임상시험심사위원회(IRB)의 리베이트 통제 역할에 관한 소고

강한철 대한변호사협회 2013 人權과 正義 : 大韓辯護士協會誌 Vol.- No.434

The original role of Institutional Review Boards established by medical institutions is to protect rights and welfare of the subjects of clinical trials. However, considering current amendments of the Medical Service Act including adoption of the Dual Punishment System and changing trend of healthcare industries, the role of Institutional Review Boards shall cover not only cursory review of the ethical relationship between investigators and trial subjects but also strict scrutiny of legal relationship between investigators and financial sponsors of clinical trials such as pharmaceutical companies and medical device businesses. If an Institutional Review Board fails to implement such responsibilities and illegal rebates are transferred in the course of clinical trials which are conducted under the supervision of the Board, the medical institution to which the Board belongs would inevitably face hugh difficulties arising from financial burdens and prohibition of medical services since the medical institution could be subject to restitution of unfair claims relating to medical services and imposition of administrative fines. And individual investigators could be subject to criminal punishments and suspensions of physician credentials. Futhermore, if the subjects or patients of clinical trials to which illegal rebate issues are related seek damages against medical institutions, whether or not relevant Institutional Review Boards properly performed their responsibilities to review and control relations between investigators and financial sponsors could play a key role in determining the medical institutions’ legal liability. To ensure an Institutional Review Board’s proper performance of its responsibility to prevent illegal rebates, it is required for external professionals separate from the medical institution and physicians’ community to actively participate in the Board. The Institutional Review Board should sufficiently review individual details of research expenses which could possibly trigger illegal rebates issue and check whether the leading personnels of pharmaceutical or medical device companies in clinical trials came from sales/marketing division or medical/academic department. And the fair market value of research compensation and the types of clinical trials should be also considered by the Institutional Review Board in the course of their review. 임상시험을 실시하는 의료기관, 즉 임상시험실시기관 소속의 임상시험심사위원회(Institutional Review Board)는 원래 피험자의 권익과 복지를 보호함을 주된 목적으로 하는 독립합의제 기관으로 설립되었다. 그러나 리베이트쌍벌제의 제정 등 최근 개정된 의료법 규정과 변화하는 보건의료법계의 동향은 임상시험심사위원회가 “시험자-피험자” 사이의 윤리관계뿐만 아니라 “시험자-재정적 후원자” 사이의 법적관계에 대해서도 엄격한 심사를 시행하도록 요구하고 있다. 만약 임상시험심사위원회가 이러한 통제기능에 소홀하여 시험자의 리베이트 수수 문제가 발생할 경우 임상시험실시기관에 대해서는 국민건강보험법상 부당청구금액환수 및 과징금부과처분이 부과될 우려가 있고 시험자는 형사처벌과 자격정지로 인한 진료공백을 감수하게 될 수 있다. 더욱이 리베이트가 문제된 임상시험의 피험자들이나 환자들이 주도하는 손해배상청구소송이 제기될 경우 임상시험심사위원회의 적정한 리베이트 통제 기능수행 여부는 의료기관의 법적 책임 인정과 관련한 핵심적인 쟁점이 될 수 있다. 이와 관련하여 ① 심사위원회의 구성과 운영에 있어 병원 및 보건의료계 외부 전문가의 적극적인 참여와 활동이 보장되었는지 여부, ② 임상시험심사위원회가 검토의 대상이 되는 임상시험 관련 연구비의 개별 비용내역에 관하여 오해나 의심을 초래할 수 있는 항목을 충분히 검토하였는지 여부, ③ 임상연구를 주도한 제약회사 또는 의료기기회사의 부서가 영업·마케팅 담당인지 아니면 의학·학술 담당인지 확인하였는지 여부,④ 연구비가 시장공정가격에 맞게 책정된 것인지 심의하였는지 여부 및 ⑤ 임상시험의 유형이 충분히고려되었는지 여부 등이 임상시험심사위원회의 적정한 리베이트 통제 여부를 판단하는 주요한 기준이될 것으로 본다.

