• 대한소아치과학회지
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• 제32권3호
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• pp.444-453
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• 2005

진정요법은 소아치과에서 사용하는 보상, 속박, 체계적 탈감작법(말-시범-시행), 친밀감 같은 통상의 방법으로는 환자의 반응이 개선되지 않아 일반적인 치과치료가 불가능할 때 사용하는 행동조절법이다. 최근 국내에서도 진정요법을 이용하는 사례가 증가하는 추세이나 그 기준이나 방법들에 대한 연구는 매우 부족한 상태이다. 미국소아치과학회의 진정요법에 관한 기준이 있기는 하지만 국내의 상황이 미국과 다르므로 한국에서의 연구가 필요하다. 이에 저자는 국내에 거주하고 있는 소아치과의사들을 대상으로 국내 소아치과에서의 진정요법 현황에 대한 실태를 조사, 그 결과를 정리하여 향후 소아치과 임상에서의 진정요법에 대한 임상 기준을 정하는데 기여하고자 국내에 거주하고 있는 대한소아치과학회 회원 573명을 대상으로 진정요법 사용 실태에 관한 설문지를 발송하여 이 중 회신을 한 220명의 설문을 분석하여 다음의 결과를 얻었다. 1. 응답자의 약 66%가 진정요법을 사용하고 있다고 답했다. 진정요법에 관한 이전 연구 결과와 비교해 볼 때, 국내 소아치과에서 진정요법의 사용빈도가 증가하였다. 2. 진정요법으로 치료를 결정하게 된 요인은 행동조절, 치료내용과 양, 보호자의 요구, 내원횟수, 전신질환의 순서이었다. 3. 진정요법으로 치료받는 환자의 연령은 만 3세가 가장 많았고, 만 4-5세, 만 2세 미만, 만 6-10세, 만 10세 이상의 순서로 조사되었다. 4. 진정요법 시 chloral hydrate는 60-70mg/kg, hydroxyzine은 10-40mg/kg(25mg/kg)을 사용하고 있었고, 경구 투여가 가장 선호하는 약물투여 경로였다. 5. 진정요법 시 사용하는 환자감시 방법은 피부나 손톱색 등의 관찰을 포함한 환자 평가와 맥박 산소측정기(pulse oximeter)를 통한 환자감시를 선호하는 것으로 조사되었다. 6. 진정요법을 사용하고 있다고 응답한 사람의 약 56%에서 심폐소생술 교육을 받은 것으로 조사되었다.

• 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.