• The Journal of KAIRB
• /
• v.2 no.1
• /
• pp.23-31
• /
• 2020

Purpose: To obtain opinions from Korean Institutional Review Board (IRB) members' self-evaluation on ability to conduct fairness review of clinical trial protocol with presence of conflict of interest and from investigators and IRB members on financial conflict of interest through surveying. Methods: IRB members and researchers in 9 different hospitals were asked to answer survey questions via email. Results: Responders were 115 personnel (IRB Chair/vice 18, medical member 30, non-medical member 28, and researcher 39) from 9 centers. Compared to IRB medical members, IRB chair/vice respondents scored higher with statistically significance on 10 point scale (8.44±1.381 vs. 7.30±1.685, p=0.005) when asked to self-evaluate fairness reviewing a protocol proposed by an investigator from the same department and a protocol from the company that supports the scientific committee of responders. When reviewing a protocol proposed by a hospital director, non-medical members scored statistically significantly higher than medical-members (7.47±1.76 vs. 8.07±2.70, p=0.034). When asked about the limitation of labor fee for principal investigator on phase 3 Human clinical trials of the Investigational new drug, while the responses range was wide, 60% answered that labor cost of principal investigator should be less than 30% of total budget for clinical trials with a budget of 100 million won. 51.3% answered that there is no need to disclose the labor cost of the principal investigator in the consent form. Since every investigator can be influenced unconsciously by conflict of interest, the answer that 'responder agrees that there is need for management' was the most chosen answer (IRB member 61.8%, investigator 64.1%, multiple answers allowed). Conclusion: Considering scores on questions of fairness by IRB members were between 7.23-8.56 on scale of 0 to 10 point when IRB members were asked about reviewing a clinical trial protocol, it cannot be said with absolute certainty that there is no issue regarding fairness in the review process. Therefore, there should be more ways to safeguard fairness for these issues. There is a need that the disclosure amount of honorarium from sponsor should be lower than 100 million Korean won. Considering the results of the survey in which respondents expressed their thoughts, it is likely that more education on the concept of conflict of interest is needed.

• Korean Journal of Psychosomatic Medicine
• /
• v.31 no.1
• /
• pp.25-32
• /
• 2023

Objectives : This study investigated the level of sexuality knowledge and gender sensitivity and factors influencing on them among Korean high school and college students. Methods : 129 questionnaires from high school and college students with consent forms, collected from July to December of 2022, were analyzed. After identification of participants' gender, age, major, their report of the practicality of sex education, and their experience of violence or sexual assaults, participants' level of sexuality knowledge and gender sensitivity were compared. Results : Females showed higher gender sensitivity, regardless of age and group (p=0.004). The early adulthood group (≥19 years old) showed higher sexuality knowledge and gender sensitivity, compared to those adolescents (<19 years old). Among college students, those who majored in health science were identified with higher sexuality knowledge and gender sensitivity, compared to non-health science major students(p<0.001; p=0.005). Conclusions : This study revealed the significant differences in sexuality knowledge and gender sensitivity according to sex, age, and majors in adolescents and early adults. Therefore, it seems to be necessary to consider the differences in sexuality knowledge and gender sensitivity among age, sex, and majors when establishing public policy or legislation for sex crimes, including digital sex crimes.

• The Korean Society of Law and Medicine
• /
• v.25 no.1
• /
• pp.87-115
• /
• 2024

