants. While trust is important for all research relationships, the longitudinal nature of precision medicine research raises particular challenges for facilitating trust when the specifics of future studies are unknown. Based on focus groups with racially and ethnically diverse patients, we describe several factors that influence patient trust and potential institutional approaches to building trustworthiness. Drawing on (...) these findings, we suggest several considerations for research institutions seeking to cultivate long-term, trusting relationships with patients: Address the role of history and experience on trust, engage concerns about potential group harm, address cultural values and communication barriers, and integrate patient values and expectations into oversight and governance structures. (shrink)

This article aims at an active dialogue between Ulrich Beck and East Asia with respect to cosmopolitan imagination. Beck’s cosmopolitan sociology requires a reflective cosmopolitan publicness to cope with various kinds of global risks. We therefore extract three different layers of publicness from neo-Confucianism – survival-oriented, deliberative, and ecological – and argue that Beck’s cosmopolitan vision can be better conceptualized when properly linked to, or founded upon, the Tianxiaweigong normative potentials of neo-Confucianism. In so doing our intention is to make (...) Beck’s implicit sensibilities and the implicit Asian orientations explicit, as a double process of cosmopolitan self-reflection and dialogue. We also draw attention to the analysis of the cosmopolitan actor in East Asia. Finally, we note that the cosmopolitan future of East Asia still remains uncertain and that reconciling global risk politics, national interests and cosmopolitan morality presents a big challenge to second modern transformation. (shrink)

This longitudinal study examined how nursing students' moral judgment changes after they become qualified nurses working in a hospital environment. The sample used was a group of 80 nursing students attending a university in Suwon, Korea, between 2001 and 2003. By using a Korean version of the Judgment About Nursing Decisions questionnaire, an instrument used in nursing care research, moral judgment scores based on Ketefian's six nursing dilemmas were determined. The results were as follows: (1) the qualified nurses had significantly (...) higher idealistic moral judgment scores than the nursing students; (2) the qualified nurses showed significantly higher realistic moral judgment scores than the nursing students; and (3) when comparing idealistic and realistic moral judgment scores, both the qualified nurses and the nursing students had higher scores for idealistic moral judgment. Further study is recommended to examine changes in moral judgment. (shrink)

BackgroundAttention deficit hyperactivity disorder is clinically diagnosed; however, quantitative analysis to statistically analyze the symptom severity of children with ADHD via the measurement of head movement is still in progress. Studies focusing on the cues that may influence the attention of children with ADHD in classroom settings, where children spend a considerable amount of time, are relatively scarce. Virtual reality allows real-life simulation of classroom environments and thus provides an opportunity to test a range of theories in a naturalistic and (...) controlled manner. The objective of this study was to investigate the correlation between participants’ head movements and their reports of inattention and hyperactivity, and to investigate how their head movements are affected by different social cues of different sensory modalities.MethodsThirty-seven children and adolescents with and without ADHD were recruited for this study. All participants were assessed for diagnoses, clinical symptoms, and self-reported symptoms. A virtual reality-continuous performance test was conducted under four conditions: control, no-cue, visual cue, and visual/audio cue. A quantitativecomparison of the participants’ head movements was conducted in three dimensions using a head-mounted display in a VR classroom environment. Task-irrelevant head movements were analyzed separately, considering the dimension of movement needed to perform the VR-CPT.ResultsThe magnitude of head movement, especially task-irrelevant head movement, significantly correlated with the current standard of clinical assessment in the ADHD group. Regarding the four conditions, head movement showed changes according to the complexity of social cues in both the ADHD and healthy control groups.ConclusionChildren and adolescents with ADHD showed decreasing task-irrelevant movements in the presence of social stimuli toward the intended orientation. As a proof-of-concept study, this study preliminarily identifies the potential of VR as a tool to understand and investigate the classroom behavior of children with ADHD in a controlled, systematic manner. (shrink)

Jonathan Edwards was a preacher, theologian, and missionary to the Native Americans. This book asserts that Jonathan Edwards stood firmly on the Reformed tradition in the doctrine of justification.

