암 환자의 임상연구에 대한 인식 : 피험자 보호 관점에서

김지예 연세대학교 보건대학원 2013 국내석사

책임에 근거한 임상연구자 윤리

이경희 동아대학교 대학원 2013 국내석사

책임에 근거한 임상연구자 윤리 The Ethics of Clinical Researchers Based on the Responsibilityp, 생명의료윤리학과 이 경 희 지도교수 김 진 경 오늘날 임상연구의 성장과 확대는 의학계의 발전과 더불어 그 속도를 더해가고 있다. 이에 따라 임상연구에서 핵심적인 역할을 하는 임상연구자의 실질적인 행위 기준이 될 수 있는 연구자 윤리에 대한 논의가 필요하다. 임상연구자는 임상연구의 시작 단계, 수행 단계, 종료 단계의 각 단계별로 요구되는 임상연구자의 책임을 숙지하여 실제 연구에 적용함으로써 연구의 객관성과 윤리성을 보장할 수 있어야 한다. 따라서 본 논문에서는 총체적이고 연속적이며 미래적인 성격을 지닌 책임을 토대로 하여 임상연구 과정에서 요청되는 연구자 윤리를 제안하고자 한다. 이러한 책임은 임상연구자의 행위를 제어하는 것이 아닌 피험자와 연구자 모두를 보호할 수 있는 윤리적 기준으로 작용하여 결과적으로 임상연구의 질을 향상시키는데 기여할 수 있을 것이다. 주요어 : 임상연구, 임상연구자, 책임, 연구자 윤리

국내외 임상연구를 위한 교육현황 비교

서정미 차의과학대학교 보건복지대학원 2015 국내석사

In spite of its dominant positioning for clinical research in Asia, South Korea has had lack of specialized and professionalized regular educational courses for clinical research. However, professionals specializing in clinical research are required to help clinical research coordinator (CRC) and clinical research associate (CRA) have the internationally accepted competences to conduct clinical trials in the rapidly changing Korean market. In this context, the present study was attempted to suggest promising educational programs for CRC and CRA in the manner of comparing training courses between S. Korea and other countries. Comparing clinical research related organizations between S. Korea and other countries, it was found that stepwise or short-term training was given by career in S. Korea, which differed from that in other countries where educational programs were divided largely into overall clinical research training courses and project management training courses. When making comparisons among universities/colleges, there was no difference between Korea and other countries in terms of the essential curricula – clinical study science, new drug development, study designing, clinical study statistics and data analyses, regulatory affairs, etc., however there was discussional or debating programs such as seminars for principal investigators in other countries only. Making comparisons of educational contents required by clinical research professionals between S. Korea and other countries, the analyses showed that training about study protocol, investigators’ responsibilities, IRB affairs, audits and inspections was performed for the same purposes in both S. Korea and other countries, while education about FDA inspections and audits was additionally given in other countries. Regarding educational contents concerning clinical study practices, a survey about the necessity of clinical study practice training showed that there was neither risk management nor project management training in S. Korea. On the other hand, such the training has been carried out in other countries. For this reason, it is suggested that risk management and project management training aiming at experienced clinical research professionals should be given through conferences or short-term educational programs. In terms of the educational courses addressing monitoring skills, study design and study protocol development, there was no difference in both the educational contents and hours provided between S. Korea and other countries. Actually, most of other countries have a longer history of clinical research as well as more active relevant activities than those of S. Korea. When clinical research related training was introduced for the first time in S. Korea, the relevant educational courses were established by bench-marking them at foreign educational institutions, and have been maintained up to the present. Nevertheless, analyses indicated that the educational programs in S. Korea are inadequate in the aspect of lack of university/college curricula at academic institutions and the educational contents concerning risk management and project management. This study has the following limitations: the failure to compare educational types, courses and contents at all educational institutions in S. Korea and other countries because institutions considered representative in S. Korea and other countries were selected and compared. As briefly mentioned above, the educational programs were categorized and compared between S. Korea and other countries. This study is meaningful in the light that it contributes to providing unexperienced clinical research personnel as well as experienced clinical research professionals with the basis to receive both theoretically and practically helpful training and furthermore, it can be utilized as reference. 임상연구에 대해 한국은 아시아에서 높은 입지를 갖고 있음에도 임상연구교육에 대해서는 전문화, 특화된 정규 교육 과정이 부족한 실정이다. 그러나 급변하는 국내 시장에서 CRC 및 CRA가 국제적인 수준의 임상시험을 수행할 능력을 갖추기 위해서는 임상시험과 관련된 전문인이 필요하다. 이에 따라 본 연구는 국내외 교육 내용을 비교해 봄으로써 현재 CRC와 CRA를 위한 교육을 제언하고자 하였다. 임상연구관련 전문기관을 국내외 기관을 비교해 보면, 국내는 경력별로 단계적으로 교육을 시행하거나, 단기적인 교육을 시행 하고 있었고, 국외는 임상연구 전반에 대한 교육과정과 프로젝트 매니지먼트 교육과정으로 분류되어 교육이 이루어지는 것에 차이가 있었다. 대학기관을 비교해 보면, 국내외 필수 교과과정에서 임상시험학, 신약개발단계, 임상시험 디자인, 임상시험 통계와 테이터 분석, 규제 관련 교육 등의 교과목은 국내와 국외에서 차이가 없었고, 임사시험책임자 세미나 등과 관련된 토론식 교육은 국외에 교육과정은 있으나 국내에는 없는 것으로 분석되었다. 임상연구 전문인력이 필요하는 교육내용으로 국내와 국외를 비교해 보았을 때, 기초/기본 교육에서 필요로 하는 교육내용을 국내외 국외를 비교해 보았을 때, 국내와 국외가 교육내용에서 임상시험계획서, 연구진들의 책임, IRB 업무, 점검 및 실사 등은 국내와 국외가 같은 목적을 갖고 시행 되고 있고 국외의 경우 FDA 실사와 점검에 대한 교육내용을 실시하고 있는 것으로 분석되었다. 임상시험 실무와 관련된 교육 내용으로는 임상시험 실무 관련 교육 필요도 조사에서 위험요소관리(Risk management)와 프로젝트 관리( Project management)은 국내에 교육이 이루어 지지 않았다. 국외의 기관에서 실시되고 있어, 경력이 있는 임상연구 전문인력을 위해 앞으로 위험요소관리 와 프로젝트 관리에 대한 교육을 컨퍼런스나 단기적인 교육을 통해 이루어지는 것을 제언한다. 모니터링 방법(Monitoring skil), 임상시험 디자인, 임상시험 계획서 개발과 관련된 교육과정은 국내와 국외가 교육내용을 교육하고 있고, 교육 시간도 차이가 없었다. 국외의 경우 임상연구의 역사가 국내보다 오래 전부터 시행되어 왔고, 국내보다 임상연구가 활발히 이루어져 왔다. 국내에서 임상연구와 관련된 교육을 시행 할 때, 국외의 교육기관을 모티브로 벤치마킹하여 교육과정을 개설하여 현재까지 유지되고 있다. 그러나 국내의 교육이 부족한 점이 있는 것으로 분석되었고, 교육기관에서는 대학과정 부족, 교육내용에서는 위험요소관리와 프로젝트 관리에 대한 교육내용이 부족한 것으로 분석되었다. 연구의 제한점으로 국내 또는 국외의 교육기관 중에 대표성이 있는 교육기관을 선정하여 비교를 하였기 때문에 모든 기관의 교육형태 및 교육과정, 교육내용을 비교하지 못한 제한점이 있다. 이상과 같이 각 교육을 분류하여 해당 교육을 국내와 국외를 비교하였다. 임상연구를 처음 접하는 임상연구 종사자와 임상연구에 경력이 있는 전문인력에게 이론적인 내용과 실무에 도움이 되는 교육을 받을 수 있도록 기반을 제공하고 참고 자료로 활용될 수 있도록 하는 데 본 연구 의의를 찾을 수 있다.

