• 성인간호학회지
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• 제19권4호
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• pp.556-566
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• 2007

Purpose: This study attempted to analyze problems of informed consent in the clinical setting and appraise ethical aspects inherent in such issues in order to boost awareness of informed consent and its implementation among healthcare professionals. Methods: Study methods included identifying ethical meanings of informed consent in the clinical setting based on the principal ethics, and exploring the process of informed consent utilizing communicative ethics and feminine care ethics Results: The ethical basis of informed consent encompasses not only respect for autonomy but also prohibiting malice, practicing beneficience, and establishing justice. These principles, however, are limited in illustrating the ethical aspects of communicative ethics and care ethics that are entailed in informed consent within clinical settings. The ethical meaning of informed consent involves a communicative and caring process between healthcare professionals, patients, and family built on mutual respect. Conclusion: Healthcare professionals must fully understand the ethical meanings of informed consent and in turn respect and protect the clients' right to know and making decisions. Nurses especially, must take on the role of mediator and advocate throughout the process of obtaining informed consent, and practice ethical caring by facilitating communication grounded in mutual understanding among the physician, patient, and family members.

• 간호행정학회지
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• 제12권2호
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• pp.255-264
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• 2006

Purpose: This study was carried out to understand the in-patients' experiences related on informed consent for examination, treatment or surgery. Method: The study was conducted with 578 patients who were admitted to the departments of internal medicine and surgery for examination, treatment or surgery requiring informed consent from November 1 to 30, 2004 at three general hospitals in Daegu, Busan and Gyeongsangbuk-do. The data was analyzed by using SPSS 11.5 for Windows. Results: Although the one who explains during the process of informed consent should be doctors, 6.6% was informed by nurses or others. In addition, the majority has been told for complications and risk while relatively fewer patients were informed for necessity, method and costs of the procedure, and no one ever heard of other alternatives or the right to terminate the procedure at any time. While 40% of patients were not the final decision-makers of examination, treatment or surgery, 11.9% of patients answered their opinions were not considered during the final decision-making process. Conclusion: The study suggest that the ethically appropriate informed consent has not been achieved in the clinical practice, and therefore it is necessary to develop the specific behavioral guidelines and nursing ethics education program for nurses in order to settle down the desirable informed consent at the dimension of nursing management.

• Journal of Korean Neurosurgical Society
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• 제60권4호
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• pp.385-390
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• 2017

The doctrine of informed consent, as opposed to medical paternalism, is intended to facilitate patient autonomy by allowing patient participation in the medical decision-making process. However, regrettably, the surgical informed consent (SIC) process is invariably underestimated and reduced to a documentary procedure to protect physicians from legal liability. Moreover, residents are rarely trained in the clinical and communicative skills required for the SIC process. Accordingly, to increase professional awareness of the SIC process, a brief history and introduction to the current elements of SIC, the obstacles to patient autonomy and SIC, benefits and drawbacks of SIC, planning of an optimal SIC process, and its application to cases of an unruptured intracranial aneurysm are all presented. Optimal informed consent process can provide patients with a good comprehension of their disease and treatment, augmented autonomy, a strong therapeutic alliance with their doctors, and psychological defenses for coping with stressful surgical circumstances.

• 사상체질의학회지
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• 제23권3호
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• pp.318-329
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• 2011

1. Objectives: We surveyed the attitude and awareness of Sasang Constitution investigators on informed consent in clinical study. This study was performed in order to improve the quality of ethical aspects in clinical study by surveying the process of obtaining informed consent. 2. Methods: We sent the questionnaire by email to Sasang Constitution investigators who had the experience in clinical study. The question was about the necessity of informed consent and the process of obtaining it. 3. Results: Twenty-two out of 24 questionnaires were collected. All of investigators recognized that informed consent is needed for clinical study. Sixty-four percent of the respondents 'fully' or 'mostly' explained the informed consent but they added only 41% of participants 'fully' or 'mostly' understood. Fifty-four point five percent of respondents provided participants enough time and opportunity to inquire the study in details to decide whether or not to participate in the study, the rest of respondents obtained informed consent without providing enough time for decision. 4. Conclusions: Sasang Constitution investigators had high awareness of necessity for informed consent in clinical study. But participants' understanding was low despite of the degree of investigators' explanation. A various strategies should be designed for improving consent forms and process. Most of all, investigators should make sure that informed consent intends to protect participants and promote ethical research conduct.

