• 제목/요약/키워드: Human research protection program

검색결과 44건 처리시간 0.036초

WIPO의 전통지식 등의 지재권 설정 논의에 관한 개략적 방안 모색 (Grope for a summary program about intellectual property protection of traditional knowledge(TK) etc. discussed in WIPO)

  • 이제현;김용진;최환수
    • 혜화의학회지
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    • 제12권2호
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    • pp.227-234
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    • 2004
  • The international government committee is progressing their agreements about intellectual property protection of traditional knowledge(TK), gene resource(GR), folklore(FL) in WIPO. It is in the course of selection with precedence of TK, GR, FL in WIPO, focused on discussions about listing of TK documents, standardization of DB construction, sharing and profit distribution of GR. There are disagreements between developed countries and developing countries about intellectual property protection agreements of TK, GR. The developed countries insist on using the existing intellectual property protection, but the developing countries ask new ones on character of TK, GR. It causes intangible assets to be valuable trade properties in future world trade. This research Groped for a summary program about intellectual property protection of traditional knowledge(TK) etc. debating in WIPO. This program confirms that such as TK, GR etc. not only to be the cultural property accumulated in human history, but also to be the original resource may be using at present. Therefore, we suggest that the focus of discussion should transfer to UNESCO instead of WIPO which only deal with the intellectual property protection. Besides, the main body which protecting and supporting TK should become its holding organization so as to achieve more effective management about it. In order to protect and support TK, the government should have firstly the recognition that TK is the property belongs to the country. By this viewpoint, it needs to setup DB through overall excavation of the unofficial knowledges in order to protect and support these TK, GR. Because the positive dealing with those WIPO's discussion means to support our TK, GR, so there should have some reorganization about existing related ones, and also needs systemic supporting policies & management' system.

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Inhibition of melanogenesis by tyrosinase siRNA in human melanocytes

  • An, Sang-Mi;Koh, Jae-Sook;Boo, Yong-Chool
    • BMB Reports
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    • 제42권3호
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    • pp.178-183
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    • 2009
  • Tyrosinase (TYR) plays a critical role in cellular melanogenesis and, thus, has been the major target of pharmacological approaches for the control of skin pigmentation. This study examined an alternative molecular approach using TYR-small interfering RNA (siRNA) to control melanogenesis in the human melanocytes. Both the mRNA and protein levels of TYR were significantly lowered by TYR-siRNA treatment, whereas TYR-related protein 1 and TYR-related protein 2 displayed no such changes. TYR-siRNA treatment inhibited the cellular melanin synthesis from the externally supplied TYR substrate L-tyrosine. TYR-siRNA also suppressed melanin synthesis and decreased the viability of cells exposed to ultraviolet radiation, supporting a critical role of melanin in protection against ultraviolet radiation. These results suggest that molecular approaches using siRNA targeted to the enzymes of melanogenic pathway may provide a novel strategy for the control of cell pigmentation.

A Study on the Copyright Survey for Design Protection in Metaverse Period

  • Kim, Gokmi;Jeon, Ju Hyun
    • International journal of advanced smart convergence
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    • 제10권3호
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    • pp.181-186
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    • 2021
  • Among human intellectual creations, the right granted by law to what is worth protecting is defined as intellectual property rights. Copyright is a legal right to creative finished products made by individuals, and in recent years, this legal right has been recognized as very important. In other words, copyright is a system created to protect the rights of individuals who created creations and to recognize their efforts. Works subject to copyright vary from poetry, thesis, novels to designs, paintings, music, and architecture, and the scope of the subject is gradually expanding. Recently, research has begun on how far the Metaverse design area absorbed into the real world among works. Computer-generated video productions and software program works are also subject to digital copyright protection, but it is also true that the interpretation of the author protection law for works, designs, and trademarks in the virtual world is unclear. This study aims to analyze copyrights based on case studies and theoretical backgrounds on copyright protection and to discuss the protection limitations of Metaverse design in the virtual world. In other words, the direction for the protection of Metaverse design is presented through clear distinction and definition of copyright protection in the tertiary virtual world. This study aims to present methods for design copyright protection in the era of Metaverse, respect copyright holders' creative activities, and develop our culture through protection of creations.

