| Summary: | 博士 === 國立臺灣大學 === 護理學研究所 === 106 === Background: With the environmental changes in clinical trials, there are more and more clinical trials in the world. There are currently 266,161 clinical trial cases in 50 states in the United States and 203 countries. The clinical trial registration number from Taiwan is up to 5241 (National Institutes of Health, 2018). Various laws, regulations and ethical norms emphasize the informed consent process, consent form content and importance of informed consent, but there is room for improvement. The purpose of this study was to explore the level of understanding and key influencing factors in the informed consent process, to explore the practical experience of cancer clinical trial subjects, principal investigator and research nurses, and to investigate the readability of consent form.
Methods: This study uses between-method triangulation with qualitative and quantitative research. The cross-sectional survey was used to explore the subjects'' experience and understanding in the process of informed consent. The qualitative interview was used to explore the experience of the clinical trial investigators, research nurses and patients in explaining the clinical trial consent. Content analysis method was to use to analyze the consent formed from the institutional review board, and the quantitative research methods to test the readability of consent forms.
Results: We recruited 375 participants who had signed an informed consent of clinical trials to join the cross-sectional survey, the provider of informed consent form information were research nurse (51.7%), Research assistant(17.9%), and Doctor(17.9%). The demeanor of the information provider was Friendly (84.8%), and used the familiar language of the subjects to explain the study (97.3%). The understanding level scores were between 3.81~4.17(out of 5). The item of “I feel I know the risks of the study” (score is 3.81), “I feel I know the benefits of the study” (score is 3.98), “I had enough time to read the consent document” (score is 3.99) were lower than others. In Exploratory factor analysis (EFA), three major themes were found in the scale: Factor 1: “Understanding of the research” , factor loading is from 0.581 to 0.759, variance is 26.763%, Cronbach’s α is 0.925. Factor 2: “Trust and confidence” , factor loading is from 0.359 to 0.658, variance is 16.817%, Cronbach’s α is 0.865. Factor 3: “Doubt and uncertainty”, factor loading is from 0.531 to 0.707, variance is 9.74%, Cronbach’s αis 0.713. The total variance is 52.954%, with Cronbach’s α of 0.917. The Kaiser–Meyer–Olkin value was 0.937, and indicating excellent sampling adequacy and relatively compact patterns of correlation. Bartlett’s test of sphericity was significant( x2= 4185.925, df = 190, p <0.0001).
Nine interviewees received in-depth interviews. After text encoding and analysis, we developed four themes, including "preparation", "communication", "hesitation" and "decision making" and twelve themes. We explored 29 cancer clinical trial consent forms were submitted for review in the institutional review board of a medical center in Central Taiwan during 2015-2017. The average number of consent form pages was 24.7 pages with an average of 15643.5 words. The common questions were "Investigation Methods, Procedures and Related Testing "(42.3%). In the readability analysis of consent form study, we obtained 54 test data, the average correct rate was 91.9537 points (out of 100 points); difficult words average rate of 0.35172 points. We found that the readability of the consent forms for phase III new drug clinical trial were lower than others and having better readability to those with "biomedical science and technology background".
Conclusion: This study establishes local empirical data to find out the important factors that affect the understanding of consent and the readability of consent, which can be used as a reference for clinical practitioners to improve and education.
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