임상시험등록정보의 산업적 활용과 시사점 : ICTRP에 등록된 COVID-19 사례중심으로

이화정 인천대학교 경영대학원 2020 국내석사

국문초록 임상시험등록정보의 산업적 활용과 시사점 : ICTRP에 등록된 COVID-19 사례중심으로 2020년 1월 30일, 세계보건기구(World Health Organization, WHO)는 신종코로나바이러스 감염증(SARS-2-Cov, 코로나 19, COVID19)으로 인해 국제보건규약(IHR) 긴급위원회를 소집하고“국제보건위기상황(Public Health Emergency of International Concern, PHEIC)”을 선포하며 감염원과 사람간의 전파력 파악 및 대응방법과 치료제 개발에 대한 범국가적인 참여와 노력을 촉구하였다. 같은 날 국내에서도 12번째 확진자가 발생하면서 사회적인 거리두기, 손씻기, 마스크 착용하기 등 방역체계을 더욱 견고히 하고 있는 반면 그에 대한 근원적인 치료 및 예방을 위한 치료제와 백신 등에 대한 개발 및 시장 대응은 기대치를 못미치고 있는 실정이며, 이러한 각국의 임상시험 및 연구참여활동은 임상시험등록정보를 통하여 확인이 가능하다. 본 연구의 주된 목적은 첫번째로 COVID-19에 관련된 국제 임상시험공개정보 서비스의 현황을 분석함으로써 등록된 임상시험의 정보의 산업적 활용가치를 국내 입장에서 시사하는 바를 살펴보고자 한다. 둘째는 양질의 축적된 임상시험 빅데이터 기반하에 정부와 산업주체 그리고 수혜대상에 대한 유기적인 제도 지원과 정책육성이 동반, 거듭 성장되어야 함을 강조코자 한다. 임상시험정보등록시스템은 연구자와 국민에게 모든 임상시험과 임상연구의 정보가 투명하게 공개되어야 하며, 이러한 임상시험공개정보를 통하여 신약 및 치료제 개발에 참여 기회를 노리는 유관 산업과 기업들에게 임상정보기반 가치투자전략의 활용자원으로 제공되어져야 함을 다시 한번 강조, 시사코자 한다. 본 연구에서는 전세계를 공포, 공황에 몰고 있는 COVID-19를 중심으로 이와 관련된 신약, 치료제, 백신, 예측-예후진단키트 및 치료법 개발에 대한 임상시험에 대한 연구 동향을 알 수 있는 임상시험연구등록 정보를 통하여 COVID-19 발생시점부터 2020년 3월30일, 약 3개월 동안의 780개의 등록된 임상시험연구 현황을 분석해보았다. 한국은 전체 780건의 연구 중 Lopinavir/Ritonavir, Hydroxychloroquine에 관련된 임상시험을 단 1건 진행 중에 있는 것으로 확인되었다. WHO의 ICTRP Platform ICTRP Platform은 국제의학학술지편집인협의회에서 헬싱키선언을 통하여 각국가의 임상시험연구활동을 등록,공개함으로써 환자와 연구자간의 참여기회를 제공하기 위하여 WHO에서 제공하는 등록플랫폼이다. 과 NIH의 ClinicalTrials.gov ClinicalTrialsgov는 미국국립보건원에서 운영하는 임상연구등록플랫폼이며, 이는 ICTRP와 연동되어 운영된다. , 질병관리본부의 임상연구정보서비스(Clinical Research Information Service,CRIS) 한국임상시험연구정보서비스(CRIS, Clinical Research Information Service)는 국내에서 진행되는 임상시험 및 임상연구에 대한 온라인 등록 시스템. 보건복지부의 지원을 받아 질병관리본부에서 구축하여 무상으로 운영 에 등록된 COVID-19 신종감염증에 대한 각국가간의 기민한 임상시험연구 활동현황을 파악하며, 국내에서의 2009년부터 질병관리본부와 식약처가 추진한 임상시험등록공개 신고제에 의지와 검토를 늦추기 보다는 시장대응을 위한 보다 더 합리적이고 비판적인 체계가 정립되어 이러한 위기 사태에도 긍정적인 유용 자원으로 활용되기를 바란다. ABSTRACT A Study of the Implication of the Clinical Trial Registration Information and its Industrial Application : Focused on 「COVID-19」 registered in ICTRP Lee, Hwa Jung Department of Business Administration Graduate School Inchoen National University The World Health Organization (WHO) convened an emergency committee meeting of the International Health Regulations (IHR) due to new coronavirus infections (SARS-2-Cov, Corona 19, COVID-19) and declared the Public Health Emergency of International Concern, PHEIC on January 30, 2020. The South Korean government, on the same day, has strengthened the national quarantine system including social distance keeping, hand washing and wearing masks along with the with the 12th COVID-19 confirmed case. The study of purpose is to analyze the current status of international clinical trial information services related to COVID-19 and to find out impact of disclosing activities of clinical trial registration on the medical and pharmaceutical industry. In addition, the study is trying to emphasize the importance of governmental supports in terms of release of regulations and developmental strategies in the domestic medical and pharmaceutical industry, which will have the opportunity to participate in the development of new drugs and therapeutics with the analyses of the data of clinical trials and from the macro perspectives. To achieve the purpose of study, we analyzed the current status of 780 registered clinical trials for COVID-19 for three months from the time COVID-19 occurred to March 30, 2020. The clinical trial research registration information showed the trends of clinical trials on the development of related new drugs, treatments, vaccines, predictive and prognostic diagnostic kits and treatments related to the COVID-19 in the world. Among the 780 clinical trial studies related to Corona 19, there was only one clinical trial conducted in South Korea and it was related to Lopinavir / Ritonovir / Hydropychloroquine. Clinical trial research information registered on the WHO’s ICTRP system discloses to the public as well as the people engaged in related industries such as researchers, patients and pharmaceutical companies participating in all clinical trials and activities under the Helsinki Declaration, in conjunction with the International Council of Medical Journal Editors (ICMJE). The ClinicalTrials.gov is a clinical research registration platform operated by the National Institutes of Health in U.S, which is operated in conjunction with ICTRP. On the other hand, the Korean Center for Disease Control (K-CDC) and the Korean Food and Drug Administration (KFDA) have established a more reasonable and critical system to respond rapidly to the market through the clinical trial registration in 2009, which is called the Korea Clinical Research Information Service (CRIS). Therefore, the study urges all medical and pharmaceutical companies to register their trials on CRIS and recommends utilizing this registered data to develop advanced drug to benefits all patients related to COVID-19. Key Words : Clinical Trial Registry, Clinical Trial Information Publication, Clinical Trial, ICTRP, CRIS, ClinicalTrials.gov, COVID-19, Corona 19