국내 Single IRB 현황 및 도입에 대한 설문조사 연구 (A Survey on Current Status and Introduction of Single Institutional Review Board (IRB) in Korea)

  • 박신영;노양희;조수진;심규영;박은영;김진석
    • 대한기관윤리심의기구협의회지
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    • 제2권1호
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    • pp.6-22
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    • 2020
  • Purpose: Clinical studies require institutional review board (IRB) approval based on the ethical principle and regulations. While the number of clinical studies has been increased and diversified, duplicated IRB review for multi-center studies has become a major issue. Therefore, single IRB system has been suggested in revised Common Rule. This study aimed to identify and assess the current status of single IRB in Korea and the anticipated needs of single IRB from researchers and IRB member or administrators. Methods: We developed 14 questions including perceived advantages and disadvantages of single IRB, and anticipated problems. The online survey collected opinions on single IRB from researchers, IRB members and IRB administrators. We also interviewed five IRB administrators who have an experience of single IRB. Results: A total of 80 responses were analyzed in this study. Although efficiencies were suggested for the advantages of single IRB in terms of reducing burden of duplicated review, respondents also perceived that the different review criteria between single IRB and each IRB would be a major hurdle for adopting single IRB system. Therefore, the standardization of standard of procedures (SOP) and the standardization of IRB submission materials should be preceded. According to the small group experiences of single IRB in Korea, we also observed the similar anticipated problems of single IRB. Conclusion: Single IRB system has many advantages for conducting multi-center trial. However, many specialists still have a lot of concerns about introducing a single IRB system in Korea. Therefore, a gradual, step-by-step process for conducting a single IRB system in Korea will be needed. Many studies for improving currently suggested single IRB system and the improvement of awareness about the essential of single IRB system would be needed.

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남극조약 체제의 발전과정과 환경보호위원회의 역할과 전망 (Development of Antarctic Treaty System and Roles and Prospects of the Committee for Environmental Protection)

  • 김지희
    • Ocean and Polar Research
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    • 제40권4호
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    • pp.259-270
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    • 2018
  • The purpose of this study is to provide information to understand the context of the Antarctic Treaty System by looking back on its development process. It also aims to review the roles and activities of the CEP in the System in order to support the improvement of our Antarctic science policy. This study considered the developmental histories of independent conventions for Antarctic conservation and Protocol on Environmental Protection to the Antarctic Treaty under the system. CEP, established in accordance with the Protocol, has expanded its roles in the ATCM under the circumstances of climate change and increasing human activities in the treaty area. I examined CEP's functions, relationships with formal observers, and its activities along with CCRWP. In addition, I have estimated the contribution of the Parties to the CEP based on the documents submitted by the Parties. The leading Parties of the System have strengthened their initiatives to expand contributions to CEP with their output based on national Antarctic Program. However, Korea has not been able to take initiatives in the System even though Korea has invested considerable resources in its Antarctic program. To strengthen Korea's capability to instigate initiatives in the system, I suggest the following approaches: Firstly, Korea should improve its Antarctic science policy based on the newly established CEP five-year work plan; Secondly, Korea should organize a long-standing expert group to focus on Antarctic environmental policy and related scientific information; finally, Korea should intensify its collaboration with other Parties in developing Antarctic environmental priority issues.

어머니의 아동기 애착, 정서, 양육행동과 아동의 문제행동의 경로모형 분석 (Path Model Analysis of the Maternal Childhood Attachment, Emotions, Parenting Behaviors and Children's Behavioral Problems)

  • 곽소현;김순옥
    • 가정과삶의질연구
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    • 제24권6호
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    • pp.95-116
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    • 2006
  • The purpose of this study was to validate a hypothetical path model of maternal childhood attachment, emotions, parenting behaviors, and child behavioral problems. The research was conducted with 240 sets or mothers and their children 70 mother-child teams from seven counseling organizations including the Children's Counseling Clinic, Community Social Welfare Service Center, and Welfare Service Center for the Disabled in Seoul, Incheon, and Pyeongtaek, and 170 elementary school children from Seoul and their mothers. Consequently, a total of 200 mother-child teams were selected for this study. The data in this study were analyzed with SPSS 12.0 program and LISREL 8.3 program. The result of this study is as follows: (1) Examining the path of paternal attachment and the internalizing and externalizing behavioral problems, it was noted that paternal attachment had the indirect effect of anxiety and over-protection on the path to internalizing problems and the indirect effect of anxiety also noted is that there is a full-mediation of anxiety and over-protection between paternal attachment and the internalizing problems. (2) Examining the path of maternal attachment and the internalizing problems, it was noted that maternal attachment has direct effect on the internalizing problems. Maternal attachment has the indirect effect of self-esteem depression, anxiety and over-protection on the Path, and the indirect effect of self-esteem, anxiety and over-protection. (3) Examining the path of maternal attachment and the externalizing problems, it was noted that maternal attachment has direct effect on the externalizing problems and on the path to the externalizing problems, and maternal attachment has the indirect effect of depression, the indirect effect of self-esteem and authoritarian control, and the indirect effect of self-esteem and depression.

