• 의료법학
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• 제12권1호
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• pp.99-131
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• 2011

To strengthen the protection of human research subjects and human materials, the Korean Ministry of Health and welfare proposed the amendment bill of Bioethics and Safety Law(2010) to the Congress. It includes so many meaningful clauses. According to the bill, the scope that this act shall apply will be expended to the research involving human subjects and human materials. In the bill, there are the principles of this act; the protection of the life, health, and dignity of the human subjects, the obtaining of the adequate informed consent, the protection of the human subject's information confidentiality and the human subject's privacy, the assessment and minimizing of the risks involved and the guarantee of the safety for the human subjects, the preparation of the special protection program for the vulnerable human subjects, and so on. According to the bill, Institutional Bioethics Review Board(the same as Institutional Review Board) will be responsible for the auditing and monitoring on the research that was approved by IBRB, conducting the education program for the researchers, IBRB members and administrative staffs, preparing of the special protection program for the vulnerable human subjects, and forming the guidelines for the researchers as well as the review of the research protocols. And the State and local governments shall take necessary measures to support the expending of the social infrastructure. In addition to, IBRB will have to be assessed and to be gained the accreditation by the Korean Ministry of Health and welfare. So, if Bioethics and Safety Law is amended, it will contribute enormously to enhance the level of the human research subjects protection. Also, if this Law is amended, IBRB will play a major role for the conduct of the ethically, scientifically, and legally proper research. But now, as a matter of fact, the capability of IBRB members and IBRB office members is not enough to charge of this role because some people and some organizations does not know the importance of IBRB exactly. In spite of, IBRB shall be able to this role to protect the human subjects and to develop the level of the research On the international level. Therefore, the State, local governments and the Organization shall back up the administrative and financial terms of the IRB and IRB Office.

• 의료법학
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• 제17권2호
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• pp.125-144
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• 2016

모든 형태의 임상시험은 시험 자체가 불확실하며, 리스크가 다양하므로 피험자를 보호하기 위한 제도가 완비되어 있어야 한다. 그럼에도 불구하고 현행 임상시험에 관한 법률은 약사법과 의료기기법에서 일정한 규정을 두고 있으나 이는 '의약행정'을 원활하게 수행하기 위한 법목적에 비추어 피험자 보호에는 일정한 한계가 있다. 더 나아가 미성년 피험자를 대상으로 하는 임상시험은 약사법 등에서 직접적인 규정을 두지 않고, '소아를 대상으로 하는 임상시험 평가 가이드라인'이나 '의약품임상시험관리기준' 등에서 일정 부분 규율하고 있으나 이는 법적 효력이 없는 권고사항이라는 점에서 일정한 한계가 있다. 미성년자 대상 임상시험에 대한 법흠결 문제는 인체침습의 정도 면에서 통상적인 의료행위의 경우보다 강한 장기이식법상의 미성년자 취급제도와 기타 외국법상의 미성년자 임상시험 제도를 검토함으로서 입법적 해결이 가능하다고 할 것이다. 그러나 근본적으로는 현행법 체계상 약사법, 의료기기법 기타 가이드라인을 중심으로 이루어지고 있는 임상시험 규율체계를 이른바 "피험자보호법"이라는 법률제정을 통해 해결하는 것이 바람직하다고 본다.

• 한국치위생학회지
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• 제9권2호
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• pp.147-163
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• 2009

This study was attempted in order to look into 'Assist work' as to Implant system which dental hygienists perform in a clinical field. Subjects of this research were 362 dental hygienists who work at general hospital, University hospital, dental hospital, and dental clinics located in Seoul, Kyeong-gi, In-chon, and Jeon-buk area. As to research tool, we produced questionnaire which was comprised of the total 25 items regarding 3 of general features (age, career of dental hygienist, and personality), 6 of implant system assist work, 3 of Informed consent before surgery, 6 of preoperative preparation and maintenance related business, and 7 items related to postoperative maintenance. By using SPSS program, collected data was analyzed. Results of analysis in this study were as follow; 1. As to implant related education, dental hygienists' experience of education was high as 77.7%, and the people who is needed more education was 86.3%. Consequently, dental hygienists' concern about the implant related education was very high. 2. It was observed that most of informed consent making approvement by announcement to the surgical operation was made by dental hygienist before implant as 95%. 3. Over 80% of dental hygienists performed acquisition of cleanliness technology, motivation, back up articles preparation, treatment area arrangement, and etc. which we can check by preoperative maintenance items. In particular, response about the motivation was very high as more than 90%. 4. When performing an operation, in the case of disinfecting finger was low for 53.9% and the method was mainly washing with drug solution, and gown sterilization was performed only in 52.2%. Therefore education regarding disinfection was urgently needed. 5. Significance of education could be known that answers of hygienists experienced education appeared highly in items of maintenance method and there was statistically significant difference(p<0.05). 6. In case that assist work were 21cases or greater, agitation measurement was the most many performed in 68.9% and difference was showed up significantly(p<0.001). 7. Evaluation about periodontal tissue was high in dental hygienists who had experienced education and also there was statistically significant difference. In conclusion, assist work of dental hygienists was very comprehensive when implant surgery was performed, and all of items excluding hand disinfection or gown disinfection were highly showed up in most of hygienists. However, since there is the limit that we didn't investigate the quality of performing contents. It is considered that further study regarding the content has to be progressed for supporting this result in the future.