임상연구간호사의 연구윤리행위 관련요인 : 혼합연구 방법

이혜영 연세대학교 대학원 2022 국내박사

1. Introduction As clinical trials become internationalized and commonplace, interest in clinical trials is increasing. In addition, research integrity, which refers to the responsibility of researchers to conduct honest and sincere research, is considered more important(Broome, Prayer, Habermann, et al, 2005). Clinical Research Nurses(CRNs) who perform clinical research practice at the forefront of clinical research have heavy ethical responsibilities. At the same time, CRNs must contribute to the progress of the intellectual body through the results of ongoing research, so conflicts inevitably arise between the current value of fulfilling their responsibilities as nurse and the future value of the intellectual body. Therefore, based on the overall analysis and abundant understanding of research ethics behavior of Korean CRNs, we intend to provide basic data for the development of research ethics education programs for CRNs. 2. The purpose of the study This study is a study using a mixed method to analyze factors related to research ethical behavior and identify their experiences for CRNs who conduct clinical research. The specific goals of this study are as follows. In the first stage of quantitative research 1) It identifies the research ethical behavior, ethical sensitivity, ethical climate, and moral distress of CRNs. 2) It analyzes the relationship between ethical sensitivity, ethical climate, moral distress, and research ethics behavior of CRNs. 3) The factors affecting the moral distress and research ethical behavior of clinical research nurses are identified. In the second stage of qualitative research 1) The experience and related factors of research ethics behavior of CRNs are identified through focus group interviews. 2) Explore whether the factors identified in step 1 are suitable as factors related to research ethics behavior of CRNs. The third stage is the integration stage. 1) Data from quantitative and qualitative studies are integrated to compare and contrast the found results. 2) Interpret meaning to gain a more comprehensive and accurate understanding. 3. Theoretical framework Based on Milliken's moral behavior model, based on a review of previous studies, and revised and supplemented to establish a conceptual framework for the research ethical behavior of CRNs. Based on the Milliken model, ethical sensitivity was set as a recognition factor, and research ethics and moral distress were set as a result factor. Ethical behavior is a dynamic inter-relational process, and its contents were grasped in qualitative studies. Based on previous studies, this was added in consideration of the fact that the ethical climate is an element related to ethical processes such as perception, response and outcome. Using this conceptual framework, ethical sensitivity, ethical climate, and moral distress were identified as related factors of research ethical behavior. 4. Research method 1) Research and design This study conducted quantitative data collection and analysis(a descriptive and cross-sectional research) in the first stage by applying The explanatory sequential design among the six methodologies of mixed methods (Creswell, Klassen, Plano Clark et al, 2011), and described qualitative data collection and analysis (a descriptive and analysis) in the second stage. 2) Data collection A) Step 1: Quantitative Research This study sent an electronic survey to 261 CRNs who joined the Korean Clinical Research Coordinator Association from May 6 to May 24, 2021. B) Step 2: Qualitative Research Participants in the focus group interview secured 11 prospective participants by directly contacting the subjects who expressed their intention to participate in the qualitative study among the contents of the questionnaire in the quantitative study. In addition, using the snowball sampling method, 7 people were introduced to them to express the related factors of research ethics, and a total of 18 people were recruited. 3) Data analysis A) Step 1: Quantitative Research The analysis of quantitative data was statistically processed using statistical program SAS 9.4 statistical software, and analyzed by frequency, percentage, mean, standard deviation, one-way ANOVA, Scheffe's test, Pearson's correlation coefficient, multiple regression analysis. B) Step 2: Qualitative Research The focus group interview data of qualitative research were analyzed in six stages according to Braun and Clarke (2006)'s Thematic Analysis method. C) Step 3: Integration The integration of related factors for research misconduct s identified in quantitative and qualitative research results was integrated using the three-step strategies of narrative, data conversion, and joint display using the connecting, building and Merging methods suggested by Petters, Curry & Creswell (2013). 5. Research Results 1) Quantitative Research Results. A) Characteristics of CRNs Among the study subjects, 261 (100%) were women. The average age was 36.6±7.45. As for the working institution, there were 243 tertiary hospitals (93.1%), and 18 general hospitals (6.9%). There were 143 individual investigators (54.8%) and 118 (45.2%) in hospitals. The degree of education was 200 university graduates (76.6%), 32 graduate school graduates (12.3%), and 29 college graduates (11.1%). The average clinical experience was 4.55±3.99 years, and the average clinical research experience was 6.48±4.45 years. 261 people (100%) completed the training of clinical trial workers. The number of annual research ethics-related training sessions was 187 (71.6%) one to three times, 42(16.1%) 0 times, and 32(12.3%) 4 times or more. The number of monthly research projects was 119 (45.6%) with 5 or less tasks, 88 (33.7%) with 6-10 tasks, and 54(20.7%) with 10 or more tasks. The average number of enrolled subjects per month was 104(39.8%) with 5 or less, 78 (29.9%) with 5-10 persons, and 79(30.3%) with 10 or more persons. The average degree of understanding of research misconduct s was 8.01±1.66 points, 159 (60.9%) with experience in research misconduct s and 102(39.1%) without them. In the number of cases of research misconduct s by the research team during the year, 122(46.7%) from 2 to 5 times, and there were no cases at all. There were 65 (24.9%), 32(12.3%) once, 28(10.7%) more than 10 times, and 14(5.4%) under 6-10 times. B) Correlation between ethical climate, ethical sensitivity, moral distress, and research misconducts. The ethical climate of CRNs averaged 2.77±0.37 points, ethical sensitivity averaged 4.76±0.58 points for moral distress averaged 3.98±2.58 points, and research misconducts averaged 1.55±0.45 points. Research misconducts had a significant positive correlation with ethical sensitivity (r=0.14 and p=0.02) and moral distress (r=0.22 and p=0.003), and had a negative correlation with ethical climate (r=-0.15 and p=0.01). Ethical climate had a significant positive correlation with ethical sensitivity (r=0.14 and p=0.02), and ethical sensitivity had a significant positive correlation with moral distress (r=0.22 and p=0.003). C) Factors influencing research misconducts and moral distress. The regression model for research misconducts was significant (F=5.38, p<.0001), and the explanatory power of research misconducts by variables was 15.6%. The influencing factors of research misconducts were ethical climate, moral distress, degree of education, and the number of cases of research misconducts by the research team. The moral distress regression model was significant (F=5.48, p<.0001), and the explanatory power of moral distress by variables was 18.3%. The influencing factors of moral distress were ethical sensitivity, research misconducts and age. The higher the ethical sensitivity score, the higher the moral distress score, and the higher the research misconducts score, the higher the moral distress. Moral distress scores were lower than those under the age of 30 to 35, under the age of 35 to 40, and over the age of 40. 2) Qualitative Research Results. A) Characteristics of study participants The focus group had 18 participants, all of whom were female and belonged to the tertiary hospital. The average age was 41.2 years old. There were 12 members belonging to the hospital and 6 individual investigator. As for the education level, there were 3 college graduates, 9 university graduates, and 6 graduate school graduates, and the average experience as a clinical research nurse was 9.25 years. B) Focus group interview results. As a result of the focus group interview, 6 themes, 14 categories, and 36 subcategories were derived for classification of research misconducts by CRNs. There were two categories of ‘diverse types of research misconducts’ and ‘distinguishing research misconducts’ in the theme of ‘situation of research misconducts’ and ‘difficulty of overcoming negative emotions’ and ‘difficulty of conflict over judgment’ in advocating patients. Expectations for environmental change for reduction Three categories were derived: ‘I hope education will increase’, ‘I hope ethical awareness will increase’,‘ and "I hope to participate with responsibility’and‘Work with responsibility’ and ‘Making Together’ 3) Integration and interpretation The factors influencing research ethical behavior of CRNs were converted into data from 18 sub-factors and 2 survey contents of each tool of quantitative research into qualitative data, integrating the results with focus group’s 6 themes and 14 categories. Based on the conceptual framework, quantitative research data were divided into eight sub-contents in the joint display strategy stage, identifying similarities in six themes of qualitative research and 14 categories, and integrating connecting, building and Merging, and finally derived six core themes according to common attributes. The final six key themes are ‘Inefficient Research Ethics’,‘Weak Ethical empowerment’, ‘Patient Advocacy based on Responsibility’,‘Participation with Responsibility’, ‘Challenge to Overcome Moral distress’ and ‘Experience of Various Levels of Research Misconducts’. 6. Discussion. This study was attempted to analyze the factors related to research ethical behavior of CRNs who are conducting clinical research at the forefront of clinical research and to identify their experiences to prepare basic data for research ethics education programs suitable for the situation in Korea. It was explanatory sequential design and the discussion through comparison with the research results and previous studies is as follows. 1) Characteristics related to the incidence of research misconducts with CRNs The subject's degree of understanding of research misconducts was 8.01 points, similar to that 97% of the studies in Pryor, Habermann & Broome (2007) showed a high or very high understanding of research misconduct s. In this study, 60.9% of the cases were experienced in misconduct of the study, which was higher than 43% of early scientists, 52% of mid-career scientists, 40% of Chinese researchers, and 59.4% of Central Asian researchers, lower than 96.2% of Nigeria researchers. In a study of research coordinators, Pror, Habermann & Broome (2007), 18.3% of cases of direct experience in research misconducts and 21.9% in educational medical institutions. However, looking at the incidence of misconduct s of the following items, excluding this, the incidence of misconduct s of the procedure-related plan was 43%, and enrollment-related 36%, but direct experience cases were reported low at 18.3%. On the other hand, in this study, the incidence of research misconduct of the plan related to the procedure, except that there is never, was 63% and 60% related to enrollment, indicating 60.9% of the experience of research misconducts similar to the actual one. In this study, only CRNs with more than one year of experience were targeted, and in the study of Pryor, Habermann & Broome (2007), there were no career restrictions, and 64% were nurses, but other occupations were included, indicating a difference in the survey results. There are differences in measurement results depending on whether research misconducts include Questionable research misconducts(QRPs) in addition to falsification, forgery, and plagiarism, and there are many differences in incidence depending on whether they are self-reported or observed (Xie, Yu, Kai Wang, & Yan Kong, 2021). Research misconducts are often intentionally hidden by detection and punishment, so the measurement is inaccurate and the possibility of observation is very low. In addition, even if research misconducts are observed, this may be inappropriate observations related to competence and power, not lack of ethics, and may be observations of fake negatives (Xie. et al, 2021). In the case of including common research misconducts, such as Questionable research misconducts(QRP), it is not easy to measure actual unethical research misconducts only by questionnaire. Through the focus group interview, it was found that the research misconduct of the plan occurred due to the dynamic situation of the patient, the situation around the study such as doctors, other departments, and Investigators. In the focus group interview, CRNs understood various research misconducts, including procedural plan misconducts, unavoidable plan research misconducts considering workload or situation , document misconducts due to poor plans or plans, and patient failure. In clinical research, both deviations from the plan and misconduct of the plan reported to the Research and Deliberation Committee were judged as misconduct of the plan due to mistakes or errors, not intentional, or misconducts due to errors of third-party clients. The tool to measure research misconducts asks for intended procedural misconducts or misconducts of enrollment-related plans, but as confirmed in focus group interviews, they also tended to equate the misconducts of plans due to mistakes. As a result, the research misconduct experience and research misconduct score are considered to have been increased, and graduate school graduates and hospital members have higher research misconducts scores for research misconducts because they are sensitive to research misconducts and are conducting high difficulty. 