미국에서의 IRB 소송과 소송 이외의 보호수단에 관한 소고

박수헌 한국법제연구원 2011 법제연구 Vol.- No.40

The most important thing in the research including human subjects is to protect the rights, safety, and welfare of the participants in that research. As explored above, however, both self-regulation by the researchers and government regulation have turned out to be not so effective safeguards to the human research subjects in the USA. Thus, the human research subjects began to make protecting their interests guaranteed by bringing legal suits to the court. Although the number of legal suits brought to the court is not significant now, I believe, it will be increasing and be the trend of the day. It is usually said that a legal suit has a huge influence on the society when the public is made aware of it. IRB suits have two different flipsides: the one is to ensure IRBs to review the protocols much more carefully and to enhance accountability; and the other can cause IRBs to act much more negatively. Although IRB suits are the current trend that can not be stopped and have much advantages, they have many disadvantages as well. Therefore, it's necessary to find the ways how to decrease the legal liabilities of IRBs, yet continue protecting the research subjects without bringing legal suits. There are several ways to do so: using independent or commercial IRBs, providing explicit provisions in federal statutes on the roles and responsibilities of IRBs, providing insurance and compensation fund, increasing supports for protecting research subjects, mandating statutory administrative exhaustion, applying accreditation program, and giving qualitative immunity to IRBs. In Korea, the number of clinical trials is increasing tremendously year by year. In proportionality, the concern to the methods for protecting research subjects is also increasing. However, Korea does not confront IRB suits like in the USA. When we consider that clinical trials may be conducted throughout the whole world and the results may be published, Korea, also may encounter IRB suits in the near future. We also know that the effect of legal suits to the society is huge through the cases of both the USA and Korea. Thus, American case laws on the IRB suits and the alternative remedies can be a good model to protect research subjects without diminishing IRB's activities in our country, Korea. 인간 대상 연구에 있어서 가장 중요한 것은 피험자의 권리, 안전 및 복지를 보호하는 것이다. 그러나, 위에서 고찰한 바와 같이, 연구자의 자율규제와 정부규제 모두 미국에서 피험자를 보호하기 위한 효율적인 안전장치로 작용하지 않는다고 판명되었다. 그래서, 피험자들은 법원에 소송을 제기하여 자신들의 이익을 보호하기 시작하였다. 비록 법원에 제기된 소송의 건수가 현재 심각할 정도로 많은 것은 아니지만, 소송 건수는 증가할 것이고 이것이 현재의 흐름이 될 것으로 필자는 믿는다. 일반 시민에게 알려질 경우, 소송은 사회에 지대한 영향을 미친다고 알려져 있다. IRB 소송은 두 가지 측면을 가지고 있다: IRB로 하여금 연구계획서를 더 신중하게 심사하게 하고 책임을 고양시키는 것을 보장하는 측면과 IRB로 하여금 더욱 소극적으로 심사하도록 만드는 측면이다. 비록 IRB 소송이 멈출 수 없는 현재의 경향이고 많은 장점을 가지고 있다 하더라도, 그에 못지 않은 단점 또한 가지고 있음을 부정할 수는 없다. 그래서, 소송을 제기하지 않고서 피험자의 보호를 계속하여 IRB의 법적 책임을 경감할 수 있는 소송 이외의 대체적 구제 수단을 강구하는 것 또한 필요하다. 해당 기관과 관련없는 외부 IRB(또는 상업용 IRB)의 적극적 활용, IRB의 역할과 책임을 연방 법률에서 명확히 규정, 보험제공 및 보상기금 조성, 피험자 보호를 위한 지원 증가, 인증 프로그램 적용, 행정심판전치주의의 의무적 적용, IRB에게 상대적 면책권 인정 등이 이러한 대체적 구제 수단에 해당한다. 우리의 경우, 임상시험 건수는 해마다 큰 폭으로 증가하고 있으며, 그에 비례하여 피험자의 보호 강화 방안에 대한 관심도 커지고 있는 실정이다. 그러나, 아직까지 미국에서와 같은 IRB 소송이 제기되고 있지는 않고 있다. 임상시험이 한 국가 내에서만 행해지는 것이 아니라 전세계 어디서든 행해질 수 있고, 그 결과를 알 수 있다는 것을 감안한다면 우리의 경우에도 IRB 소송이 가까운 장래에 제기될 소지는 언제든 있다 하겠다. 그리고, 소송의 제기는 사회에 미치는 파급효과가 매우 크다는 것을 앞서 미국의 예와 우리의 예를 통해서도 고찰하였다. 따라서, 미국의 IRB 소송에 관한 판례법 및 피험자 보호를 위한 소송 이외의 대체적 방안들이 우리에게도 향후 제기될 IRB 소송의 해결 및 IRB 활동을 위축하지 않고서 피험자 보호를 강화할 수 있는 방안으로 활용될 수 있을 것이라 생각된다.

