인체 유래 생물학적 물질의 소유권 - 사체를 중심으로 -

정규원,Jung, Kyu Won 대한의료법학회 2017 의료법학 Vol.18 No.1

전통적인 법이론에 의하여 인간은 권리의 주체이기 때문에 인체로부터 유래한 생물학적 물질은 권리의 객체가 될 수 없다. 하지만 의학과 생명과학의 발전으로 인하여 인체로 부터 유래한 생물학적 물질은 다양한 용도로 사용되고 있으며 인체로부터 유래한 생물학적 물질의 객체성 여부와 소유권 인정 여부에 대한 논의는 지속적으로 제기되고 있다. 인체로부터 유래한 생물학적 물질을 법적으로 파악하는 이론은 전통적으로 자율성에 근거한 모델이었으며 현재도 그것이 가장 보편적으로 받아들여지고 있다. 하지만 자율성 모델에 의하여 인체로부터 유래한 생물학적 물질을 파악할 경우 인체로부터 유래한 생물학적 물질을 다루는 현실을 제대로 설명할 수 없을 뿐만 아니라 오히려 배분적 정의의 측면에서 볼 때 적절하지 못한 결론에 도달할 수도 있다는 의문이 제기되고 있다. 인체 유래 생물학적 물질을 소유권의 객체로 파악하려는 소유권 모델은 인간의 존엄과 가치에 반하는 이론 구성이라는 의혹을 받고 있다. 하지만 소유권은 단일한 권리가 아니며 다양한 권리들의 집합체이며 그 내용이 어떻게 구성될 것인가는 객체의 특성 등을 고려하여 판단하면 될 것으로 생각된다. 본 논문은 인체 유래 생물학적 물질의 소유권 전체 보다는 일단 사체로부터 유래한 물질의 소유권 인정 여부를 중점적으로 다루었다. 이를 통하여 인체 유래 생물학적 물질전반에 대한 법이론적 고찰이 현재의 과학적 사실에 적합한 형태로 이루어지기를 기대한다. Ownership is the bundle of rights that allow a person or institute to use and control an object. As the biomedical science is advanced, we should consider whether human biological material should be recognized as property. Whether separated parts of the human body can be objects of ownership is a different issue. Many thought that separated parts of the human body could not be objects of ownership. This idea is primarily based on this thought: even if a piece of human biological material is separated from a person, it still relates to that person, and if treated as a thing, human dignity may be harmed. However, some commentators have admitted separated parts of the human body into the realm of property. Though a person owns his/her body or body parts, this does not mean that he/she can do anything he/she desires. There are many natural and social limitations to exercise the ownership of human biological material as discussed above. Human dignity is the core consideration whether or not we recognize that ownership of human biological material biomedical research and knowledge.

공법 : 바이오장기이식 환자와 가족 등의 관리

정규원 ( Kyu Won Jung ) 한양대학교 법학연구소 2010 법학논총 Vol.27 No.2

바이오장기연구는 동물의 세포, 조직, 장기를 인간에게 이식함으로써 질병을 치료하는 것을 궁극적 목표로 하고 있다. 바이오장기가 실제 임상적으로 적용 가능해져서 환자에게 이식되는 초기에는 환자와 그 가족 등에 대한 지속적 관리가 필요하다는 주장이 있으며 바이오장기에 대한 다수의 가이드라인들이 그러한 규정을 두고 있다. 환자나 그 가족 등에 대한 지속적 관리가 정당화될 수 있는 근거로는 타인에 대한 전파 가능성과 바이오장기이식의 장기적 부작용 및 기전의 규명이 제시되고 있다. 그런데 바이오장기이식 환자나 그 가족 등에 대한 지속적인 관리는 개인의 자유권을 침해하는 측면이 있다. 따라서 바이오장기이식 환자와 그 가족 등에 대한 지속적 관리의 필요성과 자유권의 침해라는 두 가지 측면을 어떻게 조화시킬 것인가에 대한 논의가 필요하다. Xenotransplantation is one of the hottest field in biomedical research. Xenotransplantation defines as “any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source, or (b) human body fluids, cells, tissues, or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs.” NMany suggest that life-long surveillance of recipients and their family members should be done when we introduce xenotransplantation into the clinical practices. The reason of life-long surveillance are the risk of zoonosis and the need to find the long-term complications of xenotransplantation and their mechanism. However, life-long surveillance mat harm the privacy or other basic human rights. Because of these reasons, we should carefully design life-long the surveillance system. Obligation of life-long surveillance of xenografted patients or their family members can be justified based on the risk of xoonosis. The medical purposes, such as investigation of long-term complications of xenotransplantation, are not the appropriate reason to impose obligatory life-long surveillance to patients and their family members. It can be justified only based on the informed consent of patients and their family members. New biomedical technologies, such as xenotransplantation may not be ruled properly by current legal system. We should try to make new principles or means to regulate these kind of new technologies for effective regulation.

