• 대한기관윤리심의기구협의회지
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• 제5권1호
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• pp.1-13
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• 2023

In the United States (US), due to the Common Rule, completely revised in 2017, single Institutional Review Board (IRB) review has become mandatory for government-sponsored multi-institutional research since 2020 regardless of the number of participating institutions. The goal of these changes is to reduce redundant reviews by the IRB at each institution and better protect research participants. In this paper, single IRB and Human Research Protection Program (HRPP) in the US and Korea were compared and considered, and their implications were discussed. A comparison of the HRPP evaluation and certification systems of the US and Korea includes that of SMART IRB in the US and Korea Central IRB, aiming at single IRB review for efficient review with support from the country and building a more efficient national human subject research network in the future. Its comparison and analysis will be helpful in deriving future tasks and development directions of single IRB and HRPP in Korea.

• 대한기관윤리심의기구협의회지
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• 제6권1호
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• pp.1-4
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• 2024

The strengthening of Institutional Review Board (IRB) and Human Research Protection Program (HRPP) for clinical research on advanced regenerative medicine reflecting the 3 Principles of the Belmont Report (Respect, Beneficence, Justice) is very important. The research institution IRB should naturally be in charge of managing the clinical research process. And it is crucial to reinforce HRPP for the protection of research subjects in institutions conducting advanced regeneration clinical research. So, it is needed to establish a Protection System for Advanced Regenerative Medical Research Subjects composed of clinical research management communication system for advanced regenerative medicine between KAIRB (Korean Association of IRB) of research institutes and National Management Agency for Advanced Regenerative Medical Research. In advanced regenerative medicine clinical research to verify safety and efficacy of the investigational drugs to the subjects with rare and incurable diseases rather than to treat the patients, it is hoped that a management system that guarantees the scientific characteristics of research and the rights of research subjects would be well organized and operated.

• 대한기관윤리심의기구협의회지
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• 제4권1호
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• pp.5-15
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• 2022

To suggest future directions for the improvement in the Institutional Review Board (IRB) review process and efficient operation of IRB, we have analyzed the IRB review results from 460 new research proposals submitted to the Review by the Convened IRB of the Keimyung University Dongsan Hospital IRB from January 2019 to July 2021. IRB is an independently established institutional committee to protect the human subjects by reviewing the research protocol in ethical as well as scientific aspects, so it is necessary to continuously contemplate the ethical versus scientific dilemma of 'what is ethical or scientific and what can actually protect human subjects.' Particularly, in this process, it is necessary to consider diverse ways to strengthen self-supervision through continuous Internal Audit rather than simple reporting outcomes. In addition, if it does not directly affect the protection of the human subjects, the discussion with the committee members is needed so that the comments such as administrative and typographical errors can be reduced as much as possible. Furthermore, as statistical analysis methods can have a significant impact on the safety of human subjects, if a legal basis and/or support related to statistics is provided for the composition of IRB members, a more specialized IRB review will be achieved.

• 헤리티지:역사와 과학
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• 제37권
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• pp.405-444
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• 2004

