• 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.

• 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.

• The Korean Society of Law and Medicine
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• v.16 no.1
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• pp.221-254
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• 2015

The amendment of the Korea Civil Code will take place July 1, 2013. One of the most import issues related to adult guardianship system is a part. Though more than 100 new provisions, the revised Civil Code fundamentally reformed the guardianship system to establish a system to meet the diverse and complex needs of those who need a guardian and ensure due process. The new adult guardianship system intended to respect dignity and human right of mentally incapacitated adults, to guaranee their autunomy and to minimize the public interventions for assisting them. The new guardianship system for vulnerable adult has three kinds of legal guardianship system (adult guardianship, limited guardianship and specific guardianship). Mental patients forced the hospitalization of the mental health code and will be treated as an agreement incapable person. In principle an agreement incapable person has capacity of consent. The consent of the mental patients are admitted first. It is advisable to medical care only by the consent of the guardian when the the mental patient do not agree ability. If the mental patient do not agree with the mentally ill, but there should be a supervisory capacity for a guardianship of the couple guardian supervision. In conclusion, it not lost the capacity to consent to inpatient mental illness called. Therefore, we must discuss in detail the scope of the agreement for the mental patients. Mental Health Act amendments are necessary in accordance with the amended Civil Code.

• The Korean Society of Law and Medicine
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• v.10 no.1
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• pp.389-420
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• 2009

Main Issue of Supreme Court Decision 2005Da16713 Delivered on June 24, 2005 is about the duty of medical care in the interhospital transfer of patients. According to the above Supreme Court Decision, in the interhospital transfer of patients, the decision to transfer should make from the aspect of medical treatment. The hospitals and doctors keep the duty of medical care. In addition to the duty for hospitals/doctors to check the capacity and availability of the hospital to which the patient is transferred, there are also duties to inform about emergency medical service and to sufficiently explain the need for the transfer, the medical conditions of the patient to be transferred and the hospital from which the patient is transferred. 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. including information upon referral, completeness of medical records, patient monitoring and so on. The interhospital transfer requires the consent of doctor belonging to the hospital to which the patient is transferred after the consideration of capacity and availability of the hospital and the informed consent of patients or legal representatives.

• Proceedings of the Korea Contents Association Conference
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• 2012.05a
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• pp.173-174
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• 2012

To determine whether position affects measured lung capacity of spinal cord injury patients. The study subjects were 45 patients with spinal cord injury (cervical level 15, thoracic level 15, lumbar level 15). Subjects were provided with a full explanation of the experimental procedures and all provided written consent signifying their voluntary participation. We used a spirometer (Spirometer, Micromedical Ltd, UK) to measure pulmonary function in the supine and sitting positions (straightened upper body at an angle of $90^{\circ}$). Forced vital capacity (FVC), forced expiratory volume during the first second (FEV1), tidal volume (TV), and maximum insufflation capacity (MIC) were also measured. FVC, FEV1, TV, MIC (%) were greater in the supine than in the sitting position for those with injury at the cervical or thoracic injury level. On the other hand, FVC, FEV1, TV, MIC (%) were lower in the supine position for those with an injury at the lumbar level. More attention should be paid to the effect of injury level on measured lung capacity.

• The Korean Society of Law and Medicine
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• v.24 no.2
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• pp.147-196
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• 2023

Advances in brain science have made it possible to stimulate the brain to treat brain disorder or to connect directly between the neuron activity and an external devices. Non-invasive neurotechnologies already exist, but invasive neurotechnologies can provide more precise stimulation or measure brainwaves more precisely. Nowadays deep brain stimulation (DBS) is recognized as an accepted treatment for Parkinson's disease and essential tremor. In addition DBS has shown a certain positive effect in patients with Alzheimer's disease and depression. Brain-computer interfaces (BCI) are in the clinical stage but help patients in vegetative state can communicate or support rehabilitation for nerve-damaged people. The issue is that the people who need these invasive neurotechnologies are those whose capacity to consent is impaired or who are unable to communicate due to disease or nerve damage, while DBS and BCI operations are highly invasive and require informed consent of patients. Especially in areas where neurotechnology is still in clinical trials, the risks are greater and the benefits are uncertain, so more explanation should be provided to let patients make an informed decision. If the patient is under guardianship, the guardian is able to substitute for the patient's consent, if necessary with the authorization of court. If the patient is not under guardianship and the patient's capacity to consent is impaired or he is unable to express the consent, korean healthcare institution tend to rely on the patient's near relative guardian(de facto guardian) to give consent. But the concept of a de facto guardian is not provided by our civil law system. In the long run, it would be more appropriate to provide that a patient's spouse or next of kin may be authorized to give consent for the patient, if he or she is neither under guardianship nor appointed enduring power of attorney. If the patient was not properly informed of the risks involved in the neurosurgery, he or she may be entitled to compensation of intangible damages. If there is a causal relation between the malpractice and the side effects, the patient may also be able to recover damages for those side effects. In addition, both BCI and DBS involve the implantation of electrodes or microchips in the brain, which are controlled by an external devices. Since implantable medical devices are subject to product liability laws, the patient may be able to sue the manufacturer for damages if the defect caused the adverse effects. Recently, Korea's medical device regulation mandated liability insurance system for implantable medical devices to strengthen consumer protection.

