• 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.

• Journal of Korean Academy of Nursing Administration
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• v.12 no.2
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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.

• The Korean Society of Law and Medicine
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• v.18 no.2
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• pp.105-138
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• 2017

This is case comments of several representative legal cases regarding self- determination right of patient. In a case in which an intoxicated patient attempted suicide refusing treatment, the Supreme Court ruled that the medical team's respect for the patient's decision was an act of malpractice, and that in particular medical situations (medical emergencies) the physician's duty to preserve life supersedes the patient's rights to autonomy. Afterwards, at the request of the patient's family, and considering the patient's condition (irrecoverable death stage, etc.) consistent with a persistent vegetative state, the Supreme Court deduced the patient's intention and decide to withdraw life-sustaining treatment. More recently, regarding patients who refuse blood transfusions or other necessary treatment due to religious beliefs, the Supreme Court established a standard of judgment that can be seen as conferring equal value to the physician's duty to respect patient autonomy and to preserve life. An empirical study of legal precedent with regard to cases in which the physician's duty to preserve life conflicts with the patient's autonomy, grounded in respect for human dignity, can reveal how the Court's perspective has reflected the role of the patient as a decision-making subject and ways of respecting autonomy in Korean society, and how the Court's stance has changed alongside changing societal beliefs. The Court has shifted from judging the right to life as the foremost value and prioritizing this over the patient's autonomy, to beginning to at least consider the patient's formally stated or deducible wishes when withholding or withdrawing treatment, and to considering exercises of self determination right based on religious belief or certain other justifications with informed refusal. This will have a substantial impact on medical community going forward, and provide implicit and explicit guidance for physicians who are practicing medicine within this environment.

• 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.

• The Korean Society of Law and Medicine
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• v.17 no.2
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• pp.145-173
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• 2016

A patient's Right to Self-Determination or his/her Right of Autonomy in the Republic of Korea has traditionally been understood as being composed of two elements. The first, is the patient's Right to Know as it pertains to the physician's Duty to Report [the Medical Situation] to the patient; the second, is the patient's Right to Consent and Right of Refusal as it pertains to the physician's Duty to Inform [for Patient's Consent]. The legal and ethical positions pertaining to the patient's autonomous decision, particularly those in the interest of the patient's not wanting to know about his/her own body or medical condition, were therefore acknowledged as passively expressed entities borne from the patient's forfeiture of the Right to Know and Right to Consent, and exempting the physician from the Duty to Inform. The potential risk of adverse effects rising as a result of applying the Informed Consent Dogma to situations described above were only passively recognized, seen merely as a preclusion of the Informed Consent Dogma or a denial of liability on part of the physician. In short, the legal measures that guarantee a patient's 'Wish for Ignorance' are not currently being understood and acknowledged under the active positions of the patient's 'Right Not to Know' and the physician's 'Duty to Consideration' (such as the duty not to inform). Practical and theoretical issues arise absent the recognition of these active positions of the involved parties. The question of normative evaluation of cases where a sizable amount of harm has come up on the patient as a result of the physician explaining to or informing the patient of his/her medical condition despite the patient previously waiving the Right to Consent or exempting the physician from the Duty to Inform, is one that is yet to be addressed; that of ascertaining direct evidence/legal basis that can cement legality to situations where the physician foregoes the informing process under consideration that doing so may cause harm to the patient, is another. Therefore it is the position of this paper that the Right [Not to Know] and the Duty [to Consideration] play critical roles both in meeting the legal normative requirements pertaining to the enrichment of the patient's Right to Self-Determination and the prevention of adverse effects as it pertains to the provision of [unwanted] medical information.

• The Korean Society of Law and Medicine
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• v.23 no.1
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• pp.37-80
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• 2022

By analyzing informed consent and the refusal of emergency medical treatment (called patient dumping) under the current Emergency Medical Service Act, this study suggests that an emergency medical professional is only liable for patient dumping if their duty to protect the patient's life takes precedence over the patient's right to self-determination. In emergency medical situations, as in general medical situations, medical treatment should be performed after the emergency medical professional informs the patient about the medical treatment, including its necessity and methods, and obtains consent from the patient. Refusing or evading the performance of emergency medical services on the excuse of the informed consent not considering a waiver or alteration of informed consent requirements without reasonable reasons violates the Emergency Medical Service Act and thus makes an emergency medical professional liable to administrative disposition or criminal penalty. In other words, depending on the existence of a waiver of alteration of the informed consent, patient dumping may be established. If the patient is a minor or has no decision-making ability, and their legal representative makes a decision against the patient's medical interests, the opinion of the legal representative is not unconditionally respected. A minor also has the right to decide over their body, and the decisions of their legal representatives should be in the patient's best interests. If the patient refuses treatment, in principle, the obligation of life protection of emergency medical professionals is the top priority. However, making these decisions in the aforementioned situations in the emergency medical field is difficult because of the absence of explicit regulations regarding these exceptional problems. This study aims to organize the following precedents of the Supreme Court of Korea. The court states that, when balancing the conflicting interests between the duty to provide emergency medical service and the duty to inform is unavoidable for emergency medical professionals, they should put the duty to protect the patient's life ahead of the duty to inform if the patient's life matters. Exceptionally, when a patient has seriously considered whether they should receive treatment before the emergency medical situation, their right to self-determination can be considered equal to the obligation of emergency medical professionals to provide emergency medical treatment. This research also suggests that an amendment of the Emergency Medical Service Act should include the following. First, the criteria for determining the decision-making ability of emergency patients should consist of medical content. Second, additional consent from a medical professional is unnecessary for first-aid treatment. Finally, new provisions for emergency medical obligations for minors, new provisions for the decision standard when there are conflicting opinions about the treatment of a patient, and new penalty provisions for professionals who suspend emergency medical examinations and treatments need to be established.