BackgroundThis study aimed to identify the healthcare providers’ experience and perspectives toward end-of-life care decisions focusing on end-of-life discussion and physician’s order of life-sustaining treatment documentation in Korea which are major parts of the Life-Sustaining Treatment Act.MethodsA cross-sectional survey was conducted using a questionnaire developed by the authors. A total of 474 subjects—94 attending physicians, 87 resident physicians, and 293 nurses—participated in the survey, and the data analysis was performed in terms of frequency, percentage, mean and standard deviation using the (...) SPSS 24.0 program.ResultsStudy results showed that respondents were aware of terminal illness and physician’s order of life-sustaining treatment in Korea well enough except for some details. Physicians reported uncertainty in terminal state diagnosis and disease trajectory as the most challenging. Study participants regarded factors (related to relationships and communications) on the healthcare providers’ side as the major impediment to end-of-life discussion. Study respondents suggested that simplification of the process and more staff are required to facilitate end-of-life discussion and documentation.ConclusionBased on the study results, adequate education and training for better end-of-life discussion are required for future practice. Also, a simple and clear procedure for completing a physician’s order of life-sustaining treatment in Korea should be prepared and legal and ethical advice would be required. Since the enactment of the Life-Sustaining Treatment Act, several revisions already have been made including disease categories, thus continuous education to update and support clinicians is also called for. (shrink)

BackgroundThe Life Extension Medical Decision law enacted on February 4, 2018 in South Korea was the first to consider the suspension of futile life-sustaining treatment, and its enactment caused a big controversy in Korean society. However, no study has evaluated whether the actual implementation of life-sustaining treatment has decreased after the enforcement of this law. This study aimed to compare the provision of patient consent before and after the enforcement of this law among cancer patients who visited a tertiary university (...) hospital's emergency room to understand the effects of this law on the clinical care of cancer patients.MethodsThis retrospective single cohort study included advanced cancer patients aged over 19 years who visited the emergency room of a tertiary university hospital. The two study periods were as follows: from February 2017 to January 2018 (before) and from May 2018 to April 2019 (after). The primary outcome was the length of hospital stay. The consent rates to perform cardiopulmonary resuscitation (CPR), intubation, continuous renal replacement therapy (CRRT), and intensive care unit (ICU) admission were the secondary outcomes.ResultsThe length of hospital stay decreased after the law was enforced from 4 to 2 days (p = 0.001). The rates of direct transfers to secondary hospitals and nursing hospitals increased from 8.2 to 21.2% (p = 0.001) and from 1.0 to 9.7%, respectively (p < 0.001). The consent rate for admission to the ICU decreased from 6.7 to 2.3% (p = 0.032). For CPR and CRRT, the consent rates decreased from 1.0 to 0.0% and from 13.9 to 8.8%, respectively, but the differences were not significant (p = 0.226 and p = 0.109, respectively).ConclusionAfter the enforcement of the Life Extension Medical Decision law, the length of stay in the tertiary university hospital decreased in patients who established their life-sustaining treatment plans in the emergency room. Moreover, the rate of consent for ICU admission decreased. (shrink)