이 논문은 문화재청의 자문기구로서 문화재위원회에 대한 위원들의 인지도(참여효과, 정책효과, 운영상의 문제점 등)를 측정하기 위하여 116명의 전현직 위원(전직 42명, 현직 74 명)이 제공한 설문조사 결과를 실증적으로 분석한 것이다. 조사결과에 의하면, 문화재위원회가 태도효과가 비교적 높을 뿐만 아니라, 정책효과에 있어서도 상당히 영향력을 행사하는 것으로 나타났으며, 전문 지식의 제공처로서 공정성, 대표성, 합리성을 기하는 민주적 기구임을 자임하고 위원들의 자질을 높이 샀다. 그러나, 위원들은 위원 선정 및 절차의 혁신과 심의안건 검토시간 및 의견교환의 부족 그리고 집행결과의 환류(평가, 보고)가 미흡함을 강하게 지적하고, 단순 반복적인 민원성 안건의 상정에도 상당한 불만을 나타냈다. 아울러, 문화재위원회가 의사결정 수준의 "심의가구"가 아닌 정책결정 수준의 "의결기구"로서 그 법적지위가 강화되기를 희망했으며, 심의단계는 전문위원회를 거쳐 문화재위원회(분과위원회)로 종료하는 2심제의 선호와 함께 회의록 작성에는 전적으로 동의하나 공개는 불필요하다는 응답이 압도적이었다. 이와같은 문제상황은 행정관료의 책임이 보다 크겠지만, 적어도 위원과 행정관료의 엇갈린 기대의 상호작용에서 비롯된 면도 있다는 점에서 위원과 행정관료를 위한 높은 윤리규정과 위원 선정 절차의 공정성, 투명성이 확보될 때에 기타 논리적으로 가능한 제도 및 운영상의 실천방안이 현실성을 지니게 될 것이다. 그리고 보다 구체적인 실천방안으로는 우선 1회에 심의안건을 종료하는 관례를 버리고 소위원회 또는 전문위원회를 통한 폭증하는 안건처리의 효율성을 기하는 동시에 안건의 내용이나 중요성에 비추어 필요한 경우 지속적인 회의운영을 제도화하고, 공무원들에 의한 일방적 자료제출을 통제하고 통보한 회의자료 및 검토시간 확보를 위한 지원체계를 확립하는 한편 위원들의 무책임한 발언이나 이권확보를 위한 발언 등 대외적 책임을 결여한 행태를 방지하기 위하여 원칙적으로 회의내용과 의견내용을 대외적으로 공개해야 한다는 점을 제시할 수 있겠다.

• 문화기술의 융합
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• 제5권2호
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• pp.321-327
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• 2019

본 연구는 우리나라 게임물 등급 제도의 변천을 알아보고, IARC 게임물 등급 심의 시대에 맞아 문제점과 개선방안을 모색하는 데 목적이 있다. IARC는 국제등급분류연합으로, 전세계 6개 기구 37개국이 가입되어 있다. 또한, IARC는 참여 스토어 프론트에게 게임 등급 심의의 자율권을 부여하고 있다. 우리나라의 게임물 심의 방법은 등급분류제도에 의한 직접 심의와 IARC 자체등급분류제도에 의한 위임 심의로 진행되고 있다. 게임물 등급 제도의 문제점으로 민간이 주체가 된다는 점과 설문지에 의존한다는 점, 자체등급분류제도에 의한 부작용을 들 수 있다. 게임물 등급 제도 개선 방안으로 IARC 가이드라인을 구축하는 것, 게임 개발자에 대한 페널티 및 등급 심의에 대한 교육, 참여 프론트 스토어 관리를 제안할 수 있다. 결론적으로, 오픈마켓에게 등급 심의 권한을 위임하는 것은 위험할 수 있어, 정부와 업계, 게임 개발자, 이용자, 미성년 게이머의 부모들을 포함한 등급 심의 토론의 장을 구성하여, IARC 기준을 활용하여 우리나라의 현실에 맞는 게임물 등급 제도를 만들어나가야 할 것이다.

• 한국언론정보학보
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• 제58권
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• pp.106-129
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• 2012

이 글은 SNS의 보편적 이용이 늘어나고 그것에 대한 규제논의가 증가하는 것을 배경으로 해서, SNS 표현물에 대한 현행 국내 규제체계의 문제점을 분석하고자 한다. 이를 위해 규제대상으로서 SNS표현물의 성격을 살펴보고, SNS 표현물에 대한 국내 내용규제체계의 문제점을 법률적 측면과 규제기관적 차원에서 검토했다. SNS 표현물에 대한 규제체계를 살펴보면, 법률과 행정기구 중심의 국가주의적 규제경향이 강하다는 것을 알 수 있다. 5가지 측면의 규제법률이 SNS 표현물 규제와 연계되어 있으며, 규제의 주체로서 행정기구가 내용심의를 하고 있음을 알 수 있었다. 그로 인해 민간영역의 자율기능은 상대적 약한 것으로 판단된다. SNS와 같은 인터넷공간에는 최소규제의 원칙이 적용되어야 하며, 규제에 적용되는 불법의 정의도 명확히 하고 그것의 판단주체 및 규제대상을 최소화해야 한다. 현재의 행정기구로서 방송통신심의 위원회 구조에 대한 본질적인 고민이 필요하다.

