• Title/Summary/Keyword: The informed consent

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Ethics Involving Human Subject Research in Military Medicine (군진의학 연구에서 인간대상 연구윤리)

  • Kwon, Ivo
    • The Journal of KAIRB
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    • v.4 no.2
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    • pp.23-29
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    • 2022
  • The goal of the military medicine is not as same as that of the civil medical practice, and consequently the characteristics of military biomedical researches have their own uniqueness. In front of the prerogative of national defense, some of the human rights ordinarily ensured in normal researches with human subjects are not to be fully guaranteed. The hierarchic system of the military would complicate the issue when the soldiers are enrolled as human subject for the research. Some researches could be classified as a military secret, therefore, the confidentiality issues need to be well addressed. Institutional Review Board and review procedure should be modified for the military purposes. So, it is necessary to establish the appropriate regulatory system for the military biomedical researches with human subject to manage the complicated issues involved in them.

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A Validation Study on the Translated Korean Version of the Edinbergh Postnatal Depression Scale (한국판 에딘버러 산후우울측정도구의 타당성 연구)

  • Kim, Jeung-Im
    • Women's Health Nursing
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    • v.12 no.3
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    • pp.204-209
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    • 2006
  • Purpose: The Edinbergh Postnatal Depression Scale (EPDS) has seen widespread use in epidemiological and clinical studies. The objective of this research was to translate and to test the reliability and validity of the 10-item EDPS in Korea. Methods: Subjects were 145 women who were 6 to 10 weeks post delivery. To test reliability, the internal consistency was assessed by Cronbach's alpha coefficient. Validity testing was performed using convergent validity by Pearson's correlation. Data was gathered at 3 hospitals during Oct. 2005 after obtaining an informed consent. Result: The mean age of the subjects was 29.9 years. and the mean parity was 1.46 times. The mean EPDS score was 18.4. Reliability analysis showed a satisfactory result (Cronbach's alpha coefficient=.84). There were significant positive correlations between EPDS and Mills postnatal depression and anxiety check list scores as expected(r=.69, p<.001) and thus supported convergent validity. Conclusion: The study findings showed that the Korean version of the EPDS-10 is a reliable and valid instrument that can be used for measuring postnatal depression in Korea.

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The Experience of Spirituality (영성(Spirituality) 체험 - 기독교인 중심의 현상학적 접근 -)

  • 오복자;강경아
    • Journal of Korean Academy of Nursing
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    • v.31 no.6
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    • pp.967-977
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    • 2001
  • This study explored and described the living spiritual experience and was attempted to gain an understanding of spirituality. This was done by eliciting participants′ verbal descriptions of their experiences. Method: Data was obtained from in-depth interviews with one cancer patient, one pastor, and three missionaries after obtaining informed consent from each. Interviews were tape recorded and transcribed verbatim. The transcripts were analyzed using Colaizzi′s phenomenological method. Sandelowski′s evaluation criteria for qualitative research, such as reliability, suitability and auditability, were also used to establish reliability and validity of this study. Result: The five major theme clusters that designated the essence of the spiritual experience, "spiritual awareness," "interconnectedness," "love," "tran- scendent energy," "purpose and meaning in life," emerged from the analysis. Conclusion: This study revealed that spirituality was activated by awareness through introspection and interconnectedness with a Supreme Being. The interconnectedness with a Supreme Being played an important role in harmonious relationships with others and self. It also resulted in revealing the other beneticial attributes of spirituality. Love, the core concept of the interconnectedness, worked as a transcendent energy. Also, the ability to see beyond reality and resulted in finding meaning in life and accomplishing well being.

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Needs and perception of medical communication course in the dental hygiene students (일부 치위생(학)과 학생들의 의료커뮤니케이션 교과목에 대한 필요성 및 인식 조사)

  • Ryu, Da-Young;Yang, Hyun-Suk;Choi, Yong-Keum
    • Journal of Korean society of Dental Hygiene
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    • v.14 no.5
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    • pp.623-630
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    • 2014
  • Objectives : The aim of this study was to investigate the perception and needs for medical communication course in the dental hygiene students. Methods : A self-reported questionnaire was filled out by 700 dental hygiene students after receiving informed consent from October 30 to December 20, 2013. Results : A total of 652 completely answered questionnaires were analyzed. The medical communication course proved to be very important necessary that 46.6% of the students said 'probably needed.' Only 5.1% of the students answered the course is not necessary. Conclusions : The majority of the students want the medical communication course. It is desirable that we need to set up a medical communication training and systemic course.

A Case of Myelopathy after Intrathecal Injection of Fluorescein

  • Park, Kwang-Yeol;Kim, Young-Baeg
    • Journal of Korean Neurosurgical Society
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    • v.42 no.6
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    • pp.492-494
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    • 2007
  • We present a case with seizure, confusion, hypesthesia and paraplegia after intrathecal injection of fluorescein. A 41-year-old man was admitted to our institution for the management of the CSF leakage. Intrathecal injection of fluorescein was performed and he complained of severe pain and numbness in the lower extremities at the end of the injection. Four hours later, he exhibited confusion, paraparesis and two episodes of generalized seizures. Two days later, he showed paraplegia and all sensory modalities below the T12 level were absent. Spine magnetic resonance imaging revealed myelopathic change in the lower thoracic spinal cord. There was no improvement of weakness and sensory deficits in lower extremity even 14 days after fluorescein injection. We speculated that thoracic myelopathy was associated with the intrathecal injection of fluorescein. In spite of its rarity, the complication after intrathecal injection of fluorescein could be serious. Thus, obtaining an informed consent with discussion with patient before the procedure is mandatory.

