• 대한임상약리학회:학술대회논문집
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• 1994.05a
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• pp.9-9
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• 1994

• 대한임상약리학회:학술대회논문집
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• 1994.05a
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• pp.10-10
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• 1994

• 한국과학기술학회:학술대회논문집
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• 2015.12a
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• pp.171-188
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• 2015

• 대한임상약리학회:학술대회논문집
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• 1992.11a
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• pp.17-17
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• 1992

• 대한임상약리학회:학술대회논문집
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• 1996.05a
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• pp.77-92
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• 1996

• Journal of Yeungnam Medical Science
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• v.30 no.2
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• pp.73-78
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• 2013

An institutional review board (IRB) should independently safeguard the right, safety, and well-being of all clinical trial subjects. It should consist of members who are qualified and experienced to review and evaluate the science, medical aspects, and ethics of the proposed trial. They have to pursue continuing efforts to improve the standards of review. The levels of review include the full board review, expedited review, continuing review, or exempt from review, while the levels of decision-making include approval, conditional approval, deferred approval, and disapproval. Investigators must follow the approved protocols and regulations honestly, and it is the IRB's mission to audit clinical trial sites as well.

• Proceedings of the KWS Conference
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• 1992.10a
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• pp.77-87
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• 1992

• The Journal of Korean Medicine
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• v.31 no.1
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• pp.122-129
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• 2010

Objective: To investigate institutional review boards and approved clinical trials of Oriental medical hospitals in Korea Methods: We e-mailed 16 Oriental medical hospitals a survey consisting of questions that addressed two topics, institutional review boards and the clinical trials they approved. The first part included questions about whether each hospital had an institutional review board, that board's staffing and education, reviews, and expedited reviews. The clinical trials portion covered the number and types of approved clinical trials, treatment methods, whether an investigator or a sponsor initiated the trials, diseases, time frame, and clinical trial fee. Results: We received a response to our e-mail from 14 hospitals, all of which had an institutional review board. The average number of institutional review board members was 13.57. Of these Oriental medical hospitals, 70% and 49% said that they regularly educated their institutional review board staff and clinical trial, investigators, respectively. 79% of the hospitals claimed to conduct regular reviews, and 50% said that they did so monthly. The number of approved clinical trials increased sharply from 11 in 2005 to 102 in 2008. 68% of these clinical trials were randomized, and the most-used treatment methods were herbal medicine (35%) and acupuncture (29%). The most common target diseases were circulatory (19%), urinogenital (14%), and musculoskeletal (13%) disease. Conclusions: Despite the rapid increase in clinical research in oriental medical hospitals, many more efforts including raising IRB quality, varying research diseases and increasing clinical trials in the hospitals located in non-metropolitan area, should be made.

• The Journal of KAIRB
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• v.3 no.2
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• pp.28-36
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• 2021

Purpose: The purpose of this study is to assess the status of the Human research Protection Program (HRPP) within a hospital or a research institute in Korea. Methods: Survey was conducted during June 12th-21th 2019. Survey was distributed to the members of Korean Association of IRB (KAIRB) through each IRB office. Descriptive statistics were performed using SPSS ver. 26. Results: A total of 86 people responded, and 75 (87.0%) answered that they have perceived the HRPP. Seventy out of 86 respondents (81.4%) were conducting internal audit, several institutions were operated simultaneously the other form of audits such as IRB audit, system audit. Regarding the management of Suspected Unexpected Serious Adverse Reaction (SUSAR), 62.8% answered that they have regulation that can decide to suspend the study when there is a risk to subject safety. Among the respondents, 66.3% performed 'Help desk.' Conclusion: In this study, we assessed the current status of HRPP operation at each research institution based on Ministry of Food and Drug Safety (MFDS) HRPP guidelines. The HRPP accredited institution operated the subject protection activities according to this program, and even if the HRPP was not officially operated, the related activities were conducted focusing on the cases that could have a significant impact on the safety of research subjects. In order to ensure the quality of domestic clinical trials and to stably establish the HRPP, efforts at the individual institution level will be required.

• The Journal of the Korea Contents Association
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• v.22 no.10
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• pp.374-382
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• 2022

This study aims to explore the research trends of hospice that were published in KCI from July 2003 to 2022. Using Korea Citation Index, a total of 115 papers were selected for data analysis. According to the analysis, research on terminal care were conducted mostly from 2017 to 2019. A total of 26 papers were published on Journal of Hospice and Palliative Care. 115 papers were mostly conducted with nurses and nursing students. It was found that those nurses were working in tertiary hospitals, long-term care hospitasl, and general hospitals. The research topics of the published papers are mainly related to end-of-life care attitude, end-of-life care performance, experiences of end-of-life care, and end-of-life care stress. Among them, 78.3% of the papers adopted quantitative research method. Concerning the IRB, 64.3% of the papers got an approval. It is expected that the present study can shed some lights on hospice care field by analyzing the trends of terminal care studies.