공법 : 정신질환자의 비자의입원에 대한 검토

정규원 ( Kyu Won Jung ) 한양대학교 법학연구소 2008 법학논총 Vol.25 No.4

According to the <Mental Health Act>, two types of non-voluntary admission may be allowed. One is non-voluntary admission based on the requests of the patient`s protector, including family members. The other is non-voluntary admission based on the requests of the major, the country headman, or the district leader. Considering the purposes of the Act, to cure and rehabilitate the patient, they are not appropriate provisions. Psychiatric treatment is also a kind of medical practice. So general principles that are required in medical treatment also required in psychiatric treatment. If that is true, informed consent is also required in psychiatric treatment. If the patient is competent and he/she refuses to treat, doctor can not do medical practice. Non-voluntary admission of psychiatric patient is allowed only when the patient has not the competency to consent. If the psychiatric patient has not competency to consent and the admission is required for the patient, substituted decision may be allowed. In that case, the person who makes decision for the patient should consider the patient`s will and what is the best way for the patient. For protect the psychiatric patient, the guardian who has the general power to decide should make decision for the patient. And the guardian`s substituted decision should be examined by the court. For examining the guardian`s decision, an authoritative committee which is regulated by the court. Mentally ill patient is not a special person or risky person. Everybody may be suffered from the metal illness. They should be treated as other patient who are suffered by illness. They also have the natural rights and their rights should be protected.

동물 이용 연구에 대한 법적 고찰 : 바이오장기연구를 중심으로

정규원 ( Kyu Won Jung ),양윤선 ( Yun Sun Yang ) 한양대학교 법학연구소 2009 법학논총 Vol.26 No.2

Many biomedical researches use animals as subjects. However, some argue that researches which use animals should be banned because animals are morally as valuable as human beings. There are two issues related to the biomedical researches which use animals. First, whether the use of animals in biomedical researches is necessary. Some argue that it is not necessary or even harmful, but history shows that using animals in biomedical researches is very useful. The second issue is moral issue, that is whether the use of animals in biomedical researches is morally justified. The most persuasive argument that animals are morally equal to human beings is based on the opinion that animals also feel pain. Although we can agree that animals feel pain, that is not enough to agree the argument that animals and human beings have the same moral value. In 2008, <Laboratory Animal Act> is enacted. This Act focuses on the appropriate management of laboratory animals and animal experimentation. However, there are many overlaps between <Laboratory Animal Act> and <Animal Protection Act>. These Acts should be revised to regulate using animals by human beings properly. Xenotransplantation research should use animals in nature. There are some differences between ordinary animal experimentations and xenotransplantation research. First, animals are given births in xenotransplantation research. Second biological materials which are originated from animals are transplanted onto human bodies. When we examine the ethical, legal issues of animal experimentation in xenotransplantation, we should consider these propertied.