국내 한방병원의 IRB 및 임상시험 실태조사

정희정(Hee-Jung Jung),박지은(Ji-Eun Park),최선미(Snu-Mi Choi) 대한한의학회 2010 대한한의학회지 Vol.31 No.1

기관생명윤리위원회 신속심의에 대한 법정책적 기준 마련에 관한 제언

김은애(Eunae Kim) 이화여자대학교 생명의료법연구소 2016 Asia Pacific Journal of Health Law & Ethics Vol.10 No.1

For the research review to protect the research participants, the Institutional Review Board (“IRB”) has been using two procedures: one is the review procedure by full institutional review board (“full board review procedure”) as the principled research review procedure, the other is the expedited review procedure as the exceptional research review procedure. Both procedures are recognized internationally, and they have been introduced by significant numbers of Korean IRBs. But, despite the legal requirement of the research review under the Bioethics and Safety Act, there is almost nothing about the legal standards and policy related to the expedited review unlike the full board review. Operating the expedited review procedure can greatly contribute to improved IRB task efficiency because it is possible to relatively reduce the burden on the operation of the full board review procedure relatively and make it possible to make appropriate review on the research that needs the full board review because of its risk, participation of vulnerable persons, sensitiveness of collected information and so on. Besides, the review result can be derived quickly by the expedited review procedure. Therefore, to recognize the expedited review officially, to assess the appropriateness of the actual operation, to prevent abuse and misuse of the expedited review procedure, and to make the expedited review procedure used properly, the legal standards and policy about the expedited review should be established. So in this article, I propose some considerations for establishing the legal standards and policy about the expedited review such as the level and types of research risk, vulnerability of the research participant and so on.

침구임상시험 가이드라인 개발과정에서 IRB의 윤리적ㆍ과학적 지적사항 사례 조사 연구

임정태,이승훈,한가진,김은정,서병관,김태훈,이승덕,김종욱,유아미,남동우,이준희 대한침구의학회 2015 대한침구의학회지 Vol.32 No.2

Objectives : To improve quality of clinical research for acupuncture and moxibustion, a guideline for clinical research protocol is needed. While developing a guideline for acupuncture and moxibustion clinical research, we reviewed the ethical and scientific aspects of protocols pointed out by the institutional review board. This will offer practical assistance to the researchers. Methods : Ethical and scientific aspects of acupuncture and moxibustion research protocols reviewed by Kyung Hee University Korean Medicine Hospital Institutional Review Board were gathered and reviewed. Results : Ethical and scientific aspects of protocol review was reported. Conclusions : The example of review will be helpful for new researchers when developing acupuncture and moxibustion clinical research protocol.