• The Korean Society of Law and Medicine
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• v.23 no.4
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• pp.103-131
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• 2022

2021, the Supreme Court recognized the foundation of the quasi-indecent act by force by the concept of 'alcohol blackout' although there were multiple situations that it was hard to judge insanity of the victims was evident in the cases with drunken victims. This means the consideration of insanity state due to temporary false memory rather than the total loss of mental capacity from the existing concept of insanity. However, the interpretation of insanity in the criminal law has to be strict and its application could be difficult. In particular, the comparison precedent which is very similar to the subject one was determined not to be the same with the state of the insanity or inability to resist during the sexual relation though the victim had the symptoms of alcohol blackout, denying the quasi-indecent act by force. This argument is determined to be logical remarkably, and insanity and quasi-indecent act by force should be discussed considering the medical review on the alcohol blackout of the victims sufficiently when determining the individual precedents. In addition, the most important point in the sexual crimes is the consent, and there may be possibility of negligence in case that uncertain consent is determined as the consent to continue the following act. Also, in case of uncertain consent or suspicious, universal determination not to follow the act should be able to realized. Therefore, strong evidence is required for criminality, determining that the victim is the state not to be able to do the normal judgment and the minimum willful negligence is existed that the accused uses this. In the subject ruling, the act of the accused has to be clearly punished, however, it is determined to be unreasonable for the punishment with the quasi-indecent act by force under the interpretation of the current regulations.

• 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.

• Journal of The Korean Society of Integrative Medicine
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• v.9 no.4
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• pp.11-18
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• 2021

Purpose : The purpose of this study was to investigate the effect on lung capacity of healthy men and women in their twenties by performing an intervention using the chest extension exercise and the bridge exercise, which are respiratory muscle strengthening exercises. Methods : Thirty adult men and women in their 20s participated in this study. All subjects participated in the study after hearing the explanation of the purpose and method of the study, filling out a consent form. All subjects were randomly assigned to the chest extension exercise (CEE) group and the bridge exercise (BE) group of fifteen each. Each exercise was performed twice a week for 4 weeks. Lung capacity was measured by forced vital capacity (FVC) and forced expiratory volume in one second (FEV₁) using spirometry. Lung capacity was measured before and after exercise. The measured data were compared through the dependent t-test and the independent t-test. The statistical significance level was set at .05. Results : After the intervention, the CEE group showed a significant increase in FVC and FEV₁ compared to before the intervention (p<.05). After the intervention, the BE group also had a significant increase in FVC and FEV₁ compared to before the intervention (p<.05). However, there was no difference in FVC and FEV₁ between groups before and after the intervention (p>.05). Conclusion : There was no difference between groups in lung capacity after exercise. However, both the chest extension exercise and the bridge exercise increased FVC and FEV1, which was thought to be because both exercise methods were effective in increasing lung capacity. Therefore, both chest extension exercises and bridge exercises can be effectively applied as a way to increase lung capacity.

• THE INTERNATIONAL COMMERCE & LAW REVIEW
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• v.69
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• pp.153-178
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• 2016

The United Nations Convention on the International Sale of Goods(CISG) leaves a number of aspects concerning commercial sales untouched. In particular, it is not concerned with the validity of the contract or of any of its provisions or of any usage. And UNIDROIT don't deal with all-round validity in International Commercial Contract. Especially, UNIDROIT includes declaration of intention department. The UNIDROIT contains the chapter 3 on the "validity" in terms of the defects of consent such as mistake, fraud, and threat as well as "gross disparity". Notwithstanding these provisions, the Principles did not deal with invalidity arising from the lack of capacity or authority, or immorality or illegality. On the other hand, there are arguments that the corresponding provisions of the Principles of International Commercial Contracts(UNIDROIT Principles; PICC). Therefore, Validity in International Commercial Contract is delegate by Each Country Law. So Trade practicer should know full well about Each Country Law Position. People(human, corporation, company) of position Trade practice classify each country civil law relation to validity of commercial contract. This paper is to examine the Validity of UNIDROIT Principles. Also this paper analyses comparison on each country position relation to capacity of right, capacity to act, illegality of contract, declaration of intention. In conclusion, This paper expect that people of trade practice makes use of analysis knowledge.