의료광고에 대한 법적 규율

정규원 ( Kyu Won Jung ) 한양대학교 법학연구소 2014 법학논총 Vol.31 No.3

Medical Advertisement is one of the important methods to get medical information and to help appropriate and free decision of patient. Also, it is a kind of activity of medical professionals to perform their jobs. However, medical practice has some different characteristics from other goods, very specialized activity, imbalance of information between medical professionals and patients, etc. Because of these characteristics, medical advertisement should be regulated. Historically, the method of regulation of medical advertisement had been done through positive model, that means ban of medical advertisement in principle and exceptional allow of medical advertisement. According to the basis of justification of medical practice changes, paternalism to autonomy, the method of regulation of medical advertisement has moved to negative model, allow in principle and exceptional ban. Even though the change of regulation model, there have been hot debates surrounding medical advertisement, because of the limits of allowance and criminal punishment. In this article, I discussed the current Acts and cases which are relevant to medical advertisement and proposed some standards and framework of regulation of medical advertisement.

의료정보에 대한 의료인의 권리와 의무

정규원 ( Kyu Won Jung ) 한양대학교 법학연구소 2011 법학논총 Vol.28 No.1

Medical information is the information which is collected during the medical practices from the patient. Therefore, medical information is considered as an object of patient`s right. However, considering the process of generating medical information, the role of medical professionals becomes more and more important than ever. Also, the need for using medical information in research is growing as the biomedical science is developed. Most debates on medical information have focused to protect medical information for patient`s privacy. Medical information contains private secretion of patient. If medical information is misused or abused, patient`s privacy can be harmed. There are many provisions which aim to protect medical information. Some types of medical information are generated by the contribution of medical professional`s knowledge and experiences to patient`s raw data. For example, medical professionals should decide which diagnostic tests should be done based on the patient`s subjective symptom. Their medical knowledge and experiences will influence their decision. Also, selecting treatment they will be influenced by their knowledge and experiences. Because of theses reasons, some types of medical information is the subject of patient`s and medical professional`s rights or medical professional`s right. As the situation surrounding medical practices is changing, the legal theories or regulatory framework of medical information should be changed. Medical professional`s right on medical information should be recognised as their contribution.

OAuth2.0을 변형한 금융권 통합인증 프로토콜

정규원(Kyu-Won Jung),신혜성(Hye-seong Shin),박종환(Jong Hwan Park) 한국정보보호학회 2017 정보보호학회논문지 Vol.27 No.2

현재 국내 금융거래에서는 공인인증서를 중심으로 하는 다양한 사용자 인증방식이 사용되고 있다. 이러한 공인인증서 방식은 사용자가 개별 금융사의 웹서버에 접속할 때마다 서로 다른 보안모듈을 설치해야 하는 문제가 있다. 금융사 중심의 이러한 인증방식은 앞으로 생체인증 등의 차세대 인증방식이 새롭게 도입될 때마다 금융사마다 새로운 보안모듈을 추가적으로 설치해야 하는 문제가 발생한다. 이러한 문제를 해결하기 위해 본 논문에서는 금융거래 시 각 금융사를 대신하여 사용자 인증을 전담하는 통합 인증기관을 상정하고, 이를 중심으로 사용자 및 금융사 웹서버 삼자 간에 안전한 사용자 인증을 처리하는 통합인증 프로토콜을 제안한다. 새로운 인증 프로토콜은 OAuth2.0을 변형하여 안전성과 효율성을 증가한 프레임워크로써, 인증서버 및 금융사 웹서버 간 사전에 공유된 비밀키로 도전-응답 프로토콜을 수행하는 것이 특징이다. 이를 통해 사용자는 편리하고 안전한 통합인증(SSO: Single-Sign-On) 효과를 누리게 된다. Currently, various types of user authentication methods based on public certificates are used in domestic financial transactions. Such an authorized certificate method has a problem that a different security module must be installed every time a user connects an individual financial company to a web server. Also, the financial company relying on this authentication method has a problem that a new security module should be additionally installed for each financial institution whenever a next generation authentication method such as biometric authentication is newly introduced. In order to solve these problems, we propose an integrated authentication system that handles user authentication on behalf of each financial institution in financial transactions, and proposes an integrated authentication protocol that handles secure user authentication between user and financial company web server. The new authentication protocol is a modified version of OAuth2.0 that increases security and efficiency. It is characterized by performing a challenge-response protocol with a pre-shared secret key between the authentication server and the financial company web server. This gives users a convenient and secure Single Sign-On (SSO) effect.