In Korea, exposure to stress has been accompanied by mental pain in the process of achieving many growth along with rapid development, various social problems, and the frequency of emergency hospitalization is increasing.. In the case of mentally ill patients, "unwanted hospitalization" is a problem, and police and 119 paramedics try to suppress the body of mentally ill patients, and many problems are exposed This is because the constituent requirements of the provisions of emergency hospitalization under the Mental Health and Welfare Act do not reflect reality, and each institution has a different position on one mentally ill person, and emergency hospitalization does not proceed smoothly or leads to friction between related organizations, and the safety of the mentally ill or others is not secured. Emergency hospitalization is defined as "a person who finds a person who is presumed to be mentally ill and is at high risk of harming his or her health or safety or others," and if the situation is so urgent that he or she cannot afford time to go through the hospitalization procedure to decide on his or her own hospitalization, he or she can request emergency hospitalization with the consent of a doctor and a police officer. In this case, 119 paramedics are escorted to a psychiatric institution. This provision of emergency hospitalization poses many problems in the process of transferring to psychiatric institutions. If a police officer or 119 paramedics in charge of practice use "physical force" during the emergency hospitalization process, side effects will inevitably occur, and professional negligence can be a problem. Specifically, when exercising physical force, the minimum necessary physical restraint based on laws and regulations and proportional principles is required, and the lack of the duty of care of 119 paramedics or police officers under the laws and regulations will eventually be resolved by applying other laws and regulations. Accordingly, it will be an opportunity for mentally ill patients to be transferred to psychiatric institutions in a safe environment by changing the subject of emergency hospitalization provisions under the Mental Health Welfare Act, defining and prescribing the use of physical protection guards as the enforcement regulations of the Mental Health Act, setting the duty of care for 119 paramedics and police officers, and creating an environment for transportation so that mentally ill patients can be treated safely.

• Radiation Oncology Journal
• /
• v.19 no.2
• /
• pp.127-135
• /
• 2001

Purpose : This study is a prospective randomized clinical trial comparing the efficacy and complication of anti-emetic drugs for prevention of nausea and vomiting after radiotherapy which has moderate emetogenic potential. The aim of this study was to investigate whether the anti-emetic efficacy of ondansetron $(Zofran^{\circledR})$ 8 mg bid dose (Group O) is better than the efficacy of metoclopramide 5 mg lid dose (Group M) in patients undergoing fractionated radiotherapy to the abdominal region. Materials and Methods : Study entry was restricted to those patients who met the following eligibility criteria: histologically confirmed malignant disease; no distant metastasis; performance status of not more than ECOG grade 2; no previous chemotherapy and radiotherapy. Between March 1997 and February 1998, 60 patients enrolled in this study. All patients signed a written statement of informed consent prior to enrollment. Blinding was maintained by dosing identical number of tablets including one dose of matching placebo for Group O. The extent of nausea, appetite loss, and the number of emetic episodes were recorded everyday using diary card. The mean score of nausea, appetite loss and the mean number of emetic episodes were obtained in a weekly interval. Results : Prescription error occurred in one patient. And diary cards have not returned in 3 patients due to premature refusal of treatment. Card from one patient was excluded from the analysis because she had a history of treatment for neurosis. As a result, the analysis consisted of 55 patients. Patient characteristics and radiotherapy characteristics were similar except mean age was $52.9{\pm}11.2$ in group M, $46.5{\pm}9.5$ in group O. The difference of age was statistically significant. The mean score of nausea, appetite loss and emetic episodes in a weekly interval was higher in group M than O. In group M, the symptoms were most significant at 5th week. In a panel data analysis using mixed procedure, treatment group was only significant factor detecting the difference of weekly score for all three symptoms. Ondansetron $(Zofran^{\circledR})$ 8 mg bid dose and metoclopramide 5 mg lid dose were well tolerated without significant side effects. There were no clinically important changes In vital signs or clinical laboratory parameters with either drug. Conclusion : Concerning the fact that patients with younger age have higher emetogenic potential, there are possibilities that age difference between two treatment groups lowered the statistical power of analysis. There were significant difference favoring ondansetron group with respect to the severity of nausea, vomiting and loss of appetite. We concluded that ondansetron is more effective anti-emetic agents in the control of radiotherapy-induced nausea, vomiting, loss of appetite without significant toxicity, compared with commonly used drug, i.e., metoclopramide. However, there were patients suffering emesis despite the administration of ondansetron. The possible strategies to improve the prevention and the treatment of radiotherapy-induced emesis must be further studied.