• 환경생물
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• 제32권4호
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• pp.397-402
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• 2014

1992년 6월 브라질 리우데자네이루에서 생물다양성협약(Convention on Biological Diversity, CBD)에 158개국이 서명한 이후, 현재 194개국 당사국들은 자국의 이익을 위해 다양한 형태로 논의에 참여하고 있다. 그리고 생물다양성협약 유전자원에 대한 접근 및 이익 공유(Access to genetic resources and Benefit-Sharing, ABS)를 다룬 나고야의정서가 채택되어 2014년 10월 12일에 발효 되었다. 이러한 상황에서 생물다양성협약 및 나고야의정서 발효가 해양생물다양성을 연구하는 연구자들에게 어떠한 영향을 미칠 것인가는 상당히 중요한 문제이다. 그러나 지난 생물다양성총회에서 해양 및 해양생물자원에 대한 관심은 비교적 적었으며, 이에 따라, 이와 관련된 논의도 늦어졌다. 하지만 이번 제12차 평창 생물다양성총회에서 생물학적 또는 생태학적 중요해역 (Ecologi-cally or Biologically Significant marine Areas, 이하 EBSA) 및 기타 해양관련 문제를 논의하였다. 우리나라는 나고야 의정서에 아직 정식으로 가입하지 않았지만 유전자원 이용 시 사전통보승인(Prior and Informed consent, PIC) 및 상호합의조건 (Mutually Agreed Terms, MAT) 그리고 다자간 이익공유체계 (Global Multilateral Benefit-Sharing Mechanism, GMBSM)를 중심으로 다양한 논의가 이루어졌다. 우리나라는 생물자원 보유국으로서 정부는 국내 생물자원의 관리체계 및 법률을 빠르게 정비하여야 한다. 또한 이용국으로서 학계 및 산업계가 국외의 생물자원을 보다 쉽고 효율적으로 이용하도록 정보체계를 구축할 필요가 있다고 판단된다.

• 한국보건간호학회지
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• 제25권2호
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• pp.153-173
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• 2011

Purpose: This study was conducted to analyze trends in research papers published in the Journal of Korean Public Health Nursing, and to compare and contrast similarities and differences of papers before and after listing in the Korea Citation Index (KCI) in 2007. Methods: A descriptive study was conducted with 266 published studies during the 10-year period. The criteria for analysis included types of research, characteristics of researchers and participants, designs, data collection methods and study instruments, ethical considerations, data analysis, and keywords. Results: Studies conducted with grants constituted 23.7%, and students (32.3%) and general populations (25.2%) comprised the largest proportion of the study participants. The majority of the papers were quantitative research (93.2%), and self-reported methods (63.1%) were most frequently utilized. Seventy percent of the studies obtained verbal consent from the participants. Among the study instruments, psychosocial indicators (41.1%) were most frequently employed. The trends indicated that grant studies, students and general populations as study participants, and experimental studies increased, and use of written consent increased after KCI registration. Conclusions: The results could be used to understand the context of scientific research and to improve the quality of the research papers published in the Journal of Korean Public Health Nursing.

• 간호행정학회지
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• 제11권3호
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• pp.255-264
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• 2005