• Clinical and Experimental Pediatrics
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• v.51 no.5
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• pp.447-451
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• 2008

It is fair to say that there are many ethical issues concerning the publication of medical papers. To define the best practice in the ethics of scientific publishing and a proper understanding of appropriate reporting in medical papers, this review should be useful for authors dealing with ethical issues which involve the protection of human and animal rights, the protection of confidentiality and informed consent, fabrication, falsification, plagiarism, author and authorship, copy right transfer, duplicate publication, conflict of interest, and dealing with misconduct cases.

• Journal of Families and Better Life
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• v.20 no.4
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• pp.89-102
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• 2002

Genetically modified foods may be defined as the foods deemed as safe by current technology among the many kinds of agricultural and stockbreeding products that are now under research and development using contemporary gene-modification techniques. This study examines hotly debated arguments, both for and against genetically modified- foods, in various countries. This study also investigates consumers'rights and responsibilities. Countries that are developing and exporting genetically modified organisms(GMO) have maintained that GMO can help produce more crops while reducing labor and other production-related costs, and that the genetically modified foods signify ″the second green revolution,″ which will solve future food and environmental problems by strengthening specific nutritive substances and extending shelf-life. But consumer groups, environmental organizations. and food-importing countries are more cautious about importing and consuming those foods because the potential dangers of GMO to human bodies and the environment have not been tested thoroughly yet. South Korea, following suit with others such as EU, Japan, Australia, and New Zealand, introduced a law on 'Labeling of Genetically Modified Foods', which went in effect in March, 2001, on the basis of customers'rights to make informed choices. The law takes the ″precautionary principle″ into consideration, rather than stopping at insuring ″substantial equivalence″ in developing and consuming GM foods. The actual impact of the law will depend on the level of citizens'Participation more than on the government's willingness to carry out the law. So far the level of Korean consumers'consciousness about genetically modified foods is very low. Therefore, it is hard to expect consumers to exercise their ″rights not to buy″ foods that are potentially unsafe. The Korean government must devise an effective plan to inform and educate the people about the labeling of genetically modified foods.

• Journal of Korean Academy of Nursing Administration
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• v.4 no.2
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• pp.475-487
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• 1998

This is a study to search for the ethical basis for valid informed consent of organ donors. It is an admirable action that a person give his own body part or organ as a gift to another person. The organ for transplantation can be removed only when the donor consents voluntarily to donation. It is recently proposed as the need for organ transplantation is increased that organs can be harvested although the consent of deceased cannot be obtained. This may raise many moral issues because human beings all have an unalienable right to control their own bodies. The principle of autonomy is usually regarded as an ethical basis for informed consent. However, some people criticize that the principle of autonomy requires a person and his decision to be autonomous (but there are many patients who aren't autonomous due to their confusion or unconscious condition in a clinical situation). or this principle can foster indifference to patients needing help: thus respect for principles of care and beneficence is necessary. When we consider the complexity of making a decision about organ donation. the principle of autonomy should be replaced by the principle of respect for individual autonomy. as expressed by Childress (1990). This principle requires the care givers to respect the client's individual decisions. The elements of informed consent are threshold elements: competence to understand and decide. voluntariness in deciding: information elements: disclosure of material information. recommendation of a plan. understanding of disclosure and recommendation: and consent elements: decision in favor of a plan. authorization of the chosen plan. In cases of living donors. the elements of competence and voluntariness are more important than the others. So only an adult can give a recipient his own body part. but it should be forbidden to harvest from minors or protected adults (i.e. developmentally disabled person However. when organs are removed from a cadaver donor. we ought to respect the donor's decision. So we ought to try to seek donor cards or any documents expressing the donor's opinion about organ transplant. All health care givers ought to disclose donor information about organ transplantation clearly enough for the donor to understand it and to be able to weigh the harms and benefits. We are going to propose 'the subjective standard' as the ethical standard of disclosure. This standard will assure that patients have enough information to be able to decide autonomously from their own position. Care givers have to consider the method of disclosure because donors can be influenced by it positively or negatively, Establishment of the Hospital Committee is recommended. because medical professionals will have a chance to discuss the procedure of decision and the validity of harvesting a organ from a person.

• Tuberculosis and Respiratory Diseases
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• v.48 no.3
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• pp.388-393
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• 2000

Localized fibrous tumor of the pleura is very rare. Most of them are benign, but some are malignant. This clause does not relate with the rest of the sentence. The single best predictor of clinical benignity is whether the tumor can be totally resected. We experienced a case of localized fibrous tumor of the pleura in a 57 year old man with right chest pain and cough. He was informed of a $8{\times}5cm$ mass in his right lower lung field, which was benign 3 years ago. Preoperative chest x-ray showed an increased hazy density at right lower lung field, and CT scan showed a $12{\times}8cm$ huge mass, which was located in right lower thorax. Left thoracotomy was done to excise a $12{\times}8{\times}5cm$(1200gm) sized large mass delete. The patient was discharged without any complications postoperatively.