• 의료법학
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• 제15권1호
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• pp.303-333
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• 2014

The right to self-determination in regard to one's body is a key element of human dignity, privacy and freedom. It is constitutionally enshrined in the guarantee of human dignity, in the general right of personality and, most concretely of all, in the right to physical integrity. In principle No-one may trespass another person's body against his will, whether this act improves his physical condition or not. This right of self-determination applies equally to healthy and to sick people. Hence everyone has the right either to permit or to refuse a medical treatment, unless he can not make a rational decision. If the person does not consent himself, for whatever reason, another one must do for him as guardian. Representation in consent to medical treatment is therefore the exception of self-determination rule. This article explored, 1. who can consent to the medical treatment in the case of the mentally incapacitated adult and the infant, 2. what kind of consent to the medical treatment can the deputy determinate for the mentally incapacitated adult and the infant, 3. when the deputy can not determinate without permission of the court, and 4. what can the doctor do in the case of conflict between minors and guardians.

• 의료법학
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• 제16권2호
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• pp.3-26
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• 2015

수술행위는 신체에 대한 침습을 포함하는 것이므로 의료인은 수술주체와 수술행위의 내용을 충분히 설명하여 환자가 그 수술을 받을 것인지의 여부를 선택하도록 하여야 하고, 이는 헌법 제10조에서 규정한 개인의 인격권과 행복추구권에 의하여 보호되는 환자의 자기결정권에 해당한다. 미국에서는 '대리수술'의 경우 폭행에 해당한다고 판단한 사례가 있으나, 국내에서는 아직까지 수술의사에 대한 상해죄 등을 인정한 사례가 없고, 수술행위는 환자의 신체에 대한 적대적인 손상행위가 아니므로 상해죄로 처벌하기 어려운 면이 있다. 또한 환자의 '가정적 승낙'을 폭넓게 인정하는 판례의 입장에 따르면 의사의 전단적 의료행위에 대하여 업무상과실치사상죄로 처벌하기도 어려우므로, 환자의 자기결정권 강화를 위하여 의사의 설명의무를 의료법 등에 명문화하고, 대리수술 등 전단적 의료행위에 대하여 별도의 처벌규정을 입법화할 필요가 있다.

• 의료법학
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• 제17권2호
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• pp.145-173
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• 2016

우리나라에서 전통적으로 환자의 자기결정권 내지 자율권은, 의사의 보고성 설명의무에 대응하는 알 권리 그리고 의사의 기여적 설명의무에 대응하는 수진 동의권 및 수진 거절권, 양자를 '중심'으로 해서 논의되어 왔다. 환자의 자율적 결정의 내용으로서 형성 피력되는, 자기 신체 및 의료 상황에 대해 알고 싶지 않은 희망과 그로 인한 이익에 관한 지위- 도덕적 법적 지위 - 는 환자로부터의 알 권리와 동의권의 포기 또는 (의사가 부담하는) 설명의무의 면제라는 소극적 지위 차원에서 인식되었다. 그리고 설명 동의 원칙 도그마의 적용에 의한 역기능 문제는 설명 동의 원칙의 적용 배제 및 그에 따른 의사의 책임 부인이라는 역시 소극적 접근법에 의해 '주로' 인식되었다. 즉 환자의 그러한 알고 싶지 않다는 '무지(無知)의 희망'을 실현시켜 줄 법적 수단이 환자의 '모를 권리' 및 의사의 '부작위 배려의무'라는 '적극적 지위'로 이해되고 인정되지 않았던 것이다. 이러한 당사자의 적극적 지위 설정이 전제되지 않으면 실제상 및 이론상 문제가 제기된다. 환자가 동의권을 포기한다고 선언하거나 의사의 설명의무를 면제한다고 표명했음에도 불구하고, 의사가 굳이 환자를 상대로 설명 내지 보고를 행하여 환자에게 큰 손해가 발생한 경우에, 의사의 그 행위를 규범적으로 어떻게 평가할 것인가가 문제인 것이다. 한편 의사가 설명의 역기능을 우려하여 설명을 행하지 않았고, 그 행태에 대해 적절한 것이란 평가가 가능한 경우에, 그 재량적 불설명의 적법성을 인정할 직접적 근거가 무엇인지를 밝히는 것 또한 문제이다. 이러한 문제를 해결하기 위해 근본적으로 환자에게 '모를 권리'라는 지위를, 의사에게 '배려의무'라는 지위를 인정할 필요가 있다. 요컨대 이 권리와 의무 개념은 환자의 자율성 관념의 충실화와 설명역기능 현상의 적정한 방지라는 법규범적 요구를 충족시키는 데에 매우 유용한 도구로서 수용할 수 있다.

