임상시험에서의 동의의 법적 유효성과 설명의 내용 : 일본에서의 논의와 우리나라에서의 시사점을 중심으로

송영민 한국재산법학회 2012 재산법연구 Vol.29 No.4

임상시험과정상 시험자인 의사의 설명의무의 범위와 이러한 강화된 설명의무를 부과할 수 있는 법적 근거를 중심으로 검토하였다. 이를 정리하면 아래와 같다. 먼저, 시험자인 의사의 설명의 정도에 관해서는, 임상시험의 특성상 통상적인 의료행위에서 의사에게 부과되는 의무보다는 크지 않다고 하더라도 적어도 동등한 것이어야 한다. 그리고 시험자인 의사나 피험자인 환자사이에는 신뢰관계를 기초로 하고 있으므로 일반적인 의료행위에서 인정되는 설명의무의 예외는 임상시험의 경우에는 그대로 인정될 수 없고, 연구자는 피험자에게 합리적인 사람이라면 동의를 함에 있어 고려할 모든 사실, 가능성 및 의견에 대하여 완전하고 솔직하게 설명해야 한다. 다음으로, 강화된 설명의무를 부과할 수 있는 법적 근거는 시험자인 의사와 피험자인 환자사이의 임상계약관계에서 논의하고 있다. 이를 위하여 본 논문에서는 계약관계, 그것도 전형계약의 구조를 통한 위임'적'인 계약관계라는 점에서 출발하였다. 그리고 시험자와 피험자간의 계약관계 그 자체에서 시험자의 보다 강화된 설명의무를 도출할 수 있고, 이러한 이론적 근거는 '신인의무'와 '충실의무'이며 이러한 의무는 일본민법의 입법취지에서 보면 선관주의의무와 함께 민법 제681조에서 도출할 수 있다. 다시 말하면 임상계약 자체에서 이러한 '신인의무'와 '충실의무'를 도출할 수 있고, 설명의무도 이러한 의무에 근거한 임상계약에 근거를 두고 있으며, 이러한 의무의 구체적 내용이 피험자의 자기결정권을 보장한 시험자(의사)의 의무가 되는 것이다. This study examines the range of liability for explanation of the doctor as a tester in the process of the clinical test and the legal grounds to impose the enhanced liability for explanation. They can be summarized as follows. Firstly, for the extent of explanation of the doctor as a tester, considering the characteristic of the clinical test, the liability in the clinical test should be equivalent to at least the liability imposed on the doctor in normal medical practices, nevertheless the liability in the clinical test is not greater than that in normal medical practices. In addition, the exception of the liability for explanation admitted in general medical practices should not be accepted in the clinical test because the doctor as a tester and the patient as a subject are based on the fiduciary relationship, and the researcher should explain everything to the subject fully and frankly such as facts, possibilities and opinions that the rational persons may consider carefully before giving their consents. Secondly, the legal grounds to impose the enhanced liability for explanation has been debated in the clinical contractual relationship between the doctor as a tester and the patient as a subject. Thus, this study started with the concept of the contractual relationship, and besides, the entrusted contractual relationship through the structure of typical contract. And also, more enhanced liability for explanation of a tester can be created through the contractual relationship itself between a tester and a subject, and this theory is based on 'duty of trust' and 'duty of faith', and these duties can be created through the fiduciary duty and Civil Law Article 681 in the purpose of legislation of Civil Law of Japan. That is to say, these 'duty of trust' and 'duty of faith' can be created through the clinical contract itself, and the liability for explanation is also based on the clinical contract on the basis of the liability, and the concrete contents of the liability should be the liability of a tester(doctor) who guaranteed the right of self-determination of a subject.