• Applied Biological Chemistry
• /
• v.21 no.2
• /
• pp.84-102
• /
• 1978

Barley embryoless half seeds were incubated in medium containing $10{\mu}M$ GA. Time course activity changes of ${\alpha}-amylase$ were studied in extract and medium seperately by the addition of $0.1{\mu}M,\;5{\mu}M,\;and\;10{\mu}M$ ABA in midcourse incubation of 10 hours after GA treatment. MAK profiles of nucleic acids in embryoless half seeds were compared either with $10{\mu}M$ GA treatment or concomitant treatment with $10{\mu}M$ GA and $10{\mu}M$ ABA after 10 hours incubation, Time course changes of weight increase, chlorophyll, protein and RNA consent in addition to RNase activity were studied in the presence of $10{\mu}M$ GA or $10{\mu}M$ ABA in barley coleoptile sections. After 20 hours incubation in the presence of plant hormones, MAK profiles of nucleic acids and reactive distribution of polysome and monosome were investigated. The above results were summarized as follows. 1) The production of ${\alpha}-amylase$ by treatment with GA alone increased at a linear rate in the incubation period and the active secretion of ${\alpha}-amylase$ began from 18 hours incubation in embryoless half seeds. 2) On the contrary to the partial inhibition by addition of $0.1{\mu}M$ ABA, the production of ${\alpha}-amylase$ was completely inhibited by both $5{\mu}M$ and $10{\mu}M$ ABA within 4 hours. Regardless of concentration of GA, the addition of $5{\mu}M$ ABA in midcourse completely inhibited the production of ${\alpha}-amylase$ 3) ABA treatment gave no effect on the secretion of ${\alpha}-amylase$. 4) There were no differences in RNA fractions between GA treatment and concomitant treatment with GA and ABA in the barlye embryoless half seeds. 5) While GA treatment increased the r-RNA fraction, ABA treatment decreased it and increased the s-RNA fraction in the coleoptile sections. 6) GA treatment increased RNA-DNA fraction best ABA treatment decreased it in the coleoptile sections. 7) While GA treatment suppressed RNase activity, ABA treatment increased it in the coleoptile sections. 8) GA treatment gave no great effect on the total RNA but ABA treatment remarkably diminished it in the coleoptile sections. 9) While GA treatment increased the growth and chlorophyll content, ABA treatment decreased them in the coleoptile sections. 10) GA treatment increased the protein synthesis and polysome formation but ABA treatment decreased them in the coleoptile sections. 11) The inhibition effect of ABA on polysome formation seemed to be resulted from the inhibition of r-RNA synthesis by ABA.

• Pediatric Infection and Vaccine
• /
• v.10 no.1
• /
• pp.71-80
• /
• 2003

Purpose : Four kinds of Haemophilus influenzae type b protein conjugate vaccines, PRPD, PRP-T, PRP-OMP and PRP-CRM197, have been developed, and PRP-T vaccines are currently produced by two manufacturer, $ActHib^{(R)}$ by Aventis and $Hiberix^{TM}$ by GlaxoSmith-Kline Biologicals. The purpose of this study is to evaluate the immunogenicity and safety of $Hiberix^{TM}$ in Korean infants. Methods : Seventy-three healthy infants(43 male infants) were recruited for this study after parental informed consent was obtained. Each infant was vaccinated at 2, 4 and 6 months of age with the study vaccine. At each visit, infants were also immunized with DTaP, trivalent oral polio vaccine and hepatitis B vaccine when indicated. The serum anti-PRP antibody was measured at prevaccination, 2 month later after the 2nd dose, and 1 month later after the 3rd dose by the ELISA method. The local and systemic adverse reactions of vaccination were monitored for 3 consecutive days after each immunization. Immunogenicity of vaccine was evaluated in infants who received all the scheduled immunization and the adverse reactions were evaluated for infants who received at least one dose of the study vaccine. Results : Among seventy three infants, enrolled in this study; sixty three(37 male infants) completed all the scheduled immunizations. The geometric mean titer(GMT) of anti-PRP antibodies at prevaccination was 0.17 ${\mu}g/mL$(95% confidence interval[CI]; 0.13~0.22). The GMT of anti-PRP antibodies increased to 4.14 ${\mu}g/mL$(95% CI; 2.65~6.48) at 2 month later after the 2nd dose of PRP-T and 14.65 ${\mu}g/mL$(95% CI; 10.83~19.81) at 1 month later after the 3rd dose. Anti-PRP antibody ${\geq}0.15$ ${\mu}g/mL$, was observed in 98.4%(95% CI; 91.8~100) after 2 doses and 100%(95% CI; 100~100) after 3 doses. Anti-PRP antibody ${\geq}1.0$ ${\mu}g/mL$, was obtained in 77.8%(95% CI; 67.5~88.0) after 2 doses, and 98.4%(95% CI; 95.3~100) after 3 doses. Most of the adverse reaction after vaccination were mild. Irritability, the most common systemic reaction, was observed in 45.5%, followed by drowsiness(30.5%), poor feeding(26.7%) and fever(5.6%). Among the local reactions tenderness was observed in 7.9%, redness(${\geq}5$ mm) in 2.8% and swelling(${\geq}5$ mm) in 1.8%. Conclusion : The PRP-T vaccine used in this study was highly immunogenic and safe in Korean young infants. The finding that high GMT and high frequency of infants with a protective titer achieved after 2 doses is consistent with the previous studies which were done with a PRP-T vaccine of other manufacturer. This study suggests that the immunization schedule of PRP-T vaccine for Korean infants may need re-evaluation.

