• 동의생리병리학회지
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• 제25권6호
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• pp.1089-1094
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• 2011

We examined the decision-making capacity of seniors of consent to oriental clinical research. This study was performed in order to improve the quality of ethical aspects before obtaining informed consent. Oriental investigators interviewed 251 seniors who participated in Sasang clinical research. The questionnaire was about the capacity of consent and the subjective awareness of informed consent. Two hundred fifteen out of 250 questionnaires were collected. One hundred thirty four(62.3%) seniors had the capacity of consent to research and 81(37.7%) seniors did not pass. The subjective awareness of informed consent in having the capacity group is $78.02{\pm}12.92$ and not having group is $72.17{\pm}9.17$. The investigation of senior capacity of consent was aimed at protecting seniors' interests and completing investigators' ethical responsibilities. This study found that only 62.3% of senior participants had the capacity of consent. This investigation will be expected to raise the importance of seniors' capacity of consent. Also we expect methods and procedures for capacity assessment of informed consent to be followed for increasing quality of clinical research.

• 한국사회복지학
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• 제61권3호
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• pp.55-76
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• 2009

본 연구의 목적은 국내에서 노인복지연구 참여를 위한 고지된 동의과정에 동의능력평가가 활발하게 적용될 수 있도록 한국형 동의능력척도를 실증적으로 검증하는 것이다. 본 연구를 위해 재가복지서비스를 이용하거나 노인복지시설에서 보호를 받고 있는 404명의 노인을 조사하였다. 연구 1(n=202)에서는 동의능력검사척도의 신뢰도, 탐색적 요인분석, 수렴 및 기준 타당도 분석을 하였다. 연구 2(n=202)는 연구 1을 통해 수정된 척도의 신뢰도와 타당도는 내적 신뢰도, 확증적 요인분석, 수렴 및 기준 타당도 분석 등을 통해 검증하였다. 연구결과 본 척도의 내적신뢰도 계수가 .90로 높은 수준이었고, 모델 적합도 지수(RMSEA=.057, NNFI=.94, IFI=.96, CFI=.96)도 양호하게 나타났다. 또한 관련변수와의 높은 상관관계 계수를 통해 수렴 및 기준타당도가 검증되었다. 한국형 동의능력평가척도가 우리나라 노인을 대상으로 임상(clinical) 및 조사(survey)연구 참여를 위해 동의능력을 평가하는 척도로서 적합함을 통계적으로 확인하였다. 본 척도는 노인을 대상으로 수행될 연구와 프로그램에서 고지된 동의과정을 위해 활용될 것으로 기대된다.

• 한국임상약학회지
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• 제26권1호
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• pp.33-39
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• 2016

Background: Elements of informed consent including capacity, disclosure, understanding, voluntariness, and permission of the participant, are all crucial for clinical trials to be legally and ethically valid. During the informed consent process, the patient information leaflet is an important information source which prospective research subjects can utilize in their decision-making. In the adequate provision of information, KGCP guideline necessitate 20 specific items, as well as the use language that individuals can understand. This study measures the vocabulary level of patient information leaflets in an effort to provide an objective evaluation on the readability of such material. Methods: The word difficulty of 13 leaflets was quantitatively evaluated using Kim kwang Hae's vocabulary grading framework, which was compared to the difficulty level of words found in the $6^{th}$ grade Korean textbook. The quantitative outcomes were statistically analyzed using chi-squared tests and linear by linear association for ordinal data. Results: There was a statistically significant difference between the vocabulary level and frequency of words in leaflets and the 6th Korean textbook. The leaflets were on average 260 sentences and about roughly 15 pages long, including lay language (easier or equal to language used in primary school) of around 12% less; technical language of around 4.5% more. As the vocabulary grades increase, there was a distinct difference in vocabulary level between Korean textbook and each information leaflet (p < 0.001). Conclusion: Patient information leaflets may fail to provide appropriate information for self-determination by clinical trial subject through the difficulty level of its wording. Improvements in the degree of patients' understanding and appropriate use of information leaflets are collaboratively equipped to strengthen patient's autonomy and therefore guaranteeing participant's rights.

• 대한치과기공학회지
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• 제41권4호
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• pp.359-364
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• 2019

Purpose: The objectives of this study is to collect the opinions of experts in the field of dental lab technology, and to present a plan for reforming the curriculum for producing clinical-based dental technicians. Methods: 71 experts were selected for this study. Experts were grouped into clinicians, educators, and policy-makers. First of all, the purpose and method of this study were explained to experts. After receiving the consent to participate in the research, their opinions were investigated. The survey was conducted through a questionnaire created based on their opinions and opinions collected. Results: The results showed that they were relatively satisfied with the curriculum. In addition, it was found that they hope to increase the proportion of mandatory education of digital dentistry and clinical practice. Emphasis was placed on expanding opportunities for on-the-job training as well as on time for hands-on training. As for admission capacity, the highest opinion was to keep it as it is, followed by the need for reduction. Conclusion: It seems necessary to minimize the difference between the curriculum and the clinical field in order to produce field-oriented dental technicians. To this end, it is necessary to reorganize the operation of field-oriented subjects and to increase the practice time to improve practical skills.