• Title/Summary/Keyword: Notification system

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

  • Maeng, Chi Hoon;Lee, Sun Ju;Cho, Sung Ran;Kim, Jin Seok;Rha, Sun Young;Kim, Yong Jin;Chung, Jong Woo;Kim, Seung Min
    • The Journal of KAIRB
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    • v.2 no.2
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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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A Study on Rationalization of National Forest Management in Korea (국유림경영(國有林經營)의 합리화(合理化)에 관(關)한 연구(硏究))

  • Choi, Kyu-Ryun
    • Journal of Korean Society of Forest Science
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    • v.20 no.1
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    • pp.1-44
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    • 1973
  • Needless to say, the management of national forest in all countries is very important in view of the national mission and management purposes. Korean national forest is also in particular significant in promoting national economy for the continuous increasing of the demand for wood, conservation of the land and social welfare. But there's no denying the fact that the leading aim of the Korean forest policy has been based upon the conservation of forest resources and recovery of land conservation function instead of improvement of the forest productive capacity. Therefore, the management of national forest should be aimed as an industry in the chain of the Korean national economy. And the increment of the forest productive capacity based on rationalized forest management is also urgently needed. Not only the increment of the timber production but also the establishment of the good forest in quality and quantity are to bring naturally many functions of conservation and other public benefits. In 1908 Korean national forest was historically established for the first time as a result of the notification for ownership, and was divided into two kinds in 1911-1924, such as indisposable national forest for land conservation, forest management, scientific research and public welfare, and the other national forest to be disposed. Indisposable forest is mostly under the jurisdiction of national forest stations (Chungbu, Tongbu, Nambu), and the tother national forests are under custody of respective cities and provinces, and under custody of the other government authorities. As of the end of 1971, national forest land is 19.5% (1,297,708 ha) of the total forest land area, but growing stock is 50.1% ($35,406,079m^3$) of the total forest growing stock, and timber production of national forest is 23.6% ($205,959m^3$) of the year production of total timber in Korea. Accordingly, it is the important fact that national forest occupies the major part of Korean forestry. The author positively affirms that success or failure of the management of national forest controls rise or fall of forestry in Korea. All functions of forest are very important, but among others the function of timber production is most important especially in Korea, that unavoidably imports a large quantity of foreign wood every year (in 1971 import of foreign wood-$3,756,000m^3$, 160,995,000 dollars). So, Korea urgently needs the improvement of forest productive capacity in national forest. But it is difficult that wood production meets the rapid increase of demand for wood to the development of economy, because production term of forestry is long, so national forest management should be rationalized by the effective investment and development of forestry techniques in the long view. Although Korean national forest business has many difficulties in the budget, techniques and the lack of labour due to outflow of rural village labour by development of national economy, and the increase of labour wages and administrative expenses etc. the development of national forest depends on adoption of the suitable forest techniques and management adapted for social and economical development. In this view point the writer has investigated and analyzed the status of the management of national forest in Korea to examine the irrational problems and suggest an improvement plan. The national forestry statistics cited in this study is based on the basic statistics and the statistics of the forest business as of the end of 1971 published by Office of Forestry, Republic of Korea, and the other depended on the data presented by the national forest stations. The writer wants to propose as follows (seemed to be helpful in improvement of Korean national forest management). 1) In the organization of national forest management, more national forest stations should be established to manage intensively, and the staff of working plan officials should be strengthened because of the importance of working plan. 2) By increasing the staff of protection officials, forest area assigned for each protection official should be decreased to 1,000-2,000 ha. 3) The frequent personnel changes of supervisor of national forest station(the responsible person on-the-spot) obstructs to accomplish the consistent management plan. 4) In the working plan drafting for national forest, basic investigations should be carefully practiced with sufficient expenditure and staff not to draft unreal working plan. 5) The area of working-unit should be decreased to less than 2,000 ha on the average for intensive management and the principle of a working-unit in a forest station should be realized as soon as possible. 6) Reforestation on open land should be completed in a short time with a debt of the special fund(a long term loan), and the land on which growing hardwood stands should be changed with conifers to increase productivity per unit area, and at the same time techical utilization method of hardwood should be developed. 7) Expenses of reforestation should be saved by mechanization and use of chemicals for reforestation and tree nursery operation providing against the lack of labour in future. 8) In forest protection, forest fire damage is enormous in comparison with foreign countries, accordingly prevention system and equipment should be improved, and also the minimum necessary budget should be counted up for establishment and manintenance of fire-lines. 9) Manufacture production should be enlarged to systematize protection, processing and circulation of forest business, and, by doing this, mich benefit is naturally given for rural people. 10) Establishment and arrangement of forest road networks and erosion control work are indispensable for the future development of national forest itself and local development. Therefore, these works should be promoted by the responsibility of general accounting instead of special accounting. 11) Mechanization of forest works should be realized for exploiting hinterlands to meet the demand for timber increased and for solving lack of labour, consequently it should promote import of forest machines, home production, training for operaters and careful adminitration. 12) Situation of labour in future will grow worse. Therefore, the countermeasure to maintain forest labourers and pay attention to public welfare facilities and works should be considered. 13) Although the condition of income and expenditure grows worse because of economical change, the regular expenditure should be fixed. So part of the surplus fund, as of the end of 1971, should be established for the fund, and used for enlarging reforestation and forest road networks(preceding investment in national forest).

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