한방병원의 봉약침 시술 동의서의 사용 현황과 표준 시술 동의서 개발에 대한 제안

김민정(Minjeong Kim) 대한한의학회 2020 대한한의학회지 Vol.41 No.3

한방병원의 침도 시술 동의서의 현황 조사와델파이 기법을 활용한 표준 시술 동의서 개발

김지훈,구본혁,김형준,서경숙,오명진,유명석,윤상훈,이광호,이현종,임정태,전형선,최성운,이태욱,김연학,오유나,김건형,양기영,김은석 대한한의학회 2024 대한한의학회지 Vol.45 No.1

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.

보조생식술에 있어 Informed Consent에 관한 연구 : 우리나라와 영국의 동의 체계 및 동의 서식에 대한 비교를 중심으로

김은애 이화여자대학교 생명의료법연구소 2012 생명윤리정책연구 Vol.6 No.1

In receiving the medical treatment service like as the assisted reproductive technology for the pregnancy and the gamete donation, Informed Consent is the most important thing to protect the right to self determination as well as to manage the human gamete and embryo. To the appropriate informed consent, the Informed Consent Form and System should be prepared appropriately. In UK, Human Fertilisation and Embryology Authority has offered all Informed Consent Form related to using the assisted reproductive technology officially. The UK HFEA forms are classified so much according to the right holder of the consent. And the contents of these forms are concreted so much according to the details to be obtained the consent as well as offered with the explanation of the details to be obtained. In Korea, some Informed Consent Forms related to using the assisted reproductive technology has offered by the law and some Informed Consent Forms has offered by the Ministry of Health and Welfare. But some necessary Informed Consent Forms has not offered by both of them. Also, these offered Informed Consent Forms is not appropriate to protect the right to self determination as well as to manage the human gamete and embryo because they are not enough to confirm so many details to be determined by the right holder of the consent. This article analyzes the UK HFEA Informed Consent Forms and System related to the assisted reproductive technology and compares them and KOREA Informed Consent Forms and System to seek the way to improve them.

인체유래물연구에 해당되는 의약품임상시험에서 동의 획득 기준의 법적 문제: <인체유래물연구동의서> 법정 서식의 사용을 중심으로

유수정,김은애,Yoo, Sujung,Kim, Eunae 대한기관윤리심의기구협의회 2019 대한기관윤리심의기구협의회지(JKIRB) Vol.1 No.2

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 <human material research informed consent 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.

醫師의 說明義務에 관한 硏究

昌新娟 원광대학교 법학연구소 2011 의생명과학과 법 Vol.5 No.-

Patients have the right to understand the purpose and risks of an invasive medical procedure, before they give consent for that invasive medical treatment. Doctors must offer full explanations of the treatment, risks, and the reasons for said treatment to all patients before any invasive medical procedure is performed. Doctors should also obtain a signed consent form from the patient before the invasive medical procedure in the event of any complications during the invasive medical procedure that leaves the patient in worst health after the invasive medical procedure. The consent form should describe allowed compensation in the event of any medical complication during the invasive medical procedure. If the doctor takes time to help the patient understand invasive treatments and the associated risks, patients can make informed decisions before signing any consent forms that may limit their ability to win monetary compensation in a medical malpractice suit in the event of a complication during the invasive procedure. The doctors can concentrate on healing the patient during invasive medical procedures when the doctor and patient have a mutual understanding of the invasive procedure and a signed, comprehensive consent form to cover the allowed compensation, should there be any complications during the invasive procedure. With communication and a comprehensive consent form, patients can make an informed decision to allow doctors to perform an invasive medical treatment and doctors can make an informed decision to treat a patient without the worries of any medical or legal repercussions after the said invasive treatment. A German court in 1894 determined that invasive medical procedures without patient consent were a criminal act of inflicting bodily injury. Later Anglo-American and Japanese laws require doctors to provide an explanation of the invasive medical procedure in conjunction with the consent form. In a case of an invasive medical procedure resulting in complications, a patient can seek damages if the patient can prove a lack of sufficient explanation of the procedure and/or a signed consent form prior to the invasive medical procedure. Korean laws currently consider physical damages to infringing on a person’s body and mental damages to infringing on a person’s rights in cases of insufficient explanation by the doctor in cases of complications during an invasive medical procedure. Laws requiring doctors to provide prior explanations of invasive medical procedures and patient consent forms need revision to reduce generalities. Doctors need clear legal guidelines on invasive medical procedure explanation documentation in addition to outlines for standard consent forms to assure all patients and doctors in Korea have sufficient information, before an invasive medical procedure, to make an informed decision.