의료정보 이용 및 공개에 관한 법적기준

김진경(Kim, Jinkyung),한우석(Han, Woo Sok) 한양법학회 2009 漢陽法學 Vol.28 No.-

In response to the Health Insurance Portability and Accountability Act of 1996, the U.S. Department of Health and Human Services issued the Privacy Rule in 2003. Since the Privacy Rule allows for the use and disclose of ‘protected health information (PHI)’ under certain circumstances, we reviewed when and how PHI could be disclosed and, to that end, how the individual right is protected under the Privacy Rule. The Privacy Rule permits the use and disclose of PHI with individual’s authorization. However, health services research which usually deal with population-level data would be impracticable if millions of individual authorizations are required. Thus, in addition to the individual’s authorization, the Privacy Rule further allows for the following ways to use and disclose PHI for research purposes: 1) obtain waiver or alteration of the authorization requirement by and IRB or Privacy Board, 2) use de-identified data set, and 3) use limited data set under data use agreement. The Privacy Rule also grants individuals rights, including access to their protected health information, the right to amend, and the right to an accounting of the disclosures of their information. To this end, the Privacy Rule protects the privacy of individual health information, while at the same time allows researchers to have access to the individual health information necessary to conduct the research. The review of federal individual information protections in the U.S. provides insights on establishing appropriate laws and regulations in Korea on individual privacy protection and the use and disclose of personal information for public interest.

의료정보 이용 및 공개에 관한 법적기준 -미국 프라이버시 규칙과 피험자보호 규칙의 검토-

김진경,한우석 한양법학회 2009 漢陽法學 Vol.28 No.-

In response to the Health Insurance Portability and Accountability Act of 1996, the U.S. Department of Health and Human Services issued the Privacy Rule in 2003. Since the Privacy Rule allows for the use and disclose of ‘protected health information (PHI)’ under certain circumstances, we reviewed when and how PHI could be disclosed and, to that end, how the individual right is protected under the Privacy Rule. The Privacy Rule permits the use and disclose of PHI with individual’s authorization. However, health services research which usually deal with population-level data would be impracticable if millions of individual authorizations are required. Thus, in addition to the individual’s authorization, the Privacy Rule further allows for the following ways to use and disclose PHI for research purposes: 1) obtain waiver or alteration of the authorization requirement by and IRB or Privacy Board, 2) use de-identified data set, and 3) use limited data set under data use agreement. The Privacy Rule also grants individuals rights, including access to their protected health information, the right to amend, and the right to an accounting of the disclosures of their information. To this end, the Privacy Rule protects the privacy of individual health information, while at the same time allows researchers to have access to the individual health information necessary to conduct the research. The review of federal individual information protections in the U.S. provides insights on establishing appropriate laws and regulations in Korea on individual privacy protection and the use and disclose of personal information for public interest.