• 대한두개안면성형외과학회지
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• 제19권1호
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• pp.41-47
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• 2018

Background: The number of surgical risks recalled by a patient after surgery can be used as a parameter for assessing how well the patient has understood the informed consent process. No study has investigated the usefulness of a self-developed mobile application in the traditional informed consent process in patients with a nasal bone fracture. This study aimed to investigate whether delivery of information, such as surgical risks, through a mobile application is more effective than delivery of information through only verbal means and a paper. Methods: This prospective, randomized study included 60 patients with a nasal bone fracture. The experimental group (n=30) received preoperative explanation with the traditional informed consent process in addition to a mobile application, while the control group (n=30) received preoperative explanation with only the traditional informed consent process. Four weeks after surgery, the number of recalled surgical risks was compared for analysis. The following six surgical risks were explained: pain, bleeding, nasal deformity, numbness, nasal obstruction, and nasal cartilage necrosis. Results: The mean number of recalled surgical risks among all patients was $1.58{\pm}0.56$. The most frequently recalled surgical risk was nasal deformity in both groups. The mean number of recalled surgical risks was $1.72{\pm}0.52$ in the experimental group and $1.49{\pm}0.57$ in the control group. There was a significant association between mobile application use and the mean number of recalled surgical risks (p=0.047). Age, sex, and the level of education were not significantly associated with the mean number of recalled surgical risks. Conclusion: This study found that a mobile application could contribute to the efficient delivery of information during the informed consent process. With further improvement, it could be used in other plastic surgeries and other surgeries, and such an application can potentially be used for explaining risks as well as delivering other types of information.

• 대한기관윤리심의기구협의회지
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• 제5권2호
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• pp.51-58
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• 2023

Purpose: To validate the effectiveness of obtaining consent education on errors in the consent process and to develop the education program for researchers. Methods: From February 2019 to February 2022, a 30-minute, 1:1 face-to-face consent education developed using the ADDIE model was conducted on 78 nurses as principal investigators. An informed consent audit tool, which includes 6 items developed by Asan Medical Center Human Research Protection Center, was used to analyze errors in obtaining informed consent process. Data analysis was performed using the SPSS ver. 25.0, and the Mann-Whitney U-test and χ²-test were utilized to verify the difference in errors between the experimental and control groups. Results: The participants consisted of 42 in the experimental group and 36 in the control group, with no statistically significant difference between the 2 groups. Both 2 groups showed the highest frequency of documentation errors, followed by format errors, errors related to a suitability of investigator, participant, or participant's legally acceptable representative, witness and confidentiality issues. After education, there was a significant decrease in both format errors (p=0.002) and documentation errors (p<0.001) in the experimental group. The proportion of participants without any errors in all items was higher in the experimental group (35.7%) compared to the control group (5.6%), and this difference was statistically significant (p=0.001). Conclusion: The obtaining consent education program was found to be effective in reducing informed consent errors. This study emphasizes the importance of education, suggesting the need for its expansion and accessibility, as well as the necessity for all researchers conducting clinical studies to receive the obtaining consent education.

• 한국의료윤리학회지
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• 제21권4호
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• pp.344-359
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• 2018

본 연구에서는 임상시험에 참여한 만성신장질환자를 대상으로 임상시험 설명문 및 동의서 이해도와 관련 요인을 파악하기 위한 서술적 조사 연구이다. 자료수집은 임상시험에 참여하는 만성신장질환자 85명을 대상으로 2017년 7월 1일부터 2018년 4월 30일까지 설문조사를 통해 실시하였다. 본 연구의 결과로 설명문 및 동의서 객관적 이해도의 평균은 100점 만점에 69.56점, 주관적 이해도의 평균은 5점 만점에 3.28점으로 나타났다. 임상시험 설명문 및 동의서 객관적 이해도의 관련요인으로는 참여 동기(F=13.603, p<.001), 동의서 보유 유무(F=-4.833, p<.001), 건강문해력(F=27.709, p<.001)으로 나타났다. 주관적 이해도의 관련요인으로는 참여 동기(F=5.542, p<.002), 추가정보(F=-3.095, p<.003), 질문(F=-3.399, p<.001), 동의서 보유 유무(F=-5.712, p<.001), 건강문해력(F=5.941, p<.001)으로 나타났다. 결론적으로 만성질환자의 임상시험 이해도는 국외의 연구에 비해 이해도가 낮은 수준이며, 설명문 및 동의서의 내용을 일방적으로 전달하기보다는 이해도와 관련된 요인을 고려하여 동의과정에서 대상자의 충분한 이해를 도울 수 있도록 노력이 필요할 것으로 생각된다.

