• The Korean Society of Law and Medicine
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• v.15 no.1
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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.

• The Korean Society of Law and Medicine
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• v.18 no.1
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• pp.3-35
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• 2017

The Supreme Court of Korea first admitted compensation for damages caused by breach of informed consent in 1979. From then on, specific details of informed consent are shaping up and developing through court precedents. The duty of informed consent of doctor is based on article 10 of the Constitution and medical contract, and is expressly prescribed Article 12 of Framework Act on Health and Medical Services and other acts and regulations. By the way, the regulations about duty of informed consent of doctor have been established in Medical Law revised on December 20, 2016, and the revised Medical Law will be implemented on June 21, 2017. According to the revised Medical Law, medical practices subject to description and consent are operation, blood transfusion and general anesthesia that threaten to cause serious harm to human life or to the body. When performing these medical activities, the written consent must be explained and agreed upon in advance. If a doctor violates the law, he will incur fines of less than 3 million won. Comparing and viewing the revised Medical Law and existing legal principles about the duty of informed consent, we can confirm that there is a substantial difference between the two parties. Accordingly, despite the implementation of the revised medical law, the existing legal principles are unlikely to be affected. However, from the perspective of legal uniformity and stability, it is undesirable that legal judgments on the same issues differ from each other. The revised Medical Law about informed consent needs to be reformed according to existing legal principles. And, as in the case of Germany, it is desirable to include the matters concerning informed consent in the civil code.

• The Korean Society of Law and Medicine
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• v.20 no.2
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• pp.111-140
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• 2019

The Bioethics and Safety Act provides a set of rules to regulate biobanks and research activities using human biological material, but the law seems to be defective in several folds. The law requires that, prior to collection or use of human biological materials, researchers should obtain the informed consent of the donors, but the law does not obligate biobanks to do so. Even in cases where the law requires informed consent, the ordinance of the Ministry of Health and Welfare allows open (or blanket) consent. In addition, a new article in the Act, Article 42-2 which will take effect from October 24, 2019, allows medical institutions to provide biobanks with remaining biospecimens collected in the course of diagnosis and treatment, unless the donors express their intent to opt-out, without obtaining specific consent from them. Given the need to protect the autonomy of donors and the unique characteristics of biobanks and research activities that use human biological materials, this paper concludes that such open consent-based law may not be suitable to protect the autonomy of the donors and that the broad consent requirement may be a desirable policy option. The paper acknowledges that the international community has long questioned whether broad consent (as well as open consent) is an effective choice to regulate the use of human biological materials. The paper stresses that the baseline requirement in designing the law is that the secondary use of human biological materials should be based on informed consent of the donors; the core value of the law should be a governance structure that promotes transparency and protects donor participation.

• The Korean Society of Law and Medicine
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• v.16 no.2
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• pp.3-26
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• 2015

Recently, Practicing of ghost surgery and duty of informed consent of doctors have become a big issue in the medical dispute and lawsuits. The ground of admitting the informed consent and the agreement(self-determination of patients) can be based on the dignity of man and the right to pursue his happiness guaranteed under Article 10 of the constitution in theory. However there are no explicit legal regulations on the duty of the informed consent and there is no substantive legal enactment on the informed consent, but there is a collision between self-determination of patients and the discretionary power of doctors. If the discretionary power on the duty of the informed consent was extended it may result in the infringement of the right of surgical patients, so called arbitrary medical treatment. Relating to this issue, New Jersey Supreme Court held that a patient has the right to determine not only whether surgery is to be performed on him, but also who shall perform it. Moreover it held that a surgeon who operates without the patient's consent engages in the unauthorized touching of another and, thus, commits a battery'. But there are no ghost surgery cases adopting battery theory in Korea, and professional negligence has been considered rather than the battery, regarding an absence of hostile intent to injure patient. Supreme Court of Korea held that a doctor who operates a medical procedure without the patient's valid prior consent based on wrong diagnosis commits professional negligence resulting in injury, and the patient's invalid consent do not preclude wrongfulness'. However, if a health care provider conducts a completely non-consensual treatment or substitute surgeon without consent, the action should be plead in battery, not negligence, but if a health care provider violate his duty of care in obtaining the consent of the patient by failing to disclosure all relevant information (risks) that a reasonable person would deem significant in making a decision to have the procedure, the action should be plead in negligence, not battery. Therefore, the scope of patients' self-determination can be protected by stating clearly the scope of the duty of the informed consent and the exemption of the informed consent legislatively, it is considered that it is valid to legislate the limitation of the discretionary power.