• 임상간호연구
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• 제14권2호
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• pp.59-70
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• 2008

Purpose: Purposes of this study were to promote understanding on mutually informed consent by comparing and analyzing the perception and experience of informed consent among physicians, nurses, and patients. Method: Participants in the study were 145 physicians, 300 nurses, and 178 patients from eight hospitals in Busan. To examine their understanding and experience with informed consent, all participants responded to a questionnaire. The collected data were analyzed using SPSS/PC 12.0 program. Results: On the necessity of informed consent, the affirmative percentages were 95.9% for physicians, 99.0% for nurses and 84.8% for patients. As to the most important reason for informed consent 47.6% of the physicians and 64.3% of the nurses answered 'because it is an occupational and ethical duty', while 46.6% of the patients answered 'because it is protection for physicians'. Regarding the legal decision maker for informed consent, 33.1% of the physicians, 27% of the nurses, and 42.1% of the patients answered that the legal decision-making right belonged to the 'patient'. The agreement rate on the necessity of providing a comprehensive explanation about informed consent was 89.0% for physicians, 98.3% for nurses, and 96.1% for patients. Conclusion: Most physicians, nurses, and even patients have inaccurate perceptions and inappropriate experience with informed consent.

• 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.

• 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.

• 의료법학
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• 제9권2호
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• pp.11-52
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• 2008

Based on foreign examples and past debates, the minimal conditions for passive euthanasia can be suggested as following; (1) The patient is incurable by modem medical practice and his death is impending (less than 6 months), (2) Euthanasia is practiced solely to relieve physical pain of the patient, (3) If the patient can express his will, there should be a clear and sincere request or consent, (4) More than 2 doctors including doctor in charge should consent, (5) Euthanasia should be practiced in ethical way, (6) Patient family should agree(when the patient will is assumed.) It is hard to resolve issues regarding euthanasia based on past rulings and cases without concrete law. As in United States and Germany, clear and objective provisions of euthanasia and definitive method for patient's advanced directive should be legislated to resolve medical conflict and to relieve patient and family from agony. And death with dignity debate will not be able to proceed if it is only substantively approached because of unclear definition of euthanasia and benefit comparison way of thinking. Thus it is important to establish definitive process to decided legislation of euthanasia act and resolving conflicts arising from each step of the process among interested parties exchanging medical/ethical opinions.

• 한국중재학회지:중재연구
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• 제30권4호
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• pp.51-70
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• 2020

The Mediation-Arbitration hybrid is becoming more popular since it makes an amicable relationship and thorough statement possible. The Mediation-Arbitration hybrid has been used to take advantage of both dispute resolution methods. In a Med-Arb process, negotiating a resolution to disputes is attempted with a mediator's help. If the mediation ends in an impasse or issues remain unresolved, parties can move on to arbitration. Med-Arb can also be cost-effective when disputants hire one person to serve as mediator and arbitrator (Med-Arb-Pure). However, it can disturb the fairness and neutrality of arbitrators, and awards can be annulled. Indeed, "Award by Consent" is different from the "Med-Arb-Pure" process. Arbitrators easily confuse them. Only the parties settle on the arbitral proceedings' course, and the arbitrator can help them (award by consent). The role and skill of a mediator are different from an arbitrator's. Disputants have the right to use a mediator who specializes in mediation. Moreover, mediation communication confidentiality is the essential value of mediation, and this should be protected. Therefore, in the process of "Med-Arb," separation between mediating and arbitrating is a better choice to specialize in each expertise. In this process, "Med-Arb" can be an affordable, expeditious, proper, and effective method of resolving international commercial disputes and continuing ADR prime time.

