• 대한예방의학회:학술대회논문집
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• 대한예방의학회 2001년도 제53차 추계 학술대회 연제집
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• pp.359-360
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• 2001

• 대한기관윤리심의기구협의회지
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• 제6권2호
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• pp.48-55
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• 2024

Purpose: The purpose of this study is to introduce the Institutional Review Board (IRB) member-based internal audit method performed at A University Hospital, a secondary medical institution, and to identify the differences in audit results according to the characteristics of each auditor and the factors affecting the internal audit results. Furthermore, we will find out what needs to be improved in the internal audits to achieve Quality assurance (QA) objectives for human subject research conducted in medical institutions. Methods: The auditors were divided into group A (IRB member belonging to institution A) and group B (clinical trial QA administrator belonging to other institutions) and independently inspected the 2 studies using the same internal audit checklist (consisting of 11 domains, 130 items), and the differences in the internal inspection checklists written by each auditor were compared and analyzed. Results: In the case of audit for the study 1, the number of missing checklists is 1 for group A and 0 for group B, and the number of the matters to be pointed out is 1 for group A and 12 for group B. In the case of audit for the study 2, the number of missing checklists is 2 for both A and B, and the number of points is 5 for A and 4 for B. The differences in the internal audit results written by each auditor that the authors verified are summarized as follows. First, there were more comments from group B auditor than from group A auditor. Second, the results may vary because each auditor has different criteria for evaluating the appropriateness of an item. Third, there are cases where the questions on the checklist are vague or the definition is not clear, so they have the same opinion but check it with different answers. Fourth, if the auditors make a mistake when filling out the checklist, it causes to led to different the results. Conclusion: We propose the following items that should be improved in order to conduct consistent and efficient internal audits. First, it is necessary to test the tool in order to carry out reliable and consistent internal audits. Second, it is necessary to complete specialized training related to internal audit before conducting internal audit. Third, before notifying the audit results, it is necessary to have a procedure or a final review system to check whether the audit contents are appropriate. Fourth, Institutional support is needed to recruit specialized personnel for internal audits.

• Clinical and Experimental Pediatrics
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• 제52권1호
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• pp.1-5
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• 2009

Children are not small adults and there is a need to carry out specific trials that cannot be performed in adults. In general, children (minors) are unable to consent but their assent should be obtained using age appropriate information. Institutional Review Board (IRB) need paediatric expertise to balance the benefits and risks of research in children. The lack of consent has implications on the design, analysis and the choice of comparators used in the trials, which should only be performed by trained investigators with paediatric experience. Pain, fear, distress and parental separation should be prevented and minimised when unavoidable. The children requires even more careful review. Children represent a vulnerable population with developmental, physiological and psychological differences from adults, which make age- and development- related research important for their benefit. Finally, criteria for the protection of children in clinical trials therefore need to be laid down. Specific protection should be defined for research performed in children, at all stages and ages.

• 대한기관윤리심의기구협의회지
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• 제1권1호
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• pp.5-21
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• 2019

Purpose: Institutional review board (IRB) classifies risks of clinical trials into less than minimal risk, minor increase over minimal risk, and more than minimal risk. Based on classification and evaluation for risk, IRB decides whether permitting consent exemption or asking additional protection for clinical research subject or not. The purpose of this study is to analyze how IRB members evaluate minimal risk by sending questionnaire survey with 12 predetermined scenarios. Methods: IRB members and researchers (pediatrician, gastroenterologist, neurologist, and neurosurgeon) in 11 different hospitals were asked to answer survey questions via email or online. We analyzed the differences of answers among several subgroups in each predetermined scenarios. Result: Responders were 212 personnel(110 researchers and 102 IRB members) from 11 centers. There were significant differences between IRB members and researchers in response such as blood sampling, skin prick test, one time catheterization in a girl, spinal tapping in child, non-enhance MRI in child, non-enhance MRI with chrolal hydrate in a child, spinal tapping without anesthesia in adult, bioequivalence test, gastric endoscopy, and non-enhance CT. significant differences between medical IRB members and non-medical members were also revealed in one time catheterization in a girl, spinal tapping in a child, non-enhance MRI in a child, bioequivalence test. Depending on researchers' department, they responded differently in several questionnaires as well. Conclusions: We have found that IRB members and researchers evaluate the risks differently. Researchers compared to IRB members, medical IRB members compared to non-medical members answered less than minimal risk in many cases. In assessing and evaluating the risks associated with the study, medical IRB members answered predetermined scenarios as less dangerous compared to non-medical IRB members. Difference among researchers where also revealed significantly. Researchers answered predetermined scenarios as less dangerous compare to other department researchers, especially in predetermined scenarios containing procedures they are familiar with.