醫師의 說明義務에 관한 硏究

昌新娟 원광대학교 법학연구소 2011 의생명과학과 법 Vol.5 No.-

Patients have the right to understand the purpose and risks of an invasive medical procedure, before they give consent for that invasive medical treatment. Doctors must offer full explanations of the treatment, risks, and the reasons for said treatment to all patients before any invasive medical procedure is performed. Doctors should also obtain a signed consent form from the patient before the invasive medical procedure in the event of any complications during the invasive medical procedure that leaves the patient in worst health after the invasive medical procedure. The consent form should describe allowed compensation in the event of any medical complication during the invasive medical procedure. If the doctor takes time to help the patient understand invasive treatments and the associated risks, patients can make informed decisions before signing any consent forms that may limit their ability to win monetary compensation in a medical malpractice suit in the event of a complication during the invasive procedure. The doctors can concentrate on healing the patient during invasive medical procedures when the doctor and patient have a mutual understanding of the invasive procedure and a signed, comprehensive consent form to cover the allowed compensation, should there be any complications during the invasive procedure. With communication and a comprehensive consent form, patients can make an informed decision to allow doctors to perform an invasive medical treatment and doctors can make an informed decision to treat a patient without the worries of any medical or legal repercussions after the said invasive treatment. A German court in 1894 determined that invasive medical procedures without patient consent were a criminal act of inflicting bodily injury. Later Anglo-American and Japanese laws require doctors to provide an explanation of the invasive medical procedure in conjunction with the consent form. In a case of an invasive medical procedure resulting in complications, a patient can seek damages if the patient can prove a lack of sufficient explanation of the procedure and/or a signed consent form prior to the invasive medical procedure. Korean laws currently consider physical damages to infringing on a person’s body and mental damages to infringing on a person’s rights in cases of insufficient explanation by the doctor in cases of complications during an invasive medical procedure. Laws requiring doctors to provide prior explanations of invasive medical procedures and patient consent forms need revision to reduce generalities. Doctors need clear legal guidelines on invasive medical procedure explanation documentation in addition to outlines for standard consent forms to assure all patients and doctors in Korea have sufficient information, before an invasive medical procedure, to make an informed decision.

치과 수술동의서의 한영번역 연구 : 전문어 및 형식적 장르관습 중심으로

노지은,이지민 한국외국어대학교 통번역연구소 2015 통번역학연구 Vol.19 No.4

A surgery consent form is a document that provides the patient with overall information on the surgical treatment involved and shows that he or she is giving an informed consent based on such information. This study analyzes the use of the medical terminology and the textual forms in Korean-into-English translation of surgery consent forms in the light of the genre conventions of the source and target cultures. This study chooses three sets of texts: Korean surgery consent forms (STa/STb), English translations of the Korean surgery consent forms (TTa/TTb), and surgery consent forms originally written in English (STe). This paper centers upon the level of difficulty of the medical terminology used in the texts and the variations in the formal aspect of the surgery consent forms. The findings of this study are as follows: First, there are variations between STa/STb and TTa/TTb, and between TTa/TTb and STe in the use of professional terminology, and the textual form. The level of difficulty of the terminology used in TTa/TTb has been found to be generally higher than that of the terminology in STe. Second, unlike the STa/STb and TTa/TTb that emphasize the expository aspect of the text by omitting the party who gives the surgical treatment involved and the party who receives it, STe frequently mentions the two parties explicitly as the sentential subject before asking for a consent. To target receivers who are used to both the target culture and the target language, and who have no knowledge of the professional terminology, the surgery consent forms may be difficult to understand. For this reason, when a text that belongs to a genre whose conventions are different in the two cultures involved, the target text needs to be produced in accordance with the textual conventions of the target culture, not the source culture.

