• The Journal of KAIRB
• /
• v.6 no.1
• /
• pp.5-16
• /
• 2024

Purpose: The purpose of this study is to investigate the current status of pediatric assent in nationwide hospitals and to assess the children's comprehension for pediatric assent by interviewing pediatricians/pediatric neurologists to determine whether children of the age (elementary and middle school students) can understand the purpose, risks, benefits, and concepts of voluntary participation in clinical research described in the assent form, and to help improve the administrative efficiency of multicenter clinical trials. Methods: The status of pediatric assent was surveyed online using Google Forms at 141 university hospitals with administrative staff who are members of the Institutional Review Board (IRB) administrative staff subcommittee with in Korean Association of Institutional Review Boards (KAIRB). Additionally, face-to-face interviews were conducted with 7 pediatricians/pediatric neurologists. Survey and interview responses were summarized using descriptive statistics. Results: Out of the 141 institutions surveyed, 35 institutions (24.8%) responded. Among them, 30 institutions (85.7%) reported having age criteria for acquiring pediatric assent forms in the case of children. The age range for pediatric assent acquisition have been from 7 years old to 12 years old (15 institutions, 50%), and from 7 years old to 15 years old (7 institutions, 23.3%). Nine institutions (25.7%) have had criteria for obtaining both parents' consent in cases involving the participation of children. Nineteen institutions (54.3%) have had checklists or guidelines available for use by IRB members in study protocols involving vulnerable research subjects. Three pediatricians/pediatric neurologists have believed that upper-grade elementary school students (5th-6th grade) could comprehensively understand informed consent forms. Two have believed that middle school students would be able to understand them if they included personal information. Two pediatricians/pediatric neurologists have believed that even lower-grade elementary school students (1st-4th grade) could understand the explanations if they were made simpler. Conclusion: It is suggested that not only elementary school students (7-12 years old) but also middle school students (13-15 years old) should receive pediatric assent forms, as it would facilitate a comprehensive understanding of the forms. To enhance the comprehension of assent form content, it is necessary to use age-appropriate words, language, and expressions in the forms hospital. It is also recommended to create comics or videos to make the content of the assent forms more accessible for children.

• Korean Journal of Environmental Biology
• /
• v.22 no.2
• /
• pp.259-264
• /
• 2004

Convention on Biological Diversity has authorized national sovereignty over biological resources so that legislative framework should be established. In biological resources management, the access to biological resources and the benefit sharing arising out of their utilization are two most important steps. Bonn guidelines adopted by the 6th COP of the Convention on Biological Diversity contain MAT (Mutually Agreed Terms) and PIC (Prior Informed Consent) indispensable to implement the access and benefit-sharing process. MAT is contractual agreement between provider countries and use entities while PIC is a specific measure associated with consent prior to access to biological resources. Moreover, the guidelines include the responsibilities of national focal point and competent national authority, incentives and so on. Our laws related to access to biological resources have no items on benefit-sharing and intellectual property rights. The role of the competent national authority is very important to coordinate the organization controlling information availability, opening to the public, and intellectual property rights with other stakeholders. But, the national regulations must not interfere with academic studies on biological diversity and disobey the two objectives of the Convention on Biological Diversity, the conservation of biological diversity and its sustainable use.

• Journal of the Korea Academia-Industrial cooperation Society
• /
• v.20 no.10
• /
• pp.68-75
• /
• 2019

This descriptive research study identified the factors affecting the nursing process confidence of nursing students. The study's data was collected from June 13th 2017 to June 30th, 2017. Informed consent was received from 129 students who were in their second year of nursing college. The collected data was analyzed using SPSS WIN 18.0 program. The score for self-directed learning ability was 3.45, the score for a critical thinking disposition was 3.55, and the score for nursing process confidence was 3.68. There was significant positive correlation between nursing process confidence and self-directed learning ability (r=.572, p<.001) and critical thinking disposition (r=.488, p<.001). The factor affecting the confidence in the nursing process was self-directed learning ability(32.2%). Educational methods based on building the self-directed learning ability are needed to enhance the nursing process. There are limitations in discussing the results of this study due to the lack of prior research. Further study is needed to confirm the results of this research and the relationships it revealed.

• Archives of Plastic Surgery
• /
• v.43 no.1
• /
• pp.66-70
• /
• 2016

Background In this study, we characterize the morbidity at the donor-site of partial second toe pulp free flaps in terms of wound management as well as long-term outcomes. Methods A single-institutional retrospective review was performed for patients who had undergone partial second toe pulp free flap transfer to the fingertip. Patient charts were reviewed for infection, skin necrosis, wound dehiscence, and hematoma for the donor site. Additionally, a questionnaire survey was given to patients who had a follow-up of longer than 1 year to characterize long-term postoperative pain and appearance. Results The review identified a total of 246 cases. Early wound complications were significant for wound dehiscence (n=8) and hematoma (n=5) for a wound complication rate of 5.3%. The questionnaire was distributed to 109 patients, and 54 patients completed the survey. Out of these 54 patients, 15 patients continued to have donor-site pain (28%) at a mean follow-up period of 32.4 months. However, the pain intensity was relatively low in the range between 2 to 5, on a 0-10 scale. None of these patients felt this donor-site pain interfered significantly with daily activity, nor did any patient require pain medications of any type. Donor-site appearance was satisfactory to most patients. Conclusions The partial second toe pulp flap was associated with low rates of wound complications and favorable long-term outcomes. Given the functional and aesthetic gain in the recipient finger, donor-site morbidities appear acceptable in this patient population. This study can be helpful in counseling patients regarding donor-site morbidity during the informed consent process.