2) Relationship between research misconducts and ethical climate, moral distress, and ethical sensitivity. Research misconducts showed a significant negative correlation with ethical climate(r=-0.15, p=0.01), and a significant positive correlation with ethical sensitivity (r=0.14, p=0.02) and moral distress(r=0.28, p=0.0001). A similar previous study of hospital nurses showed a positive correlation with ethical behavior as a mediating factor (Hassanian, Zahra Marzieh & Arezoo Shayan, 2019), and this study showed similar results to a significant negative correlation with research misconducts. The ethical climate is a kind of organizational work atmosphere that reflects organizational practices, procedures, and policies on ethical situations (Koskenvuri J, Numminen O, & Suhonen R., 2019). In the focus group interview, contents related to the team atmosphere dealing with research misconducts, difficulties in collaboration due to lack of understanding related to research, strengthening ethical consciousness, and the ethical climate of making together were derived. Previous studies on ethical sensitivity showed a negative correlation between ethical sensitivity and unethical behavior (Lee, C., Kim, S., Choi, K., & Kim, S.2021), and ethical sensitivity and ethical behavior showed a positive correlation(Yulianti, Emma, et al, 2021). As such, there is a relationship between ethical sensitivity and ethical behavior. In this study, ethical sensitivity and research misconduct showed a positive correlation, but in multiple regression analysis on the influencing factors of research misconduct, ethical sensitivity did not explain the research misconduct. Through this, it is believed that ethical sensitivity did not affect research misconducts, but on the contrary , ethical sensitivity increased due to experiencing research misconducts, resulting in a correlation. Ethical sensitivity showed a significant positive correlation with moral distress (r=0.22 and p=0.003). This was consistent with the results of previous studies showing a positive correlation between moral sensitivity and moral distress (Da-bok Noh, Sun-ah Kim, Sang-hee Kim, 2013; Ok-Hyun Kim et al., 2019). The higher the ethical sensitivity, the higher the moral distress, which is believed to have failed to develop the ability to solve ethical problems through frequent exposure experience to ethical issues, and argues that it is necessary to increase ethical sensitivity rather than focusing on reducing moral distress (No Dabok, Kim Sun-ah, 2013; Kim Ok-hyun, 2019). It is a common result that ethical sensitivity is high and moral distress is reduced, but contradictory results are also appearing, so it is thought that the mediating effect or contradictory relevance to failure to ethical behavior should be further studied. Nevertheless, it is unlikely that nurses who are ethically sensitive and use strategies to solve ethical problems will experience moral distress (Corly, 2002), and it is necessary to reduce moral distress by increasing ethical sensitivity. The patient-centered, a subcategory of ethical sensitivity , was the highest with 6.04 points, similar to the patient-centered with 5.69 points in studies by Kim Hae-ri and Ahn Sung-hee (2010). This trend can be said to reflect the values that nurses provide patient-centered nursing, respect patient rights, make decisions with patients, and value honesty (Han, Sung-suk, et al, 2010) and respect the patient's position in any situation (Ye-sook Seo, 2003). In the focus group interview, we were able to examine the subcategories of ethical sensitivity, such as patient-centered, professional responsibility, good deeds, and meanings, and were derived as the theme of ‘overcoming inappropriate tasks and abilities and defending patients’,‘ Responding flexibly for patients’ included patient-centered, good deeds , and meanings, professional responsibility in inexperience and complacency, conflict occurred in inexperience of plans due to excessive work, and patient-centered content was most expressed. Moral distress has a significant positive correlation with research misconduct s (r=0.28, p=<).0001) was present, but no related previous studies were found. However, in light of the fact that moral distress interferes with the ability to defend patients (Choe K, Kang Y & Park Y, 2015) and shows a negative correlation in autonomy, communication ability, and cooperation (McAndrew et al, 2018), it can be seen as a similar aspect to these results. In a study by Nam-Joo Jen (2021), moral behavior and moral distress showed a positive correlation, and it was found that nurses with high ethical sensitivity and high moral distress had high moral distress when exposed to ethical issues. The increase in moral distress due to failure to engage in moral behavior can be seen as a result similar to the positive correlation between research misconducts and moral distress in the results of this study. Due to the inter-relationship between these ethical acts and moral distress, it is believed that research misconducts increase as moral distress increases in the influencing factors of research misconducts. In the analysis of factors influencing moral distress conducted to further confirm this, it was found that moral distress increased as research misconducts increased. Therefore, in order to reduce research misconducts, it is believed that moral distress will also decrease if ethical sensitivity is increased and ethical problem-solving ability is increased. If moral distress is not resolved, you will experience helplessness, guilt, self-criticism, and low self-esteem (Deady, Richard, and Joan McCarthy, 2013), and in focus group interviews, you will experience negative feelings such as guilt, fear, shame, upset, resentment, and resentment. On the other hand, moral distress is a negative experience for most nurses, but like a study that increases the growth and development of autonomy and expertise (McAndrew et al., 2018), CRNs tend to reflect on themselves and increase their expertise based on these experiences. In conclusion, strengthening ethical problem-solving capabilities by increasing ethical sensitivity to reduce research misconducts will reduce moral distress and continuous ethical education will be needed to create a positive research ethical climate. 3) Factors influencing research ethical behaviors. Six themes based on a conceptual basis were derived in the integration process as factors influencing research misconduct s of CRNs. The "inefficient research ethical climate" is thought to be because CRNs have a large workload, experience high work intensity due to increased difficulty in planning, have difficulty judging and handling themselves through many delegations, and experience stress from research misconduct s caused by uncooperation of various departments and research teams. Therefore, additional studies on the working environment and various roles and relationships of CRNs within the organization are needed, and various research climate-related studies should be continued to change the current research climate, which is biased toward treatment and weak consideration for research. ‘Weak ethical empowerment’ was derived, which is similar to the research results in many cases where research ethics education was conducted conventionally and informally, as well as intentionally violating research ethics (Choi Yong-sung, 2007). It was found that changes through autonomous behavior of the entire research team are needed, not just research ethical education, and ethical empowerment for the entire research team is needed. Empowerment is suggested as a way to strengthen individual competence through changes through autonomous actions of members of the organization. This acts as an important variable that increases work performance and organizational commitment and increases job satisfaction. It can be seen that empowerment is required to induce active activities in a rapidly changing environment (Song Myung-sook, 2013). Therefore, it is considered necessary to introduce an ethical empowerment improvement program that is not suitable for the current situation and can lead to active changes away from conventional ethics education. Ethical sensitivity was derived as 'patient advocacy based on responsibility'. Among the categories, patient-centered content accounted for the majority, and patient-centered was also the highest in measuring the ethical sensitivity of quantitative research, which seems to be in line with the ICN Code of Ethics (ICN Code for Nurses, 2013). As such, strengthening the responsibility of CRNs and patient protection will reduce research misconduct s. In a study by Eklund, Wilde-Larsson, Petzllll & Sandin-Bojö (2014), competency and workplace atmosphere were identified as factors influencing advocacy. The working environment is an organizational characteristic of an environment in which work can be efficiently performed (Lake, 2002). As in this study, as inappropriate tasks and abilities have been derived, it is believed that the protection of subjects will be strengthened only when the working environment is improved for efficient work performance. Institutional and policy support is needed to improve the working environment of CRNs, and additional research should be conducted. A systematic curriculum is needed to enhance the capabilities of CRNs, but there is currently no curriculum for CRNs other than training such as clinical trial workers, so they are complaining of many difficulties as they are learning in the field. Therefore, it is considered that related institutional and policy changes are needed to create a systematic curriculum to enhance the capacity of CRNs. ‘Participating with Accountability’ was derived as an element that could explain moral behavior. ‘Participating with Accountability’ was derived by integrating the category of actively expressing opinions and professional responsibility to work proudly and responsibly to improve procedures in which protocols do not reflect reality or cannot proceed due to lack of communication between clients, researchers and companies. Plans have been developed mainly by clients, raising problems that do not reflect the reality of practice. In the past, there were not many opportunities to participate in the development of plans, but recently, various clients such as Parexel and Pfizer have participated in the development of plans as advisory. The participation of such CRNs in the development of plans is a desperate direction, and active participation is considered to be a good opportunity to develop expertise. However, despite this opportunity, many CRNs are hesitant because few experienced CRNs have played a role in developing and consulting plans. Therefore, in order to prepare for the role of advisory on professional plans related to practical performance, it is necessary to develop educational content that can develop the capabilities of CRNs. The theme of ‘Challenge to Overcome Moral distress’ is thought to have been derived because CRNs experience various negative emotions and conflicts in the face of research misconducts, while reflecting and overcoming them. In a study by Kim Ok-hyun et al.(2021), moral distress relief program should be developed, such as regular meetings to share moral distress experienced by them and discuss solutions with others, or practical ethics education to create a positive ethical climate. I agree with this, and research ethics programs for experience sharing optimized for the field of clinical research and research ethical climate should be developed and applied. The theme of ‘Various Levels of Research misconduct Experience’ was derived because CRNs experienced various levels of research misconducts, such as minor procedural misconducts, unavoidable procedural misconducts, and documentary misconducts. As seen in the subcategories, the experience of Questionable research misconducts(QRP) occupied the majority rather than serious research misconducts that directly hindered the authenticity of the research, such as plagiarism, falsification, and forgery. Research ethics in a broad sense includes Questionable research misconducts as professional ethics for overall research, so education to increase ethical knowledge and ethical sensitivity is needed to prevent research misconducts (Hye-young Hwang, 2017). Current research ethics education mainly deals with a narrow range of plagiarism, falsification and forgery, and the issue of subject protection is intensively dealt with only in bioethics education (Choi Kyung-seok, 2009). Research ethics education suitable for reality should be organized to include all the contents of the protection of the subject, research misconducts, and Questionable misconducts. In addition, nurses spend a lot of time with the subjects in the medical field and often face ethical dilemmas because they play the role of advocates (Hye-young Hwang, 2017). CRNs are also advocating clinical research-related subjects in the medical field and experiencing various ethical dilemmas, so it is believed that education that includes practical contents through various ethical contextual casebooks should be organized. 7. Conclusion This study is the first explanatory sequential design study in Korea to identify the factors related to research ethics of CRNs who play a pivotal role at the forefront of clinical research, and to compare and analyze the collected quantitative and qualitative research data with focus group interviews. It can be confirmed that each CRNs is trying to strengthen her capacity to overcome moral distress, advocate for patients, and practice research ethics in clinical research situations. Many of the difficulties in the field related to the research ethics of CRNs are problems related to the research ethics climate of the research team working together, other departments, etc., and the problems related to the working environment. In conclusion, it is necessary to develop and apply a practical research ethics education program that can help the CRNs in charge of practice conduct research ethics and maintain research integrity, which can help to strengthen the competency that is currently being worked on individually. However, more importantly, it is considered that policy, institutional, and organizational support are needed for the efficient and cooperative change of the ethical climate that cannot be changed individually and for the change to a good work environment. 본 연구는 임상연구의 증가와 함께 임상연구의 진실성이 중요하게 대두되고 있는 상황에서 임상연구의 최전선에서 업무를 수행하는 임상연구간호사들을 대상으로 연구윤리행위 관련 요인을 분석하고 그 경험을 규명하여, 연구윤리행위의 총체적 분석과 풍부한 이해를 바탕으로 임상연구간호사의 연구윤리 교육프로그램 개발을 위한 기초자료를 제공하자 하였다. 이에 본 연구는 연구윤리행위와 그 관련 요인을 양적연구로 파악하고, 포커스그룹 인터뷰를 통하여 부족한 부분을 보완하는 혼합연구 방법을 적용하였다. Milliken의 도덕적 행동 모델을 기반으로 하고 선행 연구 고찰에 근거하고 수정 보완하여 임상연구간호사의 연구윤리행위에 대한 개념적 틀을 구축하여, 윤리적 민감성, 도덕적 고뇌, 연구위반행위를 파악하였다. 양적연구 자료수집은 261명에 전자 설문으로 진행하였고, 포커스그룹 인터뷰는 비대면 화상으로, 4개 그룹 18명으로 진행되었다. 양적자료 분석은 빈도, 백분율, 평균, 표준 편차, two independent sample t-test, one-way ANOVA, Scheffe’s test, Pearson’s correlation coefficient, 다중회귀분석으로 분석하였으며, 질적 자료 분석은 주제분석법(Thematic Analysis)으로 분석하고, 통합은 Fetters, Curry & Creswell(2013)가 제시한 내러티브, 데이터 변환, 공동 디스플레이의 3단계 전략을 사용하였다. 연구 결과는 다음과 같다. 첫째, 양적연구 결과: 대상자는 모두 여성이고, 평균연령은 36.6 ±7.45세, 임상연구 경력은 평균 6.48±4.45년이었다. 연간 연구윤리 관련 교육 횟수는 1~3회 187명(71.6%)이었고, 0회 42명 (16.1%), 4회 이상 32명(12.3%)이었다. 한 달 진행 연구과제 수는 5과제 이하가 119명(45.6%), 6~10과제 88명(33.7%), 10과제 이상 54명 (20.7%)이었다. 한 달 평균 등록 대상자 수는 5명 이하 104명 (39.8%), 5~10명 78명(29.9%), 10명 이상 79명(30.3%)이었다. 연구위반 이해정도는 평균 8.01±1.66점이었다. 연구위반행위 사례 경험은 있다 159명(60.9%), 없었다 102명(39.1%)이었다. 한 해 동안 연구팀의 연구위반행위 사례 수에서는 2~5번 122명(46.7%), 전혀 없었다 65명(24.9%), 한번 32명(12.3%), 10번 이상 28명(10.7%), 6~10번 미만 14명(5.4%)이었다. 임상연구간호사의 윤리풍토는 평균 2.77±0.37점, 윤리적 민감성은 평균 4.76±0.58 도덕적 고뇌는 3.98±2.58점, 연구위반행위는 1.55±0.45점이었다. 연구위반행위는 윤리적 민감성(r=0.14, p=0.02), 도덕적 고뇌(r=0.22, p=0.003)와 유의한 양의 상관관계가 있고, 윤리풍토(r=-0.15, p=0.01)와는 음의 상관관계가 있었다. 윤리풍토는 윤리적 민감성(r=0.14, p=0.02)과는 유의한 양의 상관관계, 윤리적 민감성은 도덕적 고뇌(r=0.22, p=0.003)와 유의한 양의 상관관계가 있었다. 연구위반행위 회귀모형은 유의하였고(F=5.38, p<.0001), 변수들에 의한 연구위반행위의 설명력은 15.6%였다. 연구위반행위의 영향요인은 윤리풍토, 도덕적 고뇌, 교육 정도, 연구진의 연구 위반행위 사례 수가 유의한 변수로 나타났다. 산출된 도덕적 고뇌 회귀모형은 유의하였고(F=5.48, p<.0001), 변수들에 의한 도덕적 고뇌의 설명력은 18.3%였다. 도덕적 고뇌의 영향요인은 윤리적 민감성, 연구위반행위, 연령이 유의한 변수로 나타났다. 둘째, 포스커그룹 인터뷰 결과: 연구 참여자의 성별은 모두 여성이고, 평균연령은 41.2세였다. 소속은 병원 소속이 12명이고 개인 연구자 소속이 6명이고, 임상연구간호사 평균 경력은 9.25년이었다. 포커스그룹 인터뷰 결과 임상연구간호사의 연구위반행위에 대한 분류는 6개의 주제와 14개의 범주, 36개의 하위 범주가 도출되었다. 6개 주제는 ‘상황에 따라 다양한 연구위반을 하게 됨’,‘연구위반행위로 힘듦과 극복하기’ ,‘부적정한 업무와 능력을 극복하며 환자 옹호하기’ , ‘열악한 환경으로 인한 어려움’,‘연구위반행위 발생 감소를 위한 환경변화의 기대감’ , ‘책임성을 가지고 참여하기’였다. 셋째, 통합결과 : 임상연구간호사의 연구윤리행위 영향요인을 양적연구 각 도구의 하부 요인 18개와 설문조사 내용 2개를 질적 자료의 형태로 데이터 변환하여서, 포커스그룹 주제 6개와 범주 14개와 결과를 통합하였다. 개념적 기틀을 기반으로 하여 최종 도출된 하위주제 11개는 공통 속성에 따라 6개의 핵심 주제가 도출되었다. 최종 6개의 핵심 주제는 ‘비효율적 연구윤리풍토’,‘미약한 윤리적 임파워먼트’,‘책임감을 바탕으로 한 환자 옹호’,‘책임성을 가지고 참여하기’,‘도덕적 고뇌를 극복하기 위한 도전’,‘다양한 수준의 연구위반행위 경험’이다. 임상연구간호사 개개인은 임상연구 상황에서 도덕적 고뇌를 극복하고, 환자 옹호를 하며, 연구윤리행위를 하기 위하여, 스스로 역량을 강화하려고 애쓰고 있음을 확인할 수 있었다. 임상연구간호사들의 연구윤리행위와 관련된 실무현장에서 어려움의 다수는 함께 일하는 연구팀, 타부서 등의 연구윤리 풍토의 문제점과 근무환경과 관련된 문제점으로 개인의 힘으로는 변화가 어려운 부분이었다. 결론적으로 실무를 담당하는 임상연구간호사가 연구윤리행위를 수행하여, 연구진실성을 지킬 수 있도록, 현재 개별적으로 노력하고 있는 역량 강화를 도와줄 수 있는 실질적 연구윤리 교육프로그램의 개발과 적용이 필요하다. 하지만, 더욱 중요한 것은 개인으로는 변화시킬 수 없는 윤리풍토의 효율적, 협조적 변화와 좋은 근무환경으로의 변화를 위한 정책적, 제도적, 조직적 지원이 필요할 것으로 사료된다.

