• 동의생리병리학회지
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• 제25권5호
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• pp.927-933
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• 2011

This study aimed to evaluate the quality of herbal medicine-related RCT (Randomized controlled clinical trial) papers. 79 papers were searched from the domestic Hakjin paper list, and 16 papers of them were evaluated in terms of the Jadad Quality Assessment Scale and the adequacy of allocation concealment, and ethical validity. The evaluation results from Jadad Quality Assessment Scale showed that 15 papers showed high quality with the Jadad score of 3 points or higher, and none of the papers had a problem with randomization and double-blinding. The evaluation results from adequacy of allocation concealment showed that 3 of the papers were executed proper allocation concealment, and all of them had 5 points of Jadad score. IRB (Institutional Review Board) approval and written consent was investigated for the evaluation of ethical validity, and 12 papers had the IRB approval, and 14 papers had written consent. The papers published before 2005 were absent of IRB approval and written consent, and none of the papers had IRB approval number. From the above results, it is concluded that rigorous clinical research led high quality of research papers, and the ethical aspect of clinical researches are getting more important to protect the rights of research participants.

• Archives of Plastic Surgery
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• 제36권3호
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• pp.277-282
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• 2009

Purpose: The vegetative state is a clinical condition with complete unawareness of self and environment, but with preservation of brain - stem functions. Vegetative patients may have nosocomial infections in their wounds, like pressure sores and infected craniums after cranioplasties. Usually flap surgery is necessary for those wounds, but decision of undergoing surgery is difficult because of various adverse conditions of vegetative patients. We share our experience of several successful flap surgeries in vegetative patients, and evaluate obstacles and requirements to get satisfactory results. Methods: From December 2005 to September 2008, a total of 4 vegetative patients underwent surgeries. In 2 patients with infected artificial craniums, scalp reconstructions with free flaps were performed. In other 2 patients with huge pressure sores with sepsis, island flap coverage of wounds was done. Retrospective study was done on hospital day, vegetative period, number of surgeries done, underlying diseases, causative bacteria, and contents of informed consent. Results: Mean hospital day was 14 months and mean vegetative period was 17.5 months. Patients underwent average of 4.5 surgeries under general anesthesia. There were several underlying diseases like hypertension, DM, CHF and chronic anemia. MRSA(Methicilin - resistant Staphylococcus Aureus) was cultured from every patient's wounds. Informed consent included a warning for high mortality and a need of attentive familial cooperation. Conclusion: There are three requirements for doing flap surgeries in vegetative patients. First, to prevent aggravation of brain damage and underlying diseases by general anesthesia, multidisciplinary team approach is needed. Second, operation should be beneficial for prolonging patient's lifespan. Third, because postoperative care is very difficult and long hospitalization is needed, detailed informed consent and highly cooperative attitude of family should be confirmed before operation.

• 정보보호학회논문지
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• 제30권2호
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• pp.263-277
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• 2020

아동의 인터넷 사용이 활발해 짐에 따라 각 기업에서는 아동의 개인정보를 수집한다. 하지만 아동이 개인정보에 개념조차 인식하기 어려운 상황에서 아동 개인정보 유출 사건이 발생하면, 스스로 법적 권리구제를 위해 적극적으로 나서기가 쉽지 않다. 본 연구에서는 아동 개인정보 유출 사고 신문기사 분석을 바탕으로 사회과학분야에서 사용하고 있는 질적연구방법 중 하나인 근거이론을 통해 아동 개인정보 유출의 발생 과정을 살펴보았다. 근거이론은 아동 개인정보 유출에 대해 유출 현상을 파악하고 이를 통해 인과적 관계 도출이 가능 할 것으로 판단된다. 연구 결과, 법정 대리인의 동의를 통해 수집되고 있으나 상황에 따라 동의 절차를 거치지 않는 경우가 있었고, 동의를 받았더라도 미흡한 개인정보보호 조치로 인해 법정 대리인은 다양한 상황(범죄 피해, 불안감, 당혹감, 분노 등)이 발생 되는 것으로 나타났다. 이로 인해 아동 개인정보 수집 사업자는 상황에 따른 벌금을 지불하게 되었다.