타인의 생명보험에서 피보험자의 전자문서에 의한 동의 방안

장경환(Chang Kyung Whan),정완용(Chung Wan Yong) 경희법학연구소 2018 경희법학 Vol.53 No.2

As the development of information and communication technologies and the development of electronic transactions have changed the conventional PC environment into a mobile environment, mobile electronic transactions are rapidly increasing. In the case of electronic insurance transactions, the subscription and contract of insurance contracts are being made using these mobile devices, and the Enforcement Decree of the Insurance Business Act has been amended to provide legal basis. However, when a policyholder concludes a life insurance contract that covers the death of another person as an insurance accident, Article 731 of the Commercial Act stipulates that, at the conclusion of the insurance contract, the policyholder obtains the written agreement of the insured person (Article 1). It is used not only as evidence for disputes in the event of an insurance accident, but also to prevent the moral hazard of life insurance contracts on the life of another person. However, it has been argued that the written consent of the insured person has been interpreted to mean consent by paper writing, and that the consent form by electronic documents with digital signatures is not acceptable under the current law, so it should be legislated. In other words, insurance transactions are concluded by using information and communication technologies such as mobile, but in the life insurance contract of others, the consent of the insured person must be written in paper form. It has been pointed out that it can be an obstacle to the development of the insurance industry. These discussions have been reflected on October 31, 2017. Law No. 14969, Article 731 (1) of the Commercial Code has been amended and the written consent of the insured person has been replaced with “the electronic signature pursuant to Article 2 (2) of the Electronic Signature Act and an authorized electronic signature pursuant to Article 2 (3) Electronic document with credibility for identity verification and counterfeit and tamper prevention “as provided by the insured person, so that the written consent of the insured person can be made by an electronic document with electronic signature. In this paper, after reviewing briefly the purpose of life insurance and written consent system of the insured people and the purpose of consent system, the contents of revised law were reviewed. We also examined the legislations of Germany, France and Japan, which have adopted a written consent system of the insured person for the life insurance of others. In Germany, France and Japan all of their insurance laws do not explicitly state the consent of the insured person in electronic form. However, the Civil Law prescribes the legal validity of electronic documents and electronic signatures, so that the application of the relevant provisions of the Civil Code can be interpreted as the consent of the insured person’s electronic documents. In addition, the type and scope of the electronic document, the type