• The Journal of KAIRB
• /
• v.4 no.2
• /
• pp.30-35
• /
• 2022

The Human Research Protection Program (HRPP) includes all subject protection activities and entities involved in the process of planning, reviewing, and conducting clinical research and it ultimately aims that research can be conducted ethically and scientifically while protecting the rights and welfare of research subjects. At the beginning of its introduction in Korea, it was settled down by adopting the United States HRPP, especially the form of AAHRPP element and regulations. However, regulations and operating forms of HRPP have been changed according to the Korean domestic research environment. Actually, all the Korean institutions are adopted the Korean HRPP guidelines that have been officially announced by the Ministry of Food and Drug Safety in Korea. Recently, Korean domestic laws such as the "Advanced Regenerative Biology Act" or "In Vitro Diagnostic Medical Device Act" have been dramatically innovated and our research environment becomes to be more complicated. Therefore, the development of a suitable Korean HRPP model considering the Korean research environment is strongly demanded. For the early settle down of the Korean HRPP model, the positive incentive method should be applied, when the HRPP is operated and/ or properly operated. These improvements in the Korean HRPP environment will eventually lead to the appropriate protection of subjects who are participating in human clinical research and the quality improvement of clinical research.

• The Journal of KAIRB
• /
• v.3 no.2
• /
• pp.28-36
• /
• 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.

• The Journal of KAIRB
• /
• v.5 no.1
• /
• pp.1-13
• /
• 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.

• The Journal of KAIRB
• /
• v.6 no.1
• /
• pp.1-4
• /
• 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.

• The Journal of KAIRB
• /
• v.5 no.2
• /
• pp.51-58
• /
• 2023

Purpose: To validate the effectiveness of obtaining consent education on errors in the consent process and to develop the education program for researchers. Methods: From February 2019 to February 2022, a 30-minute, 1:1 face-to-face consent education developed using the ADDIE model was conducted on 78 nurses as principal investigators. An informed consent audit tool, which includes 6 items developed by Asan Medical Center Human Research Protection Center, was used to analyze errors in obtaining informed consent process. Data analysis was performed using the SPSS ver. 25.0, and the Mann-Whitney U-test and χ²-test were utilized to verify the difference in errors between the experimental and control groups. Results: The participants consisted of 42 in the experimental group and 36 in the control group, with no statistically significant difference between the 2 groups. Both 2 groups showed the highest frequency of documentation errors, followed by format errors, errors related to a suitability of investigator, participant, or participant's legally acceptable representative, witness and confidentiality issues. After education, there was a significant decrease in both format errors (p=0.002) and documentation errors (p<0.001) in the experimental group. The proportion of participants without any errors in all items was higher in the experimental group (35.7%) compared to the control group (5.6%), and this difference was statistically significant (p=0.001). Conclusion: The obtaining consent education program was found to be effective in reducing informed consent errors. This study emphasizes the importance of education, suggesting the need for its expansion and accessibility, as well as the necessity for all researchers conducting clinical studies to receive the obtaining consent education.

• The Korean Society of Law and Medicine
• /
• v.12 no.1
• /
• pp.99-131
• /
• 2011

To strengthen the protection of human research subjects and human materials, the Korean Ministry of Health and welfare proposed the amendment bill of Bioethics and Safety Law(2010) to the Congress. It includes so many meaningful clauses. According to the bill, the scope that this act shall apply will be expended to the research involving human subjects and human materials. In the bill, there are the principles of this act; the protection of the life, health, and dignity of the human subjects, the obtaining of the adequate informed consent, the protection of the human subject's information confidentiality and the human subject's privacy, the assessment and minimizing of the risks involved and the guarantee of the safety for the human subjects, the preparation of the special protection program for the vulnerable human subjects, and so on. According to the bill, Institutional Bioethics Review Board(the same as Institutional Review Board) will be responsible for the auditing and monitoring on the research that was approved by IBRB, conducting the education program for the researchers, IBRB members and administrative staffs, preparing of the special protection program for the vulnerable human subjects, and forming the guidelines for the researchers as well as the review of the research protocols. And the State and local governments shall take necessary measures to support the expending of the social infrastructure. In addition to, IBRB will have to be assessed and to be gained the accreditation by the Korean Ministry of Health and welfare. So, if Bioethics and Safety Law is amended, it will contribute enormously to enhance the level of the human research subjects protection. Also, if this Law is amended, IBRB will play a major role for the conduct of the ethically, scientifically, and legally proper research. But now, as a matter of fact, the capability of IBRB members and IBRB office members is not enough to charge of this role because some people and some organizations does not know the importance of IBRB exactly. In spite of, IBRB shall be able to this role to protect the human subjects and to develop the level of the research On the international level. Therefore, the State, local governments and the Organization shall back up the administrative and financial terms of the IRB and IRB Office.

• BMB Reports
• /
• v.47 no.10
• /
• pp.575-580
• /
• 2014

In this study, we investigate whether arsenite-induced DNA damage leads to p53-dependent premature senescence using human glioblastoma cells with p53-wild type (U87MG-neo) and p53 deficient (U87MG-E6). A dose dependent relationship between arsenite and reduced cell growth is demonstrated, as well as induced ${\gamma}H2AX$ foci formation in both U87MG-neo and U87MG-E6 cells at low concentrations of arsenite. Senescence was induced by arsenite with senescence-associated ${\beta}$-galactosidase staining. Dimethyl- and trimethyl-lysine 9 of histone H3 (H3DMK9 and H3TMK9) foci formation was accompanied by p21 accumulation only in U87MG-neo but not in U87MG-E6 cells. This suggests that arsenite induces premature senescence as a result of DNA damage with heterochromatin forming through a p53/p21 dependent pathway. p21 and p53 siRNA consistently decreased H3TMK9 foci formation in U87M G-neo but not in U87MG-E6 cells after arsenite treatment. Taken together, arsenite reduces cell growth independently of p53 and induces premature senescence via p53/p21-dependent pathway following DNA damage.

• The Journal of KAIRB
• /
• v.5 no.2
• /
• pp.43-50
• /
• 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.

• 제어로봇시스템학회:학술대회논문집
• /
• 2004.08a
• /
• pp.800-803
• /
• 2004

This paper presents a wavelet-based digital watermarking technique for still images. The digital watermarking considering human visual system (HVS) to increase the robustness and perceptual invisibility of digital watermark. The watermarking embedding is modified discrete wavelet transform (DWT) coefficients of the subbands of the images. The human visual system is number of factors that effect the noise sensitivity of human eyes that is considered to increase the robustness and perceptual invisibility of digital watermark. The watermark detection is blind watermark ( original image is not required ). Experimental results successful against attacks by image processing such as add noise, cropping, filtering, JPEG and JPEG2000 compression.

• Proceedings of the Korea Institute of Fire Science and Engineering Conference
• /
• 2008.11a
• /
• pp.216-222
• /
• 2008

A large number of Computer-based fire growth and Evacuation model have been developed for various purpose and many of these are widely used for research and engineering. And Most of Egress simulation program are ordinary case only related to human behavior But Egress safety Evaluation is very closed to smog movement. It is well known that the Egress simulation program made by Tokyo Fire Department are related to smog movement. So It is the aim of this study to investigate on the Development of Egress Simulation for Evacuation Safety Evaluation of Tokyo Fire Dept. Department in Japan.