• Strategy21
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• 통권41호
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• pp.153-173
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• 2017

On 15 December 2015, China seized an underwater drone belonging to the U.S. in the South China Sea. The underwater drone was then about to be retrieved by the Bowditch, a U.S. naval ship.Although China returned the underwater drone to the U.S. on 20 December 2016, the incident resulted in the considerable controversy involving the use of underwater drones. The reason for this is that the seizure of the underwater drone happened in the exclusive economic zone (hereafter referred to as "EEZ") of the Philippines. Part XIII of the United Nations Convention on the Law of the Sea (hereafter referred to as "UNCLOS") governs the matters of marine scientific research (hereafter referred to as "MSR"). If a State intends to use an underwater drone in the EEZ of another coastal State for the purpose of MSR, the former has to obtain the consent of the latter in accordance with relevant provisions included in Part XIII of the UNCLOS. However, it is not obvious whether the consent of a coastal State should be required to launch an underwater drone in the EEZ of the State for the purpose of hydrographic surveying or military surveying. Maritime powers such as the U.S. regard hydrographic surveying or military surveying as part of "other internationally lawful uses of the sea related to these freedoms, such as those associated with the operation of ships, aircraft and submarine cables and pipelines" found in Article 58(1) of the UNCLOS, or part of the freedom of the high seas. This interpretation is not incompatible with the implications that the UNCLOS has. Nevertheless, Korea cannot accept this kind of interpretation that is supported by maritime powers. The freedom of hydrographic surveying or military surveying could imply that the EEZ of Korea would be full of underwater drones launched by China, Japan or even Russia. Hence, Korea should claim that the data collected for the purpose of MSR cannot be distinguished from that collected for the purpose of hydrographic surveying or military surveying. This means that hydrographic surveying or military surveying without the consent of a coastal State in the EEZ of the State should not be permitted.

• 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.

• Archives of Plastic Surgery
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• 제42권1호
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• pp.46-51
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• 2015

Background In all branches of medicine, it is the surgeon's responsibility to provide the patient with accurate information before surgery. This is especially important in cosmetic surgery because the surgeon must focus on the aesthetic results desired by the patient. Methods An experimental protocol was developed based on an original questionnaire given to 72 patients. The nature of the responses, the patients' motivation and expectations, the degree of patient awareness regarding the planned operation, and the patients' perceptions of the purpose of the required consent for cosmetic surgery were all analyzed using Fisher's exact test. Results Candidates for abdominal wall surgery had significantly more preoperative psychological problems than their counterparts did (P=0.035). A significantly different percentage of patients under 40 years of age compared to those over 40 years of age searched for additional sources of information prior to the operation (P=0.046). Only 30% of patients with a lower educational background stated that the preoperative information had been adequate, whereas 92% of subjects with secondary schooling or a postsecondary degree felt that the information was sufficient (P=0.001). A statistically significant difference was also present between patients according to their educational background regarding expected improvements in their quality of life postoperatively (P=0.008). Conclusions This study suggests that patients require more attention in presurgical consultations and that clear communication should be prioritized to ensure that the surgeon understands the patient's expectations.

• 의료법학
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• 제5권2호
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• pp.294-319
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• 2004

Because the treatment of a physician generally pertains to the intrusion into body of a patient, his/her consent is a must in order for such conduct to be justifiable. To ensure effective consent of a patient, the physician should fully inform him/her of kind and details of the disease and way of treatment and risks associated with it. The patient can, then, make a decision whether he/she should accept any treatment or operation, if necessary, on the basis of such information. The obligation of physicians to explain has since long been recognized as important in view of guaranteeing the rights of patients for self-decision and protecting them from arbitrary assessment of physicians for treatment. Progress has been made in this respect even to the extent that physicians treat patients on equal terms and think first of all much of establishing trustworthy relationships with patients. Lots of studies in Korea and foreign countries have tried to explore the issues concerning the obligation of physicians to explain in the meantime but seem to have failed to make concrete and versatile approaches from the standpoint of protecting the rights of patients. Wouldn't it be really possible for patients to perceive their own rights and cope actively with the medical treatments? If physicians have full understanding to the rights of patients, they will be put in a better situation to protect themselves and patients, in turn, can identify their own responsibility correctly, which will eventually contribute to fulfilling the goal of treatment. With this background, the present paper examines briefly the obligations of physicians for explanation based mainly on the preceding theories and judicial precedents in the first place and then deals with the status quo and contents of the German medical laws, with a focus on the treaty of European Law 1997 and its working document on the applications of genetics for health purposes that stipulate the detailed criteria on the medical treatment and rights of patients and Germany's $\ulcorner$Charter of Rights for Patients$\lrcorner$ promulgated in 2003.

