커먼룰과 보관된 인체유래물에 관한 제공자의 권리

박수헌 이화여자대학교 생명의료법연구소 2012 생명윤리정책연구 Vol.6 No.1

Catalona court decided who had the rights to dispose the stored biospecimens among donors, an investigator(=Dr. Catalona), and an institute(=Washington University). According to the jurisdiction of the case, the court gave the institute rights to dispose the stored biospecimens based on the common law donation theory. However, there’s a critical opinion on this decision. Especially, it insisted that the decision violated the Supremacy Clause in the Amendment VI of the Federal Constitution. That is, the decision violated the general principle of Informed Consent that the rights of the human research subjects should not be waived by including exculpatory language. As you know, to obtain informed consent from the human research subjects is the critical element in conducting ethical research. But, according to Catalona decision, if there’s informed consent when the investigator or the institute collected the biospecimens, it’s allowed to use the stored biospecimens in any kind of research without obtaining additional informed consent from the donors. In fact, current Common Rule provided that the research could be conducted without obtaining additional informed consent from the donors if the identifiers were stripped. However, it’s necessary to consider that the complete anonymatization is not possible, especially, in the field of genomics. Changing technology in this field has dramatically increased the amount and nature of information about individuals that can be obtained from their DNA. It’s necessary to consider that the rights of donors should be protected as well. Under the Common Rule, investigators may be allowed in certain situations to obtain a general consent for future research with stored biospecimens. However, this violates HIPAA Privacy requiring that authorizations for research be study-specific. Therefore, the current Common Rule should be amended to provide the sufficient safeguards to protect the rights of donors in disposing their stored biospecimens. In order to do that, the suggestions would be helpful: the Common Rule should explicitly stipulate that it applies to research using biospecimens, the Common Rule should explicitly provide that donors retain certain rights in their biospecimens, the Common Rule should explicitly include that donors must give fully informed consent, the Common Rule should explicitly stipulate that blanket consent be prohibited, and the Common Rule should explicitly stipulate that investigators cannot anonymize a sample after its donor has requested withdrawal from research. Actually, OHRP published the Proposed Rule for the current Common Rule in the Federal Register in July 26, 2011 and received all the comments. OHRP is still working on making final rule. I hope that the final rule guarantee full informed consent of donors in research using stored biospecimens and provide additional safeguards to protect and enhance the rights of human research subjects.

Current Status, Challenges, Policies, and Bioethics of Biobanks

Kang, Byunghak,Park, Jaesun,Cho, Sangyun,Lee, Meehee,Kim, Namhee,Min, Haesook,Lee, Sooyoun,Park, Ok,Han, Bokghee Korea Genome Organization 2013 Genomics & informatics Vol.11 No.4

Many biobanks were established as biorepositories for biomedical research, and a number of biobanks were founded in the 1990s. The main aim of the biobank is to store and to maintain biomaterials for studying chronic disease, identifying risk factors of specific diseases, and applying personalized drug therapies. This report provides a review of biobanks, including Korean biobanks and an analysis of sample volumes, regulations, policies, and ethical issues of the biobank. Until now, the top 6 countries according to the number of large-scale biobanks are the United Kingdom, United States, Sweden, France, the Netherlands, and Italy, and there is one major National Biobank of Korea (NBK) and 17 regional biobanks in Korea. Many countries have regulations and guidelines for the biobanks, and the importance of good management of biobanks is increasing. Meanwhile, according to a first survey of 456 biobank managers in the United States, biobankers are concerned with the underuse of the samples in their repositories, which need to be advertised for researchers. Korea Biobank Network (KBN) project phase II (2013-2015) was also planned for the promotion to use biospecimens in the KBN. The KBN is continuously introducing for researchers to use biospecimens in the biobank. An accreditation process can also be introduced for biobanks to harmonize collections and encourage use of biospecimens in the biobanks. KBN is preparing an on-line application system for the distribution of biospecimens and a biobank accreditation program and is trying to harmonize the biobanks.

Current Status, Challenges, Policies, and Bioethics of Biobanks

강병학,박재선,조상연,이미희,김남희,민해숙,이수연,박옥,한복기 한국유전체학회 2013 Genomics & informatics Vol.11 No.4