• Pediatric Infection and Vaccine
• /
• v.13 no.2
• /
• pp.163-173
• /
• 2006

Purpose : To reduce the number of injections necessary to vaccinate young infants, various combined vaccines have been developed. The $Comvax^{TM}$ manufactured by Merck & Co. is a combination of Hepatitis B and PRP-OMP conjugate Haemophilus influenzae Type b vaccine. The purpose of this study is to evaluate the immunogenicity and safety of $Comvax^{TM}$ in Korean infants. Methods : The infants who were vaccinated at 0 months of age with Hepatitis B vaccine, were recruited for this study after parental informed consent was obtained. The subjects were vaccinated with $Comvax^{TM}$ at 2 and 4 months of age. At each visit, infants were also immunized with DTaP, inactivated poliovirus vaccine, and pneumococcal vaccine when indicated. The serum anti-PRP and anti-HBs were measured at 2 months after the 1st dose(4 months age), and the 2nd dose(6 months age) by the ELISA and chemiluminescent microparticle immunoassay method, respectively. The local and systemic adverse reactions of vaccination were monitored for 3 consecutive days after each immunization. Results : Among sixty-five healthy infants(35 male infants) enrolled in this study; fifty eight(32 male infants) completed the scheduled immunizations. The geometric mean titers (GMTs) of anti-PRP at 2 months after the 1st dose and the 2nd dose were 1.96 ${\mu}g/mL$ (95% CI; 1.38~2.78) and 10.02 ${\mu}g/mL$ (95% CI; 7.04~14.26), respectively. Anti-PRP ${\geq}1.0$ ${\mu}g/mL$, was obtained in 63.2%(95% CI; 53.75~72.65) after 1 dose, and 96.6%(95% CI; 93.05~100) after 2 doses. The GMTs of anti-HBs were 38.32 mIU/mL(95% CI; 22.42~65.51), and 101.17 mIU/mL(95% CI; 65.94~155.25) at 2 month after the 1st dose and 2nd dose of $Comvax^{TM}$, respectively. Anti-HBs ${\geq}10$ mIU/mL was observed in 73.7%(95% CI; 65.07~82.33) after 1 dose and 94.8%(95% CI; 90.45~99.15) after 2 doses. Most of the adverse reactions after vaccination were mild. Irritability, the most common systemic reaction, was observed in 24.8%, followed by drowsiness(19.2%), poor feeding(19.2%) and fever(7.2%). Among the local reactions tenderness was observed in 25.6%, redness(${\geq}5$ mm) in 19.2% and swelling(${\geq}5$ mm) in 4.8%. Conclusion : The $Comvax^{TM}$ vaccine was highly immunogenic for PRP and safe in Korean infants. Although the hepatitis B vaccine component was administered at 0, 2, 4 months, this study showed good immunogenicity against HBsAg.