Recruting members of IRBs on embryo research in Korea

전방욱,김만재 한국생명윤리학회 2008 생명윤리 Vol.9 No.2

The Korean Bioethics and Biosafety Act requires embryo research institutions to set up their own institutional review board (IRBs), consisting of more than or equal to 5 persons. The Act also asks for including at least two mandatory members, one who is not engaged in the fields of life science or medical science and the other who does not belong to the institution. Since the IRBs were established in 2005, they did not receive general attention until Hwang's stem cell research became internationally scandalized. While arguing Hwang's research misconduct, it was also revealed that the IRBs that reviewed his research did not follow any legal procedure. Although Hwang's scandal provided an opportunity to improve the IRB operation in Korea, it is not clear whether the IRB fully represents its original raison d'etre or not. Therefore, this study aims to analyze current conditions and tries to find out some plausible problems of the IRB, largely focusing on recruiting members. Some data provided by the Ministry of Health and Welfare show that the IRB members are 6.24 persons on average, and embryo producing medical institutions occupy 70.1 percent in total, whereas embryo research institutions and somatic cell embryo clones research institutions represent 27.0 percent and 2.9 percent respectively. Preliminary results reveal that, among 209 persons recruited from outside, 55.5 percent of them (116 persons) are from medical practitionersand life scientists. Considering academic environment in Korea, it is very likely that these members are selected from peer groups in favor of reviewed research. The analysis also indicates that 71.6 percent of nonprofessional members are employees of the institution, which makes it hard to expect them to review a research proposal without any conflict of interest. In conclusion, although most institutions seem to follow the law at first glance, current conditions of the IRBs in Korea are still far from what the law originally intended to pursue. The Korean Bioethics and Biosafety Act requires embryo research institutions to set up their own institutional review board (IRBs), consisting of more than or equal to 5 persons. The Act also asks for including at least two mandatory members, one who is not engaged in the fields of life science or medical science and the other who does not belong to the institution. Since the IRBs were established in 2005, they did not receive general attention until Hwang's stem cell research became internationally scandalized. While arguing Hwang's research misconduct, it was also revealed that the IRBs that reviewed his research did not follow any legal procedure. Although Hwang's scandal provided an opportunity to improve the IRB operation in Korea, it is not clear whether the IRB fully represents its original raison d'etre or not. Therefore, this study aims to analyze current conditions and tries to find out some plausible problems of the IRB, largely focusing on recruiting members. Some data provided by the Ministry of Health and Welfare show that the IRB members are 6.24 persons on average, and embryo producing medical institutions occupy 70.1 percent in total, whereas embryo research institutions and somatic cell embryo clones research institutions represent 27.0 percent and 2.9 percent respectively. Preliminary results reveal that, among 209 persons recruited from outside, 55.5 percent of them (116 persons) are from medical practitionersand life scientists. Considering academic environment in Korea, it is very likely that these members are selected from peer groups in favor of reviewed research. The analysis also indicates that 71.6 percent of nonprofessional members are employees of the institution, which makes it hard to expect them to review a research proposal without any conflict of interest. In conclusion, although most institutions seem to follow the law at first glance, current conditions of the IRBs in Korea are still far from what the law originally intended to pursue.

보건학 연구에서 연구윤리심의위원회 심의

이선희 한국보건행정학회 2022 보건행정학회지 Vol.32 No.1

With the rising attention dedicated to research ethics, the responsibility of researchers to comply with research ethics is alsohighlighted. Among a number of research ethics obligations that researchers should abide by, an institutional review board (IRB)review is the most essential step to be taken before launching research. As the health service research field grapples with humansubjects, it closely aligns with IRB deliberation. However, it seems that researchers still do not fully understand their obligations ofIRB reviews. Due to the nature of health services research, there are many cases that are exempt from IRB reviews, which often elicitsconfusion in the research field. On that note, we aim to explore the issues regarding IRB reviews that health service researchers needto know.

임상시험 피험자에게 발생하는 이상반응 관리 절차의 문제점과 개선방안

이미성 이화여자대학교 생명의료법연구소 2010 생명윤리정책연구 Vol.4 No.2

Institutional Review Board (IRB) is a committee to protect clinical research subjects’ human rights and health and to guarantee the ethicality and scientificity of research. However, the adverse event report system of domestic IRBs is not playing its role adequately as a subject protection against adverse events in clinical trials. According to the SOPs of the IRBs of five hospitals surveyed, convened IRB review is judged relying on reports submitted by the investigator, and adverse events not included in the convened IRB review are reviewed in the Expedite Review or not reviewed. This report system can be a problem in three aspects. First, the investigator may submit a wrong report because of financial or non-financial conflict of interest. Second, the investigator may misdiagnose adverse events occurring in the subjects. Third, there is no system for detecting errors even if the investigator has made an incorrect report on adverse events. In order to solve these problems, this study made a number of suggestions. First, in order to manage investigators’ conflict of interest, the IRB needs to establish SOPs related to conflict of interest and KGCP should also introduce provisions on conflict of interest. Second, in consideration of the investigator’s misdiagnosis, it is proposed to use the peer review system. It is introducing ‘second opinions on adverse events’ from medical specialists in the same major. Lastly, in order to detect errors in the investigator’s report, it is suggested to utilize a committee specializing in the review of adverse events (adverse event committee). The Special Committee on Adverse Events is a subcommittee mainly on adverse events. Such a committee may provide a more professional and intensive review for adverse events. Subject protection in the true sense cannot be attained by simple documentary works or by following a procedure. Thus, it is now necessary to see adverse event reviews are made meaningfully to individual subjects.