Effect of Cardiopulmonary Resuscitation Education on the knowledge, attitude and self-efficacy of elementary and middle school teachers (기본 심폐소생술 교육이 초·중등 교사의 심폐소생술에 대한 지식, 태도 및 자기효능감에 미치는 효과)

  • Choi, Soon-Hee
    • Journal of Korean Public Health Nursing
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    • v.29 no.1
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    • pp.18-28
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    • 2015
  • Purpose: This study was conducted to evaluate the effect of CPR education on the knowledge, attitude and self-efficacy of elementary and middle school teachers. Methods: After obtaining informed consent from participants, data were collected from 75 teachers receiving training in emergency care using questionnaires before and after education. Data were analyzed using percentage, paired t-test, and correlation. Results: The knowledge and self-efficacy scores were the middle level and the scores for attitude were the upper middle level. The knowledge, attitude, and self-efficacy scores at posttest were significantly higher than those at pretest. Conclusion: Teachers should receive CPR education regularly, so that they can acquire the knowledge, attitude, and practical ability of CPR.

Current Status and Importance of Clinical Research Involving Neonates (신생아 임상 연구의 현황과 필요성)

  • Cho, Su-Jin
    • Neonatal Medicine
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    • v.15 no.2
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    • pp.113-118
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    • 2008
  • Clinical trials in neonates of different gestational age, birth weight, postnatal age and general health status are needed to assure safe and optimal evidence-based-therapy to this special population. Pharmacodynamic maturation must be considered in grouping the neonates for clinical trials. Informed consent from the parents, protection of the neonates participating in the clinical trials, adherence to good clinical practice guidelines, and designation of short term and long term outcomes must be taken into consideration from the beginning of the trials. Collaboration between centers will be helpful in overcoming the problem with small patient size. Many of these challenges are surmountable and an well-designed clinical trial will improve the mortality and morbidity in these very small children.

First-Year Graduate Student Experience of University Life in an Unfamiliar Department of Nursing (일 대학 신설간호학과 1회 졸업예정자들의 대학생활 경험에 관한 연구)

  • Lee, Sook-Kyung;Hong, Ju-Eun
    • The Journal of Korean Academic Society of Nursing Education
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    • v.20 no.4
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    • pp.452-462
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    • 2014
  • Purpose: This study explores the experience of university life in an unfamiliar department by first-year graduate students. Method: Data were collected from participants through focus group interviews between July and August 2013 using phenomenological research methods. Colsizzi's method was used for analysis after the institutional review board of the university approved the study and informed consent was obtained from the participants. All interviews were recorded on an MP3 recorder and transcribed. Results: The analysis revealed 51 meanings that were categorized by 15 key words into 6 themes: "sense of isolation," "feeling of solidarity," "limitations," "benefits," "overcoming" and "renewing." Conclusion: First-year graduate students experience both positive and negative feelings toward "university life"; however, they eventually overcome their difficulties and adapt to the conditions of their field of study and new department.

Understanding of Clinical Trials and Application to the Real Practice (임상시험의 단계별 이해 및 실제)

  • Choi, SungKu
    • Korean Journal of Biological Psychiatry
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    • v.19 no.4
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    • pp.153-158
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    • 2012
  • Understanding of a clinical trial is essential in developing clinical guideline and adopting evidence based practice. In designing and executing clinical trials, following ethical requirements should be considered : social value, scientific validity, fair subject selection, informed consent, favorable risk-benefit ratio, institutional review board, and respect for human subjects. According to the stage of drug development, purpose of trials, accumulated scientific data, clinical trials for drug development are classified as phase 1, 2, 3, and 4. Phases of clinical trials can be overlapped and the judgment of entering into the next phase should be considered highly strategically. In reading, evaluating and interpreting clinical trial reports, various skills and challenges exist. Patient sample composition, trial duration, selection of endpoints, responders and non-responders, placebo effect, patient recruitment, and extrapolation to the real world are the examples of those challenges. Treatment success will come from the well balanced approach of evidence based decision making and consideration of specific single case.

Facial Transplantation Surgery

  • Eun, Seok Chan
    • Archives of Plastic Surgery
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    • v.41 no.2
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    • pp.174-180
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    • 2014
  • It is well known that patients with severe facial injuries accompanied by facial disfiguration are vulnerable to a poor quality of life. With the help of facial transplantation, it has become possible to achieve an optimal anatomical reconstruction. As compared to conventional methods, it can provide more desirable functional, aesthetic, and psychosocial outcomes. Face transplantation surgeons need to consider many problems associated with the criteria for selecting patients, techniques for harvesting the donor tissue, prediction of the expected functional outcomes, limitations in obtaining written informed consent for conducting the procedure, evaluation of the post-transplant immunological response and postoperative immunosuppressant requirements, psychological and social outcomes for the patients, and other concerns about funding and ethical issues.