BackgroundAlthough the Life-Sustaining Treatment (LST) Decision Act was enforced in 2018 in Korea, data on whether it is well established in actual clinical settings are limited. Hospital-acquired pneumonia (HAP) is a common nosocomial infection with high mortality. However, there are limited data on the end-of-life (EOL) decision of patients with HAP. Therefore, we aimed to examine clinical characteristics and outcomes according to the EOL decision for patients with HAP.MethodsThis multicenter study enrolled patients with HAP at 16 referral hospitals retrospectively from (...) January to December 2019. EOL decisions included do-not-resuscitate (DNR), withholding of LST, and withdrawal of LST. Descriptive and Kaplan–Meier curve analyses for survival were performed.ResultsOf 1,131 patients with HAP, 283 deceased patients with EOL decisions (105 cases of DNR, 108 cases of withholding of LST, and 70 cases of withdrawal of LST) were analyzed. The median age was 74 (IQR 63–81) years. The prevalence of solid malignant tumors was high (32.4% vs. 46.3% vs. 54.3%, P = 0.011), and the ICU admission rate was lower (42.9% vs. 35.2% vs. 24.3%, P = 0.042) in the withdrawal group. The prevalence of multidrug-resistant pathogens, impaired consciousness, and cough was significantly lower in the withdrawal group. Kaplan–Meier curve analysis revealed that 30-day and 60-day survival rates were higher in the withdrawal group than in the DNR and withholding groups (log-rank P = 0.021 and 0.018). The survival of the withdrawal group was markedly decreased after 40 days; thus, the withdrawal decision was made around this time. Among patients aged below 80 years, the rates of EOL decisions were not different (P = 0.430); however, mong patients aged over 80 years, the rate of withdrawal was significantly lower than that of DNR and withholding (P = 0.001).ConclusionsAfter the LST Decision Act was enforced in Korea, a DNR order was still common in EOL decisions. Baseline characteristics and outcomes were similar between the DNR and withholding groups; however, differences were observed in the withdrawal group. Withdrawal decisions seemed to be made at the late stage of dying. Therefore, advance care planning for patients with HAP is needed. (shrink)

This paper reports our analysis of the ELSI Virtual Forum: 30 Years of the Genome: Integrating and Applying ELSI Research, an online meeting of scholars focused on the ethical, legal, and social implications (ELSI) of genetics and genomics.

We conducted focus groups to assess patient attitudes toward research on medical practices in the context of usual care. We found that patients focus on the implications of this research for their relationship with and trust in their physicians. Patients view research on medical practices as separate from usual care, demanding dissemination of information and in most cases, individual consent. Patients expect information about this research to come through their physician, whom they rely on to identify and filter associated risks. (...) In general, patients support this research, but worry that participation in research involving randomization may undermine individualized care that acknowledges their unique medical histories. These findings suggest the need for public education on variation in practice among physicians and the need for a collaborative approach to the governance of research on medical practices that addresses core values of trust, transparency, and partnership. (shrink)

Background Participants' understanding of clinical trials is important in informed consent. However, little is known about what information participants really want to know. Aims To demonstrate the existence of a discrepancy between participants' understanding and their desire to know. Methods The participants in clinical trials at Seoul National University Hospital were surveyed. The survey consisted of 11 statements based on the essential elements of informed consent. The participants gave two responses to each statement on a five-point Likert scale to rate (...) their subjective understanding and desire to know, respectively. Information discrepancy was defined as the difference between these two ratings: if understanding exceeded desire to know for a particular item, it was defined as ‘over-informed’; if desire to know exceeded understanding for a particular item, it was defined as ‘under-informed’. Results Participants reported good understanding of ‘voluntariness’, ‘duration’, ‘study involves research’ and poor understanding of ‘confidentiality’, ‘compensation’, ‘benefits’, ‘procedures’ and ‘risks or discomforts’. For ‘risks or discomforts’, ‘who to contact’, ‘voluntariness’, ‘duration’ and ‘procedures’, participants reported high desire to know compared with ‘confidentiality’, ‘purpose’, ‘study involves research’ and ‘benefits’. The elements ‘study involves research’, ‘voluntariness’, ‘duration’, ‘purpose’ and ‘who to contact’ were over-informed, while ‘compensation’, ‘risks or discomforts’, ‘procedures’, ‘confidentiality’ and ‘benefits’ were under-informed. Participants over 50 years of age, those without a college education and those whose participation was less voluntary were relatively less informed about the clinical trials. Conclusions An information discrepancy was observed between the participants' understanding and their desire to know. By putting more emphasis on under-informed elements, the quality of informed consent could be improved. (shrink)