• Radiation Oncology Journal
• /
• v.26 no.2
• /
• pp.104-112
• /
• 2008

Purpose: To assess the toxicity and tumor response induced by $DCVac/IR^{(R)}$ dendritic cell(DC) immunotherapy combined with irradiation for refractory colorectal cancer patients with multiple liver metastases. Materials and Methods: Between May 2004 and November 2006, applicants from a pool of refractory colorectal cancer patients with multiple liver metastases were enrolled. The patients were registered after having signed the informed consent form, which had been approved by the Institutional Review Board from the Dong-A University and Busan National University Hospital. DCs were obtained from peripheral blood of each patient, and then cultured in vitro. A total of $6{\times}10^6$ DCs were packed into a vial($DCVac/IR^{(R)}$, 0.5 ml) at the convenience of each patient's schedule. On the day before and on the day of each vaccination, each patient received a 4 Gy radiation dose to the target tumor. On the day of vaccination, the indicated dose of autologous DCs was injected into the irradiated tumor using ultrasound-guided needle injection procedures. A total of four vaccinations were scheduled at three 2-week intervals and one 4 week interval at the Dong-A University and Busan National University Hospital. If the tumor status was deemed to be stable or responding to therapy, an additional vaccination dose or two was approved at 4 week intervals beyond the fourth immunization. A tolerance test for DCs was conducted by injecting a range of doses($3{\times}10^6\;to\;12{\times}10^6$ DCs) after the 3rd injection. Moreover, the maximal tolerable dose was applied to additional patients. Treatment safety was evaluated in all patients who had at least one injection. Treatment feasibility was evaluated by the 10th week by assessing the response of patients having at least 4 injections. For systemic toxicities, the evaluation was performed using the National Cancer Institute Common Toxicity Criteria, whereas adverse effects were recorded using common WHO toxicity criteria. Results: Of the 24 registered patients, 22 received the DCs injections. Moreover, of the 14 patients that applied for the tolerance test, only 11 patients completed it because 3 patients withdrew their testing agreement. A grade 3 or more side effect, which was possibly related to the DC injection, did not occur in additional patients. The $12{\times}10^6$ DC injection was identified as the maximum tolerable dose, and was then injected in an additional 8 patients. Patients tolerated the injection fairly well, with no fatal side effects. In order to assess the feasibility of DC immunotherapy, the response was evaluated in other hepatic lesions outside of the targeted hepatic lesion. The response evaluation was performed in 15 of the 17 patients who received at least 4 injections. Stable and progressive disease was found in 4 and 11 patients, respectively. Conclusion: The DC-based immunotherapy and radiotherapy is theoretically synergistic for the local control and systemic control. The $DCVac/IR^{(R)}$ immunotherapy combined with irradiation was tolerable and safe in the evaluated cases of refractory colorectal cancer with multiple liver metastases. Future work should include well designed a phase II clinical trials.

• The Korean Journal of Air & Space Law and Policy
• /
• v.30 no.2
• /
• pp.427-468
• /
• 2015

To date, we have considered the theoretical views, the standpoint of states and the discourse within the international community such as the UN Committee on the Peaceful Uses of Outer Space(COPUOS) regarding the Air/Outer Space Boundary Question which is one of the first issues of UN COPUOS established in line with marking the starting point of Outer Space Area. As above mentioned, discussions in the United Nations and among scholars of within each state regarding the delimitation issue often saw a division between those in favor of a functional approach (the functionalists) and those seeking the delineation of a boundary (the spatialists). The spatialists emphasize that the boundary between air and outer space should be delimited because the status of outer space is a type of public domain from which sovereign jurisdiction is excluded, as stated in Article 2 of Outer Space Treaty. On the contrary art. I of Chicago Convention is evidence of the acknowledgement of sovereignty over airspace existing as an international customary law, has the binding force of which exists independently of the Convention. The functionalists, backed initially by the major space powers, which viewed any boundary demarcation as possibly restricting their access to space, whether for peaceful or non-military purposes, considered it insufficient or inadequate to delimit a boundary of outer space without obvious scientific and technological evidences. Last more than 50 years there were large development in the exploration and use of outer space. But a large number states including those taking the view of a functionalist have taken on a negative attitude. As the element of location is a decisive factor for the choice of the legal regime to be applied, a purely functional approach to the regulation of activities in the space above the Earth does not offer a solution. It seems therefore to welcome the arrival of clear evidence of a growing recognition of and national practices concerning a spatial approach to the problem is gaining support both by a large number of States as well as by publicists. The search for a solution to the problem of demarcating the two different legal regimes governing the space above Earth has undoubtedly been facilitated and a number of countries including Russia have already advocated the acceptance of the lowest perigee boundary of outer space at a height of 100km. As a matter of fact the lowest perigee where space objects are still able to continue in their orbiting around the earth has already been imposed as a natural criterion for the delimitation of outer space. This delimitation of outer space has also been evidenced by the constant practice of a large number of States and their tacit consent to space activities accomplished so far at this distance and beyond it. Of course there are still numerous opposing views on the delineation of a outer space boundary by space powers like U.S.A., England, France and so on. Therefore, first of all to solve the legal issues faced by the international community in outer space activities like delimitation problem, there needs a positive and peaceful will of international cooperation. From this viewpoint, President John F. Kennedy once described the rationale behind the outer space activities in his famous "Moon speech" given at Rice University in 1962. He called upon Americans and all mankind to strive for peaceful cooperation and coexistence in our future outer space activities. And Kennedy explained, "There is no strife, ${\ldots}$ nor any international conflict in outer space as yet. But its hazards are hostile to us all: Its conquest deserves the best of all mankind, and its opportunity for peaceful cooperation may never come again." This speech seems to even present us in the contemporary era with ample suggestions for further peaceful cooperation in outer space activities including the delimitation of outer space.