IRB 지속심사와 연구 미준수 연관성 분석

박선영(Sun Young Park),최병인(Byung In Choe) 가톨릭생명윤리연구소 2023 인격주의 생명윤리 Vol.13 No.2

임상시험심사위원회 (Institutional Review Boards: 이하 ‘IRB’) 승인을 받아 진행 중인 연구에 대한 지속심사는 연구대상자를 보호하는 방법 중 하나이다. 신규과제에 대한 IRB 승인유효기간은 해당 과제의 위험정도 평가에 따라 다르긴 하지만, 일반적으로 최대 1년을 넘지 않도록 법률로 한정하고 있다. 승인된 유효기간을 연장하기 위해서는 지속심사가 필요하다. 지속심사를 통해 IRB는 연구가 승인된 계획서에 따라 수행되는지, 부작용이 적시에 보고되었는지, 위험과 이익의 비율이 합리적인지의 여부를 판단하여 연구 진행 여부를 결정한다. 본 연구는 2019년부터 2021년까지 C대학병원 IRB에서 심사한 784건의 데이터를 후향적인 방법으로 조사 분석 연구를 시행하였고 지속심사 미준수 그룹과 준수 그룹의 연구 및 연구자 특성, 미준수 유형에 따라 분석한 결과 통계적으로 유의미한 차이가 있음을 파악하였다. 지속심사 미준수 그룹은 연구자주도 연구, 임상시험 외 연구, 연구코디네이터가 없는 연구 등에서 높은 빈도를 보였고 지속심사 준수 그룹은 의뢰자주도 연구, 임상시험 연구, 공동연구자가 있는 연구, 연구코디네이터가 있는 연구 등에서 높은 빈도를 보였다. 또한 미준수 유형을 분석한 결과 지속심사 미준수 그룹에서는 IRB보고 미준수와 동의절차 미준수가 높은 빈도를 보였다. 따라서 지속심사 미준수와 연구미준수와의 연관성을 분석하여 IRB의 궁극적인 목적인 연구대상자 보호에 기여할 수 있는 방안을 모색하고자 하였다. The continuing review of ongoing research approved by the Institutional Review Boards(IRB) is one of the ways to protect human subjects. Though the approval expiration date for new tasks depends on the risk assessment of said task, it is generally limited by law not to exceed a maximum of one year. Continuing review is required to extend the approval expiration date. Through continuing review, the IRB determines whether the research is conducted under the approved protocol, whether any side effects were reported timely, and whether the risk-to-benefit ratio remains favorable. This research used 784 cases of data reviewed by the C University Hospital's clinical research support system from 2019 to 2021 in a retrospective matter and analyzed the characteristics of research and researchers in non-compliance and compliance groups, and types of non-compliances, finding significant differences. Non-compliance groups were highly frequent in investigator initiated trials(IIT), non-clinical trials, and studies without clinical research coordinators, while compliance groups were more frequent in sponsor initiated trials(SIT), studies with co-investigator, and studies with clinical research coordinators. In addition, after analyzing the types of non-compliance, the non-compliance with the IRB reporting and non-compliance with the consent process were high in non-compliance groups. Therefore, we analyzed the relationship between non-compliance and compliance groups in continuing review to find a way to contribute for the ultimate purpose of IRB, protection of human subjects.

