• Title/Summary/Keyword: capacity to consent for clinical research

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Assessing the Old Participants' Capacity of Consent to Oriental Clinical Research (한방 임상연구에 참여한 노인 대상자들의 동의 능력 평가)

  • Yoo, Jong-Hyang;Kim, Yun-Young;Kwon, Ji-Hye;Kim, Ho-Suk;Lee, Si-Woo
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.25 no.6
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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.

The Validation of a Measurement for Assessing the Capacity of Korean Older Adults to Consent to Research (한국노인의 연구참여를 위한 동의능력평가척도의 타당성 연구)

  • Lee, Min-Hong
    • Korean Journal of Social Welfare
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    • v.61 no.3
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    • pp.55-76
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    • 2009
  • This study tested the psychometric properties of the Korean version of the Capacity-to-Consent Screen: K-CCS) scale. A total of 404 South Korean older adults were e Cruited using the purposive sampling method. The participants were asked to res-Cod to a structured questiConaire which included older adults' characteristics, ADLs, IADLs, cognitive impairments and creen: K-CCS) scale. A total of. Item analysis, explonalory factor analysis(EFA), and ) sfirmalory factor analysis(CFA) were cCoducted to verifK-Che psychometric properties of the Korean Version of CCS. The sample was divided into two groups: one group for EFA(n=202) alysis(Eois(r group for CFA(n=202). The totults revealeysisae. he final version of the 8-item K-CCS with two dimensions had a excellent internof. Itemstencyonofpha value=.f) alysa CFA) sfirmed the acceptaas diviof the modef.fdi(RMSEA=.057, NNFI=.f4, IFI=.f6, CFI=.f6) to twaddition, claims for the convergent and criterion-related validdiviwere demItetnaled. Ity-tnclusion, the K-CCS can be rmed for professi sams to asersioolder participants' capacity to consent to clinical or survey research.

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Readability of Patient Information Leaflets in Clinical Trials (임상시험 시험대상자설명서의 가독성 평가)

  • Choi, Im-Soon;Yong, Chul-Soon;Lee, Iyn-Hyang
    • Korean Journal of Clinical Pharmacy
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    • v.26 no.1
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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.

A study on the reorganization of the curriculum for produce of field-oriented dental technicians (현장중심형 치과기공사 배출을 위한 교육과정 개편 방안에 관한 연구)

  • Kim, Jae-Hong;Kim, Ki-Baek;Kim, Won-Soo
    • Journal of Technologic Dentistry
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    • v.41 no.4
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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.