and effect of the electronic signature are related to the agreement of the insured person with the electronic document, and this problem is examined. In addition, the related provisions about insurance contracts on the insurance business law and the electronic financial transaction law were reviewed. In this paper, we examined the requirements of electronic signatures for securing the reliability of electronic documents in agreement with electronic documents of the insured person. In order to verify the authenticity of the electronic document and to ensure the reliability of the prevention of forgery and alteration, it should be construed that the scope of the digital signature is restricted by digital signature using encryption technology such as digital signature when applying the unauthorized digital signature according to Article 2 something to do. In the case of applying the official digital signature according to Article 2 (3), the authorized digital signature itself has 정보통신기술과 전자거래가 발달하면서 종래 pc환경이 모바일 환경으로 바뀜에 따라 모바일 전자거래가 급속히 증가하고 있다. 전자보험거래의 경우에도 이러한 모바일 기기를 활용하여 보험계약의 청약과 체결이 이루어지고 있고, 그 법적인 근거를 마련하기 위하여 보험업법시행령이 개정된 바 있다. 제3자가 타인의 사망을 보험사고로 하는 생명보험계약을 체결하는 경우 상법 제731조에서는 보험계약 체결 시에 타인인 피보험자의 서면에 의한 동의를 얻도록 규정하고 있다(제1항). 이는 보험사고 발생 시 분쟁에 대비한 증거로 사용할 뿐 아니라 타인의 생명보험계약의 도덕적 위험을 방지하기 위한 목적이 있다. 그런데 피보험자의 서면동의는 종이서면에 의한 동의를 의미하는 것으로 해석되어 왔고, 전자서명이 있는 전자문서에 의한 동의방식은 현행법상 허용되기 어렵기 때문에 입법적으로 해결하여야 한다는 주장이 제기되어 왔다. 즉, 보험거래는 모바일과 같은 정보통신기술을 이용하여 체결되지만, 타인의 생명보험계약에서 피보험자의 동의는 반드시 종이서면으로 하여야 하므로 전자적 방식의 보험계약체결에 의한 신속성과 편리성 등의 장점을 살리지 못하여 보험산업발전의 저해요소가 될 수 있다는 점이 제기되어 왔던 것이다. 이러한 논의가 반영되어 2017.10.31. 법률 제14969호로 상법 제731조 1항이 개정되어 타인의 서면에 의한 동의에 “전자서명법 제2조 제2호에 따른 전자서명 및 제2조 제3호에 따른 공인전자서명이 있는 경우로서 대통령령이 정하는 바에 따라 본인 확인 및 위조, 변조 방지에 대한 신뢰성을 갖춘 전자문서”를 포함하도록 함으로써 피보험자의 서면에 의한 동의방식을 전자서명이 있는 전자문서에 의하여 할 수 있도록 개정되었다. 본 논문에서는 다음과 같이 타인의 생명보험과 서면동의제도의 입법례와 동의제도의 취지를 간략하게 고찰한 후 개정 상법의 내용을 검토하였다. ① 타인의 생명보험에 서면동의제도를 채택하고 있는 독일, 프랑스와 일본의 입법례를 검토하였다. 독일과 프랑스 및 일본 모두 보험법에서 명시적으로 피보험자의 전자적 방식에 의한 동의를 규정하고 있지 않다. 그렇지만 민법에서 전자문서와 전자서명의 법적 효력을 규정하고 있어서 (독일에서는 학설의 다툼이 있지만) 민법의 해당규정의 적용에 의하여 피보험자의 전자문서에 의한 동의가 가능한 것으로 해석된다. ② 피보험자가 전자문서에 의한 동의를 하는 경우, 전자문서의 종류와 범위, 전자서명의 종류와 효력이 관련되므로 이 문제를 검토하였고, 아울러 보험업법과 전자금융거래법상의 보험거래에서 전자문서의 이용에 대한 규정을 검토하였다. ③ 피보험자의 전자문서에 의한 동의에서 전자문서의 신뢰성 확보를 위한 전자서명의 요건을 살펴보았다. 전자문서의 본인 확인 및 위조ㆍ변조 방지에 대한 신뢰성을 갖추기 위하여서는 전자서명법 제2조 제2호에 따른 비공인전자서명을 적용할 경우 디지털 서명과 같은 암호화 기술을 이용한 전자서명으로 그 범위가 제한된다고 하여야 할 것이다. 같은 법조 제3호에 따른 공인전자서명을 적용할 경우에는 공인전자서명 자체가 전자문서의 무결성, 부인방지 기능이 있으므로 전자문서의 위ㆍ변조 방지를 위한 신뢰성요건을 갖출 수 있다고 본다. 다만, 이 경우에도 피보험자의 전자서명이 타인에 의한 무권한 사용이나 도용 등이 이루어질 수 있으므로 피보험자의 명확한 동의 의사를 확인할 수 있는 추가적인 인증절차를 적용하는 것이 바람직하다고 본다. 비공인전자서명의 사용 시에는 이러한 추가적 인증절차를 의무화하고, 공인전자서명의 적용 시에는 권고사항으로 하는 방안이 있을 수 있으며, 생체인증기술 등이 추가적인 인증절차로 편리성과 안전성을 제공하는 방안이 될 수 있을 것이다. ④ 타인의 생명보험에서 피보험자의 서면 동의는 피보험자로 하여금 자신의 생명이 보험에 붙여짐으로 인하여 생겨날 수 있는 위험을 헤아려서 동의의 의사표시를 신중히 하도록 하게 한다는 이른바 경고기능을 수행하기 위한 것이다. 따라서 피보험자가 동의를 표시하는 전자문서에는 미리 그 위험을 헤아릴 수 있는 사항 즉, 보험금액, 보험계약자와 보험수익자의 신원, 보험기간(보험금액 또는 보험기간이 아직 확정되지 않은 경우에는 최고한도)이 빠짐없이 충분히 기재된 경우에만 그 전자문서에 의한 동의의 효력을 인정하도록 하여야 할 것이다.