임상시험심사위원회의 임무와 운영

김용진 영남대학교 의과대학 2013 Yeungnam University Journal of Medicine Vol.30 No.2

An institutional review board (IRB) should independently safeguard the right, safety, and well-being of all clinical trial subjects. It should consist of members who are qualified and experienced to review and evaluate the science, medical aspects, and ethics of the proposed trial. They have to pursue continuing efforts to improve the standards of review. The levels of review include the full board review, expedited review, continuing review, or exempt from review, while the levels of decision-making include approval, conditional approval, deferred approval, and disapproval. Investigators must follow the approved protocols and regulations honestly, and it is the IRB's mission to audit clinical trial sites as well.

우리나라 군 연구기관의 기관생명윤리위원회 운영현황과 군인 연구대상자 추가 보호 방안

박상민(Park, Sang Min),박경태(Park, Kyoung Tae),최병인(Choe, Byung In) 가톨릭생명윤리연구소 2020 인격주의 생명윤리 Vol.10 No.1

현재 군 연구기관에서 군인을 대상으로 하는 연구가 시행되고 있으며, 이 중 5개의 기관이 질병관리본부에 기관생명윤리위원회(Institutional Review Board, 이하 IRB)를 등록·운영하고 있다. 그러나 군인 연구대상자들에 대한 보호와 관련된 조사나 연구는 부족한 상황이다. 우리나라 군 연구기관에서 수행되고 있는 군인대상연구에서 연구대상자 보호가 어느 정도 되고 있는지 현황을 파악하고 개선방향을 제안해보고자 한다. 군인은 국내 법률 및 기준 상 연구 참여에 대한 의사결정 시 자율성을 침해받을 수 있는 가능성을 가진 취약한 환경에 있는 대상자로 분류된다. 더구나 우리나라는 징병제를 시행하는 국가이기 때문에 다른 국가의 군인들보다 더욱 취약한 환경에 놓여 있는 상황으로 볼 수 있다. 때문에 연구대상자보호 기능 중 하나인 IRB의 운영이 원활히 되어야 하고, 군인 연구대상자들에게는 일반 연구대상자들에 대한 보호 방안보다 좀 더 추가적인 보호 방안이 필요하다. 군 연구기관 IRB들은 기본적인 구성은 갖춰 놓았으나 세부적인 운영에 있어 개선이 필요한 부분들이 발견되었고, 군인 연구대상자에 대한 추가 보호 방안 역시 1개 기관을 제외하고는 따로 마련되어 있지 않은 것으로 확인되었다. 이와 같은 조사 결과를 바탕으로 하여, 각 기관별 IRB 운영에 관련한 개선 방안과 군인 연구대상자에 대한 추가 보호 방안을 제안하고자 한다. Korean military research is currently being conducted on active-duty soldiers in military research institutions. Five of them have registered the Institutional Review Board(IRB) with the Korea Center for Disease Control and Prevention(KCDC). Four out of 5 registered IRBs actually operate IRB functions. However, little investigation has been done on the protection program of military research participants. The purpose of this study is to understand the current status of the protection for military research participants. Active-duty military research participants are regarded as vulnerable subjects by Korean Act and Regulation. As there is possibility that autonomy may not be guaranteed in making free decisions about participation in research. And Korea is the country that implements draft system. When Korean military research participants are compared with those from other countries, they are more vulnerable than those from other countries. Due to these, the operation of IRB, one of Human Research Protection Programs, should be operated according to well-prepared Standard Operating Procedures(SOPs). Also, military research participants need more protective program than general research participants because of their special situations. With assessment of Korean military IRBs, the military research institutions have established their own IRBs. But it was founded that they need to improve IRB operations to better protect Korean military participants. And, the variations of protection programs does exist among the military research institutions. Based on this survey results, I recommend the improvement plan for each IRB operation and the protection program for the military research participants.