“임상시험심사위원회”와 위원의 민사상 책임

김기영(Kim, Ki Young) 이화여자대학교 생명의료법연구소 2011 생명윤리정책연구 Vol.5 No.1

Die klinische Forschung unterliegt nicht nur medizinischen, sondern auch ethischen Standards. Über die medizinischen Standards wacht der Arzt und kontrolliert sich selbst. Es beschEäftigt sich mit der Begründung der zivilrechtlichen Haftung für Fehler von Ethikkommissionen. Es stellt die einzelnen Aufgaben- und Verantwortungsbereiche von Ethikkommissionen ihrem rechtlichen und tatsächlichen Arbeitsumfeld gegenüber und untersucht dabei die Ausstattung und die Einordnung der Ethikkommissionen in die Verwaltungsorganisation. Zuerst wird auf die Gesetzeslage, die Rechtsnatur der Ethikkommissionen und rechtliche Rahmenbedingungen für das Handeln der Ethikkommissionen eingegangen, die typische Fehlerkonstellationen der Kommissionsarbeit anhand von Aufgaben- und Verantwortungsbereiche von Ethikkommissionen haftungsrechtlich zu analysieren. Ethikkommissionen können auf verschiedenen Ebenen Schäden verursachen, insbesondere indem sie Forschungsvorhaben ohne sachliche Rechtfertigung verzögern, einschränken oder ablehnen, oder indem sie rechtlich oder medizinisch nicht einwandfreie Forschung fälschlicherweise zulassen. Ausgehend von einer einleitenden Problematisierung wird zivilrechtliche Anspruchsgrundlagen der Haftung für Fehler von Ethikkommissionen untersucht. Im Übrigen ist das Haftungsgepflecht zwischen den Beteiligten darzustellen. Zu Prozessen gegen Ethik-Kommissionen, deren Mitglieder, Gutachter oder Sachverstandige ist es dagegen bisher nicht gekommen, obwohl deren Haftung ebenso lange diskutiert und in der Literatur grundsatzlich bejaht wird. Nachdem aber auf der einen Seite heute praktisch alle klinischen Versuche an Menschen Ethik-Kommissionen zur Begutachtung vorgelegt werden und auf der anderen Seite trotzdem weiterhin immer wieder Versuchspersonen unerwartete Schaden erleiden. Diese Feststellung betrifft rechtsdogmatische und rechtspolitische Aspekte gleichermaßen. Abschließend ist eine Auseinandersetzung mit der patientenbezogenen Problemen mit der Pflichtverletzung zu erläutern. Aufgabe der Ethik-Kommission ist es, den Schutz der Rechte, die Sicherheit und das Wohlergehen von Personen zu sichern, die an einer klinischen Prufung teilnehmen. Die Sicherungspflichten der Ethikkommissionen, ihrer Mitglieder und Gutachter konnen zugleich vertragliche Schutzpflichten sein, sofern zu den Versuchspersonen ein Schuldverhaltnis besteht. Insbesondere wird im Lichte von Sorgfaltsumfang und Haftungsrisiko einen Ausblick gegeben.

임상시험과 윤리

임인애,라선영 대한의사협회 2010 대한의사협회지 Vol.53 No.9

Based on recently developed biotechnology, many new drugs have been developed for improving patient treatment outcomes. To develop novel drugs, proper clinical trials are essential. As clinical trials involve humans in research, the protection of participants is important not only for the participants’safety but also for future patients. Ethics in a clinical trial is not the same as in clinical practice with enough evidence. Hence, the whole procedure of a clinical trial should be well organized, scientifically and ethically planned, and monitored properly by an Institutional Review Board (IRB). Here the importance of ethics in clinical trials, related issues, and the monitoring system will be discussed.