• The Journal of KAIRB
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• v.5 no.2
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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.

• The Journal of KAIRB
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• v.1 no.2
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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.

• Journal of Digital Convergence
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• v.13 no.11
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• pp.187-196
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• 2015

The purpose of this study was to examine the understanding of contents and the convenience of use of the DNR animation mobile electronic informed consent. The subjects in this study were inpatients of long-term care hospital. As for data analysis, a statistical package SPSS 21.0K was employed. The findings of the study were as follows: First, DNR choice was 33.0%, CPR choice was 54.0% in case of the outbreak of cardiac arrest. Their principal diagnosis made statistically significant differences to their choice of DNR and CPR. Second, they got 2.50 in the understanding of the content of the DNR electronic informed consent, and got 2.37 in the convenience of use. Given the findings of the study, the DNR animation electronic informed consent is expected to help patients to have a better understanding of contents, to make their decision to choose DNR or CPR, and to sign the DNR informed consent forms themselves.

• The Journal of Korean Medicine
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• v.45 no.1
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• pp.182-201
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• 2024

Objectives: This study was conducted to develop a standard acupotomy consent form that takes into account the unique characteristics of Korean Medicine. The study was motivated by the increasing importance of patient autonomy and the growing number of legal disputes related to medical malpractice in the clinical field of Korean Medicine. Methods: The analysis phase of the study involved a survey of the current status of acupotomy consent forms in Korean Medicine hospitals nationwide. The items of each form were analyzed based on the contents of the Medical law and the standard contract for medical procedures of the Fair Trade Commission (FTC). In the development and evaluation phase, the items and contents of the acupotomy consent form were evaluated using a 5-point Likert scale and content validity was assessed through two rounds of Delphi surveys. In the improvement phase, the contents of the consent form were revised based on the results of a survey of inpatient and outpatient patients in the Department of Acupuncture and Moxibustion at Pusan National University Korean Medicine Hospital, and real-time online meeting. The final version of the standard acupotomy consent form was completed after undergoing proofreading and corrections by a linguistics expert. Results: Only 30% of Korean Medicine hospitals have implemented acupotomy consent forms. The items of the consent forms did not fully include the items presented in the Medical act and the standard contract for medical procedures of the FTC. To address this issue, two rounds of Delphi surveys and a real-time discussion were conducted with a panel of 12 experts on 27 preliminary items of consent forms. The items and contents that met the criteria for content validity ratio, convergence, and consensus were derived. Based on the derived items and content, a standard acupotomy consent form was developed. Conclusions: The standard consent form for acupotomy is anticipated to ensure patient autonomy and enhance transparency and liability in acupotomy. Furthermore, it is expected to serve as evidence in case of medical disputes related to acupotomy and contribute as a reference document for the development of standard consents forms for various procedures of Korean Medicine. However, the limitations of the study include that the survey of consent forms was limited to only training hospitals of Korean Medicine, and the standard consent form is only applicable to adults in Korea. Future studies are needed to address these limitations.

• Journal of Korean Neurosurgical Society
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• v.60 no.4
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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.

• Journal of Korean Academy of Fundamentals of Nursing
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• v.24 no.4
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• pp.277-285
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• 2017

Purpose: The purpose of this study was to identify occurrence of needle stick and sharp injuries(NSI) among students, level of faculty stress, and necessity of informed consent when students practice injection skills in fundamentals of nursing practice (FNP). Methods: Data were collected using self-reporting questionnaires and 74 faculty members who teach FNP responded it. Questionnaires included general characteristics, experiences of NSI, stress level, and informed consent. Data were analyzed using frequency, percent and paired t-test. Results: Of 74 faculty members, 51.4% experienced NSI 3~4 times or more during their FNP classes. Major procedures causing NSI during FNP were 'breaking the neck of ampules', 'disposing of used items', and 'inserting needles'. The stress level of faculty was higher and more than doubled when training with human beings compared to manikins. Most faculties (86.5%) agreed to the necessity of informed consent so that the safety of faculty and students could be protected and to provide enough information even though only 10.8% of faculty in this study got informed consent. Conclusion: Because there is high risk in every procedure of NSI, faculty has a high level of stress during injection practice in FNS. Therefore, it is necessary to develop a standard NSI precaution program for junior nursing students and discuss informed consent.