임상시험 연구윤리에 대한 임상연구자들의 인식 및 태도 조사

손순영 고려대학교 보건대학원 2011 국내석사

Abstract A study of a researcher's views and attitudes concerning human research ethics Department of Health Policy and Hospital Management Graduate School of Public Health, Korea University (Supervising Professor : Hyeong-sik Ahn M.D, Ph.D) Objectives : This study aimed to step up clinical research ethics and figure out the needs of its education by reviewing domestic and foreign laws and systems of clinical research ethics and examining researchers' notions about it. Methods : The results of the survey were analysed with SPSS.12.0 of which frequency analysis, ANOVA, Two sample t-test and chi-squared test were carried out. Results : The study's major findings were as below. As for the general information of the respondents, women outnumbered men and most of them were in their 30s making their livings as researchers. Their major was mostly biotechnology. Specifically, many specialized in indirect clinical research such as studying human tissues and cells and had master's degrees. As asked their awareness of clinical research ethics related laws and systems, 34% of respondents said they were well aware. Also, those who received related education proved to be more aware of laws and systems than those who didn't. Among the respondents, those whose research plans were reviewed by IRB outnumbered those whose plans had never been. The main reason for IRB review was to 'publish papers in foreign journals' Asked how they found IRB review, most of them stated that there were too complicated procedures for documentation and too many formal documents required and called for the simplification of the procedures. As for questions asking what was the most important to raise levels of clinical research ethics, enactment and enforcement of more strict laws topped the list. Those who received ethics education emphasized the importance of the education more than those who didn't. The analysis showed statistically significant difference. Conclusion : Most of researchers generally made positive assessments on IRB review but they complained of the complicated procedures and requirements. In this regard, IRB review needed to be simplified. Most of them had only partial awareness of laws and systems which would serve as basic standards when they carried out clinical research. Therefore, to raise the levels of research ethics, more systematic and regular education programs need to be developed and implemented to get substantial results. Key words : Clinical research, Researcher, clinical research ethics, awareness and attitudes