의약품 “동정적 사용 프로그램(Expanded Access Program)”의 민사법적 고찰

최현태 ( Hyuntae Choi ) 경상대학교 법학연구소 2015 法學硏究 Vol.23 No.4

2015년 2월 초 미국식품의약청(Food and Drug Administration : 이하 ‘FDA’라 함)은 아직 승인을 받지 못한 실험약물에 대한 ‘동정적 사용’과 관련하여 ``시도 할 권리 (right-to-try) 법’을 입법하면서 신청 및 허가절차를 간소화하는 내용을 포함시켜 발표하였다. 여기서 ‘동정적 사용’이라는 용어는 원래 ‘동정적사용승인계획 또는 동정적 사용프로그램(Expanded Access Program, EAP)’을 말한다. 이는 불치병에 걸렸거나 암 말기인 환자가 적절한 치료제가 없어 치료를 포기할 상황인 때 의료당국이 시판승인·허가전의 신약을 무상으로 공급해 치료기회를 주는 제도로써, 원래 ‘FDA’에서 에이즈가 급속도로 확산되는 시기를 계기로 만들어진 프로그램으로 알려져 있다. 우리의 식품의 약품안전처 및 미국의 FDA이나 유럽의 EMA(European Medicines Agency) 등의 식품의약품의 허가기관들은 전임상시험(Preclinical trial/ Investigation)을 포함하여 신약개발의 모든 단계를 포괄적으로 규제하게 됨으로써 시판허가 및 신약의 개발에 있어서 임상시험의 기간이 길어지게 되고, 이것은 환자의 입장에서는 오히려 절망감을 가중시키는 요인이 된다. 그러므로 기존 치료제로 만족할만한 효과를 기대하기 어려운 환자에게 최후의 치료기회를 제공하기 위해 아직 시판허가가 나지 않은 상태의 의약품을 무상으로 공급하는 동정적 사용 프로그램의 활용은 점점 활성화될 것으로 예측된다. 그러나 이러한 동정적 사용 프로그램을 통해 의약품을 처방받은 환자들에게 그들이 원하는 결과의 반대 결과, 즉 일정한 손해가 발생하였을 경우 그에 대한 법적 책임이 어떠할 것인지가 상당히 중요한 문제가 될 수 있다. 이에 본 연구에서는 동정적 사용 프로그램이 무엇인지와 어떠한 상황 및 조건에서 동정적 사용 프로그램이 시행되고 허용되는 것인지(Ⅱ), 그리고 법적 분쟁이 발생했을 경우 환자 측이 권리 주장을 할 수 있는 부분과 그에 대한 의사 및 제조자 등의 책임범위에 관한 것을 살펴보고자 하였다(Ⅲ). 무엇보다도 책임법의 내용 중에서도 민사법적 시각에서 의약품 동정적 사용 프로그램 관련당사자 간의 배상책임 문제에 대해서 고찰을 주로 하였다. Clinical trials are an indispensable part of medical development. Even though there have been adverse drug reactions since human clinical trials first began, it would nevertheless be impossible to develop new drugs, technology, and new equipment without them.97) When a medical conflict arises due to pharmaceutical accident, a victim should be protected by the compensation through the legal proceeding. A doctor should bear duty of care and duty of explanation to a patient. A doctor also should be responsible for the damage accrued by the negligence of the prescription or administration of medication. The legal reason might be a default(contractual) liability and/or tort liability. The scope of compensation for damage accrued by the breach of duty of explanation should come to the damage of life, body, and health as well as noneconomic damage by the violation of the right of self-determination. Incases where an adverse drug reaction has occurred, the trial subject can file contract responsibility as stated in civil law (item 390), as well as claim damages under the Illegal Act(item 750). Furthermore ,it is the responsibility of the investigator and sponsors to fully identify any damages done. Due to a trial subject``s inability to fully report on all details concerning the cause and effect of any adverse drug reactions, it is necessary for the Institutional Review Board to trial subject in certain are as of each case.

임상연구와 환자 보호

이무상 대한의사협회 2010 대한의사협회지 Vol.53 No.9

Clinical trials are the flower of clinical research. Recently such clinical trials occur increasingly on a global scale. Korea is also one of the countries newly involved in global clinical trials,with resulting scientific, economic, industrial, and ethical implications. The sweeping and meticulous precautions must be introduced to these global clinical trials promoting patient protection through the public, national and international surveillance. These many guidelines in clinical trials are based on the Declaration of Helsinki of the World Medical Association (WMA). Fortunately,we were proud to be able to host the WMA 2008 meeting in Seoul, where the sixth edition of this declaration was announced. Thus, KMA insists that all clinical trials in Korea maintain strict standards and that all our member physicians follow the Declaration of Helsinki and be observers.