• Journal of Korean society of Dental Hygiene
• /
• v.15 no.3
• /
• pp.531-538
• /
• 2015

Objectives: The purpose of this study is to investigate third and forth year dental students' perception towards dental hygienists as professionals. Methods: A self-reported questionnaire was completed by 602 dental college students in Korea after receiving the informed consent. Except incomplete answers, 217 data were analyzed. The questionnaire consisted of three questions of the general perception towards dental hygienists, four questions of the cooperation relationship to the dental hygienists, four questions of oral health education, five questions of preventive dental health care, five questions of dental treatment cooperation, and five questions of dental health care management. The data were analyzed using PASW Statistics 18.0(SPSS Inc., Chicago, IL, USA). Results: Most of the dental college students viewed the dental hygienists as professionals. However, they did not exactly know the professional job of dental hygienists within the current national medical services system and they often viewed the dental hygienists as a medical assistant. The dental college students thought that the key role of the dental hygienists is the dental assisting. Only a small fraction of the participants recognized oral health promotion, preventive cares, and hospital management as professional roles of dental hygienists. Conclusions : Dental college students' perception towards dental hygienists as professionals needs to be improved. Understanding the job description of dental hygienists clearly is a crucial part of dental students' learning process and future practice.

• YAKHAK HOEJI
• /
• v.58 no.2
• /
• pp.112-124
• /
• 2014

This study aimed to develop a regulation system for off-label drug use to secure the safe use of marketed drugs. We searched governmental documents for national and global regulating systems of off-label drug uses and a body of academic literature to explore current regulating trends. We included European Union, United Kingdom, United States of America, Australia and Japan, and critically reviewed the regulation of off-label drug use in four issues, which were a regulatory structure, safety control before and after off-label use, and information management. The findings of the present investigation called for several measures in off-label drug uses: enhancing prescribers' self-regulation, providing up-to-date information to prescribers for evidence-based practice and to patients for their informed consent, making evidence with scientific rigor, building an official registering process for off-label use in good quality and extending the role of pharmaceutical industry in pharmacovigilance. At last, we proposed a new system so as to regulate and evaluate off-label drug uses both at national and institutional level. In the new system, we suggested a clear-cut definition for clinical evidence that applicants would submit. We newly introduced an official 'Off-Label Drug Use Report' to evaluate the safety and clinical efficacy of a given off-label drug use. In addition, we developed an algorism of the regulation of off-label drug use within an institution to help set up the culture of evidence-based practices in off-label drug uses.

• Women's Health Nursing
• /
• v.20 no.1
• /
• pp.48-61
• /
• 2014

Purpose: This study was done to explore the essence and meaning of the experience of 'aging', as a process of 40's and 50's women in Korea by applying the Parse's Human Becoming theory (2002). Methods: Data was collected from February to April, 2013, using the phenomenological research method. Data was collected through in-depth informal interview and analyzed following Colaizzi method. After IRB permission and informed consent from the participants, all interviews were recorded with MP3 recorder and transcribed for analysis. Results: Data analysis revealed 112 of meanings, 33 key subject words, 8 subject phrases, and 4 categories. The main themes were elaborated as 'going down' ('Being changed of body and mind', 'Being considered on my identity'), 'going up' ('Being expanded of productive role', 'Being transcendent multi-dimensionally'), 'pausing' ('Becoming more thoughtful about family', 'Looking back'), 'going forward again' ('Age is just a number, 'Contemplating of life and death'). Experiences in aging among women in 40's and 50's enlightened with Parse's theory of Human Becoming in terms of 'going down', 'going up', 'pausing', 'going forward again' appeared simultaneously, rather than consecutively. Conclusion: Women in 40's and 50's require holistic nursing intervention with physical, psychological, socio-economical, and spiritual aspects, rather than focusing on problematic physical symptom relief and prevention of further conditions. It is recommended to develop various nursing intervention considering on different environment, type of experience, and level of human becoming, individually.