• 의료법학
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• 제13권1호
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• pp.249-293
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• 2012

Inter-hospital transfer, depending on its medical and legal appropriateness, affect the prognosis of patients and can even lead to legal disputes. As Emergency Medical Service Act, any physician shall, in case where deemed that pertinent medical service is unavailable for such patient with the capacities of the relevant medical institution, transfer without delay such patient to another medical institution where a pertinent medical service is available. For medico-legally appropriate inter-hospital transfer, the head of a medical institution shall, in case where he transfers an emergency patient provide medical instruments and manpower required for a safe transfer of the emergency patient, and furnish the medical records necessary for a medical examination at the medical institution in receipt of such patient. And transfer process must comply with the requirements prescribed by executive rule such as attachment of the referral, provision of ambulance, fellow riders and informed consent of transfer. Those engaged in emergency medical service shall explain an emergency medical service to an emergency patient and secure his consent. In addition to the duty to inform about emergency medical service to the patient and his or her legally representative, there is also a duty for doctors to sufficiently explain to the patient and his or her legally representative during inter-hospital transfer that the need for the transfer, the medical conditions of the patient to be transferred and emergency treatment that will be provided by the hospital from which the patient is going to transferred. Likewise, the hospital to which the patient is transferred must be thoroughly informed about matters such as the patient's conditions, the treatment the patient was given and reasons for transfer by transferring doctors.

• 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.

• 의료법학
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• 제12권2호
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• pp.219-263
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• 2011

"Wrongful conception" is a medical malpractice claim in which the plaintiff is the parent of a normal, healthy infant whose conception was unplanned and unwanted. Medical malpractice in wrongful conception can be the result of a failure to provide informed consent to a patient, failure to properly perform a surgery, or a physician's negligent handling of a patient's problems. In the concrete, wrongful conception cases fall into two categories; those involving pre-conception negligence, such as a failed contraceptive, sterilization or failing of the controlling of embryo-number on the IVF, and those involving post-conception negligence, such as a failure to diagnose a pregnancy or to perform an abortion procedure. In addition, Medical malpractice can be the result of a failure to provide informed consent to a patient. When bad results occur by medical malpractice or failure to provide informed consent to a patient, the range of recovery of damages is decided by a traditional civil liability law. However the calculation of damages for wrongful conception is not easy because the high value of life is included in that case. So many courts opinions in foreign country and Seoul High Court decision in 1996 allow damages for the pregnancy, birthing process and sterilization costs, but refuses to allow damages for child rearing expenses. As to the range of recovery of damages for wrongful conception, one approach says that to allow damages in a suit such as this would mean that the physician would have to pay for the fun, joy and affection which plaintiff will have in the rearing and educating of the plaintiff's baby. To allow such damages would be against the dignity of the baby based on article 10 of the Constitution. However another approach says that damages are recoverable for all expenses related to child birth as well as for child rearing costs. Because the damages that the parents should bear a burden to the tort damage done is not a baby itself but child rearing costs. In other words, although the baby is healthy or not, economic burden of the parents can not be disregard. And denial of compensation for costs of child rearing may invalidate the role of liability law, grant the physician with a exemption certificate of liability. As a result, the medical field of procreation can be easily isolated from a liability of reparation. Therefore, on the liability law like the other medical malpractice action, parents who became pregnant or gave a birth by physician, wrongfully performed sterilization operation, etc. should be compensated for all damages relevant to unplanned and unwanted conception or birth as well as costs of child rearing.