임상연구에서의 부수적 발견(IF) 관련 제도 개선방안 고찰 : 유전정보 포함 연구를 중심으로

조혜란 연세대학교 보건대학원 2017 국내석사

임상적으로 해당 질환을 의심할 만한 증상이나 징후가 없는 환자에서 진단 목적으로 실시한 검사에서 우연히 발견되는 증상을 부수적 발견 (Incidental Finding, 이하 IF라 한다)이라 한다. 특히 CT나 MRI 등 의료영상 촬영 도중 의도치 않는 다른 증상이 발견되는 경우가 빈번하게 이루어 지고 있어 관련 가이드 등이 어느 정도 제시되고 있는 반면, 연구 영역에서는 아직 IF라는 개념조차 생소해 하고 있고 IF 발견 시에 대한 상황을 고려하고 있지 않는 실정이다. 미국 대통령위원회 보고서 중 하나인 『ANTICIPATE and COMMUNICATE』(2013)에 따르면, 대규모 유전자 시퀀싱(Large-Scale Genetic Sequencing), 인체유래물 분석(Testing of Biological Specimens), 영상검사(Imaging)를 포함하는 임상연구 진행 시 IF를 확인할 가능성이 있는 것으로 제시하고 있다. 하지만 임상연구 진행 시 발생할 수 있는 IF를 어떻게 관리해야 할지에 대한 부분은 여전히 의견이 분분하다. 연구 수행 이후 우연히 발견되는 결과를 해당 대상자에게 알려주어야 하는지 여부에 대한 논의가 이루어 지고 있는데, 아직 국내에서는 연구를 수행하는 연구진이나 연구를 심의하는 IRB(Institutional Review Board) 위원, 그리고 잠재적 연구 참여 대상자인 환자 및 가족/보호자에게 아직은 IF라는 용어조차 생소해 하고 있으며, 관련 가이드라인 등이 전무한 실정이다. 이에 본 논문에서는 임상연구에서 우연히 확인될 수 있는 IF가 무엇인지에 대한 개념을 살펴보고, 연구자, IRB 위원, 환자 및 가족/보호자로 구분하여 임상연구에서 우연히 발견될 수 있는 IF에 대한 인식도 조사와 함께 각 역할별로 어떠한 입장을 지니고 있는지에 대하여 확인하여 현재의 상황에서 어떻게 적용해 볼 수 있을지 고찰해 보고자 하였다. 특히 최근 유전체 분석 연구가 활발하게 진행되고 발전을 이루고 있음에 따라 본 논문에서는 IF 중에서도 유전학적으로 부수적인 발견(Genetic and Genomic Incidental Finding, 이하 GIF라 한다)에 해당되는 GIF에 중점을 맞추어 진행하였다. 연구 방법으로는 서울 소재 상급 종합병원인 S병원 소속 연구자와 IRB 위원, 그리고 S병원을 방문하는 환자 및 가족/보호자로 구분하여 총 8개의 항목으로 구성된 설문조사를 시행하였고, 총 79명(연구자 24명, IRB 위원 31명, 환자 및 가족/보호자 24명)이 설문에 참여하였다. 본 연구를 통하여 연구를 수행하는 연구진과 연구가 적절한지 심의하는 IRB 위원, 그리고 실제 해당 연구에 참여하게 되는 환자 및 가족/보호자들이 연구 과정에서 연구 목적과 무관하게 우연히 발견되는 IF에 대하여 알고 있는지 인식 조사와 더불어 해당 부수적 발견 확인 시 어떻게 처리를 원하는지 등에 대한 각 역할별 입장에 대해 알아볼 수 있었다. 임상연구를 진행하고 있는 연구자나 연구의 윤리적∙과학적 적절성을 심의하는 IRB 위원의 경우 임상연구 진행에 과정에서 우연히 확인될 수 있는 IF에 대하여 어느 정도 인지하고 있었던 것에 반해, 환자 및 가족/보호자의 경우에는 IF라는 용어조차 생소해 하였고 거의 대부분의 경우 IF에 대해 들어본 적 없었던 것으로 조사되었다. 하지만 연구자/IRB 위원/환자 및 가족의 역할과 무관하게 모든 입장에서 임상연구 진행 과정에서 발견되는 IF는 대상자에게 알려야 한다는 것을 확인할 수 있었는데, 다만 IF를 언제 알려야 하는지에 대해서는 의견이 분분하였다. 따라서 본 논문에서는 적어도 미국 대통령위원회에서 제시하고 있는 3가지(대규모 유전자 시퀀싱, 인체유래물 분석, 영상검사)를 포함하는 연구에서는 대상자 설명문에 부수적 발견이 확인될 수 있음을 알리고, 연구 진행 과정에서 IF가 발견되는 경우 대상자가 통지 받기를 원하는지 여부에 대하여 선택할 수 있는 항목을 마련해 둘 것을 제언하였다. 또한 현재 국내에서는 연구 참여대상자 아웃리치(participant outreach) 일환으로 임상연구에 대한 정보나 교육을 제공하고 있는 기관이 그리 많지 않은데, 환자 및 가족/보호자는 추후 임상연구에 참여하게 될 가능성이 있는 잠재적 대상자에 해당되므로 각 기관에서는 충분한 임상연구 관련 교육을 통하여 대상자가 임상연구에 대한 지식이 고취될 수 있는 기회를 제공해야 할 것이다. 해당 교육 프로그램을 통하여 IF 에 대한 환자 및 가족/보호자의 인식 역시 높아질 수 있기를 기대해 본다. Incidental findings(hereinafter referred to as IF) are previously undiagnosed medical or psychiatric conditions that are discovered unintentionally and are unrelated to the current medical or psychiatric condition which is being treated or for which tests are being performed. Particularly an incidental finding happens with frequency when analyzing medical images such as CT or MRI, etc.; however, IF is not considered in clinical research area yet. According to 『ANTICIPATE and COMMUNICATE』(2013), one of the report published by the Presidential Commission for the Study of Bioethical Issues, a research including large-scale genetic sequencing or testing of biological specimens or imaging has the possibility of giving rise IFs. It is still controversial whether IF should be informed to the research participants or not. Researchers, Institutional Review Board (hereinafter referred to as IRB) members and Patients (or their family/guardian), potential research participants, are not fully aware of IF in Korea, and there are no particular laws or guidelines for IF. That is why this paper deals with the followings: 1) the concept of IF in clinical research, 2) awareness investigation of IF and the stance classified into three categories(Researchers/IRB members/Patients or their family∙guardian), 3) how to reflect their stance in the principles and practice of clinical research. Especially, as the genetic and genomic research is rapidly developing, this paper focuses more on genetic and genomic incidental findings (GIF). The study was conducted with a questionnaire survey to the researchers, IRB members, affiliated with S hospital, a general hospital in Seoul, Korea, and the patients (or their family/guardian), visiting S hospital. Total of 79 people (24 researchers, 31 IRB members, 24 patients or their family/guardian) were participated in the survey. To some degree, researchers and IRB members are aware of what IF is; however, patients or their family/guardian are unfamiliar with IF and most of them have never heard of it. It is interesting that all of the study participants indicate agreement to inform clinical research participants IF, but there are some issues for timing when IF should be informed. Therefore, this paper suggests that when conducting researches including large-scale genetic sequencing or testing of biological specimens or imaging, participants should be informed about that the research has the possibility of giving rise IF and the participants should make a choice voluntarily of one’s own free will. Furthermore, there is little institution that provides information or education about clinical research as part of participant outreach in Korea. However, since patients or their family/guardian are the potential clinical research participants, institutions should provide information or education about clinical research so as to inspire them to be accustomed to it. With the education program, it is expected that patients or their family/guardian could be more familiar with IF.