• 의료법학
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• 제13권1호
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• pp.125-153
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• 2012

The adult guardianship system has been introduced through amendments of Korean Civil Code for the first time in the March 2011(Act No. 10429, 7. 1. 2013. enforcement). The adult guardianship system has the main purposes to provide a lot of help vulnerable adults and elderly, and protect them on the welfare related with property act, treatment, care, etc. There could be a controversy about whether the protection Legal Guardian's consent(formerly known as the Mental Health Act) or permission of the Family Court(revised Civil Code) are required to, or the Mental Health Act should be revised, when mental patient will be hospitalized forcibly. The author proposes that mental patient with Adult guardians should be determined by Legal Guardian's consent and approval of the Family Court, but mental patient without Adult guardians could be determined by Legal Guardian's consent. The issue of Withdrawing of life-sustaining treatment could be occurred due to the aging society and the development of modern medicine, and this has provided difficult, various problems to mankind in Legal, ethical, and social welfare aspects. The need of Death with dignity law or Natural death law has been reduced for a revision of the Civil Code. Therefore, on the issue of Withdrawing of life-sustaining treatment, in the future, intervention of the court is necessary in accordance with the revised Civil Code Section, and Organ Transplantation Act and the brain death criteria may serve as an important criterion.

• 스마트미디어저널
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• 제10권2호
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• pp.84-91
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• 2021

EU의 GDPR에 따르면 개인정보를 수집할 때 정보 주체(사용자)의 동의 혹은 거절하는 권리가 가장 우선시 되고 있다. 그러므로 정보 주체는 언제라도 동의 철회 및 잊힐 권리를 주장할 수 있어야 한다. 특히, 제한적인 IoT 장치(Constrained Node)에서는 프라이버시에 민감한 데이터의 수집, 처리 등에 대해 정보 주체의 동의 기능 구현 및 수집 정보의 활용 내용을 게시하기 매우 어렵다. 본 논문에서는 정보 주체가 IoT 장치에서 수집, 처리되는 데이터를 모니터링하여, 정보 유출의 문제를 인지하고, 연결 및 장치 제어가 가능한 관리 시스템을 설계하고 구현하였다. IoT 장치의 표준 OCF(Open Connectivity Foundation)와 장치 연결 프레임워크인 AllJoyn의 공통 정보를 고려하고, 정보 보호를 위한 메타 데이터 10개를 정의하였다. 이를 DPD(Data Protection Descriptor)라고 명명하였으며, DPD를 기반으로 정보 주체가 정보를 관리할 수 있는 SW인 DPM(Data Protection Manager)를 개발하였다.

• 의료법학
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• 제23권4호
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• pp.75-102
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• 2022

본 글에서는 보건의료관련 법령 중 「연명의료결정법」, 「정신건강복지법」, 「장기이식법」, 「인체조직법」, 「약사법」, 「에이즈예방법」, 「결핵예방법」, 「감염병예방법」을 검토하였다. 이들 법률에 민법적 사고가 필요한 부분은 환자의 자기결정권과 동의에 관한 부분이다. 그리고 환자가족을 통한 의사결정이 환자의 의사결정을 대행하는 것인지 환자가족이 환자를 위하여 고유의 권한으로 의사를 결정하는 것인지와 관련하여 성년후견제도에서 후견인의 동의대행과 비교하여 이해할 필요가 있다. 보건의료관련 법령은 환자의 자기결정권과 그 실현을 위한 동의대행의 문제에서 민법과 깊게 연관되어 있음에도 불구하고 개개 법률의 관련 규정은 민법의 동의에 관한 원칙이나 성년후견제도와 별개로 규정되어 있음을 확인할 수 있다. 보건의료관련법령의 일차적 목적이 환자의 자기결정권 실현에 있지 않다고 하더라도 의료관련 행정이 통일적으로 운영되기 위해서는 민법의 의사결정 및 그 대행에 관한 원칙을 이해할 필요가 있다.