• 대한기관윤리심의기구협의회지
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• 제1권2호
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• pp.30-42
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• 2019

In pharmaceutical clinical trials as human material research, the collection, use, storage and provision of human materials must be in accordance with the criteria stipulated in 「Bioethics and Safety Act」, except in the case that some criteria about it is in the law related to clinical trials such as 「Pharmaceutical Affairs Act」 and 「Enforcement Rule on Safety of Drugs, etc.」 so these take precedence over. Under 「Bioethics and Safety Act」, the core aspect of the legal standard for obtaining informed consent is the use of statutory form . The use of statutory form ensure that both those who obtain informed consent and those who give it can know the contents contained this form as well as recognize its importance. Thus, the person who has the right to informed consent can sign the statutory form after correct understanding of the contents. In reality, however, some researchers and IRB members determine that only the main informed consent form is to be used because most of contents on statutory from are included in the main informed consent form. Some other researchers and IRB members judge that the use of statutory form is not needed if human materials may only be used for laboratory testing and the rest will not be stored and provided for future use. Most of these determination and judgement is based on the interpretation of the Korea National Institute for Bioethics Policy(hereafter, KoNIBP) on IRB Information Portal Site. But, it is questionable whether the KoNIBP's interpretation is legally valid and the KoNIBP is the legal entity having authority to interpret existing statute. In some cased not only using the main informed consent form including enough information about the collection, use, storage and provision of human materials but also collecting necessary minimum human materials, and discarding the rest, unusing the statutory form may not cause the problem to respect and protect the research participant's rights. Therefore, the provision stipulating the criteria about the use of statutory form as the legal standard of obtaining informed consent that applies all human material research without exception should review to revise. At least, straighten out the confusion surrounding whether or not the statutory form is to be used, before the revision of related provision, considering the logical opinions of some researchers and IRB Members, the Ministry of Health and Welfare as the legal entity having authority to interpret existing statute should represent its opinion about permission of the acceptable exceptions.

• 의료법학
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• 제23권1호
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• pp.37-80
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• 2022

이 논문에서는 현행 응급의료에 관한 법률이 규정하고 있는 응급의료에서의 설명·동의의 원칙과 응급의료거부죄를 검토함으로써 응급의료종사자의 환자에 대한 생명보호 의무가 환자의 자기결정권 보장보다 중요한 경우에 한하여 응급의료거부죄가 성립함을 제시한다. 응급의료에서도 일반 의료상황과 마찬가지로 의료행위 시행 전 환자에게 응급의료의 필요성이나 방법 등에 관하여 설명하고 동의를 받아야 함이 원칙이다. 다만, 설명·동의 절차를 예외적 방법으로 이행하거나 생략할 수 있음에도 그 절차 준수를 이유로 응급의료를 거부·기피한 응급의료종사자는 응급의료거부금지에 따른 행정처분과 행정벌을 부담하게 된다. 즉, 설명·동의 절차 생략 가능성에 관한 판단에 따라 응급의료거부죄가 성립할 수도 있는 것이다. 환자가 미성년이거나 의사결정능력이 없는 경우 그 법정대리인이 환자의 의학적 이익에 반하는 결정을 하더라도 법정대리인의 의견이 무조건적으로 존중되는 것은 아니다. 미성년 환자도 원칙적으로 자신의 신체에 관하여 결정할 권리가 있고, 법정대리인의 결정 역시 환자의 최선의 이익을 위한 것일 때 유효하기 때문이다. 환자가 치료를 거부하는 상황에서도 원칙적으로 응급의료종사자의 생명보호의무가 더 우선한다. 그러나 현행법은 여러 예외 상황에 대해 명문의 규정을 두고 있지 않아 응급의료 현장에서 그 해석에 어려움이 있다. 한편, 우리 대법원 및 하급심 판례는 응급의료종사자의 응급의료의무와 설명의무 사이의 이익형량이 불가피한 상황에서 환자의 생명상실이 문제되는 경우 설명의무보다 응급의료를 시행하여 환자의 생명을 보호하여야 할 의무가 우선이고, 예외적으로 사전에 치료 여부·방법에 대해 환자의 진지한 숙고가 있었던 경우 환자의 자기결정권이 응급의료의무와 대등하게 고려될 수 있다는 취지로 설시하고 있으므로, 이를 체계적으로 정리하고자 한다. 나아가 현행법의 해석만으로 해결이 어려운 부분에 대하여는 1) 미성년자에 대한 응급의료의무 조항 신설, 2) 응급환자의 의사결정능력 판단 기준을 의학적 내용을 중심으로 수정·보완, 3) 응급처치시 의료인의 추가 동의가 불요함을 명시, 4) 복수의 의견 충돌이 있는 경우에 대한 제도적 보완, 5) 응급의료 중단시 벌칙조항 신설 등 입법 과제를 제시한다.