미국 임상시험심사위원회(Institutional Review Board) 인증체계에 대한 연구:

김수정(Soo-Jung KIM) 이화여자대학교 생명의료법연구소 2007 생명윤리정책연구 Vol.1 No.2

The goal of this paper is to introduce the accreditation system of human research protection programs. This paper will trace the origin of AAHRPP and examine its standard for the accreditation, including requirements, guidelines, resources for the accreditation. The overview of its accreditation program includes its detailed information on IRB organization, membership, accreditation procedure, kinds of accreditation, and its benefit. The introduction to AAHRPP will guide our consideration on the introduction of IRB accreditation and its potential benefit in Korea. As shown in the accreditation system of AAHRPP, its success depends on the expertise and effectiveness. Institutions which received AAHRPP’s accreditation claim that they received practical help in improving their human participants protection program. AAHRPP’s tailored approach toward each institution seems to be met each institution’s demand and need. Due to large pool of expertise AAHRPP could identify primary issues and update its resources. AAHRPP’s accreditation system gives us an insight in improving human participant protection program. However, the development of accreditation system in Korea might not be the same as in US. AAHRPP originated from the society which is market-oriented and emphasizes individual autonomy rather than communal values. We need to consider the necessity, possibility, and limit of accreditation system in Korea in order to develop successful accreditation system which contributes to the protection of human participants.

암환자의 임상연구에 대한 인식도 분석: 피험자 보호 관점에서

김지예,이혜란,이성윤 한국의료윤리학회 2013 한국의료윤리학회지 Vol.16 No.3

This study was designed to assess the degree of cancer patients’ awareness of the nature of clinical trials (CT) and to provide basic information for further research in developing systems of protection for vulnerable patients. Patients diagnosed with cancer and admitted for chemotherapy or receiving outpatient treatment were surveyed. The survey consisted of three parts to gather information on (1) patients’ awareness of the nature of CT in general, (2) patients’ awareness of CT from medical perspectives, and (3) the relationship between intent to participate in CT and financial compensation. Eighty-five patients participated in the survey. In the first part, many patients answered that they would participate in the study lest they be put at a disadvantage for not participating, while others said they would participate because they felt they would receive special treatment. In the second part, scores were lowest in men, the elderly, the unemployed, and those who participated as a result of decisions made by their spouses. In the third part, rewards influenced women more than men, and patients in their 60s expected a greater reward than those in other groups. Most cancer patients may not be sufficiently aware of the nature of CT and may be vulnerable when making decisions by themselves. Therefore, it is necessary for patients to receive more information on CT and for the information to be presented in terms that patients can easily understand. A system for the protection of vulnerable patients may also be needed.

미국 임상시험심사위원회(Institutional Review Board)에 대한 인간피험자보호국(Office for Human Research Protection, OHRP)의 확약

김수정(Soo-Jung KIM) 이화여자대학교 생명의료법연구소 2007 생명윤리정책연구 Vol.1 No.2

The purpose of this study is to investigate current status and role of human subject protection program in the clinical trials in the United States. This paper will introduce Federalwide Assurance of Office for Human Research Protection as major governmental oversight system. Department of Health and Human Services have codified federal human subjects research regulations as Title 45(Public Welfare), Part 46(Protection of Human Subjects), 45 CFR 46 on 30 May, 1974. It also mandates IRB in the individual institutions which seek for federal funds for their research and let the Office for Human Research Protections take in charge of its administration. This paper also examines characteristics of Federalwide Assurance and assesses its advantages and disadvantages. Furthermore, it will find out the scope and limit of governmental oversight system on human subject research protection program.