임상연구모니터요원의 의사소통능력과 직무만족도

양미진 연세대학교 보건대학원 2015 국내석사

본 연구는 임상연구모니터요원의 일반적 특성, 의사소통능력, 직무만족도를 파악하고 관련성을 규명하여 체계적이고 지속적인 의사소통능력 교육 자료를 개발하고 임상연구모니터요원의 직업적 전문성과 안정성을 높이기 위한 기초 자료를 제공하기 위하여 시행되었다. 조사대상은 서울에 있는 국내외 임상시험수탁기관, 제약회사 등에서 근무 중인 임상연구모니터요원 총 123명을 임의 표출하였으며, 자료 수집은 2014년 12월 08일부터 2015년 03월 27일까지 자기보고 설문을 실시하였다. 의사소통능력은 Rubin(1990)이 개발한 ‘의사소통능력 도구(ICCS, Interpersonal Communication Competence Scale)’를 허경호(2003)가 수정하여 개발한 ‘포괄적 대인의사소통능력 도구(GICC, Global Interpersonal Communication Competence Scale)’를 다시 배주영(2008)이 수정한 도구로 측정하였고, 직무만족도는 Paula(1976)가 개발하고 배분희(2001)가 수정하여 사용한 것을 김지숙(2008)이 임상연구모니터요원의 업무 특성에 맞게 수정하여 총 23문항(연봉-3문항, 업무요구-3문항, 전문적 지위-5문항, 행정-3문항, 연구진과의 관계-2문항, 자율성-4문항, 상호작용-3문항)으로 구성되어 있는 도구로 측정하였다. 자료 분석은 SAS 9.2 program을 이용하였고, 기술통계, T-test, ANOVA, Multiple regression analysis로 분석하였으며 사후검정은 Scheffe-test로 실시하였다. 본 연구의 주요결과는 다음과 같다. 1. 임상연구모니터요원의 의사소통능력 점수는 75점 만점에 평균 53.80±5.96점 이었다. 임상연구모니터요원의 일반적 특성에 따른 의사소통능력은 복지 중 4대 보험이 있는 경우(p=0.032), 임상연구모니터요원 지원 동기가 ‘임상연구를 하고 싶어서’인 경우(p=0.006) 의사소통능력에 통계적으로 유의한 차이가 있었다. 2. 임상연구모니터요원의 전체 직무만족도는 115점 만점에 평균 73.61±9.79점으로 직무만족도의 하부 영역별로 연봉 만족도 평균 8.97±2.47점(총점 15점), 업무요구 만족도 평균 9.45±1.29점(총점 15점), 전문적 지위 만족도 평균 17.19±3.16점(총점 25점), 행정 만족도 평균 8.79±2.13점(총점 15점), 연구진과의 관계만족도 평균 6.12±1.66점(총점 10점), 자율성 만족도 평균 12.97±2.25점(총점 20점), 상호작용 만족도 평균 10.33±2.15점(총점 15점)으로 나타났다. 3. 임상연구모니터요원의 의사소통능력과 전체 직무만족도 간에는 통계적으로 유의한 관련성이 있었고, 직무만족도의 7개 하부영역(연봉, 업무요구, 전문적 지위, 행정, 연구진과의 관계, 자율성, 상호작용) 중 연봉 만족도, 전문적 지위 만족도, 자율성 만족도, 상호작용 만족도와 양(+)의 상관관계가 있었다. 4. 임상연구모니터요원의 일반적 특성 중 소속은 행정 만족도와 양(+)의 상관관계가 있었고, 직급은 자율성 만족도 및 상호작용 만족도와 음(-)의 상관관계가 있었으며, 연봉은 연봉 만족도와 양(+)의 상관관계가 있었다. 일일 평균 근무시간은 전체 직무만족도 및 자율성 만족도와 음(-)의 상관관계가 있었고, 진행 중인 연구 수는 행정 만족도와 양(+)의 상관관계가 있었으며, 이직 의도는 상호작용 만족도와 양(+)의 상관관계가 있었고 모두 통계적으로 유의한 것으로 나타났다. 임상연구모니터요원의 의사소통능력이 향상될 때 직무만족도가 높아지므로 향후 임상연구모니터요원을 위한 체계적이고 지속적인 의사소통능력 교육 자료를 개발하고 훈련 받도록 하며 교육 효과를 평가하는 연구까지 시행함으로써 임상연구모니터요원의 직업적 전문성과 안정성을 높이고, 업무의 효율성을 증대시켜 국내 임상연구의 수준을 높이고 경쟁력을 강화하는데 기여해야 할 것이다. The present study was conducted to evaluate the possible relationship between general characteristics, communication competence and job satisfaction of the clinical research associate(CRA) in order to provide information on the development of the educational material to help the CRA enhance the communication competence, which is essential to establish the professionalism and stability. A cross-sectional descriptive design was adopted. Data were collected by a self-administered survey from December 8, 2014 to March 27, 2015 among a total of 123 randomly selected CRA who worked in domestic and foreign clinical research organizations(CROs) and pharmaceuticals located in Seoul, Korea. Communication competence was measured by the Bae Ju Young‘s(2008) modified version of the Hur Gyung Ho’s(2003) global interpersonal communication competence scale(GICC), which was based on the Rubin’s(1990) interpersonal communication competence scale(ICCS). Job satisfaction was assessed using the Kim ji Sook's(2008) modified version of the Bae Bun Hee's(2001) and original Paula's(1976) job satisfaction scale to fit the CRA's job characteristics, containing a total of 23 questionnaires (annual salary [3 questionnaires], work requirement [3 questionnaires], professional status [5 questionnaires], administration [3 questionnaires], relationship with the research staff [2 questionnaires], autonomy [4 questionnaires] and interaction [3 questionnaires]). Statistical analyses were done using the SAS version 9.2 statistical software program. Descriptive statistics, T-test, ANOVA (followed by the Scheffe post hoc test if necessary), and multiple regression analysis were employed for the data analysis. The study results are summarized as follows. 1. The mean communication competence score among the CRA is 53.80±5.96(total score 75). The score of communication competence of CRA were good, with higher scores than median values. Among the general characteristics of the CRA, the four major public insurance coverage status has a statistically significant effect on communication competence(p=0.032). CRA's motivation to conduct the clinical research also has a statistically significant effect on communication competence(p=0.006). 2. The mean total job satisfaction score is 73.61±9.79(total score 115). The mean job satisfaction score for each dimension is 8.97±2.47 for the annual salary satisfaction(total score 15), 9.45±1.29 for the work requirement satisfaction(total score 15), 17.19±3.16 for the professional status satisfaction(total score 25), 8.79±2.13 for the administration satisfaction(total score 15), 6.12±1.66 for the relationship with the research staff satisfaction(total score 10), 12.97±2.25 for autonomy satisfaction(total score 20), and 10.33±2.15 for the interaction satisfaction(total score 15). The score of job satisfaction of CRA were good, with higher scores than median values. 3. A statistically significant correlation is found between communication competence and job satisfaction. Among the sub-dimension of job satisfaction, annual salary, professional status, autonomy and interaction have a positive correlation with communication competence. 4. Among the general characteristics of the CRA, the corporation position has a positive correlation with administration satisfaction. The job position has a negative correlation with autonomy and interaction satisfaction. The annual salary has a positive correlation with annual salary satisfaction. The daily working hour has a negative correlation with overall job satisfaction and autonomy satisfaction. The number of progressive study has a positive correlation with administration satisfaction, and the turnover intention has a positive correlation with interaction satisfaction. All correlations described above are found to be statistically significant. The present study showed that communication competence has a significant positive relationship with job satisfaction. Thus, in order to strength the international competitiveness of the Korean clinical research, it is important to develop the educational material to help the CRA enhance the communication competence, which is essential to establish the professionalism, stability and work efficiency among the CRA.

임상연구요양급여 적용 신청에 대한 효율성 제고

정연 연세대학교 대학원 2021 국내석사

임상연구요양급여 적용 신청에 대한 효율성 제고 본 연구는 실제 임상현장에서 진행되고 있는 임상연구 요양급여 적용 신청 업무 절차와 운영 현황에 대해 조사하고, 임상연구 요양급여 적용 신청의 장애 요인 및 개선이 필요한 시급한 사항과 개선 방향에 대해 알 아보고자 수행하였다. 임상연구 요양급여 적용 신청 업무의 장애요인은 관련 법률에 대한 명 확한 가이드라인 제시와 관련 해석의 부족, 임상연구요양급여 적용 승인 을 위한 과다한 신청 서류, 임상연구요양급여 적용 신청을 위한 기관 인 프라 부족 등의 순서로 나타났지만, 임상연구요양급여 적용 신청이 연구 활성화 긍정적 영향을 끼친다고 생각하는 대상자는 47.6%에 해당하여 부 정적 영향으로 선택한 33.3% 보다 더 많았다. 또 임상연구 요양급여 적용 신청 개선이 필요한 사항으로는 신청 방법 의 간소화, 법적 제도 개선, 임상연구요양급여 적용 범위 확대 순으로 나 타나, 현행 제도의 개선이 불가피 함을 나타낸 것으로 볼 수 있었다. 결론으로 본 연구를 통해 임상연구 요양급여 적용 신청 업무는 연구활성 화를 위해 필요한 것임을 확인하였다. 그러나 설문에 참여한 대상자 수가 적고, 임상연구 요양급여 처방을 계획하고 있는 연구자는 대상자로 포함 되지 않아 해석이 제한적이다. 추후 대상자 수 확대를 통해 업무의 진행 방향과 나아가서는 정책 방향에도 영향을 줄 수 있는 추가 연구를 마련할 수 있는 기틀이 될 것으로 사료 된다. =========================================== 핵심되는 말: 임상연구요양급여 This study was conducted to find out working process of applying clinical research and care benefits at actual clinical sites, and to find out the factors of disability in applying for clinical research and care benefits, urgent matters that need improvement, and direction of improvement. Obstacle factors in applying for clinical research care benefits were the lack of clear guidelines and interpretations of relevant laws, excessive application documents for approval of clinical research care benefits, and lack of institutional infrastructure for applying for clinical research care benefits. However, 47.6% of the respondents thought that applying for clinical research care benefits had a positive effect on the promotion of research, compared to those who chose a negative effect. In addition, improvements in applications for clinical research and care benefits were made in the order of simplification of application methods, improvement of legal systems, and expansion of coverage of clinical research and care benefits, indicating that improvement of the current system is inevitable. In conclusion, this study confirmed that the application for clinical research and care benefits is necessary for the promotion of clinical research. However, the number of participants in the survey is small, and investigator who plan to prescribe clinical research medical care benefits are not included as subjects, so the interpretation is limited. It is believed that this will pave the way for further research that can affect the direction of work progress and further policy direction by expanding the number of subjects.

