• 대한기관윤리심의기구협의회지
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• 제2권2호
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• pp.37-48
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• 2020

Purpose: The purpose of this study is to assess the operational status and level of understanding among IRB and HRPP staffs at a hospital or a research institute to the HRPP guideline set by the Ministry of Food and Drug Safety (MFDS) and to provide recommendations. Methods: Online survey was distributed among members of Korean Association of IRB (KAIRB) through each IRB office. The result was separated according to topic and descriptive statistics was used for analysis. Result: Survey notification was sent out to 176 institutions and 65 (37.1%) institutions answered the survey by online. Of 65 institutions that answered the survey; 83.1% was hospital, 12.3% was university, 3.1% was medical college, 1.5% was research institution. 23 institutions (25.4%) established independent HRPP offices and 39 institutions (60.0%) did not. 12 institutions (18.5%) had separate IRB and HRPP heads, 21 (32.3%) institutions separated business reporting procedure and person in charge, 12 institutions separated the responsibility of IRB and HRPP among staff, and 45 institutions (69.2%) had audit & non-compliance managers. When asked about the most important basic task for HRPP, 23% answered self-audit. And according to 43.52%, self-audit was also the most by both institutions that operated HRPP and institutions that did not. When basic task performance status was analyzed, on average, the institutions that operated HRPP was 14% higher than institutions that only operated IRB. 9 (13.8%) institutions were evaluated and obtained HRPP accreditation from MFDS and the most common reason for obtaining the accreditation was to be selected as Institution for the education of persons conducting clinical trial (6 institutions). The most common reason for not obtaining HRPP accreditation was because of insufficient staff and limited capacity of the institution (28%). Institutions with and without a plan to be HRPP accredited by MFDS were 20 (37.7%) each. 34 institutions (52.3%) answered HRPP evaluation method and accreditation by MFDS was appropriate while 31 institutions (47.7%) answered otherwise. 36 institutions answered that HRPP evaluation and accreditation by MFDS was credible while 29 institutions (44.5%) answered that HRPP evaluation method and accreditation by MFDS was not credible. Conclusion: 1. MFDS's HRPP accreditation program can facilitate the main objective of HRPP and MFDS's HRPP accreditation program should be encouraged to non-tertiary hospitals by taking small staff size into consideration and issuing accreditation by segregating accreditation. 2. While issuing Institution for the education of persons conducting clinical trial status as a benefit of MFDS's HRPP accreditation program, it can also hinder access to MFDS's HRPP accreditation program. It should also be considered that the non-contact culture during COVID-19 pandemic eliminated time and space limitation for education. 3. For clinical research conducted internally by an institution, internal audit is the most effective and sole method of protecting safety and right of the test subjects and integrity for research in Korea. For this reason, regardless of the size of the institution, an internal audit should be enforced. 4. It is necessary for KAIRB and MFDSto improve HRPP awareness by advocating and educating the concept and necessity of HRPP in clinical research. 5. A new HRPP accreditation system should be setup for all clinical research with human subjects, including Investigational New Drug (IND) application in near future.

• 대한기관윤리심의기구협의회지
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• 제6권1호
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• pp.5-16
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• 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.

• 한국전통조경학회지
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• 제36권3호
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• pp.115-127
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• 2018

천연기념물 제214호 진안 평지리 이팝나무군의 고사(枯死) 및 쇠약(衰弱) 요인의 명확한 진단(診斷)과 처방(處方)을 통한 천연기념물로서의 가치 존속(存續) 방안을 강구하고자 시도된 본 연구의 결과는 다음과 같다. 첫째, 1968년 13그루의 천연기념물 지정 이후, 1973년을 시작으로 근년까지 계속적으로 고사가 진행되어 현재는 3주만 생존하고 있다. 특히 2010년 이후 마령초등학교 담장 후퇴 등 정비과정에서 복토된 토양의 일부 제거에도 불구하고, 계속적으로 고사가 이루어진 것으로 확인된다. 둘째, 지정목 중 1 3번 생존목 또한 고사된 가지가 많고, 잎이 왜소하며, 엽량이 적었다. 1번목은 수세가 '극히 불량'하고 다량의 가지가 이미 고사하였으며, 금년에는 단지 2개 가지에서만 개화가 이루어졌으며 엽량 또한 현저히 적은 상태이다. 2번목 또한 '불량'상태로 잎이 작고 엽밀도도 낮으며 수형의 변형이 이루어지는 등 수세가 쇠약한 상태이다. 현존하는 가장 큰 1번목은 논토양으로 추정되는 점질토가 복토되어 있어 우려를 더하고 있다. 셋째, 평지리 이팝나무군의 토성 분석결과, '미사질양토[微砂質壤土, Silt loam(SiL)]'로 밝혀짐에 따라 미사(Silt)의 성분비가 높음을 알 수 있다. 또한 1번목 북측의 토양산도는 pH 6.6으로 다른 부위의 흙과는 편차가 컸는데 이는 원지반 토양이 아닌 외부에서 반입된 토양으로 복토되었음에 기인한 것으로 판단된다. 더불어 유기물함량은 적정범위보다 높게 나타났는데 이는 보호관리를 위한 시비가 계속적으로 이루어진 결과가 반영된 것이라고 판단된다. 넷째, 진안 평지리 이팝나무군의 고사 및 생육 불량의 근본적 원인으로는 복토(覆土)로 인한 심각한 생리저하의 만성적 증후군으로 판단된다. 이는 신규로 식재된 후계목 또한 일부 고사된 것에서도 그 원인을 찾을 수 있다. 다섯째, 1차적으로 기존 고사의 원인으로 추정되는 복토 부분에 대한 점진적 제거가 시급하다. 무엇보다도 근계부에 복토된 점질토양의 제거를 건의한다. 복토부를 제거한 후 굵은 모래로 치환하고 뿌리의 호흡 개선을 위해 유공관을 설치한다. 그리고 고사한 4번 고사목과 5 6번의 고사흔적인 밑둥은 제근하고, 하층식생은 예초한다. 생존목은 상부 고사지를 제거, 수피 이탈부는 외과수술을 시행하는 한편 생장점 아래에서 전정하여 맹아의 발생을 유도해야 할 것이다. 여섯째, 지하부 뿌리를 확인하여 부패근 절단 및 토양호흡 개선방안을 마련한다. 근계 전반에 대한 추적 굴취 등으로 썩은 뿌리부를 단근하여 새 뿌리의 발생을 유도한다. 일곱째, 이후 잡초 발생과 답압 억제 그리고 토양 보습효과 유지를 위한 멀칭을 시도한다. 또한 지속적 영양공급을 위한 무기양료 엽면시비 및 영양제 나무주사, 무기양료의 토양관주를 고려한다. 향후 모니터링과 예찰방안을 마련하여 계속적으로 변화상을 체크해야 할 것이다.