This study is a descriptive research in investigating the perception of doctors and nurses with regard to DNR, and data were collected through survey questionnaires. The period of collecting data was between July 15 and October 30, 2004, distributing 128 questionnaires to 128 participants, and a total of 110 questionnaires from 55 doctors and 55 nurses were collected (86%)among 70 different hospitals. The collected data were analyzed using SAS program to get real number and percentage, and were also analyzed with $X^2$-test. The Study Results are as follows: 1. Respondents who agreed with the necessity of DNR was 97.27%, the reasons of DNR necessity were 59.20% of 'impossibility of recovery in spite of lots of efforts,' and 35.20% of 'for the purpose of choosing a comfortable and dignified death,' and 97.2% of respondents answered that it was necessary to give explanation of DNR to serious case patients, terminal patients and their family. 2. Problems derived from DNR decisions were 44.44% of 'lack of treatment and nursing,' 21.11% of 'guilty conscience about failing to do best efforts,' and 71.57% of CPR implementation right after DNR decision. 3. Reasons of implementing CRP for patients with DNR decision were 50.94% of 'for the presence of family and relatives at the point of patient's death,' 20.76% of 'guardian's change of DNR decision,' and 16.98% of 'no communication for the consent after DNR decision.' 4. With regard to who was to make DNR decision? there was a difference in the opinion between doctors' and nurses' group while the group of doctors chose 'by the consent of the family and the doctor in charge,' and the group of nurses chose 'patient's intension,' and with regard to Have you received DNR related education? and Will people who want DNR increase if there is explanation given? there was a difference between the two groups. 5. In the catholic institutions, respondents of 71.7% said that it was necessary to take DNR depending upon the situation, and 73% said that they had performed DNR before. 6. In the institutions with over 500 beds, 91.92% of respondents said that there should be an establishment of guideline book as a written format to implement DNR. From the results of this study, it was found that DNR was implemented and executed broadly in clinical fields in the absence of necessary instructions and/or guideline, and that DNR order was placed to the group of doctors who got less opportunity for proper education than did that of nurses.

• 여성건강간호학회지
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• 제7권3호
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• pp.393-406
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• 2001

The purpose of this study was to find out women's need and level of knowledge about episiotomy, pain and discomfort related to episiotomy on a cross-sectional survey design. The subjects were 102 postpartal women agreed on oral consent. 34 postpartal women admitted at obstetric ward of H university hospital, 34 postpartal women admitted at 2 Sanhujoriwons, and 34 women within one year afterbirth. They were selected in Seoul, Korea. Data were collected from July, 1 to September 30, 2000, by a structured questionnaire. The instrument used for this study was a questionaire consisted of 5 items of general characteristics, 12 items of obstetric characteristics, 10 items of level of knowledge (Chronbach $\alpha$ .8176), 8 items of need of education(Chronbach $\alpha$ .8836), 3 items of pain (Chronbach $\alpha$ .9252), and 3 items of discomfort (Chronbach $\alpha$ .8092). The data were analyzed by the SPSS/PC+ program using t-test, ANOVA and Scheffe test as a post hoc and Pearson Correlation Coefficient. The results of the study were as follows; 1. 63.2% of respondents had right answer on 6-8 items among 10 items. Only 4.4% of women got right answer on 10 items all. 2. The need of education was high(4.45%) on all items and the range of score was $4.25{\sim}4.64$. 3. The strength of pain was the highest within one week afterbirth(5.93/10) and became lower in 8-14 days afterbirth(2.55). And after 15days of postpartum, the pain level became to the lowest level(1.08). However, pain was delayed until more than one month afterbirth. 4. The level of discomfort was the highest one week afterbirth(6.88/10) and became lower in 8-14 days afterbirth(4.20). And after 15days of postpartum, the discomfort level became to the lowest level(2.47). Universally, the degree of discomfort was higher than pain. 5. There was a strong positive correlation between discomforts and pain ($r=.752^{**}$) and weak positive correlation between discomforts and the level of educational need($r=.308^*$). In conclusion, women have a right to choose whether she will have episiotomy or not according to her decision making based on the comprehensive knowledge of episiotomy before they get episiotomy with consent process and explanation in detail. Women health care providers like nurses have a responsibility to do conscious raising and empowerment for women so that they could lead themselves to choose given medical treatments for women's health and wellbeing and the quality of life in her life cycle.

• 한국치위생학회지
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• 제11권4호
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• pp.581-593
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• 2011