Many biobanks were established as biorepositories for biomedical research, and a number of biobanks were founded in the1990s. The main aim of the biobank is to store and to maintain biomaterials for studying chronic disease, identifying riskfactors of specific diseases, and applying personalized drug therapies. This report provides a review of biobanks, includingKorean biobanks and an analysis of sample volumes, regulations, policies, and ethical issues of the biobank. Until now, thetop 6 countries according to the number of large-scale biobanks are the United Kingdom, United States, Sweden, France, theNetherlands, and Italy, and there is one major National Biobank of Korea (NBK) and 17 regional biobanks in Korea. Manycountries have regulations and guidelines for the biobanks, and the importance of good management of biobanks isincreasing. Meanwhile, according to a first survey of 456 biobank managers in the United States, biobankers are concernedwith the underuse of the samples in their repositories, which need to be advertised for researchers. Korea Biobank Network(KBN) project phase II (2013‒2015) was also planned for the promotion to use biospecimens in the KBN. The KBN iscontinuously introducing for researchers to use biospecimens in the biobank. An accreditation process can also beintroduced for biobanks to harmonize collections and encourage use of biospecimens in the biobanks. KBN is preparing anon-line application system for the distribution of biospecimens and a biobank accreditation program and is trying toharmonize the biobanks.

생명윤리 및 안전에 관한 법률 개정에 따른 검체사용 연구에 대한 법적 윤리적 적용

장윤정,공선영 대한진단검사의학회 2015 Laboratory Medicine Online Vol.5 No.3

The recent revision of the Bioethics and Safety Act has created some confusion as to the appropriate use of biospecimens in research. Here, to avoid misunderstandings, we outline the changes to policies on the use of biospecimens in guidelines provided in a question-and-answer format, citing relevant examples where appropriate. 2013년 2월 ‘생명윤리 및 안전에 관한 법률’이 개정되었는데 실제로 검체 사용 연구에 대한 법적 윤리적 적용 기준을 연구자들이 쉽게 이해하기 어려운 측면이 있다. 따라서, 검체 사용에 대한 주요 예시를 이용해 개정 후 지침에 따라 질문과 답변을 중심으로 검체 사용 연구를 계획하는 연구자들이 쉽게 적용할 수 있도록 이를 정리하였다.

Management and Ethics of Biobank; Biorepository

Shin, Bong Kyung,Choi, Jung Woo,Lee, Hyunjuu,Kim, Aree,Kim, Insun,Kim, Han Kyeom 대한병리학회 2005 Journal of Pathology and Translational Medicine Vol.39 No.6

Research access to a large number of high-quality biospecimen, adequately annotated and ethically acquired, is critical to an improved understanding of disease and ultimately new development of effective diagnostic markers and therapeutic targets. Therefore, the importance of biobanking is widely recognized within the life science and healthcare communities. Resolution of the ethical issues, including informed consent, confidentiality and institutional review board approval, are probably the most important task to every biobank or biorepository. In Korea, the new, very strict ethical act on research, issued in 2005, requires researchers as well as biorepositories to know how they use or run a biorepository ethically without damaging the right of human subjects who gave the repository their biospecimen.

Let Archived Paraffin Blocks Be Utilized for Research with Waiver of Informed Consent

김용진,박정식,고가람,정창록 대한병리학회 2018 Journal of Pathology and Translational Medicine Vol.52 No.3

Advances in biomedical and genetic research have contributed to more effective public health improvement via bench-to-bed research and the emergence of personalized medicine. This has certainly showcased the importance of archived human tissues, especially paraffin-embedded blocks in pathology. Currently in Korea, undue legislative regulations of the Bioethics and Safety Act suspend and at times discourage studies from taking place. In this paper, the authors underline the value of paraffin blocks in the era of personalized and translational medicine. We discuss detailed clauses regarding the applicability of paraffin blocks from a legal perspective and compare Korea’s regulations with those of other countries. The necessity for allowing waived consent and Institutional Review Board (IRB) approval will be argued throughout. The authors suggest that researchers declare the following to obtain IRB approval and waiver of informed consents: research could not be practically carried out without a waiver of consent; the proposed research presents no more than minimal risk of harm to subjects, and the waiver of consent will not adversely affect the rights and welfare of subjects; and research will not utilize a tissue block if only 1 is available for each subject, to allow future clinical use such as re-evaluation or further studies.

