임상연구간호사의 연구윤리행위 관련요인:혼합연구 방법

Abstract

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.