의약품 임상시험에서 피험자 보호

위계찬 대한의료법학회 2012 의료법학 Vol.13 No.2

This study focuses on the protection of trial subjects, who participate in clinical trials for new drug. It takes long time to develop new drugs and the clinical trials are required. Usually, pharmaceutical company, which develop new drug, request a research institution(usually, hospital) to investigate the examination of security and side effects of new drug. The institution recruit trial subject to participate in the trials. The contract for clinical research of investigational new drug is concluded between the pharmaceutical company and the institution. This thesis studies the legal regulations for protection of participants of clinical research for new drug. In this respect the first matter of this study is to seek which relation between pharmaceutical firm and participants of clinical trials. Especially, there is a question which the trial subject is entitled to demand the pharmaceutical company which requested clinical trials the institution to supply the investigational new drug, after the contract for clinical trials had terminated or cancelled. This study take into account the liability of the pharmaceutical company to trial subject. Secondly, it is researched the roles and authority of Institutional Review Board(IRB). IRB is Research Ethics Committee of the institution, in which clinical trials for new drug are conducted. According to the rule of Korea good clinical practice(KGCP), IRB is the mandatory organization which is authorized to approve, secure approval or disapprove the clinical trials for investigational new drug in the institution. The important roles are the review of ethical perspective of trial research and the protection of trial subject. Thirdly, this paper focuses if the participants are to be paid for the participation for clinical research. This is ethical aspect of clinical trials. It is resonable that the participant is reimbursed for expenditure such as travels, and other expenses incurred in participation in trials. It is not allowed that the benefit of clinical trials is paid to trial subject. The payment should not function as financial inducements for participations of trials. Finally, the voluntary consent of the trial subject is required. The institution ought to inform the subject, who would like to participate in trials, and it ought to received informed consent in writing for subject. In this regard, it is matter that trial subject has ability of consent. It is principle that the subject as severely psychogeriatric patient has not ability of consent. However, it is required that not only healthy people but also patients are allowed to take part in clinical trials of new drug, in order to confirm which the investigation new drug is secure. Therefore there are cases, in which the legal representative of subject consent the participation of the trials. In addition, it is very important that the regulations concerning clinical trials of new drug is to be systematically well-modified. The approach of legal and political approach is needed to achieve this purpose.

임상시험에서의 동의의 법적 유효성과 설명의 내용 - 일본에서의 논의와 우리나라에서의 시사점을 중심으로 -

송영민 한국재산법학회 2013 재산법연구 Vol.29 No.4

This study examines the range of liability for explanation of the doctor as a tester in the process of the clinical test and the legal grounds to impose the enhanced liability for explanation. They can be summarized as follows. Firstly, for the extent of explanation of the doctor as a tester, considering the characteristic of the clinical test, the liability in the clinical test should be equivalent to at least the liability imposed on the doctor in normal medical practices, nevertheless the liability in the clinical test is not greater than that in normal medical practices. In addition, the exception of the liability for explanation admitted in general medical practices should not be accepted in the clinical test because the doctor as a tester and the patient as a subject are based on the fiduciary relationship, and the researcher should explain everything to the subject fully and frankly such as facts, possibilities and opinions that the rational persons may consider carefully before giving their consents. Secondly, the legal grounds to impose the enhanced liability for explanation has been debated in the clinical contractual relationship between the doctor as a tester and the patient as a subject. Thus, this study started with the concept of the contractual relationship, and besides, the entrusted contractual relationship through the structure of typical contract. And also, more enhanced liability for explanation of a tester can be created through the contractual relationship itself between a tester and a subject, and this theory is based on ‘duty of trust’ and ‘duty of faith’, and these duties can be created through the fiduciary duty and Civil Law Article 681 in the purpose of legislation of Civil Law of Japan. That is to say, these ‘duty of trust’ and ‘duty of faith’ can be created through the clinical contract itself, and the liability for explanation is also based on the clinical contract on the basis of the liability, and the concrete contents of the liability should be the liability of a tester(doctor) who guaranteed the right of self-determination of a subject. 임상시험과정상 시험자인 의사의 설명의무의 범위와 이러한 강화된 설명의무를 부과할 수 있는 법적 근거를 중심으로 검토하였다. 이를 정리하면 아래와 같다. 먼저, 시험자인 의사의 설명의 정도에 관해서는, 임상시험의 특성상 통상적인 의료행위에서 의사에게 부과되는 의무보다는 크지 않다고 하더라도 적어도 동등한 것이어야 한다. 그리고 시험자인 의사나 피험자인 환자사이에는 신뢰관계를 기초로 하고 있으므로 일반적인 의료행위에서 인정되는 설명의무의 예외는 임상시험의 경우에는 그대로 인정될 수 없고, 연구자는 피험자에게 합리적인 사람이라면 동의를 함에 있어 고려할 모든 사실, 가능성 및 의견에 대하여 완전하고 솔직하게 설명해야 한다. 다음으로, 강화된 설명의무를 부과할 수 있는 법적 근거는 시험자인 의사와 피험자인 환자사이의 임상계약관계에서 논의하고 있다. 이를 위하여 본 논문에서는 계약관계, 그것도 전형계약의 구조를 통한 위임‘적’인 계약관계라는 점에서 출발하였다. 그리고 시험자와 피험자간의 계약관계 그 자체에서 시험자의 보다 강화된 설명의무를 도출할 수 있고, 이러한 이론적 근거는 ‘신인의무’와 ‘충실의무’이며 이러한 의무는 일본민법의 입법취지에서 보면 선관주의의무와 함께 민법 제681조에서 도출할 수 있다. 다시 말하면 임상계약 자체에서 이러한 ‘신인의무’와 ‘충실의무’를 도출할 수 있고, 설명의무도 이러한 의무에 근거한 임상계약에 근거를 두고 있으며, 이러한 의무의 구체적 내용이 피험자의 자기결정권을 보장한 시험자(의사)의 의무가 되는 것이다.