• 의료법학
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• 제19권1호
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• pp.165-206
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• 2018

연구와 관련하여 다중적 이해관계(multiple interests)를 가지고 있는 연구자, 기관생명윤리위원회 및 임상시험심사위원회 위원, 연구기관 등은 전문적인 판단(professional judgment)을 내림에 있어 이해상충(Conflicts of Interest)의 문제가 발생하지 않도록, 즉 자신이 수행해야 하는 역할이나 이행해야 하는 의무에 의하면 반드시 고려되어야만 하거나 보다 우선시되어야하는 1차적 이해(primary interest)가 그렇지 않은 2차적 이해(secondary interest)로 인해 영향을 받지 않도록 하여야 한다. 그러므로 이해상충의 문제의 발생을 예방하거나 발생된 이해상충의 문제를 해결할 수 있도록 하기 위해 기준과 방법이 마련되어 있어야 하고, 이와 관련한 기본적인 사항은 모든 당사자가 이해하고 따를 수 있도록 하기 위해 법정책적으로 명확하게 제시될 필요가 있다. 보다 현실성 있는 법정책의 마련을 위해서는 현황 파악이 전제되어야 할 것이므로 연구 관련 주요 실무자인 기관생명윤리위원회 및 임상시험심사위원회의 운영지원인력(행정간사)을 대상으로 하여 수행된 설문조사 및 인터뷰의 결과를 살펴봄으로써 이해상충과 관련한 법정책적 쟁점과 이의 해결을 위한 대응방안에 관한 의견을 확인해보았다. 그리고 향후 이해상충에 대한 국내 법정책의 마련에 도움을 주고자 미국 보건부에서 발표한 이해상충 관련 지침의 주요 내용을 살펴보았다. 마지막으로, 이해상충과 관련한 국내 법정책의 현황을 연구자의 이해상충, 기관생명윤리위원회 및임상시험심사위원회위원의 이해상충, 기관의 이해상충으로 구분하여 파악해보고 그 개선방안을 제시하였다.

• Journal of Nutrition and Health
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• 제43권6호
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• pp.653-660
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• 2010

Along with the steady growth of health functional food (HFF) markets, research evaluating the human effects of HFF has been expanding. In this study, we investigated the regulatory and management system of human study on HFF in the USA, Japan and UK, and the Korean domestic regulations on HHF, medicines, medical devices, cosmetics and biotechnology in order to improve the domestic management system. In these four countries, institutional review board (IRB) or research ethics committee (REC) approvals are required for on human study of HHF, but regulatory and management systems differ from country to country. In the USA, human studies on HFF for structure/function claims do not require the FDA's prior approval but clinical trials of the disease treatment effects of HHF require prior approval from the FDA. In the USA, IRBs are managed by the Department of Health and Human Services (DHHS) rather than the FDA, and IRBs in those institutions which would execute the clinical trials requiring prior approval from the FDA or human studies funded by the USA federal government are required to be registered on the DHHS. In the UK, although the government does not require prior approval of human study, authorized RECs managed by the National Research Ethics Service (NRES) and other independent RECs review the human study. In Japan, human study for HFF must conform with "Ethical guidelines for epidemiological research" and IRB registration has not been required. In Korean domestic regulations, the responsibilities, compositions, functions and operations of IRBs on medicines, medical devices and biotechnology are legally specified, but not those of IRB on HHF. These foreign statuses for the management of human study on HFF and comparisons with Korean regulations are expected to be used as basic data to improve the domestic legal system.