Objectives : The purpose of this study was to examine the relationship of the work environments of dental hygienists to their occupational diseases in a bid to provide some information on their health care, health promotion and the prevention of occupational diseases. Methods : The subjects in this study were 300 dental hygienists who worked in Seoul, urban communities involving large cities and rural areas. One-on-one interviews and a self-administered survey were implemented with their consent. Results : The findings of the study were as follows: 1. 60 percent of the dental hygienists investigated replied that they had occupation-related physical symptoms. By the length of service, the dental hygienists who worked for six to 10 years had the most symptoms. 2. Out of the occupation-related symptoms, the most prevalent symptom was a pain in the shoulders and neck(41%), followed by a pain in the lower back, a pain in the legs, a pain in the wrists and skin diseases. The most painful parts of the body were hands and arms. 3. In regard to the relationship between the general characteristics and the intensity of pain, the highest group of the dental hygienists in Seoul replied that they had a severe pain, and the lowest number of those in the large cities gave the same answer. 4. Concerning the cause of occupational diseases, 65.7 percent cited the wrong posture. 5. As to relationship between the general characteristics and regular hospital-visit experiences for the prevention of pain during work hours, many of the dental hygienists who were in their 40s and 50s visited hospitals from time to time, and many of those in their 20s never did that. 6. In regard to links between the general characteristics and an opinion on the necessity of regular education, many of the respondents from Seoul and urban regions involving large cities considered it necessary to receive education on a regular basis. By daily work hours, the highest number of those who worked for eight hours or less considered that necessary, and lots of those who worked for 11 hours didn't consent to that. The gaps between them were statistically significant(p<0.05). Conclusions : Given the findings of the study, daily work hours and length of service were two integral factors to affect the regular hospital-visit experiences and pain, and the wrong posture was identified as the most common cause of occupational diseases. To ensure the successful prevention of occupational diseases, dental hygiene students should be taught the importance of occupational disease before they start to work, and supplementary education should be provided for dental hygienists to work in the right posture.

• Journal of Hospice and Palliative Care
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• 제18권3호
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• pp.208-218
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• 2015

목적: 본 연구는 심폐소생술 비시행(DNR)에 관해 간호사와 의사의 DNR에 대한 인식 및 태도가 DNR 관련 교육 및 임상경험 여부에 따른 차이가 있는지 분석하고자 하였다. 방법: 연구대상은 단일대학병원에서 근무하는 간호사와 의사로서 총 310명이었으며, 자료수집 기간은 2013년 8월 19일부터 8월 30일까지였다. 연구도구는 DNR에 관해 간호사와 의사의 임상 경험과 윤리문제에 관한 인식 및 태도를 조사하기 위해 연구자들의 문헌고찰을 통해 30문항으로 구성된 설문지를 사용하였다. 결과: 본 연구의 참여자 중에 간호사는 238명(77%), 의사는 72명(23%)이었다. 대부분의 참가자들(99%)이 DNR의 필요성에 동의하였고 이유로는 환자의 편안하고 품위 있는 죽음(52%), 회복이 불가능한 의학적 상태(23%), 환자 본인의 죽음에 대한 선택(19%)의 순이었다. DNR 임상경험에 따른 차이는 DNR 필요성의 동의, DNR 시기 및 DNR 이후의 다른 치료의 허용에 대해서 차이를 보였다. 그러나 DNR 교육 여부에 따른 차이는 DNR 시기 이외에는 유의한 차이를 보이지 못하였다. 결론: 본 연구를 통해 DNR에 대한 교육보다는 임상에서의 경험이 실제 DNR에 대한 인식 및 태도에 유의한 영향을 미치는 것을 보여주었기에 효과적인 DNR 교육을 위하여는 실제 임상 실습을 통한 교육이 필요할 것으로 생각된다.

• 보건의료생명과학 논문지
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• 제9권1호
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• pp.1-9
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• 2021

본 연구에서는 한국보건의료정보원에서 실시하는 EMR 인증기준울 이해할 수 있도록 보건의료정보관리 실습 프로그램에 인증기준을 추가한 모델을 연구하여 제시하였다. 실습 프로그램은 EMR 인증제의 기능성 기준에 해당하는 환자정보관리를 실습하고 이해할 수 있도록 보건의료정보관리 교육시스템에 환자정보관리에 대한 인증기준 기능을 추가하였다. 환자정보관리를 위한 EMR 인증기준 실습프로그램은 다음과 같은 인증기준으로 구성되었다. 등록번호 및 인적사항 관리, 진료예약 일정관리, 인적사항 수정이력관리, 동명이인 구분자 표시, 다중 등록번호 통합관리, 식별정보를 이용한 환자 검색, 진료형태에 따른 환자 검색, 수술시술 동의서 기록·조회, 개인정보활용동의서 기록·조회, 연명의료결정정보 표시, 외부 의료기관문서 등록·조회, 외부 검사결과 등록·조회. 이와 같이 인증기준에 의한 보건의료정보시스템의 기능을 운영하여 실습해봄으로써 인증기준의 기능성 영역에서 환자정보관리의 인증기준과 내역을 이해하고 실습할 수 있다. EMR 인증 기준에 맞춰 환자정보관리 실습을 수행해봄으로써 전자의무기록시스템에서의 표준화된 환자정보관리를 이해할 수 있다. 또한 EMR 인증기준의 기능을 확인할 수 있기 때문에 의료기관에서 보건의료정보관리사의 전자의무기록시스템의 관리 능력을 향상시킬 수 있을 것이다.