OBJECTIVES: Due to the unique characteristics of clinical data, clinical data warehouses (CDWs) have not been successful so far. Specifically, the use of CDWs for biomedical research has been relatively unsuccessful thus far. The characteristics necessary for the successful implementation and operation of a CDW for biomedical research have not clearly defined yet. METHODS: Three examples of CDWs were reviewed: a multipurpose CDW in a hospital, a CDW for independent multi-institutional research, and a CDW for research use in an institution. After reviewing the three CDW examples, we propose some key characteristics needed in a CDW for biomedical research. RESULTS: A CDW for research should include an honest broker system and an Institutional Review Board approval interface to comply with governmental regulations. It should also include a simple query interface, an anonymized data review tool, and a data extraction tool. Also, it should be a biomedical research platform for data repository use as well as data analysis. CONCLUSIONS: The proposed characteristics desired in a CDW may have limited transfer value to organizations in other countries. However, these analysis results are still valid in Korea, and we have developed clinical research data warehouse based on these desiderata.
Anonyms and Pseudonyms ; Ethics Committees, Research ; Ethics, Research ; Information Storage and Retrieval ; Korea ; Privacy ; Research Design ; Social Control, Formal ; Statistics as Topic

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.
Aging* ; Ethics Committees, Research ; Female ; Holistic Nursing ; Humans ; Informed Consent ; Korea ; Nursing ; Qualitative Research ; Statistics as Topic

PURPOSE: The purposes of this study were: 1) To describe the level of awareness of patient safety culture and nursing care activities for patient safety and, 2) To identify factors affecting nursing care activities for patient safety among oncology nurses working at inpatient care units. METHODS: The study sample included 221 nurses working in oncology wards. After obtaining IRB approval, data collection was done with structured self-administered questionnaires, from September 13 to October 13, 2013. Data analysis was done using SPSS WIN 18.0. RESULTS: The mean score of awareness of patient safety culture was 3.46 and the mean score of nursing care activities for patient safety was 4.31 both on a scale of 5.0. Significant factors affecting nursing care activities for patient safety were the open attitude of the supervisor toward patient safety (beta=.19, p=.005) and the degree of patient safety within a ward perceived by the oncology ward nurses (beta=.23, p=.003). These factors explained 31% of the subjects' nursing care activities for patient safety (F=6.08, p<.001). CONCLUSION: To increase nursing care activities for patient safety in the oncology ward, a strategy such as an education program for increasing the awareness of patient safety is needed.
Data Collection ; Education ; Ethics Committees, Research ; Humans ; Inpatients ; Nursing Care* ; Oncology Nursing ; Patient Safety* ; Safety Management ; Statistics as Topic ; Surveys and Questionnaires

The institutional review board is crucial to ensure the scientific and ethical quality of human participant research. This paper analyzes a survey on the current constitution and operation of institutional review boards (IRBs) in Korea, conducted by the Korean Association of Institutional Review Boards in April 2002. Out of 74 IRBs, 63 responded to the survey (85.1% response rate). IRB membership has a male-to-female ratio of approximately 80:20, a predominance of male clinicians (60%) and an underrepresentation of community people unaffiliated to the institutions (less than 10%). Most IRBs (around 80%) confine the scope of their reviews to the clinical evaluation of drugs or devices, leaving the remaining areas of research involving human participants untouched. As their role is limited, the majority of IRBs do not operate actively: 72% of responding IRBs reviewed less than one protocol per month in 2001. Sixty two percent of institutions have never discussed the need for insuring research participants' risks or making indemnity arrangements. This survey reveals many shortcomings and points for improvement by the institutional support bodies, including the need to establish regular education programs for IRB members and investigators.
Appointments and Schedules ; Clinical Trials/legislation & jurisprudence ; Clinical Trials/standards ; Data Collection ; Epidemiologic Studies ; Ethics Committees, Research*/legislation & jurisprudence ; Ethics Committees, Research*/standards ; Ethics Committees, Research*/statistics & numerical data ; Female ; Human ; Human Experimentation/legislation & jurisprudence ; Human Experimentation/standards ; Korea ; Male ; Politics ; Public Policy ; Research Design/standards

PURPOSE: This study was done to explore the lived experience of pregnancy, childbirth, postpartum and early child rearing in married immigrant women in urban areas. METHODS: Data were collected from February to April, 2011 through in-depth interviews. Nine immigrant women were selected in a metropolitan area through the purposive and snowball sampling method. After obtaining IRB permission and informed consent from the participants, all interviews were recorded with MP3 recorder and transcribed for analysis. Using the phenomenological approach, data collected through in-depth interviewing were analyzed following Colaizzi style. RESULTS: Data analysis revealed 4 categories and 10 themes related to pregnancy, childbirth, postpartum and early child rearing of married immigrant women in urban areas. These four categories were 'A clumsy foreigner's life with nostalgia', 'Crisis in the crisis', 'Unprepared for motherhood', and 'Living together with new family without regrets'. It was a common finding that they were not ready to be mothers because of the very short time for adjustment in Korea. Compared to rural, immigrant women urban women had various in social support systems. CONCLUSION: The results indicate that adequate education is needed for immigrant women regarding motherhood, and that this education should be culturally appropriate for these women.
Child ; Child Rearing ; Emigrants and Immigrants ; Ethics Committees, Research ; Female ; Humans ; Informed Consent ; Korea ; Mothers ; Parturition ; Postpartum Period ; Pregnancy ; Qualitative Research ; Statistics as Topic

Dual energy X-ray absorptiometry (DXA) has become the most common method for measuring bone mineral density (BMD) of small animals in metabolic bone disease research, and errors should be minimized in all procedures involved in research studies in order to increase the accuracy of the study results. DXA is simpler and rapid compared to Micro-computed tomography for quantitative analysis of change in trabecular bone of test subject. In human research, measuring BMD is widely used; post-operative evaluation on orthopedic surgery, evaluation of osteoporosis medication in menopause and many other areas of study. For the study, the inspector should be trained by the equipment manufacturer regarding the utilization and analysis of the equipment and regular phantom testing should be conducted to ensure the stability of the equipment, and precision tests should be conducted to analyze the positioning and data analysis. They should also be familiar with the clinical trials and conduct studies based on the approval of the Institutional Review Board. In the absolute BMD measurement of the human body, it is necessary to apply and compare the position and condition, rotation degree, region of interest, and area of the scan in the follow-up test. In the case of small animals, animal selection, measurement and equipment should be modeled to match the research. Therefore, we would like to provide information for researchers to minimize the errors, effective data management and accurate data presentation. This article reviews the process of DXA measurement for research purpose including plan for DXA examination, BMD measurement in a human body study and small animal studies.
Absorptiometry, Photon ; Animals ; Bone Density ; Bone Diseases, Metabolic ; Ethics Committees, Research ; Female ; Follow-Up Studies ; Human Body ; Humans ; Menopause ; Methods ; Orthopedics ; Osteoporosis ; Statistics as Topic