• 의료법학
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• 제13권2호
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• pp.79-113
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• 2012

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.

• 대한기관윤리심의기구협의회지
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• 제3권2호
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• pp.28-36
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• 2021

Purpose: The purpose of this study is to assess the status of the Human research Protection Program (HRPP) within a hospital or a research institute in Korea. Methods: Survey was conducted during June 12th-21th 2019. Survey was distributed to the members of Korean Association of IRB (KAIRB) through each IRB office. Descriptive statistics were performed using SPSS ver. 26. Results: A total of 86 people responded, and 75 (87.0%) answered that they have perceived the HRPP. Seventy out of 86 respondents (81.4%) were conducting internal audit, several institutions were operated simultaneously the other form of audits such as IRB audit, system audit. Regarding the management of Suspected Unexpected Serious Adverse Reaction (SUSAR), 62.8% answered that they have regulation that can decide to suspend the study when there is a risk to subject safety. Among the respondents, 66.3% performed 'Help desk.' Conclusion: In this study, we assessed the current status of HRPP operation at each research institution based on Ministry of Food and Drug Safety (MFDS) HRPP guidelines. The HRPP accredited institution operated the subject protection activities according to this program, and even if the HRPP was not officially operated, the related activities were conducted focusing on the cases that could have a significant impact on the safety of research subjects. In order to ensure the quality of domestic clinical trials and to stably establish the HRPP, efforts at the individual institution level will be required.

• 대한소아치과학회지
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• 제41권2호
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• pp.187-192
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• 2014

연구윤리는 학문을 탐구하는 사람이 갖추어야 할 가장 근본적인 자세라고 할 수 있다. 많은 선학들의 훌륭한 연구 업적 덕분에 지금의 학문 체계가 마련될 수 있었다. 최근 증가되고 있는 결과 중심의 연구 풍토와 업적을 중시하는 평가 시스템은 일부 학자로서의 양심을 벗어난 연구를 부추기는 부작용을 낳을 수 있다고 사료된다. 이에 저자는 뉘른베르크 강령과 헬싱키 선언으로 시작된 연구윤리의 개념을 되짚어보고, 이를 강조하는 주체에 대한 각국의 입장과 국내 실정을 소개하며, 최근 개정된 "생명윤리 및 안전에 관한 법률"에 따른 기관생명윤리위원회의 역할, 심의면제 그리고 심의절차 등에 관해 검토해보고, 향후 연구자가 숙지해야할 내용을 점검해 보았다. 또한 연구 객관성의 확보와 연구부정행위에 대한 검증 및 대비를 위해 연구노트의 적극적인 활용을 고려해 보는 것을 제안하는 바이다.

• 한국치위생학회지
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• 제14권2호
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• pp.241-250
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• 2014

Objectives : The purpose of the study was to examine the ethical requirements for the protection of human subjects in the publication guidelines of dental health journals. Methods : The guidelines of 27 dental health journals were reviewed to determine ethical standards alone, with Helsinki Declaration, by an institutional review board (IRB), informed consent, protection of subject privacy and confidentiality, and no conflicts of interest. Results : 1. Dentistry journals listed on National Research Foundation of Korea had a conflict of interest disclosure provisions of the contribution(76.9%) and the IRB approval(61.5%). 2. Half of the dental health journals were not listed on National Research Foundation of Korea Society but they agreed the advance posting provisions. 3. Dental hygiene journals provide 100% of ethics alone and receive 75% of IRB in the papers. 4. Dental health and dental hygiene journals have conflicts of interest disclosure regulations(59.2%) and IRB approval(51.8%). 5. There existed statistically significant differences between the dental health journals whether they were listed on the human subjects and ethical standards for protection in National Research Foundation of Korea or not. Conclusions : While the publication guidelines of dental health journals have followed to a greater extent in recent years, there is still a need for further instructions to ensure that the authors satisfy all ethical requirements in conducting research on human subjects. IRB approval for dental journals must be standardized and reinforced reflecting the characteristics of each journals. The researchers should obey the code of ethics suitable for education and the editors must review the paper continuously.