• 대한기관윤리심의기구협의회지
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• 제5권2호
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• pp.43-50
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• 2023

Purpose: Due to the stringency of regulations related to clinical research, researchers face various requirements in the Institutional Review Board (IRB) review process. Specifically, they encounter time constraints and administrative burdens. In order to cultivate a more favorable review culture and establish a robust research environment, it is necessary to analyze researchers' perceptions of the IRB review. Therefore, this study aims to assess researchers' overall experiences with the IRB and identify researchers' educational needs and demands for research-related policies. Methods: A semistructured questionnaire with 34 items was developed and refined in consultation with advisors from IRB and Human Research Protection Program (HRPP). The questionnaire was distributed via an online survey to researchers with experience in IRB review. The survey covered general characteristics, satisfaction with the IRB review process (rated on a 10-point scale), experiences with IRB review, HRPP policy demands. Results: The study's descriptive statistics revealed a moderate satisfaction level (average rating, 6.75 out of 10) with the IRB review. Researchers from clinical medicine and other disciplines showed similar satisfaction scores of 6.65 and 6.87, respectively. However, respondents with over 5 years of research experience expressed higher satisfaction (mean score, 7.03) compared to those with less experience (mean score, 6.57). Institutional support was emphasized for improving the IRB review process. Certain training topics generated higher demands for addressing frequently raised IRB issues among minor discipline researchers compared to clinical medicine (p=0.017). Conclusion: We conducted an analysis of researchers' perceptions regarding the IRB as well as their demands concerning educational and HRPP policies. It is imperative to address the pinpointed areas for enhancement and integrate a range of perspectives in order to effectively cultivate a robust research ethics culture and ensure comprehensive participant protection.

• 국방과기술
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• 1호통권167호
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• pp.20-21
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• 1993

기술개발, 경제, 전력 융합재 생산구조로서 방위산업의 구조개선 및 위상재정립을 국민적 합의로 도출하기 위한 근본적 대책으로는, 세기적 변혁에 대응할수 있는 가치창출 비전과 정책수립을 대통령 주재하에 심의 할수 있는 범국가적 기구인 "기술.경제.안보위원회"의 창설, 운영방안을 모색하고자 합니다 동시에 현재 방위산업의 구조적 문제점인 경영상태 악화, 수출지원제도상의 문제, 정부조달제도의 문제, 전문계열화 문제, 기술개발부진 등을 해결해야 합니다

• 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.

• 대한기관윤리심의기구협의회지
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• 제3권1호
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• pp.1-10
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• 2021

In 2004, India began investing in the clinical trial industry; the country now boasts a 20% market share with the help of a valuable resource - the world's second largest population. The Contract Research Organization has been able to generate profits efficiently conducting clinical trials via a large pool of participants, skilled researchers, and reduced developmental costs. As the demand and sheer number of global clinical trials increased, the International Council of Harmonization-Good Clinical Practice was introduced, and the need for the Institutional Review Board increased. While the clinical trial industry in India boomed, it came at the expense of the participants' civil rights. The increased media attention regarding the ethical issues forced the Indian Supreme Court to take action. Consequently, India is the only country, by law, that specifically compensates participants suffering from injury directly resulting from participation in clinical trials. This research paper will describe and compare the relevant laws of India and Korea including compensation criteria. In addition, the ethical issues and aspects of indemnity in clinical trials will be discussed. While the clear advantage of the compensation is one of the protected rights of a clinical subject, the current system is not perfect. Furthermore, laws created to redeem ethical issues can have unintended, negative consequences.