• Journal of Hospice and Palliative Care
• /
• v.23 no.4
• /
• pp.183-197
• /
• 2020

Purpose: In this study, the researchers closely investigated the psychosocial problems faced by terminal cancer patients and their family members in hospice palliative care units. Methods: The investigators conducted four sessions of art therapy intervention programs for the terminal cancer patients and their family members, carried out in-depth interviews about the influence of the cancer experience on their family function and quality of life, and analyzed their experiences using grounded theory methodology. Results: After providing autonomous written informed consent, six pairs of terminally ill cancer patients and their family members, accounting for a total of 17 participants with the inclusion of additional family members who took part sporadically, took part in the art therapy intervention and interviews. The raw data, in the form of verbatim records, were analyzed according to the procedures of grounded theory (open, axial, and selective coding). Through these processes, a total of 154 concepts, 56 subcategories, and 13 categories were identified. Families were classified into four types according to their family function, quality of life, and attitude toward death. Though the art therapy intervention, patients and their family members experienced three stages over time. Conclusion: This research focused on essential aspects of the family relationships and the art therapy experiences of terminal cancer patients and their family members through an art therapy intervention in the context of hospice palliative care. Based on these observations, the researchers constructed a theoretical rationale for art therapy interventions delivered to patients and their family members in the process of hospice palliative care.

• Journal of Oriental Neuropsychiatry
• /
• v.35 no.2
• /
• pp.177-189
• /
• 2024

Objectives: This study aimed to evaluate the impact of Resource Mindfulness on participants' emotional state, focusing on anxiety and stress reduction and to explore the importance of psychological resources in this process. The effectiveness of Resource Mindfulness was investigated through both quantitative and qualitative analyses, examining its influence on subjective distress, mindfulness, core emotions, and identification of personal resources. Methods: This study involved 27 participants, including Korean medicine students, psychological counselors, clinical psychologists, and Korean medicine specialists, who attended a 2-night, 3-day M&L psychological support education program from July 2 to July 4, 2022. Participants were informed of the study's purpose and procedures. They provided written consent. Quantitative measures included Subjective Units of Disturbance Scale (SUDS), Five Facet Mindfulness Questionnaire (FFMQ), and Core Seven-Emotions Inventory Short Form (CSEI-s). Qualitative analysis was conducted using the "Drawing the Rooms of the Mind" technique. Pre- and post-program assessments were conducted to compare changes in subjective distress, mindfulness, and core emotions. Data were analyzed using paired t-tests and qualitative content analysis methods. Results: Significant reductions in subjective distress and improvements in mindfulness components were observed. Core emotions showed significant decreases in negative emotions. Qualitative analysis revealed increased tranquility, relief, and confidence, with resourceful places often being nature-related. Conclusions: Resource Mindfulness effectively reduced anxiety and stress and enhanced self-awareness and self-efficacy. It is useful for managing various mental health issues. Further research is needed to generalize these findings.

• The Korean Society of Law and Medicine
• /
• v.15 no.1
• /
• pp.211-237
• /
• 2014

Because of unpredictability and high possibility of abnormal results by clinical trials compared to general medical behaviors, a procedure for ensuring with sufficient explanations by investigators must be secured. Therefore, in a sequence of clinical trials, what kinds of scope, stage, and method of explanations provided by investigators, including doctors or researchers, to trial subjects are closely related to the compensation for damages by violation of liability for explanation. In case of application of clinical trials to patients who have critical illness such as cancer, issues of "Quality of Life" regarding trial subjects, cancer patients, should be discussed. Especially, in case of clinical trials for terminal cancer patients, the right of subjects' self-determination, which is a fundamental principle in medical behaviors, should be discussed. The right of self-determination includes participation in clinical trials for the possibility of life-sustaining even a little bit, or no participation in clinical trials in order to have a time for completing the rest of his life. Like this, if the extent and scope of explanations related to the issues of "Quality of Life" are raised as main issues, the evaluation of "Quality of Life", should be a prerequisite. In many occasions, realistically, despite bad results such as deaths or serious adverse drug reactions after clinical trials, it may not be easy for compensating to trial subjects or their survivors, who requested civil compensation for damage. Futhermore, in abnormal results after concealment of clinical trials or performance of clinical trials without permission, and in the case of trial subjects' failures of proving proximate cause between the clinical trials and abnormal results, problematic results such as no protection to the trial subjects could be occurred. In performing clinical trials, investigators should provide sufficient explanations for trial subjects and secure voluntary informed consents from the trial subjects. Therefore, clinical trials without trial subjects' permissions and the informed consent process violate trial subjects' rights of self-determination, and the investigators shall be liable for compensation for damages. Then, issues might be addressed are what are essential contents of patients' "rights of self-determination" infringed by clinical trials without subjects' permissions. Two perspectives about patients' rights of self-determination might be considered. One perspective regards physical distress of patients (subjects) from therapies without sufficient explanations as the crux of the matter. The other perspective regards infringement of human dignity caused by being subjects without permission as the crux of the matter irrespective of risks' big and small influences. This research follows perspective of the latter. Forming constant fiduciary relation between investigators (doctors) and subjects (patients) pursuant medical contracts, and in accordance with this fiduciary relation, subjects, who are patients, have expectations of explanations and treatments by the best ways. If doctors and patients set this forth as a premise, doctors should assume civil liability when doctors infringe patients' expectations.