의약품 임상시험의 계약적 일고찰

송영민 대한의료법학회 2011 의료법학 Vol.12 No.1

This thesis has studied about the legal characteristic of injection of the trial drug, the position of the pharmaceutical firm as a contractor of the clinical trial, the possibility of compulsory performance of consistent injection of the trial drug, and the damage claim caused in the process of the clinical trial from the viewpoint of protecting the trial subject in the clinical trial. According to court's judgement in the United States, the lawsuit of the trial subject, although the trial subject had expected consistent injections, was dismissed because there was no direct contract between pharmaceutical and trial subject. However, Helsinki Declaration prescribe the medical research as follows. 'All patients who participated in the research should be able to use the best precaution, diagnosis, and treatment proved by the final outcome of the research'. The trial subject is entitled to demand only the pharmaceutical firm which developed and provided the trial drug, and the pharmaceutical firm has the obligation to supply the trial drug to the trial subject. Therefore, it would be not enough to protect the trial subject if the pharmaceutical firm which makes the trial drug is ruled out. In addition, especially, in case the trial drug has a constant effect with the aim of treatment, if the injection of the trial drug is suddenly stopped, the trial subject would not have the benefit of treatment by the trial drug. In this case, the best remedy against the damage is to urge a constant injection of the trial drug. Thus, in certain case, it is reasonable to consider that the pharmaceutical firm has the obligation to supply the trial drug to the trial subject constantly, and it is also necessary to compel it through effective means in case the pharmaceutical firm do not fulfill its obligation to supply the trial drug. However, as an essential prerequisite for the assertion mentioned above, it should be judged under the principle of good faith considering the concrete situation, that is, what roles the pharmaceutical firm has played.

임상시험계약상 피험자의 민사법적 보호 -의사의 진료와 의약품임상시험과의 구별을 중심으로-

김기영 ( Ki Young Kim ) 법조협회 2011 法曹 Vol.60 No.5

Die klinische Prufung von Arzneimitteln steht im Spannungsverhaltnis zwischen Erkenntnisgewinn und Integritat der betroffenen Studienteilnehmer. Die Prufung der Prufarztvertrage des Sponsors einer klinischen Prufung mit den Prufarzten oder -zentren durch die Ethikkommission. Die vertragsrechtliche Abgrenzung des Behandlungsvertrags vom Probandenvertrag mit gesunden Probanden ist fur viele Fragen von Bedeutung, die den forschenden Arzt bewegen. Um die arztliche Behandlung von der Studie zu unterscheiden, muss man sich dem burgerlichen Recht zuwenden, und zwar dem Vertragsrecht, denn in beiden Rechtsverhaltnissen, im Verhaltnis zwischen dem Arzt und dem Patienten und im Verhaltnis des Arztes zu einer gesunden Person, die an einem medizinischen Experiment teilnimmt, geht es im Kern um Vertragsrecht. Die Beziehungen des Arztes zum Patienten und zum Probanden sind zivilrechtlicher Natur. Es ist der naturlichste Weg, sie so zu interpretieren.