임상시험심사위원회(Institutional Review Board)의 임상시험에 대한 위험평가 분류조사연구 (Survey of Institutional Review Board Risk Level Classification of Clinical Trials Among Korean University Hospitals)

  • 이선주;강수진;맹치훈;신유진;유소영
    • 대한기관윤리심의기구협의회지
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    • 제4권2호
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    • pp.36-41
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    • 2022
  • Purpose: The purpose of this study is to evaluate how university hospital Institutional Review Boards (IRBs) in Korea classify risk when reviewing clinical trial protocols. Methods: IRB experts (IRB chairman, vice chairman, IRB administrator) in the university hospitals obtaining a Human research protection program (HRPP) or IRB accreditation in Korea were asked to fill out the Google Survey from September 1, 2020 to October 10, 2020. Result: Among the 23 responder hospitals, 8 were accredited by the American Association for Human Research Protection Program (AAHRPP) and 8 were accredited by the HRPP of Ministry of Food and Drug Safety (MFDS). Seven were accredited by Forum for Ethical Review Committees in Asia and the Western Pacific or Korea National Institution for Bioethics Policy. Thirteen of 23 hospitals (56.5%) had 4 levels (less than minimal, low, moderate, high risk), 4 hospitals had 3 levels (less than, slightly over, over than minimal risk), 1 hospital had 5 levels (4 levels plus required data safety monitoring board), and 1 hospital had 2 levels (less than, over than minimal risk) risk classification system. Thirteen of 23 hospitals (56.5%) had difficulty classifying the risk levels of research protocols. Fourteen hospitals (60.9%) responded that different standards among hospitals for risk level determination associated with clinical trials will affect the subject protection. Six hospitals (26.1%) responded that it will not. Three hospitals (13.0%) responded that it will affect the beginning of the clinical trial. To resolve differences in standards between hospitals, 14 hospitals (60.9%) responded that either the Korean Association of IRB or MFDS needs to provide a guideline for risk level determination in clinical trials: 5 hospitals (21.7%) responded education for IRB members and researchers is needed; 3 hospitals (13.0%) responded that difference among institutions needs to be acknowledged; and 1 hospital (4.3%) responded that there needs to be communication among IRB, investigator, and sponsor. Conclusion: After conducting a nationwide survey on how IRB in university hospital determines risk during review of clinical trials, it is reasonable to use 4-level risk classification (less than minimal, low, moderate, high risk); the most utilized method among hospitals. Moreover, personal information and conflict of interest associated with clinical trials have to be considered when reviewing clinical trial protocols.

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임상시험 및 대상자보호프로그램의 운영과 현황에 대한 설문조사 연구(2019) (Survey of Operation and Status of the Human Research Protection Program (HRPP) in Korea (2019))