임상연구간호사가 인식하는 임상연구간호활동의 수행 빈도 및 중요도

박지연 강원대학교 대학원 2023 국내석사

본 연구의 목적은 국내 임상연구간호사들이 인식하는 임상연구간호활동의 수행 빈도 및 중요도에 대한 인식을 파악하기 위하여 시도된 서술적 조사연구이다. 자료수집 기간은 2022년 5월 13일부터 2022년 5월 17일까지였고, 연구 참여에 동의한 국내 임상연구간호사 96명을 대상으로 하였다. 데이터는 온라인 설문조사를 통하여 수집되어 SPSS 28.0 program을 이용하여 기술 통계, Pearson correlation, One-Way ANOVA, Independent t-test, 산점도를 이용하여 분석하였다. 연구에 사용된 도구는 미국 국립보건원 임상센터에서 규정한 5개 영역의 52개 임상연구간호활동목록을 활용하여 빈도와 중요도를 측정하였다. 본 연구결과를 요약하면 다음과 같다. 1) 임상연구간호활동의 수행 빈도, 중요도, 상관관계 (1) 빈도 : 연구대상자의 52개 활동에 대한 수행 빈도의 평균은 2.02(±1.17)점이었고, 빈도가 가장 많은 활동은 ‘ 연구 대상자에 대한 자료를 수집한다’으로 3.67(±1.17)점, 수행 빈도가 가장 적은 활동은 ‘기관생명윤리위원회 위원으로 활동한다’으로 0.46(±0.79)점으로 나타났다. (2) 중요도 : 연구대상자의 52개 활동에 대한 중요도의 평균은 2.91(±1.24)점이었고, 중요도가 가장 높은 활동은 ‘ 국제의약품규제조화위원회 임상시험 관리기준 및 국내 임상시험관리기준을 준수한다’으로 3.66(±1.25)점 이었고, 중요도가 가장 낮은 활동은 ‘전문 분야의 전문가로 활동한다’으로 1.89(±1.35)점이었다. (3) 영역별 빈도와 중요도 : 연구대상자의 수행 빈도가 가장 높은 영역은 임상 실무 영역으로 3.04(±1.09)으로 나타났고, 수행 빈도가 가장 낮은 영역은 과학에의 기여 영역이 1.18(±0.82)점으로 나타났다. 중요도가 가장 높은 영역은 임상 실무 영역이 3.58(±1.10)점으로 가장 높았고, 과학에 기여 영역은 2.37(±1.00)점으로 가장 낮게 나타났다. (4) 빈도와 중요도의 상관관계 : 연구대상자의 52개 활동 중 ‘연구개발에 참여(r= .17, p= .094)’, ‘연구현장 방문 및 점검(r= .17, p= .090)’, ‘기관생명윤리위원회 위원으로 활동(r= .07, p= .514)’, ‘학회발표, 논문출판 및 동료와의 의사소통을 통해 임상연구의 전문 지식 및 우수 실무사례를 전파(r= .18, p= .079)’인 4개 활동은 상관관계가 없고, 나머지 48개 활동은 모두 유의한 양의 상관관계를 보였다. (5) 빈도와 중요도 영역간 상관관계 : 연구대상자의 임상실무 영역(r= .66, p<.001), 연구관리 영역(r= .58, p<.001), 대상자 돌봄 조정 및 연속성 영역(r= .48, p<.001), 인간대상자 보호 영역(r= .44, p<.001), 과학에 기여 영역(r= .30, p= .003)으로 5개 임상연구간호영역이 모두 서로 유의한 양의 상관관계를 나타내었다. 2) 대상자의 특성에 따른 임상연구간호활동 영역의 빈도와 중요도 차이 (1) 대상자의 특성에 따른 빈도 차이 : 연령에 따른 과학에의 기여 영역에서(F=4.799, p=.013), 교육수준과 연봉에 따른 연구관리 영역(F=5.318, p=.007; F=4.089, p=.020)과 과학에의 기여 영역(F=3.716, p=.028; F=8.500, p=<.001)에서, 근무장소와 고용형태에 따른 임상 실무 영역(F=4.778, p=.011; F=5.994, p=.004)과 과학에의 기여 영역(F=6.448, p=.002; F=13.204, p=<.001)에서, 임상시험전문가인증제 및 관련전문협회가입여부에 따른 임상 실무(t=-2.099, p=.039; t=-3.855, p=<.001)와 과학에의 기여 영역(t=5.460, p=<.001; t=4.753, p=<.001)에서, 결혼유무에 따른 인간대상자 보호 영역에서(t=2.118, p=.037), 임상연구참여기간과 맡고있는 과제수에 따른 임상 실무 영역(F=4.019, p=.021; F=10.064, p=.001)과 과학에의 기여 영역(F=3.285, p=.042; F=5.127, p=.012)에서 통계적으로 유의한 차이가 나타났다. (2) 대상자의 특성에 따른 중요도 차이 : 근무장소에 따른 임상 실무 영역에서(F=5.779, p=.004), 고용 형태에 따른 임상 실무 영역(F=8.546, p=<.001)과 연구 관리 영역(F=5.370, p=.006)에서, 임상시험전문가인증제 및 관련전문협회가입여부에 따른 임상 실무 영역에서(t=-2.658, p=.009; t=-2.443, p=.016), 맡고있는 과제수에 따라 임상 실무 영역(F=8.502, p=.001), 연구관리영역(F=3.522, p=.034), 돌봄 조정 및 연속성 유지 영역(F=4.758, p=.011), 인간대상자 보호 영역(F=5.726, p=.005)에서 통계적으로 유의한 차이가 나타났다. 3) 임상연구간호활동의 수행 빈도, 중요도의 분포 산점도의 가로축에는 각 항목의 빈도 점수를, 세로축에는 중요도 점수를 표시하였으며, 빈도의 평균점수(2.02)와 중요도 점수의 평균 점수(2.91)를 산출하여, 분할선을 나타내어 각 52개 항목들에 대한 평균보다 높고 낮음을 시각화한 결과, 중요도와 수행도간 차이가 나는 활동들은 모두 네 항목이었다. 중요도가 평균 이상이지만 빈도는 낮았던 활동들은 ‘데이터의 완전성을 높이기 위한 품질보증활동을 수행한다’(빈도 1.43±1.30, 중요도 3.00±1.20), ‘규제기관 및 모니터링 기관에 제출할 보고서 준비에 참여한다’(빈도 1.90±1.14, 중요도 2.94±1.19), ‘연구 현장을 방문하고 점검한다’(빈도 1.05±1.16, 중요도 2.91±1.38)였고, 평균보다 중요도는 낮게 평가하였으나 빈도는 높게 나타난 활동은 ‘연구대상자 모집에 참여한다’(수행빈도 2.18±1.44, 중요도 2.78±1.35)였다. 본 연구결과를 통하여 대상자에게 직접 간호를 제공하는 임상 실무 영역이 국내 임상연구간호사가 가장 많이 수행하고 중요하게 인식하는 영역임을 확인하였으며, 국내 임상연구간호사들에게 해당 전문 활동들에 대한 가치가 인지되어 있음이 확인되었다. 따라서 향후 간호 전문지식을 임상 연구환경에 통합하여 연구 참여자에 대한 복지와 안전을 보장하며, 질 높은 임상 연구의 완전성에 기여하기 위해 임상연구간호에 대한 개념을 정립 및 국내 임상연구간호사의 고유한 역할 확립을 위해 노력할 필요가 있다. The purpose of this descriptive research study is to identify the awareness of the frequency and importance of clinical research nursing activities recognized by clinical research nurses in South Korea. Data collection took place from May 13, 2022, to May 17, 2022, and involved 96 clinical research nurses who agreed to participate in the study. The data was collected through an online survey and was analyzed using descriptive statistics: Pearson correlation, One-Way ANOVA, Independent t-test, and scatter plots with the SPSS 28.0 program. This study utilized a list of 52 clinical research nursing activities from five domains specified by the National Institutes of Health Clinical Center in the United States to measure their frequency and importance. The summarized findings of this study are as follows: 1) Frequency, Importance, and Correlation of Clinical Research Nursing Activities (1) Frequency: the average frequency score for the 52 activities among the study participants was 2.02 (±1.17), with the activity ' collect data on research participant based on study endpoints' receiving the highest frequency score of 3.67 (±1.17) and the activity 'serve as an institutional review board member' receiving the lowest frequency score of 0.46 (±0.79). (2) Importance: the average importance score for the 52 activities among the study participants was 2.91 (±1.24). The activity with the highest importance score of 3.66 (±1.25) was 'comply with the International Conference on Harmonization (ICH)'s good clinical practice guidelines and Korean good clinical practice guidelines'. The activity with the lowest importance score of 1.89 (±1.35) was 'serve as an expert in a specialty area'. (3) Frequency and Importance by Dimension: the dimension with the highest frequency score among the study participants was 'clinical practice' with a score of 3.04 (±1.09), while the dimension with the lowest frequency score was 'contributing to the science' with a score of 1.18 (±0.82). The dimension with the highest importance score was 'clinical practice' with a score of 3.58 (±1.10), while the dimension with the lowest importance score was 'contributing to the science' with a score of 2.37 (±1.00). (4) Correlation between Frequency and Importance: among the 52 activities, the four activities showed no significant correlation. However, the remaining 48 activities all exhibited significant positive correlations. (5) Correlation between Frequency and Importance by Dimension: all five clinical research nursing dimensions, including 'clinical practice' (r = .66, p < .001), 'study management' (r = .58, p < .001), 'care coordination and continuity' (r = .48, p < .001), 'human subjects protection' (r = .44, p < .001), and 'contributing to the science' (r = .30, p = .003), showed significant positive correlations with each other. 2) Differences in the Frequency and Importance of Clinical Research Nursing Activities Dimension by Participants’ Characteristics A statistically significant difference was observed in the frequency and importance of clinical research nursing activities across dimensions, based on the characteristics of the participants. 3) Distribution of the Frequency and Importance of Clinical Research Nursing Activities A scatter plot was used to display the frequency and the importance scores on the vertical axis. The average score for frequency (2.02) and the average score for importance (2.91) were calculated. A division line was drawn to visually represent activities that had scores higher or lower than the mean for the 52 items. As a result, four activities showed differences between their importance and performance. Conclusion The findings of this study confirm that the clinical practice dimension, which involves directly providing nursing care to participants, is the most frequently performed and highly valued area among domestic research nurses. It has been observed that domestic research nurses recognize the importance of these specialized activities. Therefore, in the future, there is a need to integrate nursing expertise into clinical research environments for the integrity of high-quality clinical research and to ensure the well-being and safety of research participants. Efforts should be made to establish the concept of clinical research nursing and to establish the unique role of domestic research nurses.