• Journal of Intelligence and Information Systems
• /
• v.19 no.3
• /
• pp.57-71
• /
• 2013

Over a billion people in the world generate new news minute by minute. People forecasts some news but most news are from unexpected events such as natural disasters, accidents, crimes. People spend much time to watch a huge amount of news delivered from many media because they want to understand what is happening now, to predict what might happen in the near future, and to share and discuss on the news. People make better daily decisions through watching and obtaining useful information from news they saw. However, it is difficult that people choose news suitable to them and obtain useful information from the news because there are so many news media such as portal sites, broadcasters, and most news articles consist of gossipy news and breaking news. User interest changes over time and many people have no interest in outdated news. From this fact, applying users' recent interest to personalized news service is also required in news service. It means that personalized news service should dynamically manage user profiles. In this paper, a content-based news recommendation system is proposed to provide the personalized news service. For a personalized service, user's personal information is requisitely required. Social network service is used to extract user information for personalization service. The proposed system constructs dynamic user profile based on recent user information of Facebook, which is one of social network services. User information contains personal information, recent articles, and Facebook Page information. Facebook Pages are used for businesses, organizations and brands to share their contents and connect with people. Facebook users can add Facebook Page to specify their interest in the Page. The proposed system uses this Page information to create user profile, and to match user preferences to news topics. However, some Pages are not directly matched to news topic because Page deals with individual objects and do not provide topic information suitable to news. Freebase, which is a large collaborative database of well-known people, places, things, is used to match Page to news topic by using hierarchy information of its objects. By using recent Page information and articles of Facebook users, the proposed systems can own dynamic user profile. The generated user profile is used to measure user preferences on news. To generate news profile, news category predefined by news media is used and keywords of news articles are extracted after analysis of news contents including title, category, and scripts. TF-IDF technique, which reflects how important a word is to a document in a corpus, is used to identify keywords of each news article. For user profile and news profile, same format is used to efficiently measure similarity between user preferences and news. The proposed system calculates all similarity values between user profiles and news profiles. Existing methods of similarity calculation in vector space model do not cover synonym, hypernym and hyponym because they only handle given words in vector space model. The proposed system applies WordNet to similarity calculation to overcome the limitation. Top-N news articles, which have high similarity value for a target user, are recommended to the user. To evaluate the proposed news recommendation system, user profiles are generated using Facebook account with participants consent, and we implement a Web crawler to extract news information from PBS, which is non-profit public broadcasting television network in the United States, and construct news profiles. We compare the performance of the proposed method with that of benchmark algorithms. One is a traditional method based on TF-IDF. Another is 6Sub-Vectors method that divides the points to get keywords into six parts. Experimental results demonstrate that the proposed system provide useful news to users by applying user's social network information and WordNet functions, in terms of prediction error of recommended news.