미국 연구대상자 보호 정책의 최신 동향

정준호(Jung Jun-ho),김옥주(Kim Ock-joo) 한국생명윤리학회 2017 생명윤리 Vol.18 No.1

전면 개정되어 2018년 1월 19일부터 효력을 발휘할 미국 인간대상연구 보호를 위한 연방정책(Federal Policy for the Protection of Human Subject)인 커먼룰(Common Rule)은 21세기 들어 변화한 연구환경을 반영하는 동시에 연구대상자를 보다 잘 보호하기 위한 것으로서, 중요한 연구를 촉진하고 연구자의 부담과 지연, 모호성을 줄이면서 동시에 현재의 감독 체제를 현대화하고, 단순화하고, 강화시키는 노력으로 개정 목적을 밝히고 있다. 한국 생명윤리 및 안전에 관한 법률의 구성과 시행에 많은 영향을 미쳐 온 미국 커먼룰의 개정은 향후 한국의 연구대상자 보호 정책에도 많은 변화가 필요함을 시사하고 있다. 본 연구에서는 2017년 미국 커먼룰 개정을 중심으로, 미국 커먼룰 제정과 변천 과정을 인간대상연구윤리 관점의 시대적 변화라는 역사적 맥락에서 살펴보고 현재의 커먼룰 개정이 인간대상연구 환경의 변화를 어떻게 반영하고 있는지 보이고자 한다. 이를 통해 한국 생명윤리법 제정과 및 시행 과정에 많은 영향을 미쳐온 커먼룰의 고유한 맥락을 이해하고, 연구대상자 보호와 인간대상연구의 개념 변화의 의의에 대해 논의해 보고자 한다. Fully revised and updated U.S. Common Rule (Federal Policy for the Protection of Human Subject) will come into effect from January 19, 2018. Updated Common Rule reflects the changes in research landscape, as well as public view of human subject research. Purpose of the revision is to modernize, strengthen, and make more effective policy. It is intended to facilitate valuable research, reduce burden, delay, and ambiguity for investigator while better protecting human subject involved in research. Changes in its scope and definitions of Common Rule suggest that Bioethics and Safety Act in Korea may also need substantial revision which can reflect the current shifts in research enterprise. This study focuses on historical development of the Common Rule, and significant changes from pre-2018 rule in the final rule (2017) of the Common Rule which shows changing concept of human research protection. This will help to understand the context of development process of Common Rule that had substantial influence on Korea’s Bioethics and Safety Act.

「생명윤리 및 안전에 관한 법률」상 심의면제의 의미 및 실무 개선의 제안

이강미(Gangmi Lee),이원복(Won Bok Lee) 한국생명윤리학회 2019 생명윤리 Vol.20 No.1

생명윤리 및 안전에 관한 법률에 따르면 인간을 대상으로 하는 연구 또는 인체유래물을 대상으로 하는 연구를 시작하기 전에 연구대상자(인체유래물 기증자)의 동의와 기관위원회의 심의가 필요하다. 다만 법으로 동의와 심의면제를 할 수 있는 경우를 정하고 있다. 여기서 심의를 면제할 수 있다고 판단하는 주체를 누구로 할 것인가에 대한 해석에 있어서 정부기관은 기관위원회를 그 주체로 해석하고 있다. 그러나 생명윤리 및 안전에 관한 법률의 해석론상 기관위원회는 연구대상자(인체유래물 기증자) 및 공공에 미치는 위험이 미미한 가를 판단할 권한과 심의면제 기준인 시행규칙 제13조, 제33조에 따라 심의면제를 할 수 있는 연구인가를 판단할 권한이 있는지 의문이 있다. 오히려 해석론적으로 기관위원회에 국내 실무가 전제하고 있는 기관위원회의 면제 사유 판단 권한은 법적 근거가 없다고 생각되고, 정책론적으로 보더라도 국내 심의면제 기준은 그 범위가 좁고, 명확하며 이미 입법자가 연구대상자(인체유래물 기증자) 및 공공에 미치는 위험이 미미하다고 범위를 좁혀 정한 경우이기 때문에 기관위원회의 개입 없이도 연구자 스스로 객관적이고 정확한 판단을 하도록 유도할 수 있다고 생각한다. 따라서 심의면제에 있어서 기관위원회의 역할은 심의면제 기준에 따라 연구자가 스스로 정확한 판단을 할 수 있도록 체크리스트, 플로우 차트 등을 통해서 이끌어주는 것이며 필요 시에만 개입하도록 해야 한다. 이를 위하여 본 논문은 연구자 스스로 기관위원회 심의 면제를 판단할 수 있도록 돕는 플로우 차트를 제안한다. The Bioethics and Biosafety Act of Korea requires that a research involving human subjects or human biospecimen must obtain prior consent from the subject (or donor) as well as review by an institutional review board (“IRB”). The law also provides exemption from these consent and IRB review requirements. There is question as to who can decide whether a proposed research is eligible for exemption from IRB review. The relevant government ministry and agency appear to be of the view that an IRB has the authority to determine the eligibility. However, a strict construction of the statutes brings into question whether an IRB has the legal basis to determine whether a proposed research will pose minimal risk to the subject (or donor) or the general public, or to determine whether a proposed research falls into one of the many exempted types of research. To the contrary, a strict reading of the statutes will reveal that an IRB has no legal authority to determine whether a proposed research is eligible for exemption. From policy perspective, the narrow and specific statutory exemptions from IRB review under Korean law are amenable to self-determination by the investigator for some exemptions. The authors propose a flowchart by which the investigator of a research can self-determine the eligibility for exemption from IRB review when it is appropriate.