공법 : 바이오장기 이식에 있어서 환자의 동의

정규원 ( Kyu Won Jung ) 한양대학교 법학연구소 2011 법학논총 Vol.28 No.2

Informed consent is one of the main demands in medical practices. Because xenotransplantation is a type of medical practices, it also needs informed consent of patient. Informed consent is valid, if the patient is competent, has sufficient understanding about the relevant information, and consents freely; competency, understanding, and voluntariness. However, the patient who would be a subject of xenotransplantation may not have another choice other than receiving xenografts because if he may not he would die. So, voluntariness of consent in xenotransplantation should be examined carefully. Also, sufficient understanding of the relevant information may not be satisfied. Patient may not sufficiently understand the relevant information because there is no or enough relevant information about xenotransplantation. Another issue which is related with xenotransplantation is informed consent of patient`s relatives. They may be kept a close watch by the medical professionals during their life because of the patient who lives with them. If they do not give informed consent they may not live with patient any more. So, voluntariness of informed consent of patient`s relatives should be examined carefully. Also, sufficient understanding of relevant information by patient`s relatives should be considered. If we can not meet the elements of informed consent in xenotransplantation, we should consider the modification of the elements of informed consent or other ethical principles which would supplement informed consent. Beneficence would be an ethical principle which can make up for it`s fault. Informed consent is not the only element which should be considered in medical practices. Also, we should consider medical professionals` autonomy as well as patients` one.

인간 유전체 기능 연구의 법적 문제

정규원(Jung Kyu-Won) 한국생명윤리학회 2002 생명윤리 Vol.3 No.1

Human genome research is providing knowledge of the human genetic information and is facilitating the new diagnostic technologies and treatments. But It can make some ethical and/or legal problems, like harm to genetic privacy, problems of genetic discrimination, and abortion. When we carry out human genome research, we must use the specimens from human beings. According to some ethical and/or legal points of view, using specimens from human beings violates the dignity of human. But I think we must distinguish the case of patient-subject and the case of volunteer-subject. Another issue is autonomy or the right of self-determination. When researches select the human subject, they must respect the potential subject's autonomy. In legal terms, autonomy means the right of self-determination. To protect the potential subject's autonomy, researchers must get the informed consent. The third issue is to protect the individual's genetic privacy. To protect the individual's genetic privacy, the genetic information must not be linked with the individual's medical record. And the disclosure of individual's genetic information must be banned. The IRB(Institutional Review Board) can be useful to control the technical/scientific quality of research and the ethical and/or legal problems of research. And we can use the genetic counsellor system to assist in getting informed consent, settling the conflicts between researchers and subjects, and so on. Under these considerations, this article proposes an guideline of human genome research. This guideline includes some issues which can be happened during performing the human genome research. I intended to make an research guideline which can be followed by researchers in the research lab.

이카루스의 꿈: 충분한 설명에 근거한 동의는 실체적인가?