Patient Consent Management by a Purpose-Based Consent Model for Electronic Health Record Based on Blockchain Technology

Dara Tith,Joong-Sun Lee,Hiroyuki Suzuki,W. M. A. B. Wijesundara,Naoko Taira,Takashi Obi,Nagaaki Ohyama 대한의료정보학회 2020 Healthcare Informatics Research Vol.26 No.4

Objectives: Currently, patients’ consent is essential to use their medical records for various purposes; however, most peoplegive their consent using paper forms and have no control over it. Healthcare organizations also have difficulties in dealingwith patient consent. The objective of this research is to develop a system for patients to manage their consent flexibly and forhealthcare organizations to obtain patient consent efficiently for a variety of purposes. Methods: We introduce a new e-consentmodel, which uses a purpose-based access control scheme; it is implemented by a blockchain system using HyperledgerFabric. All metadata of patient records, consents, and data access are written immutably on the blockchain and shared amongparticipant organizations. We also created a blockchain chaincode that performs business logic managing patient consent. Results: We developed a prototype and checked business logics with the chaincode by validating doctors’ data access withpurpose-based consent of patients stored in the blockchain. The results demonstrate that our system provides a fine-grainedway of handling medical staff ’s access requests with diverse intended purposes for accessing data. In addition, patients cancreate, update, and withdraw their consents in the blockchain. Conclusions: Our consent model is a solution for consentmanagement both for patients and healthcare organizations. Our system, as a blockchain-based solution that provides highreliability and availability with transparency and traceability, is expected to be used not only for patient data sharing in hospitals,but also for data donation for biobank research purposes.

유전자 검사 및 연구에서의 동의 획득의 문제

배그린,최경석 이화여자대학교 생명의료법연구소 2009 생명윤리정책연구 Vol.3 No.1

Various genetic tests are available. Genetic research is expected to contribute to the development of medicine. Genetic test and research, however, have raised some important ethical issues including genetic privacy, confidentiality, and discrimination. Due to the sensitive characters of genetic information, protecting privacy and keeping confidentiality are the basic requirements. Obtaining informed consent is also mandatory to respect a donor’s or a patient’s autonomy and protect their personal information. Bioethics and Safety Act in Korea regulates genetic test and research. The same rule to regulate genetic test applies to genetic research. Especially the Act enacted a single legal form for both genetic test and research. But genetic research fundamentally differs from genetic test in that the former is research. Thus, the legal form reveals some problems when it is used for genetic research. First, the right to know the outcomes of genetic test might be often waived in genetic research while it should be respected in genetic test. Second, the period for keeping genetic samples should be consented after researchers basically set it up. It is not a good idea that “5 years” is provided as an option in the current legal form. Third, the right to withdrawal of consent should be respected at any time in the course of research regardless of its reasons. Samples should be destroyed without generating further data although data already made until the withdrawal may be used with the permanent deletion of personal identifiers. Therefore, a new consent form for genetic research should be made.