  • 맹치훈;이선주;조성란;김진석;라선영;김용진;정종우;김승민
    • 대한기관윤리심의기구협의회지
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    • 제2권2호
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    • pp.37-48
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    • 2020
  • Purpose: The purpose of this study is to assess the operational status and level of understanding among IRB and HRPP staffs at a hospital or a research institute to the HRPP guideline set by the Ministry of Food and Drug Safety (MFDS) and to provide recommendations. Methods: Online survey was distributed among members of Korean Association of IRB (KAIRB) through each IRB office. The result was separated according to topic and descriptive statistics was used for analysis. Result: Survey notification was sent out to 176 institutions and 65 (37.1%) institutions answered the survey by online. Of 65 institutions that answered the survey; 83.1% was hospital, 12.3% was university, 3.1% was medical college, 1.5% was research institution. 23 institutions (25.4%) established independent HRPP offices and 39 institutions (60.0%) did not. 12 institutions (18.5%) had separate IRB and HRPP heads, 21 (32.3%) institutions separated business reporting procedure and person in charge, 12 institutions separated the responsibility of IRB and HRPP among staff, and 45 institutions (69.2%) had audit & non-compliance managers. When asked about the most important basic task for HRPP, 23% answered self-audit. And according to 43.52%, self-audit was also the most by both institutions that operated HRPP and institutions that did not. When basic task performance status was analyzed, on average, the institutions that operated HRPP was 14% higher than institutions that only operated IRB. 9 (13.8%) institutions were evaluated and obtained HRPP accreditation from MFDS and the most common reason for obtaining the accreditation was to be selected as Institution for the education of persons conducting clinical trial (6 institutions). The most common reason for not obtaining HRPP accreditation was because of insufficient staff and limited capacity of the institution (28%). Institutions with and without a plan to be HRPP accredited by MFDS were 20 (37.7%) each. 34 institutions (52.3%) answered HRPP evaluation method and accreditation by MFDS was appropriate while 31 institutions (47.7%) answered otherwise. 36 institutions answered that HRPP evaluation and accreditation by MFDS was credible while 29 institutions (44.5%) answered that HRPP evaluation method and accreditation by MFDS was not credible. Conclusion: 1. MFDS's HRPP accreditation program can facilitate the main objective of HRPP and MFDS's HRPP accreditation program should be encouraged to non-tertiary hospitals by taking small staff size into consideration and issuing accreditation by segregating accreditation. 2. While issuing Institution for the education of persons conducting clinical trial status as a benefit of MFDS's HRPP accreditation program, it can also hinder access to MFDS's HRPP accreditation program. It should also be considered that the non-contact culture during COVID-19 pandemic eliminated time and space limitation for education. 3. For clinical research conducted internally by an institution, internal audit is the most effective and sole method of protecting safety and right of the test subjects and integrity for research in Korea. For this reason, regardless of the size of the institution, an internal audit should be enforced. 4. It is necessary for KAIRB and MFDSto improve HRPP awareness by advocating and educating the concept and necessity of HRPP in clinical research. 5. A new HRPP accreditation system should be setup for all clinical research with human subjects, including Investigational New Drug (IND) application in near future.

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BIDAS프로그램 : 방사성 핵종의 섭취량과 선량 평가용 생물학적분석 자료 해석 소프트웨어 프로그램 (The BIDAS Program : Bioassay Data Analysis Software for Evaluating Radionuclide Intake and Dose)

  • Tae-Yong Lee;Jong-Kyung Kim;Jong-Il Lee;Si-Young Chang
    • 방사성폐기물학회지
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    • 제2권2호
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    • pp.113-124
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    • 2004
  • 본 연구에서는 인체 내에서 방사성핵종의 거동에 관하여 국제방사선방호위원회에서 권고한 최근 호흡기 모델, 소화기 모델 및 생체동역학 모델을 사용하여 생물학적분석 자료로부터 섭취량과 예탁유효선량을 평가하기 위한 BIDAS 프로그램을 개발하였다. 프로그램은 생물학적분석 자료를 관리하는 데이터베이스 모듈, 각 방사성 핵종에 대한 예측 생물학적분석 양을 내장하고 있는 모듈, 측정된 생물학적분석 양에 근거하여 급성 및 만성 피폭으로부터 섭취량과 선량을 평가하는 계산모듈 등으로 구성되어 있다. 본 논문은 프로그램의 특성과 검증결과에 대해 기술한다.

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대전 지역 주민의 건강 향상을 위한 식습관 및 건강상태, 질병 대처 방안에 관한 기초자료와 교육 요구도 조사 (Survey on Food Habits, Health Condition and Precaution for Disease for the Health Improvement of Community People in Taejon)

  • 윤은영;임영희;왕수경;구난숙
    • 한국생활과학회지
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    • 제7권1호
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    • pp.205-216
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    • 1998
  • The objectives of this study were to investigate some problems related to health and to identify citizen's needs related to nutrition education program. The data were analyzed by using $x^2$-test, t-test, ANOVA and multiple range test. The food habits score was 70.0 of 100. The score of man was 69.0, while that of woman was 72.6. Since woman's food habit was better than man, education to man is more needed. Man's BMI was 22.5 and that of woman was 21.4. W/H ratio of man was 0.85 and that of woman was 0.80. BMI and W/H ratio increased as age increases. Systolic blood pressure was 123.5mmHg and diastolic blood pressure was 83.2mmHg. All age groups need the education of blood pressure control. Since subjects who did regular exercise were only 26.3%, these community people needed more regular exercise, specially woman. It turned out that subjects were afraid of cancer, hypertension, cerebral vascular diseases which are related with food habits. The disease or symptom having the highest mobility were dental disease, gastroenteric disorder, headache and constipation. They asked for counselling about health, diet therapy, protection methods of disease and menu planning etc. The program of education for health and good food habits should be developed according to subjects's age, sex, education etc. These results showed primary needs on the curriculum of citizen's education program for enhancing health. In addition, we suggest the research on the practical curriculum of nutrition education program.

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