정규원 ( Kyu Won Jung ) 한양대학교 법학연구소 2021 법학논총 Vol.38 No.4

충분한 설명에 근거한 동의는 의료행위에서 환자의 자기결정권을 보장하고 의사의 독단적인 의료행위를 견제하는 장치로 역할을 하여왔다. 그런데 최근에 충분한 설명에 근거한 동의가 오ㆍ남용되는 경향을 보이고 있는 것으로 생각한다. 충분한 설명에 근거한 동의가 절차적 정당화요소가 아닌 실질적 정당화 요소가 되기 위해서는 충분한 설명에 근거한 동의가 의사 결정에서 현실적으로 가능해야 한다. 충분한 설명에 근거한 동의의 과정은 (1) 하고자 하는 의료행위에 대한 의료인들 사이에서 어느 정도 합의된 정보가 존재하여야 하며, (2) 의료인은 그러한 정보를 객관적으로 인식하여야 하며, (3) 의료인은 자기가 인식한 정보를 환자에게 객관적으로 설명하여야 하며, (4)환자는 의료인의 설명을 듣고 이해하여야 하며, (5) 환자는 받아들인 정보들을 자신의 가치 체계에 비추어 숙고하여야 하며, (6) 환자는 그러한 숙고의 결과로써 당해 의료행위를 할 것인지 여부 및 어떤 종류의 의료행위를 할 것인지 등에 대한 의사결정을 하여야 하며, (7) 환자는 자신의 의사결정을 의료인에게 표시하여야 하며, (8) 의료인은 환자의 의사결정을 이해하고 환자의 의사결정을 존중하여 의료행위에 대한 결정을 해야 한다. 개인의 인식능력은 선천적 능력과 경험에 의하여 형성되며 어떠한 인식들 혹은 인식능력은 변형 경험에 의하여 타인과 공유되지 않는다. Paul이 제안한 변형 경험은 의사 측에서 보면 의사가 되기이며, 환자 측에서 보면 환자가 되기이다. 개인의 주관적 경험과 연관되어 있는 인식능력은 개인의 가치체계에도 영향을 준다. 따라서 개인의 의사결정은 주관적 의사결정일 수밖에 없으며 충분한 설명에 근거한 동의의 과정도 주관적 인식능력과 가치체계의 영향을 받을 수밖에 없다. 충분한 설명에 근거한 동의는 의사와 환자의 공동의 의사결정 과정이며 그 과정에서의 오류발생 가능성이 매우 크다. 공동의 의사결정과정에서의 오류는 참여자들의 인식능력과 이해능력의 차이, 동일한 용어의 서로 다른 용법 등에 의하여서 영향을 받기도 하지만 참여자들이 가지고 있는 편견 그리고 사회적 구조에 의한 편견과 부정의, 즉 Fricker가 말하는 증언과정에서의 부정의(Testimonial Injustice)의 영향을 받는다. 충분한 설명에 근거한 동의는 매우 중요한 절차적 의미를 가지고 있다. 공동의 의사결정과정에 참여하는 사람들은 그 결정에 대하여 책임감과 자부심을 가지게 되며, 어느 한쪽의 독단적 결정에 의하여 행위가 진행되는 것을 방지한다. 충분한 설명에 근거한 동의의 제자리 찾아주기에 대한 논의가 필요한 시점이다. Informed consent has served as a device to ensure the patient's right to self-determination and to check doctors' arbitrary medical practices in medical practice. Recently, however, informed consent tends to be excessively abused. In order for informed consent to become a practical justification factor, informed consent based must be possible in realistic decision-making. Valid informed consent requires some elements: (1) some agreed information among medical practitioners, (2) medical practitioners have to objectively recognize such information, (3) medical practitioners have to objectively explain the information to the patient, (4) patient has to listen to and understand the medical practitioner's explanation, (5) patient should consider the information he/she has accepted in light of his/her own value system, (6) patients should make decisions as a result of such consideration, (7) patients should express his/her decision to medical practitioners, and (8) medical practitioners understand and respect patient’s decision. Individual epistemic ability are formed by innate abilities and experiences, and some epistemic ability are not shared with others when that experience is a transformation experience. The epistemic ability related to an individual's subjective experience also affects the individual's value system. Therefore, individual decision-making is bound to be subjective decision-making, and the process of informed consent also affects subjective epistemic ability and cognitive ability and value system. Informed consent is a type of shared decision-making processes between doctors and patients. However, there is a very high possibility of errors in the process. Errors in the shared decision-making process are influenced by differences in participants' cognitive and understanding skills, different uses of the same words. In addition, it is influenced by participants' and/or medical practitioners’ prejudices and social structures, and testimonial injustice. Informed consent has a procedural meaning. Those who participate in the shared decision-making process take responsibility and pride in that decision> In addition informed consent prevents the action by arbitrary decision. It is time to find the right place for informed consent.